MabVax – Seeking to Gain Traction in a Forecasted $138B Market for Monoclonal Antibodies

Monoclonal Antibodies (mAbs) Market Was Valued at USD $85.4 Billion in 2015 and is Expected to Reach a Value of USD $138.6 Billion by 2024

BEND, OR / ACCESSWIRE / October 13, 2017 / According to Grandview Research, the global monoclonal antibodies (mAbs) market was valued at USD $85.4 billion in 2015 and is expected to reach a value of USD $138.6 billion by 2024. Increasing R&D pertaining to the development of therapeutic mAbs coupled with supportive government initiatives is expected to drive the monoclonal antibodies market growth over the forecast period.

Increasing demand for unique human antibody discovery and development is being driven by the fact that every individual responds in a different manner to a particular treatment. For example, if I take two aspirin and you take two aspirin, the level of pain relief will likely be different between us. As such, customized or personalized medicines are the focus of companies in clinical development. Moreover, related benefits of using mAbs for therapeutic purposes, including fewer adverse effects, homogeneity, specificity, and large-scale production, are contributing toward significant market growth.

In addition, the government initiatives to enable cost-effective production of mAbs are anticipated to propel the emergence of this sector throughout the forecast period. For instance, the biomanufacturing initiative by National Institute of Standards and Technology in the U.S. provides financial incentives for companies that adhere to the regulatory guidelines which ensure effective and safe manufacturing of protein therapeutics and to support biopharmaceutical manufacturers in offering low-cost and high-quality protein drugs across the globe.

MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX, “MabVax”) is a San Diego-based clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer. MabVax has developed a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been vaccinated against targeted cancers with their proprietary vaccines. MabVax’s lead development program is centered on their HuMab-5B1 antibody, which is fully human and 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, or (“MSK”). The antigen the antibody targets is expressed on more than 90% of pancreatic cancers, and expressed in significant percentages on small cell lung cancer, stomach, colon and other cancers, making the antibody potentially broadly applicable to many types of cancers. MabVax has discovered other fully human antibodies targeting additional antigens of which several are candidates in preclinical development.

Monoclonal antibodies are produced from a single DNA sequence encoded into multiple cells that all produce the same single antibody. MabVax generates their pipeline of antibody-based product candidates from patients who have been vaccinated with proprietary vaccines licensed from MSK. MabVax’s approach involves surveying the protective immune response from multiple patients to identify a particular monoclonal antibody candidate against a specific target on the surface of a cancer cell. Then, through standard molecular biology processes, MabVax produces larger quantities of that specific antibody for evaluation. MabVax believes this approach provides them with a novel next-generation human antibody technology platform. MabVax believes their approach to antibody discovery allows them to identify antibody candidates with superior performance characteristics while minimizing many of the toxicity and off target binding drawbacks (a phenomenon occurring when antibodies bind to non-cancer cells) of other discovery technologies.

MabVax’s lead clinical development program is a Phase 1 clinical trial of their HuMab-5B1 radioimmunotherapy product that they have designated as MVT-1075. The development of MVT-1075 is based on experience MabVax has gained through clinical studies of 50 patients with either their naked antibody MabVax designates as MVT-5873, or MabVax’s imaging agent they designate as MVT-2163. MabVax initiated the Phase I study of MVT-1075 in June 2017 and intend to treat additional patients to continue to assess the safety and potential efficacy of this treatment. Also, MabVax intends to continue clinical development of MVT-5873 in combination with gemcitabine and nab-paclitaxal in first line therapy for the treatment of patients newly diagnosed with pancreatic cancer. MabVax has treated two cohorts of patients in their combination therapy, for a total of six patients through July 2017 in this study. MabVax intends to enroll an additional cohort of patients in the combination therapy with the objective of confirming early observations.

