May 12, 2014
MabVax Therapeutics, Inc., a privately held cancer immunotherapy company and Telik, Inc., a clinical stage oncology drug development company have entered into a definitive merger agreement. Upon closing of the transaction, MabVax and Telik will be combined into a publicly traded company focused on the development of proprietary immunotherapy-based products to diagnose and treat cancer. Under the terms of the merger agreement, MabVax will merge with a wholly-owned subsidiary of Telik in an all-stock transaction. The boards of directors of both companies have approved the merger and the stockholders of MabVax have also approved the merger. The merger is subject to the approval of the Telik stockholders as well as other customary conditions. Upon the closing of the transaction, Telik will be re-named MabVax Therapeutics Holdings, Inc. and will operate under the leadership of the MabVax management team with J. David Hansen, president and CEO of MabVax, serving as the President, CEO, and Chairman of the Board. Michael M. Wick, M.D., Ph.D., who currently serves as President and CEO of Telik, will remain on the board.
On a pro forma basis calculated at the close of the merger and assuming that Telik maintains its listing on The NASDAQ Capital Market through the closing of the transaction, the Telik stockholders, warrant holders and option holders prior to the close will own 15% of the combined company and MabVax stockholders, warrant holders and option holders will own 85%. Simultaneous with execution of the merger agreement, certain accredited investors have agreed to invest $2.5 million in Telik in support of the merger. Telik expects to file a proxy statement in May for a stockholder vote on approval of the merger, certain aspects of the investment, and related matters at a meeting expected to be held in June.
David Hansen, President and CEO of MabVax, said, “Through this transaction we hope to expand our current clinical platform as we pursue our lead monoclonal antibody product, 5B1, and clinical stage cancer vaccine programs. We hope to see several of our programs achieve significant milestones in the next 24 to 30 months. Through this transaction, our combined company will have an expanded pipeline, including a Phase 3-ready drug with FDA orphan designation available for licensing, as well as access to public markets and added financial resources.”
About Telik, Inc.
Telik, Inc. of Palo Alto, CA is a clinical stage drug development company focused on discovering and developing small molecule drugs to treat cancer. The company’s most advanced drug candidate is Telintra®, a modified glutathione analog intended for the treatment of hematologic disorders including myelodysplastic syndrome. Telik’s product candidates were discovered using its proprietary drug discovery technology, TRAP®, which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at www.telik.com.
About MabVax Therapeutics, Inc.
MabVax Therapeutics, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody-based therapies to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers. Its therapeutic vaccines were developed at Memorial Sloan-Kettering Cancer Center and are exclusively licensed to MabVax. Since inception, the company has raised a total of $14.2 million in venture funding and has been awarded $6 million in National Institutes of Health (“NIH”) funding.
MabVax previously announced a contract with the NIH for development of a pancreatic cancer-imaging agent based on its lead antibody development candidate 5B1, and the company recently signed a manufacturing contract to provide clinical trial supplies for its Phase 1 clinical program involving 5B1. The first in human Phase 1 clinical program is scheduled to start in 2015 with early results anticipated in late 2016. The 5B1 antibody was discovered from patient samples recovered during a Phase 1 breast cancer vaccine trial conducted in 2008. The specific patient from whom the antibody was discovered responded positively to the vaccine and remains disease free at present. The 5B1 antibody has demonstrated an encouraging preclinical profile. In the preclinical testing, the antibody bound preferentially to metastatic pancreatic, colon, ovarian, breast, and small cell lung cancer cells and minimally to normal tissues. Additional in vivo and in vitro studies have indicated that the antibody may have utility as the targeting component in an antibody drug conjugate.
MabVax’s more mature cancer vaccines targeting recurrent sarcoma and ovarian cancer are currently in proof of concept Phase 2 multi-center clinical trials. Both studies are fully enrolled with overall survival results expected in 2016. The ovarian cancer vaccine trial is fully funded by the NIH and the early endpoint of progression free survival is anticipated in late 2014. In October 2013 the unblinded safety and efficacy data from the sarcoma vaccine trial were reviewed by an independent Data Safety Monitoring Board (DSMB), which concluded that there were no unanticipated or clinically worrisome safety concerns. In addition, the DSMB recommended that investigators and patients should remain blinded as to treatment assignment and the patients should continue to be followed to assess overall survival. During the clinical trial, the vaccine elicited an antibody response intended to kill circulating tumor cells and micrometastases in all but one of the vaccinated patients. However, the DSMB concluded that the study did not reach statistical significance for its primary efficacy endpoint of a 50% improvement in time to recurrence. The study has not yet accumulated a sufficient number of events to evaluate the secondary efficacy endpoint of overall survival, the data for which is anticipated to be available in 2016.
The company has also received funding from a group of non-profit patient support foundations to conduct an additional Phase 1 clinical trial in neuroblastoma, which is targeted to begin in late 2014. The company will use the early results from this trial to prepare for a Phase 2 clinical trial that is planned for 2015. Neuroblastoma is the second leading cause of cancer deaths in children and is eligible for orphan disease designation.
In February 2014, in anticipation of becoming a publicly traded company, MabVax hiredGregory P. Hanson, CMA, MBA as Chief Financial Officer. Mr. Hanson has more than 25 years experience as a public company CFO, investment banker, and business strategist having structured over $1 billion in financing, licensing, partnering and M&A transactions.
Additional information is available at www.mabvax.com.