CALGARY, Alberta, Canada, October 25, 2023, Zenith Epigenetics Ltd. (“Zenith” or the “Company”), a global leader in epigenetics, announced today it has entered into an agreement with Cencora (formerly AmerisourceBergen) aimed at accelerating the commercialization of Zenith Epigenetics’ ZEN-3694 program.
The ZEN-3694 program is an advanced epigenetic approach to synergistically advancing the efficacy of cancer treatment of currently marketed drugs. Existing partners and collaborators include Pfizer, Merck, BMS, Eli Lilly, Astellas, GSK, and Syndax and is supported by numerous collaborators and partners such as National Cancer Institute, National Institute of Health, Dana Farber - Harvard, Yale, UCSF, Memorial Sloan Kettering, and MD Anderson.
As part of the agreement, Cencora will provide a variety of services to strategize ZEN-3694’s market introduction. The initial focus will be in evaluating regulatory and market access to provide insights into potential barriers and opportunities for ZEN-3694's introduction. The insights will be used to tailor ZEN-3694’s development and to design successful patient access and adherence programs that add value for the entire healthcare system.
“We’re excited to work with Cencora and their team on the future of ZEN-3694,” said Donald J. McCaffrey, Zenith’s Chairman, Founder, and CEO. “They share our vision and passion for impacting patients in a positive and meaningful way, with a strong eye for what tomorrow will bring. We know that ZEN-3694 will innovate the future of oncology and are proud to work with Cencora on the next steps of bringing ZEN-3694 into the lives and homes of patients nationwide and, in time, globally.”
“For a product with the immense capabilities ZEN-3694 has, we knew we needed a partner with immeasurable experience across healthcare, unmatched distribution capabilities, and a global impact,” said Donald J. McCaffrey. “Cencora emerged as the best partner to lead the commercial and distribution strategy for ZEN-3694 with innovation, strategic thinking, and careful planning around patient access and the patient experience.”
“As biotech and pharmaceutical companies invest in the development of new products, we remain focused on delivering integrated support across the clinical and commercialization journey to help them bring their innovations to market,” said Sandra Anderson, senior vice president of International Commercialization at Cencora. “We are thrilled to support Zenith’s pre-commercial launch preparations and will provide the solutions they need to help them accelerate time-to-market and maximize commercial success.”
While Zenith continues its work on ZEN-3694’s technology platform, Cencora’s teams will identify key avenues and opportunities for ZEN-3694’s commercialization and market entry.
About Zenith and ZEN-3694
Zenith Epigenetics Ltd., a wholly owned subsidiary of Zenith 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 of BET inhibitors with other targeted agents. Our lead compound, ZEN-3694, is in clinical development for various oncologic indications and several studies are sponsored by NCI under the NCI-Zenith CRADA and CRADAs between NCI and other NCI collaborators, specifically:
- Randomized phase 2b trial in patients with metastatic castration resistant prostate (mCRPC) cancer in combination with androgen receptor inhibitor, XTANDI (enzalutamide), conducted in collaboration with Astellas Pharma and Newsoara Biopharma. Zenith and Newsoara are the trial sponsors (NCT04986423).
- Phase 1b/2 trial in patients with androgen receptor independent mCRPC in combination with immune checkpoint inhibitor KEYTRUDA (pembrolizumab) and XTANDI (enzalutamide), conducted by the University of California, San Francisco in collaboration with Merck and Zenith (NCT04471974).
- Phase 2 trial in combination with TALZENNA (talazoparib) in patients with recurrent ovarian cancer treated with prior PARPi, conducted by the University of Pittsburgh in collaboration with Zenith and Pfizer (NCT05071937).
- Phase 1b/2 trial in platinum resistant ovarian cancer patients in combination with immune-checkpoint inhibitors, OPDIVO (nivolumab) and YERVOY (ipilimumab), conducted by the NCI in collaboration with Zenith and BMS (NCT04840589).
- Phase 2 trial with TALZENNA (talazoparib), in patients with molecularly-selected solid tumors such as PARPi resistant ovarian, prostate cancer, breast, and pancreatic cancers, and solid tumors with RAS pathway alterations conducted by the NCI in collaboration with Zenith and Pfizer (NCT05327010).
- Phase 1 trial with chemotherapy (Etoposide and Cisplatin) in patients with metastatic or unresectable NUT carcinoma conducted by the NCI in collaboration with Zenith (NCT05019716).
- Phase 1 trial with abemaciclib (Verzenio) in patients with metastatic or unresectable NUT carcinoma and other solid tumors conducted by the NCI in collaboration with Eli Lilly and Zenith (NCT05372640).
- Phase 1/2 trial with the histone deacetylase inhibitor Entinostat in advanced and refractory solid tumors and lymphomas conducted by the NCI in collaboration with Zenith and Syndax (NCT05053971).
- Phase 1 trial of with the MEK inhibitor binimetinib (MEKTOVI) in solid tumors with RAS pathway alterations and metastatic TNBC conducted by the NCI in collaboration with Zenith and Pfizer (NCT05111561).
- Phase 1b trial with KEYTRUDA (pembrolizumab) and ABRAXANE (Nab-Paclitaxel) in patients with metastatic TNBC conducted by the NCI in collaboration with Zenith and Merck (NCT05422794).
- Phase 2 trial in patients with advanced squamous cell lung cancer with NSD3 gene amplification, conducted by Memorial Sloan Kettering Cancer Center in collaboration with Zenith (NCT05607108).
- Phase 1 trial in combination with Capecitabine in patients with metastatic unresectable colorectal cancer (CRC) conducted by the NCI in collaboration with Zenith (NCT05803382).
- Phase 1b trial in combination with M1774 (ATR inhibitor) for the treatment of ARID1A mutant recurrent ovarian and endometrial cancer conducted by the NCI in collaboration with Merck KGgA and Zenith (NCT05950464).
Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. Our 46,000+ worldwide team members contribute to positive health outcomes through the power of our purpose: We are united in our responsibility to create healthier futures. Cencora is ranked #11 on the Fortune 500 and #24 on the Global Fortune 500 with more than $200 billion in annual revenue. Learn more at www.cencora.com.
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This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. In particular, this news release includes forward looking information relating to the Company’s collaboration with Cencora and the Company’s development activities involving ZEN-3694 for the treatment of various oncologic indications and other disorders, as well as our partnerships, agreements, and collaborations in furtherance of these development activities. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. Zenith disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.