Anetumab ravtansine

SOUTH SAN FRANCISCO, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today announced that the Company presented advances within its conditionally-activated ADC portfolio, including the next generation EpCAM-ADC, CX-2051, at the World ADC conference taking place September 6-9, 2022, in San Diego, CA. “The momentum in the field of ADC therapeutics is incredibly exciting and holds great promise for the innovation and development of novel oncology therapeutics. Our pioneering work and experience in applying our versatile Probody® platform to the ADC modality has the potential to expand the universe of addressable targets and to further increase the therapeutic window of future molecules entering the clinic,” said Marcia P. Belvin, Ph.D., senior vice president and head of research at CytomX. “CX-2051, our EpCAM-targeted, conditionally activated ADC, is strategically tailored to optimize the therapeutic index for systemic treatment of EpCAM-expressing epithelial cancers, which is an area of high unmet need where, to date, efforts have not been successful due to dose-limiting toxicities.” “Our strategy with CX-2051 is to match payload mechanism of action with tumor sensitivity, and we have selected the topoisomerase-1 inhibitor, camptothecin, as the payload for our newest ADC,” Dr. Belvin continued. “Topoisomerase-1 inhibitor-conjugated ADCs are showing impressive clinical activity, and importantly, the safety profiles of camptothecin and its derivatives have been well characterized. Additionally, two camptothecin derivatives, irinotecan and topotecan, have been approved by the U.S. Food and Drug Administration for clinical use - irinotecan for pancreatic and colorectal cancer, and topotecan for ovarian, cervical, and small cell lung cancer. We plan to pursue multiple indications with this new therapeutic candidate and look forward to progressing to an investigational new drug application submission in the second half of 2023.” Presentation highlights include: Review of clinical activity for the conditionally activated ADCs CX-2029 and praluzatamab ravtansine (CX-2009), targeting CD71 and CD166, respectively. CD71 and CD166 have historically been inaccessible targets for traditional ADCs due to their high expression levels on normal tissues. The data presented demonstrate clinical anti-cancer activity and a therapeutic window for these previously undruggable targets. The molecular structure of CX-2051, a masked, conditionally activated, EpCAM-targeting ADC with a next generation camptothecin-based linker payload. CX-2051 highlights the potential for CytomX’s Probody technology to unlock a new ADC target (EpCAM/Trop-1), which is a target that has previously yielded promising clinical results only through locally administered therapies. CX-2051 preclinical data indicating strong anti-cancer activity and tolerability with a favorable predicted therapeutic index. The full presentation is available at the following link: Tailoring the Selection of Target, Payload, & Tumor Type to Maximize the Therapeutic Index of Conditionally Activated ADCs Marcia P. Belvin, Ph.D., Senior Vice President, Head of Research, CytomX Therapeutics Presentation Link About CytomX Therapeutics, Inc. CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises seven therapeutic candidates across multiple treatment modalities. Three of these candidates are in Phase 2 studies across multiple cancer types, including CX-2029 and praluzatamab ravtansine. CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie. Praluzatamab ravtansine is an investigational conditionally activated ADC directed toward CD166 and is being studied in patients with advanced breast cancer. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly-owned assets such as CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors and CX-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has established strategic collaborations with multiple leaders in oncology, including AbbVie, Amgen, Astellas, and Bristol Myers Squibb. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and Twitter.

Paris, August 4, 2022. Sanofi and Innovent Biologics (HKEX: 1801.HK, “Innovent”) announced a collaboration to bring innovative medicines to patients in China with difficult-to-treat cancers. Innovent is a leading biopharmaceutical company with strong clinical development capabilities and a broad commercial footprint in China. Both companies are committed to accelerating the development and commercialization of two Sanofi key clinical stage oncology assets: Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2), combining with sintilimab, the leading checkpoint inhibitor in China. In addition to the collaboration and license agreement, Sanofi will invest €300 million in Innovent through subscription of new common shares. John Reed, M.D., Ph.D. Global Head of Research and Development at Sanofi “This strategic collaboration with Innovent will not only accelerate the development, market access and future commercialization of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China. We look forward to a successful partnership with Innovent, one of the most innovative companies in China, and to leveraging their development capabilities and market leadership in the country.” Michael Yu, Ph.D. Founder, Chairman and CEO of Innovent “This strategic collaboration with Sanofi, a leading global pharmaceutical company, opens the pathway to great synergy for accelerating the pace of innovation. This pioneering partnership will leverage the synergy between Sanofi and Innovent’s pipeline and R&D resources with the mutual aim to address major unmet medical needs for cancer patients. We hope this agreement will be a great start of the two parties’ long-term partnership, and we look forward to bringing more innovative therapies to patients.” Clinical development and commercialization of tusamitamab ravtansine SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. SAR408701 is currently in a Phase 3 study for 2L NSCLC globally including China, and global Phase 2 studies in additional indications including 1L NSCLC, gastric cancers and other solid tumors. According to the agreement, Innovent will be responsible for developing and exclusively commercializing tusamitamab in multiple oncology-based indications in China. Sanofi will be entitled to receive up to €80 million development milestone payment and royalties on the net sales of the product in China upon approval. Clinical development and commercialization of SAR444245 SAR444245 is a potential first-in-class reprogrammed, site-directed, single PEGylated, recombinant human IL-2 (rIL-2) variant with extended half-life that specifically binds to the low-affinity IL-2 receptor but lacks binding affinity for the αlpha chain of the high-affinity IL-2 receptor. SAR444245(IL-2) is currently under global Phase 2 studies for skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma. Innovent and Sanofi will jointly explore the development of SAR444245 in China in various cancer types, where Innovent will lead the clinical development. Sanofi remains the sole Marketing Authorization holder for both assets and will be fully responsible for SAR245 commercialization. Innovent will be entitled to receive up to €60 million development milestone payments and royalties on the net sales of the product in China upon approval. Sanofi’s initial strategic equity investment in Innovent for €300 million In addition to the strategic multi-product collaboration and license agreement, Sanofi, subject to conditions precedent including regulatory approval and customary closing conditions, will invest in new common shares issued by Innovent for €300 million, at a price of HK $42.42 per share, representing a 20% premium to the Innovent 30-trading-day average share price as of August 3, 2022, one day prior to the signing of the agreements. Subject to mutual agreement of both parties in the future, Sanofi will have the right to acquire additional Innovent new common shares for €300 million, at a subscription price that represents 20% premium to Innovent 30-trading-day average share price as the date of the separate agreement that may be entered into by both parties. About SAR408701 SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. Tusamitamab ravtansine is currently in a Phase 3 study for second-line NSCLC globally including China, and global Phase 2 studies in additional indications including first-line NSCLC, gastric cancers and other solid tumors. About SAR444245 SAR444245 is a potential first-in-class recombinant human IL-2 (rIL-2) variant that includes a site-directed single PEG moiety/chain that prevents it from binding to the α chain of the IL-2 receptor while retaining near-native affinity for the beta/gamma subunits. SAR444245 is currently being investigated in global Phase 2 studies for the treatment of skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma. About Sintilimab (TYVYT®) Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. In China, sintilimab has been approved for six indications including relapsed or refractory classic Hodgkin’s lymphoma, first-line treatment of non-squamous NSCLC, first-line treatment of squamous NSCLC, first-line treatment of hepatocellular carcinoma, first-line treatment of esophageal squamous cell carcinoma, and first-line treatment of gastric or gastroesophageal junction adenocarcinoma, of which the first four indications have been included in the National Reimbursement Drug List (NRDL). Note: SAR408701 and SAR444245 are not approved products in China About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 34 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.