poseltinib (HM71224) / Hanmi, NOBO Medicine - LARVOL DELTA

Glofitamab, Poseltinib and Lenalidomide (GPL) for patients with relapsed/refractory diffuse large B cell lymphoma (ICML 2025) - No abstract available

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Chemotherapy-free therapy with rituximab, lenalidomide, and poseltinib in relapsed or refractory primary central nervous system lymphoma: a multi-center, phase II study (ICML 2025) - No abstract available

Clinical • P2 data • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Novomedix's 'Poseltinib' designated as orphan drug by the Ministry of Food and Drug Safety in the development stage [Google translation] (HIT News) - "Novomedison...announced on the 19th that poseltinib...has been designated as an orphan drug in the development stage by the Ministry of Food and Drug Safety. This orphan drug designation targets the treatment of relapsed and refractory primary central nervous system lymphoma...Currently, a multi-institutional joint phase 2 clinical trial targeting patients with relapsed and refractory central nervous system lymphoma is progressing smoothly at Seoul National University Hospital, Bundang Seoul National University Hospital, and Yeouido St. Mary's Hospital...Novomedison is also conducting an investigator-led multicenter phase 2 clinical trial of poseltinib for relapsed and refractory diffuse large B-cell lymphoma...This clinical trial has completed patient recruitment and is currently in the final analysis of clinical results, and the efficacy and safety results are scheduled to be announced at the International Congress of Lymphoma Research (ICML) 2025."

Orphan drug • P2 data • Diffuse Large B Cell Lymphoma • Primary Central Nervous System Lymphoma

GPL study: GPL in Patients with Relapsed/refractory Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: Seoul National University Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL6

POTENTIAL-P: NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSL (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: NOBO Medicine

New P2 trial • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Glofitamab combined with poseltinib and lenalidomide for relapsed/refractory diffuse large B cell lymphoma: Interim analysis of GPL study. (ASCO 2024) - P2 | "Interim analysis indicates that the GPL regimen is an effective and safe regimen for R/R DLBCL patients. High response rates observed support further investigation of GPL for potential synergism between T-cell engagers and BTKi. This multicenter study is actively recruiting patients and is set to complete enrollment within this year."

Atrial Fibrillation • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CD20

PHASE II STUDY OF GLOFITAMAB, POSELTINIB AND LENALIDOMIDE IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE B CELL LYMPHOMAS (EHA 2023) - P2 | "Background: Despite the groundbreaking introduction of rituximab for the treatment of diffuse large B cell lymphoma (DLBCL), approximately 30% of the patients ultimately experience refractory / relapse (R/R) disease and so far myriads attempts to improve survival outcomes have not yielded firm positive results...To mitigate the risk of glofitamab associated cytokine release syndrome, obinutuzumab premedication and cycle 1 step-up dosing was implemented...One patient with a previous history of prior COVID19 infection after TNB-486 (CD19/CD3 bispecific) clinical trial, despite receiving vaccination prior to this study enrollment, experienced COVID19 reactivation after cycle 1... Glofitamab, poseltinib and lenalidomide (GPL) is promising combination for thetreatment of R/R DLBCL. (Table) Refractory, DLBCL, Bispecific"

Clinical • P2 data • Dermatology • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • BCL6

Hanmi Pharmaceutical confirms new indications for poseltinib, a BTK inhibitor [Google translation] (Medical Observer) - P2 | N=76 | NCT05335018 | "This study confirmed the safety and effectiveness of 3-agent combination therapy including poseltinib in relapsed and refractory diffuse large B-cell lymphoma...As of May 2023, 19 patients have been enrolled, and additional clinical patients are currently being recruited...Of the 14 patients whose response was evaluated after the start of the clinical trial, 79% of them met the objective response (OR), which is the criterion for evaluating efficacy, and despite the initial data, 36% of the patients had a complete remission (CR) in which cancer cells disappeared. done. The safety cohort also had no specific adverse reactions."

P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Discovery of a potent BTK and IKZF1/3 triple degrader through reversible covalent BTK PROTAC development. (PubMed, Curr Res Chem Biol) - "Building on our previous work on ibrutinib-based reversible covalent Bruton's tyrosine kinase (BTK) PROTACs, we explored a different irreversible BTK inhibitor poseltinib as the BTK binder for PROTAC development. We showed that PS-RC-1 potently induces degradation of IKZF1 and IKZF3 but not BTK or GSPT1, accounting for its toxicity in Mino cells. We further decreased the molecular size of PS-RC-1 by shrinking the BTK binding moiety and developed PS-2 as a potent BTK and IKZF1/3 triple degrader with high specificity."

