A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination With Cetuximab and Encorafenib in Patients With Refractory BRAF V600E Metastatic Colorectal Cancer

This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). ZEN003694 is a protein inhibitor that binds to BET proteins. When ZEN003694 binds to BET proteins, it disrupts gene expression. Preventing the expression of certain growth-promoting genes may inhibit proliferation of tumor cells that over-express BET proteins. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Encorafenib is an enzyme inhibitor. It inhibits pathways that are responsible for controlling cell proliferation and survival, which may lead to a decrease in tumor cell proliferation. Both cetuximab and encorafenib have been approved to treat cancer. Adding ZEN003694 to cetuximab and encorafenib may be more effective at treating patients with refractory metastatic colorectal cancer than giving the usual treatment (cetuximab and encorafenib) alone.

开始日期2024-11-12

申办/合作机构

National Cancer Institute

NCT06161493 / Recruiting临床1期IIT

Phase l Study of a BET Inhibitor, ZEN003694, Combined With a PARP Inhibitor, Niraparib in Patients With Metastatic or Recurrent Solid Tumors

This Phase I, open label, dose determining study of oral niraparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with metastatic or recurrent solid cancer. Dose escalation will follow the mTPI-2/Keyboard design. Eligible patients will receive therapy until disease progression or unacceptable toxicities are experienced.

开始日期2024-01-23

申办/合作机构

University of Pittsburgh

[+2]

NCT05950464 / Recruiting临床1期IIT

A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN00-3694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer

This phase Ib trial tests the safety, side effects, and best dose of M1774 when given with ZEN-3694 in treating patients with ovarian and endometrial cancer that has come back (recurrent). M1774 and ZEN-3694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. M1774 and ZEN-3694 combined together has demonstrated to be better than either drug alone in killing ovarian tumor cells.

开始日期2023-12-18

申办/合作机构

National Cancer Institute

[+1]

100 项与 ZEN-3694 相关的临床结果

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100 项与 ZEN-3694 相关的转化医学

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100 项与 ZEN-3694 相关的专利（医药）

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项与 ZEN-3694 相关的文献（医药）

2022-06-01·Cancer gene therapy2区 · 医学

Combination of ZEN-3694 with CDK4/6 inhibitors reverses acquired resistance to CDK4/6 inhibitors in ER-positive breast cancer

2区 · 医学

Article

作者: Kharenko, Olesya A ; Patel, Reena G ; van der Horst, Edward H ; Calosing, Cyrus

CDK4/6 inhibitors significantly prolong progression-free survival in patients with advanced hormone receptor-positive (HR+) HER2-negative breast cancer. Despite recent successes, patients acquire resistance, necessitating the development of additional novel therapeutic strategies. Bromodomain and extra-terminal domain (BET) proteins are key epigenetic regulators that interact with acetylated lysine (AcLys) residues of histones or transcription factors. BET proteins are directly involved in modulating estrogen receptor (ER) signaling and the cell cycle. Therefore, BET inhibitors can potentially offer new strategies in the treatment of advanced ER+ breast cancer. ZEN-3694 is an orally bioavailable small molecule BET inhibitor currently being evaluated in Phase 1/2 clinical trials (NCT03901469). To assess a potential combination strategy in a CDK4/6i resistant breast cancer population, we investigated the mechanism of action of ZEN-3694 combined with CDK4/6 inhibitors in the ER+ cell lines resistant to palbociclib or abemaciclib. Here, we describe that the combination of ZEN-3694 with CDK4/6i potently inhibits proliferation and induces apoptosis in CDK4/6i resistant cell lines. The resistance to both palbociclib and abemaciclib was associated with the strong upregulation of CDK6 and CCND1 protein levels, which was reversed by the ZEN-3694 treatment. Furthermore, RNAseq data and pathway analysis elucidated the combinatorial effects of ZEN-3694 with CDK4/6 inhibitors through significant downregulation of multiple pathways involved in cell cycle regulation, cellular growth, proliferation, apoptosis, inflammation, and cellular immune response. Our data indicate that ZEN-3694 has therapeutic potential in combination with CDK4/6 inhibitors in patients with advanced ER+ breast resistant to CDK4/6 inhibitors.

