Posted on October 23rd, 2014
by David Hansen
2014 has been a year of very significant change for MabVax Therapeutics. We became a publicly listed company, received a large grant from the National Institutes of Health (NIH) for the development of one of our leading antibody-based therapeutics, concluded a deal with both Juno Therapeutics and Memorial Sloan-Kettering Cancer Center (MSKCC) on the novel use of our antibody targeting sequences, and recently received Orphan Drug Designation for our childhood cancer vaccine product. Any of these events was by itself significant for the Company and we believe value enhancing for our new shareholders.
For my inaugural blog post, I want to introduce MabVax Therapeutics, who we are as a Company, and what we aim to accomplish moving forward. First, allow me to provide some history of the Company.
On July 8, 2014, MabVax Therapeutics completed a “reverse merger” with Telik, Inc., a NASDAQ listed company, resulting in MabVax stockholders owning a significant majority of the outstanding shares of the combined publicly traded company. Two months later, on September 8, 2014, we achieved the last remaining objectives of the merger with stockholders approving the Company’s name change to MabVax Therapeutics Holdings, Inc., authorizing the change in the ticker symbol from TELK to MBVX, as well as an 8-for-1 reverse stock split. Shares of our common stock trade on OTCQB marketplace on a post-split basis under the name “MabVax Therapeutics Holdings, Inc.” and under the trading symbol “MBVX.”
MabVax is a clinical-stage biopharmaceutical company focused on discovering and developing innovative cancer vaccines and monoclonal antibody-based therapeutics for the diagnosis and treatment of specific solid tumor cancers. Our in-house research team utilizes a novel technique to discover our pipeline of antibody-based therapeutic candidates directly from patients who have been vaccinated with proprietary vaccines we have licensed from MSKCC. Our approach of surveying the protective immune response from many patients to identify the ideal monoclonal antibody candidate against a specific target on the surface of a cancer cell has yielded a novel human antibody discovery platform. We believe our proprietary approach to antibody discovery identifies antibody candidates with superior performance characteristics while minimizing many of the toxicities and drawbacks associated with other discovery technologies.
Our lead antibody candidate, HuMab 5B1, is being developed concurrently as both a diagnostic imaging agent and a therapeutic treatment for pancreatic and colon cancers. MabVax has received a contract for $1.75 million from the NIH for the development of the antibody-based imaging agent. We are manufacturing clinical supplies now and will be entering early stage clinical trials just after mid-year 2015. We expect to report results for both the diagnostic agent and the therapeutic product by the end of 2015.
Our therapeutic vaccines were developed at MSKCC and are exclusively licensed to MabVax Therapeutics. These vaccines are administered in the adjuvant setting (after surgery and/or completion of chemotherapy) and have shown in clinical studies to elicit a protective antibody response. Our lead cancer vaccines, targeting recurrent sarcoma and ovarian cancer, are currently in proof of concept Phase II multi-center clinical trials. Both trials have received substantial federal grant monies to support their development. We expect to report the pivotal endpoint of overall survival in the first half of 2016 for both vaccines.
A vaccine to address the childhood cancer neuroblastoma has completed an initial Phase I trial at MSKCC yielding encouraging results. The neuroblastoma vaccine candidate has received an NIH SBIR grant to off-set clinical manufacturing costs and is expected be ready for a Phase II trial by mid-2015. It has also recently received Orphan Drug Designation from the FDA. Additionally, MabVax has received a $400,000 grant from the Solving Kids Cancer Foundation/ Neuroblastoma Children’s Cancer Alliance UK to off-set clinical trial expenses.
Until the merger, MabVax was a venture-backed company with a low public profile. The merger changed that status and with the newly publicly traded company came responsibilities to shareholders specifically and the investor community at large. MabVax is working to build interest and raise the Company’s visibility. We have made significant progress on advancing our programs over the last few months and certainly plan to continue over the next year as we take important steps forward in putting three more products into the clinic. That means that within the next twelve months the Company will have two products in late Phase II clinical trials, a product entering Phase II, and two more entering Phase I. Four of the five programs will have important clinical data readouts within the next two years. A positive readout on any of these programs would likely have a significant impact on the valuation of the company. MabVax would likely seek to partner any early successes from its current pipeline because the Company has multiple follow-on antibody based therapeutics in its early stage pipeline that would allow it to continue to drive increasing valuations.
Thank you for taking the time to learn more about MabVax and I hope you will continue to follow our progress.
Forward Looking Statements
Certain statements contained in this blog are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this blog relate to, among other things, the offering and, expected use of proceeds from the offering. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should'" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this blog. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this blog, except as required by applicable law.