On December 8, 2025 Pillar Biosciences and AstraZeneca reported an expansion of their existing laboratory access program for NGS-based kitted liquid biopsy tumor profiling to include China.

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This expanded collaboration aims to deliver rapid, cost-effective, and clinically actionable genomic insights through liquid biopsy testing. By increasing the local availability of plasma-based tumor profiling at leading clinical laboratories in China, the partnership seeks to accelerate diagnostic turnaround times and improve access to precision oncology solutions.

China faces one of the world’s highest cancer burdens, accounting for approximately 24% of new global cancer cases and 30% of cancer-related deaths, according to the World Health Organization’s GLOBOCAN 2022 report. Lung, colorectal, and liver cancers remain among the most prevalent, and access to early detection and molecular diagnostics continues to be a significant healthcare challenge. By expanding localized liquid biopsy testing, this collaboration supports China’s ongoing initiatives to enhance early cancer detection, precision diagnostics, and equitable access to targeted therapies.

As part of the initiative, AstraZeneca, Pillar Biosciences, and Shanghai Zhengu Biological Technology Co., Ltd. (Zhengu) will collaborate to support assay validation in local hospital laboratories and facilitate the implementation of Pillar’s liquid biopsy panels to enable localized tumor profiling.

"Expanding access to decentralized, high-quality molecular testing is critical to improving outcomes for cancer patients," said Dan Harma, Chief Commercial Officer, Pillar Biosciences. "By enabling local laboratories to perform in-house next-generation sequencing, we can reduce turnaround times, lower costs, and ensure that oncologists have faster access to actionable insights that guide personalized treatment decisions."

(Press release, Pillar Biosciences, DEC 8, 2025, View Source [SID1234661284])

On December 8, 2025 Cellarity, a clinical-stage biotechnology company developing Cell State-Correcting therapies through integrated multi-omics and AI modeling, reported the presentation of new preclinical data on investigational programs for sickle cell disease (SCD) and myelofibrosis (MF) during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Cellarity has created a novel approach to drug discovery that focuses on understanding the holistic cell state. The Company’s advanced platform leverages high-dimensional transcriptomics and AI predictive algorithms to discover new biological pathways and to create novel, oral therapeutics that can effectively and safely switch disease mechanisms to healthy cell function, termed as "Cell State-Correcting." This has resulted in a growing pipeline of differentiated drug candidates, with the first now in clinical development for sickle cell disease.

"Cellarity’s novel platform is fueling meaningful progress, enabling us to explore a broad set of indications across several therapeutic areas. We are advancing our lead asset in sickle cell disease, CLY-124, currently in phase 1 clinical development, while also progressing a second hematology program focused on myelofibrosis in the preclinical stage," said Ted Myles, Chief Executive Officer of Cellarity. "Together, these efforts reinforce the strength of our platform approach and commitment to delivering highly innovative, novel therapies to patients."

"The presentations at ASH (Free ASH Whitepaper) underscore the power of Cellarity’s novel pipeline of potentially transformative programs in hematology, addressing significant unmet medical need in sickle cell disease and myelofibrosis. CLY-124 has the potential to transform the standard of care in sickle cell disease, as we believe it may induce fetal hemoglobin through a pathway that avoids cytotoxicity that limits other approaches," said Cameron Trenor, M.D., Chief Medical Officer of Cellarity. "In myelofibrosis, we have identified new candidates that are highly selective in targeting pathways implicated in mutant JAK2 signaling, which may result in the avoidance of anemia that is a common side effect associated with other therapies."

CLY-124: A first-in-class, oral globin-switching therapy for sickle cell disease
SCD is a devastating inherited disease involving sickle-shaped red blood cells that block blood vessels. Research has demonstrated that increasing fetal hemoglobin (HbF) reduces vaso-occlusive crises (VOCs), pain and organ damage, yet most compounds that increase HbF are limited by cytotoxicity and highly variable patient response. Using its integrated discovery platform, Cellarity evaluated hemoglobin regulation through erythropoiesis to predict chemical compounds that could enrich fetal hemoglobin, identifying high levels of HbF induction associated with neddylation inhibition. This led to the identification of Defective in Cullin Neddylation 1 (DCN1) – a previously unexplored target for globin gene switching. Knockout of DCN1 in vitro led to increased expression of gamma globin genes (HBG1/2) and a higher ratio of fetal vs total globin gene expression with no evidence of cytotoxicity, illustrating a potentially safer globin-switching mechanism.

