Cocaine and amphetamine-regulated transcript(Nankai University)

RESEARCH TRIANGLE PARK, N.C., Dec. 10, 2025 /PRNewswire/ -- Bantam Pharmaceutical, a clinical-stage company pioneering mitochondrial biology to develop first-in-class medicines for treating aggressive cancers, today announced that the first patient was treated at The Princess Margaret Cancer Centre in Toronto, Canada in its Phase 1 clinical trial studying BTM-3566. This milestone is an important step as the company begins testing the safety, tolerability, and early signs of effectiveness of BTM-3566 in patients. BTM-3566 is a new type of medicine that targets aggressive cancers by modulating a stress pathway inside cells which may help patients whose cancer has worsened after other treatments. This first-in-class small molecule works by activating the OMA1-ATF4 integrated stress response (ISR) pathway - a newly described mechanism that governs mitochondrial functions and how cells respond to stress. Instead of targeting an individual protein and its cancer-driver mutations, BTM-3566 specifically uses the machinery of the cancer cell to trigger cell death, making it an ideal treatment option for patients whose cancers no longer respond to standard therapies. "Enrolling the first patient in our Phase 1 trial is a pivotal milestone in our clinical development efforts," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "Princess Margaret Cancer Centre is an esteemed institution, and we are proud to collaborate with their expert investigators to advance this study for patients with limited treatment options." Bantam's Phase 1 program is active in both the U.S. and Canada to study BTM-3566 in lymphomas and solid tumors. The lymphoma cohort includes patients with relapsed/refractory mature B-cell lymphomas. The solid tumor cohort includes a broad range of cancers such as head and neck, lung, gastroesophageal/gastrointestinal, colorectal, sarcomas, uterine, renal and bladder, among others. "Princess Margaret Cancer Centre is excited to be the first institution to enroll a patient in Bantam's study of this novel therapeutic approach for those who no longer respond to standard treatments," said Dr. Albiruni Razak, Medical Oncology Lead, Sarcoma at the Princess Margaret Cancer Centre. Bantam expects to have early information from the first patient available during J.P. Morgan Week in January 2026, along with a full summary of all non-clinical monotherapy and combination data underpinning its regulatory filings in the US and Canada. For information about the ongoing U.S. trials, visit ClinicalTrials.gov and search NCT06792734 and NCT07266285. For information about the ongoing Canadian trial, visit ISRCTN.com and search ISRCTN15438979. About BTM-3566 BTM-3566 is a first-in-class small molecule targeting aggressive cancers by activating the OMA1-ATF4 ISR pathway—a newly described mechanism that governs mitochondrial homeostasis and cell survival under stress. Unlike many therapies that target specific tumor mutations, this approach triggers intrinsic apoptotic pathways by modulating mitochondrial function, making it an ideal treatment option when patients progress. In pre-clinical studies, BTM-3566 demonstrated potent anti-cancer activity, showing complete regressions in patient-derived xenograft (PDX) models of aggressive B-cell lymphomas, including double- and triple-hit DLBCL and in MCL PDX models from patient tumors that progressed on rituximab, BTK inhibitors and CAR-T therapies. BTM-3566 exhibits activity in solid tumors, including tumor regressions in multiple PDX models, where low FAM210B RNA expression is a potential biomarker for patient selection. BTM-3566 also exhibits strong synergy in combination with other drugs, including BH3 mimetics, hypomethylating agents and rituximab, enabling both monotherapy and combination development strategies. About Bantam Pharmaceutical Bantam Pharmaceutical is a clinical-stage company pioneering mitochondrial biology to develop first-in-class small molecule therapeutics for treating aggressive cancers after standard-of-care (SoC) therapies fail. The company currently holds active Investigational New Drug (IND) applications in the U.S. and a Clinical Trial Application (CTA) in Canada for its lead candidate, BTM-3566, targeting B-cell malignancies and select solid tumors. Learn more at . Media Contact Pam O'Connor Corporate Communications, Bantam Pharmaceutical [email protected] 919-621-1230 SOURCE Bantam Pharmaceutical, LLC

Similar to Carvykti’s overall survival data suggesting the potential of a cure, the Tecvayli-Darzalex combo’s OS curve also flattened. A proposed combination of Johnson & Johnson’s multiple myeloma bispecific Tecvayli has turned up positive trial data that could put some pressure on CAR T-cell therapies, including the company’s own Carvykti.The combination includes Tecvayli, which is a BCMAxCD3 T-cell engager, and J&J’s star CD38 antibody Darzalex, and it was pitted against Darzalex (D) and dexamethasone (d)’s pairing with either Bristol Myers Squibb’s Pomalyst (P) or Takeda’s Velcade (V) in the phase 3 MajesTEC-3 trial in multiple myeloma patients who had tried one to three prior lines of therapy.The Tecvayli-Darzalex regimen significantly reduced the risk of death by 54%, according to results presented Dec. 9 at the American Society of Hematology (ASH) annual meeting.While the median overall survival (OS) length was not reached for either treatment group, the three-year OS rate was 83% for the experimental arm versus 65% for the control arm.The combo also pared down the risk of progression or death by a major 83%. The median progression-free survival (PFS) time was 18.1 months for control arm patients and not reached for the novel combo, with three-year PFS rates at 29.7% and 83.4%, respectively.The MajesTEC-3 results look similar to—or even better than—what Carvykti showed in the Cartitude-4 study in a similar second-line-plus setting. In that phase 3 trial, Carvykti lowered the risk of death by 45% compared to standard of care, which consisted of DPd or PVd. The estimated 30-month survival rate was 76% for Carvykti versus 64% for the control arm.What’s more, similar to Carvykti’s OS data suggesting the potential of a cure, the Tecvayli-Darzalex combo’s OS curve also flattened, indicating no or very few additional patient deaths over time.  