Market Overview

Batu Biologics Identifies Gene Types Associated with Response to ValloVax


Preliminary Evaluation of Over 100 Patients Treated with Cancer Blood
Vessel Targeting Immunotherapy Reveals Gene Association with Clinical

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

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

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