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OncoSynergy Launches Phase I Trial for Patients With Recurrent Glioblastoma

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OncoSynergy, a patient-focused biotech startup founded by physicians trained in neurosurgery has opened enrollment in their phase 1 trial which will study OS2966, a novel therapeutic antibody, for treatment of glioblastoma.  The trial will take place at Moffitt Cancer Center in Tampa, Florida under the leadership of Michael Vogelbaum, MD, PhD.

OS2966 inhibits Beta1 integrin (CD29), a critical receptor responsible for integrating cancer promoting signals and driving cancer growth and spread.  Studies have demonstrated that resistance to anti-angiogenic therapy (i.e., bevacizumab) is associated with increased expression of Beta1 integrin.  OncoSynergy studied OS2966 in animal models implanted with patient tumor samples that had become resistant to treatment with bevacizumab.  These studies revealed that OS2966 prevented the ability of bevacizumab-resistant tumor cells to invade the surrounding brain and resulted in significant tumor cell death (Carbonell et al, 2013).

Despite advancement of several new promising cancer treatments, successful treatment of glioblastoma has been limited by the presence of the brain’s protective blood brain barrier and the invasive nature of glioblastoma.  To combat these obstacles, a technique called convection-enhanced delivery (CED) will be utilized to deliver OS2966 directly to the brain tumor and surrounding tumor-infiltrated brain.

The primary goal of this phase 1 study is to determine the safety and tolerability of OS2966 when delivered directly to the brain.  That said, given pre-clinical data demonstrating OS2966’s ability to address therapy resistant tumors and a delivery technique designed to overcome obstacles specific to glioblastoma, the ultimate hope is to improve outcomes for patients suffering from this formidable disease.

You can find out more about this trial by on Clinicaltrials.gov.

 

Original Post: https://virtualtrials.org/newsarticle.cfm?item=6957

OncoSynergy Receives $300K STTR Grant to Develop Novel Oncolytic Virus

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GREENWICH, CONN. (PRWEB) JANUARY 14, 2020

OncoSynergy, Inc., a patient-focused oncology company committed to advancing therapeutics to address dire unmet medical needs, announces today that the company has been awarded a Phase I Small Business Technology Transfer (STTR) grant valued at $300,000 from the National Cancer Institute (NCI). This award will support the development of an oncolytic virus that expresses a fragment of OncoSynergy’s proprietary antibody, OS2966, the first-ever IND approved anti-CD29 (beta 1 integrin) therapeutic. This is the company’s first STTR award.

“I am thrilled to be working with Dr. Anne-Marie Carbonell on this project, who shares the vision of developing safe and effective cancer treatments for patients,” said Balveen Kaur, PhD, Vice Chair of Research at Department of Neurosurgery, University of Texas Health Science Center at Houston and Co-Investigator for the project. “OncoSynergy’s commitment to fighting the most formidable cancers shines light on immunotherapies like OS2966 and will shape the future approach to cancer treatment.”

Preliminary testing of OS2966 in combination with the oncolytic herpes simplex virus-1 (oHSV) demonstrates the synergistic potential of the combinatory treatment approach to improve the anti-tumor efficacy of conventional oHSV therapy. In fact, Dr. Kaur’s lab reports that OS2966 treatment resulted in enhanced oHSV replication and tumor cell death in animal models of triple-negative breast cancer and glioblastoma.

“By engineering an oncolytic virus that expresses our first-in-class antibody, OS2966, we hope to unleash the full power of oncolytic viral therapy to the dramatic benefit of patients suffering from glioblastoma and other cancers,” said Anne-Marie Carbonell, MD, CEO and Chief Medical Officer of OncoSynergy. “We are grateful for NCI’s recognition of the breakthrough potential of this project and are excited to see years of collaboration with Dr. Kaur’s lab come to fruition.”

Currently, the company is preparing for their Phase I clinical trial to evaluate OS2966 in patients with recurrent glioblastoma and is set to enroll their first patient Q1 2020.

About OncoSynergy: OncoSynergy is a privately held, clinical-stage biopharmaceutical company. Founded in 2011, the company employs a patient-focused and lean capital efficient approach to the development of innovative therapies for cancers of high unmet need and of high commercial value. OncoSynergy’s lead therapeutic, OS2966, is the first-ever clinical-ready CD29 antibody under development for treatment of diverse cancers. It’s mechanism of action involves targeting fundamental interactions in the tumor microenvironment driving cancer progression, growth and treatment resistance. OS2966 was recently granted Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA). This IND approval enables OncoSynergy to initiate a Phase 1 clinical trial evaluating OS2966 in patients with recurrent glioblastoma, the most aggressive and deadly brain cancer.

About the National Cancer Institute (NCI): NCI leads the National Cancer Program and the National Institutes of Health (NIH) efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at cancer.gov or call NCI’s contact center, the Cancer Information Service, at 1-800-4-CANCER (1-800-422-6237).

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

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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 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 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.”

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

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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.