2020-10-15·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

A Phase Ib/IIa Study of the Pan-BET Inhibitor ZEN-3694 in Combination with Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer

1区 · 医学

Article

作者: Campeau, Eric ; Aggarwal, Rahul R. ; Heath, Elisabeth I. ; Attwell, Sarah ; Bauman, Lisa ; Feng, Felix Y. ; Abida, Wassim ; Pantuck, Allan J. ; Nanus, David M. ; Schweizer, Michael T. ; Small, Eric J. ; Alumkal, Joshi J. ; Snyder, Margo ; Lakhotia, Sanjay ; Norek, Karen

Abstract:

Purpose::

ZEN-3694 is a bromodomain extraterminal inhibitor (BETi) with activity in androgen-signaling inhibitor (ASI)-resistant models. The safety and efficacy of ZEN-3694 plus enzalutamide was evaluated in a phase Ib/IIa study in metastatic castration-resistant prostate cancer (mCRPC).

Patients and Methods::

Patients had progressive mCRPC with prior resistance to abiraterone and/or enzalutamide. 3+3 dose escalation was followed by dose expansion in parallel cohorts (ZEN-3694 at 48 and 96 mg orally once daily, respectively).

Results::

Seventy-five patients were enrolled (N = 26 and 14 in dose expansion at low- and high-dose ZEN-3694, respectively). Thirty (40.0%) patients were resistant to abiraterone, 34 (45.3%) to enzalutamide, and 11 (14.7%) to both. ZEN-3694 dosing ranged from 36 to 144 mg daily without reaching an MTD. Fourteen patients (18.7%) experienced grade ≥3 toxicities, including three patients with grade 3 thrombocytopenia (4%). An exposure-dependent decrease in whole-blood RNA expression of BETi targets was observed (up to fourfold mean difference at 4 hours post–ZEN-3694 dose; P ≤ 0.0001). The median radiographic progression-free survival (rPFS) was 9.0 months [95% confidence interval (CI), 4.6–12.9] and composite median radiographic or clinical progression-free survival (PFS) was 5.5 months (95% CI, 4.0–7.8). Median duration of treatment was 3.5 months (range, 0–34.7+). Lower androgen receptor (AR) transcriptional activity in baseline tumor biopsies was associated with longer rPFS (median rPFS 10.4 vs. 4.3 months).

Conclusions::

ZEN-3694 plus enzalutamide demonstrated acceptable tolerability and potential efficacy in patients with ASI-resistant mCRPC. Further prospective study is warranted including in mCRPC harboring low AR transcriptional activity.

1996-03-01·Journal of bacteriology3区 · 生物学

DNA-binding properties of the BetI repressor protein of Escherichia coli: the inducer choline stimulates BetI-DNA complex formation

3区 · 生物学

Article

作者: Rkenes, T P ; Lamark, T ; Strøm, A R

The betT and betIBA genes govern glycine betaine synthesis from choline in Escherichia coli. In an accompanying paper we report that the betT and betI promoters are divergently organized and partially overlapping and that both are negatively regulated by BetI in response to choline. (T. Lamark, T.P. Rokenes, J. McDougall, and A.R. Strom, J. Bacteriol. 178:1655-1662, 1996). In this paper, we report that the in vivo synthesis rate of the BetI protein constituted only 10% of that of BetA and BetB dehydrogenase proteins, indicating the existence of a posttranscriptional control of the betIBA operon. A genetically modified BetI protein called BetI*, which carries 7 extra N-terminal amino acids, was purified as a glutathione S-transferase fusion protein. Gel mobility shift assays showed that BetI* formed a complex with a 41-bp DNA fragment containing the -10 and -35 regions of both promoters. Only one stable complex was detected with the 41-bp fragment and all larger promoter-containing fragments tested. In DNase I footprinting, BetI* protected a region of 21 nucleotides covering both the -35 boxes. Choline stimulated complex formation but did not change the binding site of BetI*. We conclude that in vivo BetI is bound to its operator in both repressed and induced cells and that BetI represents a new type of repressor.

