[{"orgOrder":0,"company":"OncoC4","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OncoC4, Inc. Reports Phase Ia Data on Safety and Clinical Activities of ONC-392 (Nextgen Anti-CTLA-4) Monotherapy for Stage IV Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"OncoC4","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OncoC4 Announces Fast Track Designation Granted by the U.S. FDA for ONC-392 Monotherapy in PD(L)1-Resistant NSCLC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"OncoC4","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"UPDATE - OncoC4 Announces First Patient Dosed in PRESERVE-004, a Phase 2 Clinical Trial of ONC-392 in Combination with KEYTRUDA\u00ae (Pembrolizumab) in Patients with Platinum-Resistant Ovarian Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"OncoC4","sponsor":"BioNTech","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$200.0 million","newsHeadline":"BioNTech and OncoC4 Announce Strategic Collaboration to Co-Develop and Commercialize Novel Checkpoint Antibody in Multiple Solid Tumor Indications","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"OncoC4","sponsor":"BioNTech","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316\/ONC-392 Program in Metastatic NSCLC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"OncoC4","sponsor":"BioNTech","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OncoC4 Announces First Patient with Advanced Prostate Cancer Dosed in Phase 1\/2 Trial of BioNTech-partnered BNT316\/ONC-392 Program","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"OncoC4","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OncoC4 Announces FDA Clearance of IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"}]
Find Clinical Drug Pipeline Developments & Deals by OncoC4
ONC-841 is a potential first-in-class SIGLEC 10 antibody designed to block an innate and potentially adaptive immune checkpoint. It is being evaluated for the treatment of solid tumors.
BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody candidate jointly developed by BioNTech and OncoC4. BNT316/ONC-392 is currently in late-stage clinical development in combination with lutetium (177Lu) vipivotide tetraxetan in patients with mCRPC.
Lead Product(s):
Gotistobart,Lutetium Vipivotide Tetraxetan
BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody, which is investigated for the treatment of metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment.
Under the collaboration BioNTech will receive exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 monoclonal antibody candidate, ONC-392 (gotistobart), as monotherapy or combination therapy in various cancer indications.
ONC-392 is the first known acid pH-sensitive anti-CTLA-4 mAb that interacts strongly with CTLA-4 at a pH typical of normal tissues/organs and the tumor microenvironment.
ONC-392, Company’s next-gen anti-CTLA-4 monoclonal antibody (mAb) that preserves the CTLA-4 immune checkpoint function, as a single agent for the treatment of patients with metastatic NSCLC who have had disease progression on prior anti-PD-(L)1 therapy.
The data signify that ONC-392 monotherapy has promising anti-tumor activity in Stage IV cancer patients who had previously failed multiple lines of therapy and who had previously acquired resistance to PD(L)1 therapy.