Mulberry Biotherapeutics is focused on delivering transformative improvements in the health and quality of life to individuals affected by the rare genetic disorder neurofibromatosis Type 2 (NF2).
We are developing novel targeted bacteria-mediated therapy for patients with NF2 and other non-cancerous neoplasms.
Neurofibromatosis Type 2 (NF2) is a rare genetic disorder that affects about 1 in 25,000 individuals globally. Brought about by mutations in the NF2 gene, NF2 causes tumors to form on nerve tissue, including the brain and spinal cord. NF2-related schwannomas (non-cancerous neoplasms) result in severe morbidity and mortality in affected individuals. Almost all NF2 patients lose their hearing, and many lose the ability to walk and even to see. NF2 patients’ average age at death is in their 30s and many die in adolescence or early adulthood from their disease.
Mulberry Biotherapeutics is developing a platform of novel bacteria-based therapies for rare non-cancerous tumors. With the support of the NF2 community, Mulberry is collaborating with research leaders and schwannoma experts to progress the development of its platform.
Schwannomas are non-cancerous neoplasms derived from Schwann-lineage cells that typically first appear in childhood and adolescence. They may arise sporadically or from the debilitating genetic syndromes neurofibromatosis Type 2 (NF2) and schwannomatosis. Depending on location and size, these tumors can cause a variety of neurological deficits including hearing loss, imbalance, tinnitus, motor loss, severe pain, and, in some cases, fatal brain stem compression. Operative resection and symptomatic management of pain are the main current treatments for schwannoma. Resection often causes additional neurologic damage, is typically non-curative, and may be impractical due to the location or quantity of tumors. Schwannomas represent a serious life-threatening condition as defined by the FDA.
MUL001 is a live attenuated strain of Salmonella typhimurium that is being developed by Mulberry Biotherapeutics as a targeted therapy for patients with schwannomas due to NF2. MUL001 provides the foundation for a platform of engineered bacteriotherapies for treating non-cancerous neoplasms. Additional potential indications include NF1, schwannomatosis, and meningioma. MUL001 will be administered directly into the tumors by guided intra-tumoral injection.
Bacterial therapy is well-suited for schwannomas given that they are genetically stable, slow growing, and highly vascularized with hypoxic areas. Schwannomas appear to provide an ideal environment for bacterial homing and survival, and an excellent target for bacterially mediated tumor cytotoxic and anti-angiogenic effects. Furthermore, schwannomas contain immunosuppressive type 2 macrophages and regulatory T cells providing the immunological environment necessary for bacteria-mediated release from an immunosuppressive phenotype and development of host anti-tumor immunity.
Mulberry is the first company to develop a bacteria-based therapy for the treatment of non-cancerous tumors such as those seen in NF2. We have demonstrated in animal models that intra-tumoral injection of attenuated S. typhimurium decreases the volume of the injected tumor through direct cytotoxic and anti- angiogenic effects; importantly, it also induces a systemic immune response that targets distal tumors and a memory response that prevents further development of new lesions. Preliminary evidence of efficacy in animal models of neurofibromatosis type 1 (NF1) and meningioma have also been generated and represent examples of other tumor types that are potential target indications for Mulberry’s innovative approach.
Mulberry Biotherapeutics has assembled a world-class internal and external team of advisors with unique expertise in bacterial engineering, tumor biology and rare disease drug development.
Neil Kirby, PhD
BOARD OF DIRECTORS
Tal Fuhrer, MBA
Tal is Vice President of Business and Corporate Development for Neopharm Group. He previously worked for Wyeth Consumer Healthcare where he gained experience in Global Business Development and Brand Management. In this capacity, he developed new product growth strategies for Wyeth’s top global OTC brand and established valuation models to assess market potential and analyze the competitive landscape. Tal holds an MBA, a M.Sc. degree in Biotechnology and a dual B.Sc. in Management and Biology from Tel Aviv University.
Neil Kirby, PhD
Neil has a successful record of delivering innovative products to the clinic (more than 25 INDs and 10 approved products). He was Chairman of Orphan Technologies until its acquisition by Travere Therapeutics in 2020 for over $500M. He has held executive positions in multiple biopharma organizations including, most recently, Phoenix Tissue Repair and Origin Biosciences. In addition, he has founded and acted as Chief Executive Officer for multiple pharmaceutical companies. He received a Bachelor of Pharmacy and Doctorate from the University of London.
Susan Luo, CFA, MBA
Susan is an early-stage private investor in life science and healthcare companies. In addition to serving on the Board of Mulberry Biotherapeutics, she also acts as an advisor to Acclaro Corporation and GBH, and as a Trustee for South Cove Manor Nursing Facilities Foundation. She earned a B.A. in Finance from University of International Business and Economics and M.B.A. from University of Virginia Darden School of Business.
Philip Reilly, MD, JD
Phil focuses on creating and building companies that develop breakthrough therapies for orphan genetic diseases. He is passionate about working with patient groups, and helping to unite those suffering from rare diseases in order to foster a support network and potentially improve patient outcomes. Phil has authored or co-authored more than 100 articles in scholarly journals and has published seven books including most recently Orphan: The Quest to Save Children with Rare Genetic Disorders. Phil currently serves on the Advisory Board to the Boston University School of Public Health, and has served as a trustee emeritus of Cornell University, an Overseer of Weill Cornell Medical College. He earned a B.A. from Cornell University, an M.D. from Yale University, and a J.D. from Columbia University.
Gary Brenner, MD, PhD
Gary currently sees patients at the Massachusetts General Hospital Pain Management Center where he is the Director of the Mass General Pain Medicine Fellowship. He is an Associate Professor in Anesthesia at Harvard Medical School. Gary runs an NIH-funded lab focused on developing gene- and cell-based immunotherapies for the often-painful peripheral nervous system tumors associated with neurofibromatosis. He also conducts neuroscience research on the mechanism of action of opioids in the brain, and has authored more than 45 articles, reviews, chapters, and abstracts on gene therapy strategies for NF tumors, the pathophysiology of pain, basic pain mechanisms and immune function, and clinical approaches to chronic pain. He has held several national leadership positions related to pain medicine education/training. He completed his MD and PhD degrees at the University of Rochester School of Medicine and Dentistry, and completed an anesthesiology residency and a pain medicine fellowship at the Massachusetts General Hospital.
John Mekalanos, PhD
John is a Professor of the Department of Microbiology at Harvard Medical School and has served as Chairman of the Department of Microbiology and Immunobiology for 20 years. John has received many honors, including the Eli Lilly Award, AAAS Newcomb Cleveland Prize, the City of Medicine Award, the Drexel Medicine Prize and election to the National Academy of Sciences and the American Academy of Microbiology. In 2022 he received the American Society of Microbiology Lifetime Achievement Award, the society’s highest honor. He is the unprecedented recipient of a three NIH Merit Awards. John has been a member of the FDA Advisory Committee on Vaccines and Related Biologics and has consulted for numerous governmental and private agencies. John has been a founder or member of the scientific advisory board of more than a dozen companies including four involved in vaccine and immunotherapy R&D research.
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