Issued on behalf of GT Biopharma, Inc.
VANCOUVER, BC, Dec. 11, 2025 /PRNewswire/ -- Equity Insider News Commentary – November's wave of FDA oncology approvals signals the industry's shift toward platform-based precision therapies over broad-spectrum approaches[1]. The global anticancer drug market now values immunotherapies at over 45% of total cancer drug revenues, reflecting investor confidence in technologies that engineer specific biological outcomes[2]. Companies deploying proprietary platforms to target previously undruggable proteins are capturing premium valuations as the sector pivots toward modularity and rapid reuse of validated mechanisms, creating momentum for
GT Biopharma, Inc. (NASDAQ: GTBP),
Erasca, Inc. (NASDAQ: ERAS),
Foghorn Therapeutics Inc. (NASDAQ: FHTX),
OmniAb, Inc. (NASDAQ: OABI), and
Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX).
The U.S. oncology market is projected to surge from $81 billion in 2025 to $212 billion by 2034, with monoclonal antibodies and cell therapies leading growth at double-digit rates[3]. Platform technologies now account for 60% of total pharma projected pipeline value, creating optimal conditions for companies with validated platforms to capture multiple therapeutic opportunities while reducing development timelines[4].
GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company, recently reported continued progress with its Phase 1 clinical trial of GTB-3650, which has now advanced into Cohort 4 at a dose level of 10μg/kg/day. The company is developing innovative immunotherapy treatments designed to combat some of the world's most challenging cancer types using its proprietary natural killer cell engager TriKE platform technology.
The Phase 1 dose escalation study is evaluating 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.
"We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day," said Michael Breen, Executive Chairman and CEO. "We look forward to assessing higher doses, as we are now approaching the efficacy range predicted by preclinical in vivo leukemia models, and we plan to share the next trial update in the first quarter of 2026."
The six patients enrolled across Cohorts 1 through 3 have all been successfully treated with GTB-3650, demonstrating the therapy's tolerability at progressively higher dose levels. According to the company, the Cohort 4 dose level of 10μg/kg/day is more reflective of the potential clinical efficacy threshold based on positive trends observed across multiple immunological biomarkers and the complete absence of dose-limiting toxicities throughout all three completed cohorts.
The Phase 1 first in human trial 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 if necessary. Beyond Cohort 4, three additional higher-dose cohorts remain available: Cohort 5 at 25μg/kg/day, Cohort 6 at 50μg/kg/day, and Cohort 7 at the maximum planned dose of 100μg/kg/day. The company plans to provide the next trial update in the first quarter of 2026.
Beyond blood cancers,
GT Biopharma 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. The company expects to submit its regulatory application to begin human trials of GTB-5550 in late December 2025 or January 2026.
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.
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Erasca, Inc. (NASDAQ: ERAS) secured U.S. patent protection through 2043 for ERAS-0015, its potential best-in-class pan-RAS molecular glue, while strengthening scientific leadership with the promotion of Robert Shoemaker, Ph.D., to chief scientific officer. The clinical-stage precision oncology company reported $362 million in cash, cash equivalents, and marketable securities as of September 30, 2025, providing a runway into the second half of 2028.
"Clinical development of ERAS-0015 and our potential best-in-class pan-KRAS inhibitor ERAS-4001 is on track, with initial Phase 1 monotherapy data for both ERAS-0015 and ERAS-4001 expected in 2026," said Jonathan E. Lim, M.D., CEO of
Erasca. "With a strong balance sheet and a cash runway into the second half of 2028, we are well-positioned to drive our programs forward and deliver new therapeutic options with the potential to address high unmet needs of patients with RAS-driven cancers."
The company's RAS-targeting franchise continues advancing toward multiple clinical milestones, with both ERAS-0015 and ERAS-4001 progressing through Phase 1 trials in patients with RAS/KRAS-mutant solid tumors.
Erasca reported a net loss of $30.6 million for the third quarter ended September 30, 2025, compared to $31.2 million in the prior year period.
