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Chimeric Therapeutics (CHM) investor relations material
Chimeric Therapeutics Investor Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
CHM CDH17 clinical program update
Phase 1 trial of autologous CAR-T targeting CDH17 is ongoing at four major US sites, with IND cleared in Nov 2023 and fast track designation achieved in April 2024.
Eight patients have been treated, with 10/10 successful GMP manufacturing runs and no safety issues or off-target effects observed.
Tumor shrinkage up to 37% and stable disease have been observed in several patients, with one patient showing stable disease at 10 months.
Dose level 1 is completed, dose level 2 recruitment is ongoing, and dose level 3 recruitment is underway.
Phase 1 is nearing completion, with Phase 2 to begin without further FDA review; orphan drug designation is under review.
CHM CORE-NK clinical program update
CHM CORE-NK is an off-the-shelf allogeneic NK cell therapy, manufactured from universal donors, with up to 200 doses per donor.
Investigator-initiated trials at MD Anderson and Case Western are ongoing, with MD Anderson leading a frontline AML study combining CORE-NK with azacitidine and venetoclax.
Seven patients treated in the frontline study, with four complete responses and one partial response; no safety issues observed.
Dose escalation is complete, and first-line dosing is underway, aiming for up to 20 patients.
Full data readout expected mid-next year, with ongoing updates planned.
Commercial and regulatory outlook
Significant commercial interest in CDH17 asset due to large market size and unique CAR-T approach; multiple partnership discussions ongoing.
Manufacturing capacity gaps at major pharma present opportunities for scaling.
Regulatory path for CDH17 may allow for Phase 2 registration, following precedent in cell therapy approvals.
Orphan drug designation for CDH17 is under review; no designation yet for CORE-NK.
The global market size for target indications is estimated at $27.7B in 2024.
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