Press Releases

MacDougall Creative 12/17/21 MacDougall Creative 12/17/21

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, 2021 – OncoNano 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

MacDougall Creative 10/25/21 MacDougall Creative 10/25/21

$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’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

MacDougall Creative 10/14/21 MacDougall Creative 10/14/21

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

MacDougall Creative 10/8/21 MacDougall Creative 10/8/21

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, 2021 – OncoNano 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

MacDougall Creative 9/30/21 MacDougall Creative 9/30/21

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

MacDougall Creative 9/22/21 MacDougall Creative 9/22/21

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

MacDougall Creative 9/20/21 MacDougall Creative 9/20/21

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

MacDougall Creative 7/22/21 MacDougall Creative 7/22/21

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

Contacts

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

MacDougall Creative 7/19/21 MacDougall Creative 7/19/21

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

MacDougall Creative 6/17/21 MacDougall Creative 6/17/21

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.

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)

About OncoNano Medicine

MacDougall Creative 3/31/21 MacDougall Creative 3/31/21

OncoNano Awarded $15.4 Million Grant

SOUTHLAKE, Texas – August 27, 2019 – OncoNano Medicine, Inc. today announced that it has been awarded $15.4 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to advance ONM-500, one of OncoNano’s innovative oncology product candidates. In ONM500, OncoNano leverages its proprietary pH-sensitive micelle technology to deliver antigens while activating innate immunity for the treatment of cancers caused by the human papilloma virus (HPV). This grant award adds to an initial $6 million grant that the company received from CPRIT in 2014 for advancement of the company’s ONM-100, where OncoNano’s micelle technology is being used to intraoperatively image tumors during surgical resection, currently in Phase 2 clinical trials.

“We are excited to be awarded this impactful grant and are extremely grateful to CPRIT for their continued recognition and support of the development of OncoNano’s technology platform for identifying and treating cancer in its various forms,” says Ravi Srinivasan, Ph.D., CEO of OncoNano Medicine. “Our pH-sensitive micelle approach to cancer therapy with ONM500 and our other product candidates have the potential to meaningfully advance cancerspecific targeting and administration.” In part utilizing CPRIT-funded technology first invented at UT Southwestern Medical Center, ONM-500 combines contemporary advances in immunoadjuvant therapy with OncoNano’s proprietary pH-sensitive micelle delivery technology to recruit the body’s own immune system to attack cancer cells. An HPV tumor-specific antigen is packaged into immune-activating micelles that, when intradermally injected, accumulate in the lymph nodes and are endocytosed by dendritic cells. The relatively lower pH of intracellular endosomes causes the micelles to dissociate, resulting in the intracellular release of the antigen, activation of STING (STimulator of INterferon Genes) and subsequent activation of the body’s own T-cells directed at the tumor. Through the delivery of an antigen by the STING-activating micelle, the ONM-500 immunoadjuvant complex enables a targeted and orchestrated attack on cancer cells. With this grant, OncoNano will continue advancing ONM-500 through pre-clinical development towards the clinical stage where there is a substantial unmet patient need for therapies to treat cancers caused by HPV.

“This award emphasizes CPRIT’s priority of investing in early translational research into cancer detection, prevention, and treatment. OncoNano’s technologies have significant potential for breakthroughs in cancer detection and treatment,” said Wayne Roberts, CEO of CPRIT. “Nurturing projects like OncoNano’s will continue to make Texas a hub for scientific advancement and innovation. I look forward to OncoNano’s progress as they take their technologies through development.”

About the Cancer Prevention and Research Institute of Texas

To date, CPRIT has awarded $2.4 billion in grants to Texas research institutions andorganizations through its academic research, prevention, and product development researchprograms. CPRIT has recruited 181 distinguished researchers; supported the establishment,expansion, or relocation of 37 companies to Texas, and generated $3 billion in additional publicand private investment. CPRIT funding has advanced scientific and clinical knowledge andprovided 5.7 million life-saving cancer prevention and early detection services reaching Texansfrom all 254 counties. www.cprit.state.tx.us

About OncoNano Medicine

OncoNano Medicine is developing a new class of pH-activated compounds that digitalize and exploit the variability of pH in disease. pH variability is a proven, simple, and effective identifier of diseased tissue providing a foundation for the development of a broad range of highly targeted therapeutics and imaging agents. OncoNano is the first company to advance product candidates using pH as a biomarker for cancer immunotherapy, therapeutic use and intraoperative imaging based on its pH-sensitive micelle technology. www.OncoNanoMed.com

Contacts

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

MacDougall Creative 3/31/21 MacDougall Creative 3/31/21

Publication of ONM-100 Phase 1

Southlake, TX. – June 26, 2020 – OncoNano Medicine, Inc. announced today the publication of Phase 1clinical trial data in Nature Communications featuring OncoNano’s intraoperative tumor imaging productcandidate, ONM-100. The study evaluated safety, pharmacokinetics and feasibility of ONM-100 inimage-guided surgery, occult tumor detection and visualization of tumor margins in four differentcancer types. Following tumor resection, ONM-100 detected residual tumor positive margins in 9 of 9patients in whom histology confirmed tumor positive margins, and also detected occult lesions in anadditional 5 patients whose tumors were undetected by standard of care. The research paper, Exploitingmetabolic acidosis in solid cancers using a tumor-agnostic pH-activatable nanoprobe for fluorescenceguided surgery, will appear in the June 26 issue of Nature Communications.

