For the second time this year, Carisma is laying off staff. The newly announced restructure includes several company leaders hitting the exit and the discontinuation of the biotech’s sole clinical candidate.
The Philadelphia biotech is implementing a 34% workforce reduction, which includes 23 full-time employees across R&D, manufacturing, finance and corporate activities, according to a Securities and Exchange Commission (SEC) document filed Dec. 9.
The layoffs will also affect Carisma’s chief financial officer Richard Morris; senior vice president of human resources Terry Shields; and general counsel Eric Siegel, who are all slated to leave Dec. 31.
The biotech expects the layoffs will be “substantially complete” by the end of the first quarter next year.
Carisma is also discontinuing development of its lead candidate, CT-0525, a gene-modified autologous chimeric antigen receptor-monocyte (CAR-M) cell therapy designed to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).
The asset snagged FDA fast-track status in June, with initial clinical data from a phase 1 clinical trial expected by the end of this year. The open-label, single-arm study had an expected enrollment of six patients with advanced solid tumors, according to ClinicalTrials.gov.
Trial recruitment has now wrapped and the biotech has canceled plans to enroll another patient cohort, Carisma said in a Dec. 9 release. The biotech does intend on finishing ongoing trial activities, according to the SEC filing.
The company said the anti-HER2 cell therapy was safe and well-tolerated, but the discontinuation decision was rooted in an assessment of the current competitive landscape, including recently approved anti-HER2 therapies on HER2 antigen loss and downregulation.
The moves are all made in efforts to streamline operations and reduce operating costs, Carisma CEO Steven Kelly said in the release.
Now, Carisma will focus solely on macrophage-focused therapeutics, narrowing in on its in vivo macrophage engineering platform across fibrosis, oncology and autoimmune disease therapies.
The chimeric antigen receptor macrophage and monocyte (CAR-M) strategy, paired with an mRNA/LNP approach, is designed to simplify cell therapy by bypassing the need to culture patient cells out of the body.
Big biotech Moderna partnered up with Carisma back in 2022, paying $45 million cash for up to ten oncology research targets stemming from the science. This fall, Moderna expanded the deal to include two undisclosed autoimmune targets.
Carisma also has a preclinical fibrosis program aimed at addressing liver fibrosis.
Today’s announcement follows a separate restructuring this spring that included a 37% workforce reduction and termination of—ironically—a chimeric antigen receptor macrophage (CAR-macrophage) dubbed CT-0508. At the time, the asset was being studied among patients with HER2 overexpressing solid tumors in an open-label phase 1 trial.
That reorganization was designed to stretch the biotech’s cash into the third quarter of next year and followed a reverse merger with Sesen Bio in March 2023 that increased personnel costs.
As of Sept. 30, Carisma had $26.9 million cash on hand, money the biotech said should stretch into the third quarter of 2025, according to third-quarter financial documents.