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TapImmune’s Cancer Vaccine Significantly Extends Progression Free Survival In Ovarian Cancer

|Includes: Marker Therapeutics, Inc. (MRKR), RHHBY

FDA Fast Track Designation and Orphan Drug Status have both been granted.

Did better than Genentech/Roche’s (RHHBY) blockbuster oncology drug Avastin.

Current Phase 2 trial could transition it into a pivotal trial for marketing approval.

Data just published from a Mayo Clinic study in Clinical Cancer Research, a high impact oncology journal, show TapImmune’s (TPIV) cancer vaccine significantly extended progression free survival of ovarian cancer patients, as compared to the current standard of care. TapImmune’s off-the-shelf, breakthrough cancer vaccine also did better than Genentech/Roche’s (OTCQX:RHHBY) blockbuster oncology drug Avastin, approved for the treatment of ovarian cancer.

Avastin racked up sales of $6.75 billion in 2017. Genentech’s drug is approved to treat several cancers. Much of the 13% sales growth for Avastin last year came from its use in ovarian cancer where it is approved for two indications, in women newly diagnosed with advanced ovarian cancer, and in treating recurrent ovarian cancer in women who previously responded well to platinum chemotherapy.

TapImmune may have a blockbuster cancer vaccine on its hands if the positive results from the Phase 1 Mayo Clinic trial of its TPIV200 T-cell cancer vaccine are duplicated in TapImmune’s current, larger 120 patient Phase 2 trial, also being conducted by top US medical institutions including the Mayo Clinic, Sloan Kettering, and Moffit Cancer Center. The published Phase 1 data need to be taken in context of the small number of 10 evaluable patients.

FDA Fast Track Designation and Orphan Drug Status have both been granted to TPIV200 cancer vaccine for the treatment of patients with ovarian cancer in first remission following successful treatment with platinum chemotherapy.

In a March 15 conference call, TapImmune management stated that if their Phase 2 results are similar to the current Phase 1 data, they can ask the FDA to expand the current Phase 2 trial and transition it into a pivotal trial for marketing approval. This could accelerate approval by several years. The Phase 2 study is projected for completion by Q1 2019. Top line interim results from the first 60 patients are expected in mid-2019 and the full unblinded data release would come in Q4 2019. Approval of TPIV200 would be a significant advancement in the treatment of ovarian cancer.

A huge need exists for treatment of women with ovarian cancer who have successfully completed platinum based therapy, to help prevent recurrence. No other FDA approved treatment is available. Right now, there is nothing for a woman to do but wait for recurrence of disease. If approved, TPIV200 would be the first treatment to address this need.

70% of patients with ovarian cancer will have a recurrence, with nearly 50% of these having a relapse in the first 10 months. The 5-year survival rate for ovarian cancer is only 45%.

“I sat at a national meeting with the primary investigators from 17 of our trial sites for the Phase 2,” said TapImmune President and CEO Peter Hoang. “What I saw there was a lot of enthusiasm for our product. I hear time and time again this is something they were really excited about because right now their patients have no alternative.”

At this point in the treatment cycle, women want to avoid any more chemo, so that they can maintain better quality of life and not damage their immune system further. It is an ideal time to use a vaccine, according to TapImmune management.

Approximately 100 patients to date have been treated with TPIV200, which has shown to be safe, especially compared to chemotherapies that can be very toxic. TapImmune’s cancer vaccine does not produce immunosuppressive reactions, so patients don’t become immune compromised. TPIV200 patients enjoy a normal quality of life, unlike those treated with chemotherapy.

Patients treated with TPIV200 in the Phase 1 study had a median progression free survival of 528 days following vaccination. These results are far better than results reported from the largest study conducted in this patient population. A Phase 3 study for Genentechs’ Avastin published in the New England Journal of Medicine showed the standard of care offered a 313 day progression free survival, while extended treatment with Avastin resulted in a median 429 days of progression free survival. This Avastin study included the time for initial chemo treatment and surgery as part of the progression free survival, whereas the TPIV200 study did not. The TPIV200 study measured the survival time from the time of vaccination. This translates into a 50-200 day favorable difference for TapImmune.

The Phase 1 study further showed a long-lasting immune response of up to 18 months in 90% of patients treated with TPIV200. All patients treated are still alive after the last follow up, at least two years following immunization.

World class collaborators including the Mayo Clinic and Sloan Kettering are working with TapImmune. AstraZeneca (NYSE:AZN) is conducting a Phase 2 study for a combination therapy with TPIV200 in ovarian cancer. The U.S. Department of Defense has granted $13 million in non-dilutive money to fund a TPIV200 Phase 2 study in conjunction with the Mayo Clinic in triple negative breast cancer.

In total, TapImmune has 6 ongoing clinical studies, with $17 million in non-dilute grants and $8 million in cash on its balance sheet. TPIV 200 cancer vaccine addresses the $1.5 billion ovarian cancer market, plus a far larger market in cancer immunotherapy in general.

RAY DIRKS Research suggests that Readers/Investors place no more than 1% of the funds they devote to common stocks in any one issue. It's best to diversify.

Disclosure: I am/we are long TPIV.