Carisma lets go of 37% of staff, CAR-M candidate to stretch cash runway

02 Apr 2024
www.fiercebiotech.com
Phase 1Cell TherapyImmunotherapyGene TherapyIND
Its prioritized programs demonstrate the greatest overall potential and near-term milestones, Carisma CEO Steven Kelly said.
Carisma Therapeutics plans to let go of 37% of staffers and drop one of two clinical assets inCarismaort to fuel the immunotherapy-focused biotech into the third quarter of 2025.
Carisma Therapeuticshis morning, sent the company’s stock down 9%, slipping from $2.27 per share at market open to $2.08 as of 12:30 p.m. ET today.
Since increasing its head count via a reverse merger with Sesen Bio in March 2023, Carisma's personnel costs have climbed. Now, the biotech is trimming the team and implementing a revised operating plan designed to cut general and administrative expenses, according to the April 1 release.
Part of the restructure includes stopping development of CSesen Bio chimeric antigeCarismator macrophage (CAR-macrophage) being studied among patients with HER2 overexpressing solid tumors in an open-label phase 1 trial. Last fall, the biotech shared early data from 14 patients that found the investigational treatment was well tolerated, remodeled the tumor microenvironment and induced anti-tumor T-cell immunity in certain patients.
Despite this, Carisma sees more promise in its chimeric aCT-0508receptor-monocyte (CAR-monocyte) approach and plans to stop recruiting new patients for the HER25overexpressing solid tumorsso ending a sub-study that evaluated CT-0508 in combination with Keytruda.tumortumor
Carisma will instead focus on CT-0525, an ex vivo gene-modified autologous CAR-monocyte cell therapy designed to treat solid tumors that overexpress HER2. ACT-0508label phase 1 clinical trial assessing the candidate launched CT-0508beginning of this yeaKeytrudading to ClinicalTrials.gov.
The company expects to dose thCT-0525 patient in the CT-0525 study in the second quarter and plans to report initial dasolid tumorsd of 2024. The earHER2tage study has an estimated enrollment of six patients and a primary completion date set for March 2025.
Carisma believes CT-0525 will build on the clinical anti-tumor activity observed with CT-0508 while allowing for significant dose escalation, improved tumor infiltration, increased persistence and reduced manufacturing time compared to CT-0508.
Other prioritizedCT-0525ne programs include an in vivo CAtumoract with Moderna. In 202CT-0508Big Biotech paid out $45 million in cash to work with Caritumorn redirecting endogenous myeloid cells against tumor-associated antigens using mCT-0508.
The prioritized programs demonstrate the greatest overall potential andModernaerm milestones,Big BiotechO Steven Kelly said in the April 1 release.tumor
The Philadelphia-based biotech is also pausing development of CT-1119, a preclinical anti-mesoCarismaCAR-monocyte, pending additional financing, according to the release.
As of Dec. 31, 2023, Carisma had $77.6 million on hand, cash tCT-1119expected to fund the mesothelinter restructuring efforts take effect into the third quarter of 2025.
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