CD20xCD3 bispecific antibody! Regeneration Yuan and Reding Pharmaceuticals reached a strategic cooperation, Greater China to develop REGN1979 treatment B cell tumors!

09 April 2020 /
Biovalley BIOON / -- Regeneron and Zai Lab recently jointly announced that the two sides have reached a strategic cooperation on the development and commercialization of a CD20xCD3 biantibodies REGN1979 in mainland China, Hong Kong, Taiwan and Macau this collaboration will support REGN1979's global clinical research and development efforts, including the ongoing Phase II clinical study of B-cell non-Hodgkin's lymphoma (B-NHL), which could be a registered trial In addition, once REGN 1979 is approved for marketing in China, Anding Pharma will use its own commercialization team to advance its commercialization work in the protocol area REGN1979 is the most clinically advanced bispecific monoclonal antibody created by the regenerative meta-specific antibody platform to kill cancer cells by binding to b-cell tumor protein (CD20) and immune system T-cell receptor (CD3) under the agreement, Regeneration will receive a down payment of $30 million and a registration and sales milestone payment of up to $160 million Retin Pharma will share some of REGN199's global development costs and gain the right to develop and exclusively commercialize in the oncology in mainland China, Hong Kong, Taiwan and Macau In addition, the regeneration element will also receive some of the future commercialization of the product At the same time, Regeneration Element will be responsible for the production and supply of REGN1979 for development and commercialization in the Protocol area Dr Irael Lowy, Senior Vice President and Head of Clinical and Translational Sciences, Oncology , , said, "Retin Pharma is our ideal partner, and their achievements in the past are highly aligned with our vision, and we are committed to using scientific strength to bring innovative therapies to patients with serious illnesses." The support of Retin Pharma will not only help accelerate the global development of REGN1979, but will also enable this promising drug to reach patients in this important region more quickly "
, Dr Ying Du, Founder, Chairman and CEO of Reeding Pharmaceuticals, said, "Regenerative Yuan is a global leader in innovative drug development, and we are pleased to partner with ReGN1979 and establish a blood tumor product line for the company Retin Pharmaceuticals hopes to contribute to the success of REGN1979 with its professional competence in registration and clinical practice and commercialization in mainland China, Hong Kong, Taiwan and Macau We will work closely with Regeneration to expand our global business to bring innovative medicines to patients whose medical needs are not yet met "
REGN1979 has been qualified as an orphan drug by the U.S Food and Drug Administration (
FDA ) for the treatment of diffuse large B-cell lymphoma (DLBCL) and flotoma (FL) REGN1979 is currently conducting a Phase I clinical study and a Phase II clinical study that may be a registered trial in patients with advanced follicle lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) and other lymphomas rereGN199 Clinical Phase I study positive results were presented at the 2019 annual meeting of the American Society of Hematology (ASH) Data show that REGN1979 single-drug treatment recurrent or refractory diffuse large B cell lymphoma (R/R DLBCL), high dose shows increased efficacy: 8 out of 8 patients treated with 80/160/320 mg of the disease to achieve complete remission (CR), CAR-T treatment failure of 3 cases of CR in addition, , REGN1979 single-drug treatment for recurrent or refractory leachicular lymphoma (R/R FL) also showed an increase in the efficacy with the dose: 13 out of 14 patients treated with 5 mg of the disease, the total remission rate (ORR) as high as 93% (n?13/14), the total remission rate (CR) up to 71.4 ( 10/14) it's worth noting that at the 2019 ASH Annual Meeting, Roche also released 2 CD20xCD3 bispecific antibodies (mounetuzumab and CD20-TCB) treat patients with recurrent or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) - GO29781 study (NCT02500407) results show that: (1) mounetuzumab in inert NHL patients and invasive NHL patients ORR 62.7% (n?42/67) and 37.1% (n-46/124), CR 13.3% (n-29/67) and CR 19.4 (n-24/14) (2) CR showed persistence, 82.8% of inert NHL patients (n-24/29) were still in remission 26 months after initial treatment, and 70.8% (n?17/24) in invasive NHL patients were still in remission 16 months after initial treatment (3) In patients previously treated with CAR-T cell therapy, ORR was 38.9% (n?7/18) and CR was 22.2% (n-4/18) - NP30179 Study (NCT03075696) results show that: (1) CD20-TCB and Gazyva/Gazyvaro combined therapy R/R B-NHL ORR was 54% (n?15/28) and CR 46% (n?13/28) (2) In R/R FL patients, ORR and CR were 66.7% (n-4/6), in invasive NHL patients, ORR was 50.0% (n?11/22) and CR was 40.9% (n-9/22) the same mechanism as regenerative element REGN1979, Roche mounetuzumab and CD20-TCB are CD20xCD3 T cells binding bispecific antibodies, targeting CD20 on the surface of B cells and CD3 on the surface of T cells This dual-targeting activates and retargets the patient's existing T-cells by releasing toxic proteins into the B cells to eliminate the target B cells Mounetuzumab and CD20-TCB these two antibodies are structurally different, mounetuzumab structure is similar to human natural antibodies, but contains 2 Fab regions, one Fab region target CD20, the other Fab region target CD3 CD20-TCB has a novel "2:1" structure pattern, with 2 Fab regions with target CD20s and one target-bound Fab area bound to CD3 These two antibodies are part of Roche's exploration of several bispecific antibody pattern strategies to determine scenarios that maximize potential clinical benefits for patients Currently, Roche is developing mounetuzumab and CD20-TCB as a combination of monotherapy and other drugs to treat CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and ostosis (biovalleybioon.com) original origin: Regeneron, Zai Lab, Roche