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SN BioScience received US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug ‘SNB-101’ on Gastric Cancer.

On December 23, 2025 SN Bioscience Inc. (CEO Young Hwan PARK) reported that the FDA had granted Orphan Drug Designation (ODD) on December 10 for gastric cancer (including gastroesophageal junction cancer) to SNB-101 (API: SN-38) which is a polymer nanoparticle drug under phase 1b/2 clinical trial for small cell lung cancer.

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SNB-101 is the world’s first nanoparticle anticancer drug that has formulated extremely insoluble SN-38 into polymer nanoparticles, which is expected to significantly improve therapeutic efficacy and reduce side effects. It is currently undergoing active clinical development for various solid tumor indications in Korea, Europe, and the U.S.A.

Gastric cancer is classified as an extremely rare disease (with a prevalence <200,000) in the U.S. with a 5-year relative survival rate of only about 36% across all stages. Currently, the standard of care for advanced gastric cancer includes cytotoxic chemotherapy (such as irinotecan and paclitaxel) and targeted therapies like trastuzumab for HER2-positive patients. However, the prognosis for patients with advanced stages remains poor. Many patients eventually develop resistance to these first-line treatments or experience disease progression, leaving them with limited effective therapeutic options. According to SN Bioscience, SNB-101 showed excellent efficacy compared to existing standard of care treatments such as paclitaxel, irinotecan and trastuzumab in gastric cancer animal models.

Orphan drug designation is a program where the US FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. This designation provides the qualified drug developers with various benefits such as exclusive rights for 7 years from the date of marketing approval, tax credits for R&D costs, assistance for clinical trial design for clinical development, exemption from review application fees, and priority review support.

SNB-101 previously received ODDs from the US FDA for small cell lung cancer in July 2023 and pancreatic cancer in February 2024. By receiving an ODD for gastric cancer this time, SN Bioscience expects to gain momentum in indication expansion and clinical development.

(Press release, SN BioScience, DEC 23, 2025, View Source [SID1234661615])

Fapon Biopharma Publishes Pioneering Research in Cell Reports Medicine on FP008, an anti-PD 1 X IL-10M Fusion Protein for Cancer Immunotherapy

On December 23, 2025 Fapon Biopharma, a biotech in developing therapeutic biologics including cytokine-antibody fusion proteins and T-cell engagers, reported the publication of pioneering research on FP008, a novel fusion protein in Cell Reports Medicine. The peer-reviewed article details the preclinical and translational validation of FP008 (anti-PD-1 × IL-10M). This first-in-class bifunctional fusion protein is designed to address a fundamental limitation in cancer immunotherapy: the inability to reactivate terminally exhausted T cells within tumors.

Interleukin-10 (IL-10) has shown potential to directly activate and expand exhausted CD8⁺ T cells, but its clinical application has been constrained by dose-limiting hematological toxicities. Fapon’s research team addressed this limitation by engineering IL-10 into a monomeric form (IL-10M). As reported, the engineered IL-10M demonstrated a significant reduction in toxicity. The innovative "cis-delivery" mechanism enabled targeted enrichment of IL-10M onto PD-1-positive exhausted CD8⁺ T cells within the tumor micro-environment. This approach mitigates systemic toxicity while potentially enhancing anti-tumor immune responses.

The study demonstrated FP008’s robust anti-tumor activity across multiple mouse tumor models, including those resistant to anti-PD-1 therapy. FP008 reversed terminal exhaustion of CD8⁺ T cells and restored their functional capacity through localized activation, minimizing systemic exposure.

In comprehensive GLP toxicology studies in cynomolgus monkeys, FP008 exhibited a favorable safety profile at doses up to 10 mg/kg, with no significant hematological adverse events observed. The data supported that this approach has the potential to overcome prior clinical limitations of IL-10-based therapies.

FP008 has cleared an Investigational New Drug (IND) application with the U.S. FDA and China NMPA. Phase I clinical trial is currently ongoing with readout expected later this year. FP008 represents a novel therapeutic strategy for patients with advanced solid tumors refractory to or relapsed from PD-1/PD-L1 checkpoint inhibitors.

(Press release, Fapon Biopharma, DEC 23, 2025, View Source [SID1234661614])

Phio Pharmaceuticals Announces Significant Step Forward in its Drug Development Program for PH-762

On December 23, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer. Phio reported that it has taken a major step forward in its drug development program for PH-762. The company will begin a toxicology study, which is required by the FDA prior to commencing a human pivotal trial. Concurrently, initiatives are continuing to advance the delivery of commercially viable drug product in 2026 that meets FDA’s current Good Manufacturing Practices. A portion of the net proceeds from Phio’s recent financing is being directed to these two major initiatives.

Recently, positive interim safety and efficacy results were reported in the on-going Phase 1b dose escalation clinical trial with the INTASYL compound PH-762 for the treatment of skin cancer. To date, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose escalating cohorts in the Phase 1b trial. The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance). Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients in the study, however, exhibited clinical progression of disease. To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort.

