On June 12, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported that it will present new data from the ongoing ATALANTA-1 Phase 1/2 study of its investigational CD19 CAR T-cell therapy, GLPG5101, in an oral presentation at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Congress (Press release, Galapagos, JUN 12, 2025, View Source [SID1234653875]). These data demonstrate encouraging safety outcomes, including low rates of high-grade toxicities, in R/R NHL. Additionally, with a rapid vein-to-vein time enabled by Galapagos’ decentralized manufacturing platform, 95% of patients treated in the study received fresh, non-cryopreserved GLPG5101, without the need for cytotoxic bridging therapy.

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"We are excited to share new promising safety and manufacturing data for GLPG5101 across multiple R/R NHL subtypes, reinforcing the potential of our novel rapid delivery approach," said Omotayo Fasan, M.D., Clinical Development Program Head at Galapagos. "By initiating lymphodepletion immediately after cell collection, we are able to infuse fresh product as soon as it becomes available, reducing patient attrition and potentially expanding access to CAR-T therapy. We observed a low 5% attrition rate, compared to rates of up to 30% reported in some clinical trials and real-world settings, and observed a manageable safety profile. These promising results suggest that rapid delivery of fresh, stem-like early memory cell therapies may offer meaningful clinical benefits for patients with R/R NHL."

"Decentralized cell therapy manufacturing is changing how we think about CAR-T eligibility. By enabling shorter vein-to-vein times and the use of fresh, early memory phenotype cells, this approach may allow for the inclusion of patients who would otherwise not be able to receive CAR-T therapy due to historically long manufacturing timelines," said Pim Mutsaers, M.D., Associate Professor, Department of Hematology, Erasmus MC Cancer Institute.

The new ATALANTA-1 data are summarized below:
The oral presentation at EHA (Free EHA Whitepaper) features new safety and longer follow-up data for GLPG5101 in 64 patients with R/R large B-cell lymphoma (DLBCL, n=17), mantle cell lymphoma (MCL, n=13), follicular lymphoma (FL, n=29), and marginal zone lymphoma (MZL, n=5) from the ongoing ATALANTA-1 Phase 1/2 study (data cut-off: October 14, 2024). The presentation also demonstrates the feasibility of Galapagos’ decentralized manufacturing platform to deliver fresh, stem-like early memory cell therapy with a median vein-to-vein time of seven days, robust in vivo expansion, and durable persistence.

As of 14 October 2024, 64 patients underwent leukapheresis, of whom 63 received lymphodepleting chemotherapy and 61 (95%) received an infusion of GLPG5101. Of those 61 patients:
95% (58 patients) received a fresh product
89% (54 patients) received it within 7 days post-leukapheresis
7% (4 patients) received it within 8-21 days
5% (3 patients) received a cryopreserved product
None of the patients who received a fresh product required cytotoxic bridging therapy.
GLPG5101 showed an encouraging safety profile in the context of robust CAR T-cell peak expansion and durable persistence, with the majority of Grade ≥ 3 treatment emergent adverse events being hematological. Cases of CRS and ICANS were few and predominantly low-grade with only a single Grade 3 report of each. Dose-limiting toxicities were found in 8% of patients (5/61).
Durable CAR T-cell persistence was observed up to 21 months across tumor types, phases, and dose levels.
Phase 1
(n=24) Phase 2
(n=37) All patients
(n=61)
CRS, n (%) 11 (45.8) 15 (40.5) 26 (42.6)
Grade 1, n (%) 5 (20.8) 8 (21.6) 13 (21.3)
Grade 2, n (%) 5 (20.8) 7 (18.9) 12 (19.7)
Grade 3, n (%) 1 (4.2) 0 1 (1.6)
Time to onset, median (range), days 7.5 (2–20) 7.0 (1–11) 7.0 (1–20)
Duration, median (range), days 3.0 (1–17) 3.0 (1–9) 3.0 (1–17)
CRS toxicity management, n (%)
Dexamethasone 4 (16.7) 7 (18.9) 11 (18.0)
Tocilizumab 6 (25.0) 9 (24.3) 15 (24.6)
Methylprednisolone 1 (4.2) - 1 (1.6)
Vasopressin 1 (4.2) - 1 (1.6)
ICANS, n (%) 8 (33.3) 4 (10.8) 12 (19.7)
Grade 1 8 (33.3) 3 (8.1) 11 (18.0)
Grade 2 0 0 0
Grade 3 0 1 (2.7) 1 (1.6)
Time to onset, median (range), days 14.0 (3–30) 8.5 (2–12) 11.5 (2–30)
Duration, median (range), days 2.5 (1–47) 1.5 (1–3) 2.0 (1–47)
ICANS toxicity management, n (%)
Dexamethasone (ICANS) 2 (8.3) 4 (10.8) 6 (9.8)
Tocilizumab (ICANS) 1 (4.2) 2 (5.4) 3 (4.9)
Infections, Grade ≥3, n (%) 2 (8.3) 1 (2.7) 3 (4.9)
Hemophagocytic lymphohistiocytosis, Grade ≥3, n (%) 2 (8.3) 0 2 (3.3)
Prolonged cytopenias,a Grade ≥3, n/n available (%)
30 days after infusion 8/21 (38.1) 11/37 (29.7) 19/58 (32.8)
60 days after infusion 5/21 (23.8) 9/33 (27.3) 14/54 (25.9)
90 days after infusion 4/20 (20.0) 8/30 (26.7) 12/50 (24.0)
a Includes all events related to neutropenia, thrombocytopenia, anemia, and lymphopenia.
CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome.
Table 1: Adverse events of special interest

