Issued on behalf of GT Biopharma, Inc.
VANCOUVER – Baystreet.ca News Commentary – The convergence of advanced diagnostics and targeted therapeutics is reshaping cancer care, as September 2025 marked eight FDA oncology approvals[1] spanning breakthrough treatments for lung cancer, breast cancer, and rare pediatric brain tumors. The cancer immunotherapy market is projected to surge toward $443 billion by 2030[2], driven by rapid adoption of personalized treatment approaches and novel delivery systems that reduce hospital stays while improving outcomes. From cellular immunotherapies moving into outpatient settings to radiopharmaceuticals enabling precise tumor targeting, the precision oncology ecosystem is expanding access to life-extending treatments. These market dynamics create significant opportunities for companies advancing innovative platforms across the treatment spectrum, including GT Biopharma, Inc. (NASDAQ: GTBP), IO Biotech (NASDAQ: IOBT), Syndax Pharmaceuticals (NASDAQ: SNDX), Lantheus Holdings, Inc. (NASDAQ: LNTH), and GE Healthcare (NASDAQ: GEHC).
Institutional investment is accelerating as breakthrough therapy designations and fast-track approvals compress development timelines, with twelve immunotherapy drugs receiving FDA approval in the first half of 2025 alone[3]. Combination therapies pairing immunotherapy with targeted agents are demonstrating synergistic effects and improved response rates, while advances in biomarker identification and AI-driven patient selection are enhancing treatment precision. These structural shifts favor early-positioned companies with differentiated platforms addressing high unmet needs across both liquid and solid tumors, creating compelling entry points before major clinical catalysts materialize.
GT Biopharma, Inc. (NASDAQ: GTBP) is a San Francisco-based clinical-stage immunotherapy company making significant strides in developing innovative treatments for difficult-to-treat cancers. The biotech firm recently announced encouraging progress in its Phase 1 trial of GTB-3650, with both patients in Cohort 3 successfully initiating treatment without any evidence of dose-limiting toxicities or safety concerns to date. The company is now well-positioned with enrollment momentum and plans to begin dosing patients in Cohort 4 by year-end 2025, with additional data updates anticipated in the first quarter of 2026.
The Phase 1 trial is evaluating 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 particularly challenging patient populations whose cancers have either returned after initial treatment or never responded to standard therapies. The drug operates by activating the body's own natural killer cells to attack cancer cells. Treatment is administered through continuous infusions in two-week cycles, alternating two weeks on and two weeks off, for up to four months depending on patient response.
Following comprehensive safety reviews, the company successfully moved into Cohort 3 after formal evaluation of the first two patient groups revealed no safety or tolerability problems. What makes the early data particularly noteworthy is the compelling biomarker evidence. Multiple blood tests from the first four patients showed measurable increases in natural killer cell activity and expansion. Additionally, the first patient in Cohort 3 has demonstrated promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts. This biological evidence suggests the drug is performing exactly as intended—awakening the immune system and directing it against cancer cells.
The Phase 1 protocol allows for evaluation of GTB-3650 in up to approximately 14 patients, with two patients enrolled in each of seven cohorts and doses ranging from 1.25μg/kg/day in Cohort 1 to 100μg/kg/day in Cohort 7. The trial will continue to dose-escalate into the higher ranges anticipated to be necessary to translate heightened immune activation into clinically meaningful evidence of therapeutic activity.
"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 CEO 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)."
Beyond blood cancers, GT Biopharma has a second drug candidate progressing toward clinical testing. GTB-5550 targets B7H3, a protein 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 self-administer 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 Biopharma reported 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/
IO Biotech (NASDAQ: IOBT) received a significant regulatory setback following its pre-BLA meeting with the FDA, which recommended the company not submit a Biologics License Application based on data from the IOB-013 clinical trial of Cylembio for advanced melanoma. While treatment with Cylembio plus pembrolizumab improved progression free survival in the trial, the results narrowly missed statistical significance.
