UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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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 | ||