TapImmune Provides Year End 2016 Corporate and Clinical Update

JACKSONVILLE, Fla., March 14, 2017 /PRNewswire/ --

Recent Corporate and Clinical Developments:

• Launched FDA Fast Tracked Phase 2 study in platinum-sensitive ovarian cancer
• Completed first safety cohort in Memorial Sloan Kettering-sponsored Phase 2 combination study with AstraZeneca's durvalumab in platinum-resistant ovarian cancer; now more than 50% enrolled
• Advanced Phase 2 study in triple-negative breast cancer following safety review
• Completed GMP manufacturing scale up and second clinical lot of TPIV 200; to supply additional Phase 2 clinical trials
• Announced second U.S. Dept. of Defense-funded Phase 2 breast cancer study; Mayo Clinic to vaccinate women with ductal carcinoma in situ (DCIS) using HER2-targeted T-cell vaccine
• Expanded intellectual property for PolyStart™ protein expression platform

TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, today provided its first quarterly business update, following the company's uplisting to The NASDAQ Capital Market in the fourth quarter 2016.  A public conference call and live audio webcast is scheduled for today at 4:30 pm ET.

"I'm proud to say that the substantive clinical progress we achieved in 2016 has continued into the early part of 2017, and we now have multiple Phase 2 clinical studies either enrolling patients or preparing to commence in our target areas of breast and ovarian cancer," said Dr. Glynn Wilson, Chairman and CEO of TapImmune. "We are unique among biotech companies of our size to be advancing such a deep mid-stage pipeline in collaboration with top-tier industry and clinical leaders.  We believe this is a testament to the strength of our next generation T-cell cancer vaccine technology and the significant potential value of our lead clinical stage vaccine candidates.  We expect continued clinical progress to be the primary value driver for TapImmune and we look forward to reaching several upcoming catalysts as our current and planned studies advance."

Dr. Wilson continued, "In parallel, we've enhanced our efforts to position the company for significant near term growth.  We successfully scaled our manufacturing and developed final drug formulations as we advance our pipeline and look toward potential commercialization of our vaccines.  We also optimized our capital structure and balance sheet by eliminating $29 million in derivative liability through the exercise and restructuring of our outstanding warrants, raising $9 million through this and other equity financings.  We did this to enable our successful late-2016 up-listing of TapImmune stock to The NASDAQ Capital Market, which provides a pathway toward increased stock liquidity and access to long-term institutional investors.  With this enhanced infrastructure, our goal is to continue along this strong trajectory and build shareholder value through execution on our clinical and strategic initiatives."

Conference Call and Webcast Information:
The company will host a conference call and live audio webcast on Tuesday, March 14, 2017, at 4:30 p.m. ET. Interested participants and investors may access the conference call by dialing either:

• (877) 870-4263 (U.S.)
• (412) 317-0790 (International)

An audio webcast will be accessible via the New and Events section of the TapImmune website http://tapimmune.com/events/.  An archive of the webcast and presentation will remain available for 90 days beginning at approximately 6:30 p.m. ET, on March 14, 2017.

Pipeline Update:

