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OncoNano Medicine Announces Pre-Clinical Data for Dual-Activating STING agonist at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

ONM-501 shown to be promising immuno-therapeutic candidate for clinical evaluation in solid tumorsSOUTHLAKE, Texas – November 10, 2022 – OncoNano Medicine, Inc. today announced the presentation of data on its pre-clinical candidate ONM-501 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, Massachusetts. ONM-501, OncoNano’s lead therapeutic program in development, is a dual-activating STING (Stimulator of Interferon Genes) agonist advancing towards a first in human trial planned to be initiated in the first half of 2023.

Previously published data has demonstrated the differentiated mechanism of ONM-501 with dual “burst” and “sustained” STING activation, enhanced cytosolic delivery and tumor retention through encapsulation of an endogenous STING agonist - cGAMP with OnocoNano’s proprietary STING-activating OMNI™ polymeric micelles. These two mechanisms operate in concert to activate STING and potentiate this activation, providing potent anti-tumor efficacy as a monotherapy and in combination with anti-PD1 in multiple preclinical mouse models with both “hot” and “cold” tumor microenvironments. In vivo PD analysis confirmed STING activation, enhanced tumor lymphocyte infiltration, and tumor PD-L1 upregulation by ONM-501, and demonstrated the target-engagement activity of ONM-501 in multiple species, and high tolerability in rodents and non-human primates, making it a promising therapeutic candidate for clinical evaluation.

“The results presented here confirm many of our hypotheses regarding the potential of ONM-501 to provide a robust therapeutic index of immune activating STING activity that may be differentiated from other STING agonists. This is why we are so buoyed by the continued positive preclinical results for ONM-501, underscoring its potential as a monotherapy and in combination with anti-PD1 in multiple‘hot’ and ‘cold’ murine syngeneic tumor models,” said Kartik Krishnan, MD, PhD, Chief Medical Officer at OncoNano. “We look forward to bringing ONM-501 to the clinic in 2023 as we continue on our mission to deliver critical new treatments to patients in need.”

Presentation Overview

Title: ONM-501, a Polyvalent STING Agonist, Exhibits Anti-Tumor Efficacy with Increased Tumor T-Cell Infiltration in Mice and is Well Tolerated in Rats and Non-Human Primates

Date: November 10 - 11, 2022

Time: 9:00 am – 9:00 pm EST

Location: Poster Hall, Boston Convention and Exhibition Center, Boston, MA

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune- oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio

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OncoNano Medicine to Present Data on Novel Development Candidates at the Society for Immunology of Cancer (SITC) Annual Meeting

SOUTHLAKE, Texas – October 5, 2022 – OncoNano Medicine, Inc. today announced it will be presenting data on two development candidates, as well as its ON-BOARD™ delivery platform, at the 37th Annual Meeting of the Society for Immunology of Cancer (SITC), taking place November 8-12, 2022 in Boston, Massachusetts.

An oral and poster presentation by Dr. Qiang Feng detail new pre-clinical data for ONM-405, an IL-2-Fc construct formulated with OncoNano’s proprietary ON-BOARD™ polymeric-micelle delivery system. OncoNano’s lead clinical candidate, pegsitacianine, currently in Phase 2 clinical trials, is formulated with ON-BOARD™. The ON-BOARD™ platform is designed to carry oncology intervention payloads systemically to the tumor microenvironment, minimizing systemic exposure and toxicity.

OncoNano will also present a poster detailing data from studies involving the use of the ON-BOARD™ platform for encapsulation and delivery of bispecific T cell engagers. In addition, a poster will feature new preclinical data of ONM-501, a novel dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications.

Presentations Overview

Title: Ultra-pH Sensitive Nanoparticles Increase Therapeutic Index of IL-2-Fc

Presenter: Dr. Qiang Feng, Postdoctoral Fellow, Jinming Gao Lab, UT Southwestern Medical CenterDate: November 12, 2022

Time: 10:40 am – 10:50 am EST

Location: Session 302: Thomas Waldmann Memorial Plenary Session: New Immunotherapies, Boston Convention and Exhibition Center, Boston, MA

Title: ONM-501, a Polyvalent STING Agonist, Exhibits Anti-Tumor Efficacy with Increased Tumor T-Cell Infiltration in Mice and is Well Tolerated in Rats and Non-Human Primates

Date: November 10 – 11, 2022

Time: 9:00 am - 9:00 pm EST

Location: Poster Hall, Boston Convention and Exhibition Center, Boston, MA

Title: A Clinically Validated pH-Sensitive Nanomedicine Platform for Encapsulating Therapeutic Bispecific T cell engagers for Tumor Specific Delivery and Activation

Date: November 10 – 11, 2022

Time: 9:00 am - 9:00 pm EST

Location: Poster Hall, Boston Convention and Exhibition Center, Boston, MA

About OncoNano MedicineOncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immuneoncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio

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OncoNano Medicine Announces Positive Phase 2 Data for Pegsitacianine as an adjunct to Cytoreductive Surgery of Peritoneal Carcinomatosis

- Interim Phase 2 results presented at World Molecular Imaging Conference 2022 -

- Pegsitacianine demonstrated a >50% clinical event rate allowing the surgeons in the trial to detect residual disease following cytoreductive surgery -

SOUTHLAKE, Texas, September 29, 2022OncoNano Medicine, Inc. today announced positive interim clinical results from an ongoing Phase 2 study of its lead clinical development candidate, pegsitacianine, for the detection of residual disease following cytoreductive surgery (CRS). Study results were presented by Patrick Wagner, MD, Department of Surgical Oncology, Allegheny Health Network Cancer Institute, during an oral presentation at the World Molecular Imaging Congress (WMIC) in Miami, FL on September 29th. The interim results from this trial provide evidence that pegsitacianine could offer surgeons a real-time optical imaging capability that enhances their ability to detect residual cancerous tissue that would otherwise be left behind from their standard of care process for cytoreductive surgery of peritoneal metastases.

