Cellular Immunotherapy Breakthroughs Fuel $370 Billion Market Surge

Equity Insider News Commentary

Issued on behalf of GT Biopharma, Inc.

VANCOUVER, BC, Oct. 15, 2025 /PRNewswire/ -- Eight new oncology approvals between July and September 2025 marked a pivotal quarter for cancer treatment^[1], as cellular immunotherapy platforms continue redefining treatment paradigms for hematologic malignancies and expanding into solid tumors^[2]. Recent innovations including CAR-NK cells, CAR-Treg cells, and in vivo CAR-T approaches are solving manufacturing challenges^[3] while outpatient CAR-T centers now deliver advanced therapies that previously required lengthy hospital stays^[4]. Alternative drug delivery methods and targeted therapy approvals for lung cancer, breast cancer, and multiple myeloma demonstrate how precision oncology tools are accelerating patient access to breakthrough treatments^[1]. These advances position GT Biopharma, Inc. (NASDAQ: GTBP), CytoMed Therapeutics Limited (NASDAQ: GDTC), Plus Therapeutics, Inc. (NASDAQ: PSTV), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), and I-Mab (NASDAQ: IMAB).

The global cancer immunotherapy market is projected to reach $370 billion by 2033^[5], expanding at a 17.5% CAGR, driven by rapid adoption of checkpoint inhibitors and a rich pipeline of CAR T-cell therapy candidates addressing blood cancers and solid tumors^[6].

GT Biopharma, Inc. (NASDAQ:GTBP) is a San Francisco-based clinical-stage immunotherapy company making significant strides in developing innovative treatments for difficult-to-treat cancers. The biotech firm recently announced encouraging progress in its Phase 1 trial of GTB-3650, with both patients in Cohort 3 successfully initiating treatment without any evidence of dose-limiting toxicities or safety concerns to date. The company is now well-positioned with enrollment momentum 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 evaluating 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 particularly challenging patient populations whose cancers have either returned after initial treatment or never responded to standard therapies. The drug operates by activating the body's own natural killer cells to attack cancer cells. Treatment is administered through continuous infusions in two-week cycles, alternating two weeks on and two weeks off, for up to four months depending on patient response.

Following comprehensive safety reviews, the company successfully moved into Cohort 3 after formal evaluation of the first two patient groups revealed no safety or tolerability problems. What makes the early data particularly noteworthy is the compelling biomarker evidence. Multiple blood tests from the first four patients showed measurable increases in natural killer cell activity and expansion. Additionally, the first patient in Cohort 3 has demonstrated promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts. This biological evidence suggests the drug is performing exactly as intended—awakening the immune system and directing it against cancer cells.

The Phase 1 protocol allows for evaluation of GTB-3650 in up to approximately 14 patients, with two patients enrolled 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 progressing toward clinical testing. GTB-5550 targets B7H3, a protein 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 self-administer 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.

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CytoMed Therapeutics Limited (NASDAQ:GDTC) has submitted a cash bid to acquire potentially synergistic assets from TC BioPharm Limited, marking the Singapore-based company's second strategic acquisition within approximately one year. The proposed acquisition targets TCBL's donor-derived allogeneic gamma delta T cell assets, complementing CytoMed's ongoing Phase I ANGELICA Trial evaluating its proprietary CAR T cells for liquid and solid cancers.

"Based on our data, we believe there is encouraging potential in using donor-derived gamma delta T cells for cancer treatment," said Peter Choo, Chairman of CytoMed. "Our collaborator, MD Anderson Cancer Center, recently published a paper highlighting the promise of this approach. We believe that this allogeneic therapy is also safe in high doses and is cost-effective to manufacture at scale."

The acquisition will be funded through internal resources and follows CytoMed's October 2024 acquisition of one of only three licensed cord blood banks in Malaysia, providing cost-free raw materials for cord blood-derived therapeutics. The company aims to leverage Southeast Asia's low-cost infrastructure to develop affordable T effector cell therapies for patients with unmet medical needs globally.

