GT Biopharma (NASDAQ: GTBP) just initiated the dosing in Cohort 2 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
Unfortunately, relapsed/refractory CD33 expressing hematologic malignancies create a difficult situation where a cancer has either come back after treatment or has not responded well with initial therapies. In turn, they often require far more aggressive treatment options, such as the one being developed by GT Biopharma.
To date, no safety or tolerability issues were observed with the company’s Phase 1 dose escalation, allowing the company to move forward with Cohort 2, with the first patient now having been treated with the first dose cycle. In addition, patients in Cohort 1 have shown early evidence of increased immunologic activity, supporting GTB-3650’s ability to activate endogenous NK cells and induce NK cell expansion.
Helping, the company’s proprietary TriKE technology causes NK cells to become cancer serial killers, which can engage the body’s own NK cells to target and kill cancerous cells. All of which could significantly assist in the potentially successful treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
Not only could this be substantial news for GT Biopharma, but also for other companies fighting cancer. That includes Fate Therapeutics (NASDAQ: FATE), Iovance Biotherapeutics (NASDAQ: IOVA), BioXcel Therapeutics (NASDAQ: BTAI) and Pyxis Oncology (NASDAQ: PYXS).
Look at GT Biopharma, Inc. (NASDAQ: GTBP), For Example
GT Biopharma, Inc., a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE® natural killer (NK) cell engager platform, today announced successful completion of dosing in Cohort 1 and subsequent initiation of dosing in Cohort 2 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
GT Biopharma’s second-generation TriKE, GTB-3650, is currently being evaluated in a Phase 1 dose escalation trial for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies. Cohort 1 (n=2) has been successfully completed with both patients having undergone the first and second dosing cycles. Following the formal safety review, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2 (n=2), with the first patient now having been treated with the first dose cycle.
Based on multiple assays of various blood biomarkers, both patients in Cohort 1 have shown early evidence of increased immunologic activity, supporting GTB-3650’s ability to activate endogenous NK cells and induce NK cell expansion. The company plans on releasing more detailed results later in 2025 following enrollment and completion of additional dose cohorts.
The trial plans to evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) and GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. More details can be found on clinicaltrials.gov with the identifier: NCT06594445.
Other related developments from around the markets include:
Fate Therapeutics, a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, today reported business highlights and financial results for the first quarter ended March 31, 2025. “We continue to be pleased with the initial clinical profile of our FT819 off-the-shelf CAR T-cell program in patients with moderate-to-severe SLE, and we look forward to sharing new clinical data from our ongoing FT819 Phase 1 study at the EULAR Conference in June,” said Bob Valamehr, Ph.D. MBA, President and Chief Executive Officer of Fate Therapeutics. “Our primary focus remains on driving patient enrollment and achieving therapeutic differentiation in SLE, including administration of FT819 with fludarabine-free conditioning and as an add-on to maintenance therapy without conditioning. We plan to work closely with the FDA under our FT819 RMAT designation to align on a registrational pathway for FT819 in SLE, and we have now initiated regulatory submissions in Europe to expand the geographic reach of the program for lupus patients. The expansion of patient population and reach is well supported by the ability to produce FT819 in large quantities from a master cell bank, ensuring consistent on-demand product supply for a large number of patients.”
Iovance Biotherapeutics, a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported first quarter 2025 financial results and corporate updates. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “During the start of the new year, our first quarter revenue was impacted by a significant reduction in capacity during the annual scheduled maintenance at the Iovance Cell Therapy Center (iCTC). Since full production has now resumed at the iCTC, we now expect infusions to grow in the second quarter as compared to the first quarter. Additionally, based on our experience to date, we are revising full-year 2025 revenue guidance to reflect recent launch dynamics. In the first 12 months of our U.S. launch, we have executed toward our long-term adoption goals by treating more than 275 Amtagvi patients and generating more than $210 million in revenue. Beyond the U.S. launch, we are on track this year for potential Amtagvi regulatory approvals in three new ex-U.S. markets as well as a clinical data update from our registrational trial in non-small cell lung cancer.”
BioXcel Therapeutics, a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported its financial results for the first quarter of 2025 and announced that its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia is fully enrolled. “We are pleased to have achieved this major milestone in our first trial of BXCL501 in the at-home setting,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “An estimated 23 million episodes of bipolar or schizophrenia-related agitation occur annually1-3 at home, yet there are no FDA-approved acute treatment options for patients in this setting. We look forward to a data readout expected in the second half of this year and are excited by the opportunity to expand the market potential of IGALMI® and bring this drug to millions of additional patients.”
Pyxis Oncology, a clinical-stage company developing next-generation ADC therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended March 31, 2025, and provided a business update. “We are enthusiastic about the progress we are making with micvotabart pelidotin, particularly our recent preclinical data that validate its unique three-pronged mechanism of action and indicate that MICVO monotherapy may be eliciting immune responses in previously unresponsive tumors,” said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. “Our focus remains on delivering durable and efficacious therapies for patients with recurrent or metastatic head and neck squamous cell carcinoma and other advanced solid tumors, building on the tremendous potential of our next generation ADC. We look forward to reporting data from our ongoing Phase 1 trials evaluating MICVO as a monotherapy and in combination with pembrolizumab later this year.”
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