On December 17, 2025 Talus Bioscience, Inc. ("Talus Bio"), an AI-enabled regulome therapeutics company, reported a strategic collaboration with PRISM BioLab Co., Ltd. ("PRISM") to accelerate the discovery and development of novel small-molecule modulators of transcription factor (TF) and protein-protein interaction (PPI) targets. The collaboration combines Talus Bio’s pioneering regulome profiling and AI-guided drug discovery platform with PRISM’s innovative chemistry.

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"This collaboration gives us an unprecedented opportunity to pursue targets that have resisted conventional drug discovery," said Alex Federation, PhD, CEO and Co-Founder of Talus Bio. "Integrating PRISM’s chemistry with Talus’ regulome profiling and AI models allows us to see, in real time, how compounds reshape transcriptional networks in human cells. It’s a step-change in our ability to drug the undruggable."

Under the agreement, the companies will deploy PRISM’s proprietary small-molecule libraries in Talus Bio’s AI-guided regulome profiling screens to identify and optimize novel compounds against high-value TF and PPI targets. The collaboration aims to generate first-in-class chemical matter with direct functional effects on TF and PPI activity in live human cells. Talus Bio and PRISM will share the costs of discovery research and development and any profits generated from out-licensing and commercialization of discovered drug products.

"We are delighted to partner with Talus on this exciting project," commented Dai Takehara, PRISM’s President and CEO. "We at PRISM have developed chemistries for PPI targets, but because of the complex nature of these targets, it is often challenging to properly model protein-protein interactions in a biochemical assay. Even when we are successful, we can interrogate only one target at a time, whereas Talus can profile hundreds to thousands of these targets in parallel and in their native environment. We believe that the combination of PRISM’s chemistry platform and Talus’s regulome profiling platform has the potential to discover a plethora of inhibitors against previously ‘undruggable’ TF and PPI targets and open a path for the development of novel therapeutics."

This collaboration is a pivotal step in establishing a systematic, scalable strategy to address TF and PPI targets. Together, the companies are creating a unified platform capable of revealing and modulating regulatory mechanisms that have remained undruggable for decades. The approach opens the door to long-needed therapies for transcriptionally driven diseases that lie beyond the capabilities of traditional small-molecule approaches.

Talus Bio will be attending the 2026 J.P. Morgan Healthcare Conference in San Francisco, January 12–15. For information on partnership and co-development opportunities, contact the Talus Bio team here. Follow Talus Bioscience on LinkedIn for the latest news and updates.

(Press release, Talus Bioscience, DEC 17, 2025, View Source [SID1234661516])

On December 17, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of a new study in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The paper, titled "Broad Utility of Ultrasensitive Analysis of ctDNA Dynamics across Solid Tumors Treated with Immunotherapy," details results from Dr. Rodrigo Toledo and a leading team at the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain. The study provides compelling clinical evidence that the company’s ultra-sensitive, tumor-informed molecular residual disease (MRD) assay, NeXT Personal, can effectively predict patient outcomes across a diverse set of cancers and immunotherapy modalities.

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The study analyzed 202 patients with stage IV solid tumors—spanning 24 different cancer types—treated with immune checkpoint inhibitors and other immunotherapies. Utilizing a personalized testing approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor, the NeXT Personal test achieves ultrasensitive detection of small traces of circulating tumor DNA (ctDNA) from a patient’s blood sample.

Key findings published in Clinical Cancer Research include:

High Sensitivity: The test detected ctDNA in 98% of patients at baseline across all 24 tumor types, demonstrating robust performance even in a diverse set of cancers.
Early ctDNA Dynamics are Highly Prognostic: Patients who demonstrated decreases in ctDNA levels early in immunotherapy treatment had significantly higher overall survival. Conversely, patients with increasing ctDNA levels early while on immunotherapy had a zero percent overall response rate.
Durable ctDNA Clearance was a Positive Predictor: Patients who achieved durable molecular clearance (negative ctDNA for at least 180 days) had 100% overall survival (OS) in the study.
"We are excited about these results showing how NeXT Personal can be used to monitor therapy in late-stage metastatic patients," said Rich Chen, M.D., M.S., Chief Medical Officer and Executive Vice President, R&D at Personalis. "This study, together with our previous publications, shows the broad potential impact of ultrasensitive ctDNA testing, both in early and late stage cancers."