Plus Therapeutics, Inc. (NASDAQ:PSTV) announced that its wholly-owned subsidiary CNSide Diagnostics has secured a national coverage agreement with UnitedHealthcare Insurance Company, effective September 15, 2025, covering over 51 million people throughout the United States for its CNSide® Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test.

The CNSide® CSF Assay Platform has demonstrated superior clinical utility with 92% sensitivity and 95% specificity while influencing treatment decisions in 90% of cases across more than 11,000 tests performed at over 120 U.S. cancer institutions since 2020.

The Houston-based clinical-stage pharmaceutical company is advancing a pipeline of targeted radiotherapeutics for central nervous system cancers, with lead programs in leptomeningeal metastases and recurrent glioblastoma combining image-guided local beta radiation with targeted drug delivery approaches. The UnitedHealthcare agreement represents a significant milestone for commercial expansion of the CNSide® platform, which supports rapid diagnosis, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases.

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) has selected InspiroGene by McKesson as the specialty pharmacy partner for Amtagvi® (lifileucel), the first FDA-approved tumor-infiltrating lymphocyte therapy and first cell therapy approved for solid tumors. The partnership leverages Biologics by McKesson's over 30 years of specialty pharmacy expertise to expand access to Amtagvi for patients with advanced melanoma who have received prior immune checkpoint inhibitor and targeted therapy.

"We chose InspiroGene by McKesson to pioneer the Amtagvi specialty pharmacy option due to their offerings and commitment to cell and gene therapy patient access," said Dan Kirby, Chief Commercial Officer at Iovance Biotherapeutics. "We believe that InspiroGene will play a critical role in ensuring seamless delivery and coordination of Amtagvi to authorized treatment centers. The addition of the specialty pharmacy channel marks a significant step forward in Iovance's objective to bring innovative, life-extending therapies to more patients, more efficiently."

Iovance is pioneering a transformational approach using the immune system's natural cancer-fighting ability through personalized TIL therapy, which extracts, expands, and re-infuses a patient's own T cells from their tumor. InspiroGene will provide tailored services including order management, reimbursement navigation, and patient support specifically designed for cell and gene therapy delivery to authorized treatment centers nationwide.

I-Mab (NASDAQ:IMAB) announced that updated Phase 1 monotherapy data for givastomig in heavily pre-treated gastroesophageal carcinoma patients has been accepted as a short-talk presentation at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference, scheduled for October 22-26 in Boston, Massachusetts. The presentation will feature updated safety, efficacy, and biomarker analysis from the Phase 1 study of givastomig, a novel Claudin 18.2/4-1BB bispecific antibody, delivered by Dr. Samuel J. Klempner of Massachusetts General Hospital on October 23.

"As we follow patients in the fully enrolled givastomig Phase 1b dose expansion study and advance the program towards the initiation of a randomized Phase 2 study in gastric cancers, we appreciate the opportunity to present additional Phase 1 data demonstrating givastomig's monotherapy activity and engage with the oncology community," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "These data support our Phase 2 strategy to combine givastomig with standard of care in first line GEC patients with a broad range of Claudin 18.2 expression levels."

Givastomig conditionally activates T cells through the 4-1BB signaling pathway specifically in tumor microenvironments where Claudin 18.2 is expressed, demonstrating promising anti-tumor activity while minimizing toxicities commonly associated with other 4-1BB agents in Phase 1 trials. The U.S.-based global biotech company is jointly developing givastomig with ABL Bio for first-line metastatic gastric cancers and other Claudin 18.2-positive gastrointestinal tumors, with I-Mab serving as lead party and sharing worldwide rights equally with ABL Bio, excluding Greater China and South Korea.

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.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/
2. https://www.mdpi.com/1422-0067/26/19/9587
3. https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1519671/full
4. https://atriumhealth.org/dailydose/2025/09/25/retraining-your-immune-system
5. https://www.precedenceresearch.com/cancer-immunotherapy-market
6. https://cancerletter.com/sponsored-article/20251003_6/

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