The trial will continue to evaluate the efficacy and safety of this combination in patients with locally advanced or metastatic germline wild type BRCA1/2 TNBC. This Phase 2b trial is an extension of the recently completed Phase 1b/2 trial which met its primary efficacy endpoint of clinical benefit rate comprised of objective responses plus stable disease and which showed that the combination regimen was well tolerated. The Phase 2b extension will enroll patients who have previously been treated with a TROP2 antibody drug conjugate for locally advanced or metastatic disease.
'The data from the Phase 1b/2 trial has shown that the ZEN-3694 plus talazoparib combination regimen induced durable responses in tumors of TNBC patients which do not harbor mutations in BRCA1/2,' said Dr.
In
Single agent PARPi are approved for gBRCAm HER2-negative locally advanced or metastatic breast cancer, as both PARP inhibition and non-functioning DNA repair proteins BRCA1/2 are required to block DNA repair and kill tumor cells (synthetic lethality). Preclinical and clinical data has shown that
'We are very pleased to advance our TNBC program to Phase 2b and closer to possible registration,' said
The data from the completed Phase 1b/2 part of the clinical trial will be presented in an oral poster discussion section at the annual ASCO conference in
About Zenith and ZEN-3694
Zenith Epigenetics Ltd. , a wholly-owned subsidiary ofZenith Capital Corp. , is a clinical stage biotechnology company focused on the discovery and development of novel therapeutics for the treatment of cancer and other disorders with significant unmet medical need. Zenith Epigenetics is developing various novel combinations ofBET inhibitors with other targeted agents. The lead compound, ZEN-3694, is in clinical development for various oncologic indications, specifically: 1. Phase 2b metastatic castration resistant prostate (mCRPC) cancer trial in combination with androgen receptor inhibitor, XTANDI (enzalutamide), conducted in collaboration withAstellas Pharma and Newsoara Biopharma. Zenith and Newsoara are the trial sponsors. 2. Phase 2b Triple Negative Breast Cancer (TNBC) trial in combination with the PARP inhibitor TALZENNA (talazoparib), conducted in collaboration withPfizer and Newsoara Biopharma. Zenith and Newsoara are the trial sponsors. 3. Phase 1b/2 androgen receptor independent mCRPC trial in combination with immune checkpoint inhibitor KEYTRUDA (pembrolizumab) and XTANDI, conducted in collaboration withMerck , theUniversity of California, San Francisco , and theUniversity of Michigan . 4. Phase 1b/2 ovarian cancer trial in combination with immune-checkpoint inhibitors, nivolumab and ipilimumab, conducted by theNational Cancer Institute in collaboration with Zenith and BMS.
About Triple Negative Breast Cancer ('TNBC')
TNBC is an aggressive form of breast cancer with low survival rates. TNBC accounts for about 10-15% of all breast cancers and it differs from other types of invasive breast cancer in that it tends to grow and spread faster, has fewer treatment options, and tends to have a worse prognosis. The term triple-negative breast cancer refers to the fact that the cancer cells have only low or no amount of the receptors ER, PR, and HER2. Approximately 75,000 women in the US,
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