“We are encouraged by the Phase 2 study results for pegsitacianine in the detection of residual disease for both mucinous and non-mucinous metastatic nodules across multiple cancer types and look forward to further exploring the clinical utility of this novel molecular imaging agent in cancer surgery,” said Patrick Wagner, MD, one of the lead investigators on the trial.

The Phase 2 study (NCT04950166) remains open to enrollment and is designed to evaluate the ability of pegsitacianine, a micellar fluorescence agent, to detect residual malignancies following CRS, an operation to completely resect peritoneal metastases. As an adjunct to tactile and visual cues for detecting residual disease, pegsitacianine may allow surgeons a more accurate evaluation of the completeness of surgery, or potentially to augment the results by removing additional lesions. A total of 27 patients were administered pegsitacianine at a dose of 1 mg/kg, proceeded to surgery with intra- operative imaging occurring between 24- and 72-hours post-dose, and completed pathology examination of resected specimens. The data presented revealed that 15 patients (55%) have demonstrated a clinically significant detection of pathology-confirmed residual disease following the completion of intended surgery. In this ongoing study, pegsitacianine continues to be well-tolerated with no observed drug-related serious adverse events. The most common adverse event observed with the use of pegsitacianine has been infusion-related reactions that have been mild to moderate and self-resolving.

About Pegsitacianine

Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine for the detection of cancerous tissue in patients undergoing surgical resection. Relying on an ultra pH-sensitive activation mechanism of OncoNano’s ON-BOARD™ platform, pegsitacianine exists in a fluorescently dark “Off” state at physiological pH but transitions rapidly to a fluorescently “On” state in the presence of the elevated acidic tumor microenvironment. Pegsitacianine’s unique mechanism of action provides it with the potential for intraoperative near infrared imaging across a variety of solid tumor types. Pegsitacianine has previously been studied in Phase 1 and 2 clinical trials where breast, head and neck, colorectal, and esophageal cancers were successfully imaged following an intravenous dose of pegsitacianine.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD™ platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agon ist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM -501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

MacDougall Advisors
Lauren Arnold
larnold@macdougall.bio
(617) 694-5387

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OncoNano Medicine to Present at Cantor Fitzgerald Oncology & HemOnc Conference

SOUTHLAKE, Texas – September 19, 2022 – OncoNano Medicine, Inc., a clinical-stage biotechnology company focused on the development of novel cancer interventions, today announced that Chief Medical Officer Kartik Krishnan, MD, PhD, will present at the Cantor Fitzgerald Oncology, Hematology & HemeOnc Conference at the Lotte New York Palace in New York City on Wednesday, September 28, 2022.

Dr. Krishnan will be participating in the panel discussion, “Predictive Biomarkers, Sequencing and Diagnostics, Oh My!” at 9:50 am ET.

For more information or to schedule a one-on-one meeting with Dr. Krishnan, CEO Martin Driscoll and CFO Matthew Head at the meeting, please contact your Cantor representative directly or contact OncoNano at https://onconano.com/#contact.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the  continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts
MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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OncoNano Medicine Announces Oral Presentation of Phase 2 Study Data at the World Molecular Imaging Congress 2022

SOUTHLAKE, Texas – September 14, 2022 – OncoNano Medicine, Inc. today announced a presentation of data from its ongoing Phase 2 study of pegsitacianine at the World Molecular Imaging Congress (WMIC), occurring September 27 – October 1, 2022. The presentation will be given during the Cancer: Innovations in Molecular Imaging session.

Details of the oral presentation are as follows:

Presentation Title: Detection of Residual Peritoneal Metastases following Cytoreductive Surgery, Using the pH-sensitive Micellar Imaging Agent Pegsitacianine: An Interim Review of an Ongoing Phase 2 Study

Presenter: Patrick Wagner, MD, Department of Surgical Oncology, Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania

Date/Time: Thursday, September 29, 3:12 - 3:22 PM EST

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts
MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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OncoNano Medicine Appoints Kartik Krishnan, M.D., Ph.D., as Chief Medical Officer

- Oncology Development Veteran to Lead the Advancement of OncoNano’s Portfolio

SOUTHLAKE, Texas – June 1, 2022 – OncoNano Medicine, Inc. today announced the appointment of Kartik Krishnan, M.D., Ph.D., as Chief Medical Officer. Dr. Krishnan will be responsible for formulating and leading all clinical development efforts and operations at OncoNano. Additionally, Dr. Krishnan will develop and implement the strategic clinical plans for OncoNano, including the creation of a medical affairs team, as the company further advances its clinical oncology development programs.

