Pivotal Therapeutics, Inc. is a clinical‐stage biopharmaceutical company focused on the discovery and development of targeted immunotherapies for oncology and autoimmune indications. Headquartered in Cambridge, Massachusetts, the company leverages a proprietary platform that integrates high‐throughput screening with computational immunology to identify and optimize novel biologic drug candidates. Pivotal Therapeutics’ mission is to advance next‐generation therapies that address unmet medical needs by harnessing the body’s own immune system.
The company’s pipeline is anchored by two lead candidates: PVT‐101, a monoclonal antibody targeting the IL-15 receptor designed for the treatment of non-muscle invasive bladder cancer, and PVT-201, a bispecific biologic engineered to engage both PD-1 and TIGIT pathways in solid tumors. PVT-101 has completed a Phase 1 safety trial and is preparing for a pivotal Phase 2 study, while PVT-201 is in late‐stage preclinical development ahead of an anticipated Investigational New Drug (IND) application. In addition, Pivotal Therapeutics is advancing several discovery‐stage programs in autoimmune disorders, including a novel anti-cytokine antibody portfolio for rheumatoid arthritis and inflammatory bowel disease.
Founded in 2014 as a spin-out from Harvard Medical School, Pivotal Therapeutics has built research operations in the United States and Europe, collaborating with leading academic centers in Boston, London and Berlin. The company’s translational research team works closely with external partners to validate preclinical models and accelerate IND‐enabling studies. Pivotal has also established strategic collaborations with biomanufacturing facilities in North Carolina and Ireland to scale its biologics for clinical and commercial supply.
Under the leadership of CEO Dr. Jane E. Roberts, an immunologist with over 20 years of experience in biologics development, and CSO Dr. Michael T. Alvarez, Pivotal Therapeutics has assembled a management team with deep expertise in clinical development, regulatory affairs and commercial strategy. The company continues to expand its pipeline and pursue partnerships with larger pharmaceutical organizations to advance its immunotherapy candidates through late‐stage development and potential commercialization.
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