项与 ZEN-3694 相关的新闻（医药）

2024-02-29

·BioSpace

Zenith Epigenetics Proudly Supports Rare Disease Day

ZEN-3694 Expands Development to Include Multiple Rare Oncology Indications Calgary, Alberta--(News - February 29, 2024) - Zenith Epigenetics Ltd. ("Zenith" or the "Company") announces its support of Rare Disease Day by highlighting our expanded development efforts of BET inhibitor ZEN-3694 for rare oncology diseases. Rare Disease Day takes place every year on the last day of February, with this leap year day being the rarest of all Rare Disease Days. This event is a global movement to promote equity in healthcare, and access to diagnosis and therapies for individuals living with rare diseases. We are developing ZEN-3694 for the treatment of two aggressive rare cancers with very poor prognosis and no effective approved therapies, NUT carcinoma (NC) and malignant peripheral nerve sheath tumors (MPNST). In addition to clinical trials, we have also provided ZEN-3694 for compassionate use to multiple patients with these diseases and are excited to soon announce results from these important studies. "We are proud to be developing ZEN-3694 to help patients with aggressive, rare forms of cancer, who currently have no access to effective therapies. We are very pleased that NUT carcinoma patients receiving ZEN-3694 in clinical trial and compassionate use settings have benefitted from our drug," said Donald McCaffrey, CEO of Zenith Epigenetics. "Our goal is to improve outcomes and quality of life for NUT carcinoma patients, and we are committed to developing ZEN-3694 through registration for the treatment of this disease. We are also excited about exploring the activity of ZEN-3694 in MPNST, a rare cancer with devastating impact on patients' lives." NC is a highly aggressive type of squamous cell cancer with very poor prognosis that often forms in the head, neck, or lungs. There are currently no effective treatments for this devastating disease that primarily affects adolescents and young adults with a median survival of only 6 months. New diagnostic technologies have allowed for much better diagnosis of NC. The diagnosis rate is increasing rapidly with growing awareness and analytical testing for this disease. ZEN-3694 is being developed in two separate NC clinical trials. The first NC trial, NCT05019716, which combines ZEN-3694 with chemotherapy (etoposide/platinum), is active and recruiting patients. The second trial NCT05372640, combines ZEN-3694 with the CDK4/6 Inhibitor Abemaciclib and is also accruing patients. Both of these trials have shown promising activity. MPNST is a cancer of the cells that form the sheath that covers and protects peripheral nerves. The prevalence of MPNST in the general population is one in 100,000 and comprises 5-10% of all soft-tissue sarcomas. MPNST is most common in young adults, and the prognosis of patients with metastatic disease is extremely poor, with a median survival of less than one year. A clinical trial with ZEN-3694 is in the late planning stage and initiation is expected in the second half of 2024. About NUT Carcinoma and BET inhibition NUT carcinoma is driven by NUTM1 genetic alterations, most commonly fusion to BRD4 (bromodomain-containing protein 4) resulting in a fusion oncoprotein. ZEN-3694 is a BET bromodomain inhibitor that directly binds to NUT fusion proteins, disrupts their activity, and inhibits cancer growth. NUT carcinoma is diagnosed by testing tumor tissue for the fusion protein using immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) or by DNA sequencing to identify the NUT fusion oncogene. About MPNST and BET inhibition MPNST is driven by NF1 gene mutation in 40% of cases. Researchers have identified a BET protein dependency in these NF1-mutant MPNST tumors, and thus ZEN-3694 may disrupt this dependency and inhibit cancer cell growth. 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 such as metastatic castration resistant prostate cancer, NUT carcinoma, ovarian cancer and RAS activated tumors. Several of these studies are sponsored by NCI under the NCI-Zenith Cooperative Research & Development Agreements (CRADA) and CRADAs between NCI and other NCI collaborators. For further information, please contact: Investor Relations Phone: 587-390-7865 Email: info@zenithepigenetics.com Website: Forward-Looking Statement 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 development activities involving ZEN-3694 in NUT carcinoma, malignant peripheral nerve sheath tumor, prostate cancer, ovarian cancer, RAS activated tumors, and other tumor types, as a single agent, or in combination with chemotherapies, including etoposide/platinum, CDK4/6 inhibitors, and other chemotherapy agents, 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 . 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. To view the source version of this press release, please visit

