1stOncology™: Cancer Intelligence Service – Page 37 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Phio Pharmaceuticals Announces Participation in Third Annual DealFlow Discovery Conference

On January 26, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that it will participate in the DealFlow Discovery Conference, taking place January 28-29, 2026 at the Borgata Hotel in Atlantic City, NJ.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Robert Bitterman, CEO and Chairman of the Board of Phio Pharmaceuticals will deliver a company presentation on January 28th at 9 AM in Borgata Hotel Room #1 and the management team will be available for one-on-one investor meetings throughout the event.

"All investors are invited to join this event to learn more about Phio Pharmaceuticals and our continuing pursuit towards a cancer free future using our INTASYL technology," stated Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals. "Completion of treatment in the Phase 1b trial for PH-762 marks a significant step forward in advancing a promising treatment option for skin cancer."

Event Details are as follows:

3rd Annual DealFlow Discovery Conference

The Borgata Hotel, Casino & Spa

Atlantic City, NJ

January 28-29, 2026

Investors interested in scheduling a meeting with Phio Pharmaceuticals management team can register (Investors – DealFlow Discovery Conference) to attend the conference at no cost.

(Press release, Phio Pharmaceuticals, JAN 26, 2026, View Source [SID1234662214])

Primmune Therapeutics Announces Additional Close of Series B Financing

On January 26, 2026 Primmune Therapeutics, a biotech company harnessing the power of the innate immune system, reported an additional close of its Series B financing round for a total of $8.6 million with participation from Bioqube Ventures, Oberland Capital and Samsara Biocapital. This close brings the total Series B raise to $23.3 million. These funds will be used to support the further clinical development of PRTX007, a novel orally administered, systemically acting, small molecule toll-like receptor 7 (TLR7) agonist as an immunotherapy for solid tumors.

With the latest close of the Series B financing, Primmune Therapeutics will initiate Study PRTX007-003, a Phase 2 neoadjuvant efficacy study using PRTX007 in combination with standard-of-care anti-PD-1 therapy in patients with Stage III resectable melanoma.

"This financing enables us to rapidly advance PRTX007 into a clearly defined proof-of-principle study with validated efficacy and safety endpoints, with the goal of establishing PRTX007 as a class-leading immunotherapy option for patients with solid tumors," said Charlie McDermott, Chief Executive Officer and Director of Primmune Therapeutics. The study will be conducted entirely in Australia by Primmune Therapeutics Pty Ltd. in conjunction with Novotech acting as the in country clinical research organization.

About PRTX007
PRTX007 is a novel orally administered, systemically acting, toll-like receptor 7 (TLR7) agonist designed in house at Primmune to functionally tune immune signaling toward an IRF7-driven poly-interferon response and away from the NF-KB-mediated pro-inflammatory cytokine signaling that has limited the utility of systemically acting TLR7, TLR7/8, and TLR8 agonists. PRTX007 has been administered to over 100 healthy human volunteers in two separate phase 1 clinical studies (Study PRTX007-001 and Study PRTX007-002). In these studies, PRTX007 drove the desired systemic IRF7 poly-IFN response without the undesired NF-KB pro-inflammatory response. PRTX007 was generally well-tolerated with no serious adverse events (SAEs).

(Press release, Primmune Therapeutics, JAN 26, 2026, View Source [SID1234662212])

NUCLIDIUM Announces Issuance of New U.S. Patent Covering its 61Cu-based Radiodiagnostic Program for PSMA-positive Prostate Cancer

On January 26, 2026 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, reported that U.S. Patent No. 12,527,885 has been granted by the United States Patent and Trademark Office (USPTO). This critical achievement strengthens and extends the scope of the intellectual property portfolio for NUCLIDIUM’s NU101 radiotheranostic program. The patent protects the Copper-61 based diagnostic as well as its use in combination with the Copper-67 based therapeutic in a theranostic setting. NUCLIDIUM’s NU101 theranostic program was designed to utilize high-radiopure Copper-61 to diagnose and Copper-67 to treat Prostate-Specific Membrane Antigen (PSMA)-positive tumors, making it a true theranostic by using the same radiometal.

"This patent grant validates the scientific innovation behind our copper-based radiopharmaceutical platform and strengthens our ability to advance differentiated therapies across our pipeline. Robust intellectual property is critical as we accelerate the clinical development of our best-in-class copper-based radiotheranostic programs and strive to deliver new treatment options for patients with difficult-to-treat cancers, including prostate and metastatic breast cancer," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM.

The issued patent covers the composition of matter and methods of using the radiodiagnostic 61Cu-NU101 in radioimaging, including Positron Emission Tomography (PET) and Single Photon Emission Computed Tomography (SPECT) imaging of PSMA-positive tumors, as well as the subsequent combination with the therapeutic pair 67Cu-NU101. Over 90% of prostate tumors express PSMA[1], rendering this surface-level antigen an attractive target for cancer diagnosis and treatment. NUCLIDIUM’s 61Cu-based NU101 diagnostic component allows for delayed imaging, in which even very small metastases can be detected. Based on these imaging data, the 67Cu-based NU101 therapeutic can enable targeted treatment with a potentially reduced radiation burden for the patient.

