EX-99.1 2 tm2419051d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

1 Clinical Activity Observed in HER2 3+ Patients Correlation of target expression and clinical activity supports mechanism of action Change in tumor ctDNA at week 4 based on HER2 status: % change in ctDNA 1 * BOR of SD per RECIST v1.1 HER2 status: HER2 2+ HER2 3+ ctDNA : Circulating Tumor DNA; PFS: Progression - Free Survival; Signatera assay used for CtDNA ; 1 From day 8 to week 4 CT - 0508 Monotherapy Correlation between HER2 status and Best Overall Response PD: n=5 SD: n=4 PD: n=5 HER2 2+ HER2 3+ v KEY TAKEAWAYS • Best Overall Response of Stable Disease was seen in HER2 3+ (n=4/9, 44% SD) • All pts with HER2 2+ tumors had PD Clinical activity as measured by imaging or ctDNA correlates with HER2 expression

 

 

2 ctDNA Reduction Observed in 75% of HER2 3+ Patients ctDNA reductions are clear evidence of clinical activity ctDNA in 8 evaluable HER2 3+ pts Days post infusion CT - 0508 Monotherapy 80% decrease at week 4 37% decrease at week 4 33% decrease at week 4 86% decrease at week 4 93% decrease at week 4 82% decrease at week 4 KEY TAKEAWAYS • 75% (6/8) of HER2 3+ patients exhibited a decrease in ctDNA , indicating direct tumor killing activity • Up to 93% decrease in ctDNA levels • Decreases were observed in multiple tumor types • Peak response occurred ~4 weeks post CT - 0508 infusion, suggesting potential timing for redosing • Consistent with clinical assessments, no decreases in ctDNA were observed in HER2 2+ patients ctDNA : Circulating Tumor DNA; ctDNA is a biomarker of tumor burden; dotted grey line is infusion of CT - 0508 ctDNA (molecules/mL)

 

 

3 Operating Plan and Corporate Milestones Capital efficient R&D program designed to reach significant value inflection points * In late March 2024, Carisma made the decision to cease further development of CT - 0508, including monotherapy and in combinatio n with pembrolizumab 1. Target undisclosed; 2. Moderna collaboration has identified 5 total oncology targets, with the option to identify an addit ion al 7 oncology targets THERAPEUTIC AREA PRODUCT CANDIDATE PLATFORM RECENT AND ANTICIPATED MILESTONES Ex Vivo Oncology HER2+ solid tumors CT - 0525 CAR - Monocyte (1st Gen CAR) 4Q’23 IND cleared ✓ 2Q’24 Treat first patient ✓ 4Q’24 Report initial data from Phase 1 study □ CT - 0508* CAR - Macrophage (1 st Gen CAR) 3Q’24 Report data from Phase 1 combination sub - study □ In Vivo Oncology GPC3+ solid tumors TBD CAR - Macrophage + mRNA/LNP 4Q’23 Nominate first in vivo CAR - M lead candidate ✓ 2Q’24 Development Candidate nominated ✓ TBD IND submission □ Oncology 4 Additional Targets 2 CAR - Macrophage + mRNA/LNP 4Q’23 Report proof of concept data for in vivo CAR - M (SITC 2023) ✓ Fibrosis and Immunology Liver Fibrosis TBD Engineered macrophage 2Q’24 Report preclinical proof of concept data (ASGCT 2024) ✓ 1Q’25 Nominate Development Candidate □