Journal • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Targeted Protein Degradation • GSPT1 • IKZF1 • IKZF3

GPL in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Seoul National University Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL6

GPL in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - P2 | N=76 | Not yet recruiting | Sponsor: Seoul National University Hospital

New P2 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL6

Synergistic Effects of BTK Inhibitor HM71224 and Methotrexate in a Collagen-induced Arthritis Rat Model. (PubMed, In Vivo) - "The combination of HM71224 and MTX improved the therapeutic effect with no drug-drug interactions in RA."

Journal • Preclinical • Immunology • Inflammation • Inflammatory Arthritis • Osteoarthritis • Rheumatoid Arthritis • Rheumatology

Target modulation and pharmacokinetics/pharmacodynamics translation of the BTK inhibitor poseltinib for model-informed phase II dose selection. (PubMed, Sci Rep) - P1 | "Desirable PK and PD properties were observed, and a modeling approach was used for rational dose selection for subsequent trials. Poseltinib was confirmed as a potential BTK inhibitor for the treatment of autoimmune diseases.Trial registration: This article includes the results of a clinical intervention on human participants [NCT01765478]."

Journal • P2 data • PK/PD data • Immunology • Rheumatoid Arthritis • Rheumatology • CD40LG • CD8 • CSF1 • IL2 • PLCG2

Safety and Efficacy of Poseltinib, Bruton's Tyrosine Kinase-Inhibitor, in Patients With Rheumatoid Arthritis: A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase-2 Study. (PubMed, J Rheumatol) - "While no safety findings precluded continuation, the study was terminated after interim data demonstrated low likelihood of benefit in RA."

Clinical • Journal • P2 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Hanmi Pharma shares tumble on Eli Lilly’s clinical trials suspension (The Investor) - "Eli Lilly will discontinue the clinical study for HM71224, an experimental Bruton’s tyrosine kinase inhibitor for the treatment of rheumatoid arthritis because it is 'unlikely to meet the primary efficacy endpoint in the ongoing phase 2 trials...Hanmi shares fell 8.5 percent to 495,000 won (US$464), wiping away 523 billion won market value."

Stock price • Trial suspension • Immunology • Rheumatoid Arthritis

Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers (clinicaltrials.gov) - P1; N=62; Completed; Sponsor: Hanmi Pharmaceutical Company Limited; Not yet recruiting -> Completed

Trial completion • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

Eli Lilly & Hanmi collaborate to develop Hanmi's Tyrosine kinase inhibitor (RTTNews) - "Eli Lilly and Company (LLY: Quote) and Hanmi Pharmaceutical Co., Ltd. announced they have entered into an exclusive license and collaboration agreement for the development and commercialization of Hanmi's oral Bruton's tyrosine kinase inhibitor, HM71224, for the treatment of autoimmune and other diseases. Hanmi will receive an initial payment of $50 million and is eligible for up to $640 million in potential development, regulatory, and sales milestones....Lilly will receive worldwide rights to the molecule for all indications excluding China, Hong Kong, Taiwan, and Korea. Lilly will take development, regulatory, manufacturing, and commercial leadership for the molecule in the Lilly territories."

Licensing / partnership • Regulatory • Rheumatoid Arthritis

SAFETY AND EFFICACY OF LY3337641, A BRUTON’S TYROSINE KINASE INHIBITOR IN PATIENTS WITH RHEUMATOID ARTHRITIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART PHASE 2 STUDY (EULAR 2019) - "Although there were no safety findings that precluded continuation of the study, the study sponsor determined that the observed benefit-risk profile of LY3337641 in the study did not warrant its continuation."

Clinical • P2 data

Lilly returns rights for Hanmi’s BTK inhibitor candidate (Korea Biomedical Review) - "Hanmi Pharmaceutical said Wednesday that Lilly has returned licensing rights for LY3337641/HM71224...Lilly decided to discontinue the phase-2 trials of selective BTK inhibitor LY3337641/HM71224 in patients with rheumatoid arthritis because interim results showed that the study could fail to demonstrate its target effectiveness in January last year....Hanmi plans to receive all clinical and developmental data from Lilly within 90 days of returning the BTK inhibitor right, and intends to proceed independently to develop other indications for the drug."

Licensing / partnership • Trial termination