About GLPG5101 and ATALANTA-1 (EudraCT 2021-003272-13; NCT 06561425)
GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5101 are currently being evaluated in the ATALANTA-1 Phase 1/2 study in eight1 hematological malignancies with high unmet need. The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×106 (DL1), 110×106 (DL2) and 250×106 (DL3) CAR+ viable T-cells. The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR) while the secondary objectives include Complete Response Rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe.

On June 12, 2025 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported positive updated clinical data from KOMET-007, a Phase 1a/1b trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care in patients with newly diagnosed NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) (Press release, Kura Oncology, JUN 12, 2025, View Source [SID1234653844]). The data for the combination with cytarabine/daunorubicin (7+3) were presented as an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (EHA2025) being held in Milan, Italy from June 12-15, 2025.

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"The findings presented at EHA (Free EHA Whitepaper)2025 underscore the potential of ziftomenib in combination with 7+3 as an early intervention in the frontline setting of AML and could offer a meaningful opportunity to improve patient outcomes," said Harry Erba, M.D., Ph.D., Director of the Leukemia Program at the Duke Cancer Institute. "The high rates of complete remission and MRD negativity across the 7+3 cohorts are particularly encouraging. The continued rapid enrollment in the Phase 1b portion of this study underscores the urgency and enthusiasm for further evaluating this combination approach."

"We remain very encouraged by the updated clinical activity, safety and tolerability data from the KOMET-007 study evaluating ziftomenib with 7+3 in newly diagnosed AML patients with NPM1 mutations or KMT2A rearrangements," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These updated data reinforce the combination potential of ziftomenib in the frontline setting, strengthening our confidence in its ability to provide a valuable treatment option for a significant portion of the AML population. We and our partners at Kyowa Kirin are working in earnest to prepare for the KOMET-017-IC and NIC pivotal Phase 3 studies, which will enable us to test ziftomenib-based combinations and their potential, if approved, to transform care for AML patients worldwide."

In the ongoing study, ziftomenib dosed once daily at 600 mg in combination with 7+3 continued to demonstrate robust and evolving clinical activity in patients with newly diagnosed AML. Among 71 response-evaluable patients, 92% (65/71) achieved a composite complete remission (CRc) (93% for NPM1-m, 89% for KMT2A-r patients) and 80% (57/71) achieved a complete remission (CR) (84% for NPM1-m, 74% for KMT2A-r patients) at the time of data cutoff. A rate of CR minimal residual disease (CR-MRD) negativity of 71% for NPM1-m with a median time to MRD negativity of 4.7 weeks and a rate of CR-MRD negativity of 88% for KMT2A-r patients with a median time to MRD negativity of 4.4 weeks were observed. Ziftomenib did not delay time to neutrophil and platelet count recovery, which was comparable to intensive chemotherapy regimens.

Median follow-up times for the two populations were 24.9 weeks (range 4.3-47.1) in NPM1-m patients and 15.7 weeks (range 1.1-40.3) in KMT2A-r patients. Among response-evaluable NPM1-m patients, neither a median duration of CR nor a median overall survival (OS) had been reached. Among response-evaluable KMT2A-r patients, a median duration of CR was determined to be 25.6 weeks (95% CI, range 8.3-NE), and a median OS had not been reached. Notably, 96% (47/49) of NPM1-m patients and 88% (29/33) of KMT2A-r patients remained alive and on study.

