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May 03
0

FDA Grants Third Orphan Drug Designation for OS2966

By | news

STAMFORD, CONNECTICUT, January 10, 2023.

Research at Children’s Hospital Los Angeles has resulted in a novel therapeutic receiving orphan drug status from the Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML)—an aggressive cancer with poor survival rates.

The study, led by Yong-Mi Kim, MD, PhD, MPH, in the Cancer and Blood Disease Institute, found that the investigational drug—combined with chemotherapy—prolonged survival in preclinical models of AML.

Based on that data from CHLA, the FDA granted OncoSynergy Inc. orphan drug designation for the compound, OS2966, a first-in-class monoclonal antibody that targets a protein called integrin beta-1. The designation provides incentives to advance the development of new therapies for conditions affecting fewer than 200,000 people in the U.S.

Dr. Kim’s team presented the findings Dec. 12 at the American Society of Hematology Annual Meeting in New Orleans.

“These encouraging results bring us closer to a potential clinical trial in patients,” she says. “That’s important because there is a dire need for new treatments in AML.”

‘Unsticking’ cancer cells

Like other leukemias, AML is a cancer of the blood and bone marrow. But while acute lymphoblastic leukemia (ALL) now has a near-90% cure rate in children, AML’s survival rates are much lower. In patients under age 20, five-year survival is 69%; that number plummets to just 27% for those 20 or older.

One contributing factor to that lower survival: a lack of new therapies. “We have had many new drugs come forward for ALL. But in AML, we have been using the same drugs for the past 50 to 60 years,” Dr. Kim explains. “Although the FDA has approved a few new therapies recently, the majority of those only target specific sub-groups of AML. They are not for all patients.”

That need for new and more effective treatments is what drove Dr. Kim to expand her research to include AML. The team, which has long studied drug resistance in ALL, began investigating whether similar factors could be making AML more resistant to chemotherapy.

A major focus of the group’s research involves proteins called integrins. Integrins are located on the surface of cells and act like glue, enabling cells to “stick” in certain spots. Each of these proteins has two units: an alpha unit and a beta unit.

Dr. Kim’s lab previously discovered that both integrin alpha 4 and integrin alpha 6 help leukemia cells adhere to the bone marrow—a place where they are shielded from chemotherapy.

“It’s a glue in the wrong spot,” Dr. Kim explains. “We don’t want the cancer cells glued in the bone marrow, where they’re sheltered and not vulnerable to chemotherapy.”

New findings

Based on those earlier discoveries, the team sought a way to downregulate, or “turn off,” those integrins in AML, with the goal of dislodging cancer cells from their safe haven in the bone marrow.

The investigators—which included first author Heather Ogana in Dr. Kim’s lab—chose to target integrin beta-1 because it is a partner to both of the alpha units already shown to play a key role in leukemia drug resistance. To test their hypothesis, the researchers used CRISPR-Cas9 gene editing tools to delete the gene that encodes integrin beta-1.

“We found that knocking out integrin beta-1 also decreased expression of several alpha units,” Dr. Kim says. “That supported our idea that integrin beta-1 was a good potential target. We could target one molecule but impact many others at the same time.”

The team then tested the OS2966 antibody to try to block integrin beta-1 in preclinical mouse models of AML. The study showed that combining OS2966 with chemotherapy significantly prolonged survival in these models. In addition, the antibody made AML cells more sensitive to chemotherapy.

“We think the blocking of integrin beta-1 may be helpful in two ways,” Dr. Kim says. “It could physically unstick the cells, potentially drawing them out from hiding. But we also believe that the gluing of AML cells to their microenvironment may give off intracellular signaling that is critical for their survival. When we unstick them, we may be disrupting this signaling.”

Importantly, Dr. Kim’s studies used AML samples derived from patients. “Using patient samples, in addition to AML cell lines, is key to making these preclinical studies more realistic,” she explains. “That’s critical for future success.”

Aiming for a clinical trial

The goal now is to test OS2966 in a clinical trial for both adults and children with AML. Dr. Kim is working on preliminary plans for such a trial with Deepa Bhojwani, MD, Director of the Leukemia and Lymphoma Program at CHLA, and Marina Konopleva, MD, PhD, of Albert Einstein College of Medicine in New York.

Meanwhile, her team is also investigating the underlying signaling mechanisms behind integrin beta-1 and to determine whether this pathway is relevant for all types of AML. “So far it looks promising that this could apply to different AML patients, but more study is needed before we move to a trial,” she says.

OS2966 is under development by OncoSynergy, led by CEO Anne-Marie Carbonell, MD. It is currently in a phase 1 clinical trial for recurrent glioblastoma, a difficult-to-treat brain cancer.

Dr. Kim adds that the orphan drug designation is an important milestone to support the drug’s ongoing development. “We need more therapeutic options in AML,” she says. “My hope is that this research can help pave the way for new treatments to improve the outcomes for patients with this cancer.”

Study authors were Heather Ogana; Samantha Hurwitz; Zesheng Wan, PhD; Hye Na Kim, PhD; Samy Jambon, PhD; Hisham Abdel-Azim, MD; Miller Huang, PhD; Babak Moghimi, MD; Nora Heisterkamp, PhD; Anne-Marie Carbonell, MD; Chintan Parekh, MD; Marina Konopleva, MD, PhD; Deepa Bhojwani, MD; and Yong-Mi Kim, MD, PhD, MPH.

Learn more about the Cancer and Blood Disease Institute.

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, ovarian cancer, and acute myeloid leukemia.

Original Post: https://www.chla.org/blog/experts/research-and-breakthroughs/study-leads-orphan-drug-status-acute-myeloid-leukemia

Apr 16
2

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

By | news

STAMFORD, CONNECTICUT, 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, CONNECTICUT, 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, CONNECTICUT (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).

Apr 26
0

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

By | news

GREENWICH, CONNECTICUT (PRWEB), April 02, 2019.

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.”

Feb 25
0

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

May 08
3

OncoSynergy raises Series A Round

By | news

SAN FRANCISCO, California (PRWEB), May 04, 2018.

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

Jun 20
0

OncoSynergy and Infuseon Therapeutics Partner to Combat Glioblastoma

By | news

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

May 09
0

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.

Mar 17
1

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.”