Recently, David Hansen, the CEO of MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), spoke to Jane King of Small Cap Nation about current developments at the clinical-stage biotechnology company. They were joined by Jeffrey Kraws, founder and senior analyst at Crystal Research Associates.
MabVax is an oncology drug development company with a number of technologies to discover antibodies from patient immune responses against their cancers. The antibodies so derived from humans are then used to develop products for the diagnosis and treatment of metastatic solid tumor cancers. Human-derived antibodies have less chance of being rejected by the body, as CEO David Hansen explained:
“MBVX is primarily an antibody discovery company and what makes us unique is that we have tied our capabilities of discovery of antibodies from the natural immune response of patients to a vaccine program that was started some years ago at Memorial Sloan Kettering Cancer Center.”
MabVax is collaborating with key cancer research centers and oncology companies, including Memorial Sloan Kettering, Rockefeller University and Heidelberg Pharma, as it researches diagnostic and therapeutic solutions for gastrointestinal cancer (GI).
“So we have a license with Memorial Sloan Kettering so that any patient who is vaccinated with any of these vaccines against the cancers that they have… we get blood from those patients… we bring it back to our lab in San Diego and we essentially isolate the cells that produce the antibodies of interest… we clone out that antibody DNA, we recombinantly express it, have enough to be able to examine it and then that becomes our discovery process whereby we can now discover new antibody therapies,” continued Hansen.
The company’s lead antibody development program is HuMab-5B1, which provides the basic tumor-targeting platform upon which MabVax has created a number of products. These include MVT-5873, which is in phase I trials for pancreatic and GI cancers with an early readout expected in Q4 2016; the MVT-2163 Imaging Platform, which is in phase I trials for pancreatic cancer with an early readout in Q4 2016; and MVT-1075, a radio-immunotherapy agent, a New Drug Application (NDA) for which is expected to be filed in Q4 2016.
At present, there is no cure for pancreatic cancer. The only treatment is surgical removal of the infected tissue. According to the Pancreatic Cancer Action Network (http://nnw.fm/rEQN1), it is estimated that, in 2015, 48,960 Americans will be diagnosed with pancreatic cancer, and 40,560 will die from the disease. Roughly 50,000 people are diagnosed with pancreatic cancer each year, and about 72 percent of them die within the first year of diagnosis.
These numbers indicate a huge unmet need. A GBI Research Report indicates that the global pancreatic cancer treatment market will grow from its current level of $1.9 billion to $2.9 billion by 2021. Since, as David Hansen points out, “…even the best of the new chemotherapy agents are only prolonging life by roughly… three or four months”, the hurdle to market acceptance is “pretty low.”
Phase I clinical trials for MVT-5873 began in February 2016, led by Dr. Eileen M. O’Reilly who co-heads the pancreatic cancer treatment program at Memorial Sloan Kettering. Phase I trials for MVT-2163, the diagnostic candidate, started in late June and are being led by Drs. Wolfgang Weber and Christian Lohrmann from the nuclear medicine group at Memorial Sloan Kettering.
The company’s IP defenses are robust. It has licenses for all the vaccines used to treat the patients who generated the blood samples from which the antibodies were derived. These were all phase I and phase II programs conducted at Memorial Sloan Kettering, so it’s “very difficult for someone to follow closely in our footsteps,” continued Hansen. “Once we identify that an antibody is worth pursuing, then we patent that antibody. We patent the sequence and we patent all the uses surrounding that antibody.”
In the U.S., MabVax Therapeutics has 11 issued patents and three pending, and internationally it has four issued patents and three pending applications. The company has been on the OTCQB for the last couple of years, but recently uplisted to the NASDAQ Capital Market. In a recent public offering, it raised $9.4 million.
For more information, visit www.MabVax.com
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