PHILADELPHIA, PA — Carisma Therapeutics Inc. (Nasdaq: CARM) recently reported financial results for the quarter ended September 30, 2023, and highlighted recent business updates.
“During the third quarter, Carisma made several key advancements across our clinical and pre-clinical programs and reported data from both our Phase 1 clinical study of CT-0508 and our pre-clinical work with Moderna developing in vivo CAR-M,” said Steven Kelly, President and Chief Executive Officer of Carisma. “We continue to progress CT-0508 and CT-0525, our assets targeting HER2 overexpressing tumors, as we work to validate our first-in-class engineered macrophage platform. We believe that we have value-driving, next-generation cell therapies in our pipeline that have the potential to improve the treatments available for patients with cancer and other serious disorders.”
Third Quarter 2023 and Recent Business Highlights
- CT-0508
- Announced updated data from the Company’s Phase 1 clinical trial of CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M), which included data from the first five patients from group 2 (single-day bolus dosing). Preliminary results from the nine patients in group 1 (fractionated dosing) were presented in November 2022. The group 2 data, which were presented at the 8th Annual CAR-TCR Summit, support primary safety and manufacturing feasibility endpoints of single-day bolus dosing. The Company believes that translational analyses on early data from the combined groups 1 and 2 show that biomarkers of tumor microenvironment activation, T cell activation, and HER2 status correlate with best overall response of stable disease, providing further evidence of the CT-0508 mechanism of action.
- Announced updated data from the Company’s Phase 1 clinical trial of CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M), which included data from the first five patients from group 2 (single-day bolus dosing). Preliminary results from the nine patients in group 1 (fractionated dosing) were presented in November 2022. The group 2 data, which were presented at the 8th Annual CAR-TCR Summit, support primary safety and manufacturing feasibility endpoints of single-day bolus dosing. The Company believes that translational analyses on early data from the combined groups 1 and 2 show that biomarkers of tumor microenvironment activation, T cell activation, and HER2 status correlate with best overall response of stable disease, providing further evidence of the CT-0508 mechanism of action.
- CT-1119
- Selected a clinical candidate for the CT-1119 program, a CAR-Monocyte for mesothelin overexpressing solid tumors. CT-1119 will incorporate two key enhancements: a next-generation CAR that, as demonstrated in pre-clinical studies, leads to a significant increase in tumor killing and cytokine release, and the incorporation of SIRPα knockdown to overcome the CD47 immune checkpoint. SIRPα knockdown is achieved using Carisma’s proprietary intronic shRNA platform, which enables CAR delivery and gene knockdown using a single vector. The Company is targeting an Investigational New Drug Application (IND) for CT-1119 in 2025.
- Selected a clinical candidate for the CT-1119 program, a CAR-Monocyte for mesothelin overexpressing solid tumors. CT-1119 will incorporate two key enhancements: a next-generation CAR that, as demonstrated in pre-clinical studies, leads to a significant increase in tumor killing and cytokine release, and the incorporation of SIRPα knockdown to overcome the CD47 immune checkpoint. SIRPα knockdown is achieved using Carisma’s proprietary intronic shRNA platform, which enables CAR delivery and gene knockdown using a single vector. The Company is targeting an Investigational New Drug Application (IND) for CT-1119 in 2025.
- In Vivo CAR-M (Moderna Collaboration)
- Presented pre-clinical proof of concept data demonstrating feasibility, tolerability, and early efficacy of mRNA/LNP in vivo CAR-M therapy at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. Accepted as a late-breaking abstract and oral presentation, “In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy,” showcased data that demonstrated CAR-M can be directly produced in vivo, or within the body, successfully redirecting endogenous myeloid cells against tumor-associated antigens using mRNA/LNP. This novel approach to cancer immunotherapy offers an off-the-shelf solution that has the potential to increase access to CAR-based therapies and be the basis of up to 12 oncology programs developed under the Carisma and Moderna collaboration.
Upcoming Milestones
- The Company recently submitted an IND to the U.S. Food and Drug Administration (FDA) for CT-0525. Subject to regulatory feedback, the Company expects to treat the first patient in the first half of 2024.
- The Company expects to present data from the sub-study of its Phase 1 clinical trial of CT-0508 in combination with pembrolizumab in the first half of 2024.
- The Company expects pre-clinical proof of concept data for its initial program outside of oncology, in liver fibrosis, in the first half of 2024.
- The Company is targeting an IND for CT-1119 in 2025.
Third Quarter 2023 Financial Results
- Cash, cash equivalents and marketable securities as of September 30, 2023, were $94.1 million, compared to $117.1 million as of June 30, 2023.
- Research & development expenses were $19.6 million for the third quarter of 2023, compared to $15.6 million for the same period in 2022. The increase of $4.0 million was primarily due to a $2.9 million increase in direct costs associated with the pre-clinical development of CT-0525, a $1.2 million increase in personnel costs due to growth in research and development employee headcount, and a $0.3 million increase in direct costs associated with the pre-clinical development related to CT-1119, partially offset by a $0.2 million decrease in direct costs associated with CT-0508 and a $0.1 million decrease of other clinical and pre-clinical development expenses associated with tracking CT-0525 and CT-1119 separately.
- General & administrative expenses were $6.6 million for the third quarter of 2023, compared to $3.8 million for the same period in 2022. The increase of $2.8 million was primarily due to a $1.4 million increase of higher personnel costs as a result of an increase in headcount, a $0.4 million increase in facilities and supplies due to an increase in office expenditures, a $0.6 million increase in legal and professional fees in support of the Company’s patent portfolio and expanding infrastructure, as well as a $0.4 million increase in other expenses due to an increase in travel expenses and subscriptions.
- Net loss was $21.4 million for the third quarter of 2023, compared to net loss of $18.3 million for the same period in 2022, primarily due to increased research and development expenses to support CT-0525 as well as an increase in expanding headcount and infrastructure, which was partially offset by Moderna collaboration revenue.
Outlook
Carisma believes that its cash, cash equivalents and marketable securities of $94.1 million as of September 30, 2023, are sufficient to sustain Carisma’s planned operations into the first quarter of 2025.
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