Precision's Payoff: Targeted Therapies Drive $131B Solid Tumor Market Surge

VANCOUVER, British Columbia, Dec. 24, 2025 (GLOBE NEWSWIRE) -- Equity Insider News Commentary – The U.S. oncology market is projected to surge from $81 billion in 2025 to $212 billion by 2034^[1], driven by a fundamental shift in how physicians combat cancer's most resistant forms. Targeted therapies and immunotherapies are increasingly offering viable alternatives to chemotherapies that have stood for decades as treatment mainstays^[2], replacing blunt cytotoxic approaches with precision mechanisms that attack cancer cells while preserving healthy tissue. This pivot toward precision efficacy drives the investment thesis for GT Biopharma, Inc. (NASDAQ:GTBP), Lyell Immunopharma, Inc. (NASDAQ:LYEL), Caribou Biosciences, Inc. (NASDAQ:CRBU), SELLAS Life Sciences Group, Inc. (NASDAQ:SLS), and Nurix Therapeutics, Inc. (NASDAQ:NRIX).

The pancreatic cancer precision medicine market alone is predicted to surge from $823 million in 2025 to $4.03 billion by 2034^[3], reflecting aggressive capital deployment toward previously untreatable indications. Functional Precision Medicine platforms now combine AI-driven drug testing with live tumor cells to deliver actionable treatment results within days^[4], replacing population-based guesswork with evidence-based targeting that improves response rates and extends survival across solid tumor categories.

GT Biopharma, Inc. (NASDAQ:GTBP), a clinical-stage immuno-oncology company, recently reported advancing its Phase 1 clinical trial of GTB-3650 to Cohort 4, where patients now receive 10μg/kg/day dosing. The company specializes in developing next-generation immunotherapy treatments targeting some of the world's most resistant cancer types through its proprietary natural killer cell engager TriKE platform.



GT Biopharma's Phase 1 dose escalation trial evaluates GTB-3650 in patients facing relapsed or refractory blood cancers expressing CD33, particularly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These cancers represent exceptionally challenging cases where conventional treatments have either failed completely or provided only temporary benefit before disease returned.

The therapy harnesses the patient's natural killer cells, an immune cell type that instinctively identifies and eliminates abnormal cells, directing them to attack cancer specifically. Treatment delivery follows a continuous infusion schedule structured as two-week treatment periods followed by two-week rest intervals, with cycles continuing up to four months depending on individual patient response.

"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 throughout Cohorts 1, 2, and 3 have completed GTB-3650 treatment successfully, establishing the therapy's safety profile across escalating dose concentrations. GT Biopharma indicates the current Cohort 4 dose of 10μg/kg/day represents a threshold where clinical efficacy becomes more likely, supported by encouraging immunological biomarker trends and zero dose-limiting toxicities across all completed cohorts.

The first-in-human Phase 1 protocol plans for approximately 14 patients distributed across seven cohorts, with each cohort enrolling two patients at progressively increasing doses starting from 1.25μg/kg/day in Cohort 1 and potentially reaching 100μg/kg/day in Cohort 7 if warranted. Following Cohort 4, three additional escalation levels remain: Cohort 5 testing 25μg/kg/day, Cohort 6 evaluating 50μg/kg/day, and Cohort 7 examining the maximum protocol dose of 100μg/kg/day. The company anticipates providing its next comprehensive trial update during first quarter 2026.

Beyond hematologic malignancies, GT Biopharma is advancing GTB-5550, targeting B7H3, a protein prevalent across multiple solid tumor categories including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. Regulatory submission to initiate GTB-5550 human trials is expected in late December 2025 or January 2026.

Designed as a subcutaneous injection, GTB-5550 offers the potential for eventual self-administration at home, significantly reducing patient burden.

Both therapeutic candidates leverage GT Biopharma's proprietary TriKE platform utilizing specialized antibody fragments initially discovered in camels and llamas. These molecules provide distinct advantages compared to traditional antibodies through their compact size and enhanced stability. GT Biopharma maintains exclusive worldwide licensing rights from the University of Minnesota for this technology.

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Lyell Immunopharma (NASDAQ:LYEL) presented positive data showing rondecabtagene autoleucel (ronde-cel) achieved 93% overall response, 76% complete response, and 18-month median progression-free survival in third-line or later large B-cell lymphoma. In second-line patients, predominantly primary refractory, ronde-cel demonstrated 83% overall response and 61% complete response, with 70% maintaining response at six months or longer. The allogeneic anti-CD19 CAR-T therapy showed no high-grade cytokine release syndrome and less than or equal to 5% Grade 3 or higher immune effector cell-associated neurotoxicity syndrome.

"These data from the ongoing clinical trial showing high rates of durable complete responses along with a manageable safety profile in patients with high-risk large B-cell lymphoma represent the potential of ronde-cel to improve patient outcomes," said Mehdi Hamadani, MD, Professor of Medicine at Medical College of Wisconsin. "The two pivotal trials underway, including the first-of-its kind head-to-head CAR T-cell trial, are expected to provide a comprehensive and robust evaluation of the potential for ronde-cel to demonstrate differentiated benefit over approved CD19 CAR T-cell therapies."

