B cell tumor target new drug! MEI/Concord Kirin cooperates to develop PI3K inhibitor MEI-401 to treat total remission rate of 75-100% for class 3 tumors

April 26, 2020 /
PRNewswire
BIOON/ -- MEI Pharma is a late-stage, clinical biopharmaceutical company dedicated to developing innovative therapies for cancer treatment Recently, the company announced a global licensing, development and commercialization agreement with Japan Pharmaceutical Company Association and Kyowa Kirin to further develop and commercialize ME-401 The drug is an oral selective phospholipid inositol-3-kinase inhibitor developed for the treatment of malignant tumor of B cells the agreement essentially preserves and consolidates the terms of the license agreement between the two parties for the development and commercialization of MEI-401 in Japan in 2018 According to the terms of the latest agreement, in the United States, MEI and Concord Kirin will jointly develop and promote the ME-401, the two sides will be 50-50 to share costs and profits Outside the U.S., Concorde has exclusive commercialization rights and MEI will be eligible for incremental tiered royalties MEI will receive $100 million in cash advances and be eligible for milestones of up to $582.5 million based on specific development, regulatory, and commercial milestones The two sides have agreed to a development plan to extensively evaluate the of ME-401 for the treatment of various B-cell malignant tumors, including joint applications with other drugs ME-401 is a in the study of oral phosphatidyl inositol 3-kinase (PI3K) inhibitors, and is currently under clinical development to evaluate and treat a wide range of B-cell malignancies PI3K inhibitors are often over-expressed in cancer cells and play a key role in the proliferation and survival of blood tumors ME-401 is highly selective to the PI3K subtype and has different drug characteristics than other PI3K inhibitors, which have the potential to become the best-in-class (bet-in-cla) PI3K inhibitor its clinical characteristics suggest that as a single-drug therapy or in combination with other cancer drugs, there is an opportunity to address a range of B-cell malignant tumor at the end of March this year, the United States THE FDA
GRANTED MEI-401 FAST-TRACK ELIGIBILITY (FTD) FOR THE TREATMENT OF ADULT PATIENTS WITH RECURRENT OR REFRACTORY OSTOIDAL LYMPHOMA (R/R FL) WHO HAVE RECEIVED AT LEAST 2 SYSTEMIC THERAPIES Currently, MEI is conducting a global Phase II TIDAL clinical trial evaluating ME-401 as a single therapy for patients in Adult R/R FL who have received at least 2 systemic therapies, including chemotherapy and anti-CD20 antibodies The results of the trial will be used to support an application to the U.S FDA to expedite the approval of the ME-401 market the differentiated characteristics of MEI-401
in addition to the TIDAL trial, MEI is also conducting a multi-arm, open label, Ib dose increment and expansion trial to evaluate ME-401 as a monotherapy, with other therapies (e.g rituxima) or drugs (e.g Brukina (zanrutubinib, Zebutini), Bacchi Shenzhou BTK inhibitor) combined drug to treat recurrent or refractory B-cell malignant tumor , including lifsic lymphoma (FL), chronic lymphocytic leukemia
/small cell lymphoma (CLL/SLL), marginal lymphoma (MZL), set cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL) In addition, MEI launched a Phase I trial in 2019 to evaluate MEI-401 as a single-drug therapy for patients with japanese inert B cell malignant tumor
David M Uro, Chief Operating Officer and General Counsel of MEI, said, "Global collaboration with Concord Kirin is a key step towards our goal of broadly developing and commercializing ME-401, optimizing opportunities for patients with multiple B-cell malignant tumors , both in the United States and beyond, and creating value for our shareholders." Our decision to expand our alliance with Concord Kirin is based on our successful partnership to date under the 2018 Japan License Agreement, our respect for Concord Kirin and their ability to jointly implement our common vision for ME-401 in the United States and around the world Tomohiro Sudo, Director of Strategic Product Planning at Concord e-Concorde, , said: "I am pleased to expand our agreement with ME Pharma on the development and commercialization of ME-401 worldwide We believe that ME-401 has the potential to provide patients with an important new treatment option and further strengthen our global oncology pipeline "
last October, MEI published updated data for the Ib period study The results showed that the total remission rate (ORR) of all patient
groups treated with ME-401 (FLL-CLL/SLL) was 75-100%, specifically: (1) 78%
of ORR in all FL patients (n-43/55), ME-401 mono-drug treatment group ORR7% and ME-401-Litoson group of OR7% combined with R7% all (2) Among Patients with CLL/SLL, ORR was 89% (n-16/18), orRR in the ME-401 mono-drug treatment group was 100%, and ME-401-rituxima-combination treatment group orRR was 71% the study, ME-401 Continuous Administration Program (CS) and Intermittent Administration (IS) showed high remission and long-lasting remission in both FL and CLL/SLL patients, but the rate of ME-401 treatment-related level 3 adverse events observed by the IS program group was lower than in the CS protocol group For example, the incidence of stage 3 diarrhea/colitis was 5 per cent in the IS programme group and 23 per cent in the CS programme group November 2018, Baiji Shenzhou entered into a non-exclusive clinical partnership with MEI Pharmaceuticals to assess the potential of ME-401 and Brukina to jointly treat the of B-cell malignant tumors Currently, the ME-401-Brukina joint treatment program has been included in the above-mentioned multi-arm, open-label Ib study to assess the potential of treatment FL, MCL, and DLBCL Brukina (Zebrutinib) is a BTK inhibitor in Baiji Shenzhou that was accelerated by the U.S FDA in November 2019 to treat adult set cell lymphoma (MCL) patients who have received at least one treatment in the past In particular, Brukina is the first product developed and approved by Baiji Shenzhou, marking a major milestone in the company's development history, but also marked the first fully independent research and development by Chinese enterprises, in the United States FDA approved the listing of new anti-cancer drugs, to achieve China's original research and new drugs out to sea "zero breakthrough." (BiovalleyBioon.com) Original Source: MEI Pharma and Kyowa Kirin Kirin Announce Global Licene, Development and Commercialization Agreement for ME-401