Clinical Breakthroughs Converge as Immunotherapy Market Surges Past $136 Billion

Issued on behalf of GT Biopharma, Inc.

Vancouver, BC – October 6, 2025 – USA News Group News Commentary – Major pharmaceutical companies are unveiling breakthrough cancer data at the European Society for Medical Oncology Congress taking place October 17-21 in Berlin^[1], while the global cancer immunotherapy market reached $137.70 billion in 2024 and analysts project explosive growth toward $261.74 billion by 2033^[2]. The timing reflects a critical inflection point as HHS doubled federal funding for its Childhood Cancer Data Initiative from $50 million to $100 million, while researchers discovered how cancer uses a hidden hormone to shield itself from immune attack^[3]. Against this backdrop of scientific momentum and institutional capital deployment, clinical-stage immunotherapy developers including GT Biopharma, Inc. (NASDAQ: GTBP), Leap Therapeutics, Inc. (NASDAQ: LPTX), IO Biotech (NASDAQ: IOBT), Celcuity Inc. (NASDAQ: CELC), and MAIA Biotechnology, Inc. (NYSE-American: MAIA).

With eight new oncology approvals issued from July through September^[4] and regulatory agencies accelerating approval pathways through breakthrough therapy designations, institutional forecasters at Precedence Research project the market will expand at a 10.65% CAGR through 2034^[5] as long-term survival data validates immunotherapy durability. The convergence of rising disease burden, proven efficacy across cancer types, and expanded federal research support creates favorable conditions for early-positioned companies with differentiated mechanisms advancing through clinical milestones before broader institutional recognition materializes.

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 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/

Leap Therapeutics, Inc. (NASDAQ: LPTX) are set to present final clinical results from Part B of the DeFianCe study at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin, Germany. The Phase 2 study evaluated sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy compared to bevacizumab and chemotherapy alone in patients with advanced microsatellite stable colorectal cancer who received one prior systemic therapy for advanced disease.

The final results will be presented in a Mini Oral Session on October 19, 2025 at 4:05 p.m. CEST, with the presentation providing detailed efficacy and safety data from the second-line treatment cohort. Leap Therapeutics‘ pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 protein, as the company continues developing targeted and immuno-oncology therapeutics for solid tumor indications.

IO Biotech (NASDAQ: IOBT) announced that the U.S. Food and Drug Administration has recommended against submitting a Biologics License Application based on data from the IOB-013 clinical trial, in which Cylembio plus pembrolizumab improved progression free survival but narrowly missed statistical significance. The company is implementing a restructuring that includes an approximate 50 percent reduction in full-time employees and expects to incur a non-recurring charge of between $1.0 million and $1.5 million in the third quarter of 2025.

“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. Additionally, we plan to discuss the data from our IOB-013 study with European regulators and determine a path to submission in the EU.”

The company plans to design a new registrational study for Cylembio for the treatment of first-line patients with advanced melanoma and currently has capital to run its operations into the first quarter of 2026. IO Biotech is pursuing a pathway to regulatory approval while working to complete ongoing studies of its immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate.

Celcuity Inc. (NASDAQ: CELC) will present detailed efficacy and safety data from the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 trial at the European Society of Medical Oncology Congress 2025 in Berlin, Germany. The late breaking abstract has been selected for an oral presentation on October 18, 2025 at 10:15 a.m. CEST in a Proffered Paper Session, with the presentation covering results from gedatolisib plus fulvestrant with or without palbociclib versus fulvestrant in patients with HR+/HER2-/PIK3CA wildtype advanced breast cancer.

The VIKTORIA-1 trial has completed enrollment and reported topline data for the PIK3CA wild-type cohort, while the company continues enrolling patients for the PIK3CA mutant cohort. Celcuity is also conducting its VIKTORIA-2 Phase 3 trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer, along with a Phase 1/2 trial combining gedatolisib with darolutamide in metastatic castration resistant prostate cancer patients.

MAIA Biotechnology, Inc. (NYSE American: MAIA) has been awarded a $2.3 million grant by the National Institutes of Health for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer. The grant, to be distributed over three years from 2025-2027, will support expenses related to enrollment of U.S. patients who are resistant to chemotherapy and immunotherapy, with Parts A and B of THIO-101 demonstrating median overall survival of 17.8 months for 22 patients in third-line treatment compared to 5 to 6 months for standard-of-care chemotherapy treatments.

“We are thrilled to receive this prestigious NIH grant for the expansion of our Phase 2 trial,” said Vlad Vitoc, M.D., CEO of MAIA Biotechnology. “It’s a great honor to have the support of the National Institutes of Health as we seek to further validate the efficacy of our lead agent ateganosine and its potential to be a breakthrough treatment within the vastly underserved NSCLC market. With the clearance of FDA Investigational New Drug (IND) for THIO-101 in 2023, we can begin enrolling U.S. patients in the expansion phase of the trial immediately.”

The first patient in the expansion of the trial was dosed in July 2025 in Taiwan, with the NIH grant enabling MAIA to access a substantially larger patient pool across multiple continents. Ateganosine is a first-in-class investigational telomere-targeting agent that induces telomerase-dependent telomeric DNA modification and activates both innate and adaptive immune responses, currently being developed as a second or later line of treatment for NSCLC patients who have progressed beyond standard-of-care checkpoint inhibitor regimens.

Article Sources: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/

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