Issued on behalf of GT Biopharma, Inc.
VANCOUVER – Baystreet.ca News Commentary – The 2025 American Society of Hematology meeting showcased pivotal advances in blood cancer treatment, with novel immunotherapies and bispecific antibodies demonstrating unprecedented response rates across leukemia, lymphoma, and multiple myeloma[1]. November delivered multiple FDA oncology approvals including breakthrough designations for next-generation therapies targeting previously resistant blood cancers[2]. These developments position clinical-stage and commercial hematology companies to capture significant market share as standard-of-care definitions evolve. Leading this transformation are GT Biopharma, Inc. (NASDAQ: GTBP), Karyopharm Therapeutics Inc. (NASDAQ: KPTI), GSK plc (NYSE: GSK), Protagonist Therapeutics, Inc. (NASDAQ: PTGX), and Takeda Pharmaceutical Company Limited (NYSE: TAK).
Industry analysts project cancer therapy revenues expanding from $243.62 billion in 2025 to $403.99 billion by 2030, reflecting a robust 10.64% compound annual growth rate driven by breakthrough immunotherapy platforms[3]. Big Pharma partnerships accelerated throughout November with multibillion-dollar acquisitions targeting innovative oncology assets, creating favorable liquidity conditions for companies advancing differentiated mechanisms through clinical validation milestones[4].
GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company, recently reported continued progress with its Phase 1 clinical trial of GTB-3650, which has now advanced into Cohort 4 at a dose level of 10μg/kg/day. The company is developing innovative immunotherapy treatments designed to combat some of the world's most challenging cancer types using its proprietary natural killer cell engager TriKE platform technology.
The Phase 1 dose escalation study is evaluating 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.
"We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day," said Michael Breen, Executive Chairman and CEO. "We look forward to assessing higher doses, as we are now approaching the efficacy range predicted by preclinical in vivo leukemia models, and we plan to share the next trial update in the first quarter of 2026."
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 based on positive trends observed across multiple immunological biomarkers and the complete absence of dose-limiting toxicities throughout all three completed cohorts.
The Phase 1 first in human trial 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 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. The company plans to provide the next trial update in the first quarter of 2026.
Beyond blood cancers, GT Biopharma 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. The company expects to submit its regulatory application to begin human trials of GTB-5550 in late December 2025 or January 2026.
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: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
Karyopharm Therapeutics Inc. (NASDAQ: KPTI) has reported Q3 2025 financial results with total revenue of $44.0 million and U.S. XPOVIO net product revenue of $32.0 million, representing an 8.5% increase compared to Q3 2024. The company completed enrollment of its Phase 3 SENTRY trial in myelofibrosis with 353 patients in early September 2025, marking a pivotal milestone as the company prepares for top-line data expected in March 2026.
"This has been a very productive quarter as we have strengthened our financial foundation and made meaningful clinical progress with enrollment completion of our Phase 3 SENTRY trial in myelofibrosis," said Richard Paulson, CEO of Karyopharm Therapeutics. "With SENTRY enrollment complete, our teams remain focused on clinical trial execution, preparing for top-line data in March, potential regulatory filings, and commercial launch readiness, as we work to redefine the standard-of-care for frontline myelofibrosis patients, pending regulatory approvals."
The company reaffirmed full-year 2025 guidance with total revenue expected between $140 million and $155 million and U.S. XPOVIO net product revenue between $110 million and $120 million. Karyopharm reported cash, cash equivalents and investments of $46.2 million as of September 30, 2025, with pro forma liquidity of approximately $78 million following recent financing transactions, expected to fund operations into Q2 2026.
GSK plc (NYSE: GSK) presented new haematology portfolio data at ASH highlighting updated DREAMM-8 results with median 35.8 months follow-up exploring depth of response and sustained benefit for belantamab mafodotin in relapsed or refractory multiple myeloma. DREAMM-7 post hoc analysis explored patient characteristics and outcomes associated with duration and depth of response in responders with progression-free survival greater than three years, while DREAMM-9 evaluated optimal dosing schedules in transplant-ineligible newly diagnosed multiple myeloma patients.
Additional momelotinib analyses from MOMENTUM and SIMPLIFY-1 highlighted the ability to improve hemoglobin levels and achieve dual response—both transfusion independence and spleen volume reduction—with preliminary results from the ODYSSEY trial evaluating momelotinib in combination with luspatercept in transfusion-dependent myelofibrosis patients. Belantamab mafodotin combinations are approved in relapsed or refractory multiple myeloma in the European Union, UK, Japan, Canada, Switzerland and Brazil, while momelotinib is approved in 21 countries for myelofibrosis.
Protagonist Therapeutics, Inc. (NASDAQ: PTGX) and Takeda Pharmaceutical Company Limited (NYSE: TAK) announced 52-week results from the pivotal Phase 3 VERIFY study showing rusfertide delivered sustained hematocrit control in polycythemia vera patients, with 61.9% maintaining absence of phlebotomy eligibility through Week 52. Four-year data from the THRIVE extension study demonstrated a 13-fold reduction in annual phlebotomy rate, dropping from 9.2 to 0.7 phlebotomies per year.
"The totality of these data further demonstrates rusfertide's well tolerated safety profile and ability to deliver durable hematocrit control and clinical response as defined by absence of phlebotomy eligibility and support its potential to expand the treatment armamentarium for PV and positively impact the lives of patients with PV," said Arturo Molina, M.D., M.S., Chief Medical Officer at Protagonist. "We look forward to continuing to work with our partner, Takeda, to prepare for submission of an NDA to the FDA."
The companies are advancing rusfertide toward New Drug Application submission by end of 2025, with the therapy having received Breakthrough Therapy Designation, Orphan Drug Designation and Fast Track Designation from the FDA. Mean hematocrit remained below 43% through Week 52, with the most common adverse events being injection site reactions (47.4%), anemia (25.6%) and fatigue (19.6%).
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 CITED:
1. https://www.mdanderson.org/cancerwise/4-notable-presentations-from-ash-2025.h00-159781968.html
2. https://www.targetedonc.com/view/november-2025-key-fda-highlights-in-oncology
3. https://www.mordorintelligence.com/industry-reports/cancer-therapy-market
https://www.labiotech.eu/trends-news/top-biotech-deals-in-november-2025/
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