Protalex, Inc. (OTCMKTS:PRTX) is a clinical-stage biotechnology company focused on the development and commercialization of allogeneic cell-based immunotherapies for oncology and infectious diseases. Utilizing a proprietary platform that engineers and expands donor-derived natural killer (NK) and T cells, the company seeks to deliver off-the-shelf therapeutic candidates that target tumor-associated antigens and viral pathogens. Protalex’s pipeline includes early-stage programs designed to address high-unmet-need conditions such as acute myeloid leukemia and solid tumors, with the goal of offering scalable and cost-effective alternatives to autologous approaches.
The company’s lead asset, PRTX-101, is an engineered NK cell therapy currently in Phase I/II trials for patients with relapsed or refractory hematological malignancies. This candidate is designed to recognize and eliminate cancer cells through a combination of receptor-mediated targeting and enhanced in vivo survival. In parallel, Protalex is advancing PRTX-201, a next-generation T cell product tailored for solid tumor indications, leveraging cytokine armoring to improve persistence and anti-tumor activity. Both programs reflect Protalex’s commitment to integrating novel gene-editing techniques and optimized manufacturing protocols to improve safety, efficacy and patient accessibility.
Headquartered in Cambridge, Massachusetts, Protalex maintains research and production facilities in the United States and Europe, supporting scalable GMP manufacturing and global clinical development. The company collaborates with academic centers and contract research organizations across North America, Europe and Asia to accelerate IND filings and broaden its clinical footprint. Protalex’s cross-functional teams oversee end-to-end process development, from donor selection and cell expansion to quality control and regulatory compliance, ensuring robust supply chain management for multi-site trials.
Protalex is led by a management team with deep expertise in cell therapy, process engineering and regulatory affairs. President and Chief Executive Officer John P. Lancaster brings more than 25 years of experience in biotech leadership, having previously held senior roles at both Amgen and Genentech. Chief Scientific Officer Dr. Linda Wu, a recognized authority in immune cell engineering, spearheads the company’s R&D strategy, while Chief Operating Officer Mark Reynolds oversees manufacturing scale-up and strategic partnerships. Together, this leadership team positions Protalex to advance its proprietary immunotherapy platform toward commercialization.
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