On November 3, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported clinical data for CT0596, an allogeneic BCMA-targeting CAR-T product candidate developed on its proprietary THANK-u Plus platform for relapsed/refractory multiple myeloma (R/R MM), and for CT1190B, an allogeneic CD19/CD20-targeting CAR-T product candidate for relapsed/refractory non-Hodgkin’s lymphoma (R/R NHL). The data showed that both allogeneic CAR-T products demonstrated initially favorable safety profiles and encouraging efficacy signals.

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Data for CT0596 in Relapsed/Refractory Multiple Myeloma

CT0596 is a BCMA-targeted allogeneic CAR-T cell therapy candidate developed based on CARsgen’s THANK-u Plus platform and is currently being evaluated in an investigator-initiated trial (IIT) for malignant plasma cell neoplasms. The study has now entered the dose expansion phase with a determined lymphodepletion regimen. Future work will involve dose escalation of the cells to further determine the Recommended Dose (RD).

As of June 24, 2025, the reported clinical trial (NCT06718270) had enrolled 8 R/R MM patients who received CT0596 infusion from the dose-escalation phase. The median number of prior lines of therapy was 4.5 (range: 3-9). Five patients had prior exposure to triple-class drugs (PI, IMiD, and anti-CD38 monoclonal antibody), and five patients had a history of autologous stem cell transplantation. CAR-T cell doses administered were 1.5e8 (n=1), 3e8 (n=5), and 4.5e8 (n=2).

All 8 infused patients were evaluable for efficacy, with a median follow-up time of 2.56 months (range: 0.9-5.9 months). For lymphodepletion, 6 patients received fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²), while 2 patients received a reduced lymphodepletion dose. Five patients achieved partial response (PR) or above: 3 achieved complete response / stringent complete response (CR/sCR) (all of whom had received the full dose of lymphodepletion), 1 achieved PR, and 1 achieved very good partial response (VGPR). Six patients achieved minimal residual disease (MRD)-negativity at Week 4. No patients got progression disease. Pat 01 has ongoing sCR and MRD negative for nearly 6 months. CAR-T cell expansion was observed in all 8 patients. No dose-limiting toxicities (DLT), treatment discontinuations, or deaths were observed. Four patients experienced Grade 1 cytokine release syndrome (CRS), all of which resolved within 2-10 days.

Previously, in October 2025, CARsgen announced preliminary clinical data for CT0596 in relapsed/refractory primary plasma cell leukemia (pPCL). Two heavily pretreated pPCL patients with high disease burden and rapid progression both achieved sCR after receiving CT0596 treatment.

Data for CT1190B in Relapsed/Refractory Non-Hodgkin’s Lymphoma

CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy candidate developed based on CARsgen’s THANK-u Plus platform and is currently being evaluated in multiple IITs for indications including R/R NHL.

As of October 17, 2025, this reported clinical trials (NCT07053670, NCT06734871) had enrolled 14 patients, including 3 with follicular lymphoma (FL), 3 with mantle cell lymphoma (MCL), and 8 with diffuse large B-cell lymphoma (DLBCL). The dose escalation study has been completed, preliminarily determining the recommended lymphodepletion regimen and cell dose.

At the lymphodepletion dose of Fludarabine 30mg/m²×3 days + Cyclophosphamide 500mg/m²×3 days, all three FL patients achieved CR. One of these FL patients had failed immunochemotherapy, a PI3K inhibitor, chemotherapy + autologous hematopoietic stem cell transplantation, and CD3/CD20 bispecific antibody therapy; another FL patient had failed immunochemotherapy + autologous hematopoietic stem cell transplantation and CD19 CAR-T therapy. The peak copy number of expansion in these three patients reached 10³-10⁴ copies/µg gDNA.