“We are thrilled that OncoNano has been successful in attracting such a noted and impressive scientist as Dr. Krishnan. Kartik is a proven and respected oncology drug developer, with extensive experience in leading the development of novel oncology therapeutic programs,” said Martin Driscoll, CEO of OncoNano. “His breadth of experience and history of drug development success will be instrumental to our company as we progress our differentiated portfolio of oncology development candidates into multiple clinical trials.”

Dr. Krishnan previously served as Chief Medical Officer at Arcus Biosciences, where he led the expansion of the company’s portfolio into novel indications and combinations, as well as the initiation of a number of pivotal Phase 3 trials. Prior to joining Arcus, he served as Executive Medical Director at Astex Pharmaceuticals, providing strategic direction and tactical support across multiple programs in all phases of development. Dr. Krishnan has also held positions in clinical drug development at Genentech, FivePrime Therapeutics, BioMarin and Amgen. Dr. Krishnan earned both his M.D. and Ph.D. in Cellular, Molecular, and Biophysical Studies from Columbia University.

“My passion is working with novel technologies that have the potential to benefit the treatment of patients with cancer. I am excited about the potential for the core platform technology at OncoNano that can deliver oncology payloads in a targeted and efficient manner to the tumor microenvironment,” said Dr. Krishnan. "I believe I am joining OncoNano at an ideal time because I can immediately impact the strategic development plans for the OncoNano therapeutics programs and lead the execution of the clinical programs at the company. I am impressed with the OncoNano organization and look forward to working with Marty and the OncoNano team to successfully advance our pipeline and achieve the company’s mission to benefit cancer patients.”

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention and Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

Media:

MacDougall Advisors
Nick Chang
781-235-3060
NChang@macdougall.bio

Investor Relations:

LifeSci Advisors
Ashley R. Robinson
617-430-7577
arr@lifesciadvisors.com

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OncoNano Medicine Announces the Appointment of Elina Lavit as Vice President, Business Development

SOUTHLAKE, Texas – May 10, 2022 – OncoNano Medicine, Inc. today announced the appointment of Elina Lavit as Vice President, Business Development. Mrs. Lavit brings over 18 years of experience in leadership roles in organizations ranging from start-ups to Fortune 100 corporations in various therapeutic areas, including oncology and surgery. At OncoNano, Mrs. Lavit will be responsible for driving strategic partnerships and business development activities to support the company’s continued growth.

“OncoNano continues to build momentum as we are entering a rapid phase of growth with pegsitacianine poised to enter Phase 3 clinical trials and our first therapeutic candidate, ONM 501, currently in IND-enabling studies,” said Martin Driscoll, CEO of OncoNano Medicine, Inc. “Elina’s background and her track record of success in leading business development efforts for pharmaceutical companies will be instrumental in helping us execute upon our goals.”

Mrs. Lavit previously served as Executive Director, Program Management at Taysha Gene Therapies, where she led alliance, strategy, and execution for one of the company’s leading assets. Prior, she served as Director of Program Management at Myokardia (acquired by BMS) providing strategic program management support for first in class drug candidate. Mrs. Lavit gained significant strategic collaboration experience while working at Pharmacyclics, Abbvie, and Ethicon (a subsidiary of Johnson & Johnson). Mrs. Lavit earned her Bachelor of Science in Economics and Biology and Master of Science in Medical Science from Tel Aviv University.

“OncoNano’s highly innovative platforms have produced promising and differentiated therapeutic candidates,” said Mrs. Lavit. “I look forward to working with the OncoNano team on advancing these platforms and candidates that exploit the universal pH biomarker of solid tumors to enhance real-time surgical imaging and precisely deliver potent anti-tumor therapeutics.”

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer. OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

Media:

MacDougall Advisors
Nick Chang
781-235-3060
NChang@macdougall.bio

Investor Relations:

LifeSci Advisors
Ashley R. Robinson
617-430-7577
arr@lifesciadvisors.com

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OncoNano Medicine Announces Positive Preclinical Data for ONM-501 at AACR 2022 Annual Meeting

- ONM-501 is a dual-activating polyvalent STING agonist for immuno-oncology applications formulated with OMNI™, the company’s core immune activating polymer technology -

SOUTHLAKE, Texas – April 13, 2022 – OncoNano Medicine, Inc. today announced positive results from a preclinical study of ONM-501, a novel dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications. The data, presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, demonstrate the efficacy and tolerability of ONM-501 in animal models for multiple tumor types. ONM-501 is formulated with the core OncoNano OMNITM polymer technology consisting of STING-activating pH-sensitive micelles loaded with an endogenous agonist.

“We are thrilled by the continued positive preclinical results for ONM-501. STING has consistently been a challenging pathway to target, so we are encouraged by the constellation of our impressive preclinical data showing anti-tumor efficacy and an adaptive response differentiated from cyclic dinucleotide (CDN) STING agonists,” said Ruolan Han, Ph.D., Vice President of Nonclinical & Translational Medicine for OncoNano Medicine. “In preclinical studies to date, ONM-501 has demonstrated the ability to produce a burst and sustained activation of the STING signaling pathway that leads to a robust adaptive immune response with low systemic drug exposure and toxicity. We look forward to continuing our IND-enabling activities as we advance ONM-501 toward our first in human trial in early 2023.”

