MabVax Files IND With FDA, Shares Up On News


According to a report by IMS Health earlier this year, global spending on cancer medicines reached $100 billion in 2014. In 2014, spending on cancer drugs accounted for more than 10% of all drug spending worldwide.

IMS expects spending on cancer drugs to rise to between $117 billion and $147 billion by 2018.

Much of the increase in spending on oncology drugs is being driven by the availability of new treatment options. It’s safe to say that cancer research is a hot area in the biotech space.

Pancreatic cancer is a severely underserved area. By the end of this year, the worldwide pancreatic cancer treatment market is expected to be worth $1.2 billion, according to Transparency Market Research. In the U.S. alone, some 30,000 patients are diagnosed with pancreatic cancer each year.

Transparency Market Research notes in its report on the global pancreatic cancer treatment market that it has among the highest unmet therapy needs in the overall oncology market.

This morning, San Diego, California-based MabVax Therapeutics Holdings Inc. (OTCQB:MBVX) announced that it has filed an Investigational New Drug Application (‘IND) with the U.S. FDA for
its lead fully human antibody product HuMab 5B1 as a therapeutic agent.

MBVX is focused on the development of vaccine and antibody-based products and vaccines to address unmet medical needs in the treatment of cancer. The company has discovered a pipeline of human monoclonal antibody products, HuMab 5B1 being one of them.

Apart from HuMab 5B1, the company has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof-of-concept Phase II multi-center clinical trials. The company also has a vaccine
targeting neuroblastoma, which will be ready to enter a Phase II clinical trial next year.

The Phase I trial for HuMab 5B1 will assess the safety, tolerability and pharmacokinetics of the antibody product candidate as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer.

David Hansen, President and CEO at MabVax, said that the filing of the first two planned INDs for the company’s novel HuMab 5B1 antibody is a significant achievement for the company.

Hansen said that pending FDA acceptance of the IND, the company will begin the dose escalation portion of the Phase I trial as early in 2016 as possible and anticipates reporting on the early safety assessment and determination of a maximum tolerated dose in mid-year 2016.

Shares of MBVX are up on the news with a gain of 3% in mid-day trading, however are trading at the low end of their 52-week range.

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