VANCOUVER, BC — December 4, 2025 — Leads & Copy —Triple-therapy immunotherapy and natural killer cell research are advancing blood cancer treatments, positioning companies such as GT Biopharma, Inc. (NASDAQ: GTBP), Geron Corporation (NASDAQ: GERN), and Kura Oncology, Inc. (NASDAQ: KURA) for success.
GT Biopharma, Inc. (NASDAQ: GTBP) recently reported the completion of a safety review for its Phase 1 clinical trial of GTB-3650, with no safety concerns observed in the third dosing group. The company is moving forward with testing of Cohort 4, where patients will receive 10μg/kg/day. Patient screenings are underway and dosing is anticipated to begin in the coming weeks. An update is expected in the first quarter of 2026.
The Phase 1 study of GTB-3650 is focused on patients with relapsed or refractory blood cancers expressing the CD33 protein, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The treatment involves continuous infusions for two weeks, followed by a two-week rest period, repeated for up to four months.
All six patients in Cohorts 1 through 3 were successfully treated with GTB-3650, demonstrating tolerability at increasing doses. The company believes the Cohort 4 dose level of 10μg/kg/day reflects the potential clinical efficacy threshold, based on biomarker trends and the absence of dose-limiting toxicities.
The Phase 1 trial will involve approximately 14 patients across seven cohorts, with escalating doses from 1.25μg/kg/day to a maximum of 100μg/kg/day in Cohort 7. The trial assesses safety, pharmacokinetics, pharmacodynamics, in vivo expansion of natural killer cells, and clinical activity.
GT Biopharma is also developing GTB-5550, which targets B7H3, found in solid tumor types such as breast, lung, ovarian, pancreatic, bladder, and prostate cancers. The company anticipates filing a regulatory application to begin human trials of GTB-5550 in either the fourth quarter of 2025 or in January 2026. GTB-5550 is designed to be administered via subcutaneous injection.
Both GTB-3650 and GTB-5550 utilize the company’s TriKE platform technology, based on antibody fragments from camels and llamas, licensed from the University of Minnesota.
Geron Corporation (NASDAQ: GERN) reported $47.2 million in RYTELO net product revenue in the third quarter of 2025. Enrollment of 320 patients has been completed in its Phase 3 IMpactMF clinical trial. Interim analysis results are expected in the second half of 2026 and final analysis in the second half of 2028. The company has reduced its 2025 total operating expenses guidance to between $250 million and $260 million. Cash, cash equivalents, restricted cash and marketable securities were approximately $421.5 million as of September 30, 2025.
Kura Oncology, Inc. (NASDAQ: KURA) has announced that KOMZIFTI (ziftomenib) has been included in the NCCN Guidelines as a Category 2A recommended treatment option after receiving full FDA approval on November 13, 2025. The addition of KOMZIFTI to the NCCN Guidelines in Oncology underscores the potential impact for patients with R/R NPM1-mutated AML and supports our commitment to ensuring that patients have access to this important treatment option
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is advancing its Phase 3 REGAL trial of GPS with final analysis anticipated by year-end 2025. Data for SLS009 in combination with azacitidine and venetoclax have been accepted for presentation at the ASH Annual Meeting in December 2025. SELLAS received approximately $54.6 million in gross proceeds from warrant exercises in September and October 2025 and plans to initiate an 80-patient trial in newly diagnosed first-line AML patients in the first quarter of 2026.
TScan Therapeutics (NASDAQ: TCRX) has reached an agreement with the FDA on its pivotal trial design for TSC-101. The company has also implemented a commercial-ready manufacturing process that shortens manufacturing time and lowers cost. 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 launch its pivotal trial for TSC-101 in the second quarter of 2026.
CONTACT:
USA NEWS GROUP
info@usanewsgroup.com
(604) 265-2873
Source: GT Biopharma, Inc.