CLY-124 is being developed as a potent DCN1 inhibitor with optimized pharmacology and pharmacokinetic properties. Preclinical evaluation of CLY-124 demonstrated superiority to hydroxyurea in both fetal hemoglobin protein and globin gene ratios (HBG1/2 over total beta-like globin transcripts), approaching levels reported for recent gene therapy programs. Further, pre-clinical combination studies demonstrated robust synergistic effects when combining CLY-124 with hydroxyurea and with no dose-limiting toxicities. CLY-124 is currently progressing through a phase 1 dose escalating study in healthy volunteers and adults with sickle cell disease.

Selective targeting of mutant JAK2 to address myelofibrosis
Myelofibrosis is a blood cancer caused by mutated gene called JAK2V617F (JAK2) in stem cells within the bone marrow, causing fibrosis, inflammation, and dysfunctional blood cells that lead to anemia, enlargement of the spleen and eventual bone marrow failure. Current JAK2 inhibitor therapies like ruxolitinib manage disease symptoms but are limited by dose because they inhibit both healthy and mutant JAK2 signaling resulting in cytopenias.

Cellarity leveraged high-dimensional transcriptomics from patient samples to map gene signatures uniquely associated with JAK2-mutant hematopoietic stem cells. Through its AI-powered, transcriptomic-driven discovery platform and iPSC (induced pluripotent stem cell)-based disease models, the company identified a novel, druggable biological target and small molecule interventions that selectively suppress the JAK2-mutant clone while sparing normal hematopoiesis.

(Press release, Cellarity, DEC 8, 2025, View Source [SID1234661300])

On December 7, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that clinical data from its ongoing Phase 2 study of SLS009, a highly selective CDK9 inhibitor, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented today at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 6 – 9, 2025, in Orlando, Florida.

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In this Phase 2 expansion study, R/R AML-MR patients (N = 35 evaluable) were studied in three separate cohorts (cohorts 3-5) who were previously treated with VEN-based regimens and either relapsed and/or were refractory to VEN and were then treated with SLS009 plus AZA/VEN. The median age of participating patients was 69 years, and 98% of patients had ELN adverse-risk AML, with the most frequent mutations being ASXL1, RUNX1, TP53, and SRSF2.

SLS009 in combination with AZA/VEN demonstrated clinically meaningful activity in patients with R/R AML-MR, and among the 35 evaluable patients, the overall response rate (CR+CRi+MLFS) was 46%, including 29% achieving CR/CRi. Patients harboring ASXL1 or TP53 mutations achieved response rates of 48% (19% CR/CRi) and 57% (29% CR/CRi), respectively. The median overall survival (mOS) was exceedingly higher than the expected 2.6 months in this R/R AML patient population, and in the least pretreated cohort, mOS reached 8.9 months. Across all cohorts, patients with one prior line of therapy experienced the greatest benefit, with a 58% response rate and mOS not yet reached. No dose-limiting toxicities (DLTs) or treatment-related deaths were observed, and the combination was well tolerated.

"These results further reinforce the therapeutic potential of SLS009 to overcome resistance to venetoclax-based regimens by suppressing the expression of MCL-1, a key mechanism of resistance to BCL-2 inhibition in AML," said Dr. Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS. "The combination of SLS009 with azacitidine and venetoclax demonstrates encouraging activity in a heavily pretreated population with adverse-risk AML-MR, including those harboring ASXL1 and TP53 mutations. We are particularly encouraged by the strong responses in patients with limited prior therapy and look forward to expanding this combination regimen into newly diagnosed AML with high-risk features."

