July 14, 2014 Issue
The Most Powerful Name In Corporate News and Information
Preclinical Drug Development for ValloVax(TM), the first anti-angiogenic cellular cancer vaccine
Founded in 2013, Batu Biologics is a preclinical biopharmaceutical company focusing on developing and commercializing allogeneic cell therapies in the area of immune modulation. The company’s products are centered around the idea of creating or breaking immune tolerance. The company is currently in the preclinical stages of drug development for its two flagship products: Immstem and Vallovax. With the recent successes of immunotherapy in a variety of tumors, Batu Biologics believes there is an increasing unmet need for non-toxic immune modulators that can augment efficacy of existing therapeutics. Our team is motivated to bring novel therapeutics to the forefront of medical research that use the power of the body’s own immune system to extend life expectancy. Batu Biologics has filed two provisional patents in the field of cancer immunotherapy and plans to significantly expand its IP in 2014.
Last month, Batu Biologics announced efforts to raise $100,000 through donation-based crowd funding to support completion of the company’s preclinical research in preparation of the filing of an Investigational New Drug (IND) application to the FDA.
9255 Towne Centre Drive
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine,
Published – July 14, 2014
Mr. Wagner, would you tell us the concept
behind Batu Biologics?
CEOCFO: How does your approach differ from what is available or what is being researched today?
Mr. Wagner: Current conventional methods of treatment for non-small stage lung cancer include chemotherapy, radiotherapy, and surgery. There are several disadvantages of the current therapies on the market, the first being that cancer has many mechanisms that allow itself to develop acquired drug resistance. The second disadvantage are the serious toxic side effects of current therapies that often compromise the patients immune system, and may often result in toxicity associated death. The third disadvantage is that relapse is common, current cancer therapies are not conducive to sustainable tumor regression, meaning that the eventual recurrence of cancer results in the patient having to return to conventional therapies.
We feel that there are several reasons why our product has advantages. We are targeting the tumor blood vessels because blood vessels are your own body’s cells and therefore they are less likely to develop drug resistance. Secondly, angiogenesis, the process of new blood vessel formation, is key to sustainable tumor growth. Without this process called angiogenesis, the tumors cannot grow bigger than one to two millimeters in diameter. We are trying to stop tumor growth and metastasis by stimulating an immune response specifically against those blood vessels. Instead of attacking the tumor directly, we are essentially trying to choke the tumor of its blood supply and in doing so we hope to stop tumor growth and allow for sustainable remission. Lastly, there have been recent studies published that provide conclusive evidence that the tumor blood vessels play a role in suppressing the host’s immune response against the tumor. By facilitating the destruction of the tumor endothelium, we are not only cutting off the blood supply, but also allowing for more T-cell infiltration into the tumor site, further increasing the chances of remission and extended patient survival.
CEOCFO: What is the drug actually doing that allows this to happen?
Mr. Wagner: We are taking these cells from a highly angiogenic environment that simulates the cancer microenvironment. Then we are making them more immunogenic in the lab, meaning the upregulation of specific identifying markers will allow your body will quickly recognize these cells as foreign. When a patient is vaccinated with these proprietary cells, the body recognizes the ValloVax™ cells as a potential pathogen. The ValloVax™ cells are then engulfed by antigen presenting cells which present the identifying markers that characterize ValloVax™ to the B cells in the patients lymph nodes. This results in the production of a wide immune response against multiple antigens expressed on the tumor endothelium; this is why we are calling our product the first anti-angiogenic polyvalent vaccine, because there are multiple pathways and targets of our immunotherapy.
CEOCFO: Why has no one done this before?
Mr. Wagner: Cellular therapy is an emerging field. Specifically with endothelial type vaccinations no one has actually gone through the FDA process to get the drugs approved. We are trying to build upon the existing scientific rationale and differentiate our products through several proprietary improvements that will make it more effective and more powerful.
CEOCFO: You have some patents?
Mr. Wagner: Yes currently Batu Biologics has two provisional patents in the field of cancer immunotherapy. We are very invested in expanding our IP during these preclinical stages.
CEOCFO: Is the medical establishment onboard?
Mr. Wagner: We are currently in the preclinical stages of development. What this means is that we are finalizing some of the animal efficacy and safety studies necessary to submit an Investigational New Drug application to the FDA. This IND application will allow us to enter Phase 1 clinical trials and that is the largest short-term inflection point that we are aiming for. Once we enter clinical trials we will be seeking to get doctors onboard and endorsing our products. Right now we are focusing on building a board of directors that are veterans in the biotech field and establishing a solid scientific advisory board.
CEOCFO: Where do you stand with funding today?
Mr. Wagner: We are using some unconventional methods of raising money. We currently launched a crowd funding campaign seeking to raise $100 thousand to complete our preclinical experiments in preparation for the filing of an IND application to the FDA. There are several advantages to the crowd funding campaign, one is that it is a non-dilutive strategy to raise capital and another is that it really gets the community a chance to be involved with scientific progress and to feel some attachment to this project.
CEOCFO: Has crowdfunding been effective in this arena?
Mr. Wagner: Crowdfunding has typically not been successful in the area of life sciences; it is difficult to raise money when people do not fully understand your product. We are trying to pull out a grassroots promotion and different methods of establishing scientific credibility such as increasing the amount of publications and scientific interviews with known figures in the industry. We are using many different approaches to attach credibility to our name but also get the eyes on us from people who would understand the product and that are already in the biotech field and would want to support our cause.
CEOCFO: What gives you the confidence that you are going in the right direction?
Mr. Wagner: I feel fortunate to be working with my colleagues that comprise the Batu Biologics team. Specifically it has been a pleasure to work alongside Dr. Thomas Ichim, who is a mentor to me and has taken the position of Chairman of the Board of Directors for the company. Dr. Ichim subsequently worked at Medistem, Inc. as the CEO for seven years and eventually had a successful $26 million exit when the company was bought out by Intrexon, which is trading on the NYSE. His experience in regulatory work, preclinical development, and IND filing can be directly applied to our company’s business strategy and development. He also brings many business opportunities and connections to the table.
CEOCFO: What are the next steps as you accumulate money?
Mr. Wagner: Over the next month we will be developing released criteria for ValloVax™. Once we develop the released criteria and optimize our extraction protocol for allogeneic tissue, we will be securing clinical-grade manufacturing under good manufacturing practices. Once this is done we will use the money that we have received from our crowd funding campaign to complete the remaining animal efficacy studies and toxicology reports that are required for the filing and submission of the IND application with the FDA.
CEOCFO: At what point will you look at partnerships?
Mr. Wagner: Right now, we have a couple different collaborations that are in the works.
CEOCFO: Why pay attention to Batu Biologics?
Batu Biologics is a privately held immunotherapeutic company and we have
laboratories at the Jansen Research and Development in San Diego, which is a
subsidiary of J&J. We also have corporate offices in San Diego. We are
focusing on developing cellular therapies that modulate the immune system.
We are specifically interested in how we use these cellular therapies to
create or break immunological tolerance. Our lead product, ValloVax™, is a
cancer vaccine that is targeting the tumor blood vessels for the initial
condition of non-small stage lung cancer. Batu Biologics should be on
everyone’s radar in the upcoming months as we prepare to enter Phase I
clinical trials. The biotech sector is dominated by industry veterans, and
we will stand out as a promising company led by a young group of motivated
entrepreneurs and scientists.
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