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 Pharmaceutical announced on June 12 that the interim results of the phase 2 clinical trial of triple-drug combination therapy, a follow-up study of 'Poseltinib', a BTK inhibitor returned by Eli Lilly, a global pharmaceutical company, were presented at EHA(European Hematology Association) held in Frankfurt, Germany from June 8th to 11th.

This study, supported by Hanmi Pharmaceutical and Genome Opinion, confirmed the safety and effectiveness of the triple-drug combination therapy 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 in charge of the presentation.

Poceltinib is a BTK inhibitor that Hanmi Pharmaceutical initially developed and licensed out to Eli Lilly in 2015 for a total of 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 the 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 being 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, but 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 billion dollars.

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 the field of metabolic diseases such as obesity through follow-up development.