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MabVax Therapeutics Holdings, Inc. Provides Corporate Overview and Business Outlook

2.5
2.5 from 2 votes
Wednesday, October 18, 2017

SAN DIEGO - MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, provided a corporate overview and business outlook for the remainder of 2017.

David Hansen, MabVax's President and Chief Executive Officer, commented, "We have made significant steps forward over the course of 2017 prioritizing our pipeline development candidates and continuing to secure additional capital to advance our clinical development strategy. Our technology platform continues to be validated through our growing body of data along with our collaborative efforts with leading institutions."

"Our focus as we move forward is to continue in two major clinical development areas: (1) to advance the development of our lead program, our radioimmunotherapy product MVT-1075, and (2) to enroll additional patients in our HuMab MVT-5873 study in combination with gemcitabine and nab-paclitaxel in first-line therapy. We remain on track to report interim data for both studies near the end of the year. We continue to implement strategies that will drive value for the Company and provide the additional capital resources necessary for continuing the development of our potentially transformative treatment therapies for unmet needs in cancer," Mr. Hansen added.

Clinical Programs Overview -- Making Great Strides in Advancing Pipeline

MVT-1075 Radioimmunotherapy – In October 2017, MabVax announced the initiation of patient enrollment at Memorial Sloan Kettering Cancer Center ("MSK") in New York, representing a second site for its Phase 1 clinical trial evaluating the Company's new human antibody-based radioimmunotherapy ("RIT") product MVT-1075. Earlier in June 2017 MabVax announced the commencement of patient dosing in the Phase 1 clinical trial of MVT-1075 at the first site, Honor Health in Scottsdale, Arizona.

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 for patients with locally advanced or metastatic adenocarcinoma of the pancreas ("PDAC") or other CA19-9 positive malignancies including colon and lung cancers. The primary objective is to determine the maximum tolerated dose and safety profile in late stage patients with recurring disease who have failed prior therapies. Secondary objectives include evaluating tumor response rate and duration of response by RECIST 1.1, and determining dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design.

The Company intends to enroll additional patients in the Phase 1 trial to continue to assess the safety and potential efficacy of this treatment. MabVax expects to report interim data near year-end.

MVT-5873 Combination with Chemotherapy – Based upon observations from the first two cohorts of patients treated, the Company is continuing clinical development of MVT-5873 in combination with gemcitabine and nab-paclitaxal as a first line therapy for the treatment of patients newly diagnosed with pancreatic cancer. MabVax has treated six patients as of October 12, 2017 and is actively enrolling additional patients with the objective of obtaining additional safety and tumor response (RECIST 1.1) data.

Results From Completed Phase 1a Clinical Trials Announced Earlier This Year

MVT-5873 as Monotherapy in Late Stage Patients - Earlier this year the Company reported Phase 1a clinical trial results for 32 patients with advanced pancreatic cancer and other CA19-9 positive cancers treated with the therapeutic antibody MVT-5873, and evaluated for safety and tolerability in patients, in a poster presentation at the American Society of Clinical Oncology ("ASCO") Annual Meeting on June 3, 2017. The Company highlighted that the single agent MVT-5837 appears safe and well tolerated in patients at biologically active doses and that the maximum tolerated dose had been achieved. Furthermore, 32 patients were evaluated by RECIST 1.1 for tumor response and 11 patients achieved stable disease in this dose escalation safety trial.

The Company also reported results from the Phase 1a clinical trial of MVT-2163, a PET imaging agent based on combining the MVT-5873 antibody with 89Zr, a clinically validated radionuclide for PET imaging, at the annual meeting of the Society for Nuclear Medicine and Molecular Imaging ("SNMMI"). Twelve patients have been treated in this first-in-human trial evaluating the safety and feasibility of MVT-2163 to image pancreatic tumors and other CA19-9 positive malignancies. Uptake of MVT-2163 was observed in primary tumors and metastases as early as day 2 and continuously through day 7. Standard Uptake Values ("SUV"), a measurement of activity in PET imaging, were considered very significant. The investigators reported that the high SUV are amongst the highest lesion uptake measurements they have seen for a radiolabeled antibody. Bone and soft tissue disease were readily visualized and lesion uptake of the radiotracer was higher than typically seen with PET imaging agents. The reported correlation with Computerized Tomography ("CT") scans was also high.