Surgical resection remains a cornerstone treatment strategy for solid tumors today and incompletetumor removal can be predictive of cancer recurrence and metastasis. Despite imaging advances, thereare no approved imaging options to provide real-time feedback to surgeons that specifically targettumor masses but are agnostic to cancer type. ONM-100, a pH-sensitive micelle conjugated to afluorescent tag, targets the relatively acidic pH of the tumor microenvironment – a universal biomarkerof solid tumors – to precisely label tumor masses. ONM-100 is intravenously administered prior tosurgery and visualized during surgery using existing surgical fluorescent imaging equipment. Exploitingthis universal biomarker of solid tumors confers the potential for ONM-100 to be used in various cancertypes, irrespective of tissue of origin.

“We are extremely pleased to have this critical work published in Nature Communications,” commentedGooitzen Michell van Dam, MD, PhD, CEO of TRACER BV and professor at the University Medical Centerof Groningen, Netherlands. As Principal Investigator and corresponding author of the manuscript hestates, “ONM-100 was able to detect tumor positive resection margins and several cancerous lesionsthat standard of care procedures missed in diverse types of solid cancers. We eagerly anticipate seeingONM-100’s potential further explored in Phase 2 clinical trials.”

“We are delighted to see the scientific community’s validation of ONM-100 that is demonstrated by thisacceptance in Nature Communications,” commented Ravi Srinivasan, PhD, Cofounder and CEO ofOncoNano. “ONM-100 has the potential to substantially simplify and enhance the effectiveness oftumor resection surgeries, and given its possible tumor-agnostic applications, it may be used in broadpatient populations in the future. We look forward to this same pH-sensitive micelle technology beingutilized for other oncology applications, such as tumor-specific therapeutic delivery.”ONM-100 is currently being evaluated in Phase 2 clinical trials in the United States in several uniquecancer indications, including breast, ovarian, prostate and colorectal cancers. Learn more about this trialat www.clinicaltrials.gov.

About ONM-100

ONM-100 is OncoNano’s lead product candidate that utilizes the pH-sensitive micelle platform toencapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidicpH of the tumor microenvironment – to intraoperatively image tumors. ONM-100 micelles remaininactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelledissociation and fluorescent tag expression, making tumors visible during surgery with standard surgicalimaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded forclinical research by the Cancer Prevention and Research Institute of Texas.

About OncoNano Medicine

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

Contact

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

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Study Reveals Compelling Data for a New Nanoparticle-based Immuno-Therapeutic to Treat Cancer

- UTSW scientists demonstrate that a novel pH-sensitive polymer prolongs STING-mediated activation of innate immunity against solid cancers

- OncoNano Medicine’s ONM-501, containing the polymer and an endogenous STING ligand, could overcome the clinical challenges observed with related immuno-oncology compounds

February 10, 2021

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced that a research paper titled “Prolonged activation of innate immune pathways by a polyvalent STING agonist” published in Nature Biomedical Engineering shows that a pH-sensitive nanoparticle-based drug developed by Dr. Jinming Gao and team at the University of Texas Southwestern Medical Center (UTSW) could boost the body’s innate immune pathways in the treatment of multiple cancers with a unique mechanism of activating the STimulator of INterferon Genes (STING). OncoNano licensed this technology from UTSW for further development as part of the company’s proprietary pH-activated micelle platform, and Dr. Gao, a co-founder of OncoNano, currently also serves as a consultant for the company.

“We are excited about the study published by our colleagues at UTSW demonstrating that the STING activating polymeric micelle can be selectively triggered in the endosomes and enter the cytoplasm of phagocytic cells to achieve robust antitumor immunity,” said Marty Driscoll, CEO at OncoNano Medicine, Inc. “The novel polymer component can bind uniquely to the STING target and produce longer activation of this critical innate immune pathway. Our development candidate, ONM-501, utilizes the STING activating pH-sensitive micelle technology encapsulated with an endogenous high affinity ligand to produce a dual and prolonged activation of STING.”

The STING pathway plays a crucial role in mediating the body’s innate immune system. The development of ONM-501 represents a new concept in STING activation that could overcome the challenges observed with earlier STING agonist compounds. ONM-501 micelles enable targeted and efficient delivery of the endogenous ligand and the STING activating polymer to the phagocytic cells in tumors where they are released by low pH-induced micelle dissociation. Preclinical studies have shown that both the polymer and the endogenous ligand payload of ONM-501 bind to and activate the STING protein in the cell in a synergistic manner, enabling activation for up to 48 hours. The polymers bind to a non-competitive STING surface site distinct from the conventional cyclic dinucleotide-binding pocket, and also induce condensation of STING proteins via polyvalent interactions. Preclinical studies showed that ONM‑501 used in combination with a checkpoint inhibitor produces an immune response effective in treating multiple cancer types.