"We had a productive meeting with FDA; while this is not the outcome we had hoped for, we respect FDA's feedback and remain confident in the therapeutic potential of Cylembio," said Mai-Britt Zocca, PhD, CEO of IO Biotech. "We look forward to continuing the dialogue with FDA to align on the design for a potential new registrational study."
The company is implementing a restructuring plan that includes reducing its workforce by approximately 50% and expects to incur non-recurring charges of $1.0-$1.5 million in Q3 2025. With capital to run operations into the first quarter of 2026, IO Biotech plans to design a new registrational study for Cylembio while pursuing discussions with European regulators for potential EU submission.
Syndax Pharmaceuticals (NASDAQ: SNDX) achieved a major clinical milestone as the National Comprehensive Cancer Network updated its Clinical Practice Guidelines to include Revuforj (revumenib) as a category 2A recommendation for relapsed or refractory acute myeloid leukemia with an NPM1 mutation. The update was based on positive pivotal results from the AUGMENT-101 trial published in the journal Blood in 2025, with the NCCN Guidelines also continuing to include revumenib as a category 2A recommendation for relapsed or refractory acute leukemia with a KMT2A rearrangement.
"The inclusion of revumenib as a recommended treatment option for R/R NPM1 mutated AML in the NCCN Guidelines underscores the strength of our clinical data in this population and further solidifies revumenib's leading position," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "Given the pivotal role NCCN Guidelines play in guiding the decision-making process for clinicians, payers, patients, and other key stakeholders in the U.S. and beyond, this is a major milestone for Syndax and the entire acute leukemia community."
The company has submitted a supplemental New Drug Application seeking approval of revumenib for the treatment of relapsed or refractory NPM1 mutated AML, which has been granted Priority Review by the FDA with a PDUFA target action date of October 25, 2025. Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1 mutated or KMT2A rearranged AML.
Lantheus Holdings, Inc. (NASDAQ: LNTH) and GE HealthCare (NASDAQ: GEHC) announced an exclusive licensing agreement for GE HealthCare to develop, manufacture, and commercialize Lantheus' piflufolastat F18 (PYLARIFY in the U.S. market) in Japan for prostate cancer diagnostics and companion diagnostic use. The agreement includes transfer of regulatory dossiers, manufacturing competencies, and technical support to enable clinical development in Japan toward potential regulatory submissions and commercial launch, with GE HealthCare leveraging its extensive manufacturing network and R&D expertise following its March 2025 acquisition of Nihon Medi-Physics Co., Ltd., a leading radiopharmaceutical company in Japan.
"This partnership is expected to meaningfully extend the reach of our diagnostic imaging agent in key international markets," said Brian Markison, CEO of Lantheus. "GE HealthCare and NMP's deep regional expertise will enable us to advance the detection and care of prostate cancer and drive significant impact in an important market."
Under the terms of the agreement, GE HealthCare will pay Lantheus an upfront license fee, development milestones, and tiered royalties based on product sales in Japan, with a Joint Steering Committee established to oversee development and commercialization activities. PYLARIFY was FDA-approved in 2021 and is the number one utilized PSMA PET imaging agent in the U.S., with over 500,000 scans performed across 48 states, and was approved in the European Union in 2023 where it is marketed as PYLCLARI.
"This collaboration represents a strategic advancement for GE HealthCare as we expand our pipeline of radiopharmaceuticals and continue to deliver on our commitment to improving patient access to innovative diagnostics," said Kevin O'Neill, President & CEO of the Pharmaceutical Diagnostics segment of GE HealthCare and President of NMP. "Working alongside Lantheus gives us access to one of the best-in-class PET imaging agents that is already approved in the U.S. and in Europe, and if approved locally, could provide clinicians and their patients with a powerful new option for detecting and monitoring prostate cancer."
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
1. https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/
2. https://www.grandviewresearch.com/press-release/global-cancer-immunotherapy-market
3. https://binaytara.org/cancernews/article/top-oncology-innovations-that-shaped-the-first-half-of-2025
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