On October 28, 2025 Starpharma reported Quarterly Activities Report and Appendix 4C for the quarter ended 30 September 2025 (Q1 FY26).

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(Press release, Starpharma, OCT 28, 2025, View Source,and%20executive%20directors%20of%20$355%2C000. [SID1234661699])

On October 28, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported updated results from the single-arm squamous cell anal carcinoma (SCAC) cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq) in patients with ≥2L metastatic SCAC. Patients from this cohort continue to be followed, and additional efficacy data are expected to be reported.

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The combination of pelareorep and atezolizumab achieved an objective response rate (ORR) of 30% (six among 20 evaluable patients). This represents a greater than 2x improvement over the historical benchmark of 13.8% ORR reported for the only FDA-approved immunotherapy for 2L SCAC.

Importantly, there have been two durable complete responses among the six responders, with one ongoing beyond two years, and the other lasting 15 months. In addition, another patient has an ongoing response at 64 weeks. The overall median duration of response for patients receiving pelareorep and atezolizumab is 15.5 months compared to 9.5 months for the current standard of care at this stage of treatment.

These updated results from this ongoing SCAC cohort reinforce the potential of pelareorep to drive durable immunologic tumor control in gastrointestinal tumors. The results also demonstrate the durability and depth of responses achievable with the combination of pelareorep and checkpoint inhibitors without chemotherapy.

"This is the most encouraging efficacy signal with a non-chemo regimen we have ever seen in anal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. "Achieving a 30% objective response rate — more than double the benchmark of the only approved immunotherapy — along with multiple responses lasting more than a year, including two complete responses, underscores pelareorep’s ability to unlock deep and durable immune responses. We believe the data represent our best chance to obtain an accelerated approval in a rare disease with virtually no options outside of chemotherapy."

The SCAC cohort is part of Oncolytics’ broader GOBLET study, a Phase 1/2 trial evaluating pelareorep in combination with checkpoint inhibitors and standard therapies across multiple gastrointestinal cancer indications, including pancreatic, colorectal, and anal cancers.

Based on these compelling data, Oncolytics intends to engage the U.S. Food and Drug Administration (FDA) to discuss a potential single-arm study designed for accelerated approval in second-line or later SCAC, with a potential launch date for such a study expected in the first half of 2026.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

(Press release, Oncolytics Biotech, OCT 28, 2025, View Source [SID1234657071])

On October 28, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported another successful readout for its ECD program, which is evaluating a blood-based screening test for the detection of CRC and advanced adenomas (AA). This latest analysis from the U.S. based, prospective PROCEED-CRC clinical trial (NCT06620627) focused on the detection of AAs, which are precancerous polyps with specific features that indicate a higher risk of progression to colorectal cancer. Detecting these lesions early is a critical step in preventing cancer before it develops.

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PROCEED-CRC has enrolled approximately 5,000 average-risk asymptomatic screening participants with blood draws taken pre-colonoscopy. This analysis started with approximately 1,400 PROCEED-CRC cases that were collected prior to the cutoff date, incorporating 92 sequentially collected AA samples and a representative cohort of 366 normal controls. The study showed sensitivity of 22.5% (CI: 15.4%-32.4%) and specificity of 91.5% (CI: 88.2%-93.9%)​​ and encompassed all histologic subtypes, including serrated polyps. When adjusted for subtype prevalences found in two recent CRC screening FDA-enabling trials1,2, sensitivity was 22.4% and 23.7%. Additionally, in this study, 98.9% of AA cases were less than 30 millimeters and 93.5% were below 20 millimeters, which represents a challenging size distribution because smaller lesions can be more difficult to detect.

Earlier in 2025, Natera reported preliminary AA performance data from a pilot study with 18% sensitivity and 91% specificity. Since that time, several technology changes have resulted in improved assay performance. These findings create increased confidence going into the FIND clinical trial (NCT07046585), an FDA-grade validation study, which was initiated in 2025 and continues to make significant progress.

