Zanzalintinib

Issued on behalf of GT Biopharma, Inc. USA News Group News Commentary VANCOUVER, BC, Dec. 4, 2025 /PRNewswire/ -- Triple-therapy immunotherapy approaches are demonstrating complete leukemia elimination in preclinical models by reprogramming how cancer cells die to trigger powerful immune responses[1], while breakthrough natural killer cell research is revealing new pathways to supercharge the body's innate tumor-fighting capabilities[2]. These developments position GT Biopharma, Inc. (NASDAQ: GTBP), Geron Corporation (NASDAQ: GERN), Kura Oncology, Inc. (NASDAQ: KURA), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), and TScan Therapeutics, Inc. (NASDAQ: TCRX). The FDA's November approval of the first once-daily menin inhibitor for relapsed NPM1-mutated AML[3] validates targeted blood cancer therapies as investors and institutions recognize timing advantages before late-stage clinical catalysts materialize across the competitive landscape. GT Biopharma, Inc. (NASDAQ: GTBP) recently announced successful completion of the formal safety review for its ongoing Phase 1 clinical trial of GTB-3650's third dosing group (Cohort 3), with no safety or tolerability issues observed. With all the significant recent progress of GTB-3650, GTBP is currently advancing innovative immunotherapy treatments designed to combat some of the world's most challenging cancer types. This latest milestone has allowed GT Biopharma to advance into Cohort 4, where patients will receive 10μg/kg/day. Now the company is actively screening patients for Cohort 4 and anticipates initiating dosing in the coming weeks, with the next comprehensive update expected in the first quarter of 2026. The Phase 1 study is testing GTB-3650 in patients battling relapsed or refractory blood cancers that express the CD33 protein, specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These represent some of the most difficult cancer cases to treat, involving patients whose disease either came back after initial therapy or never responded to conventional treatment options. GTB-3650 works by stimulating the patient's natural killer cells, a type of immune cell that naturally hunts down and destroys abnormal cells, to specifically target cancer cells. Patients receive the therapy through continuous infusions following a structured schedule: two weeks of treatment followed by two weeks of rest, repeating this cycle for up to four months based on how they respond. The six patients enrolled across Cohorts 1 through 3 have all been successfully treated with GTB-3650, demonstrating the therapy's tolerability at progressively higher dose levels. According to the company, the Cohort 4 dose level of 10μg/kg/day is more reflective of the potential clinical efficacy threshold. This assessment is based on positive trends observed across multiple immunological biomarkers from the previous six patients, the complete absence of dose-limiting toxicities throughout all three completed cohorts, and recognition that the earlier cohorts utilized lower dose levels that may have been below the therapeutic range where meaningful clinical benefit occurs. The Phase 1 design calls for testing GTB-3650 in approximately 14 patients across seven cohorts, with two patients per cohort receiving progressively higher doses from 1.25μg/kg/day in Cohort 1 up to 100μg/kg/day in Cohort 7 if necessary. Beyond the current Cohort 4, three additional higher-dose cohorts remain available: Cohort 5 at 25μg/kg/day, Cohort 6 at 50μg/kg/day, and Cohort 7 at the maximum planned dose of 100μg/kg/day. This wide dosing range reflects the trial's goal of identifying where GTB-3650 delivers optimal therapeutic benefit while maintaining an acceptable safety profile. The trial is measuring safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient natural killer cells, and clinical activity. Beyond blood cancers, the company is developing GTB-5550, which targets B7H3, a protein commonly found across various solid tumor types including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. GT Biopharma plans to file its regulatory application to begin human trials of GTB-5550 either in the fourth quarter of 2025 or in January 2026. GTB-5550 is being designed as a subcutaneous injection that patients might eventually self-administer at home. Both candidates utilize GT Biopharma's proprietary TriKE platform technology, which employs specialized antibody fragments originally found in camels and llamas. These molecules offer advantages over conventional antibodies due to their smaller size and greater stability. The company holds an exclusive worldwide license from the University of Minnesota for this technology. CONTINUED… Read this and more news for GT Biopharma, Inc. at: Geron Corporation (NASDAQ: GERN) achieved $47.2 million in RYTELO net product revenue in the third quarter of 2025 and completed enrollment of 320 patients in its Phase 3 IMpactMF clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis. The commercial-stage biopharmaceutical company strengthened its leadership team with the appointment of Ahmed ElNawawi as Chief Commercial Officer and now has approximately 1,150 ordering accounts for RYTELO, an increase of approximately 150 quarter-over-quarter. "The high unmet need in lower-risk MDS is well known, and RYTELO is a therapy with a novel mechanism of action and the potential to significantly impact the treatment paradigm," said Harout Semerjian, President and CEO of Geron. " Geron is positioned, with our realigned leadership team, to strengthen commercial execution, increase both physician and patient awareness, and drive RYTELO sales in the U.S." Geron expects the IMpactMF interim analysis readout for overall survival