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Issued on behalf of GT Biopharma, Inc.
VANCOUVER, BC, Dec. 19, 2025 /CNW/ -- USA News Group News Commentary – The recent FDA approval in November of the first bispecific antibody combination for second-line blood cancer treatment marks the departure from traditional chemotherapy that oncologists have been anticipating for decades[1]. Engineered cell therapies and bispecific antibodies are now achieving response rates exceeding 90% in patients with relapsed and refractory hematologic malignancies, demonstrating the transformative power of immunotherapy in blood cancers[2]. These breakthroughs position companies like GT Biopharma, Inc. (NASDAQ: GTBP), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), Genmab A/S (NASDAQ: GMAB), Autolus Therapeutics plc (NASDAQ: AUTL), and Lyell Immunopharma, Inc. (NASDAQ: LYEL).
Market forecasters project the CAR-T cell therapy market will surge from $3.87 billion in 2024 to $13.25 billion by 2030, driven by unprecedented efficacy in relapsed and refractory patient populations[3].
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.
CONTINUED… Read this and more news for GT Biopharma, Inc. at: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented data from the Phase 1/2 LINKER-MM4 trial showing Lynozyfic monotherapy achieved very good partial response or better of ≥70% across all three dose groups in newly diagnosed multiple myeloma patients despite limited follow-up. The first-ever BCMAxCD3 bispecific monotherapy trial in this setting demonstrated that 95% of evaluable responders achieved minimal residual disease negative status at 10⁻⁵ sensitivity.
"Lynozyfic monotherapy is already achieving MRD negativity rates comparable to quadruplet regimens but earlier in the treatment course, and these compelling results are expected to deepen with longer follow up," said Robert Orlowski, M.D., Ph.D., Deputy Chair, Professor of Medicine, and Director of Translational Myeloma Research in the Departments of Lymphoma/Myeloma and Experimental Therapeutics at The University of Texas MD Anderson Cancer Center and the lead investigator for the LINKER-MM4 trial. "These results underscore Lynozyfic's potential as a foundational component of frontline treatment regimens for multiple myeloma – or even a monotherapy regimen – for both transplant-eligible and transplant-ineligible patients."
The broad clinical development program includes ongoing Phase 2 expansion at the recommended 200mg dose and the LINKER-MM6 trial evaluating combination therapy in transplant-ineligible newly diagnosed patients. Regeneron will host a virtual Regeneron Roundtable investor event on December 10 to discuss its multiple myeloma development program.
Genmab A/S (NASDAQ: GMAB) announced new data from its Phase 1b/2 EPCORE CLL-1 trial demonstrating epcoritamab's effectiveness as both monotherapy and in combination regimens for patients with Richter transformation, a rare and aggressive evolution of chronic lymphocytic leukemia. In first-line monotherapy, patients achieved a 57% overall response rate with 52% complete response, while 95% of evaluable responders achieved minimal residual disease negative status across all dose groups.
"The results from these trials demonstrate the potential of epcoritamab as a monotherapy, and in combination, in patients with Richter transformation, a rare, often fatal, transformation of chronic lymphocytic leukemia into an aggressive lymphoma, mostly diffuse large B-cell lymphoma," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We are deeply committed to exploring epcoritamab as a potential core therapy across a range of B-cell malignancies, both as an initial treatment and as a later line of therapy."
Genmab continues expanding epcoritamab's development across hematologic malignancies through multiple ongoing Phase 3 trials in collaboration with AbbVie.
Autolus Therapeutics plc (NASDAQ: AUTL) presented initial clinical data from its CATULUS Phase 1 trial demonstrating obe-cel achieved a 95.5% overall response rate with 90.9% complete response in pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The safety profile was consistent with the adult experience, showing low rates of high-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (both 8.7%), with 20 of 21 responding patients remaining in ongoing remission at data cutoff.
"Pediatric patients with r/r B-ALL have a poor prognosis, particularly those who relapse early," said Dr. Matthias Will, Chief Development Officer of Autolus. "We were pleased to share the first data from the Phase 1 CATULUS trial showing obe-cel can produce high remission rates in this pediatric patient population, including in patients with high-risk relapse and patients with primary CNS relapse. Consistent with our experience in the adult population, data show low rates of severe CRS and ICANS."
Autolus also presented post-hoc analyses from the FELIX pivotal trial demonstrating that CAR T-cell persistence at three months post-infusion may serve as a marker for predicting long-term outcomes in adult r/r B-ALL patients. Planning for the Phase 2 expansion of the CATULUS trial is underway to further explore obe-cel in pediatric relapsed/refractory B-ALL patients.