临床研究

2023-10-26

·BioSpace

Zenith Epigenetics Ltd. Announces Collaboration with Cencora on ZEN-3694

Calgary, Alberta--(News - 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). About Cencora 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 . For further information, please contact: Investor Relations & Communications Zenith Epigenetics Phone: 587-390-7865 Email: info@zenithepigenetics.com Website: 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 . 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. To view the source version of this press release, please visit

临床2期临床1期免疫疗法

2023-06-01

·BioSpace

Zenith Epigenetics Reports Advancement of ZEN-3694 in NUT Carcinoma

Zenith's BET inhibitor ZEN-3694 providing significant clinical benefit in patients with aggressive cancer type Calgary, Alberta--(News - June 1, 2023) - Zenith Epigenetics Ltd. ("Zenith" or the "Company") reports clinical activity and the advancement in development of its BET inhibitor (BETi) ZEN-3694 in patients with NUT carcinoma (NC). NC is a highly aggressive type of squamous cell cancer with very poor prognosis that often forms in the head, neck, or lungs. There are currently no effective treatments for this devastating disease that primarily affects adolescents and young adults with a median survival of only 6 months. NC is considered underdiagnosed with an estimated 1100 cases going undiagnosed in the US every year. The diagnosis rate is increasing rapidly with growing awareness and analytical testing for this disease. Zenith Epigenetics has provided ZEN-3694 to two NC patients for compassionate use and both experienced significant clinical benefit and durable reduction of their tumors. In one case ZEN-3694 was administered as a single agent and in another case in combination with chemotherapy. Concurrently with compassionate use, ZEN-3694 is also being evaluated in two NUT carcinoma clinical trials sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), through the Cancer Therapy Evaluation Program (CTEP) under a Cooperative Research and Development Agreement (CRADA) between Zenith and the NCI. The first trial, NCT05019716, which combines ZEN-3694 with chemotherapy (etoposide/platinum), is active and recruiting patients. The second trial NCT05372640, is in the startup phase and combines ZEN-3694 with the CDK4/6 Inhibitor Abemaciclib. These combinations may increase the response rate and durability above that of either agent alone. "We are very pleased that NUT carcinoma patients receiving ZEN-3694 for compassionate use have benefitted from our drug," said Donald McCaffrey, CEO of Zenith Epigenetics. "We are also very optimistic that the ongoing clinical trials will show clinical benefit and improved quality of life to a patient population with such poor prognosis and no approved therapy options. Besides NUT carcinoma, ZEN-3694 is also currently being evaluated in multiple oncology indications including CRPC, breast cancer, ovarian cancer, colorectal cancer, and lung cancer in 11 clinical trials with various drug combinations. We continue to advance these programs with our partners and are committed to bring this important therapy to these patients." About NUT Carcinoma and BET inhibition NUT carcinoma is driven by NUTM1 genetic alterations, most commonly fusion to BRD4 (bromodomain-containing protein 4) resulting in a fusion oncoprotein. ZEN-3694 is a BET bromodomain inhibitor that directly binds to NUT fusion proteins, disrupts their activity, and inhibits cancer growth. NUT carcinoma is diagnosed by testing tumor tissue for the fusion protein using immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) or by DNA sequencing to identify the NUT fusion oncogene. 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: 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 2b trial in Triple Negative Breast Cancer (TNBC) patients in combination with the PARP inhibitor (PARPi) TALZENNA (talazoparib), conducted in collaboration with Pfizer and Newsoara Biopharma. Zenith and Newsoara are the trial sponsors (NCT03901469). Phase 1b/2 trial in patients with androgen receptor independent mCRPC in combination with immune checkpoint inhibitor KEYTRUDA (pembrolizumab) and XTANDI (enzalutamide), conducted in collaboration with Merck, the University of California, San Francisco, and the University of Michigan (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 2 trial in patients with advanced squamous cell lung cancer with NSD3 gene amplification, conducted by Memorial Sloan Kettering Cancer Center (NCT05607108). Phase 1b/2 trial in solid tumors and 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 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 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 of with the MEK inhibitor MEKTOVI (binimetinib) in solid tumors with RAS pathway alterations and metastatic TNBC conducted by the NCI in collaboration with Zenith and Pfizer (NCT05111561). 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 in combination with Capecitabine in patients with metastatic unresectable colorectal cancer (CRC) conducted by the NCI (NCT05803382). For further information, please contact: Investor Relations & Communications Zenith Epigenetics Phone: 587-390-7865 Email: info@zenithepigenetics.com Website: 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 development activities involving ZEN-3694 in NUT carcinoma, prostate cancer, breast cancer, lung cancer, ovarian cancer, pancreatic cancer, lymphomas, colorectal cancer, and other tumor types, as a single agent, or in combination with chemotherapies, including etoposide/platinum, CDK4/6 inhibitors, PARP inhibitors, immune checkpoint inhibitors, androgen receptor inhibitors, MEK inhibitors, histone deacetylase inhibitors, antineoplastics, antimetabolites and other chemotherapy agents, 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 . 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. To view the source version of this press release, please visit

