Immunotherapy: A New Paradigm in Cancer Treatment

 


Cancer was the second leading cause of death in the US in 2015, claiming more than half a million lives.

The number of new cancer cases globally is expected to rise more than 50% over the next two decades, surpassing 22 million cases annually.

While more and more people will battle cancer in the years to come, recent advances in science and technology are ushering in a new era of promise for improved patient outcomes.

At the forefront of this paradigm shift in the battle against cancer is immunotherapy.

Immunotherapy: Enhancing the Immune System to Fight Cancer

Immunotherapy, in the simplest terms, uses a body’s own immune system to control or eliminate diseases such as cancer.

Far from a new concept, immunotherapy’s roots can be traced back to Dr. William B. Coley in the late 19th century. Known as the Father of Immunotherapy, Coley’s work, which used live pathogenic bacteria injected into patients’ tumors, led to durable complete remission of several types of cancers.

Despite its success, the lack of a known mechanism of action was considered too high a risk for broad adoption. Instead, oncologists pursued surgery and radiotherapy options as the ideal standards of care.

As such, immunotherapy remained in the background throughout much of the 20th century. Only in the 1990s did it finally begin to gain the spotlight as a viable treatment option.

IL-2 (T-cell growth factor interleukin 2), which enhances T-cell production, was approved by the FDA for kidney cancer in 1991 and later metastatic cancer in 1998.

Milstein and Köhler’s pioneering work in monoclonal antibodies in the 1970s set the groundwork for IDEC Pharmaceuticals’ rituximab, which was approved by the FDA in 1997 to treat B-cell non-Hodgkin lymphomas resistant to chemotherapy regimens.

While there were many other important milestones in the resurgence of immunotherapy, the biggest advances have come much more recently.

One such example would be Merck’s Keytruda, a therapeutic antibody that binds to and blocks the PD-1 (programmed cell death protein 1) receptor. Known as a checkpoint inhibitor, Keytruda helps the body recognize and attack cancer cells, essentially releasing the brakes on the immune system.

In May, Merck won approval to use Keytruda as a first-line treatment in all patients whose tumors have a specific biomarker, or biological trait. This is a major step forward for immunotherapies in general.

Prior to this approval, sales of Keytruda were already surging, hitting $584 million in the first quarter, up 134 percent compared to the same period last year.

Bristol-Myers Squibb’s (NYSE: BMY) Opdivo, a rival checkpoint inhibitor also targeting PD-1, topped $1.1 billion in sales in Q1, up 60 percent over the prior year period.

 

These and other successes clearly demonstrate the viability of immunotherapy.

In fact, the immuno-oncology market, which was estimated at $62 billion in 2016, is expected to grow at a five-year CAGR of 12.4%, reaching more than $110 billion by 2021.

Developing Therapies from the Protective Human Immune Response to Cancer

MabVax Therapeutics (NASDAQ: MBVX), a San Diego-based clinical stage biotechnology company, is an emerging player in the burgeoning immuno-oncology market.

MBVX in collaboration with leading cancer researchers has been studying the protective immune response created by repeated vaccination of cancer patients. The company’s antibody discovery technology identifies and recovers the antibodies patients have made against the vaccines and thus against the cancers.

By searching for the very best antibody any one patient makes against the vaccine, MBVX can identify optimal monoclonal antibody development candidates. With the successful completion of two Phase 1 clinical trials in the first half of 2017, it appears MBVX’s approach is working quite well.

MBVX reported results from its Phase 1 trial of its therapeutic antibody MVT-5873 at the ASCO Annual Meeting in early June. MVT-5873 is being evaluated to treat patients with advanced pancreatic cancer and other CA19-9 (a tumor marker) positive cancers.

The results of the study of 32 patients showed MVT-5873 to be safe and well tolerated in patients at biologically active doses, and evaluating for tumor response, one patient achieved complete response while 11 more patients achieve stable disease.