in the second half of 2026 and final analysis in the second half of 2028. The company reduced its 2025 total operating expenses guidance to between $250 million and $260 million from the previously announced $270 million to $285 million, with cash, cash equivalents, restricted cash and marketable securities of approximately $421.5 million as of September 30, 2025. Kura Oncology, Inc. (NASDAQ: KURA) announced that KOMZIFTI (ziftomenib), the first and only once-daily FDA-approved menin inhibitor for adults with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation, has been included in the NCCN Guidelines as a Category 2A recommended treatment option. The drug received full FDA approval on November 13, 2025, supported by data from the KOMET-001 clinical trial demonstrating a 21.4% complete response rate and median duration of response of 5 months, and is now commercially available to prescribers in the U.S. through a limited network of specialty pharmacies and distributors. "The addition of KOMZIFTI to the NCCN Guidelines in Oncology underscores the potential impact of KOMZIFTI for patients with R/R NPM1-mutated AML and supports our commitment to ensuring that patients have access to this important treatment option," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "NPM1-mutated disease carries a substantial risk of relapse and historically poor outcomes in the relapsed or refractory setting. We are pleased to have received inclusion in the NCCN guidelines so rapidly after FDA approval and are committed to making KOMZIFTI available to patients in the United States." Kura Oncology is advancing zanzalintinib's development program in front-line AML treatment with the potential for combination with approved therapies to benefit a broader spectrum of patients earlier in their disease course. The company maintains a focus on pioneering advancements in menin inhibition and farnesyl transferase inhibition for high-need hematologic malignancies and solid tumors. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) continues to advance its Phase 3 REGAL trial of GPS in acute myeloid leukemia patients who achieved complete remission following second-line salvage therapy, with final analysis anticipated by year-end 2025 once 80 deaths are reached. The company's Phase 2 data for SLS009, a selective CDK9 inhibitor, in combination with azacitidine and venetoclax for relapsed or refractory AML have been accepted for presentation at the American Society of Hematology (ASH) Annual Meeting in December 2025. "We remain highly encouraged by the continued, strong execution across our programs and the expanding body of clinical and preclinical data reinforcing the strength of our AML-focused pipeline," said Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS. "The Phase 3 REGAL trial of GPS is advancing as planned as highlighted by the key opinion leaders at our recent R&D event. Momentum around SLS009 also continues to build—our positive Phase 2 data were accepted for presentation at the upcoming ASH Annual Meeting, and we recently presented preclinical results at ESMO demonstrating clear survival benefits in T-PLL." SELLAS received approximately $54.6 million in gross proceeds from warrant exercises in September and October 2025, providing the company with $44.3 million in cash as of September 30, 2025, plus an additional $29.1 million received in October. The company plans to initiate an 80-patient trial in newly diagnosed first-line AML patients in the first quarter of 2026. TScan Therapeutics (NASDAQ: TCRX) reached agreement with the FDA on its pivotal trial design for TSC-101 following a productive end of Phase 1 meeting, with the agency approving a study design that mirrors the current ALLOHA Phase 1 trial using a biologically-assigned internal control arm expected to enable efficient enrollment and streamlined assessment of study endpoints. The company also implemented a commercial-ready manufacturing process that shortens manufacturing time by five days while lowering cost of goods and reducing ex vivo T cell expansion, with initial technology transfer to an external contract development and manufacturing organization completed. "Following a productive meeting with the FDA, we now have a clearly defined pivotal trial design for TSC-101, and we also have an improved commercial-ready manufacturing process in place," said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. "We are focused on advancing this promising program for patients with AML and MDS and look forward to sharing updated results from the ALLOHA Phase 1 trial at ASH next month." The company made the strategic decision to prioritize clinical development of its heme program and pause further enrollment in its PLEXI-T solid tumor Phase 1 trial while focusing preclinical efforts on in vivo engineering for solid tumors and target discovery in autoimmunity. With cash, cash equivalents, and marketable securities of $184.5 million as of September 30, 2025, TScan expects to fund operations into the second half of 2027, with plans to present updated clinical data including two-year relapse data at the upcoming 67th American Society of Hematology Annual Meeting and launch its pivotal trial for TSC-101 in the second quarter of 2026. Article Sources: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. 