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.

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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])

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.

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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])

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])

On December 23, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage companies focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported continued progress across its AI-enabled drug development platform at its 2025 annual investor conference, reinforcing its strategic position as the global immuno-oncology landscape enters a period of generational transition.

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Global blockbuster immune-oncology products now face major patent expirations before 2030 pharmaceutical companies are either actively developing or acquiring next-generation assets that are highly combinable, scalable across multiple tumor types with potential of becoming treatment standard in different types of cancers. Senhwa is addressing this demand through an integrated strategy that combines artificial intelligence validation, precision clinical development, and global pharmaceutical partnerships.

Recently, Google DeepMind applied its latest C2S-Scale biological AI model to analyze more than 4,000 drug candidates and identified Senhwa’s lead compound Silmitasertib (CX-4945) as the most potential compound to revigorate immune system to combat with cancer. The study, supported by Google’s computing infrastructure, DeepMind’s proprietary AI models, and preclinical validation conducted by Yale University, demonstrated that CX-4945 significantly enhances tumor antigen presentation—an essential mechanism for improving immune recognition of cancer cells.

This independent third-party validation highlights the potential of CX-4945 as an immune-sensitizing agent and represents a notable milestone in the application of AI to oncology drug discovery. By addressing the long-standing challenge of immunologically "cold" tumors, which had limited response to immunotherapy, CX-4945 has a unique position in the rapidly expanding field of cold-to-hot tumor conversion.

In parallel, Senhwa continues to advance its clinical pipeline through strategic international collaboration. The company recently announced a clinical collaboration with BeOne Medicines to evaluate Senhwa’s lead candidate, Pidnarulex (CX-5461), in combination with BeOne’s commercially approved, best-in-class PD-1 inhibitor tislelizumab. The initial focus of the collaboration includes pancreatic cancer and advanced solid tumors, including immunotherapy-resistant melanoma.

CX-5461 is a first-in-class small molecule with a differentiated dual mechanism of action that stabilizes DNA G-quadruplex (G4) structures while inhibiting RNA polymerase I (Pol I). This dual activity induces replication stress in tumor cells and activates the innate immune cGAS–STING pathway, effectively converting immune-cold tumors into immune-active environments. Robust preclinical data supports the application of CX-5461 in enhancing the efficacy of existing immunotherapies and becoming the ideal candidate for combination therapy with immune-oncology products.

Senhwa believes this pathway-level, multi-target strategic approach positions CX-5461 as a potential next-generation treatment back bone in cancers where immunotherapy is used, rather than positioning the compound as a single-asset or indication-specific solution. This strategic positioning has attracted interest from global pharmaceutical companies seeking high value added platform assets, as reflected by ongoing and prior collaborations involving leading multinational partners.

Looking ahead, Senhwa expects multiple value-driving catalysts over the next one to three years, including clinical data readouts for CX-5461 and CX-4945, expansion of global partnerships, potential licensing collaborations, and increased visibility at major international medical conferences such as ASCO (Free ASCO Whitepaper), AACR (Free AACR Whitepaper), and ESMO (Free ESMO Whitepaper).

"Senhwa has transitioned beyond early-stage discovery and development into a company building a scalable, AI-validated oncology platform," said the Company. "At a pivotal moment for immuno-oncology, we are focused on advancing differentiated science with the potential to create long-term value for patients, partners, and shareholders."

(Press release, Senhwa Biosciences, DEC 23, 2025, View Source [SID1234661616])

On December 23, 2025 Vyriad, Inc., a clinical-stage biotechnology company developing targeted genetic therapies for cancer and other serious diseases, reported the closing of the $25M final tranche to its Series B financing, bringing the total Series B round to $85M. This additional funding supports the imminent first-in-human testing of VV169, Vyriad’s in vivo CAR-T candidate, in patients with relapsed or treatment-refractory multiple myeloma.

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The Series B, including this latest tranche, was led by Mr. Harry Stine of Stine Seed Farms, Inc., the world’s largest private seed company and a technology leader in plant genetics. Several significant family offices also participated.

"Our mission is to transform the future of medicine with targeted genetic therapies," said Vyriad co-founder and CEO, Dr. Stephen Russell. "We are excited to launch the first-in-human Phase 1 clinical trial of VV169 and bring this therapy to patients. Our work builds on years of research and optimization around cell-specific targeting, G-protein engineering, and immune evasion — the core capabilities needed to enable effective CAR T therapies. We’re looking forward to validating our delivery technology platform and our in vivo CAR T therapeutic candidates in the clinic."

"The closing of this final tranche reflects the confidence investors have in the Vyriad team, which continues to be laser-focused on improving patient care based on its best-in-class technology," said Ed Kania, managing partner at Farfield Partners and chairman of the Vyriad board of directors. "The capabilities of this team have already been demonstrated through our partnered programs with Regeneron and Novartis, and it is increasingly clear that the company’s delivery platform has differentiated capabilities in targeted reprogramming of immune cells directly in the body — an advancement that could significantly broaden access to CAR T therapies. We are optimistic about the potential of our wholly owned in vivo CAR T therapy, which will enter the clinic in 2026."

Vyriad’s lentiviral platform leverages engineered G proteins to enable precise, direct in vivo CAR delivery without compromising transduction efficiency. By combining high specificity and blood stability with reduced immunogenicity, this approach eliminates complex ex vivo manufacturing. The result is a scalable solution that significantly expands patient access to CAR T therapies. VV169 is one of the first in vivo CAR T candidates leveraging this platform, combining an engineered CAR transgene with the optimized lentiviral delivery vector LV-169. It is being developed as a single intravenous administration targeting B-cell maturation antigen (BCMA) proteins on malignant cells in multiple myeloma. At the ASH (Free ASH Whitepaper) 2025 Annual Meeting, Vyriad presented preclinical data that showed VV169 completely eliminated disseminated multiple myeloma in all humanized mouse models, even at the lowest dose level.

(Press release, Vyriad, DEC 23, 2025, View Source [SID1234661617])