USA News Group
News Commentary -
Issued on behalf of GT Biopharma, Inc.
VANCOUVER, BC, Oct. 15, 2025 /PRNewswire/ -- USA News Group News Commentary - Biomarker-driven drug development is accelerating across oncology as companies advance novel mechanisms targeting previously difficult-to-treat patient populations. The cancer immunotherapy market reached $226 billion in 2024 and continues expanding rapidly, driven by precision approaches that pair targeted agents with immunotherapy, identify genetic vulnerabilities, and deploy radioligand therapies for metastatic disease[1]. Recent clinical data demonstrating high response rates in biomarker-selected populations underscore the shift toward molecularly defined patient subgroups, while FDA priority reviews and breakthrough designations are compressing development timelines for innovative platforms. This convergence of scientific innovation and regulatory momentum positions companies advancing differentiated mechanisms across multiple tumor types for significant value creation, including GT Biopharma, Inc. (NASDAQ: GTBP), IDEAYA Biosciences, Inc. (NASDAQ: IDYA), Zymeworks Inc. (NASDAQ: ZYME), Novartis AG (NYSE: NVS), and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN).
The industry's focus on combination strategies and novel targets is yielding promising clinical results, with antibody-drug conjugates, metabolic inhibitors, and immune-activating platforms demonstrating enhanced efficacy when paired with complementary mechanisms[2]. Major pharmaceutical companies are investing heavily in radioligand therapy and precision medicine infrastructure, while emerging biotech firms leverage genetic screening to identify patient populations most likely to benefit from targeted interventions. These dynamics create compelling opportunities for companies with diversified pipelines addressing both common and rare cancers through validated biological mechanisms, particularly those approaching key clinical readouts and regulatory milestones in high-value indications.
GT Biopharma, Inc. (NASDAQ: GTBP) is a clinical-stage immunotherapy company making significant progress in its fight against difficult-to-treat cancers. The San Francisco-based biotech has been advancing its lead drug candidate, GTB-3650, through a Phase 1 clinical trial targeting blood cancers that have stopped responding to other treatments. In August, the company successfully moved into Cohort 3 after formal safety reviews of the first two patient groups showed no safety or tolerability problems. The trial had treated five patients by mid-August, with encouraging early signals of immune system activation.
"We are pleased with the enrollment momentum in our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which continues to advance on schedule," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "Moving into the third dose cohort after a successful safety review and encouraging early evidence of immunological activity, mark important steps forward in the development of GTB-3650. We look forward to sharing more data later this year to reinforce the ability of our TriKE constructs to activate endogenous NK cells, and the potential for broader utility with other targets to treat solid tumors (GTB-5550) and autoimmune indications (GTB-7550)."
The Phase 1 trial is testing GTB-3650 in patients with relapsed or refractory CD33-expressing blood cancers, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These are patients whose cancers have come back or never responded to standard therapies. The drug works by activating the body's own natural killer cells to attack cancer cells. Patients receive the treatment through continuous infusions in two-week cycles, alternating two weeks on and two weeks off, for up to four months based on how well they're responding.
What makes the early data particularly interesting is the biomarker evidence. Multiple blood tests from the first four patients showed measurable increases in natural killer cell activity and expansion. This suggests the drug is doing exactly what it was designed to do-wake up the immune system and direct it against cancer. GT Biopharma expects to release more detailed Phase 1 results later this year after completing additional dose cohorts.
Beyond blood cancers, GT Biopharma has a second drug candidate moving toward the clinic. GTB-5550 targets a protein called B7H3 that appears in many different types of solid tumors, including breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers. The company expects to submit its application to start human testing of GTB-5550 during the fourth quarter of this year. Unlike many cancer immunotherapies that require lengthy hospital infusions, GTB-5550 is being developed as a simple injection that patients could potentially give themselves at home, similar to insulin shots.
Both drug candidates are built on GT Biopharma's proprietary TriKE platform, which uses specialized antibody fragments originally discovered in camels and llamas. These molecules are smaller and more stable than traditional antibodies, allowing them to work more effectively. GT Biopharma holds an exclusive worldwide license from the University of Minnesota to develop and commercialize therapies using this technology.