The diagnostic component 61Cu-NU101 is currently in clinical evaluation. Data from a Phase 1 trial showed favorable imaging performance for 61Cu-NU101 in PSMA-positive prostate cancer compared with an FDA-approved standard of care diagnostic imaging agent. 61Cu-NU101 visualized additional lesions in 50% of the patients which were not seen with the FDA-approved standard of care agent and demonstrated favorable tumor-to-background ratios. The number of detected lesions on the 61Cu-NU101 PET increased for up to 4 hours after administration, highlighting the diagnostic benefits of 61Cu-NU101’s 3.3-hour half-life and high positron yield. Based on these favorable data, NUCLIDIUM is planning to initiate Phase 2 clinical trials for the NU101 diagnostic and therapeutic pair in 2026.

(Press release, NUCLIDIUM, JAN 26, 2026, https://nuclidium.com/nuclidium-announces-issuance-of-new-u-s-patent-covering-its-61cu-based-radiodiagnostic-program-for-psma-positive-prostate-cancer/ [SID1234662211])

First Site Activated and First Patient Randomised in new brain cancer study VIGOR – EORTC‑2427‑BTG

On January 26, 2026 EORTC reported the activation of the first site for the VIGOR study (EORTC-2427-BTG), a pivotal Phase III trial evaluating vorasidenib as maintenance treatment following completion of first-line chemoradiotherapy in patients with IDH-mutant glioma WHO CNS Grade 2 or 3 astrocytoma, worked in collaboration with Servier Affaires Médicales (NCT06809322).

In addition to the first site being activated, the study has already successfully randomised its first patient, marking a strong start to recruitment.

About the VIGOR Study
The VIGOR trial aims to determine whether vorasidenib, an oral brain-penetrant inhibitor of mutant IDH1/2 enzymes, can improve progression-free survival (PFS) compared to placebo, in patients who have completed standard chemoradiotherapy. This approach builds on promising results from the INDIGO trial, which demonstrated significant benefits in delaying disease progression in IDH-mutant gliomas. VIGOR adopts a rigorous design to validate these findings in a broader setting.

It is a Phase III study that is randomised, placebo-controlled, and triple-blind, intending to involve around 470 patients across multiple international sites. The primary endpoint focuses on progression-free survival (PFS) assessed using the RANO 2.0 criteria, while secondary endpoints include overall survival (OS), time to next intervention, safety and adverse events, and health-related quality of life measures, ensuring a comprehensive evaluation of the treatment’s impact.

The VIGOR trial is coordinated by Dr. Matthias Preusser (Medical University of Vienna, Austria) and co-coordinated by Dr. Marjolein Geurts (Erasmus MC Cancer Institute, Rotterdam, The Netherlands).

Dr. Preusser says:

"The VIGOR trial has the potential to define a new standard of care for patients with IDH-mutant gliomas and will provide valuable new insights and opportunities for further research to improve the diagnostic and therapeutic possibilities for this disease".

Dr. Geurts:

"The randomization of the first patient in the VIGOR study is an exciting and important milestone for patients with IDH-mutant astrocytoma. It reflects the strong collaboration and shared commitment to improving outcomes and expanding treatment options early in the disease course. We are very much looking forward to the next milestones as we work together to make a real difference for patients and their families"

Why this study matters
Patients with IDH-mutant astrocytoma typically experience long survival but face inevitable recurrence. VIGOR seeks to establish whether maintenance therapy can extend the time before progression and reduce the need for subsequent interventions, improving long-term outcomes and quality of life.

The activation of the first site, and the successful randomisation of the first patient, represent early and encouraging milestones in this international effort. Recruitment will expand across more than 50 leading cancer centres in Europe and beyond, with EORTC coordinating the study, in collaboration with the Canadian Cancer Trials Group (CCTG) and the Cooperative Trials Group for Neuro-Oncology (COGNO).

(Press release, EORTC, JAN 26, 2026, View Source [SID1234662210])

Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)

On January 26, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib.

"We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "We look forward to the continued collaboration with the FDA as we work to bring the first new treatment option in over twenty years to this patient population."

This Breakthrough Therapy Designation is based on results from the PEAK trial which demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. The combination was well tolerated, and no new safety risks were observed when compared to the known safety profile of sunitinib. Breakthrough Therapy Designation is intended to expedite the review of medicines that treat a serious or life-threatening condition and have shown clinical evidence indicating the potential for substantial improvement over available therapies.

Earlier this month, the FDA agreed to accept Cogent’s NDA under the FDA’s Real-Time Oncology Review (RTOR) program which allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

Cogent plans to present full results from the PEAK trial at a major medical meeting during the first half of 2026. Additionally, in mid-2026 Cogent expects to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.

(Press release, Cogent Biosciences, JAN 26, 2026, View Source [SID1234662208])