[{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"Pfizer Inc","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alphamab Oncology Announces Clinical Supply Collaboration with Pfizer on KN026 in Combination with Ibrance(R) (palbociclib)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alphamab Oncology Received U.S. FDA IND Approval to Initiate A Phase II Clinical Trial of KN046 For NSCLC in the United States","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alphamab Oncology and Sanofi Enter Collaboration on KN026 in HER2+ Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"Institut Pasteur Shanghai","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alphamab Oncology and Institut Pasteur Shanghai Announce Partnership to Co-develop COVID-19 Neutralizing Antibody","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"CHINA","productType":"Large molecule","productStatus":"Undisclosed","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Corning Jerry's Bispecific Antibody Kn046 Was Granted Orphan Drug Designation by the Us FDA for the Treatment of Thymic Epithelial Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"Jiangsu Alphamab Biopharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alphamab Received U.S. FDA IND Clearance to Initiate A Phase II Pivotal Clinical Trial of KN046 (KN046-205,ENREACH-Thymic) in the U.S.","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alphamab Oncology Presented Clinical Data of KN046 Combined with Nab-Paclitaxel in the Treatment of mTNBC at AACR 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alphamab Oncology Presents Phase 2 Clinical Data on KN046 Combined with Chemotherapy for the Treatment of Advanced ESCC at ASCO 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"TRACON Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TRACON Pharmaceuticals Announces Amended ENVASARC Protocol Approved and Open at all 30 Clinical Sites in the U.S. and U.K.","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alphamab Oncology","sponsor":"TRACON Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TRACON Pharmaceuticals Announces Positive Results Based on Ongoing Double-Digit Objective Response Rate for Single Agent Envafolimab in the ENVASARC Phase 2 Pivotal Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Jiangsu Alphamab","sponsor":"Glenmark Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Glenmark, Jiangsu Alphamab Biopharmaceuticals and 3D Medicines Announce the Signing of a License Agreement for KN035 (Envafolimab) for Multiple Geographies around the World","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals by Alphamab Oncology
Glenmark will be responsible for further developing, registering, and commercializing KN035 (envafolimab), approved in China for the treatment of adult patients with previously treated MSI-H or dMMR advanced solid tumor, in multiple geographies around the World.
KN035 (envafolimab) is a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor, which is investigated for MSI-H/dMMR advanced solid tumors.
Result demonstrated highly tolerable safety profile and significantly higher objective response rate observed in lower weight patients in ENVASARC, to increase dose of envafolimab to 600 mg every three weeks, which is double the original envafolimab dose of 300 mg Q3W.
KN046-204 is a phase II clinical study in China to evaluate the efficacy and safety of KN046 monotherapy or plus chemotherapy for unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.
KN046-203 is a phase Ib/II, open label, multi-center clinical study, evaluating the efficacy, safety, and tolerability of KN046 in combination with nab-paclitaxel in patients with TNBC.
KN046 is a bispecific antibody targeting PD-L1 and CTLA-4 immune checkpoints. Alphamab will conduct a open label, multi-center phase II pivotal clinical study in the U.S to evaluate the efficacy, safety and tolerability of KN046 for the treatment of thymic carcinoma.
The recombinant humanized PD-L1/ CTLA-4 bispecific antibody KN046 was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of thymic epithelial tumors.
According to the agreement, Alphamab Oncology and Institut Pasteur Shanghai will form a joint project team. Alphamab Oncology is responsible for providing its proprietary Mixed Antibodies Platform, constructing humanized antibodies and recombinant engineered cell lines,
According to the terms of the agreement, after reaching certain clinical milestones, Sanofi will have the right to negotiate the exclusive right to introduce KN026 during the exclusive period.
KN046's Phase I clinical trials in Australia and China, along with multiple Phase II trials in China have shown a good safety profile and promising efficacy.
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