TPIV 200: Lead T-Cell vaccine targeting folate receptor alpha

• Launched FDA Fast Tracked Phase 2 study in platinum-sensitive ovarian cancer
  Multicenter, blinded, randomized, placebo-controlled Phase 2 study currently enrolling 80 women with ovarian cancer who were responsive to recently completed platinum-based therapy.  The two-arm study will evaluate TPIV 200 as a consolidation therapy to potentially reduce the rate of cancer recurrence compared to placebo.  This program will benefit from FDA Fast Track, as well as Orphan Drug designation.  TapImmune expects to complete enrollment mid 2019.  An interim analysis is planned based upon 50% patient enrollment, which the company anticipates completing in the second half of 2018.
• Completed first safety cohort in Memorial Sloan Kettering-sponsored Phase 2 combination study with AstraZeneca's durvalumab in platinum-resistant ovarian cancer
  Sponsored by Memorial Sloan Kettering Cancer Center (MSKCC), this 40-patient, single-arm study will enroll women who either progressed while receiving or within six months of completing platinum-based therapy.  TPIV 200 will be tested in combination with another immunotherapy: AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab.  Successfully completing the first safety cohort enabled MSKCC to increase the number of patients that can be enrolled and will subsequently increase the study's enrollment rate. Currently more than 50% of patients have been enrolled.  An interim analysis is planned in the fourth quarter of 2017.
• Advanced Phase 2 study in triple-negative breast cancer following safety review
  An independent data safety monitoring board (DSMB) reviewed the safety in this ongoing Phase 2 currently enrolling women with stage IIb-III triple-negative breast cancer who have completed initial surgery and chemo/radiation therapy. The randomized four-arm study is evaluating two doses of TPIV 200 (a high dose and a low dose), each of which will be tested both with and without immune priming with cyclophosphamide prior to vaccination. The planned safety review was performed when enrollment reached the 25% benchmark (20 out of 80 total patients), and showing no safety issues, the study has continued to enroll patients at multiple clinical sites. The study is expected to complete enrollment by year end 2017, with top-line data expected in early 2018.
• Completed GMP manufacturing scale up and second clinical lot of TPIV 200; to supply additional Phase 2 clinical trials
  TapImmune successfully completed a multi-gram production scale-up as well as GMP manufacturing of a second clinical lot of TPIV 200.  The vaccine supply will be used in the company's ongoing Phase 2 study in platinum-sensitive ovarian cancer, as well as the planned 280-patient Phase 2 study sponsored by the Mayo Clinic and funded by the U.S. Dept. of Defense for treating triple-negative breast cancer. TapImmune also made various improvements to the vaccine manufacturing process, resulting in a superior formulation of the vaccine that is more amenable to large scale manufacturing and commercialization.

TPIV 110: T-Cell vaccine targeting HER2/neu

• Expects to launch a Phase 1b/2a trial of TPIV 110 in HER2/neu+ breast cancer following submission of an updated IND
  TapImmune has completed its pre-IND meeting with the FDA and expect to file the amended IND later this year.
• Announced second U.S. Dept. of Defense-funded Phase 2 breast cancer study; Mayo Clinic to vaccinate women with ductal carcinoma in situ (DCIS) using TapImmune HER2-targeted T-cell vaccine
  Recently, TapImmune announced that its partners at the Mayo Clinic received a grant from the U.S. Dept. of Defense to conduct a Phase 2 study of TapImmune's HER2-targeted vaccine candidate in an early form of breast cancer called DCIS.  This is the second TapImmune vaccine to be tested in a fully funded Phase 2 study sponsored by the Mayo Clinic. If successful, TapImmune's vaccine may replace standard surgery and chemotherapy, and potentially could become part of a routine immunization schedule for preventing breast cancer in healthy women.  The study is expected to enroll 40-45 women with DCIS and commence in 2017.

PolyStart™ protein expression platform

• Expanded intellectual property for PolyStart™ antigen expression platform
  TapImmune received a Notice of Allowance from the U.S. Patent and Trademark Office for its application titled, "Chimeric nucleic acid molecules with non-AUG initiation sequences and uses thereof," which expands upon the company's intellectual property for its proprietary PolyStart™ antigen expression technology.  The technology is designed to elevate expression of antigenic epitopes for use in next-generation vaccines for cancer or infectious diseases. Once granted, the patent would extend coverage into 2035, covering the use of PolyStart to express Class I and II antigenic peptides of HER2, which is overexpressed by more than 20% of all breast cancer patients.

Financial Highlights:

At the time of uplisting to The Nasdaq Capital Markets TapImmune raised $9 million, which gives the company sufficient cash to execute its programs this year.

About TapImmune, Inc.
TapImmune, Inc. is an immuno-oncology company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The company's peptide or nucleic acid-based immunotherapeutics, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient's killer T-cells, helper T-cells and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. The company's technologies may be used as stand-alone medications or in combination with current treatment modalities.

Please visit the company's website at www.tapimmune.com for more details. 

Forward-Looking Statement Disclaimer
This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements". Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The company assumes no obligation to update the forward-looking statements. 

SOURCE TapImmune, Inc.

Related Links

http://www.tapimmune.com