PR Newswire
Equity Insider
News Commentary
Issued on behalf of GT Biopharma, Inc.
VANCOUVER, BC
, Oct. 17, 2025 /PRNewswire/ — Equity InsiderNews Commentary – MIT and Harvardscientists recently created engineered CAR-NK cells that hide from the immune system and more effectively destroy cancer, opening doors to off-the-shelf treatments doctors can administer immediately after diagnosis instead of waiting weeks for personalized cell production[1]. Eight new oncology approvals between July and September 2025 demonstrate how cellular immunotherapy platforms are solving manufacturing challenges while expanding from blood cancers into solid tumors, with researchers discovering ways to reprogram immune cells to fight cancer for days without fatiguing[2]. This convergence of natural killer cell activation, T-cell engagers, personalized vaccines, and precision delivery systems positions GT Biopharma, Inc. (NASDAQ: GTBP), Evaxion A/S (NASDAQ: EVAX), RenovoRX, Inc. (NASDAQ:RNXT), EDAP TMS S.A. (NASDAQ: EDAP), and Xencor, Inc. (NASDAQ: XNCR).
The global cancer immunotherapy market stood at $105.7 billion in 2024 and is expected to grow to $254.6 billion by 2033, driven by increasing cancer incidence and rapid developments creating better tailored therapies[3]. 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 creating favorable conditions for immune-activating therapies offering reduced toxicity compared to conventional chemotherapy.
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 Biopharmareported approximately $5.3 million in cash and cash equivalents, with management projecting this capital would support operations through the first quarter of 2026.
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Evaxion A/S (NASDAQ: EVAX) will present comprehensive two-year data from its Phase 2 trial evaluating EVX-01, an AI-designed personalized cancer vaccine, at the European Society for Medical Oncology Congress 2025 in Berlin on October 17. The oral presentation will include clinical efficacy, immunogenicity and safety data, building on previously reported interim results that demonstrated a 69% overall response rate and tumor-specific immune responses triggered by 80% of EVX-01 vaccine targets in patients with advanced melanoma.
“We are eagerly anticipating the presentation of the data and the subsequent discussions with medical and scientific colleagues as well as potential partner companies,” said Birgitte Rønø, CSO and interim CEO of Evaxion. “We are excited to have been selected for oral presentation at an event as important as the ESMO Congress, one of the most prestigious medical oncology conferences in the world. This is a testament to the interest in EVX-01 and the field of personalized cancer vaccines in general.”
The company will host a webinar on October 22, 2025 featuring trial investigator Dr. Muhammad Adnan Khattak to discuss the Phase 2 findings and challenges in treating advanced melanoma. Evaxion’s AI-Immunology platform enables personalized therapy tailored to each patient’s unique tumor profile and immune characteristics, with the trial evaluating EVX-01 in combination with MSD’s anti-PD-1 therapy KEYTRUDA.
RenovoRx, Inc. (NASDAQ: RNXT) has successfully completed the first registry-eligible patient procedure in its PanTheR Post-Marketing Registry Study at the University of Vermont Cancer Center, with Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center joining as additional participating clinical sites. The multi-center observational registry is designed to evaluate long-term safety and survival outcomes for patients with solid tumors treated using RenovoCath, the company’s FDA-cleared drug-delivery device, with participating cancer centers purchasing devices for study use.
“We are pleased to be the first site to initiate cancer treatment delivery by RenovoCath in the important PanTheR registry study,” said Dr. Conor O’Neill of the University of Vermont Cancer Center. “This study provides a crucial opportunity to evaluate how RenovoCath can improve drug-delivery in patients diagnosed with solid tumors, while potentially, and importantly, improving survival and quality of life outcomes. By contributing to this registry study, we aim to generate meaningful real-world data that can guide future treatment decisions for patients with difficult-to-treat cancers.”
The PanTheR study will capture real-world data across a broader range of solid tumors to inform future clinical trial designs and enhance safety protocols for RenovoCath applications. RenovoRx received its first commercial purchase orders for RenovoCath devices in December 2024 and continues expanding to additional medical institutions, including several high-volume National Cancer Institute-designated centers, while actively exploring revenue-generating activities either independently or with medical device commercial partners.
EDAP TMS S.A. (NASDAQ: EDAP) achieved unprecedented national exposure for its Focal One Robotic HIFU treatment during Prostate Cancer Awareness Month, with a patient success story featured on Health Uncensored with Dr. Drew on the Lifetime Network on September 26, reaching millions of viewers nationwide. The segment showcased patient Peter D.’s journey selecting the non-invasive, nonsurgical treatment option and his rapid return to normal activities with minimal disruption.
“More patients like Peter are seeking an effective treatment for their prostate cancer without impacting their quality of life,” said Dr. Eric Giesler following the broadcast. “We have entered a new era in the management of prostate cancer where eligible patients now have a non-invasive treatment option with Focal One Robotic HIFU that precisely targets the cancer in the prostate while avoiding the morbidity and the complications of radical treatments such as surgery and radiotherapy. Through advancements in technology, we are now able to diagnose a patient with prostate cancer more accurately which enables us to offer a non-invasive treatment to certain patients, maximizing cancer control and minimizing side effects, which can significantly impact a patient’s quality of life on a daily basis.”
The company’s awareness campaign included multiple patient education events and partnerships with hospitals and practices for local community outreach. EDAP TMS develops minimally invasive medical devices using ultrasound technology, combining imaging, robotics and precise non-invasive energy delivery in its therapy platform, with Focal One representing the leading prostate focal therapy controlled by urologists and potential to expand to multiple indications beyond prostate cancer.
Xencor, Inc. (NASDAQ: XNCR) will present initial Phase 1 dose-escalation results of XmAb819, a first-in-class bispecific ENPP3 x CD3 T-cell engaging antibody, in patients with clear cell renal cell carcinoma at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston. The poster presentation on October 24 will include detailed safety analysis along with efficacy results from the target dose range, representing an updated data-cut beyond the placeholder abstract submitted with limited detail based on a previous data-cut showing high-level safety summary across all dosing cohorts.
Management will host a webcast and conference call to discuss the results following the embargo lift, with full abstracts scheduled for release by the conference on October 22. XmAb819 engages the immune system to activate T cells for highly potent and targeted lysis of tumor cells expressing ENPP3, an antigen highly expressed on kidney cancers with low-level expression on normal tissues, utilizing Xencor’s XmAb 2+1 format with two tumor-antigen binding domains and one T-cell binding domain to bind more avidly and selectively kill tumor cells with higher antigen density while potentially sparing normal cells.
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://scitechdaily.com/mit-and-harvard-build-invisible-immune-cells-that-obliterate-cancer/
2. https://www.prnewswire.com/news-releases/cellular-immunotherapy-breakthroughs-fuel-370-billion-market-surge-302584861.html 3. https://www.pharmiweb.com/press-release/2025-10-07/cancer-immunotherapy-market-analysis-growth-trends-and-forecast-report-2025-2033-featuring-amgen-a
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