Presentation Details:

Title: Phase 2 Study of SLS009 in Combination with Azacitidine and Venetoclax for Relapsed/Refractory AML with MDS-Related Changes (AML-MR) After Prior Venetoclax Treatment

Session Date and Presentation Time: Sunday, December 7, 2025, 6:00 – 8:00 PM EST

Session Title: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II

Location: Orange County Convention Center (OCCC) – West Halls B3-B4

Lead Author: Joshua F. Zeidner, MD, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC

Publication Number: 3423

(Press release, Sellas Life Sciences, DEC 7, 2025, View Source [SID1234661216])

On December 7, 2025 Genmab A/S (Nasdaq: GMAB) reported primary data from the pivotal Phase 3 EPCORE FL-1 study evaluating fixed duration EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study showed that treatment with EPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.14-0.31, p<0.0001) compared to standard of care R2. Additionally, the overall response rate (ORR) in patients treated with EPKINLY + R2 was 95% (95% CI: 91.5, 97.4) compared to 79% in patients treated with R2 (95% CI: 73.6, 84.1; P<.0001). The EPCORE FL-1 study results were presented during an oral presentation (abstract 466) at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, Florida, featured in the "Emerging Therapies and Immunotherapies in Blood Cancers" ASH (Free ASH Whitepaper) press briefing, and have been simultaneously published in The Lancet.

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"Patients with relapsed or refractory follicular lymphoma have historically had limited treatment options," said Lorenzo Falchi, M.D., Lymphoma Specialist, Department of Medicine, Memorial Sloan Kettering Cancer Center. "The EPCORE FL-1 results demonstrate that epcoritamab plus R2 is the first bispecific antibody-based, chemotherapy-free combination to show superior clinical benefit over standard of care in a Phase 3 trial, underscoring its potential to redefine the second-line treatment landscape for follicular lymphoma."

The EPCORE FL-1 study included patients with R/R FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors. Among patients who were treated with EPKINLY + R2 at the second planned interim analysis (median follow-up, 14.8 months), 83% achieved a complete response (CR) (n=201/243, 95% CI: 77.4, 87.3) compared to a 50% CR rate among patients treated with R2 (n=122/245, 95% CI: 43.4, 56.2). The 12-month duration of response (DOR) was 89% (95% CI: 83.6, 93.0) versus 49% (95% CI: 38.8, 57.5) for patients treated with EPKINLY + R2 and R2, respectively.

The safety profile of EPKINLY + R2 in the EPCORE FL-1 study was consistent with the known safety profiles of the individual regimens (epcoritamab and R2). Grade 3 or 4 treatment-emergent adverse events (TEAE) were reported in 90.1% of patients treated with EPKINLY + R2 compared to 67.6% of patients treated with R2, the difference being primarily driven by higher rates of Grade 3 or 4 neutropenia (68.7% vs. 42.0%) and infections (33.3% vs. 15.1%). Fatal TEAEs occurred in 1.6% of patients treated with EPKINLY + R2 compared to 3.8% patients treated with R2. TEAEs leading to discontinuation occurred in 18.9% and 12.2% of patients treated with EPKINLY + R2 and R2, respectively. With the three step-up dosing regimen, CRS events were low grade and occurred in 26.3% of patients (21.2% Grade 1, 5.3% Grade 2).

"The pivotal results from the EPCORE FL-1 trial demonstrate the potential of epcoritamab, in combination with established therapies, to enable earlier intervention across sites of care and deliver improved outcomes for patients with relapsed or refractory follicular lymphoma," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We remain committed to developing epcoritamab, as a monotherapy and in combination, as a potential core therapy for B-cell malignancies and as a therapeutic innovation that can shift the treatment paradigm."

In November 2025, the U.S. Food and Drug Administration (FDA) approved the combination of EPKINLY + R2 for the treatment of patients with relapsed or refractory FL after one or more lines of systemic therapy. EPKINLY is also approved in the U.S. to treat adults with relapsed/refractory FL after two or more prior treatments.

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). Patients were randomized to receive EPKINLY in combination with rituximab and lenalidomide (n=243) or rituximab and lenalidomide alone (n=245). Patients received EPKINLY in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR).

