On December 8, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported presentation of preliminary data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Dr. Matthias Will, Chief Development Officer of Autolus, said: "Patients with srSLE have limited remaining treatment options and represent a difficult to treat population with a critical unmet need. Data reported from the CARLYSLE trial show an encouraging high rate of DORIS responses and a deep reset in the B cell compartment induced by obe-cel, suggesting the possibility for an immune reset. Based on this positive initial experience with obe-cel in the CARLSYLE trial we have initiated the LUMINA trial, a Phase 2 trial in lupus nephritis with registrational intent."

Abstract 302
Title: Obecabtagene autoleucel (obe-cel), a CD19-targeting chimeric antigen receptor (CAR) T-cell therapy, in patients with severe, refractory systemic lupus erythematosus (SLE) in the Phase I CARLYSLE study: initial safety, preliminary efficacy, pharmacokinetics, and biomarker results
Session Name: Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Emerging CAR-T Cell Therapies for Acute Leukemias and Autoimmune Diseases
Session Date and Time: December 8, 2025; 11:30 – 11:45am ET
Session Room: Orange County Convention Center; Valencia Room W415D
Publication Number: 815
Presenting Author: Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL)

Summary: Updated Phase 1 data with longer follow-up, and data in patients who received both 50×106 (50M) and 100×106 (100M) CAR T-cells were presented. Nine adult patients were infused with obe-cel, including six at the 50M dose and three at the 100M dose.

Obe-cel was well tolerated in all patients. No dose limiting toxicities (DLTs) or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed at the 50M dose. Grade one cytokine release syndrome (CRS) was observed in three patients at the 50M dose and three patients at the 100M dose. Hypertension was observed in five patients at the 50M dose, with three of those patients having pre-existing history of hypertension. A case of transient Grade three liver toxicity was observed in one patient of the 100M cohort.

At the 50M dose, three patients (50%) achieved CRR and five patients (83%) achieved DORIS with a median onset of 5.1 months (range: 4.9–8.9), without evidence of new disease activity at a median of 12 months of follow up (range: 8.5–16.3). All non-renal manifestations of the disease resolved by month four. Urinary protein creatinine (UPC) ratio levels decreased over time, demonstrating significant decline or absence of disease activity. Data show high peak expansion and deep B cell aplasia consistent with known obe-cel characteristics in oncology indications. Peak expansion was reached at a median of 10 days (range: 9–13). The median time to loss of CAR T-cell persistence based on Kaplan-Meier analysis was 3.0 months. The B-cell reconstitution profiles suggest that obe-cel may induce a reset of pathologic autoimmunity.

Emerging data in the 100M cohort is consistent with the 50M adult cohort, and evaluation is ongoing.

Data support progressing obe-cel as a treatment for srSLE and 50M has been selected as the recommended Phase 2 dose. Autolus has aligned with U.S. Food and Drug Administration (FDA) on a Phase 2 trial design in LN and potential registrational path to approval. The LUMINA trial is now enrolling.

Dr. Christian Itin, Autolus Chief Executive Officer, said: "Obe-cel’s safety profile is based on a robust database spanning several clinical trials in B-ALL and B-NHL indications. Data presented today now also show the ability to induce deep depletion of B-cell lineages in patients with srSLE. Obe-cel successfully underwent the regulatory approval process with the FDA, EMA and MHRA in adult r/r B-ALL and launched commercially in the US and UK in 2025. Building on this strong foundation of clinical data, and demonstrated commercial and manufacturing capabilities, we believe Autolus is well positioned for a successful and efficient path into the autoimmune setting."

(Press release, Autolus, DEC 8, 2025, View Source [SID1234661278])

On December 8, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported it will present new data demonstrating how comprehensive genomic profiling (CGP) can refine diagnosis and guide treatment decisions for patients with myeloid malignancies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held Dec. 6–9, 2025, in Orlando, Florida.

