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FDA Acceptance of IND Application for Phase I Trial of OS2966 in Patients with Recurrent Glioblastoma

By | news

OncoSynergy, Inc., a patient-focused oncology company committed to advancing therapeutics to address dire unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OS2966, a first-in-class therapeutic targeting CD29. This IND approval enables OncoSynergy to initiate a Phase I clinical trial evaluating OS2966 in patients with recurrent glioblastoma, the most aggressive intrinsic brain cancer.

“I remember the exact moment at the lab bench, over a decade ago, when the concept for OS2966 began to take shape,” said, Co-Founder and Chief Executive Officer of OncoSynergy, Shawn Carbonell, MD, PhD. “Now, with the accomplishment of this major milestone, OncoSynergy is officially a clinical-stage company. We are grateful for all the support from advisors, investors, collaborators, and, most recently, FDA.”

OncoSynergy has partnered with Infuseon Therapeutics, a Cleveland Clinic spin-out, and Michael Vogelbaum, MD, PhD, Program Leader of Neuro-Oncology and Chief of Neurosurgery at Moffitt Cancer Center, and an inventor of the Infuseon Cleveland Multiport Catheter.

“I worked with Dr. Vogelbaum to design an innovative trial that made the most sense for patients and specifically addressed the challenges associated with treatment of glioblastoma,” said Co-Founder and Chief Medical Officer of OncoSynergy, Anne-Marie Carbonell, MD. “We strived to build a collaborative relationship with FDA and I am grateful to have worked with an excellent and highly responsive review team.”

OS2966 is the first-ever clinical-ready CD29 antibody under development for treatment of diverse cancers and targets fundamental interactions in the tumor microenvironment driving growth and treatment resistance. OncoSynergy has demonstrated the preclinical potential of OS2966 in the setting of treatment resistant solid and hematologic malignancies and in unique immunotherapy combinations.

Founding Scientific Advisory Board (SAB) member and eminent cell biologist at the Lawrence Berkeley National Laboratory, Mina J. Bissell, PhDcommented, “For decades, I have asked tough biological questions to understand how cancer growth and progression are regulated at the level of tissue organization.” Dr. Bissell continued, “It is exciting to see OncoSynergy translate this approach with OS2966, and take into account the critical context of the tumor microenvironment.”

OS2966 has been awarded FDA Orphan Drug Designation in the treatment of glioblastoma and ovarian cancer. The target of OS2966, CD29 (also known as beta1 integrin), is overexpressed in the majority of cancers representing a tremendous opportunity in oncology.

Jean Pierre Bizzari, MD, former Celgene Group Head of Clinical Oncology Development, current Board Member of the European Organization of Research and Treatment of Cancer (EORTC), and member of OncoSynergy’s SAB stated, “I have dedicated my professional life to helping patients by advancing novel cancer therapeutics. I am thrilled to see OncoSynergy advance their first-in-class therapeutic, OS2966, to the clinic for patients suffering from glioblastoma, a devastating brain cancer.”

OncoSynergy Announces Submission of IND Application for OS2966 in the Treatment of Glioblastoma

By | news

GREENWICH, CONNECTICUT, February 25, 2021.

OncoSynergy announced that it has submitted an FDA application for a first-in-human trial of its Orphan Drug designated experimental therapeutic OS2966 for malignant brain cancer.

OncoSynergy, a venture-backed oncology company launched from UCSF and the JLABS South San Francisco incubator, announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a phase I clinical study of OS2966 in patients with recurrent/progressive glioblastoma.

OS2966 is the first-ever clinical-ready CD29 antibody under development for the treatment of diverse cancers. In particular, OncoSynergy has demonstrated the preclinical potential of OS2966 in the setting of treatment resistant malignancies and in unique immunotherapy combinations. The FDA has granted 2 Orphan Drug Designations for OS2966 including in the treatment of glioblastoma, the most common malignant primary brain cancer in adults.

As a patient-focused company founded by physicians, OncoSynergy has been committed to advancing solutions to address dire unmet medical needs. “This IND submission marks a major advancement in OncoSynergy’s mission to bring novel therapeutics from the bench to the bedside of patients suffering from the most formidable diseases,” said Chief Medical Officer and Co-Founder of OncoSynergy, Anne-Marie Carbonell, MD. “We are thrilled to emerge as a clinical-stage company, but most importantly, we look forward to bringing OS2966 to patients with glioblastoma.”

OncoSynergy has forged a strategic alliance with Infuseon Therapeutics, a spinout of the Cleveland Clinic. The Infuseon Cleveland Multiport Catheter (ICMC), a cutting-edge FDA 510(k) cleared medical device, will be used to deliver OS2966 to the site of disease. Michael Vogelbaum, MD, PhD, Chief Medical Officer of Infuseon Therapeutics and Program Leader of Neuro-Oncology and Chief of Neurosurgery at Moffitt Cancer Center, is an inventor of ICMC. He stated, “This two-part trial represents an innovative therapeutic approach for tackling this difficult disease and we are excited to take the collaboration with OncoSynergy to the next level.”

