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USA News Group News Commentary
Issued on behalf of GT Biopharma, Inc.
USA News Group News Commentary Biomarker-driven drug development accelerates across oncology as companies advance novel mechanisms targeting previously difficult populations, with recent clinical data demonstrating high response rates in molecularly defined patient subgroups while FDA priority reviews compress development timelines for innovative platforms1. Multi-cancer early detection blood tests have correctly identify two thirds of cancers with a single blood draw and pinpoint the original cancer site in 85% of cases, detecting over 50 cancer types including 47 that lack recommended screening today while simplifying diagnosis processes that traditionally require expensive tests or invasive biopsies2. This convergence of targeted protein degraders, early detection diagnostics, immune activation platforms, and bispecific antibodies positions GT Biopharma, Inc. (NASDAQ: GTBP), Nurix Therapeutics, Inc. (NASDAQ: NRIX), GRAIL, Inc. (NASDAQ: GRAL), C4 Therapeutics, Inc. (NASDAQ: CCCC), and Pfizer, Inc. (NYSE: PFE).
According to Precedence Research, the global precision oncology market reached $133 billion in 2025 and is predicted to surpass $312 billion by 2034, driven by increasing cancer prevalence and continuous advancement in genomic profiling techniques allowing more accurate and personalized therapies3. Regulatory agencies increasingly approve therapies for earlier disease stages while expanding patient populations through label expansions, creating favorable conditions for companies developing targeted degraders eliminating undruggable proteins, blood tests enabling intervention before symptoms appear, and combination strategies pairing novel mechanisms with established immunotherapy platforms4.
GT Biopharma, Inc. (NASDAQ: GTBP) is a clinical-stage biotechnology company headquartered in San Francisco that's focused on harnessing the power of the immune system to fight cancer. The firm is currently advancing innovative immunotherapy treatments designed to combat some of the most challenging cancer types, with recent progress showing promise in its ongoing Phase 1 clinical trial of GTB-3650. The company has successfully enrolled both patients in the trial's third dosing group (Cohort 3), with neither patient experiencing concerning side effects or dose-limiting toxicities thus far. GT Biopharma expects to commence treatment for Cohort 4 patients before the end of 2025, with further data releases planned for early 2026.
The Phase 1 study is testing GTB-3650 in patients battling relapsed or refractory blood cancers that express the CD33 protein, specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These represent some of the most difficult cancer cases to treat, involving patients whose disease either came back after initial therapy or never responded to conventional treatment options.
GTB-3650 works by stimulating the patient's natural killer cells, a type of immune cell that naturally hunts down and destroys abnormal cells, to specifically target cancer cells. Patients receive the therapy through continuous infusions following a structured schedule: two weeks of treatment followed by two weeks of rest, repeating this cycle for up to four months based on how they respond.
After thorough safety assessments, the company successfully advanced into Cohort 3 following formal reviews of the initial two patient cohorts that found no safety or tolerability issues. The early results are particularly encouraging based on biomarker data, objective biological measurements that indicate whether the drug is working as designed. Blood analysis from the first four patients revealed measurable increases in both natural killer cell activity and proliferation.
The initial patient in Cohort 3 has shown encouraging signs of immune activation at levels comparable to those seen in patients from the earlier, lower-dose cohorts. This biological response suggests GTB-3650 is functioning precisely as intended: activating the immune system and directing it to attack cancer cells.
The Phase 1 design calls for testing GTB-3650 in approximately 14 patients across seven cohorts, with two patients per cohort receiving progressively higher doses from 1.25μg/kg/day in Cohort 1 up to 100μg/kg/day in Cohort 7. The trial will continue escalating doses into higher ranges expected to translate immune activation into meaningful clinical benefits.
"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, the company is developing GTB-5550, which targets B7H3, a protein commonly found across various solid tumor types including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. GT Biopharma plans to file its regulatory application to begin human trials of GTB-5550 in the fourth quarter of 2025. GTB-5550 is being designed as a subcutaneous injection that patients might eventually self-administer at home.
Both candidates utilize GT Biopharma's proprietary TriKE platform technology, which employs specialized antibody fragments originally found in camels and llamas. These molecules offer advantages over conventional antibodies due to their smaller size and greater stability. The company holds an exclusive worldwide license from the University of Minnesota for this technology.