Foghorn Therapeutics Inc. (NASDAQ: FHTX) advanced its wholly-owned selective degrader portfolio with its Selective CBP degrader entering non-GLP toxicology studies in Q4 2025 and progressing toward IND-readiness in 2026 for potential treatment of EP300-mutant cancers and ER+ breast cancer.
"Momentum is strong for our wholly-owned, first-in-class selective degrader programs targeting CBP, EP300 and ARID1B with program updates highlighted during our recent virtual investor event," said Adrian Gottschalk, CEO of
Foghorn. "Our Selective CBP degrader, with potential in ER+ breast cancer, entered non-GLP toxicology studies in Q4 2025 and is advancing towards IND in 2026, and our Selective EP300 degrader continues to show broad spectrum efficacy across hematological malignancies and favorable tolerability in preclinical studies, differentiating it from dual CBP/EP300 approaches."
Foghorn's Selective EP300 degrader demonstrated robust preclinical anti-tumor activity across over 70% of hematological sub-lineages tested with favorable tolerability including no significant thrombocytopenia, while its Selective ARID1B degrader is advancing toward in vivo proof of concept in 2026 with relevance in up to 5% of solid tumors including endometrial, gastric, gastroesophageal junction, bladder, and non-small cell lung cancer. The company reported collaboration revenue of $8.2 million for the third quarter ended September 30, 2025, compared to $7.8 million in the prior year period, with a net loss of $15.8 million.
OmniAb, Inc. (NASDAQ: OABI) reported Q3 2025 revenue of $2.2 million as the antibody discovery platform company continued expanding its partnered pipeline with 104 active partners and 399 active programs, including 32
OmniAb-derived programs in clinical development or being commercialized as of September 30, 2025. The company maintained $59.5 million in cash and investments while advancing multiple partner oncology programs, including
Immunovant's batoclimab showing 80% response rates in Graves' disease patients and
Arcus Biosciences' zimberelimab demonstrating 26.7 months median overall survival in gastroesophageal cancer.
"Throughout the third quarter we continued to execute on our strategic initiatives while further demonstrating the value of our proprietary technology platform to a growing base of partners," said Matt Foehr, CEO of
OmniAb. "In August we completed a private placement and strengthened our balance sheet while continuing to expand our suite of leading-edge technologies. We look forward to next month's launch of OmniUltra™, an important new technology that we expect will expand our platform and open new business opportunities."
OmniAb plans to launch its new OmniUltra™ transgenic chicken platform in December 2025 at the Antibody Engineering & Therapeutics conference, featuring cow-like antibodies with exceptionally long complementarity-determining regions. Partner highlights included
Aptevo Therapeutics reporting 100% remission rates with mipletamig in acute myeloid leukemia and
CStone Pharmaceuticals securing European approval recommendations for sugemalimab in non-small cell lung cancer.
Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX) delivered positive Phase 1b/2 results from its TUPELO trial of REC-4881, an investigational allosteric MEK1/2 inhibitor for familial adenomatous polyposis, with 75% of evaluable patients showing reductions in total polyp burden and a 43% median reduction after 12 weeks of treatment. Notably, 82% of evaluable patients maintained durable reductions at Week 25—12 weeks after stopping therapy—with a 53% median decrease from baseline, marking the first clinical validation of the
Recursion OS platform.
"These Phase 2 results mark a meaningful validation of the Recursion OS," said Chris Gibson, Ph.D., CEO of
Recursion. "An unbiased phenotypic insight from our platform and driven by AI—linking MEK1/2 inhibition to APC loss-of-function biology—has now translated into rapid, substantial, and durable reductions in polyp burden in patients. This is a powerful example of how even the earliest versions of the
Recursion OS can uncover therapeutic opportunities in diseases with no approved pharmacotherapy options."
The TechBio company plans to engage the
FDA in the first half of 2026 to define a potential registration pathway while expanding the trial population from ≥55 to ≥18 years old and optimizing the dosing schedule. REC-4881 demonstrated a safety profile consistent with MEK1/2 inhibition, with the majority of treatment-related adverse events being Grade 1 or 2, Grade 3 events occurring in 15.8% of safety-evaluable patients, and no Grade ≥4 events reported to date.
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