[{"orgOrder":0,"company":"ACEA Therapeutics","sponsor":"Sorrento Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sorrento Acquired Exclusive Rights to Abivertinib with Completed Registrational Trial Data in Non-Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Sorrento Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Clears Abivertinib for Phase 2 Safety and Efficacy Study in Hospitalized Patients with Moderate to Severe COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Sorrento Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ANVISA Authorizes Sorrento Therapeutics\u2019 Large Phase 2 Clinical Trial of Abivertinib in Mild, Moderate and Severe COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"ACEA Therapeutics","sponsor":"Sorrento Therapeutics","pharmaFlowCategory":"D","amount":"$450.0 million","upfrontCash":"Undisclosed","newsHeadline":"Sorrento Enters Into Merger Agreement to Acquire Late-Stage Oncology Company ACEA Therapeutics","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"ACEA Therapeutics","sponsor":"Sorrento Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sorrento Completes Acquisition of ACEA Therapeutics, Creating a Major Oncology Franchise","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Sorrento Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sorrento Announces FDA Authorization to Proceed With Phase 2 Study of Abivertinib (Fujovee) to Treat Metastatic Castrate Resistant Prostate Cancer (MAVERICK Trial)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Sorrento Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sorrento Announces Significant Positive Pivotal Trial Results as Assessed by an Independent Review Committee (IRC) With Matured Long-Term (Over Three Years) Follow-Up Data of Abivertinib for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Sorrento Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sorrento Announces Positive Phase IIa Study Results of Abivertinib for the Treatment of Relapsed\/Refractory Marginal Zone Lymphoma (R\/R MZL) and Its Plan for a Pivotal Phase III Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Abivertinib
STI-5656 (abivertinib maleate) is a pyrrolopyrimidine-based, mutant EGFR and BTK dual inhibitor with potential across multiple indications like Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL).
In this pivotal study conducted in China, The overall response rate (ORR) for Fujovee (abivertinib), as confirmed by the IRC was 56.5% (118/209) and among them, 11 patients had complete responses with a CR rate of 5.3% (11/209) and median overall survival of 28.2 months.
Fujovee (abivertinib) is a novel small molecule tyrosine kinase inhibitor that selectively targets both mutant forms of epidermal growth factor receptor as well as Bruton's tyrosine kinase and has been shown to inhibit extragonadal androgen production in preclinical models.
This is a value-inflection acquisition for Sorrento as it brings in multiple NCE drug product candidates, including the previously licensed Abivertinib as an anchoring small molecule drug product for treating many different cancers and autoimmune diseases.
The acquisition will include late clinical stage drug Abivertinib, clinical stage candidate AC0058, preclinical stage candidate AC0939, and ACEA’s extensive proprietary library of small molecules, which potentially have applications for numerous human disease indications.
The Brazil study is a Phase 2 Study of the Safety and Efficacy of STI-5656 in Subjects Hospitalized Due to COVID-19, particularly looking at the potential clinical benefits of the drug associated with its broad ability to reduce inflammatory cytokine storm.
Abivertinib demonstrated in-vitro the ability to simultaneously lower multiple critical inflammatory cytokines associated with cytokine storm and poor prognosis in COVID-19 patients.
Sorrento gets an exclusive license to ACEA’s Abivertinib, a novel small molecule tyrosine kinase inhibitor that selectively targets both mutant forms of the epidermal growth factor receptor and Bruton’s tyrosine kinase, across all indications for all territories outside China.