As of June 30, 2025, GT Biopharma reported approximately $5.3 million in cash and cash equivalents, with management projecting this capital would support operations through 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/
Nurix Therapeutics, Inc. (NASDAQ: NRIX) has outlined pivotal trial plans for bexobrutideg in relapsed/refractory chronic lymphocytic leukemia, reporting an 80.9% objective response rate in Phase 1a data presented at the Society of Hematologic Oncology 2025 Annual Meeting. The company reported third quarter 2025 revenue of $7.9 million and maintained a strong cash position of $428.8 million as of August 31, 2025.
"Nurix is preparing to initiate pivotal studies for bexobrutideg in relapsed/refractory CLL patients in the fourth quarter of 2025 and we have outlined our plans for potential accelerated approval with a single arm study as well as a confirmatory randomized control Phase 3 study for full approval," said Arthur T. Sands, M.D., Ph.D., CEO of Nurix Therapeutics. "With a strong wholly owned pipeline and world-class partnerships, Nurix is well positioned to establish degrader-based medicines as a new standard of care in both cancer and autoimmune diseases."
The company's pipeline advancement includes preclinical data for GS-6791, an IRAK4 degrader developed in collaboration with Gilead Sciences, presented at the European Academy of Dermatology and Venereology 2025 Congress. Nurix continues to advance its autoimmune disease programs, including a STAT6 degrader with Sanofi currently in IND-enabling studies.
GRAIL, Inc. (NASDAQ: GRAL) has announced a strategic collaboration with Samsung C&T and Samsung Electronics to commercialize its Galleri multi-cancer early detection test across key Asian markets. Samsung C&T and Samsung Electronics will invest $110 million into GRAIL at $70.05 per share, with Samsung C&T serving as the exclusive distributor in South Korea, with potential expansion to Japan and Singapore.
"We look forward to partnering with Samsung to bring multi-cancer early detection to Asia, beginning in South Korea," said Sir Harpal Kumar, President, International Business & Biopharma, at GRAIL. "Samsung's significant equity investment strengthens our balance sheet and provides further cash runway as we advance through key milestones to secure reimbursement for Galleri in the U.S. and key international markets."
The Galleri test can detect more than 50 types of cancer with a simple blood draw before symptoms appear, doubling the number of cancers detected when added to standard screening protocols. The investment is subject to execution of definitive collaboration agreements and is expected to close in early 2026, with commercial operations beginning soon after.
C4 Therapeutics, Inc. (NASDAQ: CCCC) has entered into a clinical trial collaboration with Pfizer Inc. (NYSE: PFE) to evaluate the combination of cemsidomide and elranatamab for treating relapsed/refractory multiple myeloma. Under the agreement, Pfizer will supply elranatamab (ELREXFIO), a BCMAxCD3 targeted bispecific antibody, at no cost for C4 Therapeutics' upcoming Phase 1b trial expected to initiate in Q2 2026.
"We look forward to initiating this trial to evaluate cemsidomide in combination with elranatamab in the hopes we can develop a new treatment regimen and potentially improve outcomes for multiple myeloma patients in earlier lines of therapy," said Andrew Hirsch, CEO of C4 Therapeutics. "Our supply agreement with Pfizer creates an opportunity for cemsidomide to be combined with elranatamab, which is on the path to potentially becoming a standard of care BCMAxCD3 bispecific in a growing market."
The Phase 1b trial will evaluate cemsidomide, an IKZF1/3 degrader, combined with dexamethasone and elranatamab as second-line or later therapy, seeking to establish an optimal dose for the combination. Data from the cemsidomide Phase 1 trial demonstrated robust T-cell activation and cytokine expression, suggesting the combination may amplify anti-myeloma immune response when paired with BCMAxCD3 bispecific antibodies.
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.prnewswire.com/news-releases/next-generation-targeted-therapies-reshape-precision-oncology-landscape-302584906.html
- https://www.nihr.ac.uk/news/new-blood-test-finds-two-thirds-cancers
- https://www.precedenceresearch.com/precision-oncology-market
- https://www.grandviewresearch.com/industry-analysis/precision-oncology-market-report
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