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[{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cullinan Pearl Announces Presentation of Preliminary Safety and Efficacy of CLN-081 in EGFR Exon 20 NSCLC Patients at ESMO 2020","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Zai Lab","pharmaFlowCategory":"D","amount":"$231.0 million","upfrontCash":"$20.0 million","newsHeadline":"Zai Lab and Cullinan Oncology Announce Strategic Collaboration and License Agreement for CLN-081 in Greater China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Taiho Pharmaceutical","pharmaFlowCategory":"D","amount":"$405.0 million","upfrontCash":"$275.0 million","newsHeadline":"Cullinan Oncology and Taiho Pharmaceutical Announce Strategic Collaboration to Jointly Develop and Commercialize CLN-081\/TAS6417 and Taiho\u2019s Acquisition of Cullinan Pearl","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Taiho Pharmaceutical","pharmaFlowCategory":"D","amount":"$405.0 million","upfrontCash":"$275.0 million","newsHeadline":"Cullinan Oncology and Taiho Pharmaceutical Complete Agreement for Strategic Collaboration to Jointly Develop and Commercialize CLN-081\/TAS6417","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cullinan Oncology to Provide Clinical Update for CLN-081 in NSCLC EGFR Exon 20 Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cullinan Oncology to Host CLN-081 Regulatory Update Webinar on March 28, 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cullinan Oncology Announces Clinical and Regulatory Update for CLN-081 in NSCLC EGFR Exon 20 Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cullinan Oncology to Present Updated Data Highlighting the Therapeutic Potential of CLN-081 in Patients with EGFR Exon 20 Insertion Mutation Positive Non-Small Cell Lung Cancer at the 2022 ASCO Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Cullinan Therapeutics","sponsor":"Taiho Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cullinan Oncology to Present Updated Data Demonstrating the Therapeutic Potential of CLN-081 in Patients with EGFR Exon 20 Insertion Mutation Positive Non-Small Cell Lung Cancer at the 2022 ASCO Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Taiho Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"REZILIENT3 Global First-Line Trial of Zipalertinib Launched in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Zipalertinib
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Details:
TAS6417 (zipalertinib) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR.
Lead Product(s):
CLN-081 ,Pemetrexed ,Cisplatin
Therapeutic Area: Oncology
Product Name: TAS6417
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 03, 2023
Details:
Taiho has also completed its acquisition of Cullinan Oncology’s subsidiary, Cullinan Pearl Corp. (Cullinan Pearl) which has worldwide rights outside of Japan* to CLN-081/TAS6417.
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: TAS6417
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Taiho Pharmaceutical
Deal Size: $405.0 million
Upfront Cash: $275.0 million
Deal Type: Collaboration
June 23, 2022
Details:
TAS6417 (CLN-081), is designed as a next-generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer (NSCLC).
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: TAS6417
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Taiho Pharmaceutical
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 31, 2022
Details:
Under the agreement, Taiho will acquire Cullinan Oncology’s subsidiary, Cullinan Pearl, which has worldwide rights outside of Japan* to CLN-081/TAS6417, EGFR exon20 non-small cell lung cancer (NSCLC) regulatory milestones.
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: TAS6417
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Taiho Pharmaceutical
Deal Size: $405.0 million
Upfront Cash: $275.0 million
Deal Type: Collaboration
May 12, 2022
Details:
CLN-081 or TAS6417 is an orally available, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: TAS6417
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 27, 2022
Details:
CLN-081 was administered orally at dose levels including BID showed promising response durability previously observed in initial phase 1 patient cohort (n=13) with estimated median response duration > 15 months and median progression free survival of 12 months.
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: CLN-081
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 28, 2022
Details:
CLN-081 is an orally available, irreversible epidermal growth factor receptor (EGFR) inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: TAS6417
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 17, 2022
Details:
CLN-081 is an orally available, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: CLN-081
Highest Development Status: Phase I/ Phase II
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 13, 2021
Details:
Zai Lab gets exclusive license for the development, manufacturing and commercialization of CLN-081 in Greater China. Zai Lab to lead development and commercialization of CLN-081 in Greater China.
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: TAS6417
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Zai Lab
Deal Size: $231.0 million
Upfront Cash: $20.0 million
Deal Type: Collaboration
December 28, 2020
Details:
The poster presentation will summarize the initial Phase 1 experience with CLN-081 up to the data cutoff of September 1, 2020, including data on 22 patients treated at dose levels ranging from 30-150 mg administered orally twice daily.
Lead Product(s):
CLN-081
Therapeutic Area: Oncology
Product Name: TAS6417
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 17, 2020