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])

On December 7, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a global leader in relapsed/refractory AL Amyloidosis, reported positive phase 2 NXC-201 results in an oral presentation at ASH (Free ASH Whitepaper) 2025 presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center. NXC-201 demonstrated a complete response (CR) rate of 75% (15/20) (at s/u IFE(-) level) by independent review committee. In four out of five pending patients, MRD negativity in bone marrow predicts future complete response, potentially increasing future CR rate to 95%. NEXICART-2 final readout and BLA submission are planned for 2026.

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"In the larger patient set Phase 2 results presented today at ASH (Free ASH Whitepaper), we are thrilled to see complete response rates continue to improve in NEXICART-2. These excellent results demonstrate the potential of NXC-201 to address the significant unmet medical need in relapsed/refractory AL Amyloidosis," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "This exciting Phase 2 milestone brings us one step closer to delivering this promising therapy to patients upon planned BLA submission in 2026."

ASH Presentation Results – Phase 2

Prior to NXC-201 treatment, all patients were exposed to an anti-CD38 antibody and a proteasome inhibitor. Median prior lines of therapy was 4 (range: 1-10). All patients had baseline relapsed/refractory AL Amyloidosis organ involvement. After NXC-201 treatment, complete responses (CRs) were observed in 75% (15 out of 20 patients) (at s/u IFE(-) level) by independent review committee. In four out of five pending patients, minimum residual disease (MRD) negativity in bone marrow predicts future complete response, potentially increasing the future CR rate to 95%. Downstream clinical improvement, including organ responses, were observed in 70% of evaluable patients (7/10). No neurotoxicity was observed. Only low-grade cytokine release syndrome has been observed with a median duration of 1 day. The ASH (Free ASH Whitepaper) presentation contains clinical data as of November 13, 2025.

Current treatments typically result in a 10% or lower complete response (CR) rate in relapsed/refractory AL Amyloidosis according to Zanwar, et al 2024, indicating a high unmet medical need.

KOL Event Discussing NXC-201 ASH (Free ASH Whitepaper) 2025 Oral Presentation of Phase 2 Clinical Results

A Key Opinion Leader (KOL) event with lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center, Shahzad Raza, MD, of Cleveland Clinic, and Vaishali Sanchorawala, MD, of Boston Medical Center will be held Sunday, December 7, 2025 8:00pm ET to discuss the significance of the NEXICART-2 Phase 2 Clinical Results. Register to attend here.

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is expected to enroll 40 patients.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.

The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

(Press release, Immix Biopharma, DEC 7, 2025, View Source [SID1234661202])

On December 7, 2025 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company", Stock Code: 9887.HK) reproted an oral presentation on the opening day of the conference featuring the Phase I/II clinical results of LBL-034, a GPRC5D/CD3 bispecific antibody with a unique 2:1 structure and conditional activation, independently developed using the proprietary LeadsBody platform, for the treatment of relapsed/refractory multiple myeloma (RRMM) at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") held in Orlando, Florida, USA.

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The study, led by Professor Jin Lu of Peking University People’s Hospital and conducted across 17 centers in China, demonstrated that LBL-034 achieved favorable safety and highly encouraging anti-tumor activity, including in high-risk refractory subgroups, highlighting its potential as a best-in-class therapeutic candidate.

The key clinical highlights of LBL-034

Safe escalation to 1200 μg/kg with no DLTs or MTD reached.
Adverse events impacting quality of life were predominantly Grade 1–2 and occurred mainly during Cycle 1, with markedly lower incidence thereafter. Taste, skin, and nail toxicities were infrequent and generally self-resolving.
Strong efficacy across dose levels 400–1200 μg/kg (n=40).
ORR reached 82.5%, with ≥CR at 52.5%, ≥VGPR at 72.5%, and MRD negativity at 80.0%.
At 800 μg/kg, ORR and ≥CR were 90.9% and 63.6%, respectively.
Robust activity in difficult-to-treat RRMM subgroups.
Extramedullary disease (EMD): ORR 75.0%, including two sCRs. At 1200 μg/kg, ORR in EMD patients reached 100%, with rapid EMD lesion regression observed.
Prior BCMA-treated patients: ORR 85.7%, with CR/sCR 57.1%.
Durable clinical benefit.
Across the 400–1200 μg/kg range, the 12-month PFS rate was 61.2% (median follow-up: 9.6 months). At 400 μg/kg (n=11), median follow-up reached 13.1 months, with a 12-month PFS rate of 56.8%.
Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:

"We are delighted that the strong efficacy and clinical potential of LBL-034 have been recognized by the international scientific community. A Phase II trial evaluating the safety and efficacy of LBL-034 with a RP2D at 1200 μg/kg in 4 populations, including 4L+RRMM, 2L+RRMM with EMD, 4L+RRMM with prior BCMA therapy, and R/R Plasma Cell Leukopenia (PCL) is currently ongoing. With our focused and efficient clinical development strategy, we aim to deliver new treatment options to patients with multiple myeloma, particularly those who are refractory or have extramedullary disease, as quickly as possible."

About LBL-034

LBL-034 is a bispecific T-cell engager (TCE) that targets both GPRC5D and CD3, developed using the Company’s proprietary LeadsBody platform. Designed with a 2:1 binding format—two sites for GPRC5D and one for CD3—LBL-034 can selectively target GPRC5D+ cancer cells, conditionally activate T cells, reduce the risk of cytokine release, minimize the risk of systemic toxicity, and lower the risk of T cell exhaustion, thereby exerting anti-tumor effects in an efficient, low-toxic, and long-term stable manner.

In preclinical studies, LBL-034 has demonstrated strong efficacy signals, comparable to or exceeding those of leading competitors. The molecule is currently being evaluated in a Phase I/II clinical trial for relapsed or refractory multiple myeloma (RRMM) in China. According to Frost & Sullivan, as of November 2024, LBL-034 is the second most clinically advanced GPRC5D-targeted CD3 T-cell engager globally. In October 2024, LBL-034 received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of multiple myeloma.

(Press release, Nanjing Leads Biolabs, DEC 7, 2025, View Source [SID1234661218])