SAN DIEGO--(BUSINESS WIRE)--Samuel C. Wagner, President and CEO of Batu Biologics, has issued the following letter to the shareholders of the Company, providing a comprehensive update on the clinical progress of the ValloVax immune therapy:
On behalf of Batu Biologics, I am pleased to provide a synopsis of our current progress in the development of our tumor angiogenesis targeting immune therapy, ValloVax.
2017 was a landmark year for the Company. Last year we published mechanistic animal model data supporting the preclinical proof of concept for ValloVax in the Journal Oncotarget. Additionally, we established SOPs for the full GMP production of our vaccine at a prestigious university facility with over 20 years of cell therapy experience to support our Phase I clinical trial for ValloVax. We were also pleased to announce the recruitment of several key members to our team such as Dr. Santosh Kesari as our Chief Medical Officer and Dr. Vijay Mahant as an active member of our Scientific Advisory Board. The year ended in a climax with the FDA’s formal clearance of our Investigational New Drug application for ValloVax, enabling the Company to proceed with a Phase I study for NSCLC.
Batu Biologics has broken several historical benchmarks in developing our therapeutic through this critical milestone. We have brought ValloVax from “bench to bedside” in less than 4 years, and with less than $3 Million in invested capital; thus demonstrating our capital efficiency and laser focus for the continued development of the program. Typically within the industry, following the discovery of a compound with potential therapeutic efficacy, it can take over 5 years and approximately $10 Million in capital to receive a cleared Investigational New Drug Application with the FDA. Moreover, on average only 5 out of 5,000 drugs that enter preclinical testing progress to human testing1.
While transitioning from preclinical to clinical stage, we understand that animal models can often be poor predictors of response to therapy. Whereas some might favor an expedited pathway to market with a focus on a single indication, our scientific consensus has been that a larger scale pilot study would more accurately define the next steps that we should take for the best chance at commercialization of ValloVax. In essence, we wanted to have more clinical experience with our “first in class” therapy to yield a better understanding of dose response, immunogenicity, safety, and efficacy in specific solid tumor indications of interest. The goal of this approach was to test our approved protocol and make preliminary modifications prior to the deployment of a US Phase ½ study in order to ensure the highest likelihood of successful outcomes.
In October 2017 we had the opportunity to connect with the CHIPSA Hospital, an integrative immunotherapy hospital based out of Playas Tijuana, Mexico, which had a treatment model that we were intrigued to explore further. CHIPSA focuses on combining alternative and conventional strategies to fight cancer, supplementing the conventional theories of tumor immunology on the basis of the following key pillars: a.) damaging the tumor directly b.) inducing intratumor inflammation and c.) generally stimulating the immune system.
Together, Batu and CHIPSA recognized an opportunity to join forces in a paradigm shifting mission. We developed a common goal of commercializing ValloVax in Mexico in parallel to our US clinical development, with the objective of seeking formal registration with COFEPRIS, the Mexican regulatory authority on drug development. The initial step toward this milestone was implemented in November of 2017 when CHIPSA agreed to launch an investigator initiated pilot clinical study for ValloVax in metastatic solid tumor patients who have failed the conventional standard of care.
The protocol developed for the clinical study at the CHIPSA hospital is based on our FDA protocol, and patients who meet the eligibility criteria receive a total of 5 immunizations. Once weekly for three weeks, with booster immunizations on month 3 and month 6 of follow up.
Batu Biologics is proud to announce the following highlights from our clinical trial with the CHIPSA Hospital:
- We have reached the target enrollment of 100 patients and the study is scheduled for completion in December of 2018.
- The vaccine has been well tolerated with no signs of autoimmunity against healthy vasculature or any effect on normal wound healing, primary concerns based on the mechanism of action of our approach.
- In collaboration with Northwestern University, we have quantified antibody responses against VEGFR1, VEGFR2, Endoglin, and TEM-1 in the first 17 patients, demonstrating immunological proof of concept. We are in the process of evaluating these targets as potential functional biomarkers that can 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.
- We plan to use more in depth methods of analyzing the cellular immune response for the CHIPSA trial such as TCR sequencing to gain a more in depth understanding of the diverse T cell response to therapy.
The developments as part of the investigator initiated trial with the CHIPSA Hospital have allowed us to optimize the Phase I protocol for Non Small Cell Lung Cancer, we are now preparing to launch the clinical trial at the John Wayne Cancer Institute in collaboration with our CMO Dr. Santosh Kesari.
Batu Biologics has launched a fundraising effort seeking $3M in gross proceeds at $1.50 per share under a Regulation D 506(c) offering to fund the deployment of our Phase I study designed to evaluate the safety and immunogenicity of ValloVax in patients with lung cancer. Currently, the offering is available exclusively for accredited investors.
By specifically targeting private investors, and staying away from Venture Capital investment, the Company will be able to minimize dilution, maintain control, and adhere to our mission of bringing this therapeutic all the way from conceptual stage to market.
It is also worth noting here that the recent “Right to Try” legislation signed into law by President Trump signals a new shift in drug development and commercialization strategies within the United States that will benefit Batu Biologics. This new set of laws allows doctors in the United States to administer drugs that have passed through a Phase I clinical trial. This means that Batu Biologics can take steps to ensure that patients with cancer across the country have access to the ValloVax immune therapy in the short term future.
Going forward, the completion of the Phase I study for NSCLC will be a primary value driver for the Company and will set the stage for pharmaceutical partnership and liquidity events for our shareholder base.
Thank you very much for your steadfast support of our mission to transform the standard of care for the treatment of cancer.
Samuel C. Wagner
President and CEO
Safe Harbor Statement:
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Private Placement Memorandum. To the extent that statements in this press release are not strictly historical, including statements as to product launch timing, revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future collaboration agreements, or otherwise as to future events, such statements are forward looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.