Equity Insider News Commentary
Issued on behalf of GT Biopharma, Inc.
VANCOUVER, BC, Oct. 8, 2025 /PRNewswire/ -- Ohio State researchers recently solved a critical mystery explaining why some cancer immunotherapies fail[1], while a University of Chicago team discovered a common supplement that supercharges immune cells against tumors[2]. These breakthroughs are propelling the global cancer treatment market from $282 billion in 2025 toward $643.5 billion by 2034[3], creating powerful momentum for companies pioneering next-generation approaches including GT Biopharma, Inc. (NASDAQ: GTBP), Lexeo Therapeutics, Inc. (NASDAQ: LXEO), Anixa Biosciences, Inc. (NASDAQ: ANIX), Tempus AI, Inc. (NASDAQ: TEM), and Citius Oncology, Inc. (NASDAQ: CTOR).
Cancer immunotherapy spending alone is forecast to double from $58 billion in 2024 to $120 billion by 2030, according to Mordor Intelligence[4], while over 120 clinical trials are testing RNA-based cancer vaccines that have already reduced melanoma recurrence by 44%[5].
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 announced today that both patients in Cohort 3 of its Phase 1 trial testing GTB-3650 have successfully initiated treatment with no evidence of dose-limiting toxicities or safety concerns to date. The company is now well on track with enrollment 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 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.
Recently, the company successfully moved into Cohort 3 after formal safety reviews of the first two patient groups showed no safety or tolerability problems. 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, and the first patient in Cohort 3 has shown promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts. This suggests the drug is doing exactly what it was designed to do-wake up the immune system and direct it against cancer.
The Phase 1 protocol allows evaluation of GTB-3650 in up to approximately 14 patients, with two patients 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 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.
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Lexeo Therapeutics, Inc. (NASDAQ: LXEO) has achieved significant progress with the FDA regarding its LX2006 gene therapy for Friedreich ataxia cardiomyopathy, with the agency indicating openness to pooling Phase I/II data with pivotal study data to support an accelerated approval pathway. Interim clinical data showed participants with abnormal left ventricular mass index achieved an 18% mean reduction at 6 months and 23% mean reduction at 12 months, exceeding the FDA-aligned 10% threshold, while more than 70% of participants demonstrated clinically meaningful improvements across both cardiac and neurologic measures.
"We are encouraged by our recent dialogue with the FDA on LX2006, and we appreciate the Agency's collaborative spirit as we work to deliver a potentially life-changing therapy to the FA community as efficiently as possible," said R. Nolan Townsend, CEO of Lexeo Therapeutics. "Given the highly compelling data to date that demonstrate clinically meaningful improvements across both cardiac and neurologic measures of FA, we are now pursuing a development strategy that could enable a smaller pivotal study, given the potential to pool data with the ongoing Phase I/II trials, as well as potentially assessing the co-primary endpoint of LVMI earlier than 12 months."
The company plans to initiate its pivotal study in the first half of 2026, with LX2006 having received Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Orphan Drug and Fast Track designations from the FDA. Treatment with LX2006 has been generally well tolerated with no Grade 3+ serious adverse events to date across 17 participants.
Anixa Biosciences, Inc. (NASDAQ: ANIX) has completed the final patient visit in its Phase 1 breast cancer vaccine clinical trial, marking a major milestone in the first-in-human evaluation of this novel vaccine invented at Cleveland Clinic. The trial enrolled 35 women across three cohorts: 26 patients with triple-negative breast cancer at risk of recurrence, four in a prevention group with genetic mutations who elected preventive mastectomy, and five receiving the vaccine concurrently with pembrolizumab.
"While cancer vaccines have historically faced considerable challenges, our approach targets a novel antigen that has not been explored in this setting," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We believe this strategy could represent a new paradigm in immuno-oncology, with potential utility in both the prevention and treatment of breast cancer."
Cleveland Clinic will present full clinical results at the San Antonio Breast Cancer Symposium on December 11, 2025, following submission of the final study report to the U.S. Department of Defense and a Clinical Study Report to the FDA.
Tempus AI, Inc. (NASDAQ: TEM) subsidiary Ambry Genetics has announced an enhanced breast cancer risk assessment solution through its Ambry CARE Program that integrates breast density into the Tyrer-Cuzick scoring model within electronic health records. The enhancement addresses a critical gap in breast cancer screening, as 93% of women with elevated risk who qualify for breast MRI based on medical and family history never receive one, with the updated tool providing four Tyrer-Cuzick score options aligned with BI-RADS breast density categories to guide screening decisions.
"Accurately assessing breast cancer risk is key to improving outcomes, but important factors like breast density often get overlooked," said Tom Schoenherr, CEO of Ambry Genetics. "By bringing together Tyrer-Cuzick scoring and breast density right in the EHR, CARE shows how Ambry is making it easier for providers to get actionable insights within their workflow, ultimately helping patients get the care they need."
A recent study published in the Journal of the National Comprehensive Cancer Network demonstrated that CARE interprets NCCN Guidelines with 99.5% accuracy, reinforcing its reliability as a trusted digital risk assessment tool for clinicians and patients.
Citius Oncology, Inc. (NASDAQ: CTOR) has established international access to LYMPHIR (denileukin diftitox-cxdl) through Named Patient Programs in Europe, South America and the Middle East, including an exclusive distribution agreement with Integris Pharma S.A. covering Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia. LYMPHIR, approved by the FDA in August 2024 for relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy, targets an initial U.S. market that management estimates exceeds $400 million and continues to grow.
"As we prepare to launch LYMPHIR in the U.S., expanding access to international markets through Named Patient Programs is both a patient-driven mission and a strategic opportunity for Citius Oncology," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "These programs allow us to serve patients who urgently need new treatment options, while also giving physicians valuable firsthand experience with LYMPHIR. Our recently signed exclusive distribution agreement with Integris Pharma S.A. further strengthens this effort, establishing a trusted partner to help us bring LYMPHIR to patients across Southern Europe and the Balkans."
The company is in active discussions with multiple prospective distribution partners across several European Union member states, South America, and select Middle Eastern territories, reflecting its commitment to positioning LYMPHIR for growth in key markets outside the United States. Named Patient Programs provide formally recognized pathways for physicians to request promising therapies on behalf of individual patients when no adequate approved alternatives exist, bridging the gap between clinical trial completion and broad market introduction while LYMPHIR remains available only through country-specific programs where permitted by local law.
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SOURCES CITED:
- https://www.sciencedaily.com/releases/2025/10/251003033909.htm
- https://www.sciencedaily.com/releases/2025/10/251001092214.htm
- https://www.openpr.com/news/4212200/cancer-treatment-market-to-surpass-usd-643-5-billion-by-2034
- https://www.mordorintelligence.com/industry-reports/cancer-therapy-market
- https://pmc.ncbi.nlm.nih.gov/articles/PMC12153701/
View original content:https://www.prnewswire.co.uk/news-releases/breakthrough-discoveries-unlock-643b-cancer-treatment-market-by-2034-302578503.html