At the lymphodepletion dose of Fludarabine 30mg/m²×3 days + Cyclophosphamide 1000mg/m²×2 days (the recommended lymphodepletion dose), 8 patients were enrolled, including 2 MCL patients (cell dose 6e8) and 6 DLBCL patients (cell dose 3e8: 1 patient; 4.5e8: 1 patient; 6e8: 4 patients). The details are below:

Six patients were evaluable for efficacy, achieving an ORR of 83.3%, comprising 4 patients who achieved CR (2 MCL, 2 DLBCL) and 1 patient who achieved PR (DLBCL).
Focusing on the 6e8 cell dose, 6 patients were enrolled. Four of them were evaluable for efficacy, and 3 achieved a response, all of which were CR. The remaining 2 DLBCL patients had not reached the timepoint for efficacy assessment. A total of 6 patients received the full lymphodepletion and recommended cell dose, with a median Cmax reaching levels on the order of 10⁵ copies/ug gDNA.
The primary safety signals of CT1190B were CRS, cytopenia, and infections. Other adverse reactions, such as immune effector cell-associated neurologic syndrome (ICANS) and graft versus host disease (GVHD) were not observed.

About CT0596

CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen’s proprietary THANK-u Plus platform. It is currently being evaluated in investigator-initiated trials for relapsed/refractory multiple myeloma (R/R MM) or plasma cell leukemia (PCL). CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. The company anticipates submitting an Investigational New Drug (IND) application in the second half of 2025.

About CT1190B

CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy developed based on CARsgen’s THANK-u Plus platform. Ongoing clinical trials include IITs for relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), and for moderate-to-severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc).

(Press release, Carsgen Therapeutics, NOV 3, 2025, View Source [SID1234659302])

On November 3, 2025 Abcuro, Inc., a late-stage clinical biotechnology company developing potential first-in-class immunotherapies for the benefit of people living with debilitating and progressive rare autoimmune diseases and cancers, reported that the Company will present interim data from the Phase 1/2 clinical trial evaluating the safety, tolerability, and hematological effect of ulviprubart in patients with T cell large granular lymphocytic leukemia (T-LGLL) who suffer from neutropenia and/or anemia. The interim data will be presented in an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida.

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T-LGLL is a hematological cancer characterized by clonally expanded CD8+ differentiated T cells resulting in neutropenia and anemia. Neutropenia can lead to frequent infections, a major cause of premature death in patients with T-LGLL, while anemia results in transfusion dependence in approximately one third of patients.

Oral Presentation Details:

Title: Clinical Activity, Tolerability, and Pharmacodynamics of Ulviprubart in Patients with T-Cell Large Granular Lymphocytic Leukemia: Interim Results of a Phase 1 Trial
Presenter: Salvia Jain, MD; Massachusetts General Hospital
Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Novel Agents or Therapeutic Approaches in T-Cell Lymphoma
Session Date and Time: Monday, December 8, 2025, from 10:30 a.m. – 12:00 p.m. ET
Presentation Date and Time: Monday, December 8, 2025, from 11:30 a.m. – 11:45 a.m. ET
Location: OCCC – Tangerine Ballroom F1
Abstract Number: 779

About Ulviprubart
Ulviprubart (ABC008) is a first-in-class anti-KLRG1 antibody product candidate capable of selectively depleting highly cytotoxic T cells, while sparing naïve, regulatory and central memory T cells. Ulviprubart is designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia (T-LGLL). The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have each granted orphan drug designation to ulviprubart for the treatment of IBM. The FDA has also granted Fast Track designation for ulviprubart in IBM.

(Press release, Abcuro, NOV 3, 2025, View Source [SID1234659237])

On November 3, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported its R&D pipeline with the addition of EVX-04, an AI-designed precision cancer vaccine candidate. We will pursue clinical development of EVX-04, currently in preclinical development, as a new therapeutic vaccine against acute myeloid leukemia (AML).

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EVX-04 is designed to target non-conventional ERV (endogenous retrovirus) tumor antigens from the dark genome. These antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines.

Leveraging our proprietary AI-Immunology platform, Evaxion has identified ERV antigens in patient tumor sequencing data. Uniquely, the platform then selects optimal fragments from these antigens based on their potential to be effective vaccine targets across a wide range of patients.

