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Trillium Therapeutics Inc. (TSX:TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that it has dosed the first acute myeloid leukemia (AML) patient with TTI-622 (SIRPα-IgG4 Fc), an investigational checkpoint inhibitor of the innate immune system, in combination with azacitidine and venetoclax.
TTI-622 is a fusion protein that is designed to block the inhibitory activity of CD47, a molecule that is overexpressed by a wide variety of tumors. CD47 binds to SIRPα on macrophages and delivers a “don’t eat me” signal that inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that TTI-622 exhibits anti-tumor activity against AML cells as a monotherapy that is enhanced when combined with azacitidine or venetoclax.
“The dosing of this patient marks the second combination cohort that has been initiated with TTI-622,” commented Dr. Ingmar Bruns, Trillium’s Chief Medical Officer. “AML is an important part of a Phase 1b/2 program we initiated to evaluate TTI-622 with various combination agents in five hematologic malignancy and solid tumor indications, building upon the monotherapy activity that we have observed in multiple hematologic cancers.”
The combination of TTI-622 and azacitidine and venetoclax is being assessed as part of the ongoing, open-label study (NCT03530683). Approximately 50 elderly patients (≥75 years old) or patients unfit for intensive induction chemotherapy with newly diagnosed TP53-wild type AML will be enrolled. The primary endpoints are safety and complete response rate.
“Significant unmet medical need remains for elderly AML patients or those who are unfit for intensive chemotherapy,” added Dr. Bruns. “We believe that the combination of TTI-622 and azacitidine and venetoclax has strong potential to address this population and have a significant impact on the frontline AML treatment landscape, if approved.”
Trillium continues to build on its robust foundation and strong cash position and is now executing on its ambitious Phase 1b/2 program, in multiple patient settings across hematologic and solid tumor cancers. The company looks forward to generating a strong flow of data over the next couple of years.