Dr. Rodrigo Toledo, Group Leader of the Biomarkers and Clonal Dynamics Laboratory at VHIO and senior author of the study, noted, "immunotherapy has revolutionized cancer care, but response patterns can be difficult to interpret using imaging alone. Our findings show that ultrasensitive ctDNA dynamics provide a clear, early molecular view of benefit or non-response, offering a powerful tool to guide patient management across a broad spectrum of solid tumors."

(Press release, Personalis, DEC 17, 2025, View Source [SID1234661515])

On December 17, 2025 Incyte (Nasdaq:INCY) reported that the European Commission (EC) has approved Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.

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"The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL," said Bill Meury, President and Chief Executive Officer, Incyte. "Historically, FL patients have had limited treatment options in the second-line setting, and we are proud to drive this important advancement for the lymphoma community as we seek to deliver innovative medicines for patients with cancer."

The EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in November 2025. This marks the second indication for Minjuvi, which was previously approved by the EC in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The EC decision is based on data from the Phase 3 inMIND trial evaluating the efficacy and safety of Minjuvi in combination with rituximab and lenalidomide as a treatment for patients with relapsed or refractory FL. Results from the trial showed that Minjuvi combined with rituximab and lenalidomide met its primary endpoint. The data demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab. Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56].

Minjuvi was generally well-tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of tafasitamab to lenalidomide in combination with rituximab. The most common adverse reactions in the Phase 3 study (≥20%) in recipients of Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough.2

FL is the most common slow-growing form of B-cell non-Hodgkin lymphoma (NHL), representing about 30% of NHL cases globally. It is considered incurable, with patients frequently relapsing after initial therapy and experiencing a progressively worsening prognosis with each recurrence.3 Despite advances in treatment, there remains a significant unmet need for additional options for relapsed or refractory FL, with approximately 2-4 out of every 100,000 people affected in Western countries.1

"Relapsed or refractory FL is an incurable, complex and persistent cancer," said Stefano Luminari, M.D., Professor of Oncology, University of Modena and Reggio Emilia, Italy and inMIND study investigator. "The EC approval of Minjuvi in combination with lenalidomide and rituximab represents an important innovation, as it brings the first CD19- and CD20-dual-targeted immunotherapy to eligible patients with FL in Europe, which has demonstrated a meaningful reduction in the risk of disease progression, including among those with high-risk disease."

About inMIND
A global, double-blind, randomized, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years).

The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.

For more information about the study, please visit
View Source

About Minjuvi (tafasitamab)
Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received accelerated approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In the European Union, Minjuvi also received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

Safety Information from the EU Summary of Product Characteristics (SmPC)
Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.

Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded.

In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%).

The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).

Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.

For more information, see the Minjuvi SmPC.

(Press release, Incyte, DEC 17, 2025, View Source [SID1234661514])

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.

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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])

On December 17, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company will participate in the following investor events:

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Zanidatamab HERIZON-GEA-01 Investor Webcast on Friday, January 9, 2026

The Company will host an investor webcast on Friday, January 9, 2026, at 6:30 a.m. PT / 3:30 p.m. GMT to review results from the Phase 3 zanidatamab HERIZON-GEA-01 trial. The webcast will include commentary from the Company’s senior management and Dr. Geoffrey Ku, Associate Attending physician on the Gastrointestinal Oncology Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center. The webcast will take place following the oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) on January 8, 2026.

44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026

The Company will webcast its corporate presentation at the 44th Annual J.P. Morgan Healthcare Conference. Renee Gala, president and chief executive officer, will provide an overview of the company strategy and a business update on Tuesday, January 13, 2026, at 11:15 a.m. PST / 7:15 p.m. GMT.
Audio webcasts of the presentations may be accessed via the Investors section of the Jazz Pharmaceuticals website at View Source A replay of the webcasts will be available on the website for 30 days.

(Press release, Jazz Pharmaceuticals, DEC 17, 2025, View Source [SID1234661512])