squamous cell lung carcinoma

Both companies have agreed to work on the drafting of a definitive agreement, and the combined company will advance the entry into the cancer monitoring market and gain access to integrating whole genome data into GEDiCube’s AI-ML platform GEDiCube, Cyclomics to advance cancer testing. (Credit: Darko Stojanovic from Pixabay) GEDiCube, a subsidiary of Renovaro focused on AI-powered cancer detection, has executed a binding Letter of Intent (LOI) to acquire a 75% stake in Dutch diagnostics company Cyclomics. Both the parties have agreed to work on the drafting of a definitive agreement. The combined company will advance the entry into the cancer monitoring market and gain access to integrating whole genome data into GEDiCube’s AI-ML platform. Cyclomics has developed CyclomicsSeq, a novel circulating tumour DNA (ctDNA) assay based on Oxford Nanopore sequencing, for monitoring early cancer recurrence. Unlike other available ctDNA-based methods, CyclomicsSeq is said to ensure that even a single ctDNA molecule in the blood can be detected at very high accuracy. The company’s Omni-Omic 4th generation technology is expected to disrupt the cancer diagnostics market and clinical practice. It enables rapid, reliable, and ultra-sensitive early test results or cancer recurrence detection using next-generation whole genome sequencing. Cyclomics has also developed CyclomicsSeq TP53, an in vitro diagnostic (IVD) kit that integrates an advanced sequencing methodology and analysis software for early detection. It can be applied to other cancer types harbouring TP53, such as small-cell lung cancer, squamous cell lung cancer, and triple-negative breast cancer, among others. Cyclomics co-founder Alessio Marcozzi said: “Our Omni-Omic technology was developed to help empower AI platforms and thereby transform non-invasive healthcare solutions to detect cancers and other diseases as early as possible. “GEDiCube’s innovative deep learning algorithms have created robust multi-omics panels that perform remarkably well. Together, I believe we will change the field.” GEDiCube is committed to the early detection of cancer and has developed AI-powered high-performing biomarker panels for 13 frequently occurring cancer types. The company’s technology advances the development and validation of panels into diagnostic products through in-silico validation, saving development time and money. The panels focused on early detection of cancer and its recurrence, prediction of response to therapy, and personalised treatment, all through liquid biopsy tests. GEDiCube’s platform, dubbed The Cube, combines unique AI, ML technology and algorithms, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team. The platform deploys next-generation AI running on NVIDIA’s latest chips and stacks genetic and protein expression on top of DNA mutation for accuracy in cancer detection. GEDiCube is focused on developing advanced diagnostic and monitoring tests that use multi-omics, integrating data from each stage of genetic expression. GEDiCube CEO Coenraad van Kalken said: “There is enormous power in applying AI to multiple omics data layers that can be detected from a vial of blood from every patient with cancer. “I believe that integrating Cyclomics into GEDiCube will allow us to gain greater accuracy and widespread Omni-omic measurements through next-generation sequencing and enter the cancer monitoring market this year.”

