Issued on behalf of GT Biopharma, Inc.
VANCOUVER – Baystreet.ca News Commentary – Major biotechnology companies are presenting multi-cancer detection data and breakthrough clinical results at the European Society for Medical Oncology Congress October 17-21[1], while regulatory agencies accelerated eight oncology approvals through September spanning immune activation, protein degradation, and combination strategies[2]. The convergence reflects a fundamental shift from broad cytotoxic approaches toward precision platforms that detect cancer earlier through blood tests, activate natural killer cells against treatment-resistant malignancies, deliver concentrated therapies directly into tumors, and degrade disease-driving proteins through novel mechanisms. Companies advancing these differentiated approaches across the cancer care continuum include GT Biopharma, Inc. (NASDAQ: GTBP), Intensity Therapeutics, Inc. (NASDAQ: INTS), GRAIL, Inc. (NASDAQ: GRAL), C4 Therapeutics, Inc. (NASDAQ: CCCC), and Pfizer Inc. (NYSE: PFE).
With HHS doubling federal funding to $100 million for cancer research[3] and breakthrough discoveries[4] revealing how tumors evade immune destruction, institutional capital is flowing toward platforms demonstrating clinical proof-of-concept in historically resistant cancers including triple-negative breast cancer, treatment-refractory blood malignancies, and relapsed multiple myeloma. The emergence of pathological complete responses in aggressive solid tumors, validated multi-cancer screening with low false positive rates, and immune-activating combinations with bispecific antibodies creates favorable conditions for early-positioned companies with clinical-stage assets proving efficacy across the precision oncology spectrum before major pharmaceutical consolidation accelerates in these high-value 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 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 Biopharma reported 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/
Intensity Therapeutics, Inc. (NASDAQ: INTS) has reported a pathological complete response in the first evaluated patient from its INVINCIBLE-4 trial testing INT230-6 for presurgical triple-negative breast cancer. The patient received two doses of INT230-6 eight days apart followed by standard of care immunochemotherapy, with tumor scans showing significant necrosis before initiation of standard therapy.
"As was seen in our prior studies, tumor scans indicate high levels of drug absorption and significant tumor necrosis with evidence of immune activation before the initiation of the standard of care therapy, and we are excited that the first patient evaluated who received our drug had a pCR," said Lewis H. Bender, CEO of Intensity Therapeutics. "Our objective is to reinitiate enrollment and complete the study as soon as possible."
The company has temporarily paused new patient enrollment after some participants experienced localized skin irritation near the tumor, with modifications being implemented to resolve this cosmetic issue. Intensity continues advancing its Phase 2/3 program while maintaining its Phase 3 INVINCIBLE-3 trial in soft tissue sarcoma.
GRAIL, Inc. (NASDAQ: GRAL) will present new Galleri multi-cancer early detection test data from more than 32,000 participants across its PATHFINDER 2, SYMPLIFY, and REFLECTION studies at ESMO Congress 2025 and the Early Detection of Cancer Conference. The registrational PATHFINDER 2 results, which will be submitted to the FDA as part of the Galleri Premarket Approval application, demonstrated substantially greater additional cancer detection and higher positive predictive value when added to standard of care screening.
"Galleri is the only available MCED test with demonstrated performance in an intended use population being screened for cancer," said Josh Ofman, MD, MSHS, President of GRAIL. "These new data build on the results from our first clinical implementation study, PATHFINDER, which was published in the Lancet in 2023, and showed that Galleri approximately doubled the number of cancers identified when added to standard of care screening. We're witnessing the beginning of a transformative era for cancer screening, with these results demonstrating Galleri's ability to detect cancers earlier, when they can be easier to treat and are potentially curable."
The blood-based test can detect more than 50 types of cancer before symptoms appear and has demonstrated the lowest false positive rate of any MCED test. PATHFINDER 2 represents the largest MCED interventional study conducted in the United States in an intended use population with no clinical suspicion of cancer.
C4 Therapeutics, Inc. (NASDAQ: CCCC) has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) to evaluate cemsidomide in combination with elranatamab for relapsed/refractory multiple myeloma. Under the agreement, Pfizer will supply elranatamab (ELREXFIO), a BCMAxCD3 targeted bispecific antibody, at no cost for C4 Therapeutics' upcoming Phase 1b trial expected to initiate in Q2 2026.
"We look forward to initiating this trial to evaluate cemsidomide in combination with elranatamab in the hopes we can develop a new treatment regimen and potentially improve outcomes for multiple myeloma patients in earlier lines of therapy," said Andrew Hirsch, CEO of C4 Therapeutics. "Our supply agreement with Pfizer creates an opportunity for cemsidomide to be combined with elranatamab, which is on the path to potentially becoming a standard of care BCMAxCD3 bispecific in a growing market."
The Phase 1b trial will evaluate cemsidomide, an IKZF1/3 degrader, with dexamethasone and elranatamab as second line or later therapy, seeking to establish optimal dosing for the combination. Data from cemsidomide's Phase 1 trial demonstrated robust T-cell activation and cytokine expression, suggesting the combination may amplify the anti-myeloma immune response when paired with a BCMAxCD3 bispecific.
Article Sources: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
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SOURCES
1. https://www.onclive.com/view/inside-the-most-anticipated-lung-cancer-abstracts-what-to-expect-from-esmo-2025
2. https://www.curetoday.com/view/all-fda-oncology-approvals-from-september-2025
3. https://www.nih.gov/news-events/news-releases/hhs-doubles-ai-backed-childhood-cancer-research-funding
4. https://www.sciencedaily.com/releases/2025/09/250921091002.htm