OS2966 was manufactured in partnership with AGC Biologics A/S, a world-class contract development and manufacturing organization. “AGC Biologics is very pleased to have supported OncoSynergy in preparation for clinical trials with their innovative oncology molecule, OS2966 and we look forward to continuing the partnership with positive outcomes from these trials,” said Gustavo Mahler, PhD, President and CEO of AGC.

Published on PR Web: click here

OncoSynergy raises Series A Round

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OncoSynergy, an oncology therapeutics spinout from UCSF and current resident of the prestigious JLABS South San Francisco incubator, announced that it has closed a Series A equity round led by Connecticut Innovations (CI) with participation by the current shareholders, including NLabs, Inc., and Korea Information & Communication Co., Ltd. The venture financing will be used to accelerate their lead program, OS2966, to the clinic for the treatment of glioblastoma, the most common and deadliest primary brain tumor in adults.

OncoSynergy has developed a new class of oncology therapeutics called Resistance Mechanism Inhibitors (RMIs). RMIs feature multiple simultaneous mechanisms of action, synergy in combination with other treatments, including immunotherapies in preclinical models, and can potentially be used to treat many types of solid and hematological cancers. The FDA has granted two Orphan Drug Designations for OS2966, the lead RMI program, including in the treatment of glioblastoma.

The planned clinical trial is a strategic alliance with Infuseon Therapeutics, a medical device spinout of the Cleveland Clinic.

“We are very pleased to fund OncoSynergy’s highly innovative OS2966 program toward the clinic,” commented Amanda Hayward, PhD, Managing Director of Venture Capital Investments at CI. “Glioblastoma remains a major unmet need, and we believe RMIs have the potential to be a game-changer not only in brain cancer, but in oncology more broadly.”
Jean Pierre Bizzari, MD, former Global Head of Oncology at Celgene and member of the OncoSynergy Advisory Board, concurred, saying, “I strongly believe OncoSynergy’s OS2966 RMI program represents a major advance toward providing durable outcomes for cancer patients.”

OncoSynergy will be relocating its headquarters to Connecticut and expanding its team in anticipation of its first clinical trial in 2019.

“We are grateful for the immense support of Amanda Hayward and the entire CI team and look forward to building OncoSynergy into a leading clinical stage biopharma company,” said W. Shawn Carbonell, MD, PhD, Founder and CEO at OncoSynergy. “As physicians, the founding team of OncoSynergy are absolutely thrilled to be able to bring OS2966 from the lab bench to patients for the first time.”

About OncoSynergy:
Oncosynergy is a UCSF spinout with primary operations in JLABS @ SSF, California. The company was founded in 2011 to provide solutions for treatment-resistant cancer through the development of a new class of oncology therapeutics, called Resistance Mechanism Inhibitors (RMIs). RMIs are unique multi-action, tumor-agnostic drug platforms that have shown preclinical promise as monotherapy and in strategic combinations. The lead RMI drug candidate, OS2966, is on track for Phase I clinical trials. To learn more, please visit [http://www.OncoSynergy.com.

About Connecticut Innovations:
Connecticut Innovations (CI) is the leading source of financing and ongoing support for Connecticut’s innovative, growing companies. To maximize growth potential, CI provides venture capital and strategic support for early-stage technology companies; financial support for innovation and collaboration; and connections to its well-established network of partners and professionals. For more information, please visit http://www.ctinnovations.com.

See original release http://www.prweb.com/releases/2018/05/prweb15464398.htm

OncoSynergy Appoints Oncology Drug Development Veteran Jean Pierre Bizzari, MD to Scientific Advisory Board

By | news

SAN FRANCISCO, California, May 10, 2016.

OncoSynergy, Inc., a biopharma company developing a novel class of therapies for oncology, Resistance Mechanism Inhibitors (RMIs), announced today that it has appointed former Celgene and Sanofi-Aventis Executive, Jean Pierre Bizzari, MD, to its Scientific Advisory Board. Dr. Bizzari brings 33 years of industry experience with several major accomplishments including overseeing the approval of multiple leading oncology products such as ABRAXANE® ,TAXOTERE®,, REVLIMID® and ELOXATIN®.

Most recently, Dr. Bizzari was Group Head, Clinical Oncology Development at Celgene Corporation where he also was Chairman of the Hematology Oncology Development Committee. He currently serves on the Boards of Transgene SA, Halozyme Therapeutics, Inc., Celator Pharmaceuticals, Inc., Pieris Pharmaceuticals, Inc., Iteos Therapeutics SA, and Onxeo SA.  He is also a Board Member of the European Organization of Research and Treatment of Cancer (EORTC) and Chairman of the New Drug Advisory Committee.