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

—During the reporting period, Akeso's revenue was RMB3,676.9 million, an increase of 2,154.4% from 2022H1; Akeso recorded a profit of RMB2,489.5 million. —RMB2,915.2 million was recognized by Akeso as license fee income during the reporting period due to the receipt of an upfront payment equivalent to US$500 million for Akeso's PD-1/VEGF bispecific antibody (ivonescimab) out-licensing agreement with Summit Therapeutics Inc. —The total product sales were RMB794.7 million. —The New Drug Application (NDA) of ivonescimab (PD-1/VEGF bispecific antibody) has been accepted and granted priority review by China NMPA; 2 NDAs for non-oncology segment products have been accepted: 2 indications for PCSK9 monoclonal antibody ebronucimab for the treatment of hypercholesterolemia, and IL-12/IL-23 monoclonal antibody ebdarokimab for the treatment of moderate-to-severe plaque psoriasis. HONG KONG, Aug. 29, 2023 /PRNewswire/ -- Akeso (9926. HK) released its 2023 interim performance: the Company achieved financial profitability for the first time in the first half of 2023, reaping success in new drug development, commercialization and globalization. Currently, Akeso has a total of 13 registrational Phase III clinical trials underway for 4 products, 3 drugs are approved. Cadonilimab (PD-1/CTLA-4) Patient enrollment was completed on the registrational Phase III clinical trials of PD-1/CTLA-4 bispecific antibody cadonilimab for the first-line treatment of advanced cervical cancer and gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. The Phase III clinical trial of cadonilimab for the adjuvant treatment of hepatocellular carcinoma is undergoing efficiently. The clinical development for lung cancer, pancreatic cancer, esophageal squamous cancer and other major tumor diseases is also in orderly progress. In addition, 40+ Investigator initiated trials (IITs) for cadonilimab are underway. Ivonescimab(PD-1/VEGF) Ivonescimab(PD-1/VEGF) is Akeso's another bispecific antibody. 1 NDA of ivonescimab has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). There are 4 Phase III clinical trials been initiated/are underway globally, of which 3 are Phase III clinical trials with PD-1 monoclonal antibody as the positive control drug, 2 are international multicenter Phase III clinical trials; 9 Phase II clinical trials for Ivonescimab have been conducted. 4 Phase III trials of ivonescimab: Patient enrollment was complete in the registrational Phase III clinical trial of ivonescimab versus pembrolizumab for the first-line treatment of PD-L1 positive NSCLC; Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi / AK112-301) is enrolling patients; An international Phase III clinical trial of ivonescimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy as first-line treatment for metastatic squamous NSCLC has also been initiated； In China, a registrational Phase III clinical trial of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy as first-line treatment for advanced squamous NSCLC is underway. In December 2022, Akeso out-licensed Summit Therapeutics exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan in. Akeso is to receive a US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive a low double-digit percentage of royalties on net product sales of ivonescimab . Ivonescimab is engaged in many clinical trials for multiple types of lung cancer, gastric cancer, biliary tract cancer, pancreatic cancer, triple-negative breast cancer, head and neck squamous cell carcinomas, ovarian cancer and other gynecologic cancer, colorectal cancer, hepatocellular carcinoma, as well as other solid tumors. It is noteworthy that Akeso announced clinical progress and new products and therapies. In addition to the two bispecific antibodies mentioned above, AK129 (PD-1/LAG-3 bispecific antibody) and AK130 (TIGIT/TGF-β bispecific antibody) have already entered into the clinical trial, and AK131 (PD-1/CD73 bispecific antibody) and AK132 (Claudin18.2/CD47 bispecific antibody) are about to be approved for the clinical trial. Akeso also announced that a number of ADC drugs will soon enter clinical trials, including bispecific antibody ADC drugs. The clinical development of CD47, IL-4R, IL-17, CD73, TIGIT and other phase II and III target products is also in orderly progress. "We are very encouraged to see that our team has continued to achieve excellent results.In the first half of 2023 we had our best results since the company's inception in terms of financial performance, commercialization of new drugs, clinical development, and operation." Said Dr. Michelle Xia, founder, Chairwoman, CEO, and President of Akeso. "Such achievements do not come easily in a complex and difficult external situation. We would like to thank Akeso's team for their ten years of continual pursuit of excellence and improvement. We have put into practice the concept of new drug development driven by clinical value, maintain a forward-looking strategic layout and exceptional managerial efficiency, calmly respond to market changes, seize development opportunities, and grow on an ongoing basis. In the future, with successive approval of our innovative core products and their broad indications, and the further increase in our operational and managerial capabilities, Akeso will enter another period of rapid growth. We will continue to work diligently, professionally, and effectively to promote the more rapid, thorough, and wide-ranging translation of new drug innovations into global value, and we look forward to seeing the company enter a new stage of commercialization and sustained profitability in the coming years, to better deliver innovative clinical value to patients, and reward society and investors."Dr. Michelle Xia said. SOURCE Akeso, Inc.