By including multiple of these fragments in EVX-04, the vaccine is designed to be effective in all patients regardless of immune and tumor ERV antigen differences. This makes EVX-04 a so-called "off-the-shelf" vaccine preproduced and ready for immediate administration after diagnosis.

"We are very excited to select a lead candidate for our ERV-based precision cancer vaccine concept. Representing a completely novel approach, EVX-04 is a great example of how AI-Immunology enables us to design and develop new therapies that could lead to better outcomes for patients. This approach could enable broader use of cancer vaccines, including for patients who do not respond to conventional immunotherapies," says Birgitte Rønø, CSO and interim CEO of Evaxion.

New data to be presented at ASH (Free ASH Whitepaper) Meeting
New preclinical data demonstrates that EVX-04 induces strong T-cell responses and kill cancer cells. The data will be presented at an oral session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Florida on December 6, 2025.

"The ASH (Free ASH Whitepaper) meeting is a fantastic opportunity for us to present the data and introduce EVX-04 to both scientists, doctors and potential business partners. We are thrilled to have been selected to do an oral presentation and are looking very much forward to share and discuss the data and concept," says Birgitte Rønø.

Presentation details
Abstract Title: Dark genome interrogation identifies novel antigens in acute myeloid leukemia – developing an off-the-shelf vaccine from machine learning to clinic
Abstract#: #278
Session: Emerging Tools, Techniques, and Artificial Intelligence in Hematology: MRD Assays and Novel Drug Discovery Pipelines
Location: Hyatt – Regency Ballroom R
Date/Time: December 6, 2025, at 2:00pm ET/20:00 CET
Presenter: Rasmus Villebro, Bioinformatics Manager at Evaxion

About ERVs
ERVs are remnants of ancient viruses lying dormant in our genome. ERVs are often overexpressed in cancer but not in healthy tissue, making them visible to the immune system and hence promising targets for cancer vaccines. AI-Immunology is crucial in allowing the identification of therapeutically relevant ERV tumor antigens from genomic patient tumor data.

About AML
AML is an aggressive hematologic malignancy characterized by the clonal expansion of undifferentiated myeloid precursor cells (AML blasts) in the bone marrow. The malignant proliferation leads to suppression of normal hematopoiesis, resulting in cytopenia, increased
susceptibility to infections, bleeding, and fatigue (Döhner et al. 2022).

If left untreated, the disease is fatal, often within weeks to months, with patients typically succumbing to infections within weeks to months.

(Press release, Evaxion Biotech, NOV 3, 2025, View Source [SID1234659253])

On November 3, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune disease, reported that updated clinical data from the NX-5948-301 Phase 1a/1b clinical trial have been selected for presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6 – 9, 2025, in Orlando, Florida. The data will be featured in two presentations: an oral presentation with new results in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and a poster presentation with updated results in patients with Waldenström macroglobulinemia.

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In addition to these clinical presentations, Nurix and its collaborators will also present new mechanistic insights into resistance to Bruton’s tyrosine kinase (BTK) targeted therapies at a separate ASH (Free ASH Whitepaper) poster session, highlighting discoveries that expand the understanding of BTK biology.

Oral Presentation Details:

Title: Bexobrutideg (NX-5948), a Novel Bruton’s Tyrosine Kinase (BTK) Degrader, Demonstrates Rapid and Durable Clinical Responses in Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL): New and Updated Findings from an Ongoing Phase 1a/b Trial
Presenter: Zulfa Omer, M.D., Assistant Professor Internal Medicine, College of Medicine, University of Cincinnati, Cincinnati, OH, USA
Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Treatment of CLL in Relapse and in Richter Transformation
Abstract #: 86
Session Date and Time: Saturday, December 6, 2025, 9:30 a.m. – 11:00 a.m. ET
Presentation Time: 9:45 a.m. – 10:00 a.m. ET
Room: Orange County Convention Center – W224ABEF