ONM-501 was evaluated for anti-tumor efficacy and tolerability in multiple animal oncology models. The findings from multiple preclinical studies evidence the following about ONM-501:

  • STING activation was observed by measuring IFNB1 and CXCL10 mRNA in PBMCs from different species

  • Anti-tumor efficacy both as a monotherapy and in combination with anti-PD1 in both immune “hot” and “cold” tumor models

  • Anti-tumor effect mediated by host STING and dependent on CD8+ T cells

  • Ability to induce an abscopal effect - tumor inhibition was observed in both primary and distal tumors in the same animal

  • Ability to induce adaptive immune memory

  • Ability to inhibit lung metastasis in an immune “cold” triple negative orthotopic breast cancer 4T1 model

  • Unique nanoparticle formulation delivered intratumorally achieves high local drug retention, low systemic exposure and a potential for a reduced risk of toxicity


Presentation Overview

TITLE: ONM-501: A polyvalent STING agonist for oncology immunotherapy

PRESENTER: Qingtai Su, Ph.D., Senior Scientist, OncoNano Medicine

About OncoNano MedicineOncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time imageguided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

MacDougall Advisors
Nick Chang
781-235-3060
NChang@macdougall.bio

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OncoNano Medicine Announces Positive Preclinical Data for Tumor Specific Delivery with the ON-BOARD Platform at AACR 2022 Annual Meeting

SOUTHLAKE, Texas – April 12, 2022 – OncoNano Medicine, Inc. today announced positive results from the company’s ON-BOARD™ pH-sensitive nanoparticle platform. The data, presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, demonstrate that the clinically validated ON-BOARD™ platform has the potential to be a universal tool for tumor specific activation and the efficient delivery of proteins for an improved therapeutic index.

“Our ON-BOARD micelle platform is designed to efficiently carry a broad range of payloads to the tumor microenvironment. Capable of being tuned to deliver either small molecules or biologics, the ON-BOARD platform has the potential to be a universal tool for targeted delivery of therapeutics to a range of cancers,” said Tian Zhao, Ph.D., Vice President of Research & Development for OncoNano Medicine, Inc. “We are pleased with the positive data from our research efforts to encapsulate therapeutic antibodies with our ON-BOARD delivery technology and look forward to the further development of protein payloads with an improved therapeutic index.”

A variety of biosimilar monoclonal antibodies including those of atezolizumab, cetuximab, pembrolizumab, trastuzumab and ipilimumab were encapsulated by the ON-BOARD™ platform.

The findings indicate that ON-BOARD™ demonstrated:

  • Encapsulation of antibodies without additional modification of the original antibody

  • Encapsulation efficiency ranging from 50-100%

  • Formulations characterized as uniformly distributed particles < 100nm in size with good stability

  • Over a 100-fold activation window between the acid-activated and intact formulations based on in vitro assessment by cell-based reporter assays

  • pH-dependent activation that was further confirmed by affinity and binding assay

  • Tumor specific accumulation that was demonstrated by a biodistribution study


Presentation Overview

TITLE: Encapsulating therapeutic antibodies for tumor specific activation and delivery using a clinically validated pH-sensitive nanoparticle platform

PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time imageguided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts
MacDougall Advisors
Nick Chang
781-235-3060
NChang@macdougall.bio

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OncoNano Medicine to Present at the American Association for Cancer Research (AACR) Annual Meeting 2022

March 10, 2022

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2022, taking place April 8-13, 2022 in New Orleans, Louisiana.

Full details of the presentations are listed below:


TITLE:
Encapsulating therapeutic antibodies for tumor specific activation and delivery using a clinically validated pH-sensitive nanoparticle platform

PRESENTER: Jason Miller, Ph.D.

DATE: April 11, 2022

TIME: 1:30 – 5:00 PM CT

LOCATION: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 20

TITLE: ONM-501: A polyvalent STING agonist for oncology immunotherapy

PRESENTER: Qingtai Su, Ph.D.

DATE: April 13, 2022

TIME: 9:00 AM – 12:30 PM CT

LOCATION: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 38


About OncoNano Medicine

OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer. Learn more at OncoNano.com.

Contacts

MacDougall Advisors
Lauren Arnold
781-235-3060
larnold@macdougall.bio

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OncoNano Medicine Appoints Brett Giroir, M.D., to Board of Directors

-  Former Assistant Secretary of Health and Admiral in the U.S. Public Health Service to help advance company's mission to advance the identification and treatment of cancer

SOUTHLAKE, Texas – December 17, 2021OncoNano Medicine, Inc. today announced the appointment of Brett Giroir, M.D., to the company’s Board of Directors. “It is my pleasure to welcome Dr. Giroir to our Board and work with him as we advance our differentiated technology platform for the development of novel interventions and treatments for cancer patients,” said Martin Driscoll, CEO of OncoNano Medicine, Inc. “Brett’s wealth of experience and expertise in clinical practice, public health and entrepreneurial enterprises will be instrumental as we enter a pivotal stage for the growth of our company.”