Lyell Immunopharma, Inc. (NASDAQ: LYEL) presented new clinical data from its ongoing trial of rondecabtagene autoleucel showing 93% overall response and 76% complete response rates with median progression-free survival of 18 months in patients with relapsed/refractory large B-cell lymphoma in the third-or-later-line setting at the 67th American Society of Hematology Annual Meeting. Patients evaluated in the second-line setting, comprised predominantly of those with primary refractory disease, achieved an 83% overall response rate and 61% complete response rate, with 70% of complete responders remaining in complete response at six months or longer.
"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 Sarah M. Larson, MD, Associate Professor at the David Geffen School of Medicine, University of California, Los Angeles. "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."
Ronde-cel demonstrated a manageable safety profile appropriate for outpatient administration with no high-grade cytokine release syndrome and five percent or less of patients experiencing Grade 3 or greater immune effector cell-associated neurotoxicity syndrome following dexamethasone prophylaxis. Lyell has initiated two pivotal clinical trials, PiNACLE-H2H, a Phase 3 head-to-head randomized controlled trial versus lisocabtagene maraleucel or axicabtagene ciloleucel in the second-line setting, and PiNACLE, a single-arm registration trial enrolling up to 120 patients in the third-or-later-line setting.
Article Sources: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
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USA NEWS GROUP
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DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of GT Biopharma, Inc. but reserve the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of GT Biopharma, Inc. by CDMG; this is a paid advertisement, we currently own shares of GT Biopharma, Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
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USA News Group
News Commentary –
Issued on behalf of GT Biopharma, Inc.
VANCOUVER, BC, Oct. 15, 2025 /PRNewswire/ -- USA News Group News Commentary – Biomarker-driven drug development is accelerating across oncology as companies advance novel mechanisms targeting previously difficult-to-treat patient populations. The cancer immunotherapy market reached $226 billion in 2024 and continues expanding rapidly, driven by precision approaches that pair targeted agents with immunotherapy, identify genetic vulnerabilities, and deploy radioligand therapies for metastatic disease[1]. Recent clinical data demonstrating high response rates in biomarker-selected populations underscore the shift toward molecularly defined patient subgroups, while FDA priority reviews and breakthrough designations are compressing development timelines for innovative platforms. This convergence of scientific innovation and regulatory momentum positions companies advancing differentiated mechanisms across multiple tumor types for significant value creation, including GT Biopharma, Inc. (NASDAQ: GTBP), IDEAYA Biosciences, Inc. (NASDAQ: IDYA), Zymeworks Inc. (NASDAQ: ZYME), Novartis AG (NYSE: NVS), and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN).
The industry's focus on combination strategies and novel targets is yielding promising clinical results, with antibody-drug conjugates, metabolic inhibitors, and immune-activating platforms demonstrating enhanced efficacy when paired with complementary mechanisms[2]. Major pharmaceutical companies are investing heavily in radioligand therapy and precision medicine infrastructure, while emerging biotech firms leverage genetic screening to identify patient populations most likely to benefit from targeted interventions. These dynamics create compelling opportunities for companies with diversified pipelines addressing both common and rare cancers through validated biological mechanisms, particularly those approaching key clinical readouts and regulatory milestones in high-value indications.
GT Biopharma, Inc. (NASDAQ: GTBP) is a clinical-stage immunotherapy company making significant progress in its fight against difficult-to-treat cancers. The San Francisco-based biotech has been advancing its lead drug candidate, GTB-3650, through a Phase 1 clinical trial targeting blood cancers that have stopped responding to other treatments. In August, the company successfully moved into Cohort 3 after formal safety reviews of the first two patient groups showed no safety or tolerability problems. The trial had treated five patients by mid-August, with encouraging early signals of immune system activation.
"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 Chief Executive Officer 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)."
The Phase 1 trial is testing 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 patients whose cancers have come back or never responded to standard therapies. The drug works by activating the body's own natural killer cells to attack cancer cells. Patients receive the treatment through continuous infusions in two-week cycles, alternating two weeks on and two weeks off, for up to four months based on how well they're responding.
What makes the early data particularly interesting is the biomarker evidence. Multiple blood tests from the first four patients showed measurable increases in natural killer cell activity and expansion. This suggests the drug is doing exactly what it was designed to do—wake up the immune system and direct it against cancer. GT Biopharma expects to release more detailed Phase 1 results later this year after completing additional dose cohorts.
