PR Newswire
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 Biopharmaplans 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:
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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:
https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
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SOURCES:
1. https://www.sciencedaily.com/releases/2025/11/251120002609.htm
2. https://www.worldwidecancerresearch.org/our-latest-news/news-and-press/exciting-new-immunotherapy-breakthrough/
3. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation
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