“We are honored to welcome Dr. Bizzari to our Scientific Board,” said Shawn Carbonell, MD, PhD, Co-Founder and CEO of OncoSynergy. “Jean-Pierre has been a major driver of advances in oncology, orchestrating efforts to bring new innovative medicines to cancer patients with grave unmet needs. His wealth of industry experience will be a major asset to OncoSynergy, most notably as we continue development of our first-in-class RMI candidate, OS2966, towards clinical trials in the next year.

“I look forward to working with the team at OncoSynergy to advance their novel RMI drug platforms towards the clinic,” said Dr. Bizzari. “I strongly believe their highly innovative approach targeting the tumor microenvironment to inhibit multiple cancer hallmarks with a single therapy represents a major advance towards providing meaningful patient outcomes in oncology.”

Dr. Bizzari will serve along side other leading clinicians and scientists on the OncoSynergy SAB including Mina J. Bissell, PhD, tumor microenvironment pioneer and the 2016 E.B. Wilson Medal Awardee; Rick Horwitz, PhD, discoverer of the integrin family of adhesion receptors and the founding Executive Director of the Allen Institute for Cell Science; and Pamela Munster, MD, Director of the Early Phase Clinical Trials Unit and Leader of the Developmental Therapeutics Program at UCSF.

FDA Grants Second Orphan Drug Designation for OS2966

By | news

SAN FRANCISCO, California, January 20, 2015. 

OncoSynergy announced today that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for OS2966 in the treatment of ovarian cancer. The investigational drug candidate, a neutralizing anti-CD29 monoclonal antibody, received orphan designation for glioblastoma last summer.

OS2966 is a first in class therapeutic candidate that selectively blocks CD29 (integrin β1 subunit), a critical path driver of cancer and therapy resistance. Pre-clinical data suggest OS2966 may be active against numerous solid cancers including ovarian, brain, and breast cancer.

“We are pleased to achieve this important regulatory milestone and to begin a collaborative relationship with the Agency and the OOPD as we advance OS2966 towards clinical trials,” commented Dr. Anne-Marie Carbonell, MD, Vice President of Clinical Development for OncoSynergy. “Orphan designation is a major step towards expediting this promising therapy to a patient population with few treatment options.”

The mission of the FDA OOPD is to advance the development of products for the diagnosis and/or treatment of rare diseases.  By providing incentives to sponsors the program has successfully enabled development of greater than 400 drugs and biologics for rare diseases since 1983.

“This is an encouraging development for patients with ovarian cancer,” said Dr. Pamela Munster, MD, Professor of Medical Oncology at UCSF. “OS2966 has shown great promise in pre-clinical models of metastatic and resistant ovarian cancer including malignant ascites.”

OncoSynergy and CMC partner to combat Ebola

By | news, Uncategorized

SEATTLE, SAN FRANCISCO, COPENHAGEN (Denmark), and STRASBOURG (France), December 16, 2014.

Experimental monoclonal antibody to be used in clinical trials with patients in West Africa infected with the Ebola virus. Recent data from the World Health Organization said the virus has infected 18,000 people, with a fatality rate greater than 60%.

CMC Biologics and OncoSynergy have entered into an agreement for process development and GMP manufacture of OS2966 – a novel potential treatment for Ebola. The investigational drug candidate, designed to inhibit a major cellular adhesion receptor (CD29) that is fundamental for progression of aggressive and resistant cancer tumors, was granted orphan drug designation by the U.S. FDA earlier this year in the treatment of glioblastoma. Previous studies have suggested CD29 is required for Ebola virus infection; blocking CD29 could halt Ebola’s spread in the body.

OS2966, a monoclonal antibody, is being investigated in multiple models of highly aggressive cancers and other diseases of high unmet need. Recently, in collaboration with multiple eminent Ebola scientists internationally, OncoSynergy has demonstrated OS2966 blocks the ability of Ebola virus to enter cells in laboratory models. Further studies, including primate models, are ongoing or in development. Proposed West Africa trials will examine safety and dosing and test the effectiveness of OS2966 against Ebola virus disease in humans.

“We are truly honored to be a strategic partner with OncoSynergy to help address this current global health crisis, and deploying resources necessary to produce clinical material as quickly as possible,” said Global Chief Operations Officer of CMC Biologics, Gustavo Mahler. “In December last year, we began working with OncoSynergy for development and GMP manufacturing of OS2966 for their IND enabling studies and clinical trials in cancer. Given our strong relationship, we were able to quickly put in place an agreement that enables aggressive timelines and provides a progressive coststructure that benefits this global health program. Projects like these best define our commitment to the advancement of protein therapeutics to help our customers worldwide.”