Beyond blood cancers, GT Biopharma has a second drug candidate moving toward the clinic. GTB-5550 targets a protein called B7H3 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 give themselves 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 Biopharmareported cash and cash equivalents of approximately $5.3 million, which management expected would fund operations into the first quarter of 2026.
CONTINUED… Read this and more news for GT Biopharma, Inc. at: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
IDEAYA Biosciences, Inc. (NASDAQ: IDYA) has reported positive Phase 1/2 data for its combination of IDE397, a potential first-in-class MAT2A inhibitor, with Gilead's Trodelvy® in MTAP-deletion urothelial cancer, achieving an overall response rate of 57% at the higher dose level. The trial enrolled patients with late-line MTAP-deletion urothelial cancer, where MTAP-deletion is estimated to occur in approximately 25-30% of urothelial cancer patients, with 68% of participants having progressed after two or more prior therapies.
"We are pleased with the progress we are making with the Trodelvy and IDE397 combination and are encouraged by the early response rate data we are seeing in previously treated MTAP-deleted urothelial cancer," said Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences. "These results set the stage for further testing of the combination in non-small cell lung cancer, where we have just dosed the first patient in our clinical trial."
The combination demonstrated a manageable safety profile consistent with known adverse events of both drugs as single agents, with no treatment-related serious adverse events observed at the recommended expansion dose. IDEAYA is targeting selection of the recommended Phase 2 dose by end of 2025, with the next update planned for a medical conference in the first half of 2026.
Zymeworks Inc. (NASDAQ: ZYME) will present preliminary Phase 1 data for ZW191, an antibody-drug conjugate targeting folate receptor-α, at the AACR-NCI-EORTC Conference on October 22-26, 2025. ZW191 is engineered to target a protein found in approximately 75% of high-grade serous ovarian carcinomas and 70% of lung adenocarcinomas, utilizing Zymeworks' proprietary bystander active topoisomerase-1 inhibitor payload, ZD06519.
"We are excited to share early clinical data from Part 1 of our first-in-human, Phase 1 trial of ZW191 in patients with advanced solid tumors," said Sabeen Mekan, M.D., Senior Vice President of Clinical Development of Zymeworks. "These initial results reinforce our confidence in our novel ADC design and its potential to deliver improved treatments for broader patient populations."
The company will host a live webcast on October 23, 2025 at 3:30 pm ET to discuss the data with lead author Patricia LoRusso and senior management. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, with ZW251 expected to enter clinical trials in 2025.
Novartis AG (NYSE: NVS) will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology Congress 2025 in Berlin from October 17-21, 2025. Key data from the PSMAddition trial has been selected for a Presidential session, showcasing the efficacy and safety of Pluvicto plus standard of care versus standard of care alone in PSMA-positive metastatic hormone-sensitive prostate cancer, while the NATALEE five-year analysis will provide further long-term insights into Kisqali's risk of recurrence reduction in early breast cancer.
"We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients," said Dushen Chetty, Ph.D., Global Head of Oncology Development, Novartis, Ad Interim. "Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy."
The oncology strategy of Novartis focuses on people living with cancer and their caregivers, with approximately 35 research and development projects across solid tumors, hematology and radioligand therapy. The company is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. FDA has approved Libtayo® (cemiplimab-rwlc) as the first and only immunotherapy for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. The approval, granted under Priority Review, is based on the pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), with results published in the New England Journal of Medicine and presented at ASCO 2025.
"This approval provides patients with CSCC at high risk of disease recurrence following surgery and radiation a much-needed option, as Libtayo is the only immunotherapy to demonstrate efficacy in this setting," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. "Now with five FDA-approved indications, Libtayo is firmly established as a strong and versatile PD-1 inhibitor option for patients with a variety of cancers."
An additional regulatory application is under review in the European Union, with a decision expected by the first half of 2026. Regeneron has launched Libtayo Surround™, offering financial and educational resources to help support patients throughout their treatment journey, with cutaneous squamous cell carcinoma being one of the most common skin cancers with an estimated 1.8 million cases diagnosed annually in the U.S.
Article Sources: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
CONTACT:
USA NEWS GROUP
info@usanewsgroup.com
(604) 265-2873
DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of GT Biopharma, Inc. but reserve the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of GT Biopharma, Inc. by CDMG; this is a paid advertisement, we currently own shares of GT Biopharma, Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
SOURCES:
- https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market
- https://www.labiotech.eu/in-depth/oncology-trends-2025/
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