Part I of II: Expect Near Term Positive News on Lead Product Candidates from MBVX
MabVax Therapeutics (MBVX) Share Information
Shares outstanding: 5.6 million
Approximate float: 3.8 million
Close on 8/29/16: $5.00
Market cap: ~ 28 million
Repeat investments from Dr. Phillip Frost and OPKO Health (OPK) began in April 2015 and account for an approximate 15% stake in MabVax
Pancreatic cancers are extremely complex and, unfortunately, highly lethal. According to the American Cancer Society the one-year relative survival rate is 20% and the five-year rate is 7% for all stages of pancreatic cancer combined. The 5-year survival rate for patients with metastatic pancreatic cancer is approximately 1 (one) percent. This is a horrific disease in which survivability for the vast majority of patients is measured in weeks and months.
However, an area of research in pancreatic cancer treatment that shows initial and growing promise is in the development of immuno-oncology and cancer vaccines. The American Cancer Society notes that:
“Immune therapies attempt to boost a person’s immune system or give them ready-made components of an immune system to attack cancer cells. Some studies of these treatments have shown promising results.”
“Several types of vaccines for boosting the body’s immune response to pancreatic cancer cells are being tested in clinical trials. Unlike vaccines against infections like measles or mumps, these vaccines are designed to help treat, not prevent, pancreatic cancer. One possible advantage of these types of treatments is that they tend to have very limited side effects. At this time, vaccines are available only in clinical trials.”
MabVax Therapeutics (web site) has shown early, promising results in clinical trials of immuno-oncology products developed from the human immune response to cancer, with an emphasis on pancreatic cancer.
Additionally, MabVax has:
- an attractive, multi-pronged drug development pipeline
- wide and expanding patent moat
- recent (August 17th) NASDAQ uplisting
- low float (3.8 million shares)
- significant and recurring investments from Dr. Phillip Frost and OPKO Health, Inc.
- including recent capital raise, (closed August 22), MabVax Therapeutics can access $16M cash with a burn rate of ~ $1M/month
- positive near term drivers- early data from promising Phase 1 studies of lead product candidates expected within 5 weeks
MabVax Therapeutics Holdings, Inc., a clinical-stage biopharmaceutical company, engages in the discovery, development, and commercialization of proprietary human monoclonal antibody products and vaccines for the diagnosis and treatment of various cancers. It has a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers. The company generates its pipeline of antibody-based product candidates from patients who have been vaccinated with propriety vaccines licensed from Memorial Sloan-Kettering Cancer Center (MSKCC). Its lead cancer vaccines targeting recurrent sarcoma and ovarian cancer are in proof of concept Phase II multi-center clinical trials. The companys product candidates include 5B1 antibody program, 5B1 imaging program, and 5B1 antibody drug conjugate, which targets an antigen over expressed on metastatic pancreatic, colon, stomach, ovarian, breast, and small cell lung cancers. It also develops follow-on antibody products, including 1B7 and 31F9 antibody programs to the antigen GD2, which is over expressed on sarcoma, melanoma, and neuroblastoma. The company has collaboration agreement with Heidelberg Pharma GmbH, as well as a research collaboration agreement with Rockefeller University’s Laboratory of Molecular Genetics and Immunology. MabVax Therapeutics Holdings, Inc. was founded in 2006 and is based in San Diego, California.
Lead Product Candidates MVT-5873 (Therapeutic Agent) and MVT 2163 (Imaging Agent)
MVT-5873 (Therapeutic Agent Study)
The Phase I trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first group of patients will be enrolled in a traditional dose escalation regimen to assess safety, the pharmacokinetics and determine the optimal dose of the antibody. A second group of patients will establish the safety and optimized dose of the antibody when administered with a standard of care chemotherapy as a first line therapy for the treatment of patients with advanced cancer.