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The poster, "Comprehensive genomic profiling refines diagnosis and reveals actionable fusions in myeloid malignancies: A real-world analysis," evaluated outcomes using the Neo Comprehensive Myeloid panel, a next-generation sequencing (NGS) assay that provides a complete view of genomic changes in myeloid cancers. By assessing mutations and fusions in a single test, this CGP panel detects important genomic variants that may otherwise be missed, and supports diagnosis, prognosis, and therapy selection for diseases such as acute myeloid leukemia (AML), myelodysplastic neoplasms (MDS), and myeloproliferative neoplasms (MPN).

Researchers analyzed data from 533 patients with myeloid disorders, integrating NeoGenomics’ molecular results with clinical data from national health information exchanges. The analysis found that in about one-third of patients tested, CGP identified pathogenic changes earlier in their disease, leading to diagnostic reclassification in several cases. It also revealed rare but clinically significant fusions—including PDGFRA, PDGFRB, FGFR1, and JAK2—that helped guide targeted treatment decisions.

"This study underscores our leadership in hematologic malignancy diagnostics and our long-standing commitment to improving cancer care in the community setting," said Warren Stone, President and Chief Operating Officer at NeoGenomics. "Patients living with complex blood cancers rely on timely and definitive answers, and their physicians deserve access to best-in-class molecular tools, regardless of practice location. Our next-generation myeloid CGP solution combines DNA and RNA sequencing in a single, comprehensive assay, providing actionable insights that smaller or DNA-only panels may miss. By expanding access to advanced diagnostics, we are enabling more personalized treatment decisions and working to improve the path to care for every patient, everywhere."

The study will be presented in session 908A, Outcomes Research: Myeloid Malignancies: Poster III, on December 8 from 6:00 to 8:00 p.m. ET. Conference attendees can also visit Booth #1971 in the ASH (Free ASH Whitepaper) 2025 Exhibit Hall to learn more about NeoGenomics’ hematology testing portfolio and ongoing research.

(Press release, NeoGenomics Laboratories, DEC 8, 2025, View Source [SID1234661294])

On December 8, 2025 Abcuro, Inc., a late-stage clinical biotechnology company developing potentially first-in-class immunotherapies designed to benefit people living with debilitating and progressive rare autoimmune diseases and for other indications where certain cytotoxic T cells are pathogenic, reported interim data from the ongoing Phase 1/2 clinical trial evaluating ulviprubart (ABC008) in patients with T cell large granular lymphocytic leukemia (T-LGLL) with anemia and/or neutropenia, 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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Ulviprubart is a potentially first-in-class, potent, monoclonal antibody targeting KLRG1, a novel mechanism of action to drive selective depletion of highly differentiated T cells and modify disease progression. Ulviprubart was designed to target KLRG1-expressing T cells while sparing B and regulatory T cells that are required to maintain normal immune system homeostasis.

"The data presented at ASH (Free ASH Whitepaper) continue to support the potential of ulviprubart to selectively target and deplete highly differentiated T cells that drive debilitating diseases like T-LGLL. At the interim analysis, ulviprubart had an acceptable safety profile and was generally well tolerated across ascending doses, further supporting ulviprubart’s potential in treating patients with T-LGLL," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Abcuro.

T-LGLL is a hematological cancer driven by pathogenic expansion of immune cells that are frequently KLRG1+, 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.

Key Highlights from Oral Presentation:

The Phase 1/2 clinical trial (NCT05532722) is an open label, ascending dose study of ulviprubart patients with T-LGLL. The primary objective is to evaluate safety and tolerability. Secondary objectives include evaluating initial efficacy and pharmacokinetic/pharmacodynamic (PK/PD) profile of ulviprubart.

As of the data cut-off date of November 15, 2025:

21 patients were enrolled and evaluable for safety. 95% (n=20) of patients had neutropenia and 57% (n=12) of patients had anemia at baseline.
62% (n=13) of patients achieved >12 weeks of Q4W dosing on ulviprubart.
Among evaluable patients, seven experienced sustained depletions of >50% of CD8+ CD57+ KLRG1+ T cells at two or more consecutive visits. Three patients experienced sustained depletions of >90% of both CD8+ CD57+ KLRG1+ T cells and the CD8+ CD57+ parent population.
Among evaluable patients, all had neutropenia and nine patients had anemia at baseline.
With treatment, seven patients had a neutropenia response, defined as an absolute neutrophil count (ANC) increase of ≥50% from baseline for ≥4 weeks or ANC levels ≥1000 cells/µL for ≥4 weeks.
With treatment, two patients had an anemia response, defined as hemoglobin increased ≥1 g/dL for ≥4 weeks and not attributable to transfusion or growth factor.

