Issued on behalf of GT Biopharma, Inc.
VANCOUVER – Baystreet.ca News Commentary – Researchers at Ohio State University just unlocked why many cancer immunotherapies fail, identifying a protein stress pathway that can be blocked to restore immune cell function and dramatically improve treatment outcomes[1]. This breakthrough arrives as the ESMO Congress 2025 prepares to showcase pivotal late-breaking abstracts that could reshape cancer treatment across multiple tumor types[2], while scientists at UC Irvine demonstrated a pan-cancer immunotherapy that destroys diverse tumors without harming healthy tissue[3]. The convergence of immune system insights, and precision targeting mechanisms is creating unprecedented opportunities for biotech innovators including GT Biopharma, Inc. (NASDAQ: GTBP), Celcuity Inc. (NASDAQ: CELC), Bolt Biotherapeutics (NASDAQ: BOLT), Kazia Therapeutics Limited (NASDAQ: KZIA), and GRAIL, Inc. (NASDAQ: GRAL).
The global cancer immunotherapy market is projected to reach $261.74 billion by 2033, expanding at 7.9% annually[4], driven by accelerating FDA approvals and September's wave of breakthrough therapy designations spanning novel immune cell therapies and antibody-drug conjugates[5]. With October's ESMO Congress positioning companies presenting pivotal Phase 3 data ahead of regulatory submissions and emerging discoveries showing common supplements can supercharge T-cell tumor-fighting power[6], early-positioned oncology firms stand to capture outsized gains as institutional capital flows toward clinical-stage innovators delivering tangible patient outcomes.
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 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/
Celcuity Inc. (NASDAQ: CELC) will present pivotal Phase 3 data from its VIKTORIA-1 trial at the 2025 European Society for Medical Oncology (ESMO) Congress in a late-breaking oral presentation scheduled for October 18, 2025. The presentation will provide detailed efficacy and safety data from the PIK3CA wild-type cohort evaluating gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor, in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer.
The company has completed enrollment and reported topline data for the PIK3CA wild-type cohort while currently enrolling patients for the PIK3CA mutant cohort of VIKTORIA-1. Celcuity is also advancing VIKTORIA-2, a Phase 3 trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer.
Bolt Biotherapeutics (NASDAQ: BOLT) announced it is modifying its clinical trial protocol for BDC-4182 to implement step-up dosing following strong immune responses observed at initial dose levels in its Phase 1 dose escalation study. The company now expects to report initial clinical data for BDC-4182, a next-generation Boltbody ISAC clinical candidate targeting claudin 18.2, in the third quarter of 2026 and is implementing a 50% workforce reduction to extend its cash runway into 2027.
"Amid challenging market conditions, our strategic imperative is the clinical advancement of BDC-4182 and the support of our ISAC collaborations to increase shareholder value," said Willie Quinn, President and CEO. "We look forward to continuing our mission and to providing updates on BDC-4182 later next year."
BDC-4182 is currently being evaluated in patients with gastric and gastroesophageal cancer, and the step-up dosing approach has been successfully used commercially for T-cell engagers. The company is also seeking to partner its Dectin-2 agonist BDC-3042, which recently completed a first-in-human Phase 1 dose escalation trial.
Kazia Therapeutics Limited (NASDAQ: KZIA) reported that paxalisib achieved complete disruption of circulating tumor cell clusters in blood samples from Stage IV HER2-positive metastatic breast cancer patients in an ex vivo study led by Professor Sudha Rao at QIMR Berghofer. The investigational PI3K-mTOR inhibitor demonstrated 100% disruption of CTC clusters containing three or more cells and achieved statistically significant reductions in single circulating tumor cells, which are biomarkers of aggressive disease and metastasis.
"This monotherapy ex-vivo result extends our understanding of paxalisib's potential beyond triple-negative breast cancer into HER2-positive disease," said Dr. John Friend, CEO of Kazia Therapeutics. "The ability to disrupt circulating tumor cell clusters, which are strongly associated with metastasis and poor prognosis, represents a transformative therapeutic avenue."
These findings complement Kazia's ongoing Phase 1b trial in Stage IV triple-negative breast cancer, where initial patient data announced in July 2025 demonstrated significant reductions in circulating tumor cells and clusters. Detailed datasets encompassing metastatic signatures and disrupted progenitor populations in Stage IV HER2-positive breast cancer have been submitted for presentation at an upcoming global oncology meeting in 2025.
GRAIL, Inc. (NASDAQ: GRAL) will present new Galleri data from more than 32,000 participants across its PATHFINDER 2, SYMPLIFY, and REFLECTION studies at ESMO Congress 2025 and the Early Detection of Cancer Conference. First results from the registrational PATHFINDER 2 study, the largest multi-cancer early detection interventional study conducted in the U.S., have been accepted as a late-breaking presentation at ESMO and will be submitted to the FDA as part of the Galleri Premarket Approval Application.
"Galleri is the only available MCED test with demonstrated performance in an intended use population being screened for cancer," said Josh Ofman, MD, MSHS, President of GRAIL. "These new data build on the results from our first clinical implementation study, PATHFINDER, which was published in the Lancet in 2023, and showed that Galleri approximately doubled the number of cancers identified when added to standard of care screening. We're witnessing the beginning of a transformative era for cancer screening, with these results demonstrating Galleri's ability to detect cancers earlier, when they can be easier to treat and are potentially curable."
The Galleri multi-cancer early detection test can detect more than 50 types of cancer before symptoms appear with a simple blood test and has demonstrated the lowest false positive rate of any MCED test. Top-line results from evaluable PATHFINDER 2 participants showed that adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection and substantially higher positive predictive value than observed in the first PATHFINDER study.
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.sciencedaily.com/releases/2025/10/251003033909.htm
2. https://www.onclive.com/view/inside-the-most-anticipated-lung-cancer-abstracts-what-to-expect-from-esmo-2025
3. https://medicalxpress.com/news/2025-09-unique-pan-cancer-immunotherapy-destroys.html
4. https://www.openpr.com/news/4211860/cancer-immunotherapy-market-size-to-reach-us-261-74-billion
5. https://www.targetedonc.com/view/september-2025-fda-roundup
https://www.sciencedaily.com/releases/2025/10/251001092214.htm
