Issued on behalf of GT Biopharma, Inc.
VANCOUVER – Baystreet.ca News Commentary – Scientists have engineered breakthrough cell therapies that can be mass-produced and stored ready-to-use, addressing key barriers in treatment access and cost[1]. Researchers also discovered how tumors exhaust immune cells, revealing an entirely new pathway to revive cancer-fighting T cells and overcome treatment resistance[2]. These advances are positioning a new generation of immunotherapy companies to capitalize on the rapidly expanding treatment landscape for hematologic malignancies. Among those positioned to benefit are GT Biopharma, Inc. (NASDAQ: GTBP), C4 Therapeutics, Inc. (NASDAQ: CCCC), Bristol Myers Squibb (NYSE: BMY), Roivant Sciences Ltd. (NASDAQ: ROIV), and Zai Lab Limited (NASDAQ: ZLAB).
The hematologic malignancies treatment market reached $72 billion in 2025 and is projected to nearly double to $139 billion by 2034, driven by accelerating adoption of novel therapeutics[3].
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: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
C4 Therapeutics, Inc. (NASDAQ: CCCC) completed an equity offering that resulted in $125 million in gross proceeds, extending the company's cash runway to the end of 2028 with potential to earn up to an additional $225 million if outstanding warrants are exercised. The company presented Phase 1 data demonstrating that cemsidomide in combination with dexamethasone achieved a 40% and 53% overall response rate at the two highest dose levels in heavily pre-treated multiple myeloma patients, with differentiated safety and tolerability profiles supporting potential best-in-class positioning.
"We remain laser-focused on initiating cemsidomide's next phase of development in early 2026, which includes a Phase 1b trial in combination with elranatamab as well as the Phase 2 MOMENTUM trial in combination with dexamethasone, which has potential for accelerated approval," said Andrew Hirsch, CEO of C4 Therapeutics.
C4 Therapeutics entered into a clinical trial collaboration and supply agreement with Pfizer for the combination of cemsidomide and elranatamab in relapsed/refractory multiple myeloma, with the company planning to initiate the registrational Phase 2 MOMENTUM trial in Q1 2026 and the Phase 1b combination trial in Q2 2026. For the third quarter of 2025, the company reported total revenues of $11.2 million with research and development expenses of $26.0 million, reflecting reduced clinical trial costs as the CFT1946 Phase 1 trial neared completion.
Bristol Myers Squibb (NYSE: BMY) received approval from the European Commission to expand use of Breyanzi for adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a Bruton's tyrosine kinase inhibitor. In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% achieving complete response and 41.2% of patients still in response at 24 months.
"This approval for Breyanzi in relapsed or refractory mantle cell lymphoma marks another important step as we continue to deliver on the promise of cell therapy for more eligible patients across Europe – the fourth approval for Breyanzi in Europe," said Emma Charles, senior vice president, Europe Region, Bristol Myers Squibb.
The approval is applicable to all European Union member states as well as European Economic Area countries Iceland, Norway and Liechtenstein. Safety results were consistent with Breyanzi's well-established profile, with the majority of cytokine release syndrome and neurologic toxicities developing during the first 14 days post-infusion.
Roivant Sciences Ltd. (NASDAQ: ROIV) reported consolidated cash of $4.4 billion as of September 30, 2025, supporting cash runway into profitability, following brepocitinib 30 mg demonstrating clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints in the Phase 3 VALOR study in dermatomyositis. The company plans to file an NDA for brepocitinib in dermatomyositis in the first half of calendar year 2026, while Phase 3 enrollment in non-infectious uveitis continues with topline readout expected in the first half of calendar year 2027.
"This quarter unquestionably represents a moment of transformation for Roivant, with the brepocitinib data in DM putting us on a new and exciting trajectory," said Matt Gline, CEO of Roivant. "This is further supported by Immunovant's remission data in Graves' disease, and by strong continued execution and progress across the board."
Immunovant's study in uncontrolled Graves' disease patients treated for 24 weeks showed the first-ever potentially disease-modifying outcome with six-month off-treatment data, while Immunovant anticipates sharing topline results from both batoclimab Phase 3 thyroid eye disease studies concurrently in the first half of calendar year 2026. In September 2025, the court issued a favorable Markman ruling in the Pfizer/BioNTech case as part of Genevant's ongoing LNP litigation, with a jury trial in the U.S. Moderna case scheduled for March 2026.
Zai Lab Limited (NASDAQ: ZLAB) reported third quarter 2025 revenues growing 14% year-over-year to $116.1 million while improving operating loss by 28% to $48.8 million, leading the company to raise full year 2025 revenue guidance to at least $460 million. Updated Phase 1 data on zocilurtatug pelitecan (zoci) presented at the AACR-NCI-EORTC conference demonstrated a 68% best overall response rate at the 1.6 mg/kg dose in second-line extensive-stage small cell lung cancer, with an 80% response rate in patients with untreated brain metastases and no Grade ≥2 interstitial lung disease.
"Zai Lab is entering the next phase of our growth, powered by the rapid advancement of our global pipeline and supported by a commercially profitable and scalable business in China," said Dr. Samantha Du, founder, chairperson, and CEO of Zai Lab. "With zoci moving into pivotal development less than two years after IND and multiple differentiated global programs progressing in parallel, we are demonstrating the speed, scientific rigor, and global ambition of our R&D engine."
The company initiated a global registrational study for zoci in second-line-plus extensive-stage small cell lung cancer and launched a global Phase 1 study for ZL-1503, an IL-13/IL-31R bispecific antibody for atopic dermatitis. Zai Lab plans to submit an IND for ZL-6201, an LRRC15 ADC for sarcoma and other solid tumors, by year-end 2025 while preparing for the anticipated approval of KarXT for schizophrenia in China, which was recently included in the country's national-level treatment guidelines.
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://scitechdaily.com/mit-and-harvard-build-invisible-immune-cells-that-obliterate-cancer/
2. https://www.nature.com/articles/s41568-025-00869-w
3. https://www.mordorintelligence.com/industry-reports/cancer-therapy-market
4. https://scitechdaily.com/mit-and-harvard-build-invisible-immune-cells-that-obliterate-cancer/