About Ulviprubart
Ulviprubart (ABC008) is potentially a first-in-class, potent, monoclonal antibody targeting KLRG1, a novel proposed mechanism of action to drive selective depletion of highly differentiated T cells and modify disease progression. KLRG1 is a cell surface receptor predominantly expressed on highly differentiated T cells, while moderately or minimally expressed on other immune cells. Ulviprubart was designed to selectively deplete KLRG1-expressing T cells while sparing B and regulatory T cells that are required to maintain normal immune system homeostasis.

(Press release, Abcuro, DEC 8, 2025, View Source [SID1234661246])

On December 8, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team and Dr. Claire Harrison will participate in a virtual fireside chat as part of Baird’s Biotech Discovery Series on Wednesday, December 10, 2025 at 12:00 p.m. ET. Dr. Harrison is Professor of Myeloproliferative Neoplasms, Clinical Director at Guy’s and St. Thomas’ NHS Foundation Trust and a leading international expert in myelofibrosis.

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A live webcast of the event can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay following the event.

(Press release, Karyopharm, DEC 8, 2025, View Source [SID1234661262])

On December 8, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases and Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, and along with its subsidiaries, hereafter referred to as "Dr. Reddy’s"), reported that their respective wholly-owned subsidiaries, Immutep SAS and Dr. Reddy’s Laboratories SA, have entered into a strategic collaboration and exclusive licensing agreement for the development and commercialisation of Eftilagimod Alfa (efti) in all countries outside North America, Europe, Japan, and Greater China.

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Efti is Immutep’s first-in-class novel immunotherapy that directly activates the immune system to fight cancer, which is under evaluation in TACTI-004 (KEYNOTE-F91), a registrational Phase III trial for the first-line therapy of advanced or metastatic non-small cell lung cancer. Efti is also being investigated in other indications including head & neck cancer, breast cancer, and soft tissue sarcoma.

The terms of the licensing agreement provide Immutep with significant milestones and preserves its ability to capture material future upside in the licensed markets as efti advances commercially. Further, Immutep holds the global manufacturing rights to the product across all markets and will supply the product to Dr. Reddy’s in the licensed markets, while Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan.

Additionally, as per the agreement, Immutep will receive from Dr. Reddy’s an upfront payment of USD 20 million (~AUD 30.2 million). It is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million (~AUD 528.4 million), plus double-digit royalties on commercial sales in these markets.

"This collaboration marks our continuous efforts to deliver first-in-class and innovative therapies for cancer treatment. Efti is a novel immunotherapy with the potential to set a new standard of care in combination with pembrolizumab (Keytruda) and chemotherapy as first-line therapy for non-small cell lung cancer. Its broad potential extends to other major cancers across multiple stages of disease. Through this agreement, we look forward to leveraging our expertise and strong market access to advance the development and commercialization of this promising cancer therapy in the licensed markets," stated M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s.

"This agreement with Dr. Reddy’s marks a significant milestone for Immutep and further validates the potential of efti. Dr. Reddy’s proven capabilities and reach in the licensed markets make them an ideal partner to maximise the impact of our innovation and serve a large number of patients across the globe. Additionally, this partnership allows us to capture significant value for efti in the licensed markets, while retaining full rights in key markets such as North America, Europe, and Japan, and ensures we remain very well-positioned for future value creation," said Marc Voigt, CEO of Immutep.

About Eftilagimod Alfa (Efti):

Efti is a first-in-class soluble LAG-3 protein and MHC Class II agonist delivered subcutaneously that uniquely activates antigen-presenting cells or APCs (e.g., dendritic cells, monocytes) via major histocompatibility complex (MHC) class II ligands. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. This has been demonstrated across early-stage trials in NSCLC and HNSCC, which have laid the foundation for the larger randomized clinical trial in NSCLC. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, DEC 8, 2025, View Source [SID1234661279])