Lyell initiated PiNACLE – H2H, a Phase 3 head-to-head trial versus approved CAR-T therapies in second-line disease. The FDA granted Regenerative Medicine Advanced Therapy designation in both third-line and second-line settings.

Caribou Biosciences (NASDAQ:CRBU) announced positive Phase 1 results showing vispacabtagene regedleucel (vispa-cel), an allogeneic anti-CD19 CAR-T therapy, achieved 82% overall response, 64% complete response and 51% progression-free survival at 12 months in second-line large B-cell lymphoma patients. An optimized profile cohort of 35 patients demonstrated 86% overall response, 63% complete response and 53% progression-free survival at 12 months, with the longest responding patient maintaining complete response at three years. The therapy showed manageable safety with no graft-versus-host disease, no Grade 3 or higher immune effector cell-associated neurotoxicity syndrome, and less than 5% Grade 3 or higher cytokine release syndrome.

"This clinical dataset demonstrates vispa-cel's efficacy and durability are comparable to autologous CAR-T therapies, yet its off-the-shelf availability and favorable tolerability profile make it well suited for outpatient administration at both large academic centers and sophisticated community hospitals," said Mehdi Hamadani, MD, Professor of Medicine at Medical College of Wisconsin.

Caribou plans a pivotal Phase 3 randomized trial evaluating approximately 250 patients in second-line large B-cell lymphoma. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy, Orphan Drug and Fast Track designations for B-cell non-Hodgkin lymphoma.

SELLAS Life Sciences Group (NASDAQ:SLS) presented positive Phase 2 data of SLS009, a highly selective CDK9 inhibitor, combined with azacitidine and venetoclax for relapsed or refractory acute myeloid leukemia with myelodysplastic syndrome-related changes following prior venetoclax-based treatment. The combination achieved a 46% overall response rate across all cohorts and 58% in patients with one prior line of therapy, with median overall survival reaching 8.9 months in the least pretreated cohort versus a historical benchmark of approximately 2.5 months. Among 35 evaluable patients with a median age of 69 years, 98% had adverse-risk AML with frequent ASXL1, RUNX1, TP53, and SRSF2 mutations.

"These results further reinforce the therapeutic potential of SLS009 to overcome resistance to venetoclax-based regimens by suppressing the expression of MCL-1, a key mechanism of resistance to BCL-2 inhibition in AML," said Dr. Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS. "The combination of SLS009 with azacitidine and venetoclax demonstrates encouraging activity in a heavily pretreated population with adverse-risk AML-MR, including those harboring ASXL1 and TP53 mutations."

SELLAS plans to expand the study in Q1 2026 to evaluate SLS009 plus azacitidine and venetoclax in newly diagnosed AML patients with high-risk features. The company's lead product candidate GPS targets the WT1 protein across multiple hematologic malignancies and solid tumor indications.

Nurix Therapeutics (NASDAQ:NRIX) presented new clinical data from its Phase 1 trial of bexobrutideg, a Bruton's tyrosine kinase degrader, in patients with relapsed or refractory Waldenström macroglobulinemia at the 67th American Society of Hematology Annual Meeting. The study demonstrated a 75% objective response rate including three very good partial responses in heavily pretreated patients with a median age of 71 years and median of three prior lines of therapy, with median duration of response and progression-free survival not reached at a median follow-up of 8.1 months. Among 31 patients treated at doses ranging from 200mg to 600mg once daily, 77% had MYD88 mutations and 19% had CXCR4 mutations, with responses observed regardless of baseline mutations.

"Collectively, these clinical data and recent data highlighting the unique properties of our potent and highly selective BTK degrader contribute to a growing body of evidence that support bexobrutideg's potential to be the best-in-class and an important new therapeutic option for patients," said Arthur T. Sands, CEO of Nurix Therapeutics. "We believe bexobrutideg is an innovative therapy with the potential to transform care in CLL, WM, and additional NHL indications, while supporting long-term value creation as its development expands into inflammatory and autoimmune settings."

Bexobrutideg was well tolerated with no dose-limiting toxicities, no grade 5 adverse events, and no new onset atrial fibrillation observed. Nurix is currently evaluating bexobrutideg in the DAYBreak CLL-201 pivotal Phase 2 trial for relapsed or refractory chronic lymphocytic leukemia and continues enrollment in multiple Phase 1 studies across B-cell malignancies.

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.prnewswire.com/news-releases/platform-technologies-drive-211b-surge-in-precision-cancer-treatment-302639367.html
2. https://www.prnewswire.com/news-releases/studies-point-to-a-growing-role-for-new-therapies-and-immunotherapies-in-treating-blood-cancers-302634658.html
3. https://www.precedenceresearch.com/pancreatic-cancer-precision-medicine-market
4. https://www.bio-itworld.com/news/2025/12/11/rethinking-precision-oncology-in-the-age-of-functional-data