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The Spree River, Berlin, Germany iStock, TomasSereda Pfizer, Merck, AstraZeneca and Bristol Myers Squibb were among the many biopharmas showing off novel cancer modalities at ESMO, with antibody-drug conjugates, bispecific antibodies and kinase inhibitors demonstrating encouraging efficacy and safety for various cancers. The 2025 congress of the European Society for Medical Oncology came to a close on Tuesday, wrapping up five days of cutting-edge cancer research that pushed the boundaries of the field. Here, BioSpace rounds up the impactful and cutting-edge presentations at ESMO, the ones most likely to push forward patients’ clinical care and the broader biopharma industry. ADC Arena Heats Up Pfizer and Merck made waves in the antibody-drug conjugate sector, joining together to combine the former’s ADC Padcev with the latter’s mega-blockbuster PD-1 inhibitor Keytruda. Interim data from the Phase III EV-303/KEYNOTE-905 trial showed that the combo regimen reduced by 60% the risk of tumor recurrence, progression or death in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin treatment. Padcev plus Keytruda also led to a 50% improvement overall survival versus surgery alone, an effect that was statistically significant. Analysts at Guggenheim Partners wrote in a Tuesday note that these findings point to the “potential to change standard-of-care treatment for cisplatin-ineligible MIBC patients” and are likely to “provide [a] tailwind” for Padcev. Aside from its Padcev partnership, Merck showed work from its ADC alliance with China’s Sichuan Kelun-Biotech, which has the companies working on the anti-TROP2 ADC sacituzumab tirumotecan, being tested for EGFR-mutated non-small cell lung cancer (NSCLC). Results from a Phase III trial, conducted in China , demonstrated a significant 51% reduction in the risk of death or disease progression. Overall survival (OS) outcomes were likewise significant, with the ADC suppressing the likelihood of death by 40% versus pemetrexed plus platinum-based chemotherapy. Also in the TROP2 game is AstraZeneca with its Daiichi Sankyo–partnered ADC Datroway. At ESMO, the companies showed that Datroway resulted in a significant 43% progression-free survival (PFS) improvement in patients with locally recurrent or metastatic triple-negative breast cancer. The partners also presented data for the HER2-targetig ADC Enhertu. In patients with HER2-positive early breast cancer with residual invasive disease, the therapy resulted in a 53% decrease in the likelihood of death or recurrent invasive disease, as compared with Roche’s Kadcyla. Disease-free survival in these patients likewise improved by 53% after Enhertu treatment. Likewise presenting data at ESMO are Bristol Myers Squibb and SystImmune, which are advancing iza-bren, a bispecific ADC targeting both the EGFR and HER3 proteins. Phase I data pointed to “ promising antitumor activity ,” the companies said, with a confirmed response rate of 55% and a median PFS of 5.4 months. As for safety, common side effects were blood-related, including neutropenia, though most were generally manageable and “rarely” necessitated dose reductions. BMS and SystImmune are testing iza-bren for advanced solid tumors, including metastatic or unresectable NSCLC. Bispecifics on the Rise One of the most highly anticipated presentations at ESMO was for Akeso and Summit Therapeutics’ PD-1/VEGF bispecific antibody ivonescimab, which the partners are testing for advanced NSCLC. In the Phase III HARMONi-6 study, patients treated with ivonescimab plus chemotherapy saw a 40% PFS advantage versus those who were treated with BeOne’s PD-1 inhibitor Tevimbra plus chemotherapy. The companies did not release OS data, but analysts at Truist Securities were nevertheless encouraged by the ESMO presentation. The PFS readout, the analysts wrote, “leaves no room for doubts at this juncture, in our view,” for the benefit of ivonescimab as a frontline NSCLC treatment option. Summit, which is in charge of ivonescimab in the U.S., is planning a regulatory filing for the asset by year-end, management said in its Q3 call earlier this week. The company is specifically eyeing an approval for second-line EGFR-mutated NSCLC. Cutting off the Cascade Kinase blockers gained their own head of steam at ESMO. These are drugs that block signaling cascades that otherwise culminate in a tumor’s growth and proliferation. One such asset is zongertinib, developed by Boehringer Ingelheim for HER2-mutant advanced NSCLC. In the Phase Ib Beamion LUNG-1 study, zongertinib resulted in a 77% objective response rate and 96% disease control rate. Of note, 8% of responders showed no detectable signs of cancer in the body after treatment, while 69% reached partial treatment response. While data were not yet mature at the time, Boehringer reported an “encouraging” 79% PFS rate at six months. Going up against Boehringer is Bayer, which is developing its own tyrosine kinase inhibitor sevabertinib, likewise for HER2-mutated NSCLC. Bayer released results from a Phase I/II study, showing that in those who had been previously treated but not with a HER2-targeted agent, objective response rate reached 64% , which lasted for a median of 9.2 months. Meanwhile, in patients who had been exposed to an anti-HER2 ADC, response rate was 38% and lasted for 8.5 months. Bayer also tested sevabertinib in treatment-naive patients, of whom 71% responded to the agent, with a median duration of 11 months. There was action at ESMO for kinase inhibitors beyond NSCLC. Exelixis, for instance, tested its drug zanzalintinib for metastatic colorectal cancer (mCRC), touting a median overall survival of 10.9 months versus 9.4 months in comparators treated with Bayer’s Stivarga. OS estimates for zanzalintinib at 12 and 24 months were 46% and 20%, respectively. Analysts were effusive about these results, with William Blair saying in a Monday note that zanzalintinib set “a new survival bar in the third-line or later mCRC setting.” Exelixis is taking the drug to the FDA with these data and anticipates a filing within the year.