About Follicular Lymphoma (FL)
Follicular lymphoma (FL) is typically an indolent, or slow-growing, form of non-Hodgkin lymphoma (NHL), that arises from B-lymphocytes. The second most common form of NHL, FL accounts for 20-30% of all NHL cases and is diagnosed in approximately 15,000 people in the U.S. every year.i,ii FL is considered incurable with current standard of care therapies.iii Patients often relapse, and with each relapse the remission and time to next treatment shorten.iv Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.v

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vi

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with R2 compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, DEC 7, 2025, View Source [SID1234661201])

On December 7, 2025 ImCheck Therapeutics reported updated results from its Phase I/II EVICTION study evaluating ICT01, a first-in-class γ9δ2 T-cell activator, in combination with azacitidine and venetoclax in newly diagnosed AML patients ineligible for intensive chemotherapy. The data were presented by Dr. Sylvain Garciaz (Institut Paoli-Calmettes, Marseille, France) in an oral session at the 67th ASH (Free ASH Whitepaper) Annual Meeting, taking place December 6-9, in Orlando, Florida. The data presentation follows ImCheck’s recently announced agreement to be acquired by Ipsen, pending transaction close.

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The ASH (Free ASH Whitepaper) 2025 dataset builds on the promising efficacy signals previously shared at ASCO (Free ASCO Whitepaper) [2] 2025, highlighting rapid, deep, and durable responses with a favorable safety profile and encouraging early overall survival. Notably, responses were strongest at the 10mg ICT01 dose, which has now been endorsed by the FDA for further development. In 2025, ICT01 also received Orphan Drug Designation from both the FDA[3] and EMA.

"ICT01 continues to demonstrate rapid and durable responses across AML subtypes. The updated ASH (Free ASH Whitepaper) data further strengthens our confidence in ICT01’s ability, when added to Aza-Ven, to deliver deep, lasting remissions that have the potential to translate into meaningful overall survival improvement for patients" said Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. "We see an early onset of complete remissions, consistently strong efficacy at the selected dose across molecular subtypes, and signs of durable responses even in adverse-risk patients. These findings together with the encouraging early survival signal create a compelling case as we advance toward late-stage development."

Key Highlights:
Patient population: At the data cut-off on October 6, 2025, 57 patients aged 51 to 87 had been enrolled. Of these, 41 received 10 mg ICT01 and 16 received 75 mg ICT01, each in combination with Aza-Ven.
Rapid responses: More than 90% of patients treated with ICT01 (10 mg) achieved CRc4 as their best response already by end of Cycle 2.
Broad molecular activity: The 10 mg dose selected for future studies produced higher CR/CRc rates across molecular subtypes, including favorable-, intermediate-, and adverse-risk AML (e.g., TP53-mutated) versus the 75 mg dose.
Durability emerging: At a median follow-up of 10.8 months median DoR[5] was not yet reached for the 10 mg ICT01 dose.
Early survival signal: A 12-month OS[6] rate of 62% was observed, which is numerically higher than the ~54% reported for the Aza-Ven regimen in recent Phase 3 trials.
Favorable benefit–risk profile: Safety of the novel triplet regimen ICT01-Aza-Ven remains well manageable, with a 30-day mortality rate of 4%, and no deaths attributed to ICT01.
Regulatory momentum: ICT01 received Orphan Drug Designation from both FDA and EMA. The 10 mg ICT01 dose has been endorsed by FDA for further clinical development of the triplet regimen.
"ImCheck has in hand the alignment of strong clinical activity, a favorable safety profile, Orphan Drug Designations on both sides of the Atlantic, and now a clear regulatory-endorsed dose for ICT01 for accelerated late-stage development," added Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics. "These results arrive at a transformative moment for ImCheck, following the announced acquisition agreement with Ipsen. We remain deeply grateful to the patients, investigators, and our team for bringing ICT01 to this important inflection point."

(Press release, ImCheck Therapeutics, DEC 7, 2025, View Source [SID1234661217])