There’s one key difference between the two trials. Because of the Darzalex component, MajesTEC-3 excluded patients who were refractory to anti-CD38 antibodies. In contrast, in Cartitude-4, 23% of patients were Darzalex-refractory at baseline.Overall, about 5% of MajesTEC-3 patients had previously received Darzalex, whereas about 26% of Cartitude-4 patients previously had an anti-CD38 drug. The Tecvayli-Darzalex cocktail did show consistent benefit between Darzalex-exposed (but not refractory) and -naïve populations.It’s not just Carvykti that could face some competition. Release of the top-line MajesTEC-3 data in an ASH abstract last week pressured the shares of BCMA CAR-T developer Arcellx, which released pivotal data for its Gilead Sciences-partnered anito-cel in the late-line setting at the conference.MajesTEC-3 is about having another treatment option available for patients in the second line, Imran Khan, M.D., Ph.D., J&J’s vice president of hematology medical affairs, said in an interview with Fierce Pharma. It offers doctors simplicity by incorporating Tecvayli into a similar schedule as Darzalex, and it’s a steroid-free approach, Khan noted. CAR-T vs. BispecificCarvykti, as a one-time therapy, “has been nothing short of transformational for us,” Khan said. Now, the MajesTEC-3 regimen could offer community doctors who are not able to refer their patients to Carvykti an equally efficacious therapy, he added.Some patients would prefer to get a single infusion of Carvykti and be done with their treatment, while others—for various reasons—may get treated locally in the community setting, where CAR-T therapies are not available, Khan explained.That once-and-done feature will appeal to some patients and potentially payers, J&J’s Carvykti partner Legend Biotech argued. “As a one-time, time-limited infusion, Carvykti offers a different clinical profile and carries different economic implications, offering meaningful payer savings versus combination regimens that require continuous therapy,” Legend said in a statement to Fierce. Tecvayli landed on the U.S. multiple myeloma market as a late-line therapy in 2022 at a list price of $39,500 per month. Given that patients on average were expected to be on the drug for about 10 months, the drug’s total treatment cost was estimated to be about $395,000, below Carvykti’s one-time list price of $465,000.Now, in the second-line setting, patients in the MajesTEC-3 trial were on the experimental combo for a median 32 months, and that includes Tecvayli and Darzalex, which is also a patent-protected antibody drug. Tecvayli’s dosing schedules and strengths are different in the two treatment settings, but second-line patients are expected to receive significantly more Tecvayli doses than late-line patients.In a Nov. 24 note following MajesTEC-3’s top-line revelation in an ASH abstract, Leerink Partners analysts said T-cell engager combinations are “a major threat to CAR-T,” given that CAR-T therapies are trying to expand from large treatment centers to the community.“That said, CAR-T still offers a long treatment-free period that patients clearly value,” the team added.In a Dec. 7 note, the Leerink team further pointed out that MajesTEC-3’s exclusion of CD38-refractory patients runs against current U.S. and European standard-of-care practice of using CD38 agents in the first line. Khan, for his part, pointed out that many patients still don’t get Darzalex in the front-line setting.T-cell engagers are not easy treatments to provide, either, the Leerink team added. In MajesTEC-3, cytokine release syndrome happened in 60% of patients in the experimental arm, with no grade 3 or above cases.Infections, which are a top concern with BCMA bispecifics, happened in 96% of patients in the experimental arm, including 54% at grade 3 or 4, and 13 (5%) patients died due to infection with the Tecvayli-Darzalex combo. In the control group, the overall rate of infection was 84%, including 43% at grade 3 or 4. To manage infections, patients may receive immunoglobulin replacement therapy as supplementation and prophylactic antimicrobials. A second-line nod could give Tecvayli a sales boost. In contrast to Carvykti’s strong growth following its second-line nod by the FDA, Tecvayli appeared relatively stagnant with a 7.5% year-over-year sales increase in the U.S. in the first nine months of 2025 to $334 million.J&J is also exploring other combinations for Tecvayli, including one with the company’s GPRC5DxCD3 bispecific Talvey. The phase 2 portion of the RedirecTT-1 trial showed that the Tecvayli-Talvey combo spurred a response in 79% of 90 patients with previously treated multiple myeloma and extramedullary disease. Among those who had a response, 64% enjoyed a response duration of at least a year.J&J “plans to bring the Talvey-Tecvayli combination to patients with relapsed or refractory multiple myeloma, including those with extramedullary disease, as quickly as possible,” a company spokesperson said in a statement to Fierce Pharma. “Discussions on regulatory submissions and approvals are ongoing.”The combo is currently being tested as part of the randomized phase 3 MonumenTAL-6 trial in multiple myeloma patients who received one to four prior lines of therapy.