Dr. Giroir is a physician-scientist and innovator, whose career has been dedicated to improving public health and medicine. Formerly, he served as the 16th Assistant Secretary for Health in the U.S. Department of Health and Human Services, Acting FDA Commissioner and Admiral in the U.S. Public Health Service Commissioned Corps. Dr. Giroir also served as the U.S. Representative to the Executive Board of the World Health Organization within the Department of State, and was on the front lines of the COVID-19 response as a member of the White House Task Force and the national lead for testing and diagnostics. Dr. Giroir is a graduate of Harvard University and the University of Texas Health Science Center, where he served on the faculty for ten years. “I am excited to assist in the development and commercialization of OncoNano’s novel platform technology, which has the realistic potential to revolutionize targeting of tumors with anti-cancer therapies and cancerimaging agents,” said Dr. Giroir. “I look forward to working with OncoNano’s outstanding team and world-renowned scientific founders to advance this broadly applicable anti-cancer technology for the benefit of patients with unmet medical needs.”

About pegsitacianine

Pegsitacianine utilizes OncoNano’s proprietary pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of solid tumors – the relatively acidic pH of the tumor microenvironment – to provide real-time surgical imaging for cancer surgeons. Pegsitacianine is currently in Phase 2 trials involving patients with peritoneal metastases and lung tumors.

About ONM-501

ONM-501 is a novel immune-therapeutic that activates the STimulator of INterferon Genes (STING) target and has demonstrated efficacy and good tolerability in multiple preclinical oncology models. ONM-501 utilizes PC7A, a novel synthetic polymer from the proprietary OncoNano library that binds STING through a non-canonical biomolecular condensation. The combination of a payload consisting of a synthetic version of the endogenous ligand, cGAMP, with PC7A yields a polyvalent or dual-activation of the STING target. ONM-501 has been demonstrated to stimulate a robust adaptive immune response in the tumor microenvironment in preclinical studies. OncoNano is currently conducting IND-enabling activities for ONM-501 and anticipates submitting an IND for a Phase 1a/1b trial in the second half of 2022.

Pegsitacianine and ONM-501 have been partially funded by the Cancer Prevention and ResearchInstitute of Texas.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer. Learn more at OncoNano.com

Contacts

MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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$18.4 Million Equity Investment by the Cancer Prevention and Research Institute of Texas

-Will convert previous grant awards to an equity investment in OncoNano’s Series B-Additional capital infusion will close OncoNano’s Series B at $68.4 million and continue to support the clinical program for pegsitacianine and IND-enabling activities for ONM 501

SOUTHLAKE, Texas – October 25, 2021 – OncoNano Medicine, Inc. today announced that the Cancer Prevention and Research Institute of Texas (CPRIT) will convert $18.4 million in grant award funding into an equity investment in OncoNano. Proceeds of the financing will be used to support the clinical development of pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first internal therapeutic development program, ONM-501, a novel immune therapeutic formulated with the company’s core delivery technology. This conversion will close  OncoNano’s Series B financing round with $68.4 million in total committed capital.

CPRIT awarded OncoNano with a grant totaling $15.4 million in 2019 to advance the company’s differentiated STING (STimulator of INterferon Genes) agonist development candidate, ONM 501, and provided a $9.97 million grant in 2020 to advance pegsitacianine, the company’s IV  fluorescent nanoprobe for use in image-guided cancer surgeries. After this investment,  OncoNano will still have $6.97 million of the 2020 grant available to advance the use of  pegsitacianine in the visualization and resection of metastatic disease. 

“CPRIT has played a crucial role in the establishment and advancement of the expanding life sciences research community in Texas. We are thrilled to continue our close partnership with  CPRIT and welcome them as shareholders in OncoNano through this conversion of earlier grant awards to an equity investment in our over-subscribed Series B financing,” said Martin Driscoll,  CEO at OncoNano Medicine, Inc. “With the continued support of our investors, including this infusion of new capital from CPRIT, we can accelerate the development of our novel programs and expand our operations in North Texas. Our successful Series B financing will be instrumental  in advancing pegsitacianine into a pivotal trial program in the U.S. and Europe and advance ONM 501 to a first in human trial in early 2023. We look forward to working together with CPRIT and  our partners to bring important new interventions and treatments to cancer patients in need.”

“CPRIT supported the initial research in Dr. Gao’s laboratory at The University of Texas  Southwestern Medical Center that led to the therapies OncoNano Medicine is commercially developing today,” said Wayne Roberts, CEO, CPRIT. “We’re thrilled to see the company translating that groundbreaking research into products to improve cancer patient care. With the  additional equity investment in OncoNano Medicine, CPRIT helps secure Texas’ investment in,  and ability to benefit from, this technology and the potential therapies it could produce.” 

About the Cancer Prevention and Research Institute of Texas

To date, CPRIT has awarded $2.9 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT  has recruited 237 distinguished researchers, supported the establishment, expansion or relocation of 43 companies to Texas and generated over $5.7 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided  7.4 million life-saving cancer prevention and early detection services reaching Texans from all  254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment to provide an additional $3 billion to CPRIT for a total $6 billion investment in cancer research and prevention. 

