UNITED STATES
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FORM
CURRENT REPORT
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Item 8.01. Other Events.
On July 9, 2024, Carisma Therapeutics Inc. (the “Company”) will announce new analysis related to the Company’s Phase 1 clinical trial of CT-0508, a human epidermal growth factor receptor 2 (“HER2”) targeted chimeric antigen receptor macrophage for the treatment of HER2 overexpressing cancers, during a presentation at the Stifel Virtual Cell Therapy Forum. An excerpt from the presentation is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The Company is providing the following analysis related to its Phase 1 clinical trial of CT-0508:
The Company recently completed analysis of circulating tumor DNA (“ctDNA”) from 13 patients enrolled in groups 1 and 2. Based on preliminary results assessed to date, the Company observed that 75% (n=6/8) of evaluable HER2 3+ patients experienced a ctDNA reduction, indicating direct tumor killing activity. Zero percent (n=0/5) of evaluable HER2 2+ patients experienced a ctDNA reduction. In the 6 patients that experienced a ctDNA reduction, the median decrease was 81% (range 33%-93% decrease in ctDNA 4-weeks post treatment with CT-0508).
While the results from this early clinical trial data are both preliminary and limited, the Company believes that repeat dosing of its follow-on product, CT-0525, in patients with HER2 overexpressing cancers could prolong pharmacologic efficacy and response.
Consistent with prior disclosure, enrollment of new patients in the Company’s Phase 1 clinical trial of CT-0508 and its sub-study utilizing CT-0508 in combination with pembrolizumab was halted in April 2024 in connection with the implementation of the Company’s revised operating plan. As of July 2024, all activities with respect to the patients enrolled in the Phase 1 clinical trial and sub-study have been completed. The Company only has preliminary results from the Phase 1 clinical trial and expects clinical data updates in the third quarter of 2024.
Item 9.01. Financial Statements and Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Excerpt from Company Presentation, dated July 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CARISMA THERAPEUTICS INC. | ||
| By: | /s/ Steven Kelly | |
| Date: July 9, 2024 | Steven Kelly | |
| President and Chief Executive Officer | ||
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 □