"The conduct of this nonclinical study is a very significant step in progressing the drug development pathway of PH-762 toward an NDA approval. Phio’s communication with FDA is essential in advancing our development strategy for PH-762," stated Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals. "In addition, the initiative to deliver commercially viable drug product from our US supplier is on target for later in 2026. This is another critical advancement in the drug development program of PH-762."

(Press release, Phio Pharmaceuticals, DEC 23, 2025, View Source [SID1234661613])

Agenus Reports Deep, Durable Responses with Botensilimab + Balstilimab in Highly Refractory Ovarian Cancer, Published in JITC

On December 23, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported the publication of clinical results from the ovarian cancer cohort of its Phase 1b C-800-01 trial evaluating botensilimab plus balstilimab (BOT+BAL) in The Journal for ImmunoTherapy of Cancer (JITC).

The peer-reviewed manuscript titled, "Botensilimab (Fc-enhanced anti–CTLA-4 antibody) plus balstilimab (anti–PD-1 antibody) in patients with treatment-refractory ovarian cancer," is available online here.i

In this heavily pretreated population, BOT+BAL demonstrated clinically meaningful activity and durable benefit in women with treatment-refractory ovarian cancer, a population with few remaining options. The combination achieved a 23% overall response rate and 31% clinical benefit rate, including durable responses with a median duration of 9.7 months. Median overall survival reached 14.8 months, with an estimated of 75% of patients alive at 12 months.

These findings build on results from the broader C-800-01 dataset presented at ESMO (Free ESMO Whitepaper) 2025, where BOT+BAL showed activity across multiple refractory solid tumors. Collectively, these data reinforce the potential of BOT+BAL to generate meaningful immune responses in cancers historically considered unresponsive to immunotherapy.

High Unmet Need in Treatment-Refractory Ovarian Cancer

Ovarian cancer causes approximately 13,000 deaths annually in the U.S. and 200,000 globallyii,iii, and outcomes are particularly poor once tumors become platinum-resistant or platinum-refractory. Therapy with first-generation checkpoint inhibitors has yielded modest responses, with objective response rates between 8–10% and median progression-free survival of roughly 2 monthsiv,v, leaving many women with rapidly diminishing options and no approved immunotherapy combinations.

Publication Highlights

The study enrolled 44 women with treatment-refractory ovarian cancer who had received multiple prior lines of therapy. Nearly three-quarters were platinum-resistant or platinum-refractory, and most had high-grade serous tumors.
Activity was demonstrated in primary platinum-refractory patients—a rare and high-risk group often excluded from clinical studies.
Responses occurred in multiple ovarian cancer subtypes including high-grade serous, clear cell, and endometrioid tumors.
The BOT+BAL combination demonstrated a manageable and reversible safety profile, consistent with CTLA-4 and PD-1 therapy. Most common treatment-related adverse events such as diarrhea/colitis (43%; 16% grade 3), fatigue and nausea (36%) were effectively managed using established treatment guidelines. No treatment-related deaths were reported.
Steven O’Day, MD, Chief Medical Officer, Agenus, commented, "These results offer a meaningful signal of clinical activity for women with platinum-refractory ovarian cancer, a group that has seen little therapeutic progress. Botensilimab’s unique immune activation profile translated into clinically significant responses in a population long considered resistant to immunotherapy. These findings strengthen our confidence in BOT+BAL’s potential and support moving this combination into larger, randomized studies."

Rebecca Porter, M.D., Ph.D., Dana-Farber Cancer Institute and Lead Author added, "These women faced some of the most treatment-resistant forms of ovarian cancer, yet several achieved meaningful and durable benefit. Seeing this level of activity in such a heavily pretreated population is encouraging and provides important insights to the field regarding therapy approaches for patients with very limited remaining options."

Patient Access and Ongoing Development

BOT+BAL continues to advance through global clinical development across multiple tumor types. In parallel, eligible patients may be able to access BOT+BAL through regulatory-authorized early access mechanisms, including France’s AAC program, where treatment is reimbursed, as well as paid named-patient programs in select countries where permitted by local regulations. These programs are intended to provide access for patients with serious or life-threatening diseases who lack satisfactory therapeutic alternatives.

(Press release, Agenus, DEC 23, 2025, View Source;Balstilimab-in-Highly-Refractory-Ovarian-Cancer-Published-in-JITC/default.aspx [SID1234661612])

Immuneering to Announce 12-Month Overall Survival Data from Phase 2a Clinical Trial of Atebimetinib + mGnP in First-Line Pancreatic Cancer Patients on January 7, 2026

On December 23, 2025 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that it will host a conference call and live webcast at 4:00 p.m. ET on Wednesday, January 7, 2026 to provide an update on 12-month overall survival (OS) from its ongoing Phase 2a clinical trial of atebimetinib + modified Gemcitabine / nab-paclitaxel (mGnP) in first-line pancreatic cancer patients.

"We are excited to share updated overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "We are increasingly confident in atebimetinib’s ability to extend and improve the lives of patients with pancreatic cancer."

The conference call will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

(Press release, Immuneering, DEC 23, 2025, View Source [SID1234661609])