Mirror Biologics, Inc., a clinical stage immunotherapy company specializing in the development, manufacturing, commercialization and clinical translation of next generation immunomodulatory and therapeutic in-situ vaccines for cancer and infectious diseases, today announced the appointment of David Fineberg, MD, MBA, as Chief Medical Officer effective January 1, 2022.
Dr. Fineberg brings to the Company more than 18 years’ experience in the pharmaceutical industry with extensive experience in clinical development, regulatory affairs, pharmacovigilance and quality systems. Dr. Fineberg will oversee global clinical development activities for the patented “off-the-shelf,” non-genetically manipulated patented T cell product, AlloStim®, as well as managing the launch of new indications and future generations of this drug. Initial focus will be on accelerating current late stage clinical trials toward registration, including an ongoing pre-registration Phase IIb multi-site study in third line metastatic colorectal cancer being conducted in the USA and a planned randomized, controlled Phase II/III registration trial in advanced/metastatic hepatocellular carcinoma (liver cancer) in SE Asia expected to launch in early 2022.
Dr. Fineberg will also work to expand clinical development of the ongoing Phase I/II universal anti-viral prophylaxis vaccine study being conducted in the USA and oversee launch of a planned Phase I/II anti-aging study in SE Asia. Dr. Fineberg will also oversee efforts to obtain regulatory approval for launch of an expanded access program (compassionate use) in order to provide chemotherapy-refractory metastatic cancer patients access to the Allostim® investigational drug product outside of a formal clinical trial.
Adi Raviv, CEO of Mirror Biologics stated: “On behalf of the Board of Directors, I would like to congratulate David on his appointment as Chief Medical Officer. I am confident that he will be a tremendous asset to Mirror and a great addition to our executive management team. David is an experienced medical leader and international medical monitoring expert with experience across many disciplines including oncology, immunology, infectious disease, hematology, and surgical indications. He has experience managing clinical development of experimental drugs through all phases of clinical development. I believe that expanding our medical team with his leadership, broad expertise in drug development and management of global clinical trials will serve us well as we continue to build our clinical capabilities overall and strive towards achieving regulatory approvals for AlloStim®, our experimental, allogeneic- ‘off-the-shelf,’ non-genetically altered, living immune cell drug.”
Dr. Fineberg commented: “It is my honor to accept this opportunity to join the Mirror Biologics team and lead the Medical Affairs and Clinical Research activities of the Company as Chief Medical Officer. I look forward to advancing our current and planned clinical programs to further develop AlloStim® for the treatment of solid tumors, viral disease and anti-aging indications. This experimental drug, currently being evaluated in clinical trials in the US and overseas, elicits a powerful therapeutic immune response in patients regardless of the type of cancer cell or specific viral threat causing the disease and regardless of the age or health of the patient’s immune system. As the population ages, cancer, infectious disease and healthy aging are critical therapeutic targets with unmet medical needs. Mirror Biologics’ products are focused on both preventing and treating the worst of these diseases and hold promise for potentially improving the availability, affordability, tolerability, and treatment outcomes for patients worldwide.”
Dr. Fineberg most recently served as Vice President of Medical Affairs at Asahi Kasei Pharma America, and Vice President, Clinical Development Lead for ART-123 (thrombomodulin alfa) at Veloxis Pharmaceuticals. During his time at Asahi Kasei, Dr. Fineberg was responsible for all medical aspects of the development of the experimental ART-123 drug for the indications of sepsis-associated coagulopathy and prevention of oxaliplatin-induced peripheral neuropathy in patients with metastatic colorectal cancer receiving FOLFOX chemotherapy. Prior to these positions, Dr. Fineberg served for over 11 years at Grifols (previously Bayer Biological products, then Talecris Biotherapeutics) in the areas of quality systems, regulatory affairs, pharmacovigilance, and was the medical director for the Plasmin program pursuing the indication of acute peripheral arterial occlusion.
Dr. Fineberg received his undergraduate training at Syracuse University, studied medicine at the Sackler School of Medicine at Tel Aviv University, completed a residency in general surgery at the University at Buffalo, completed a fellowship in plastic and reconstructive surgery at the Albert Einstein College of Medicine, and obtained his Global Executive MBA from the UNC Kenan-Flagler Business School at the University of North Carolina at Chapel Hill.
About Mirror Biologics
Mirror Biologics is a clinical stage immunotherapy company specializing in the development, manufacturing and clinical translation of next generation therapeutic and preventative in-situ vaccines for cancer and infectious diseases. This international biopharmaceutical company was founded in 2019 and is headquartered in Tampa, Florida where it conducts advanced bioengineering research and development into commercial-scale living cell manufacturing systems and is establishing a 21 CFR 1271-compliant blood donor and cell processing center. As a Florida licensed medical facility, the Tampa site is being prepared for the compassionate treatment of patients pursuant to FDA guidelines such as Expanded Access and Right to Try provisions. Mirror also operates a GMP cell manufacturing facility in Jerusalem, Israel and has clinical and distribution partner offices in Bangkok, Thailand and Kuala Lumpur, Malaysia. The lead experimental drug, AlloStim®, is an “off-the-shelf,” non-genetically manipulated, patented, living immune cell differentiated from precursor cells purified from blood of healthy donors and formulated with monoclonal antibody-coated microparticles attached. Proprietary “artificial lymph node” bioreactors are being developed and are expected to enable the economical, high cell density, commercial scale-up of AlloStim®. The Mirror Effect® technology platform and related applications are protected by over 200 worldwide patents.
For more information on Mirror Biologics technology, visit our website: www.mirrorbio.com.
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