SAN DIEGO--(BUSINESS WIRE)--Batu Biologics, a clinical stage immuno-oncology Company, announced today the filing of a patent application covering methods of selecting patients likely to respond to ValloVax.
ValloVax is a placental endothelial cell based immunotherapy that is designed to stimulate an immune response against several antigens associated with tumor blood vessel formation, or angiogenesis.
“It is well established in the area of organ transplantation that the rate and degree of tissue rejection is largely determined by HLA composition of the donor transplanted organ in relation to the HLA composition of the recipient. Therefore, the relationship between the HLA of the transplant and the patient directly plays a role in determining the immunogenicity of the transplant,” stated Samuel Wagner, President and CEO of Batu Biologics. “In the case of cellular therapeutic cancer vaccines, you can think of the cellular product as a transplant that is designed to be rejected. The stronger the degree of tissue rejection, the stronger the immunogenicity of the vaccine. Batu Biologics has developed proprietary methods of personalizing the immunogenicity of our vaccine by predicting clinical response using specific HLA alleles found to be restricted to patients who have historically responded to our therapy.”
“The concept of personalizing the immunogenicity of Batu Biologics’ lead program ValloVax, means that the Company is in the process of developing screening methodologies to identify patients who are ideal candidates to receive this immunotherapy,” said Dr. Santosh Kesari, consulting Chief Medical Officer of Batu Biologics. “Therapeutic cancer vaccines designed to stimulate immunity to cancer have been well studied with the first FDA approval of a dendritic cell based vaccine for prostate cancer, Provenge, in April 2010. However demonstrating clinical efficacy in a statistically significant manner in the broad population has historically been difficult, and this has been demonstrated by numerous cancer vaccine failures in the Phase 3 setting. Traditionally patient stratification for cancer vaccines has been focused on matching vaccine targets to mutations on the patient’s tumor. However this approach fails to address a critical aspect of vaccine development: the efficacy of vaccines is primarily dependent on the patient’s ability to initiate a T cell response against the antigens of interest. Batu Biologics is taking a new approach to cancer vaccines, by addressing a key issue in vaccine development: the variability of immunogenicity on a patient-to-patient basis.”
By preselecting patients who are predisposed to have a stronger T cell mediated and antibody mediated immune response to the vaccine, Batu Biologics may be able to improve outcomes without the need to include toxic adjuvants in the formulation of the therapeutic product. Traditionally, adjuvants are carefully selected to modulate an immune response to vaccine antigens of interest. In Batu Biologics’ case, we are leveraging a natural understanding of transplantation immunology to optimize the immunogenicity of our vaccine.
Batu Biologics anticipates initiating a Phase 1/2 study for patients with metastatic non small cell lung cancer in the United States in late 2018. The phase 1 component of the study will focus on evaluating the safety and immunogenicity of ValloVax at two different dose levels. The Phase 2 component of the trial will focus on demonstrating efficacy of ValloVax directly compared to the standard of care in a defined patient population.