Poster Presentation Details

Title: Bexobrutideg (NX-5948), a Novel Bruton’s Tyrosine Kinase (BTK) Degrader, Shows High Clinical Activity and Tolerable Safety in Patients with Waldenström Macroglobulinemia: Updated Results from an Ongoing Phase 1a/b Study
Presenter: Scott Huntington M.D., MPH, Associate Professor of Internal Medicine (Hematology), Yale School of Medicine
Session Name: 623: Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Abstract # 5359
Session Date and Time: Monday, December 8, 2025, 6:00 p.m. – 8:00 p.m. ET
Location: Orange County Convention Center – West Halls BЗ – B4

Title: Molecular and Structural Basis of Pan-Resistance to BTK Targeting Therapies via BTK A428D Mutation
Presenter: Quinlan Sievers, M.D., Ph.D. Memorial Sloan Kettering Cancer Center, New York, NY
Session Name: 641:Chronic Lymphocytic Leukemia: Basic and Translational Poster I
Abstract # 2102
Session Date and Time: Saturday, December 6, 2025, 5:30 p.m. – 7:30 p.m. ET
Location: Orange County Convention Center – West Halls BЗ – B4

About Bexobrutideg (NX-5948)
Bexobrutideg is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia. Nurix also continues enrollment in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) of bexobrutideg in patients with relapsed or refractory B cell malignancies. Additional information on the ongoing clinical trials can be accessed at clinicaltrials.gov.

(Press release, Nurix Therapeutics, NOV 3, 2025, View Source [SID1234659269])

On November 3, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported it will present further preclinical proof-of-concept data on its logic-gated CD3 Switch-DARPin T cell engager (TCE) with CD2 co-stimulation in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 meeting, taking place in National Harbor, MD, USA from November 5-9.

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Clinical development of TCEs for solid tumors is often limited by systemic toxicity in the absence of specific enough tumor antigens and by impaired efficacy due to insufficient T cell activity. To address this, Molecular Partners designed a logic-gated Switch-DARPin TCE using an AND-gate to achieve conditional tumor-localized immune activation targeting mesothelin (MSLN) and epithelial cell adhesion molecule (EpCAM), which are highly co-expressed in ovarian cancer and other solid tumors. The Switch-DARPin TCE is designed for the CD3-engaging DARPin to be unmasked ("Switch" on) and activate T cells only upon binding to both MSLN and EpCAM (AND-gate).

Preclinical data to be presented at SITC (Free SITC Whitepaper) show that the Switch-DARPin demonstrated selective T cell cytotoxicity against cells co-expressing both tumor-associated antigens, with attenuated activity against cells in healthy tissues expressing only MSLN or only EpCAM. In addition, T cells repetitively exposed to CD2/CD3 Switch-DARPin showed a fundamentally improved activation and proliferation profile as compared to CD3 engagement alone, highlighting the potential of CD2/CD3 Switch-DARPin to overcome T cell exhaustion. Finally, the Switch-DARPin induced significant tumor regression in a xenograft mouse model expressing MSLN and EpCAM without causing systemic cytokine release, indicating a favorable safety profile.

"These data further underline the potential of Molecular Partners’ wholly-owned logic-gated and co-stimulated T cell engager program, which allows for targeted, conditional immune activation only in the presence of defined targets. The Switch-DARPin only activates T cells when both tumor-associated antigens are bound, and remains inactive in circulation, which allows the addition of a CD2 DARPin for co-stimulation of T cells. This approach is an opportunity for novel cancer treatments through logic-gated tumor-directed immune activation with increased efficacy and safety over modalities targeting a single tumor antigen," said Martin Steegmaier, Ph.D., CSO of Molecular Partners.

Details of the presentation

Title: A next-generation conditional Switch-DARPin T cell engager with CD2 co-stimulation enabling selective activity against solid tumors which co-express mesothelin (MSLN) and EpCAM

Abstract number: 829

Time: November 7, 2025

Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC

(Press release, Molecular Partners, NOV 3, 2025, View Source [SID1234659287])