Polyvalent Vaccines Targeted Against Cancers With High Unmet Medical Need

MabVax Therapeutics has secured rights from MSKCC to exploit key aspects of the work of Dr. Philip Livingston and colleagues, who over the last 30 years have developed a series of monovalent (targeting a single tumor cell surface antigen) cancer vaccines against cancers of neuroectodermal (sarcoma, melanoma, neuroblastoma) and epithelial (breast, ovarian, colon, pancreatic) origin as well as small cell lung cancer (SCLC) which has attributes of both neuroectodermal and epithelial origin. These target molecules on malignant cells, known as carbohydrate antigens, are the most extensively expressed antigenic targets on the cell surface of these types of cancers and play a key roll in tumor progression and metastasis. The company benefits from the years of work and significant MSKCC investment in development and testing of the vaccines incorporating these antigens. Researchers at MSKCC have progressively developed highly immunogenic monovalent vaccines to each of the 11 validated target antigens that comprise the eight distinct vaccines in-licensed by the company. These monovalent vaccines or the combination of the monovalent forms into polyvalent vaccines (targeting multiple antigens) have been tested and refined not only in animal models but also in multiple clinical trials establishing immunogenicity, tolerability, and therapeutic utility. The company’s license agreement with MSKCC calls for MSKCC to transfer each vaccine IND to MabVax prior to the start of Phase II clinical trials for continued development and eventual commercialization.

Two distinct polyvalent vaccine products entered proof of concept randomized, controlled, Phase II clinical trials in sarcoma and ovarian cancer in July of 2010. Enrollment for both trials is proceeding on schedule to produce primary efficacy results in the second half of 2013. A Phase I confirmatory trial in small cell lung cancer is scheduled to begin in the second quarter of 2011. The company will be ready to initiate a Phase II SCLC clinical trial in the first half of 2012. Each of these cancer vaccines addresses a pressing unmet medical need and has significant market potential.