By: Dylan Sikes - AllPennyStocks.com News

Monday, March 21, 2016

After seeing a huge sell-off at the start of this year, the biotechnology sector is showing signs of a recovery. As sentiment on risk assets has improved in recent weeks, the biotech sector has once again found favor among investors. The iShares NASDAQ Biotechnology (ETF) (NASDAQ:IBB) is up sharply in trading today. At last check, the ETF was up 2.38% to $257.32. While the ETF is still down almost 25% for the year, it has cut back some of its losses since the start of this month. In fact, for the month of March, the IBB is up 1.16%.

One Company making waves in the biotech sector today is MabVax Therapeutics Holdings Inc. (OTCQB:MBVX). Based in San Diego, California, MBVX is a clinical-stage oncology drug development company. The company is currently focusing on the development of vaccine and antibody-based products and vaccines to address unmet medical needs in the treatment of cancer.

At last check, MBVX shares were up 1.01% to $0.798 on above average volume of 68,127.

MBVX shares have edged higher in trading today after the company announced that it has commenced a Phase I clinical trial of HuMab-5B1 for patients with locally advanced or metastatic adenocarcinoma of the pancreas or other CA19-9 positive malignancies. The CA19-9 target is expressed on more than 90% of pancreatic cancers and is a validated biomarker for the disease.

MBVX filed the Investigational New Drug (IND) application for HuMab-5B1 in November last year. The U.S. Food and Drug Administration (FDA) accepted the IND in December last year, enabling the company to proceed with a clinical trial.

The Phase I trial will determine the safety, maximum tolerated dose (MTD), and pharmacokinetics (PK) of HuMab-5B1. The trial will also evaluate the tumor response rate based on RECIST 1.1 and the duration of response of HuMab-5B1 as a single agent or in combination with a standard of care chemotherapy regimen. The company plans to enroll approximately 60 patients at multiple centers in the U.S. In January, the company received authorization from the FDA to proceed with a second Phase I clinical trial with [Zr-89]-HuMab-5B1 as a new generation PET imaging agent in patients with pancreatic cancer.

David Hansen, President and CEO at MabVax Therapeutics, said that data generated in the early portions of the two Phase I trials could demonstrate important initial safety, PK and targeting specificity data of the antibody and signal the potential utility of the HuMab-5B1 antibody in the diagnosis and treatment of patients with pancreatic cancer.

MBVX expects to report interim-study data from both the trials by the middle of this year.

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