Hanmi Pharmaceutical is confirming new indications for a self-developed new drug that was returned by global pharmaceutical company Eli Lilly, exploring the possibility of a turn around.
Hanmi announced on June 12 that the interim results of phase 2 clinical trial of triple-drug combination therapy, a follow-up study of 'Poseltinib', which is a BTK inhibitor returned by Eli Lilly, a global pharmaceutical company, were presented at EHA(European Hematology Association) held in Frankfurt, Germany from June 8 to 11th.
This study, supported by Hanmi Pharmaceutical and Genome Opinion, confirmed the triple-drug combination therapy's safety and effectiveness, including poseltinib in relapsed and refractory diffuse large B-Cell lymphoma (DLBCL). Professor Jaemin Byun from the Department of Hematology-Oncology at Seoul National University Hospital was responsible for the presentation.
Poceltinib is a BTK inhibitor that Hanmi Pharmaceutical initially developed and licensed to Eli Lilly in 2015 for 690 million dollars.
After the rights were returned, Hanmi Pharmaceutical, which has revealed its will for follow-up development of poseltinib, signed a joint development contract with Genome Opinion in October 2021. Researcher-led clinical trials have been conducted for patients with relapsed and refractory DLBCL through a triple-drug combination therapy combining ' Lenalidomide'.
Named 'GPL study' after the first letters of the drug used in triple-drug therapy, this clinical trial is being conducted at multiple institutions in Korea, centered on institutions belonging to the Lymphoma Research Society of the Korean Hematology Society. As of May 2023, 19 patients have been enrolled, and additional clinical patients are currently being recruited.
In the interim results presented at this EHA, the research team confirmed the safety and effectiveness of GPL therapy. Of the 14 patients whose response was evaluated after the start of the clinical trial, 79% met the objective response (OR), which is the criterion for evaluating efficacy. Also, despite preliminary data, complete remission (CR) with the disappearance of cancer cells was observed in 36% of the patients. The cohort evaluating safety also did not show any significant adverse reactions. The research team evaluated that the GPL combination therapy has sufficient potential as a new treatment option for patients as it can broadly control the carcinogenesis of DLBCL compared to existing therapies.
Professor Seong-Soo Yoon, the principal investigator of the overall clinical trial from the Department of Hematology-Oncology at Seoul National University Hospital, stated, “This treatment could provide new hope for patients with relapsed or refractory DLBCL who have failed standard therapies, including CAR-T.”
According to the research team, several bispecific antibodies have recently been approved for use in patients with relapsed and refractory DLBCL, showing relatively excellent efficacy. However, the limitations are still clearly shown through frequent relapses after antibody monotherapy. An official from Hanmi Pharmaceutical said, "Since the safety and effectiveness of the combination therapy of poseltinib and bispecific antibody have been confirmed, we expect that the final clinical results will provide new treatment options to medical staff in the future."
Meanwhile, Hanmi Pharmaceutical continues to conduct follow-up research on candidate substances returned after out-licensing, steadily creating cases of reversal. For example, HM12525A (Epinopegdutide), an obesity and diabetes treatment that Janssen returned in 2019, changed its indication to a NASH treatment and out-licensed it again to MSD in the US in 2020 at a scale of 1 trillion won.
MSD plans to present the results of the global phase 2a clinical trial conducted after the introduction of HM12525A orally at The European Association for the Study of the Liver (EASL) to be held in Vienna, Austria on June 21st. In addition, the long-acting GLP-1 biologic drug ‘Efpeglenatide’ returned by Sanofi in 2020, is also seeking new possibilities in metabolic diseases such as obesity through follow-up development.
[Explanation of terms]
Poseltinib: Oral treatment for autoimmune diseases and blood cancer with a mechanism that selectively inhibits BTK (Bruton's Tyrosine Kinase), an enzyme involved in the activation signal of B lymphocytes in our body.
Diffuse Large B-Cell Lymphoma (DLBCL): Lymphoma refers to a tumor caused by malignant transformation of lymphoid tissue cells, and lymphoma includes Hodgkin's lymphoma and non-Hodgkin's lymphoma (malignant lymphoma). Diffuse large B-cell lymphoma is an aggressive type, accounting for approximately 30-50% of non-Hodgkin's lymphomas, and is the most frequent.
Glofitamab: A bispecific antibody treatment developed by Roche of Switzerland that simultaneously targets T cells and B cells (CD3xCD20), showing therapeutic efficacy in various hematological cancers.
■ Contact info:
Official Websites: www.hanmipharm.com
innovation@hanmi.co.kr, +08-2-410-0467