Grant Award Details
Complete nonclinical and IND-enabling activities including GLP toxicity studies. Manufacture product to support IND enabling activities and Phase 1 trial. Generate clinical protocol and file IND for Phase 1 trial.
Grant Application Details
- Development of CLT030-ADC, a Leukemic Stem Cell Trageting Antibody-Drug-Conjugate, for Treatment of Acute Myeloid Leukemia
Therapeutic Candidate or Device
CLT030-ADC, a novel drug targeting a leukemic stem cell surface protein CLL1, is intended to improve therapeutic outcome for AML patients.
CLT030-ADC is intended to improve remission rates in AML patients.
CLT030-ADC is an antibody-drug conjugate targeting leukemic stem cell surface protein CLL1. Leukemic stem cells (LSC) are believed to be responsible for disease recurrence and are resistant to chemotherapy. CLT030-ADC specifically targets LSC as a primary mode of action. CLT030-ADC is stable in the bloodstream and releases its DNA binding payload upon binding to LSC and internalization. The payload binds to the cellular DNA and kills the cell.
Unmet Medical Need
The current standard of care for AML patients is inadequate as evidenced by low survival rates. The chemotherapy does not kill LSC, which are believed to be responsible for relapse. By targeting LSC with CLT030-ADC, remission rates could be higher resulting in prolonged survival.
Filing of IND for Phase 1 trial.
Major Proposed Activities
- Complete nonclinical and IND-enabling activities including GLP toxicity studies
- Manufacture product to support IND enabling activities and Phase 1 trial
- Generate clinical protocol and file IND for Phase 1 trial
Approximately 20,000 new AML cases are diagnosed annually in the United States, and about 8% of the cases are in California. The five-year survival rate is around 25% and 5% for patients over 65. CLT030-ADC has the potential of prolonging patients’ lives and improving quality of life. This could help productive citizens reenter the workforce and decrease the burden on the California healthcare system. Also the state’s economy benefits by creating more jobs from the growth of this company.