On September 6, 2017, MabVax announced that they have engaged Greenhill & Co. (GHL) to serve as a financial advisor to assist MabVax in exploring and evaluating strategic options with the goal of maximizing shareholder value. MabVax is evaluating inbound inquiries and transaction options, as well as identifying new opportunities, which could include the acquisition of MabVax by another company, the sale or divestiture of specific assets coupled with a reverse merger, merging with another company, or licensing of selected technologies. MabVax does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the evaluation will result in any strategic alternative being announced or consummated. MabVax will continue to advance its Phase 1 clinical programs, including the MVT-1075 radioimmunotherapy clinical trial for the treatment of pancreatic, colon, and lung cancers, and the MVT-5873 clinical trial in combination with one or more chemotherapy agents in first line therapy for patients newly diagnosed with pancreatic cancer.

Clinical Development Programs and Plans for 2017

MVT-1075 – MabVax’s lead development program as a Radioimmunotherapy for Pancreatic Cancer.

In June 2017, MabVax initiated a Phase 1 clinical trial of our HuMab-5B1 radioimmunotherapy product, MVT-1075, based on experience MabVax gained through clinical studies of 50 patients with either the naked antibody MVT-5873 or MabVax’s imaging agent MVT-2163.

MVT-1075 combines the demonstrated targeting specificity of the HuMab-5B1 antibody with the proven clinical success of a low-energy radiation emitter, 177Lutetium (“177Lu”). MabVax dosed MVT-1075 in its first patient in June 2017. This Phase 1 first-in-human clinical trial is an open-label, multi-center study evaluating the safety and efficacy of MVT-1075 in up to 22 patients with CA19-9 positive malignancies. The primary objective is to determine the maximum tolerated dose and safety profile in patients with the recurring disease who have failed prior therapies. Secondary endpoints are to evaluate tumor response rate and duration of response by RECIST 1.1, and to determine dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design that is commonly used by companies as a dose escalation strategy typical for Phase I trials for the treatment of cancer. The investigative sites are Honor Health in Scottsdale, Arizona, and Memorial Sloan Kettering Cancer Center in New York City.

Supporting the MVT-1075 RIT clinical investigation are the Company’s successful Phase 1a safety and target specificity data reported at the annual meetings of the American Society for Clinical Oncology (ASCO) and the Society for Nuclear Medicine and Molecular Imaging(SNMMI) in June 2017, including the clinical results for the Company’s HuMab-5B1 products, MVT-5873, a single agent therapeutic antibody, and MVT-2163, an immuno-PET imaging agent. The combined results from 50 patients in the Phase 1 MVT-5873 and MVT-2163 studies established safety and provided significant insight into drug biodistribution and an optimal dosing strategy, which MabVax has incorporated into the MVT-1075 program. In April 2017, MabVax reported preclinical results for MVT-1075 at the American Association of Clinical Research (AACR) Annual Meeting, demonstrating marked suppression, and in some instances, regression of tumor growth in xenograft animal models of pancreatic cancer, potentially making this product an important new therapeutic agent in the treatment of pancreatic, colon, and lung cancers.

The key players serving the monoclonal antibodies market are Pfizer, Inc., GlaxoSmithKline plc, Novartis AG, Merck & Co., Inc., Amgen, Inc., Abbott Laboratories, AstraZeneca, Eli Lilly and Company, Mylan N.V., Daiichi Sankyo Company, Ltd., Bayer AG, Bristol Myers Squibb Co., Johnson & Johnson Services, Inc., Biogen Inc., Thermo Fisher Scientific, Inc., Sanofi Genzyme, F. Hoffmann-La Roche Ltd., and Novo Nordisk A/S. MabVax, based on their clinical success, may represent an attractive acquisition candidate to one of the companies listed above. A monoclonal antibody company in clinical development named True North was acquired by Bioverativ (BIVV), ~$6.4B market cap, for an upfront consideration of $400M plus additional payments of up to $425M contingent on the achievement of future development, regulatory and sales milestones in June of 2017. It would seem, based on the True North acquisition, as well as other recent monoclonal antibody development companies being acquired, that it is an exciting time to be developing monoclonal antibody solutions.

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SOURCE: Sylva International LLC

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