Vallovax and CHIPSA
In October of 2017 Chipsa was introduced to Batu Biologics, a San Diego based Biotech company, whose mission aligned with Chipsa’s. How can we harness the power of the immune system to treat cancer?
Batu Biologics presented us with a novel therapy. A blood based vaccine that sought to target what many see as the achilles heel of solid tumors, the tumor endothelium vasculature. This is the system that feeds the tumors. Their goal was to literally “starve” the tumor of nutrients, causing them to shrink.
Current therapies were targeting only the endothelium growth factor, which is the oxygen supply for the tumors but neglected the actual food supply of the tumors, the endothelium vasculature.
Additionally Batu had received an investigational new drug (IND) approval from the FDA that would allow them to initiate clinical trual in the United States.
After review by our team of doctors, it was believed that ValloVax™ could fit well into Chipsa’s existing model for fighting solid tumors, a) damage the tumor directly b) induce intra-tumor inflammation and c) generally stimulate the immune system.
In November of 2017, Batu and Chipsa combined forces with common goal of bringing this treatment from bench to bedside in Mexico and together launched an Investigator initiated pilot clinical study for ValloVax™ in metastatic solid tumor patients who had failed the conventional standard of care.
The protocol developed for the clinical study at the CHIPSA hospital is structured around the ValloVax™ FDA protocol. Patients who met the eligibility criteria received a total of 5 immunizations. Once weekly for three weeks, with booster immunizations on month 3 and month 6 of follow up.
Below is an VIDEO that explains the mechanism of action of the ValloVax Immunotherapy:
The Highlights
Batu Biologics and CHIPSA are proud to announce the highlights of the clinical trial at Chipsa Hospital:
- The target enrollment of 100 patients was reached and the study is scheduled for completion in December of 2018.
- Vallovax™ was well tolerated with no signs of autoimmunity against healthy vasculature or any effect on normal wound healing.
- In collaboration with Northwestern University antibody responses we noted in the first 17 patients, demonstrating immunological proof of concept. These biomarkers may be used to predict clinical response to therapy.
- Within the next couple months we will be analyzing a second batch of patients to compare immune responses across the two different dose cohorts.
The developments of the trial at CHIPSA Hospital are now being used optimize the Phase I protocol for Non Small Cell Lung Cancer, that Batu is preparing to launch the clinical at the John Wayne Cancer Institute in collaboration with our CMO Dr. Santosh Kesari.
What The Future Holds
With the recent successes of immunotherapy in a variety of tumors, CHIPSA and Batu Biologics believe there is an increasing need for non-toxic options. Our Team is excited to bring immunotherapy to the forefront of medical research and will keep updated as more develops.
For more information on the Chipsa and Vallovax journey please one of previous articles “FDA Approves ValloVax for Phase 1 Trial…But It’s Available at CHIPSA Now!” by clicking here: