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OncoSynergy and Infuseon Therapeutics Partner to Combat Glioblastoma

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South San Francisco, California – June 20, 2017 – Infuseon Therapeutics and OncoSynergy have entered into a strategic alliance to test an investigational glioblastoma therapeutic, OS2966, in combination with a novel delivery device, the Cleveland Multiport CatheterTM. Glioblastoma is the most common and malignant primary brain tumor. Despite a median survival of merely 12 months, there have been only four FDA approved therapies and no improvement in overall survival in nearly three decades. This unmet need is driven in part by the inability of most chemotherapies and particularly biologics to penetrate the blood-brain-barrier.

Infuseon Therapeutics’ unique therapy delivery device, the Cleveland Multiport CatheterTM (CMC), a multiport convection-enhanced delivery catheter, was designed by neurosurgeon Michael Vogelbaum, MD, PhD, from Cleveland Clinic’s Brain Tumor and NeuroOncology Center, to more effectively deliver life-saving drugs to patients at the site of their disease. The reliability of the CMC as a loco-regional delivery device has been validated in pilot clinical trials involving delivery of a chemotherapy along with an MRI visible tracer in patients with recurrent high grade gliomas.

OncoSynergy is a UCSF spinout headquartered at Johnson & Johnson Innovation, JLABS (JLABS) in South San Francisco. JLABS @ SSF is a 30,000 square-foot life science innovation incubator, located in South San Francisco. The labs provide a flexible environment for start-up companies pursuing new technologies and research platforms to advance medical care. Through a “no strings attached” model, Johnson & Johnson Innovation does not take an equity stake in the companies occupying JLABS and the companies are free to develop products – either on their own, or by initiating a separate external partnership with Johnson & Johnson Innovation or any other company. OncoSynergy’s  first-in-class humanized and de-immunized monoclonal pan-CD29 antibody, OS2966, has demonstrated dramatic efficacy in multiple models of highly aggressive and metastatic solid cancers. Based on these data, the FDA has granted two Orphan Drug Designations for OS2966 including in the treatment of glioblastoma.

“We are pleased to join forces with Infuseon Therapeutics to tackle the complex biology of glioblastoma,” commented Anne-Marie Carbonell, MD, Vice President of Clinical Development at OncoSynergy. “The innovative combination of OS2966 and the CMC device seeks to address a huge unmet need and potentially change the way we treat patients suffering from malignant brain tumors.”

The collaboration aims to establish proof of concept that OS2966 can be successfully delivered directly to the brain with the CMC device as an impetus for a Phase I trial for the treatment of glioblastoma.

“Infuseon’s Cleveland Multiport Catheter was designed specifically to deliver therapeutics directly to the site of disease,” said Michael Vogelbaum, MD, PhD, co-Founder and Chief Medical Officer of Infuseon Therapeutics. “We are excited to pursue a potentially novel therapeutic approach to this difficult disease.”

About Infuseon Therapeutics – Infuseon Therapeutics was founded in 2012 by Cleveland Clinic for the purpose of developing its patented unique therapeutic delivery device, the Cleveland Multiport CatheterTM (CMC). Infuseon has collaborated with Parker-Hannifin Corporation, a global leader in motion and control technologies to enhance the medical design, development, and manufacturing expertise of the company. As an inventor of the multiport catheter, Dr. Vogelbaum is entitled to a portion of any commercialization revenues Cleveland Clinic receives from Infuseon. To learn more visit www.infuseontherapeutics.com

Media contact: Neema Mayhugh, PhD   nmayhugh@infuseontherapeutics.com  (216) 312-9165

 

About OncoSynergy – Oncosynergy is a UCSF spinout with primary operations in JLABS @ SSF, California. The company was founded in 2011 to address the complexity of cancer for more durable patient outcomes through the development of a new class of oncology therapeutics, called Resistance Mechanism Inhibitors (RMIs). RMIs uniquely inhibit multiple Cancer Hallmarks simultaneously. The lead RMI drug candidate, OS2966, is on track for Phase I clinical trials in 2018. To learn more visit www.oncosynergy.com

Media Contact:  Shawn Carbonell, MD, PhD, info@oncosynergy.com +1 (415) 666-2391

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.”

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 at UCSF for glioblastoma, the most common and malignant brain tumor in adults.

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

OncoSynergy a Sponsor of 2014 Race for Hope (curebraintumors.org)

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OncoSynergy is proud to be the Social Media Sponsor for the 17th running of the Race for Hope. This annual event to be held on May 4, 2014 in Washington, DC raises money and awareness for brain tumor research.

In addition, the race will be run by Team OncoSynergy including our very own Dr. Shawn Carbonell (Founder and CEO) and Dr. Anne-Marie Carbonell (VP of Clinical Development). Please visit our Team Page.

The Race for Hope will benefit both Accelerate Brain Cancer Cure (ABC2) and the National Brain Tumor Society.

Follow Race for Hope on FACEBOOK.

Left to Right: Anne-Marie Carbonell, MD (VP of Clinical Development, OncoSynergy); Max Wallace (CEO, ABC2); W. Shawn Carbonell, MD, PhD (Founder & CEO, OncoSynergy)

Left to Right: Anne-Marie Carbonell, MD (VP of Clinical Development, OncoSynergy); Max Wallace (CEO, ABC2); W. Shawn Carbonell, MD, PhD (Founder & CEO, OncoSynergy)

 

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