All Posts By

Onco_staff

Apr 16
2

OncoSynergy Announces First Patient Treated in First-in-Human Clinical Trial of OS2966 in Recurrent Glioblastoma

By | news

STAMFORD CONN. March 9, 2021

OncoSynergy, Inc., a physician-founded oncology company committed to advancing therapeutics to address dire unmet medical needs, announced today that the first patient was treated in the Company’s First-in-Human Phase 1 clinical trial evaluating OS2966 for the treatment of recurrent glioblastoma at Moffitt Cancer Center in Tampa, Florida.  OS2966 is a first-in-class immunotherapy, and the first ever anti-CD29 (beta 1 integrin) therapeutic to reach human trials.

“Glioblastoma is a devastating brain cancer with few treatment options.  Its invasive growth pattern, propensity for rapid treatment resistance, and the presence of the blood-brain-barrier (BBB) preventing many therapeutics from reaching the site of disease, makes successful treatment of glioblastoma one of the biggest challenges facing oncologists and neurosurgeons,” said OncoSynergy Co-Founder and Chief Executive Officer, Anne-Marie Carbonell, MD.  “After a decade developing and demonstrating the pre-clinical potential of OS2966 in the most difficult to treat cancers, we are thrilled to have treated our first patient in a study specifically designed to overcome these challenges.”

OS2966 is a monoclonal antibody blocking CD29, a critical cell surface receptor governing multiple fundamental biological processes driving cancer growth, invasiveness, and resistance.  In OncoSynergy’s First-in-Human Phase 1 trial, OS2966 is delivered directly to the patient’s brain tumor by convection-enhanced delivery (CED), a minimally invasive technique used to bypass the BBB.  As CED involves placement of one or more catheters, OncoSynergy has partnered with Infuseon Therapeutics, a Cleveland Clinic spinout company and is utilizing Infuseon’s Cleveland Multiport Catheter™ to deliver OS2966.

Patients enrolled in the study must have recurrence or progression of their disease which requires tumor resection.  Incorporating tumor resection into the trial design allows for acquisition of therapeutic-infused tumor tissue enabling researchers to perform critical studies that provide additional near real-time information on how the drug performs as well as inform dosing.

“Surgical removal of a glioblastoma tumor alone is not curative because tumor cells infiltrating into the surrounding brain cannot be safely removed.  The fact that nearly all therapeutics cannot cross the blood-brain-barrier to get to those residual tumor cells means that there is an opportunity for neurosurgeons to become more involved in the therapeutic development process,” said Michael Vogelbaum, MD, PhD, Program Leader of Neuro-Oncology and Chief of Neurosurgery at Moffitt Cancer Center. Dr. Vogelbaum continued,  “Trials that consider the importance of successful delivery of a therapeutic, like OncoSynergy’s OS2966, to treat glioblastoma will provide an advantage to improving patient outcomes.”  Dr. Vogelbaum is also the Chief Medical Officer of Infuseon Therapeutics and inventor of the Cleveland Multiport Catheter™.  His role as the Primary Investigator of OncoSynergy’s trial is addressed under a conflict-of-interest management plan approved by Moffitt Cancer Center.

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 high commercial value. OncoSynergy’s lead therapeutic, OS2966, is the first-ever clinically used CD29 antibody under development for treatment of diverse solid and hematologic cancers. Its mechanism of action involves targeting fundamental interactions in the tumor microenvironment driving cancer progression, growth, and treatment resistance. OS2966 was granted Investigational New Drug approval by the U.S. Food and Drug Administration (FDA) enabling a clinical trial in recurrent glioblastoma and holds FDA Orphan Drug Designation for treatment of glioblastoma and ovarian cancer.

Original Post: https://www.prnewswire.com/news-releases/oncosynergy

Nov 17
0

OncoSynergy Launches Phase I Trial for Patients With Recurrent Glioblastoma

By | news

STAMFORD, CONN. November 17, 2020

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: Musella Foundation for Brain Tumor Research & Information

Jan 24
0

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

By | news

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).

Jun 20
0

OncoSynergy and Infuseon Therapeutics Partner to Combat Glioblastoma

By | news

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:  Anne-Marie Carbonell, MD, info@oncosynergy.com +1 (203) 428-6507