As of June 30, 2025, GT Biopharmareported cash and cash equivalents of approximately $5.3 million, which management expected would fund operations into the first quarter of 2026.
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/
IDEAYA Biosciences, Inc. (NASDAQ: IDYA) has reported positive Phase 1/2 data for its combination of IDE397, a potential first-in-class MAT2A inhibitor, with Gilead's Trodelvy® in MTAP-deletion urothelial cancer, achieving an overall response rate of 57% at the higher dose level. The trial enrolled patients with late-line MTAP-deletion urothelial cancer, where MTAP-deletion is estimated to occur in approximately 25-30% of urothelial cancer patients, with 68% of participants having progressed after two or more prior therapies.
"We are pleased with the progress we are making with the Trodelvy and IDE397 combination and are encouraged by the early response rate data we are seeing in previously treated MTAP-deleted urothelial cancer," said Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences. "These results set the stage for further testing of the combination in non-small cell lung cancer, where we have just dosed the first patient in our clinical trial."
The combination demonstrated a manageable safety profile consistent with known adverse events of both drugs as single agents, with no treatment-related serious adverse events observed at the recommended expansion dose. IDEAYA is targeting selection of the recommended Phase 2 dose by end of 2025, with the next update planned for a medical conference in the first half of 2026.
Zymeworks Inc. (NASDAQ: ZYME) will present preliminary Phase 1 data for ZW191, an antibody-drug conjugate targeting folate receptor-a, at the AACR-NCI-EORTC Conference on October 22-26, 2025. ZW191 is engineered to target a protein found in approximately 75% of high-grade serous ovarian carcinomas and 70% of lung adenocarcinomas, utilizing Zymeworks' proprietary bystander active topoisomerase-1 inhibitor payload, ZD06519.
"We are excited to share early clinical data from Part 1 of our first-in-human, Phase 1 trial of ZW191 in patients with advanced solid tumors," said Sabeen Mekan, M.D., Senior Vice President of Clinical Development of Zymeworks. "These initial results reinforce our confidence in our novel ADC design and its potential to deliver improved treatments for broader patient populations."
The company will host a live webcast on October 23, 2025 at 3:30 pm ET to discuss the data with lead author Patricia LoRusso and senior management. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, with ZW251 expected to enter clinical trials in 2025.
Novartis AG (NYSE: NVS) will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology Congress 2025 in Berlin from October 17-21, 2025. Key data from the PSMAddition trial has been selected for a Presidential session, showcasing the efficacy and safety of Pluvicto plus standard of care versus standard of care alone in PSMA-positive metastatic hormone-sensitive prostate cancer, while the NATALEE five-year analysis will provide further long-term insights into Kisqali's risk of recurrence reduction in early breast cancer.
"We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients," said Dushen Chetty, Ph.D., Global Head of Oncology Development, Novartis, Ad Interim. "Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy."
The oncology strategy of Novartis focuses on people living with cancer and their caregivers, with approximately 35 research and development projects across solid tumors, hematology and radioligand therapy. The company is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. FDA has approved Libtayo® (cemiplimab-rwlc) as the first and only immunotherapy for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. The approval, granted under Priority Review, is based on the pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), with results published in the New England Journal of Medicine and presented at ASCO 2025.
"This approval provides patients with CSCC at high risk of disease recurrence following surgery and radiation a much-needed option, as Libtayo is the only immunotherapy to demonstrate efficacy in this setting," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. "Now with five FDA-approved indications, Libtayo is firmly established as a strong and versatile PD-1 inhibitor option for patients with a variety of cancers."
An additional regulatory application is under review in the European Union, with a decision expected by the first half of 2026. Regeneron has launched Libtayo Surround, offering financial and educational resources to help support patients throughout their treatment journey, with cutaneous squamous cell carcinoma being one of the most common skin cancers with an estimated 1.8 million cases diagnosed annually in the U.S.
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:
- https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market
- https://www.labiotech.eu/in-depth/oncology-trends-2025/
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