临床2期临床1期免疫疗法临床结果

100 项与 ZEN-3694 相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
三阴性乳腺癌	临床2期	中国更多	Zenith Epigenetics Ltd. 更多
去势抵抗性前列腺癌	临床2期	美国更多	Merck Sharp & Dohme Corp. 更多
转移性去势抵抗性前列腺癌	临床2期	美国更多	Lonza AG 更多
前列腺癌转移	临床2期	美国更多	Zenith Epigenetics Ltd. 更多
乳腺癌	临床1期	美国更多	National Cancer Institute 更多

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04471974 (ESMO2022) 人工标引	临床2期	转移性去势抵抗性前列腺癌 MSI-High	22	ZEN-3694+enzalutamide+pembrolizumab	顧蓋鹹網選積窪觸壓夢(鬱鹽糧窪網鹽憲窪膚糧) = ZEN 72 mg daily + ENZ 160 mg/day + P 200 mg IV q 3 weeks 齋糧淵齋鏇襯積顧繭鑰 (構範遞顧築淵壓範鑰醖 ) 更多	积极	2022-09-10
NCT03901469 (ASCO2022) 人工标引	临床1/2期	三阴性乳腺癌 ER Negative \| PR Negative \| HER2 Negative	51	ZEN-3694+talazoparib	簾憲製鹹壓憲積遞獵鑰(衊襯獵鬱蓋構膚範積製) = RP2D was determined to be 48mg qd ZEN-3694 plus 0.75mg qd talazoparib. 觸構鏇遞鹹襯壓遞憲窪 (鬱衊鏇繭積願鹽觸鏇鹽 ) 更多	积极	2022-06-02
NCT03901469 (ASCO2022) 人工标引	临床1/2期	三阴性乳腺癌 ER Negative \| PR Negative \| HER2 Negative	51	ZEN-3694+talazoparib (TNBC at diagnosis patients)		积极	2022-06-02
NCT02711956 (Pubmed \| Clin Cancer Res) 人工标引	临床1/2期	转移性去势抵抗性前列腺癌	75	Enzalutamide+ZEN-3694	餘艱壓網遞憲鬱窪鑰築(簾壓糧壓夢廠構顧獵觸) = 憲獵觸廠衊壓鏇膚憲艱鹹繭艱蓋廠廠蓋繭廠鏇 (網醖膚繭積鹽鑰齋獵鹹 ) 更多	积极	2020-10-15