Issued on behalf of GT Biopharma, Inc.
VANCOUVER – Baystreet.ca News Commentary – Scientists engineered invisible immune cells in October 2025 that hide from rejection while destroying tumors[1], as antibody drug conjugates expanded rapidly into earlier treatment lines following decades of development[2]. The global cancer therapy market reached $244 billion in 2025 with projections climbing to $404 billion by 2030, powered by next-generation platforms including natural killer cell activators, tumor-infiltrating lymphocyte therapies, and selective protein degraders. These precision advances position GT Biopharma, Inc. (NASDAQ: GTBP), Genmab A/S (NASDAQ: GMAB), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), SELLAS Life Sciences Groupd, Inc. (NASDAQ: SLS), and Nurix Therapeutics, Inc. (NASDAQ: NRIX).
The immunotherapy market is forecast to surge from $58 billion in 2024 to $120 billion by 2030[3], as cell therapy manufacturing advances enable off-the-shelf treatments at significantly reduced costs[4]. The convergence of breakthrough cellular engineering, precision antibody conjugates targeting treatment-resistant cancers, and novel protein degradation platforms creates favorable conditions for companies advancing differentiated therapies before competitive pressures intensify across high-value oncology segments.
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 in the fourth quarter of 2025. 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/
Genmab A/S (NASDAQ: GMAB) reported encouraging clinical results from its Phase 1/2 RAINFOL-01 trial, with investigational antibody-drug conjugate rinatabart sesutecan (Rina-S) achieving a 50% confirmed objective response rate, including two complete responses, in heavily pretreated patients with advanced endometrial cancer at the 100 mg/m² dose. The responses were observed regardless of FRα expression levels, with 63.6% of responders maintaining their responses at a median study follow-up of one year.
"These data signals with Rina-S in the updated Phase 1/2 RAINFOL-01 data are encouraging – they point to the possibility of providing more choices for patients in the future," said Dr. Noelle Cloven, Texas Oncology Fort Worth, Sarah Cannon Research Institute, and study investigator.
Genmab is advancing Rina-S through late-stage development with the ongoing Phase 3 RAINFOL-03 trial in endometrial cancer now underway and the Phase 3 RAINFOL-02 trial in platinum resistant ovarian cancer. The U.S. Food and Drug Administration recently granted Breakthrough Therapy Designation to Rina-S for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has expanded patient access to Amtagvi, the first FDA-approved tumor-infiltrating lymphocyte therapy for solid tumors, by selecting InspiroGene by McKesson as its specialty pharmacy partner. This partnership opens the specialty pharmacy channel for Amtagvi, enabling flexibility for authorized treatment centers while leveraging Biologics by McKesson's more than 30 years of specialty pharmacy and deep clinical expertise in oncology.
"We chose InspiroGene by McKesson to pioneer the Amtagvi specialty pharmacy option due to their offerings and commitment to cell and gene therapy patient access," said Dan Kirby, Chief Commercial Officer at Iovance Biotherapeutics, Inc. "The addition of the specialty pharmacy channel marks a significant step forward in Iovance's objective to bring innovative, life-extending therapies to more patients, more efficiently."
InspiroGene will provide tailored services including order management, reimbursement navigation and patient support, all tailored to the unique needs of cell and gene therapy delivery. Amtagvi is a one-time personalized treatment option for patients with advanced melanoma after immune checkpoint inhibitor and targeted therapy, harnessing a patient's own T cells which are extracted from the tumor, expanded and re-infused into the patient to help fight their cancer.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) presented preclinical efficacy data for its highly selective CDK9 inhibitor SLS009 (tambiciclib) at the European Society for Medical Oncology Congress 2025, demonstrating that both monotherapy and combination with venetoclax significantly prolonged overall survival in an in vivo patient-derived xenograft model of relapsed/refractory T-cell prolymphocytic leukemia. SLS009 monotherapy and the combination prolonged overall survival to 7.4 weeks and 7.9 weeks, respectively, compared to venetoclax alone at 4.4 weeks, a statistically significant difference (p<0.05), while achieving better control of circulating T-PLL cells in the peripheral blood.
"These results are highly encouraging and provide important preclinical evidence that selective CDK9 inhibition with SLS009 may play a critical role in the treatment of T-PLL, an aggressive leukemia with very limited treatment options," said Dr. Dragan Cicic, Senior Vice President, Chief Development Officer at SELLAS. "Notably, SLS009 alone and in combination with venetoclax prolonged survival more effectively than venetoclax monotherapy, while demonstrating favorable tolerability."
SELLAS is developing SLS009 as potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases.
Nurix Therapeutics, Inc. (NASDAQ: NRIX) has initiated the DAYBreak pivotal study, a single-arm Phase 2 trial evaluating bexobrutideg (NX-5948) at 600 mg once daily in patients with relapsed or refractory chronic lymphocytic leukemia who have experienced disease progression following treatment with a covalent BTK inhibitor, a BCL-2 inhibitor, and a non-covalent BTK inhibitor. The 600 mg dose selection follows completion of analysis from a randomized cohort within the Phase 1b study and reflects alignment with global regulators including the U.S. Food and Drug Administration, the U.K. Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency.
"The initiation of the DAYBreak study marks Nurix's transition to a pivotal-stage company and a major milestone for bexobrutideg, which our data demonstrate has a potential best-in-class profile," said Arthur T. Sands, M.D., Ph.D., CEO of Nurix. "With the DAYBreak study underway, we are advancing the development of bexobrutideg and are one step closer to registration and commercialization."
Nurix plans to initiate a randomized confirmatory Phase 3 trial in the first half of 2026 in relapsed/refractory CLL patients whose disease has previously progressed while receiving a covalent BTK inhibitor, comparing bexobrutideg monotherapy to an investigator's choice of pirtobrutinib monotherapy, bendamustine plus rituximab, or idelalisib plus rituximab. New preclinical data support bexobrutideg's potential best-in-class BTK degrader profile, demonstrating superior degradation potency, broad coverage of clinically relevant BTK mutations, and exquisite selectivity.
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/