On March 21, 2016, MabVax announced the initiation of the Phase 1 trial of MVT-5873 in patients with pancreatic cancer. This is an open label, multi-center, dose escalation clinical trial with patient enrollment initiated at three clinical trial sites: Memorial Sloan Kettering Cancer Center (MSK) in New York as well as two sites within the Sarah Cannon Research Institutes network at the Tennessee Oncology site in Nashville, TN, and Sarah Cannon Research Institute at Florida Cancer Specialists in Sarasota, FL.
The initial cohort of patients will be treated with 1, 3, 6 or 10 mg/kg of MVT-5873 to determine the MTD. This dose will then be utilized in an expansion cohort of approximately 10 subjects to examine additional safety and PK parameters. For the combination study, the first cohort will be treated with one dose below the MTD with escalation up to the MTD. This dose will then be utilized in an expansion study where MVT-5873 will be administered alongside the standard of care chemotherapeutic agent gemcitabine.
See ClinicalTrials.gov for in-depth study information.
Positive Early Results Hinted at in 10-Q Filing on 8/11/16:
On page 24 of the 10-Q filing for the quarter ending June 30, 2016, MabVax Therapeutics disclosed (in relation to MVT-5873) that:
“Of the nine patients who have been dosed to date, five have been treated for three or more months and investigator observations have noted stable disease for a subset of those patients. We are continuing to escalate the drug dose to assess safety and reach an MTD and anticipate initiating the second portion of the trial where our drug is dosed in combination with chemotherapy in the fourth quarter of this year. We expect to have the preliminary results of this clinical trial later in the third quarter in 2016.”
Now, a “stable disease for a subset of those patients” (with late-stage, metastatic pancreatic cancer) could be a very positive near term driver. Expect a press release on these exciting early results by end of the current quarter…within the next 5 weeks based on the SEC filing.
MVT-2163 (Imaging Study)
As a bit of background, part of the reason pancreatic cancers are so lethal is because they typically cause no symptoms, or (at best) vague symptoms in the earlier stages. As a result, the diagnosis of pancreatic cancer is most often made at a very late, metastatic, stage IV disease.
Widespread screening, (analogous to mammograms for breast cancer or colonoscopy for colon cancer), is not practical for this less common cancer. However, improved diagnostic imaging tests can be extremely useful in high-risk groups, such as those with a strong family history of pancreatic cancer.
Simply put, the earlier this devastating disease can be identified and aggressively managed, the better the chance for survival. Because of this, MabVax Therapeutics received a $1.75 Million contract for development of the HuMab-5B1/MVT-2163 Imaging Agent from the National Institutes of Health (NIH).
The Phase I clinical trial for MVT-2163 (see ClinicalTrials.gov) was initiated in the second quarter of 2016 at Memorial Sloan Kettering Cancer Center for the Company’s new generation fully human immuno-PET imaging agent. In this Phase I trial, the safety, pharmacokinetics and biodistribution of MVT-2163 is being evaluated in patients with pancreatic and other CA19-9 positive cancers. The trial will determine the ideal dose and conditions for an optimal PET scan image.
MVT-2163 has demonstrated high-resolution images of tumors in xenograft animal models, potentially making it an important new tool to aid in the diagnosis, monitoring and assessment of patients with pancreatic cancer and an attractive companion diagnostic for the MVT-5873 therapeutic product.
Like the early results from the MVT-5873 study, MabVax Therapeutics plans to provide an update on MVT-2163 in the near term according to the August 11th 10-Q filing which states:
“Investigator observations showed scans potentially highlighting smaller metastatic sites not seen on standard CT scans. These results are preliminary and require more patients to confirm. We expect to have the preliminary results of this clinical trial later in the third quarter 2016”
Clearly there are exciting times ahead for investors in MabVax Therapeutics, and more significantly, some cause for optimism in the future treatment of pancreatic cancer.
See Part II: MabVax Therapeutics (MBVX): A Compelling, Strong Buy with Multiple Near Term Positive Drivers
See also: MabVax September Investor Presentation