VANCOUVER, BC, Oct. 7, 2025 (CNW Group via COMTEX) --
Equity Insider News Commentary
Issued on behalf of GT Biopharma, Inc.
 Equity Insider News Commentary â?? Major pharmaceutical companies presenting at the European Society for Medical Oncology Congress October 17-21[1] are unveiling pivotal survival data[2] and late-breaking lung cancer[3] results that demonstrate how diverse mechanisms are succeeding where traditional approaches stalled, while regulatory agencies issued multiple September approvals spanning gene therapies, bispecifics, and novel delivery systems[4]. The momentum reflects a fundamental shift as researchers discovered how cancer hijacks immune pathways to evade attack, spurring development of targeted platforms that activate natural killer cells, enhance radiation effects, detect disease earlier, and deploy bispecific antibodies against previously undruggable targets[5]. Clinical-stage developers advancing these differentiated mechanisms include GT Biopharma, Inc. (NASDAQ: GTBP), I-Mab (NASDAQ: IMAB), enGene Holdings Inc. (NASDAQ: ENGN), Onconetix, Inc. (NASDAQ: ONCO), and Nanobiotix S.A. (NASDAQ: NBTX).
With HHS doubling federal funding for cancer research to $100 million[6] and multiple companies reporting pivotal trial data across blood cancers, gastric malignancies, bladder cancer, pancreatic detection, and esophageal tumors, institutional capital is flowing toward platforms addressing the 60-70% of patients who don't respond to standard checkpoint inhibitors. The convergence of immune activation technologies, precision diagnostics, gene therapies, and nanoparticle-enhanced radiation creates favorable conditions for early-positioned companies with clinical-stage assets proving efficacy in historically resistant cancer types before major consolidation accelerates in these emerging categories.
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 doâ??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 Biopharma reported cash and cash equivalents of approximately $5.3 million, which management expected would fund operations into the first quarter of 2026.
CONTINUEDâ?¦ Read this and more news for GT Biopharma, Inc. at:Â https://equity-insider.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
I-Mab (NASDAQ: IMAB) has announced accelerated investment in givastomig, its lead Claudin 18.2-directed bispecific antibody, with plans to initiate a global randomized Phase 2 study in first-line metastatic gastric cancers in Q1 2026. The company expects to report Phase 1b dose expansion data in Q1 2026 and is expanding development into additional Claudin 18.2-positive tumor types including biliary tract cancer and pancreatic ductal adenocarcinoma.
"2025 has been a year of significant progress for I-Mab. Compelling Phase 1b combination data and positive investigator engagement have accelerated the givastomig program and reinforced our confidence in its potential to be a best-in-class Claudin 18.2-directed therapy for metastatic gastric cancers in the 1L setting," said Sean Fu, PhD, CEO of I-Mab. "Based on these accomplishments, we are expanding our investment in givastomig, with plans to initiate a randomized Phase 2 study in Q1 2026."
I-Mab appointed Wei Fu as Executive Chairman and Dr. Sean Cao as Chief Business Development Officer to support the company's growth initiatives. With cash and marketable securities of $224.9 million expected to fund operations into 2027, the company is positioned to advance its precision immuno-oncology pipeline through multiple clinical milestones.
enGene Holdings Inc. (NASDAQ: ENGN) achieved target enrollment of 100 patients in the pivotal cohort of its LEGEND Phase 2 trial evaluating detalimogene voraplasmid in high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The company was granted Regenerative Medicine Advanced Therapy designation by the FDA and plans to provide a data update from the pivotal cohort in 4Q 2025, positioning for a Biologics License Application submission in 2H 2026.
"Reaching target enrollment in LEGEND's pivotal Cohort 1 and securing RMAT designation are important milestones that mark our continued momentum," said Ron Cooper, CEO of enGene Holdings Inc. "We look forward to providing a data update from the LEGEND pivotal cohort later this year. These advances bring us closer to our planned BLA filing in 2026 with the ultimate goal of delivering detalimogene to patients as a therapy designed for efficacy, safety, and ease-of-use."
The company reported third quarter 2025 net loss of $28.9 million, or $0.57 per share, driven by increased manufacturing and clinical costs related to the LEGEND study. With cash, cash equivalents and marketable securities of $224.9 million as of July 31, 2025, enGene expects to fund operating expenses and capital expenditures into 2027.
Onconetix, Inc. (NASDAQ: ONCO) announced that its wholly owned subsidiary Proteomedix has signed a licensing agreement with Immunovia AB to provide manufacturing intellectual property for the PancreaSure pancreatic cancer test. Under the agreement, Immunovia will make payments totaling $700,000 to Proteomedix in 2025 and 2026, plus a 3% royalty on net sales of PancreaSure from 2026 to 2032.
"We are proud to have contributed to the development of PancreaSure and are excited to now support its manufacturing," said Beat Rheiner, PhD, CEO of Proteomedix. "Earlier detection of pancreatic cancer through PancreaSure gives patients real hope for better outcomes."
The licensing agreement enables Immunovia to independently produce antibodies related to three of the five biomarkers included in PancreaSure while Onconetix continues to focus on commercializing Proclarix, its CE-certified in vitro diagnostic test for prostate cancer. Proteomedix will provide master cells and key manufacturing intellectual property to support the production of reagents for the pancreatic cancer diagnostic test.
Nanobiotix S.A. (NASDAQ: NBTX) reported first Phase 1 data from its dose escalation study evaluating JNJ-1900 (NBTXR3) in 13 patients with locally advanced esophageal adenocarcinoma, demonstrating an 85% disease control rate and 69% objective response rate with 6 complete responses and 3 partial responses. The treatment, which combines hafnium oxide nanoparticles activated by radiotherapy with concurrent chemotherapy, was well-tolerated with the recommended Phase 2 dose established at 33% of gross tumor volume for photon chemoradiation.
"Esophageal cancer remains one of the most difficult contexts for both patients and clinicians, where existing standards of care can create significant burdens for patients," said Louis Kayitalire, Chief Medical Officer at Nanobiotix. "We believe that JNJ-1900 (NBTXR3), through its broadly applicable mechanism of action, could offer a novel approachâ??one designed to enhance local control and potentially reduce the need for highly invasive procedures such as esophagectomy."
The study, sponsored by The University of Texas MD Anderson Cancer Center, is actively recruiting 17 additional patients for dose escalation and expansion cohorts evaluating both photon and proton chemoradiation followed by surgery.
Nanobiotix is developing JNJ-1900 (NBTXR3) in collaboration with Janssen Pharmaceutica NV, a Johnson & Johnson company, with the potential to expand into new indications for locally advanced esophageal cancer and additional activation modalities beyond standard radiation therapy.
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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