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the second half of 2022. Learn more at www.OncoNano.com

Contacts

MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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Pegsitacianine Demonstrates Tumor-Agnostic Real-Time Surgical Imaging in Phase 2 Study

Update on pH-sensitive fluorescent nanoprobe from late-breaking oral presentation at The World Molecular Imaging Congress

Pegsitacianine has successfully detected disease in six different tumor types with four different FDA-approved imaging devices

SOUTHLAKE, Texas – October 14, 2021 – OncoNano Medicine, Inc. announced results from  a Phase 2 study of its lead clinical development candidate, pegsitacianine, presented as a late- breaking oral presentation at the 2021 World Molecular Imaging Congress (WMIC). This late- breaking oral presentation by Dr. Jason Newman of the University of Pennsylvania Health System revealed the fluorescent nanoprobe, pegsitacianine, provided real-time surgical imaging in a tumor-agnostic manner for the accurate identification of malignant tissue in the operating room.

Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine for the detection of cancerous tissue in patients undergoing removal of their solid tumor. Relying on an ultra pH-sensitive activation mechanism of OncoNano’s ON-BOARDTM platform, pegsitacianine exists in a fluorescently dark ( “Off”) state at physiological pH but transitions rapidly to a fluorescently “On” state in the presence of the elevated acidic tumor microenvironment. Pegsitacianine’s unique mechanism of action provides it with the potential to function as a tumor agnostic imaging agent compatible with most clinical cameras designed for ICG imaging across a variety of solid tumor types. Pegsitacianine has previously been studied in a Phase 1 clinical trial where breast, head and neck, colorectal, and esophageal cancers were successfully imaged following an intravenous dose of pegsitacianine.

“The Phase 2 study results for pegsitacianine presented at the recent World Molecular Imaging Congress indicate this fluorescent nanoprobe has the potential to change the current surgical paradigm,” said Dr. Newman. “With the real-time feedback that pegsitacianine provides, we could now have a tool that offers real-time surgical imaging on margin status and provides a greater degree of confidence in achieving complete tumor resection. Given the unique activation mechanism of targeting a universally dysregulated tumor metabolic signature, pegsitacianine could be beneficial in aiding surgical oncologists across multiple tumor disciplines.”

The recently completed Phase 2 study (NCT03735680) was a non-randomized, open-label, multi-center study being conducted at three U.S. sites. This exploratory study further confirmed the selected dose-schedule, expanded upon the drug’s safety profile and increased the number of tumor types in which pegsitacianine imaging was shown to be feasible. Together, the results demonstrated that pegsitacianine is well-tolerated in patients and provides the surgeon with accurate, real-time feedback in the operating room. Intraoperative imaging observations demonstrated a high correlation with the pathological assessments of collected tissues, and imaging can be reliably performed using multiple FDA-cleared NIR imaging devices. Results from evaluable patients demonstrated favorable sensitivity (100%) and specificity (92%) values, as well as a strong negative predictive value (100%) for detecting histologically normal tissue that was collected as part of standard of care surgery.

“The high sensitivity and specificity valuesfrom the Phase 2 trial not only corroborated our Phase 1 observations to further support the use of OncoNano’s ON-BOARDTM platform in surgical imaging, but also highlight the potential benefit of this pH-activatable platform for tumor-targeted delivery of therapeutic payloads with an increased therapeutic window,” commented Jinming Gao, PhD, OncoNano’s Chief Scientific Officer.More information on the Phase 2 trial can be found at ClinicalTrials.Gov

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer. OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the second half of 2022. Learn more at www.OncoNano.com.

Contacts

MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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Positive Preclinical Data for ONM-501 at AACR Virtual Conference

OncoNano Medicine Announces Positive Preclinical Data for ONM-501 at AACR Virtual Conference on Tumor Immunology and Immunotherapy

SOUTHLAKE, Texas – October 8, 2021OncoNano Medicine, Inc. announced positive results from its preclinical study of ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications. The data, presented at The American Association for Cancer Research (AACR) Virtual Conference on Tumor Immunology and Immunotherapy, demonstrate strong efficacy in multiple tumor models.

“We are excited by the positive preclinical results for ONM-501 recently presented at AACR. STING plays a crucial role in mediating our innate immune systems but has consistently been a challenging pathway to target,” said Martin Driscoll, Chief Executive Officer of OncoNano Medicine, Inc. “We are encouraged by the constellation of preclinical data that demonstrates ONM-501 could have a clinical profile differentiated from earlier generation cyclic dinucleotide STING agonist compounds. The novel ONM-501 formulation consisting of our STING activating pH-sensitive micelle loaded with an endogenous agonist has demonstrated a capability to produce a dual and prolonged activation of STING while recruiting a robust adaptive immune response to the tumor microenvironment. We look forward to continuing our IND-enabling activities as we advance ONM-501 to first in human trials.”

Presentation Overview

TITLE: ONM-501 ― A synthetic polyvalent STING agonist for cancer immunotherapy

PRESENTER: Qingtai Su, Ph.D., Senior Scientist, OncoNano Medicine, Inc.

