On December 18, 2025 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that members of the Replimune management team will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 at 1:30 PM PT.

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!

A simultaneous webcast will be available in the Investors section of Replimune’s website at replimune.com. A replay will be available for 30 days following the conference.

(Press release, Replimune, DEC 18, 2025, View Source [SID1234661535])

On December 18, 2025 Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable precision radiopharmaceuticals for cancer, reported that Lori Lyons-Williams, president and chief executive officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 at 10:00 a.m. PT.

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!

Ms. Lyons will provide an overview of the company and its pipeline of first-in-class radiotherapeutics, including ABD-147 targeting delta-like ligand 3 (DLL3) that is currently being evaluated in a Phase 1 clinical trial for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC), and ABD-320, targeting 5T4 with pan-cancer potential, which is on-track to enter clinical development in 2026.

(Press release, Abdera Therapeutics, DEC 18, 2025, View Source [SID1234661551])

On December 18, 2025 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with resectable pancreatic ductal adenocarcinoma (PDAC) who have received surgery and chemotherapy.

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!

RASolute304.jpeg
Revolution Medicines RASolute 304 clinical trial logo
RASolute 304 is anticipated to enroll approximately 500 patients with PDAC harboring oncogenic RAS mutations who have undergone resection and completed perioperative chemotherapy. The trial will assess whether daraxonrasib can improve disease-free survival compared to observation. The primary endpoint in RASolute 304 is disease-free survival, and secondary endpoints include overall survival, safety, and tolerability.

"We are pleased to begin enrolling patients into RASolute 304, which expands the clinical evaluation of daraxonrasib into another important treatment setting for patients with RAS mutant pancreatic cancer," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "This trial enables us to investigate daraxonrasib even earlier in the treatment paradigm, which could potentially improve the rate of long-term disease-free survival in patients with resectable pancreatic cancer."

Daraxonrasib is currently being evaluated in four global Phase 3 clinical trials, including three trials in PDAC and a trial in locally advanced or metastatic RAS mutant non-small cell lung cancer.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.3,4

About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

(Press release, Revolution Medicines, DEC 18, 2025, View Source [SID1234661536])

On December 18, 2025 Daiichi Sankyo and Merck & Co. reported that phase 3 program for their investigational antibody-drug conjugate has been hit with a hold after an unexpected number of deaths were reported in the global trial.

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!

"Due to a higher than anticipated incidence of grade 5 interstitial lung disease (ILD) events identified in the IDeate-Lung02 phase 3 trial, Daiichi Sankyo initiated a voluntary pause in recruitment and enrollment," a spokesperson for the partners told Fierce Biotech. The companies did not answer questions regarding how many deaths have occurred.

"Following the initial pause, the FDA has placed the trial on a partial clinical hold," the spokesperson explained.

The unexpected deaths come as the pharma partners said they were aiming for an accelerated approval of the investigational B7-H3-directed ADC—known as ifinatamab deruxtecan or I-DXd—for pretreated small cell lung cancer (SCLC) based on a phase 2 readout. In 2023, Merck paid out $5.5 billion in upfront and near-term payments to gain access to a clutch of Daiichi’s ADCs.

Under the hold, Daiichi will work with the FDA and an independent data monitoring committee to review safety data and "determine any necessary further actions," the spokesperson told Fierce.

"Of note, it does not impact other studies in the I-DXd clinical development program," the spokesperson added.

Patients currently enrolled in IDeate-Lung02 will be able to continue treatment, but no new participants will be recruited during this time, according to the spokesperson.

"We are evaluating the potential impact of the partial clinical hold on study data readout timing, currently projected for fiscal year 2027," the spokesperson said.

The deaths and consequential hold have not been announced publicly by either Merck or Daiichi, but instead were first reported by oncology-focused publication ApexOnco. The temporary halts began in several European countries—such as France, Germany and Italy—at the end of September, according to the European clinical trial registry.

(Press release, FierceBiotech, DEC 18, 2025, https://www.fiercebiotech.com/biotech/patient-deaths-prompt-partial-hold-daiichi-mercks-global-phase-3-adc-program [SID1234661552])

On December 17, 2025 Cofactor Genomics, a leader in cancer immunotherapy predictive diagnostics, reported results from the PREDAPT non-small cell lung cancer (NSCLC) trial validating the company’s OncoPrism-NSCLC test. OncoPrism-NSCLC is powerful clinical tool to identify which patients with late stage NSCLC are most likely to benefit from immune checkpoint inhibitor (ICI) therapy—enabling more precise, timely, and cost-effective treatment strategies in oncology.

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!

The study evaluated a total of 1,487 patient samples drawn from four independent NSCLC cohorts, making it one of the most extensive biomarker validation efforts in immuno-oncology to date. These studies included two ICI-treated cohorts—195 patients treated with anti-PD-L1 agents and 89 from the multi-center PREDAPT cohort treated with anti-PD-1 therapies—as well as two non-ICI-treated cohorts (n=193 and n=1,010, respectively). Across the ICI-treated groups, OncoPrism-NSCLC consistently predicted key clinical outcomes, including overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Crucially, OncoPrism-NSCLC showed no predictive signal in the two non-ICI cohorts, confirming that it is a predictive biomarker of ICI benefit rather than a general prognostic tool.

The findings also revealed that OncoPrism-NSCLC outperformed the current standard-of-care biomarker, PD-L1 Tumor Proportion Score (TPS), which showed no correlation with response, PFS, or OS in the PREDAPT cohort. In contrast, patients identified as "OncoPrism High" had a two to three-fold improvement in all three measures compared to lower scoring groups. These results offer oncologists a clinically actionable alternative to PD-L1 TPS, which has long struggled with limited predictive power and assay variability.

"For more than a decade, clinicians have lacked a reliable test that predicts which lung cancer patients will benefit from immunotherapy—leaving physicians and patients to make high-stakes decisions with limited information," said Jarret Glasscock, PhD, CTO of Cofactor Genomics and senior author on the publication. "This study, drawing on nearly 1,500 NSCLC patient samples from four independent cohorts, finally delivers what the field has been asking for: a powerful immunotherapy predictive diagnostic, rather than a prognostic marker with limited clinical utility. OncoPrism-NSCLC brings precision medicine to immunotherapy."

The test uses RNA extracted from routine formalin-fixed, paraffin-embedded (FFPE) tumor biopsy samples, making it compatible with standard clinical workflows. In addition to its analytical robustness, the test demonstrated strong reproducibility across reagent lots, operators, and processing conditions—critical attributes for robust clinical use. OncoPrism-NSCLC was initially launched last year and is run in Cofactor’s CAP-accredited, CLIA-certified laboratory. These results confirm the test’s robust predictive performance.

Key readouts from the PREDAPT NSCLC study are now available as a preprint on MedRxiv. Cofactor encourages oncologists, researchers, and healthcare partners to review the findings and learn more about how OncoPrism-NSCLC is changing the landscape of immunotherapy selection.

(Press release, Cofactor Genomics, DEC 17, 2025, View Source [SID1234661513])