On March 14, 2017 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, reported that its collaborators at the Mayo Clinic, recently received a $3.7 million grant from the U.S. Department of Defense (DoD) to conduct a Phase 2 clinical study on TapImmune’s HER2/neu-targeted T-cell vaccine that will enroll women diagnosed with an early form of breast cancer called ductal carcinoma in situ (DCIS) (Press release, TapImmune, MAR 14, 2017, View Source [SID1234518113]). 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.

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"This is our second T-cell vaccine candidate to be tested in a DoD-funded Phase 2 study to the Mayo Clinic, and it marks our expansion into a second breast cancer indication," said Dr. Glynn Wilson, chairman and CEO of TapImmune. "In addition to ongoing and planned Phase 2 studies of our lead TPIV 200 vaccine for treating triple-negative breast cancer, this new study of our HER2neu vaccine in DCIS has the potential to validate our novel approach to establishing lasting immunity against breast cancer and precancerous lesions. Her2neu is overexpressed in about 30% of all breast cancer patients amounting to approximately 220,00 patients per year. We look forward to the advancement of this fully funded study, as it further broadens our robust clinical pipeline, which also includes two additional Phase 2 trials for treating ovarian cancer."

The study is expected to begin in 2017 and will be led by Keith Knutson, Ph.D., Director of the Discovery and Translational Labs Cancer Research Program at Mayo Clinic’s Florida campus. It is expected to enroll 40-45 women with DCIS, who will receive the vaccine six weeks prior to standard surgical resection. The vaccine has already been shown to stimulate production of T-cells directed against breast cancer cells that overexpress the oncogene HER2 in a completed Phase 1 study.

TapImmune has licensed the HER2neu vaccine technology that will be used in this study and has the worldwide exclusive rights to commercialize the technology. TapImmune will be funded for providing the manufactured product for this trial.

Dr. Knutson added, "DCIS is a significant health problem, accounting for about 20% of U.S. cases of breast cancer. We ultimately want to eliminate ductal carcinoma in situ, which means preventing disfiguring surgeries and toxic therapies in the 60,000 women who receive this diagnosis every year in the U.S."

On March 14, 2017 AstraZeneca reported results from the Phase III SOLO-2 trial demonstrating a significant improvement in progression-free survival (PFS) in germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients treated with Lynparza (olaparib) tablets (300mg twice daily) compared with placebo in the maintenance setting (Press release, AstraZeneca, MAR 14, 2017, View Source [SID1234518106]). The trial met its primary endpoint of investigator assessed PFS (HR 0.30; 95% CI 0.22 to 0.41; P<0.0001; median 19.1 months vs 5.5 months).

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PFS as measured by Blinded Independent Central Review (BICR) evaluation, a pre-specified analysis supporting the primary endpoint, demonstrated a median PFS of 30.2 months vs 5.5 months for placebo, representing an improvement of 24.7 months (HR 0.25; 95% CI 0.18-0.35; P<0.0001).

Additionally, a statistically-significant benefit in time to second progression or death (PFS2) was also seen in patients treated with Lynparza (HR 0.50; 95% CI 0.34 to 0.72; P=0.0002; median not reached vs 18.4 months) compared with placebo, as well as improvements in other key secondary endpoints.

Progression-Free Survival by investigator and BICR assessment:

Analysis
Median progression-free survival, months
Hazard ratio
Investigator-assessed analysis
Lynparza
19.1

0.30 (95% CI, 0.22-0.41), P<0.0001
Placebo

5.5

Blinded Independent Central Review
Lynparza

30.2

0.25 (95% CI, 0.18-0.35), P<0.0001
Placebo

5.5

These results, presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in National Harbor, USA, build upon prior data in this setting, demonstrating the benefit of Lynparza as a maintenance therapy in relapsed ovarian cancer. Eric Pujade-Lauraine, Head of the Women Cancers and Clinical Research Department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, AP-HP and Principal Investigator of SOLO-2, said: "Today’s results are very encouraging, as they build upon previous trials examining Lynparza in platinum-sensitive relapsed BRCA-mutated ovarian cancer. Most importantly, patients were able to maintain quality of life while experiencing an impressive delay in disease progression, demonstrating the benefits of Lynparza tablets for these women whose cancer is often difficult to treat." Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "We are extremely pleased with the results from SOLO2, which support the potential benefit of Lynparza tablets as a maintenance therapy for patients with relapsed ovarian cancer. The tablet formulation may offer patients a reduced pill burden for Lynparza and a safety profile that is generally consistent with previous trials. We will work with regulatory authorities to make Lynparza tablets available to patients as quickly as possible." The safety profile for patients treated with Lynparza tablets during the trial was consistent to those observed with the currently-approved capsule formulation. Any adverse events (AE) Grade ≥3 were reported in 36.9% of patients treated with Lynparza and in 18.2% of patients who received placebo. The most common non-haematological AEs reported at a frequency of ≥20% were nausea (75.9% [grade ≥3, 2.6%]), fatigue/asthenia (65.6% [grade ≥3, 4.1%]), and vomiting (37.4% [≥3, 2.6%]). The most common haematological AEs reported in the Lynparza arm versus placebo were anaemia (43.6% [grade ≥3, 19.5%]), neutropenia (19.5% [grade ≥3, 5.1%]), and thrombocytopenia (13.8% [grade ≥3, 1.0%]). The 300mg twice-daily tablet dose reduces the pill burden for patients from sixteen capsules to four tablets per day.

NOTES TO EDITORS

About SOLO-2
SOLO-2 was a Phase III, randomised, double-blind, multicentre trial designed to determine the efficacy of Lynparza tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed or recurrent gBRCA-mutated (BRCAm) ovarian cancer. The trial, conducted in collaboration with the European Network for Gynaecological Oncological Trial Groups (ENGOT) and Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein (GINECO), randomised 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at least 2 prior lines of platinum-based chemotherapy and were in complete or partial response. Eligible patients were randomised to receive 300mg Lynparza tablets twice daily or placebo tablets twice daily.

About Lynparza
Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. It is approved by regulatory authorities in the EU and US for the treatment of women with BRCAm ovarian cancer. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer cells. In a previous study Lynparza capsules were shown to result in a significant improvement in PFS compared to placebo in platinum-sensitive, relapsed ovarian cancer (PSR OC) patients (HR 0.35; 95% CI 0.25-0.49; p <0.0001) as well as in the subgroup of patients whose tumours harbour BRCA mutations (HR 0.18; 95% CI 0.10-0.31; p <0.0001).

About ENGOT
ENGOT (European Network for Gynaecological Oncological Trial groups) is a research network of the European Society of Gynaecological Oncology (ESGO) and was founded in 2007. Currently, ENGOT consists of 19 cooperative groups from 15 European countries. ENGOT’s ultimate goal is to bring the best treatment to gynaecological cancer patients through the best science, and enabling every patient in every European country to access a clinical trial. ENGOT coordinates and promotes multinational clinical trials within Europe on patients with gynaecological cancer. This coordination is particularly relevant for academic clinical trials, translational research, research on rare diseases, and for clinical trials sponsored by the industry.

About GINECO
GINECO (Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein) is the French Cooperative Group in Oncology labelled by INCA (Institut National du Cancer or French NCI) for developing and conducting gynaecological and advanced breast cancer clinical trials at the national and international level. The network is nationwide with 700 specialized investigators belonging to more than 150 public or private oncology units. The GINECO group was founded in 1993 and is member of international consortia such as ENGOT and GCIG (Gynecologic Cancer InterGroup). GINECO was the ENGOT leading group for SOLO-2 trial.