CA19-9 is broadly expressed in various cancers including pancreatic, colon, and small cell lung cancer, making MBVX’s fully human antibody potentially useful for a much larger patient population.

More recently, MBVX announced positive Phase 1 results for its complimentary ImmunoPET Imaging Agent, MVT-2163.

To date, 12 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.

Commenting on the trial results, MBVX president and CEO, David Hansen, stated, “We are encouraged with the safety and quality of the PET images obtained with MVT-2163.”

Importantly, results of the study also support the use of the company's MVT-1075 Radioimmunotherapy product which utilizes the same antibody to deliver a radiation dose for the treatment of patients with pancreatic, lung, and colon cancers. Initial dosing of patients in a Phase 1 trial for MVT-1075 is expected to begin in late June of this year.

Significant Valuation Potential

To understand the potential value of a new maintenance therapy for pancreatic cancer, investors can look at Merrimack’s ONYVYDE, the only approved second-line therapy comparable to MabVax’s MVT-5873.

Approved in late 2015, ONIVYDE generated $53 million in sales in 2016. Through licensing agreements with Baxalta (for markets outside the US and Taiwan), Merrimack received $100 million in upfront fees, another $100 million in R&D expenses, plus $520 million for regulatory milestones, and could get up to another $250 million for achieving sales milestones.

With key collaborations in place, including Memorial Sloan Kettering, Rockefeller University, and more, plus positive results across multiple early trials, the odds of MabVax securing lucrative partnerships or licensing agreements continue to improve.

New Opportunities and Expanding Collaborations

Longer term, MabVax’s HuMab 5B1, a fully human antibody technology, could result in new therapies for pancreatic, small cell lung, colon, and stomach cancers.

Based on a variety of data sources, the market for treatment of these cancers could reach well over $10 billion in the coming years.

In May, MBVX announced a research agreement with Memorial Sloan Kettering Cancer Center (MSK) to develop novel chimeric antigen receptor (CAR) T-cell therapeutics using antibody targeting sequences derived from MabVax's fully-human antibodies for pancreatic, small cell lung, and other solid tumor cancers.  

CAR T-cell therapy has been dubbed the “fifth pillar” of cancer treatment, and MBVX’s collaboration with MSK could lead to significant additional upside with the release of positive results.

Kite Pharma (NASDAQ: KITE), a clinical stage biopharma focused on CAR T-cell therapies commands a $5 billion market cap, up well over 100% since its 2014 IPO.

New Financings and Upcoming Milestones

MBVX closed on a total of $5 million in new financing, including a $4.1 million public offering and an $850,000 private placement in May 2017. The new cash will help fund current and upcoming trials, including the soon to launch Phase 1 trial for MVT-1075, MabVax’s radio-immunotherapy program.

In addition to an early readout on safety and other data from the MVT-1075 trial, the second half of the year should see several other major milestone achievements for MBVX, including:

  • Full Phase 1 trial results for MVT-5873 monotherapy
  • Complete enrollment of MVT-5873 trial in combination with chemo and full Phase 1 results
  • Launch Phase 1b trial for MVT-2163 for pre-surgical assessment

Value Proposition

With a market cap of just under $13 million, the upside potential for MBVX is huge.

As comparison, consider Nordic Nanovector (OSE: NANO), a $600 million market cap biotech. NANO is currently in Phase 1/2 trials for non-Hodgins lymphoma using a similar radioimmunotherapy-based monoclonal antibody.

With a growing pipeline and impressive results to date, in combination with multiple major near-term milestones on the horizon, fast-acting investors have a tremendous opportunity with MBVX.

Learn more today by visiting: https://www.redchip.com/company/Healthcare/MBVX/193/mbvx.

 

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MabVax Therapeutics Holdings (NASDAQ: MBVX) is a client of RedChip Companies, Inc. MBVX agreed to pay RedChip Companies, Inc. a monthly cash fee and 20,000 shares of Rule 144 stock for each six month period of RedChip investor awareness services and consulting services.

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