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Immunome to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors

On December 14, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the company will host a conference call and webcast on Monday, December 15, 2025 at 8:30 am ET to disclose the topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat, an investigational, oral, once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors.

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Webcast, Presentation Slides and Conference Call Information

Immunome will host a webcast and conference call on Monday, December 15, 2025, at 8:30 a.m. ET / 5:30 a.m. PT to discuss the Phase 3 RINGSIDE trial topline results. A live webcast, which will include presentation slides, can be accessed using this link or by visiting the Events and Presentations section of the Immunome website at View Source The conference call can be accessed by clicking on the call link and completing the online registration form, which will enable the selection of a dial-in number or callback from the system. A live question-and-answer session will follow the prepared remarks. Participants wishing to ask a question must do so via the conference call; the webcast will be listen-only. After the live webcast, the event will remain archived on the Immunome website for 90 days.

(Press release, Immunome, DEC 14, 2025, View Source [SID1234661414])

Zelluna Completes First GMP Batch of ZI-MA4-1, a Novel TCR-NK Cell Therapy, to Treat Patients in Upcoming First-in-Human Trial

On December 12, 2025 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of cancer, reported the successful manufacture and QC (Quality Control) testing of the first GMP (Good Manufacturing Practice) batch of its lead candidate, ZI-MA4-1. This material is intended for use in Zelluna’s upcoming first-in-human clinical trial, marking a major milestone in the company’s progress toward regulatory submission and patient dosing.

The GMP batch was successfully produced using Zelluna’s proprietary manufacturing process, which was finalised and locked in April 2025. The process is designed to deliver high-quality TCR-NK products, with the ability to generate hundreds of doses from a single manufacturing run, offering both broad patient access and cost-of-goods advantages.

"Having our first GMP batch in storage and ready for our first clinical trial fills us with hope and excitement as we move closer to bringing our TCR-NK therapies to patients," said Emilie Gauthy, Head of CMC at Zelluna. "This successful GMP run, backed by our robust development data, strengthens our confidence in delivering safe, potent, and consistent therapies at a scale capable of meeting patient’s needs."

ZI-MA4-1 is the world’s first MAGE-A4-targeting TCR-NK therapy, designed to harness both the innate cancer-killing properties of NK cells and the precision targeting of affinity-enhanced TCRs. The therapy aims to overcome key challenges facing current cell therapies in solid tumours, including tumour heterogeneity and antigen loss, while offering an anticipated favourable safety profile and broad patient access.

"As we approach CTA submission, this achievement represents the final operational step on our path to the clinic," said Namir Hassan, CEO of Zelluna. "Together with our compelling preclinical data showing ZI-MA4-1’s potent and selective activity in solid tumour models, this milestone underscores the strength of our science, our process, and our team. We believe ZI-MA4-1 is a highly differentiated therapy with the potential to redefine what is possible for patients with solid tumours. This is a proud and energising moment for everyone at Zelluna."

Zelluna remains on track to submit a CTA for ZI-MA4-1 in 2H 2025 with initial clinical data expected mid-2026.

(Press release, Zelluna Immunotherapy, DEC 12, 2025, View Source [SID1234664035])

BeyondSpring Announces ESMO Asia Presentation on Plinabulin + Docetaxel Improving Survival in Large Phase 3 DUBLIN-3 Asian Subset for EGFR WT NSCLC Compared to Docetaxel, Strengthening the Case for a Global Registration Path

On December 12, 2025 BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, reported results from the Asian subset (n=488) of its global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel compared to docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer (NSCLC). Dublin-3’s global intent-to-treat (ITT) patient data was published in Lancet Respiratory Medicine in 2024. These new findings were presented by Dr. Baohui Han of Shanghai Chest Hospital at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2025.

In this large Asian intent-to-treat cohort, Plinabulin + docetaxel (DP, n=243) achieved a statistically significant improvement in overall survival compared to docetaxel (D, n=245): DP 10.8 months vs. D 8.8 months, HR 0.81, p=0.0426.

In the mechanism-based non-squamous subgroup, the hazard ratio was 0.69 with a median OS benefit of 3 months (p=0.0064), highlighting enhanced benefit in patients whose disease biology aligns with Plinabulin’s immune-modulating and tumor vasculature-targeting mechanisms.
The combination also doubled 2-year and 3-year survival rates, reflecting durable benefit consistent with Plinabulin’s first-in-class dendritic-cell maturation mechanism.

Plinabulin demonstrated a marked reduction in docetaxel-induced grade 4 neutropenia (DP: 3.9% vs. D 26.5%, p<0.0001), while maintaining a favorable tolerability profile. This safety improvement supports better treatment exposure, an important driver of chemotherapy benefit.

"These data from nearly 500 Asian patients further strengthen the robust global evidence supporting Plinabulin’s potential to become a new standard of care for EGFR wild-type NSCLC," said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring.

"The consistent survival benefit, particularly in the mechanism-aligned non-squamous population, together with the marked reduction in severe neutropenia, reflects Plinabulin’s first-in-class immune-modulating mechanism and its ability to improve chemotherapy tolerability. These results reinforce our confidence as we advance Plinabulin into a global Phase 3 confirmatory study."

About Plinabulin

Plinabulin is a first-in-class, brain-penetrating, dendritic-cell maturation small molecule. It has been used in over 700 cancer patients, with good tolerability and showed durable anti-cancer benefit across multiple clinical studies. As a reversible binder at a distinct tubulin pocket, plinabulin does not change tubulin dynamics or antagonize tubulin stabilizing agents, such as docetaxel, which contributes to its differentiated activity and tolerability compared to other tubulin binders. In addition, plinabulin significantly reduces chemotherapy-induced neutropenia and could thereby increase docetaxel tolerability.