“Our experience with CMC Biologics’ cell line and process development capabilities to develop GMP material for our clinical studies in cancer has been outstanding,” said Dr. Shawn Carbonell, founder and CEO of OncoSynergy. “They have exceeded expected expression levels in a high productivity system while producing quality material. Excellent technical capabilities applied to cell line development; rapid, sophisticated product analysis; and streamlined formulation development have resulted in an expedited path to provide material for Ebola clinical trials. This performance, combined with our strong relationship and satisfaction with our project team experience, has given us the confidence to move the Ebola project forward quickly to address the current West African outbreak.”

Orphan Drug Designation Obtained for OS2966

By | news
SAN FRANCISCO, PRNewswire-iReach, August 12, 2014.
OncoSynergy announced today that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for the investigational drug candidate OS2966, a neutralizing anti-CD29 monoclonal antibody, for the treatment of glioblastoma, the most common and deadliest primary adult brain tumor.

(Photo: http://photos.prnewswire.com/prnh/20140811/135194)

OS2966 is a first in class therapeutic being investigated in multiple models of highly aggressive and resistant solid cancers. OS2966 selectively modulates CD29 (integrin b1 subunit), a critical path driver of multiple mechanisms of tumor growth and progression including proliferation, invasion, angiogenesis, and therapy resistance. Pre-clinical data suggest OS2966 may be active against numerous solid cancers including recurrent and therapy resistant glioblastoma.

“The FDA’s decision to grant orphan drug designation highlights the promise of our program and the dire unmet need in glioblastoma where median survival is a mere 15 months despite maximal current therapy,” commented Dr. W. Shawn Carbonell, MD, PhD, Founder and CEO of OncoSynergy.

The mission of the FDA OOPD is to advance the development of products for the diagnosis and/or treatment of rare diseases.  By providing incentives to sponsors the program has successfully enabled development of greater than 400 drugs and biologics for rare diseases since 1983.

“We are pleased to achieve this important regulatory milestone and to begin a collaborative relationship with the Agency and the OOPD as we advance OS2966 towards clinical trials,” said Dr. Anne-Marie Carbonell, MD, Vice President of Clinical Development for OncoSynergy. “Orphan designation is a major step towards expediting this promising therapy to a patient population with few treatment options.”

About OncoSynergy – OncoSynergy is a biopharmaceutical company based in San Francisco, California focused on addressing unmet needs in oncology, particularly orphan cancers. Our vision is to radically improve outcomes for cancer patients though our unique “S.M.A.R.T.” targeted approach allowing for broad inhibition of multiple fundamental cancer growth and progression mechanisms with a single drug. OncoSynergy’s lead drug candidate, OS2966, blocks a critical path target driving multiple malignant cancer phenotypes and has demonstrated preclinical efficacy in several solid cancer models including therapy resistant glioblastoma. To learn more, visit www.oncosynergy.com.

Media Contact: W. Shawn Carbonell, MD, PhD, OncoSynergy, Inc., 415-666-2391

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE OncoSynergy, Inc.

Emerging Company Profile in BioCentury, The Bernstein Report

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OncoSynergy and our lead therapeutic program, OS2966, were featured in an ‘Emerging Company Profile’ in BioCentury, The Bernstein Report on BioBusiness.

See pdf 061614_ECP_OncoSynergy

The Bernstein Report is the flagship weekly publication of BioCentury Publications, Inc. providing analysis and commentary on the biopharma industry.

OS2966 is currently under development for the treatment of orphan cancers with high unmet need. A Phase I clinical trial is being planned for glioblastoma, the most common and malignant brain tumor in adults.

Please contact us at info@oncosynergy.com for more information.

OncoSynergy and CMC Biologics Enter into Agreement for OS2966 Drug Program

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OncoSynergy and CMC Biologics enter into agreement to develop and manufacture material for IND enabling studies and phase I clinical trials. This work will advance OncoSynergy’s OS2966 monoclonal antibody drug platform based on its “Targeted Synergy” approach — a transformative strategy allowing single drug inhibition of multiple fundamental cancer growth and treatment resistance mechanisms. OS2966 is being developed for glioblastoma, an aggressive, therapy resistant brain cancer.

For more information, please see the official joint news release.

Translational Research Award at World Federation of Neuro-Oncology Meeting

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OncoSynergy collaborator, Manish K. Aghi, MD, PhD, Associate Professor of Neurosurgery at University of California at San Francisco, was awarded the Young Investigator Award for Basic/Translational Research at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology for work further describing a novel mechanism of antiangiogenic treatment resistance in glioblastoma. This builds upon initial research by OncoSynergy Founder and CEO, W. Shawn Carbonell, MD, PhD and further demonstrates the outstanding potential of OS2966 for the treatment of malignant brain cancers.