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

NB02 (Poseltinib) combined rituximab and lenalidomide in R/ R PCNSL (POTENTIAL-P): Initial results of safety lead-in cohort. (ASH 2025) - P2 | "These initial results from the safety lead-in cohort suggest that the combination of poseltinib, rituximab,and lenalidomide has a manageable safety profile and demonstrates promising preliminary anti-tumoractivity in patients with R/R PCNSL. Enrollment in the study is ongoing, and updated results will bepresented."

Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • CNS Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Thrombocytopenia

Poseltinib combined with rituximab and lenalidomide is a promising chemotherapy-free therapy in relapsed or refractory primary central nervous system lymphoma (ASH 2025) - P2 | "All patients received methotrexate-based chemotherapy as first-line treatment.Nine patients received poseltinib 40 mg twice daily, while the last enrolled patient received 60 mg twicedaily. ConclusionsPoseltinib in combination with lenalidomide and rituximab may represent a promising therapeuticapproach for patients with R/R PCNSL. Further studies with larger cohorts and integrated genomicanalysis are warranted."

CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • CD79B • MYD88 • PIM1

Go-Pro-DLBCL: Golcadomide, Poseltinib, and Rituximab for Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=20 | Not yet recruiting | Sponsor: Seoul National University Hospital

New P1/2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Nobo Medicine…announced the early clinical results of its poseltinib-based triple combination therapy for patients with relapsed and refractory primary central nervous system lymphoma (R/R PCNSL) at the 67th American Society of Hematology (ASH) Annual Meeting held in Orlando, USA. [Google translation] (Nate) - "Lead-in safety data for the poseltiniib, lenalidomide, and rituximab combination included in this presentation were collected in six patients. No dose-limiting toxicities (DLTs) were observed, and Grade 3/4 adverse reactions occurred in two patients, but no treatment discontinuations occurred, confirming a favorable safety profile."

P2 data • CNS Lymphoma

Chemotherapy-Free Salvage Therapy with Rituximab, Lenalidomide, and Poseltinib in Relapsed or Refractory Primary Central Nervous System Lymphoma: A Multi-Center, Phase II Study. (PubMed, Cancer Res Treat) - "The median age was 70 years (range, 53-75), and all had received methotrexate-based first-line chemotherapy. No dose modifications were required due to toxicity. Poseltinib in combination with lenalidomide and rituximab showed activity in patients with R/R PCNSL, warranting further investigation in larger studies."

Journal • P2 data • CNS Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • CD79B

NOBO Medicine demonstrates initial safety of poseltinib combination therapy for brain lymphoma (Korea Biomedical Review) - "No dose-limiting toxicity (DLT) emerged in the initial six-patient cohort. Grade 3–4 adverse effects included neutropenia, thrombocytopenia, and elevated liver enzymes, all of which are controllable. Of the first two patients to complete response evaluation, one achieved complete remission (CR) and one partial remission (PR), indicating prompt antitumor activity."

P2 data • CNS Lymphoma

POTENTIAL-M: NB02(POSELTINIB) Monotherapy in R/R Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: NOBO Medicine

Monotherapy • New P1 trial • 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) - "The median age of the nine patients was 69 years (range, 53–74), and all received methotrexate-based chemotherapy as first-line treatment. This study demonstrated that poseltinib, combined with lenalidomide and rituximab, is effective and safe in patients with R/R PCNSL. Given the clinical unmet need in treatment approach for R/R PCNSL, further research is warranted to investigate a poseltinib-based regimen in this patient population. Acknowledgments: We thank the participating patients and their families, all study coinvestigators, and research coordinators."

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

NOBO Medicine wins KDDF support for phase 2 trial of BTK inhibitor in CNS lymphoma (Korea Biomedical Review) - "NOBO Medicine said its investigational anticancer agent, poseltinib, has been selected for clinical development support under the 2025 first-round funding program of Korea Drug Development Fund (KDDF), a pan-ministerial national new drug R&D initiative. The selection secures government funding for the next two years to support a phase 2 clinical trial of Poseltinib in patients with relapsed or refractory primary central nervous system lymphoma (PCNSL), a rare B-cell lymphoma with poor prognosis. However, the company did not unveil how much financial support it will receive through the program."

Financing • Primary Central Nervous System Lymphoma

GLOFITAMAB, POSELTINIB AND LENALIDOMIDE FOR PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA (ICML 2025) - P2 | "GPL regimen demonstrates excellent efficacy in terms of ORR and CRR in aged R/R DLBCL patients. Safety profiles did not show any new signals compared to GLO monotherapy demonstrating good tolerability of this chemotherapy-free regimen."

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

TRIAL IN PROGRESS : PHASE 2 TRIAL TO NB02 (POSELTINIB) COMBINED RITUXIMAB AND LENALIDOMIDE IN R/?R PCNSL (POTENTIAL-P) (EHA 2025) - P2 | "As of Feb 19, 2025, 1 patient has been enrolled. This trial is registered at ClinicalTrials.gov (NCT06737250)."

P2 data • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma

Preparation and utilization of an immunoadsorption column for aflatoxin B1 composed of nanobodies and pre-crosslinked agarose microspheres. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "The activated microspheres were coupled with the anti-AFB1 nanobody Nb02, creating an immunoaffinity packing called CDI-SA-A-Nb02 (D1-IAC)...The preparation process for D1-IAC shows great consistency, and the column's performance is better than that of available immunoaffinity columns. This study explores using an IAC to extract and purify AFB1, which is then quantified using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS)."

Journal

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