TapImmune Announces Publication of Clinical Trial Results for the TPIV200 Cancer Vaccine in Clinical Cancer Research

Phase 1 Demonstration of Safety and Long-Lasting Immune Responses in Ovarian and Breast Cancer

JACKSONVILLE, FL, USA I March 15, 2018 I TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today announced the publication of clinical data from a Phase 1 trial of TPIV200, the company’s multi-epitope T-cell vaccine targeting Folate Receptor Alpha (FRa) in patients with ovarian and breast cancer. The study by Kalli, Block, et al., titled, “Folate Receptor Alpha Peptide Vaccine Generates Immunity in Breast and Ovarian Cancer Patients”, will be published in the leading peer-reviewed oncology journal Clinical Cancer Research and will be available online today. The results show that TPIV200 vaccination was well tolerated by all patients and over 90% developed robust and durable antigen-specific immune responses against FRa without regard for HLA type, which aligns with the intended mechanism of action of the vaccine.

The Phase 1 study was not designed to show efficacy and involved a small number of patients. Yet, a retrospective analysis showed that among the subset of ovarian cancer patients who were vaccinated following a first remission (n=10), median progression-free survival (PFS) was extended compared to published clinical results1 for a similar patient population that received standard of care chemotherapy. TapImmune has published a white paper that further details this preliminary data and its potential implications for the company’s ongoing Phase 2 clinical trial of TPIV200 in women with platinum-sensitive ovarian cancer.

Peter Hoang, President and CEO of TapImmune, stated, “Although this safety trial was not designed to evaluate clinical efficacy outcomes, all patients remained alive at last follow-up, at least two years following initiation of immunization, and the large majority of vaccinated patients developed lasting immune responses against multiple FRa epitopes. The potential PFS benefit observed in women with ovarian cancer in first remission is very intriguing to TapImmune and our clinical investigators, especially in the context of our ongoing Phase 2 study of TPIV200, which is enrolling patients at the same stage of disease. While our population of 10 patients in ovarian first remission cannot be deemed to be statistically significant, the observed median PFS of 528 days is certainly an interesting result, particularly in light of the historical data where patients receiving stand-of-care in this setting had a median PFS in the 313-day range.  Should we see a similar result in our larger ongoing randomized, double-blind, controlled Phase 2 trial, we believe that TPIV200 has a viable pathway toward potential approval in this indication. Enrollment in the study is currently ongoing, and we expect to conduct an interim analysis by mid-2019, once the data from the first half of enrollment is achieved.”

Dr. Richard Kenney, Acting Chief Medical Officer for TapImmune, stated, “There remains a significant unmet need in ovarian cancer to delay or prevent disease recurrence following successful platinum-based therapy. That is why TapImmune is focusing on TPIV200 immunotherapy at this earlier stage in the treatment paradigm where no approved therapies currently exist in the ongoing Phase 2 study.  Women in first remission are likely to have healthier immune systems, having not gone through multiple rounds of chemotherapy and cancer recurrence, and may be better positioned to benefit from vaccination with TPIV200.  We are grateful to Dr. Keith Knutson and his team for conducting the study and publishing the results.  Should TPIV200 demonstrate a significant benefit in prolonging disease-free survival in this patient population, TapImmune will be well positioned to address a unique segment within the ovarian cancer treatment landscape.”

1 Perren, et al., (2011) “A Phase 3 Trial of Bevacizumab in Ovarian Cancer.” NEJM 365:2484-96

About Phase I Trial Results
The initial clinical study was designed to evaluate the safety and long-term immune response of ovarian and breast cancer patients to TPIV200. Patients were immunized over a six-month period following pretreatment with cyclophosphamide, and then monitored for an additional twelve months. The study demonstrated that the TPIV200 vaccine generated robust immune responses and was well tolerated by all patients, with only one Grade 3 adverse event related to vaccination (a local ulceration that resolved). Generation of T-cell immunity following immunization was robust and long-lasting. Analysis showed 91% of patients had an antigen-specific response, with 89% of those patients responding to multiple epitopes included in TPIV200 (median=3/5 FRa epitopes). T-cell responses developed slowly over the course of vaccination, with a median time to maximal immunity of five months. As is desired for a therapeutic vaccine, this T-cell immunity to FRa was durable, with antigen-specific T cells remaining at high levels through the 12-month post-immunization monitoring period. Finally, it was observed that ovarian cancer patients who entered the study in their first remission (n=10) had a median progression-free survival time of 528 days (95% confidence interval 110-548 days).

About TapImmune Inc.
TapImmune, Inc. is a leader in the TapImmune Inc. is a leader in the development of novel immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer. The company's peptide- or nucleic acid-based immunotherapeutic products comprise 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. This unique approach can produce off-the-shelf T-cell vaccine candidates that elicit a broad-based T-cell response and can be given without respect to HLA type. The company's technologies may be used as stand-alone medications or in combination with other treatment modalities.

SOURCE: TapImmune

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