The safety population included 82 newly diagnosed adult patients with NPM1-m or KMT2A-r AML from the pooled Phase 1a/1b portions of the trial at the 600 mg QD dose of ziftomenib. The safety profile observed with ziftomenib was consistent with previously reported data. Ziftomenib-related adverse events (TRAEs) of ≥ Grade 3 (Gr3), which occurred in more than 10% of patients were febrile neutropenia (15%), decreased platelet count (15%), anemia (11%) and decreased neutrophil count (11%). One case of differentiation syndrome (KMT2A-r, Gr3) was successfully managed by protocol-specified mitigation strategies. Two cases of investigator-assessed QTc prolongation (both KMT2A-r, Gr3) were reported; both patients were on other medications (posaconazole and/or piperacillin/tazobactam), which have been identified as potentially causing QT prolongation at the time of QT assessment. No dose-limiting toxicities, drug-drug interactions, clinically meaningful ziftomenib-associated QTc prolongation or additive myelosuppression were observed.

"Despite the availability of approved therapies for AML, up to 70% of patients who initially achieve a complete response relapse within three years – highlighting a substantial unmet need," said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. "The data presented at EHA (Free EHA Whitepaper)2025 suggest a favorable safety, tolerability, and efficacy profile for ziftomenib. We are encouraged by its potential as a future first-line treatment option and are committed to advancing the KOMET-017 Phase 3 trial, expected to begin later this year, to further evaluate its value in AML care."

The EHA (Free EHA Whitepaper)2025 oral presentation highlighting ziftomenib combined with 7+3 in newly diagnosed (1L) NPM1-m and KMT2A-r AML, and an encore presentation of results from the KOMET-001 registrational trial of ziftomenib in relapsed/refractory (R/R) NPM1-m AML (also presented during EHA (Free EHA Whitepaper)2025) are available in the Posters and Presentations section of the Kura website. The KOMET-017 protocol consists of 2 separate Phase 3 studies, which will investigate the benefits and risks of adding ziftomenib to standards of care treatments in patients newly diagnosed NPM1-m or KMT2A-r AML and which is registered at www.clinicaltrials.gov as NCT07007312.

Virtual Investor Event

Kura will host a virtual investor event featuring company management and investigators from the KOMET-007 trial of ziftomenib in combination with 7+3 in patients with NPM1-m and KMT2A-r AML at 4:30pm ET / 1:30pm PT on Wednesday, June 18, 2025. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The event can also be accessed on the Investors section of Kura’s website at www.kuraoncology.com. An archived replay will be available shortly after the conclusion of the live event.

On June 12, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported the presentation of AI/ML driven predictive computational research at upcoming international scientific conferences reflecting Compugen’s scientific capabilities in understanding complex cancer biology (Press release, Compugen, JUN 12, 2025, View Source [SID1234653860]).

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Poster details:

Conference: 2025 Annual Congress of the European Association for Cancer Research, June 16-19 Lisbon, Portugal
Poster number: EACR25-3113
Title: Prediction of immune evasion and immunotherapy resistance mechanisms associated with distinct TNBC subtypes
Presenting author: Amir Toporik, Computational Discovery, Compugen
Date of presentation: June 18, 2025

Conference: International Society for Computational Biology and European Conference on Computational Biology- Annual International Conference on Intelligent Systems for Molecular Biology, July 20-24, 2025, Liverpool, UK
Poster number: 947
Title: Computational prediction of TNBC tumor subtypes from an integrative single cell atlas elucidates immune evasion and immunotherapy resistance mechanisms
Presenting author: Itamar Borukhov, Ph.D., Computational Discovery, Compugen

Posters will be available in the publications section of Compugen’s website, www.cgen.com, following presentation.

On June 12, 2025 Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to ITM), reported a license agreement with Visterra, Inc. to advance Visterra’s next-generation biotherapeutic pipeline for immune-mediated and autoimmune diseases, leveraging Nona’s proprietary HCAb Harbour Mice technology platform (Press release, Nona Biosciences, JUN 12, 2025, View Source [SID1234653845]).

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Nona’s HCAb Harbour Mice platform enables the generation of fully human heavy-chain-only antibodies (HCAbs), offering key advantages such as reduced immunogenicity and enhanced versatility for next-generation biotherapeutics. This innovative platform has been clinically validated and widely recognized by global partners.

"We are pleased to collaborate with Visterra and support the development of their biotherapeutic pipeline," said Jingsong Wang, MD, PhD, Chairman of Nona Biosciences. "This collaboration reflects our commitment to advancing biotherapeutic innovation. By leveraging our fully human HCAbs, we aim to unlock new therapeutic possibilities and accelerate the development of transformative medicines for patients worldwide."

On June 12, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that it will present research findings on two of its first-in-class hematologic oncology assets—golidocitinib and DZD8586—at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and the 18th International Conference on Malignant Lymphoma (ICML) (Press release, Dizal Pharma, JUN 12, 2025, View Source [SID1234653861]). These include long-term follow-up data on golidocitinib as a maintenance therapy in peripheral T-cell lymphoma (PTCL) after first-line systemic therapy and pooled analysis results for DZD8586 in chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), both selected for oral presentations at ICML.