ONM-501 demonstrated antitumor efficacy in six different syngeneic mouse models from different tissues of origin (MC38, 4T1, TC-1, B16-F10, CT26 and A20). The animals were treated intratumorally with ONM-501 as a monotherapy or in combination with PD-1 blockade. The findings indicate that ONM-501 demonstrated:

  • Strong antitumor efficacy across all tumor models tested as a mono or combo therapy

  • Significantly improved efficacy with increased complete response in several modelswhen combined with PD-1 blockade

  • Successful combination of a novel, proprietary STING activating micelle with theendogenous cGAMP potentially offers a synergistic immunotherapy strategy against cancer

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image- guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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Present at The American Association for Cancer Research Virtual Conference

OncoNano Medicine to Present at The American Association for Cancer Research Virtual Conference on Tumor Immunology and Immunotherapy

SOUTHLAKE, Texas – September 30, 2021 – OncoNano Medicine, Inc. today announced a poster presentation at The American Association for Cancer Research (AACR) Virtual Conference on Tumor Immunology and Immunotherapy to be held on October 5-6, 2021.

Full details of the presentation are listed below:

TITLE: ONM-501 ― A Synthetic Polyvalent STING Agonist for Cancer Immunotherapy

PRESENTER: Qintai Su, Ph.D.

DATE: October 5-6, 2021

LOCATION: Virtual

The development of ONM-501 represents a new concept in STING activation that could overcome the challenges observed with earlier STING agonists. ONM-501 encapsulates the endogenous STING agonist cGAMP with a proprietary micelle that induces polyvalent STING condensation and prolongs innate immune activation to offer dual ‘burst’ and ‘sustained’ STING activation for a potential highly effective immunotherapy against cancer.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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Expanded Research Collaboration with UT Southwestern Medical Center

OncoNano Medicine Announces Expanded Research Collaboration with UT Southwestern Medical Center to Advance Development of New Cancer Therapies

- Expanded collaboration for multi-year translational research of novel cancer treatments- OncoNano has an exclusive option to license new technologies from the collaboration

SOUTHLAKE, Texas – September 22, 2021 – OncoNano Medicine, Inc., a clinical-stage company utilizing the principles of molecular cooperativity in drug design to exploit universal tumor and immune targets to diagnose and treat cancer, today announced a multi-year collaboration with The University of Texas Southwestern Medical Center (UTSW) to discover and conduct translational research of novel cancer therapeutics that leverage OncoNano’s core nanotechnology platform. OncoNano will sponsor research efforts in the laboratory of Professor Jinming Gao of UTSW with the objective of uncovering new cancer therapies that can benefit from OncoNano’s ultra pH-sensitive polymeric micelles. OncoNano will have an exclusive option to license new technology arising from the research conducted under this agreement.

“We are excited to expand our research collaboration with the UT Southwestern Medical Center and the prominent UTSW laboratory led by Dr. Jinming Gao,” said Martin Driscoll, Chief Executive Officer of OncoNano Medicine, Inc. “UTSW’s rich scientific discovery environment combined with world-class translational research capabilities presents a wonderful opportunity for our scientists to engage in a multi-year cooperative research effort to leverage our core technology platform and advance more novel cancer therapeutics into clinical development.”

Dr. Gao and his team at UTSW invented the ultra pH-sensitive nanoparticle technology that represents the core of OncoNano’s differentiated oncology research platform. OncoNano iscurrently advancing two development programs that utilize the ultra pH-sensitive nanoparticle technology. Pegsitacianine, a fluorescent nanoprobe for real-time surgical imaging, is currentlyin Phase 2 clinical trials for multiple tumor types, and ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications, is advancing toward a first in human study planned for early 2023.

“OncoNano’s multi-year support for basic research will broaden our capability to harness molecular cooperativity design that incorporates pathophysiological responses into the development of tumor-activatable compounds with increased therapeutic windows,” said Jinming Gao, Professor of Oncology, Pharmacology and Cell Biology in the Harold C. Simmons Comprehensive Cancer Center at UTSW and Chief Scientific Officer of OncoNano. “We are working to expand the micelle technology platform developed at UTSW so it can be used to deliver additional payloads, including protein therapeutics such as cytokines, checkpoint inhibitors and bispecific antibodies. We look forward to this research collaboration with OncoNano Medicine to continuously translate lab discoveries into potentially important clinical applications.”

About The University of Texas Southwestern Medical Center

UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes and includes 23 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,500 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately 3 million outpatient visits a year.

About OncoNano Medicine, Inc.

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit universal and immune targets for cancer diagnosis and therapy. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image- guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to fight cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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OncoNano Medicine to Present at The World Molecular Imaging Congress

SOUTHLAKE, Texas – September 20, 2021 – OncoNano Medicine, Inc. today announced an oral presentation at The World Molecular Imaging Congress 2021 (WMIC) to be held virtually on October 6-9, 2021.

Full details of the presentation are listed below:

TITLE: Fluorescence Image-Guided Surgical Resection of Solid Tumors Using the pH-Responsive Micellar Imaging Agent Pegsitacianine: A Summary of an Ongoing Phase 2 Study

PRESENTER: Dr. Jason Newman

DATE: October 8th, 2021

TIME: 10:00 – 11:30 AM

LOCATION: Virtual

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next-generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in-human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.