About DUBLIN-3 Study (103 Study)
DUBLIN-3 (n=559, NCT02504489) was a multicenter, single-blinded (patient) and randomized, phase 3 trial in 58 medical centers (US, China, and Australia). Only patients with EGFR wild-type NSCLC who had progressed after first-line platinum-based therapy were enrolled. Patients were randomized (1:1) to receive docetaxel (75 mg/m2) on Day 1 and either plinabulin (30 mg/m2) or placebo on Days 1 and 8 in 21-day cycles until progression, unacceptable toxicity, withdrawal, or death. Treated patients were included in the safety analysis and ITT population in the primary efficacy analyses. The primary endpoint for the study was OS, and secondary endpoints were PFS, ORR, Duration of Response (DoR), Grade 4 neutropenia and Quality of Life. The study was published in Lancet Resp Med 12:775, 2024.

(Press release, BeyondSpring Pharmaceuticals, DEC 12, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-esmo-asia-presentation-on-plinabulin-docetaxel-improving-survival-in-large-phase-3-dublin-3-asian-subset-for-egfr-wt-nsclc-compared-to-docetaxel-strengthening-the-case-for-a [SID1234661418])

Gilead Provides Update on Phase 3 STAR-221 Study

On December 12, 2025 Gilead Sciences and Arcus Biosciences reported the discontinuation of the Phase 3 STAR-221 study evaluating the anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and chemotherapy versus nivolumab plus chemotherapy as first-line treatment for HER2-negative advanced gastric and esophageal cancers. The decision is based on the recommendation from the Independent Data Monitoring Committee (IDMC) following their review of data from a pre-specified interim analysis of overall survival (OS).

In the pre-specified interim analysis, the combination of domvanalimab plus zimberelimab and chemotherapy did not improve OS relative to nivolumab plus chemotherapy, the standard of care, and there was low likelihood of achieving a positive survival benefit with further follow-up. The safety profile for the combination of domvanalimab plus zimberelimab and chemotherapy was consistent with the control arm, nivolumab plus chemotherapy, and there were no new safety findings.

The companies are informing regulators and communicating with investigators for the STAR-221 and the Phase 2 EDGE-Gastric studies to determine appropriate next steps for patients. The companies are conducting a detailed analysis to understand these results, which will be published in the future.

"These results offer valuable insights into the complexity of treating advanced gastroesophageal cancers," said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. "We will collaborate closely to understand the full scope of the data and engage key stakeholders in determining the appropriate next steps. We are deeply grateful to the patients, families, and healthcare professionals who participated in the STAR-221 study and contributed to this important work."

Currently, there are no changes to other ongoing domvanalimab studies beyond the upper gastrointestinal (GI) program. Arcus and Gilead will share further guidance as it becomes available.

Domvanalimab and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

(Press release, Gilead Sciences, DEC 12, 2025, View Source [SID1234661411])

Natera and MEDSIR to Collaborate on the MiRaDoR Trial in Breast Cancer

On December 12, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and MEDSIR (Medica Scientia Innovation Research), a global leader in oncology research, reported their collaboration on the MiRaDoR (NCT05708235) study, which is a multicenter, phase II clinical trial in hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer.

Breast cancer is the most common cancer in women worldwide, with approximately 2.3 million new cases diagnosed in 2022.1 Despite advances in treatment, recurrence remains a key concern for patients with HR+/HER2- disease, which represents roughly 70% of all breast cancer cases.2

Funded by F. Hoffman-La Roche Ltd., and sponsored by MEDSIR, MiRaDoR will use Signatera Genome to evaluate the efficacy of different therapeutic approaches in early-stage HR+/HER2- breast cancer. Up to 60 patients who are Signatera-positive without clinical nor radiological evidence of disease recurrence will be sequentially enrolled into one of four treatment arms:

Arm A: Standard of care endocrine therapy given during the first 90-day period, then patients switch to Arms B, C or D
Arm B: Giredestrant (oral selective estrogen receptor degrader)
Arm C: Giredestrant plus Abemaciclib (CDK4/6 inhibitor)
Arm D: Giredestrant plus Inavolisib (PIK3CA inhibitor; for patients with PIK3CA mutations)
The trial will enable investigators to evaluate serial circulating-tumor DNA (ctDNA) levels in each treatment arm as a predictive marker of treatment response. The study’s primary endpoint is the proportion of patients who have achieved a 90% decrease or clearance in baseline ctDNA after three months of treatment. Participants will have additional Signatera testing at 6, 9 and 12 months, and every six months thereafter until study treatment discontinuation. Results may help determine if specific therapy combinations are more effective in terms of ctDNA decrease than standard of care endocrine treatment.

"Uniting Signatera Genome’s ability to detect molecular residual disease with genomic profiling creates a new standard for precision oncology clinical trials," said Angel Rodriguez, M.D., senior medical director of oncology at Natera. "In the MiRaDoR trial, investigators are moving beyond surveillance; they are also characterizing the specific genomic driver, PIK3CA, and no longer just asking ‘is the cancer back?’ but also answering ‘how do we treat it?’"

Enrollment for MiRaDoR is underway, with several U.K. sites already active and additional site activations expected in Europe in 2026.

(Press release, MedSIR, DEC 12, 2025, View Source [SID1234661410])