Functional Force: Precision Platforms Disrupt the 2026 Tumor Landscape

Issued on behalf of GT Biopharma, Inc.

VANCOUVER, BC, Jan. 16, 2026 /CNW/ -- Equity Insider News Commentary – The precision medicine sector is undergoing a structural realignment toward platform-based biologics, as the market prepares to surge from $138 billion this year to over $537 billion by 2035^[1]. This shift marks the end of "one-size-fits-all" treatments, as investors rotate capital into modular systems designed to hunt multiple cancer targets at once. This secular transition is creating massive opportunities for specialized platforms that can scale across high-prevalence killers like lung, breast, and pancreatic cancers, led by GT Biopharma, Inc. (NASDAQ: GTBP), ImmunityBio (NASDAQ: IBRX), Erasca, Inc. (NASDAQ: ERAS), NovaBridge Biosciences (NASDQ: NBP), and Coherus Oncology (NASDAQ: CHRS).

Biological cancer therapies anchored by NK-cell platforms and CAR-based modalities^[2] are projected to reach $225 billion by 2030, finally cracking the code on the "armored" microenvironments of solid tumors. Institutions are now positioning for an immuno-oncology expansion to $185.69 billion by 2035^[3] as the industry enters the "Immunotherapy 2.0" era. With next-generation bispecific antibody frameworks scaling from $11.29 billion toward $52.08 billion by 2035^[4], the 2026 clinical cycle is proving that the real value lies in the "code" of the platform itself.

GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company, recently announced that it submitted an investigational new drug application to the FDA in December 2025 for GTB-5550, a B7-H3-targeted natural killer cell engager designed to treat solid tumor cancers. The company develops next-generation immunotherapy treatments through its proprietary TriKE platform, which harnesses natural killer cells to attack cancer.

GTB-5550 represents GT Biopharma's third NK cell engager advancing toward clinical development, targeting B7-H3, a protein prevalent across breast, lung, ovarian, pancreatic, prostate, bladder, and head and neck cancers.

The therapy addresses a portion of the estimated $362 billion global solid tumor market according to Data Bridge Market Research. Designed as a subcutaneous injection administered in the abdominal area for five consecutive days during weeks one and two followed by two weeks off treatment, GTB-5550 offers potential for more patient-friendly dosing compared to continuous infusion schedules. The planned Phase 1 basket trial will evaluate GTB-5550 across seven distinct metastatic disease cohorts.

"The IND for GTB-5550 represents another NK cell engager we plan to move into clinical development and a tremendous accomplishment for the company," said Michael Breen, Executive Chairman and CEO of GT Biopharma. "As we continue actively enrolling the Phase 1 trial with GTB-3650 in myeloid blood cancer, we expect the next data readout in 1H 2026 could provide potential evidence of clinical activity. Initiation of a Phase 1 basket trial with GTB-5550 for multiple solid tumors is planned for 2026. We look forward to applying the clinical learnings from the GTB-3650 study to help inform the GTB-5550 program, which targets a patient population with B7-H3 expressing solid tumors that is orders of magnitude larger than the myeloid blood cancer patient population."

Meanwhile, GT Biopharma continues advancing its Phase 1 clinical trial of GTB-3650 to Cohort 4, where patients now receive 10μg/kg/day dosing. The trial evaluates GTB-3650 in patients with relapsed or refractory blood cancers expressing CD33, particularly acute myeloid leukemia and high-risk myelodysplastic syndrome. The six patients enrolled through Cohorts 1, 2, and 3 completed treatment successfully, establishing the therapy's safety profile with zero dose-limiting toxicities.

Both therapeutic candidates leverage GT Biopharma's proprietary TriKE platform utilizing specialized antibody fragments initially discovered in camels and llamas, providing advantages through compact size and enhanced stability.

GT Biopharma's dual-program advancement positions the company to address both blood cancers and solid tumors, potentially expanding its addressable patient population significantly as clinical data emerges throughout 2026.

CONTINUED… Read this and more news for GT Biopharma, Inc. at: 
https://equity-insider.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/

ImmunityBio (NASDAQ: IBRX) reports continued execution and sales momentum with preliminary net product revenue of approximately $113 million for fiscal year 2025, representing a 700% year-over-year increase for ANKTIVA. The commercial-stage biotechnology company delivered fourth quarter preliminary revenue of approximately $38.3 million, marking a 20% sequential increase and a 431% year-over-year improvement, while demonstrating 750% unit sales volume growth during 2025.

"We delivered strong quarter-over-quarter revenue growth, reflecting accelerating adoption of ANKTIVA and the continued execution of our commercial strategy," said Richard Adcock, President and CEO of ImmunityBio. "This momentum is further reinforced by the approval of ANKTIVA plus BCG in Saudi Arabia, building on existing approvals in the U.S. and U.K, as well as conditional approval in the EU."

