- Company presents results of IND enabling studies supporting development of radioimmunotherapy product MVT-1075 and synopsis of the Phase 1 clinical trial design -
- Company also presents manufacturing, quality, and stability work completed to support the manufacture of clinical grade MVT-1075 drug product -
- Patient enrollment of Phase 1 trial in patients with advanced pancreatic cancer expected in Q2 2017-
SAN DIEGO, April 5, 2017 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, announces that it will present two posters in this morning's session featuring MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1), the Company's novel fully human antibody-based radioimmunotherapy (RIT) currently in clinical development, initially being evaluated for the treatment of pancreatic cancer and other CA19-9 positive malignancies, at the American Association for Cancer Research (AACR) Annual Meeting being held April 1-5, 2017 in Washington, D.C.
Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, "We look forward to sharing the significant progress we have made through these preclinical investigations that add to a growing body of safety, efficacy, and manufacturing data supporting further development of MVT-1075 in clinical studies for the treatment of pancreatic cancer and other CA19-9 cancers. MVT-1075 represents a more potent analog of our fully human HuMab-5B1 therapeutic antibody. We believe the data being presented today bring us an important step closer in providing a much-needed treatment option for patients who have these devastating cancers."
The Company will present the following posters today, Wednesday, April 5, 2017 from 8:00 – 12:00 PM EDT:
Title: Preclinical development of MVT-1075 as radioimmunotherapy for pancreatic cancer and other CA19-9 positive malignancies
Abstract Number: 5204, Wednesday Apr 5, 2017 8:00 AM - 12:00 PM, (Houghton, et al)
Presenting Author: Toni Jun, Ph.D., Director of Pharmacology, MabVax Therapeutics, Holdings
The poster summarizes the IND supporting preclinical pharmacology, efficacy, and safety studies of MVT-1075 that supported starting dose determination and includes a synopsis of the phase I clinical trial design. These non-clinical studies include xenograft and orthotopic models of human pancreatic cancer and demonstrate tumor growth suppression and regression after a single dose of MVT-1075. These investigations provide supporting evidence that efficacy of MVT-1075 when administered as a single dose or as a fractionated dose is maintained. Fractionated doses may be useful to potentially minimize adverse effects. Biodistribution data comparing normal to tumor bearing mice demonstrate that approximately 70% of the dose administered was bound to tumor tissue within 24 hours of administration.
Title: IND enabling investigations of MVT-1075, a CA19-9 targeting Radioimmunotherapy (Gately, et al)
Abstract Number: 5206, Wednesday Apr 5, 2017 8:00 AM - 12:00 PM
Presenting Author: Paul Maffuid, Ph.D., Executive Vice President, Research and Development, MabVax Therapeutics, Holdings Inc.
The poster summarizes the chemistry, manufacturing, and controls (CMC) IND enabling investigations conducted to support the manufacture of clinical grade MVT-1075 drug product and includes details of the manufacturing process and characterization studies including product stability. MVT-1075 can be reproducibly manufactured as a high-quality product with conditions that maintain antibody affinity and integrity. Stability investigations support product manufacturing, storage and shipment to clinical trial sites.
MabVax received notification from the U.S. Food and Drug Administration (FDA) in January of 2017 to proceed with a phase I clinical trial to establish safety as well as a phase II clinical dose for MVT-1075 in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies. MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1) combines a potent radiotherapy with the tumor targeting specificity of the Company's HuMab-5B1 antibody. The Company plans to initiate patient enrollment in during the second quarter of 2017 and evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status and early readouts on product effectiveness will be evaluated based on tumor measurements using RECIST 1.1 criteria.
In February 2017 MabVax reported encouraging positive data on the clinical safety and target specificity of the HuMab-5B1 antibody from the phase I trial of MVT-5873, the Company's therapeutic antibody, and the phase I trial of MVT-2163, MabVax's immunoPET imaging agent. The Company has initiated three clinical programs in the past fourteen months that are based on discovery of the HuMab-5B1 antibody from the immune responses of patients with cancer who had been vaccinated with one of the Company's proprietary cancer vaccines.
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of fully human monoclonal antibody products based on the protective immune responses generated by patients who have been vaccinated against targeted cancers with the Company's proprietary vaccines. MabVax's HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a phase I trial at Memorial Sloan Kettering Cancer Center. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers, making the antibody potentially broadly applicable to most patients suffering from this type of cancer. Additional information is available at www.mabvax.com.
Forward Looking Statements:
This press release contains "forward-looking statements" regarding matters that are not historical facts, including statements relating to presentations at the AACR Annual Meeting. We have no assurance that all the product development pipeline will be fully developed by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "anticipates," "plans," "expects," "intends," "will," "potential," "hope" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements because of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its annual report on Form 10-K for the fiscal year ended December 31, 2016, as amended and supplemented from time to time and the Company's Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
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SOURCE MabVax Therapeutics Holdings, Inc.
Released April 5, 2017