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

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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 Designation for OS2966

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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.”

Orphan Drug Designation Obtained for OS2966

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SAN FRANCISCOAug. 12, 2014 /PRNewswire-iReach/ — 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.

Martin Karplus awarded the 2013 Nobel Prize in chemistry

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Martin Karplus, a co-inventor of key OncoSynergy technologies, awarded the 2013 Nobel Prize in chemistry. Professor Karplus is the Theodore William Richards Professor of Chemistry Emeritus at Harvard and Visiting Professor at the University of Strasbourg’s Institute of Science and Supramolecular Engineering (CNRS/ Université de Strasbourg).

http://www.nobelprize.org/nobel_prizes/chemistry/laureates/2013/press.html