"This data represents another important milestone in our efforts to advance blood-based colorectal cancer screening," said Alexey Aleshin, M.D., general manager of oncology and early cancer detection, and chief medical officer at Natera. "Detecting advanced adenomas is critical for intercepting colorectal cancer before it develops, and this exceptional performance highlights the strong potential of our technology to transform early detection."

These results build on previously reported case-control data from screen-detected CRC cases, which were also announced earlier this year showing overall sensitivity of 95% (95% CI: 92-99%) and specificity of 91% (95% CI: 88-94%). Among patients with stage I disease, sensitivity was 92% overall. Stage-adjusted sensitivity was 91% in screen-detected individuals.

(Press release, Natera, OCT 28, 2025, View Source [SID1234657087])

On October 28, 2025 ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), reported the initiation and recent dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) with MDX2004, a first-in-class trispecific antibody-fusion protein for oncology and immune disorders. The study is designed to evaluate the safety, tolerability, and biologic activity of MDX2004 as an immunotherapy for advanced cancers.

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MDX2004 is designed to stimulate T cells through three signaling pathways to enhance immune activation. This proprietary multispecific antibody engages CD3, CD28, and 4-1BB and is expected to activate T lymphocytes, including stem and memory T cells. Because stem T cells undergo self-renewal and give rise to mature T cells, the drug aims to recruit and replenish, or "rejuvenate," cellular immunity. Unlike previous 4-1BB antibody therapies, recognition of 4-1BB by this molecule does not involve antibody binding because it binds as a ligand to the natural receptor.

"Patients with advanced solid tumors may have limited options with existing treatments, facing challenging disease control rates and low long-term survival," said Giovanni Abbadessa, M.D., Ph.D., Chief Medical Officer of ModeX. "The MDX2004 multispecific antibody aims to rejuvenate T cells and sustain an expanded immune response in a broad range of tumors. We look forward to exploring further via this clinical trial."

"We are excited to bring MDX2004 to patients as a first-in-class trispecific antibody with a unique design aiming for a specific mechanism of action. By stimulating and sustaining immune function, this T cell rejuvenator has potential to treat diverse cancers and reverse immune impairment caused by chemotherapy, chronic diseases, infection and aging," said Phillip Frost, M.D., Chairman and CEO of OPKO Health and Gary Nabel, M.D., Ph.D., President and CEO of ModeX and Chief Innovation Officer of OPKO Health.

Preclinical proof-of-concept data as well as clinical dose selection analyses to support the MDX2004 development will be showcased in two poster presentations at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), National Harbor, MD, on November 5-9, 2025.

About MDX2004
MDX2004 is a novel trispecific antibody–fusion protein that targets CD3, CD28, and 4-1BB (CD137) on human T cells. It is designed to promote the expansion of stem and memory T cell populations, thereby rejuvenating immune function and enhancing anti-tumor immunity. This trifunctional approach aims to expand and sustain both stem and mature memory T cell subsets, which have been associated with favorable responses to immunotherapy. It may thus help restore immune function in subjects with underlying immune impairment from aging, chronic diseases such as diabetes, infections or chemotherapies.

Beyond bispecifics: ModeX Synergistic Targeting of Antibody Receptors (MSTAR)
Multispecific antibody therapeutics can help generate medicines of the future by targeting multiple disease pathways simultaneously. Many untreatable or complex conditions arise from multiple root causes; yet most medicines only act on a single target. ​​ModeX overcomes these challenges by combining natural protein structures using a platform known as the ModeX Synergistic Targeting of Antibody Receptors (MSTAR) to create unique multispecific medicines. The platform generates multispecific antibodies from modular building blocks intended to modulate potency and maximize specificity to address multiple disease pathways simultaneously.

(Press release, Opko Health, OCT 28, 2025, View Source [SID1234657072])

On October 28, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim 2nd Annual Healthcare Innovation Conference being held from November 10-12, 2025 in Boston.

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Details of the event are as follows:
Date: Tuesday, November 11, 2025
Time: 3:00 p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

(Press release, Adicet Bio, OCT 28, 2025, View Source [SID1234657088])