B-cell lymphoma recurrent

RESEARCH TRIANGLE PARK, N.C., March 6, 2025 /PRNewswire/ -- Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, today announced it is proceeding with a Phase 1 clinical trial evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas, based on a recent Clinical Trial Application (CTA) cleared by Health Canada. This regulatory milestone enables Bantam to expand its ongoing clinical program and to activate multiple clinical trial sites in Canada early in the second quarter of 2025. This clearance follows the recent activation of Bantam's first U.S. clinical trial site at The University of Texas MD Anderson Cancer Center for its BTM-3566 Phase 1 study. BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets mitochondrial homeostasis via the ATF4-Integrated Stress Response (ISR) pathway to treat aggressive tumors. "Activating clinical sites in Canada alongside our U.S. study sites is a key step in building a high-quality, efficient, and thoughtful clinical program," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "This complementary approach accelerates the identification of clinically active doses for lymphoma patients while maintaining the scientific rigor needed to ensure a meaningful impact for those in need. We anticipate this expansion to enable us to achieve our clinical objectives sooner than originally projected." The Phase 1 trial is designed to evaluate the safety, tolerability, and preliminary efficacy of BTM-3566 in patients with relapsed/refractory mature B-cell lymphomas. The Canadian trial will follow a similar overall design to the ongoing U.S. Phase 1 trial, a multicenter, open-label, and dose-escalation study assessing the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of BTM-3566. The dual country strategy was implemented to accelerate the development of BTM-3566 and will support future harmonization between the studies to generate a robust dataset and inform future development. Initial clinical data from the trial are expected in the second half of 2025. For more information about the ongoing clinical trial, visit ClinicalTrials.gov and search NCT number NCT06792734. About BTM-3566 BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development into solid tumors, broadening its potential impact for patients with limited treatment options. About Bantam Pharmaceutical Bantam Pharmaceutical is a drug discovery and development company leveraging the power of mitochondrial dynamics to address critical unmet needs in oncology. Using its unique expertise in mitochondrial cellular biology, Bantam is advancing novel, first-in-class oral small molecule therapeutics for difficult-to-treat hematological and solid tumors. The company currently holds an active Investigational New Drug (IND) application in the U.S. and a Clinical Trial Application (CTA) in Canada for its lead candidate, BTM-3566, targeting B-cell malignancies, with plans to expand clinical development into solid tumors. Learn more at . Media Contact Jennifer Almond Corporate Communications Bantam Pharmaceutical [email protected] SOURCE Bantam Pharmaceutical, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI, China I January 13, 2025 I CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that KJ-C2219, an allogeneic CAR T-cell therapy targeting CD19/CD20, has administered the first dose to a patient in an investigator-initiated trial (IIT). KJ-C2219 is developed based on CARsgen’s THANK-u Plus platform and is designed for the treatment of hematologic malignancies and autoimmune diseases. An investigator-initiated trial is ongoing in China to evaluate KJ-C2219 for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). About THANK-u Plus CARsgen has developed the THANK-u Plus platform as an enhanced version of its proprietary THANK-uCAR ® allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR ® . Preclinical studies show that THANK-u Plus delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR ® . Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus has broad potential for developing diverse allogeneic CAR-T therapies. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S., focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Internally, CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen’s mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer curable. Contact CARsgen For more information, please visit https://www.carsgen.com/ SOURCE: CARsgen Therapeutics

Clinical-stage CAR T company dosed first patient for Phase 1 trial to evaluate SynKIR™-310, a new drug candidate for relapsed/refractory B cell Non-Hodgkin Lymphomas PHILADELPHIA, PA, USA I January 10, 2025 I Verismo Therapeutics , a clinical-stage CAR T company developing novel KIR-CAR platform technology, today announced that it has dosed the first patient in its CELESTIAL-301 Phase 1 clinical trial. The patient was infused at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado. CELESTIAL-301 aims to assess safety, tolerability, and preliminary efficacy of SynKIR™-310 in patients with relapsed/refractory (r/r) B cell Non-Hodgkin Lymphomas (B cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL). The Phase 1 multicenter clinical trial is enrolling patients who previously received CAR T therapy but who have since relapsed or become refractory to it as well as patients who never received CAR T therapy. CELESTIAL-301 trial seeks to address several areas of high unmet medical need. Commercially approved CAR T cell therapies have shown impressive high initial response rates in blood cancers. Over time, however, these therapies result in relapse in an estimated 40-50% of patients 1 . Such relapses are due in part to lack of long-term T cell effector function and persistence. There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies. SynKIR™-310 relies on Verismo’s unique KIR-CAR platform and proprietary CD19 binder (DS191) . SynKIR™-310 targets CD19, similarly to the commercially approved CAR T therapies, with the added potential of prolonged anti-tumor T cell function and persistence. These KIR-CAR improvements may prevent early disease relapse in patients with advanced B cell lymphomas. “The initiation of patient dosing in the CELESTIAL-301 trial marks an exciting milestone for Verismo Therapeutics as we advance our mission to develop transformative therapies for patients facing advanced lymphomas. CBCI’s commitment to patients and to conducting novel early-stage clinical trials has allowed us to reach this milestone earlier than expected,” according to Dr. Laura Johnson, Chief Operations Officer and Chief Scientific Officer at Verismo Therapeutics. “SynKIR™-310 is uniquely designed to prolong T cell functional persistence and combat the challenges of disease relapse, offering a potentially life-saving option for these patients.” “We are thrilled to administer this promising therapy,” said Michael Tees, MD, the principal investigator at SCRI at Colorado Blood Cancer Institute (CBCI), where the first patient was dosed. “Emerging treatments like SynKIR™-310 have potential to reshape care for patients with advanced lymphomas, offering new hope. This milestone showcases the impact of CBCI and other expert research centers in advancing early-stage clinical trials.” Verismo achieved IND clearance from the FDA in May 2024 to proceed with this multicenter Phase 1 clinical trial investigating SynKIR™-310. SynKIR™-310 is Verismo’s second clinical pipeline following SynKIR™-110 targeting aggressive mesothelin-expressing solid tumors. For more information about the CELESTIAL-301 clinical trial, please visit ClinicalTrials.gov: NCT06544265 . About Verismo Therapeutics Verismo Therapeutics, a subsidiary of HLB Innovation, is a pioneer in multi-chain KIR-CAR technology, with its first assets SynKIR™-110 and SynKIR™-310 currently in Phase 1 clinical trials. Verismo is the only company developing the KIR-CAR platform, using a modified NK cell derived receptor and DAP12 pairing, designed to improve persistence and efficacy against aggressive tumors. The KIR-CAR platform technology was developed specifically to address areas of high unmet medical need, including advanced solid tumors and B cell associated disorders and malignancies. For more information, visit: www.verismotherapeutics.com About the KIR-CAR Platform The KIR-CAR platform is a multi-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to tumor regression in preclinical models that are resistant to traditional CAR T cell therapies. 1 Blood Adv (2020) 4 (22): 5607-5615 https://doi-org.libproxy1.nus.edu.sg/10.1182/bloodadvances.2020003001 ; Biol Blood Marrow Transplant (2019) 25(11): e344-e351 https:doi.org/10.1016/j.bbmt.2019.06.036 ; Front Pediatr (2024) 11. https://doi-org.libproxy1.nus.edu.sg/10.3389/fped.2023.1305657 SOURCE: Verismo Therapeutics