ImmunityBio continues advancing its first-line NMIBC program, with enrollment in the ongoing Phase 2b QUILT-2.005 trial progressing ahead of internal expectations and full enrollment anticipated in the first half of 2026. The company ended the quarter with an estimated $242.8 million in cash, cash equivalents and marketable securities as of December 31, 2025.

Erasca, Inc. (NASDAQ: ERAS) announces promising data for ERAS-0015 with confirmed partial responses in multiple tumor types during dose escalation, demonstrating clinical activity at doses as low as 8 mg once daily. The clinical-stage precision oncology company reported encouraging early clinical activity coupled with favorable safety, tolerability, and well-behaved pharmacokinetics for its pan-RAS molecular glue, with the AURORAS-1 Phase 1 trial enrolling ahead of plan.

"During dose escalation, ERAS-0015 has already demonstrated promising early clinical activity with multiple ongoing confirmed and unconfirmed responses achieved, along with encouraging safety and tolerability data and well-behaved PK," said Jonathan E. Lim, M.D., Erasca's chairman, CEO, and co-founder. "We believe that observing first clinical responses in multiple patients at just 1/10th of the dose at which first clinical responses were observed with RMC-6236 is thesis-reinforcing in terms of ERAS-0015's potential differentiation."

Initial Phase 1 monotherapy data for ERAS-0015 is planned for the first half of 2026, with initiation of monotherapy expansion cohorts and combination dose escalation cohorts planned for the second half of 2026. Erasca expects to report monotherapy expansion data and combination dose escalation data during 2027.

NovaBridge Biosciences (NASDAQ: NBP) presents positive data from the Phase 1b combination study of givastomig with 77% ORR at 8 mg/kg and 73% ORR at 12 mg/kg in first-line HER2-negative metastatic gastric cancer patients. The global biotechnology platform company reported median progression-free survival of 16.9 months at 8 mg/kg, with the CLDN18.2 x 4-1BB bispecific antibody demonstrating robust efficacy when combined with nivolumab and mFOLFOX6 chemotherapy across wide ranges of PD-L1 and CLDN18.2 expression levels.

"The dose expansion data reinforce the strong signals we observed in dose escalation. The efficacy is clear at 8 mg/kg, with robust ORRs, including in subgroups defined by low PD-L1 and/or CLDN18.2 expression," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. "We remain enthusiastic about the 12 mg/kg dose because exposure analysis shows higher exposure is consistently associated with a higher probability of response, without a higher probability of toxicity."

NovaBridge is on track to initiate enrollment in a global, randomized Phase 2 study evaluating both doses against standard of care in Q1 2026. The combination was well tolerated with safety comparable to current standard of care treatment, with detailed Phase 1b dose expansion data expected to be presented at a medical conference later in 2026.

Coherus Oncology (NASDAQ: CHRS) announces publication in Molecular Cancer Therapeutics highlighting the strong pharmacology of investigational CCR8 antibody tagmokitug, formerly CHS-114. The commercial-stage innovative oncology company reported preclinical and clinical biomarker research demonstrating picomolar binding affinity, high selectivity for CCR8 with no off-target binding, and significant effector-mediated killing of CCR8+ cells, with the antibody selectively eliminating CCR8+ T regulatory cells while sparing other T cells.

"This publication presents the robust pharmacology of tagmokitug in preclinical and clinical studies, and with a selectivity profile and potent binding and killing of CCR8+ T regulatory cells and not other immune cells," said Theresa LaVallee, PhD, Chief Scientific and Development Officer at Coherus. "The data show a high abundance of CCR8 target expression in a broad range of solid tumors suggesting the promise of the tagmokitug program."

Tagmokitug is currently being evaluated in Phase 1b/2a clinical trials in patients with solid tumors in combination with toripalimab and chemotherapy. First-in-human clinical study data established proof of mechanism with translational data showing tagmokitug administration leads to selective reductions in CCR8+ Tregs and not other T cell subsets in cancer patients.

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

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SOURCES CITED:
1.   https://www.precedenceresearch.com/precision-medicine-market
2.   https://www.globenewswire.com/news-release/2026/01/14/3219034/0/en/BCC-Research-Forecasts-7-5-CAGR-for-Global-Biological-Cancer-Therapies-Market.html
3.   https://www.globenewswire.com/news-release/2026/01/14/3218904/0/en/The-185B-Cancer-Surge-Why-the-FDA-s-Fast-Track-Pivot-is-Scaling-a-New-Immunotherapy-Era.html
4.   https://www.precedenceresearch.com/next-generation-bispecific-antibody-market

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