Contacts

MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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OncoNano Medicine Raises ~$50 Million in Series B Financing

Financing round led by Advantech healthcare investment team

Funds will support Phase 3 program for pegsitacianine and IND-enabling activities for ONM-501

June 17, 2021

SOUTHLAKE, Texas - (BUSINESS WIRE) - OncoNano Medicine, Inc. today announced the raise of an approximate $50 million Series B financing led by the healthcare investment team at Advantech Capital, a China-based cross border institutional investment fund. Proceeds of the financing will be used, in part, to support the Phase 3 clinical trials in the U.S. and Europe for pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first therapeutic development program, ONM-501, a novel immune-therapeutic formulated with the company’s core delivery technology.

“We are thrilled to welcome Advantech as an investor in OncoNano and look forward to continuing the momentum we’ve built with our lead development programs that utilize our proprietary pH-activated micelle platform,” said Martin Driscoll, CEO at OncoNano Medicine, Inc. “We plan to initiate our pegsitacianine pivotal trial program in the U.S. and Europe and submit an IND for our first therapeutic development program in 2022. The funds from this Series B raise combined with the support of our partners from the Cancer Prevention & Research Institute of Texas (CPRIT) provide the resources to operate our company for several years, advance pegsitacianine further towards commercialization, and progress our novel immuno-oncology compound, ONM-501, through our Phase 1a/1b clinical program. With the inclusion of the new capital, we now have the capability to accelerate our development programs and work to achieve our goal of bringing novel interventions and treatments to cancer patients.”

“We are impressed with the potential for OncoNano’s innovative core technology,” said Benjamin Qiu, partner at Advantech Capital. “We see great promise in OncoNano and are excited to support the company through its further advancement of pegsitacianine into a pivotal clinical development program and its novel dual-activation STING agonist towards a first in human study to help address the persistent and challenging unmet needs in cancer surgery and treatment.”

About Advantech Capital

Advantech Capital is a private equity investment fund, focusing on innovation-driven growth opportunities in China, mainly investing in TMT, pharmaceuticals, and healthcare.

About Cancer Prevention & Research Institute of Texas (CPRIT)

CPRIT has awarded $2.72 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 233 distinguished researchers, supported the establishment, expansion, or relocation of 42 companies to Texas, and generated more than $5.5 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.1 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment providing an additional $3 billion to CPRIT, for a total $6 billion investment in cancer research and prevention efforts across Texas, one of the largest state funded research programs in United States history and the second largest source of funding for cancer research in the world.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the second half of 2022. Learn more at www.OncoNano.com.

Contacts

MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com

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OncoNano Medicine to Present at the 2nd Annual LifeSci Partners Private Company Summer Symposium

July 19, 2021

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced a presentation at the 2nd Annual LifeSci Partners Private Company Summer Symposium, to be held virtually July 21-23, 2021. Martin Driscoll, CEO of OncoNano, will present on Thursday, July 22nd at 1:30 p.m. ET.

To register for the event, please click here.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the second half of 2022. Learn more at www.OncoNano.com.

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OncoNano Medicine Raises ~$50 Million in Series B Financing

Financing round led by Advantech healthcare investment team

Funds will support Phase 3 program for pegsitacianine and IND-enabling activities for ONM-501

June 17, 2021

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced the raise of an approximate $50 million Series B financing led by the healthcare investment team at Advantech Capital, a China-based cross border institutional investment fund. Proceeds of the financing will be used, in part, to support the Phase 3 clinical trials in the U.S. and Europe for pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first therapeutic development program, ONM-501, a novel immune-therapeutic formulated with the company’s core delivery technology.

“We are thrilled to welcome Advantech as an investor in OncoNano and look forward to continuing the momentum we’ve built with our lead development programs that utilize our proprietary pH-activated micelle platform,” said Martin Driscoll, CEO at OncoNano Medicine, Inc. “We plan to initiate our pegsitacianine pivotal trial program in the U.S. and Europe and submit an IND for our first therapeutic development program in 2022. The funds from this Series B raise combined with the support of our partners from the Cancer Prevention & Research Institute of Texas (CPRIT) provide the resources to operate our company for several years, advance pegsitacianine further towards commercialization, and progress our novel immuno-oncology compound, ONM-501, through our Phase 1a/1b clinical program. With the inclusion of the new capital, we now have the capability to accelerate our development programs and work to achieve our goal of bringing novel interventions and treatments to cancer patients.”

“We are impressed with the potential for OncoNano’s innovative core technology,” said Benjamin Qiu, partner at Advantech Capital. “We see great promise in OncoNano and are excited to support the company through its further advancement of pegsitacianine into a pivotal clinical development program and its novel dual-activation STING agonist towards a first in human study to help address the persistent and challenging unmet needs in cancer surgery and treatment.”

About Advantech Capital

Advantech Capital is a private equity investment fund, focusing on innovation-driven growth opportunities in China, mainly investing in TMT, pharmaceuticals, and healthcare.

About Cancer Prevention & Research Institute of Texas (CPRIT)

CPRIT has awarded $2.72 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 233 distinguished researchers, supported the establishment, expansion, or relocation of 42 companies to Texas, and generated more than $5.5 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.1 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment providing an additional $3 billion to CPRIT, for a total $6 billion investment in cancer research and prevention efforts across Texas, one of the largest state funded research programs in United States history and the second largest source of funding for cancer research in the world.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer.

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the second half of 2022. Learn more at www.OncoNano.com.

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