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Golidocitinib Shows Potential to Significantly Improve Patient Outcomes in PTCL

PTCL patients who achieved tumor response with first-line standard therapy will relapse. Approximately 40% of patients with complete response and 80% with partial response experienced disease progression within 2 years after initial tumor response, and the prognosis of these relapsed patients was very poor.

The 24-month follow-up results from JACKPOT26, a prospective, multicenter Phase 2 clinical study of golidocitinib will be unveiled at EHA (Free EHA Whitepaper) and featured as an oral presentation at ICML. The data suggest that golidocitinib showed promising efficacy in maintaining and enhancing tumor response with an acceptable and manageable safety profile in patients with PTCLs post first-line therapies.

In Cohort 1 (patients with complete response), the 24-month disease-free survival (DFS) rate reached 74.2%, with consistent efficacy observed across different subtypes.
In Cohort 2 (patients with partial response), the complete response rate (CRR) was 50.0%, the median duration of response (DoR) was 23.9 months, and the median progression-free survival (PFS) was 17.4 months, with the longest PFS reaching 35.9 months and the patient was still responding.
"Golidocitinib, a next-generation oral and highly selective JAK1 inhibitor, addresses a critical unmet need for effective maintenance therapy following first-line treatment in PTCL," said Professor Jie Jin, lead principal investigator of the JACKPOT26 study at the First Affiliated Hospital of Zhejiang University School of Medicine. "Its unique mechanism of action not only delivers strong anti-tumor activity—allowing 50% of patients with partial remission (PR) to achieve complete remission (CR)—but also modulates the tumor immune microenvironment through its anti-inflammatory and immunomodulatory effects. These unique features help delay relapse and extend survival, positioning golidocitinib as a highly promising option for maintenance therapy in PTCL."

In addition, golidocitinib has shown encouraging antitumor activities and favorable safety profiles in combination with CHOP in 1st line PTCL patients, as well as in rare T-cell lymphoma subtypes, including relapsed/refractory T-cell large granular lymphocytic leukemia (r/r T-LGLL) and monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL). Further studies are warranted to validate the results.

DZD8586 Overcomes Multi-Drug Resistance in CLL and other B-NHL

A pooled analysis of two phase I/II studies of DZD8586 in CLL/SLL patients previously treated with covalent/non-covalent Bruton’s Tyrosine Kinase (BTK) inhibitors and BTK degraders was presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and will be presented at EHA (Free EHA Whitepaper). Subgroup analyses will be presented as an oral presentation at ICML.

In heavily pretreated CLL/SLL, DZD8586 achieved an ORR of 84.2%. Tumor response with a manageable safety profile was observed irrespective of prior covalent/non-covalent BTKi, BTK degrader, or BCL-2 inhibitor treatment, and in patients with classic BTK resistance mutations (C481X) as well as other BTK mutations, including kinase-dead mutations. No drug-related bleeding, atrial fibrillation, or major cardiac events observed.

A Phase II study of DZD8586 monotherapy in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) will also be presented at EHA (Free EHA Whitepaper) and ICML. Clinical activities from small molecule targeted drugs such as BTK inhibitors have been less than desired for the treatment of DLBCL. Compensatory or redundant pathway activation could be one of the main escape mechanisms. DZD8586, a novel LYN/BTK dual inhibitor, is designed to overcome these limitations by blocking both BTK and LYN signaling pathways, and thus potentially improve therapeutic outcomes.

At recommended phase 2 doses (RP2Ds) of 50 mg and 75 mg QD, DZD8586 monotherapy demonstrated promising anti-tumor activity in r/r DLBCL. The majority of patients showed target lesion shrinkage, with a CRR of 35.5%. Complete responders showed durable responses, with 81.8% of patients remaining in response and the median DoR was not reached. Notably, it showed efficacy in both GCB and non-GCB subtypes, supporting its broad therapeutic potential.

Dr. Xiaolin Zhang, CEO of Dizal, remarked, "We are excited that golidocitinib and DZD8586 have demonstrated promising potential in PTCL and B-cell non-Hodgkin lymphoma (B-NHL), two areas with substantial unmet clinical needs. The selection of multiple studies for oral presentations at global leading conferences represents a strong recognition of our capabilities in research and development and further affirms our commitment to bringing transformative therapies to patients worldwide."

About golidocitinib (DZD4205)
Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About DZD8586
DZD8586 is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

DZD8586 has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. Phase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.