Our Pipeline
ACEA has a robust pipeline of small and large molecules and cell therapies in development for the treatment of cancer, COVID-19 and autoimmune diseases.
Our lead compound Olgotrelvir is a next generation standalone oral treatment for COVID-19. We have completed Phase III trial treatment of over 1200 patients. Submission of NDA to National Medical Products Administration of China (NMPA) is under the plan and expect to get an approval by the end of 2023.
Abivertinib as a next generation BTK inhibitor, is evaluated as a drug to treat COVID-19 patients with moderate to severe symptoms for the Phase III trial in Brazil. Additional indications for Abivertinib as BTK inhibitor that are currently in clinical trials include B Cell lymphoma (BCL) and prostate cancer. As a more potent inhibitor of mutant than wild-type EGFR, Abivertinib is in Phase III clinical trial of patients with non-small cell lung cancer (NSCLC) harboring the EGFR T790M mutation. In the USA, FDA granted IND clearance for Phase II study of Abivertinib to treat patients with resistance to Tagrisso (Osimertinib).
AC0058, a potential treatment for autoimmune diseases, has entered Phase Ib trial for systemic lupus erythematosus (SLE) in the USA.
STI-6129, an antibody drug-conjugate that targets CD38, has entered Phase Ib development in the US and China for the treatment of AL amyloidosis and multiple myeloma.
AC0939, a novel small molecule inhibitor of FMS-like tyrosine kinase 3 (FLT3), has reached Phase I development in China for the treatment of acute myeloid leukemia (AML).
Also, we have several compounds in preclinical development across multiple cancer settings.
Product | Target | Indication | Screening | Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
---|---|---|---|---|---|---|---|---|---|
Abivertinib | Mutated EGFR | NSCLC | China/US | ||||||
Abivertinib | BTK | B-cell lymphoma | China | ||||||
Abivertinib | BTK | Prostate Cancer | US | ||||||
Abivertinib | BTK | Severe COVID-19 | US/Brazil | ||||||
Olgotrelvir | Mpro/Cathepsin | Mild/moderate diseases | China/US/ AUS/Mexico | ||||||
AC0058 | BTK | Auto-immune diseases | US/China | ||||||
STI-6129 | Anti-CD38 ADC | MM/AL | US/China | ||||||
AC0939 | FLT-3 and others | AML/HCC | China | ||||||
AC-PRO | traditional “undruggable” targets (PROTAC) | Various tumors | US/China | ||||||
STI-1492 | AntiCD38 A2 KOKI DAR-T cells | Cancers | US |
Abivertinib | |||||
Target: Mutated EGFR | |||||
Indication: NSCLC | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
China/US | |||||
Abivertinib | |||||
Target: BTK | |||||
Indication: B-cell lymphoma | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
China | |||||
Abivertinib | |||||
Target: BTK | |||||
Indication: Prostate Cancer | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
US | |||||
Abivertinib | |||||
Target: BTK | |||||
Indication: Severe COVID-19 | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
US/Brazil | |||||
Olgotrelvir | |||||
Target: Mpro/Cathepsin | |||||
Indication: Mild/moderate diseases | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
China/US/ AUS/Mexico | |||||
AC0058 | |||||
Target: BTK | |||||
Indication: Auto-immune diseases | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
US/China | |||||
STI-6129 | |||||
Target: Anti-CD38 ADC | |||||
Indication: MM/AL | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
US/China | |||||
AC0939 | |||||
Target: FLT-3 and others | |||||
Indication: AML/HCC | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
China | |||||
AC-PRO | |||||
Target: traditional “undruggable” targets (PROTAC) | |||||
Indication: Various tumors | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
US/China | |||||
STI-1492 | |||||
Target: AntiCD38 A2 KOKI DAR-T cells | |||||
Indication: Cancers | |||||
Pre-clinical | Phase I | Phase II | Phase III | NDA | Country |
US |