OncoNano Medicine, Inc. is developing ONM-501 as a potential immuno-therapeutic treatment for multiple cancers. Development of the core technology of ONM-501, the STING activating polymer, has been partially funded by a grant from the Cancer Prevention and Research Institute of Texas.

About OncoNano Medicine

Contact

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

MacDougall Creative 2/9/21 MacDougall Creative 2/9/21

Study Reveals Compelling Data for a New Nanoparticle-based Immuno-Therapeutic to Treat Cancer

- UTSW scientists demonstrate that a novel pH-sensitive polymer prolongs STINGmediated activation of innate immunity against solid cancers

- OncoNano Medicine’s ONM-501, containing the polymer and an endogenous STING ligand, could overcome the clinical challenges observed with related immuno-oncology compounds

SOUTHLAKE, Texas – February 10, 2021 – OncoNano Medicine, Inc. today announced that a research paper titled “Prolonged activation of innate immune pathways by a polyvalent STING agonist” published in Nature Biomedical Engineering shows that a pH-sensitive nanoparticlebased drug developed by Dr. Jinming Gao and team at the University of Texas Southwestern Medical Center (UTSW) could boost the body’s innate immune pathways in the treatment of multiple cancers with a unique mechanism of activating the STimulator of INterferon Genes (STING). OncoNano licensed this technology from UTSW for further development as part of the company’s proprietary pH-activated micelle platform, and Dr. Gao, a co-founder of OncoNano, currently also serves as a consultant for the company.

The STING pathway plays a crucial role in mediating the body’s innate immune system. The development of ONM-501 represents a new concept in STING activation that could overcome the challenges observed with earlier STING agonist compounds. ONM-501 micelles enable targeted and efficient delivery of the endogenous ligand and the STING activating polymer to the phagocytic cells in tumors where they are released by low pH-induced micelle dissociation. Preclinical studies have shown that both the polymer and the endogenous ligand payload of ONM-501 bind to and activate the STING protein in the cell in a synergistic manner, enabling activation for up to 48 hours. The polymers bind to a non-competitive STING surface site distinct from the conventional cyclic dinucleotide-binding pocket, and also induce condensation of STING proteins via polyvalent interactions. Preclinical studies showed that ONM-501 used in combination with a checkpoint inhibitor produces an immune response effective in treating multiple cancer types.

About OncoNano MedicineOncoNano 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. Learn more at www.OncoNano.com.

Contacts

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

MacDougall Creative 2/1/21 MacDougall Creative 2/1/21

OncoNano Medicine Announces Martin Driscoll as CEO

Mr. Driscoll’s deep experience in the biopharmaceutical industry particularly the immuneoncology field makes him ideally suited to assume the leadership of OncoNano Medicine

SOUTHLAKE, TX – February 1, 2021 – OncoNano Medicine, Inc. today announced the appointment of Martin Driscoll as Chief Executive Officer and a member of the company’s Board of Directors. An accomplished industry veteran with multiple decades of biopharmaceutical development and commercialization experience, Mr. Driscoll most recently served as President and Chief Executive Officer of Spring Bank Pharmaceuticals. Mr. Driscoll succeeds co-founder and CEO Ravi Srinivasan, Ph.D., who has stepped down in a planned transition to pursue other interests.

“We are thrilled to welcome Marty to our team. Marty’s extensive experience and proven track record at the helm of several successful biopharmaceutical development companies will undoubtedly provide OncoNano with the leadership to advance our business and translate our novel discoveries into important new interventions and treatments for cancer patients,” said Al Guillem, Ph.D., Chairman of OncoNano. “Marty joins OncoNano at an important time as we progress our lead program into the pivotal trial stage and advance our first oncology therapeutic, ONM-501, towards the first human studies for this novel immuno-modulator.” Dr. Guillem continued, “On behalf of the OncoNano board of directors, I want to thank Ravi for his many contributions to the growth of our company and wish him great success in his future endeavors.”

“I’m joining OncoNano at an exciting point in the evolution of the company and I look forward to building on the strong foundation established by Ravi and the OncoNano team as we advance the clinical development of our impressive portfolio of differentiated programs,” said Mr.Driscoll. “I was attracted to this opportunity to lead OncoNano by the exciting potential for the company’s innovative core technology that exploits the universal pH biomarker of solid tumors to enhance real-time surgical imaging and enable more efficient and effective delivery of cancer treatments.”

Mr. Driscoll brings a proven record in leading privately-held and publicly-traded biopharmaceutical development and commercial-stage companies. He has been involved with or led the commercialization of several important therapies, the direct negotiation of numerous licensing and M&A transactions, multiple private and public capital fundraising efforts and the successful submission of major global product regulatory filings. Mr. Driscoll has also served as a director on the boards of eight biopharmaceutical and diagnostic companies during his career.

About OncoNano Medicine

Contacts

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