The combined results from a total of 50 patients treated 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 the Company has incorporated into the MVT-1075 program.

Corporate Development – Strategic Initiative Designed to Unlock Significant Value

As previously announced, MabVax has engaged Greenhill & Co. (NYSE: GHL) to serve as a financial advisor to assist the Company in exploring and evaluating strategic options with the goal of maximizing shareholder value. Greenhill will be assisting the Company in evaluating transaction options currently being considered 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. The Company does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

Strengthened Balance Sheet – Recent Financings Enable Continued Advancement of Lead Programs

MabVax has raised $5.2 million of new capital over the past three months. The additional capital has been raised in several tranches at progressively increasing share prices as the stock of the Company has strengthened over the last quarter. The Company plans to use this capital to fund the enrollment of additional patients in the MVT-1075 and MVT-5873 clinical trials and maintain company operations.

"We are pleased to be able to leverage the expertise of Greenhill in our continued efforts to identify ways to drive value for the Company. The successful completion of our recent financings not only demonstrates the continued support of our loyal investors, but importantly extends our cash runway, ensures the continued advancement of our clinical programs and enables Greenhill to continue to implement and advance their strategic process designed to unlock value for our shareholders," stated Gregory Hanson, Chief Financial Officer of MabVax.

End of Year Significant Milestones

Report interim data from the Phase 1 study evaluating MVT-1075 for the treatment of CA19-9 positive malignancies including pancreatic, colon and lung cancers;
Present additional data from the MVT-5873 Phase 1 program including interim results from the administration of MVT-5873 in combination with gemcitabine and nab-paclitaxel in first-line therapy;
Present new preclinical data demonstrating the use of CA19-9 as a translational biomarker for both MVT-5873 and MVT-1075 clinical products and the MVT-2163 immunoPET imaging agent;
Present the initial data from the Company's HuMab-Tn antibody preclinical program summarizing optimization of a lead candidate for a follow-on fully human antibody development program.

Mr. Hansen concluded, "We are more encouraged than ever with the potential of our pipeline and the promise these clinical programs hold to provide solutions to physicians, patients and their families battling cancer every day. We believe 2017 will continue to be an important year of building solid clinical, regulatory, financial and corporate foundations for our company, which should help position MabVax for a transformational 2018."

About MabVax

MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer. Our antibody MVT-5873, is a fully human IgG1 monoclonal antibody (mAb) that targets sialyl Lewis A (sLea), an epitope on CA19-9, and is currently in Phase 1 clinical trials as a therapeutic agent for patients with pancreatic cancer and other CA19-9 positive tumors. CA19-9 is expressed in over 90% of pancreatic cancers and in other diseases including small cell lung and GI cancers. CA19-9 plays an important role in tumor adhesion and metastasis, and is a marker of an aggressive cancer phenotype. CA19-9 serum levels are considered a valuable adjunct in the diagnosis, prognosis and treatment monitoring of pancreatic cancer. With our collaborators including Memorial Sloan Kettering Cancer Center, Rockefeller University, Sarah Cannon Research Institute, Honor Health and Imaging Endpoints, we have treated 50 patients with either our therapeutic antibody designated as MVT-5873 and our PET imaging diagnostic product designated as MVT-2163 in Phase 1 clinical studies, and demonstrated early safety, specificity for the target and a potential efficacy signal. Patient dosing has commenced for our lead clinical development program, the Company's Phase 1 study of our radioimmunotherapy product MVT-1075, with open enrollment now at two centers. For additional information, please visit the Company's website, www.mabvax.com.

Source: MabVax Therapeutics Holdings, Inc.
2.5
2.5 from 2 votes
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