TapImmune Provides First Quarter 2017 Corporate and Clinical Update

JACKSONVILLE, Fla., May 31, 2017 /PRNewswire/ -- 

Recent Corporate and Clinical Developments:

• Appointed Dr. Richard Kenney as Head of Clinical Development
• Continued advancing multiple Phase 2 clinical studies of lead vaccine candidate
  TPIV 200 in ovarian and triple-negative breast cancers
• Progressed preclinical development of proprietary PolyStart™ vaccine expression technology

Anticipated 2017 Milestones:

• 2Q 2017: On track to achieve 50% enrollment in ongoing Phase 2 dosing study of TPIV 200 for treating triple-negative breast cancer (TNBC)
• 3Q 2017: Publish long-term safety, immune response and survival data from completed Phase 1 clinical study of TPIV 200
• 3Q 2017: Report interim results from ongoing Phase 2 study of TPIV 200 in combination with AstraZeneca's durvalumab in patients with platinum-resistant ovarian cancer
• 3Q 2017: Mayo Clinic to initiate 280-patient Phase 2 study of TPIV 200 in women
  with advanced triple-negative breast cancer
• 4Q 2017: On track to complete enrollment in Phase 2 dosing study of TPIV 200 in TNBC
• Year end 2017: File amended investigational new drug application (IND) for TPIV 110 for treating HER2/neu+ breast cancer

TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women's cancers, 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.

"TapImmune is entering a period where we expect to reach several substantive clinical milestones over the next 18 months," said Dr. Glynn Wilson, Chairman and CEO of TapImmune. "By the end of 2017, we expect to have four active Phase 2 studies ongoing in multiple high-need cancers, including clinical studies sponsored by our top-tier partners, the Mayo Clinic and Memorial Sloan Kettering Cancer Center. Two of the planned Phase 2 studies are fully funded by approximately $17 million in U.S. Government grants to the Mayo Clinic, which continues to be a significant source of non-dilutive clinical funding. Based on the breadth of our pipeline, we believe TapImmune is the only immune-oncology company of our size that is poised to generate such substantial value through the continued development of our novel vaccine candidates. We look forward to advancing our extensive pipeline and to translating our anticipated clinical milestones in to multiple value inflection points for our shareholders."

Dr. Wilson continued, "Adding to this position of clinical strength is our earlier stage PolyStart™ technology platform, which is designed to improve antigen expression compared to current vaccines. We continue to generate encouraging in vitro and in vivo data that demonstrate how PolyStart may be able to enhance the potency of virtually any expression-based vaccine. Once matured, we expect that TapImmune will benefit from multiple opportunities to leverage this next-generation technology, both to continue expanding our in-house oncology pipeline, as well as to out-license PolyStart to strategic partners developing vaccines for infectious disease. We plan to explore several ways to monetize this valuable and proprietary platform."

Current Clinical Studies:

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

• Memorial Sloan Kettering-sponsored Phase 2 combination study with AstraZeneca's durvalumab in platinum-resistant ovarian cancer
  This is the first study to evaluate the combination of a cancer vaccine with a checkpoint inhibitor.  The single-arm study has enrolled 27 out of the planned 40 women whose cancer progressed after receiving platinum-based therapy. If successful in this extremely difficult-to-treat patient population, there is potential for this novel combination regimen to be a breakthrough for these patients, who have very poor survival prognosis and no available treatment options.  Results from the planned interim analysis are expected to be available in the third quarter 2017. If the safety profile remains favorable and there are sufficient signs of tumor response, patient enrollment will resume and TapImmune expects the study to be completed as planned in 2018.
  
• FDA Fast Tracked Phase 2 maintenance therapy study in platinum-sensitive ovarian cancer
  Multicenter, blinded, randomized, placebo-controlled study currently enrolling 120 women with ovarian cancer who responded to standard platinum-based therapy.  The two-arm study will evaluate TPIV 200 as a maintenance therapy to potentially reduce the time to cancer recurrence compared to GM-CSF alone. This program will benefit from FDA Fast Track as well as Orphan Drug designation. TapImmune plans to conduct an interim analysis once the study is 50% enrolled, which is currently expected in the second half of 2018.
  
• Multi-center Phase 2 dosing study in triple-negative breast cancer
  The randomized study is designed to determine the optimal vaccine dosing and regimen that may maximize the anti-tumor immune response in maintenance-phase patients, who have completed standard surgery and chemotherapy/radiation. The study continues to enroll and randomize patients into the four different study arms following a favorable safety review by an independent data safety and monitoring board (DSMB). The study is on track to reach 50% enrollment in the second quarter of 2017, and completion of patient enrollment is anticipated by year end 2017.  Once enrolled, top-line data from the completed study is anticipated in the second half of 2018.

Planned Clinical Studies:

TPIV 200:

• Mayo Clinic is expected to initiate a Phase 2 study designed to determine the efficacy of TPIV 200 in prolonging disease-free survival in women with advanced triple-negative breast cancer. This 280-patient study is planned to commence in the third quarter 2017, and is completely funded by a ~$13 million grant from the U.S. Department of Defense.

TPIV 100/110 T-cell vaccine targeting HER2/neu:

• TapImmune plans to initiate a Phase 1b/2a clinical trial of TPIV 110, a novel vaccine with an enhanced antigen composition compared to predecessor vaccine candidate TPIV 100.  The Company expects to submit an amended investigational new drug application (IND) by year-end 2017, and upon FDA acceptance of the amended IND, initiate the study to evaluate TPIV 110 for treating women with HER2/neu+ breast cancer.
  
• Mayo Clinic is expected to initiate a Phase 1b/2a study of TPIV 100 in women with an early form of breast cancer called ductal carcinoma in situ (DCIS) breast cancer.  This study is also fully funded by a grant from the U.S. Dept. of Defense. If successful, TapImmune's HER2/neu-targeted vaccine may complement standard surgery and chemotherapy, and potentially could become part of a routine immunization schedule for preventing breast cancer in healthy women.

Conference Call and Webcast Information:
The company will host a conference call and live audio webcast on Wednesday, May 31, 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 May 31, 2017.

About TapImmune, Inc.
TapImmune, Inc. is a leader in the immunotherapy of woman's cancers advancing multiple Phase 2 and Phase 1b/2 clinical studies for the treatment of ovarian and breast cancer. The company's peptide- or nucleic acid-based immunotherapeutic products comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient's killer T cells and 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 http://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. 

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SOURCE TapImmune, Inc.