CT-0525 / CARISMA Therap - LARVOL DELTA

Study 102: CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Carisma Therapeutics Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor • HER-2

A Phase 1, First-in-Human study of autologous monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2 overexpressing solid tumors (SABCS 2024) - P1 | "The anti-HER2 CAR-Macrophage cell therapy product, CT-0508, was evaluated in a Phase 1 trial as a monotherapy and in combination with pembrolizumab...CT-0525 is an autologous anti-HER2 CAR-Monocyte cell therapy based on CD14+ monocytes engineered with an Ad5f35 adenoviral vector to express an anti-HER2 CAR...Filgrastim mobilized autologous CD14+ monocytes are collected by apheresis, followed by manufacturing and cryopreservation...Nature Biotechnology. 2020; 38: 947-953"

IO biomarker • P1 data • Breast Cancer • Oncology • Solid Tumor • CD14

Carisma Therapeutics Announces Strategic Restructuring to Re-prioritize Pipeline (PRNewswire) - "Carisma Therapeutics....announced a strategic reprioritization of its pipeline, cessation of development of CT-0525, and a reduction in the workforce by 34%....Discontinuation of anti-HER2 Development: The Company's decision was based on an assessment of the competitive landscape in anti-HER2 treatments, including the impact of recently approved anti-HER2 therapies on HER2 antigen loss/downregulation, and the effects on the future development strategy of any anti-HER2 treatment. The Company has completed patient enrollment of the Phase 1 clinical trial of CT-0525 and will not enroll patients in the previously planned Cohort 3 of the study."

Discontinued • Solid Tumor

A phase 1, first-in-human study of autologous monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2 overexpressing solid tumors (SITC 2024) - "We previously developed human chimeric antigen receptor macrophages (CAR-Macrophage) and have shown potent anti-tumor activity in pre-clinical solid tumor models.1 The anti-HER2 CAR-Macrophage cell therapy product, CT-0508, was evaluated in a Phase 1 trial as a monotherapy and in combination with pembrolizumab...Methods This Phase 1, first-in-human study evaluates the preliminary safety, feasibility, tolerability, trafficking, TME activation, and initial evidence of efficacy of the investigational CAR-Monocyte product CT-0525 in pts with locally advanced unresectable/metastatic solid tumors overexpressing HER2...Filgrastim mobilized autologous CD14+ monocytes are collected by apheresis, followed by manufacturing and cryopreservation...Correlative assessments include pre- and post-treatment biopsies and blood samples for safety, immunogenicity, pharmacokinetics, tumor trafficking, TME modulation, epitope spreading, and other translational biomarkers. Ethics Approval The..."

P1 data • Oncology • Solid Tumor • CD14

Carisma Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights (PRNewswire) - "Carisma expects to report initial data for Cohorts 1 and 2 of its Phase 1 study of CT-0525 in the first quarter of 2025...Further, we experienced a $0.9 million decrease in direct costs associated with pre-clinical development of CT-0525 due to the timing of the development program..."

Commercial • P1 data • Oncology • Solid Tumor

Carisma Therapeutics Announces Upcoming Presentations at SITC 2024 (PRNewswire) - "Carisma Therapeutics Inc...today announced its upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC), taking place in Houston, Texas, November 6 -10, 2024."

P1 data • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • HER-2

Carisma Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights (PRNewswire) - "Second Quarter 2024 Highlights and Upcoming Milestones...GPC3+ solid tumors (CAR-M + mRNA/LNP; Moderna Collaboration)...The Company expects to present preclinical data from the development candidate at an upcoming medical meeting...Research and development expenses for the three months ended June 30, 2024 were $15.3 million....The decrease of $3.2 million was primarily due to a $2.9 million decrease in our facilities and other expenses associated with a decrease in sponsored research agreement fees, a $1.7 million decrease in direct costs associated with CT-0508, a $0.2 million decrease in direct costs associated with the pre-clinical development related to CT-1119, a $0.1 million decrease in costs associated with a reduction in pass through studies, partially offset by a $1.2 million increase in direct costs associated with pre-clinical development of CT-0525 and a $0.5 million increase in personnel costs due to severance costs related to the revised operating plan."

Commercial • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Oncology • Solid Tumor

Carisma Therapeutics Granted FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors (PRNewswire) - "Carisma Therapeutics Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2)....'Currently, we are enrolling patients in the Phase 1 clinical trial and remain on track to report initial clinical data by the end of 2024'."

Fast track • P1 data • Oncology • Solid Tumor

A phase 1, first-in-human study of autologous monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2-overexpressing solid tumors. (ASCO 2024) - P1 | "The anti-HER2 CAR-M cell therapy product, CT-0508, is currently being evaluated in a Phase I trial as a monotherapy and in combination with pembrolizumab...Filgrastim mobilized autologous CD14+ monocytes are collected by apheresis, followed by manufacturing and cryopreservation...CT-0525 will be administered without conditioning chemotherapy. Primary endpoints include assessment of safety and tolerability, as well as manufacture feasibility. Correlative assessments include pre- and post-treatment biopsies and blood samples for safety, immunogenicity, pharmacokinetics, tumor trafficking, TME modulation, epitope spreading, and other translational biomarkers."

P1 data • Oncology • Solid Tumor • CD14

Carisma Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial of CT-0525, a Novel HER2-Targeting CAR-Monocyte (PRNewswire) - "Carisma Therapeutics Inc....announced that the first patient was dosed in its Phase 1 clinical trial evaluating CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy, for the treatment of patients with solid tumors that overexpress human epidermal growth factor receptor 2 (HER2)...'We look forward to progressing this trial and expect to report initial data by the end of 2024.'....The Phase 1 clinical trial for CT-0525 is an open-label study designed to assess the safety, tolerability, and manufacturing feasibility of CT-0525. This trial will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. The study will consist of two dose escalation cohorts."

Trial status • Oncology • Solid Tumor • HER-2

Carisma Therapeutics Announces Upcoming Presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting (PRNewswire) - "Carisma Therapeutics...announced its upcoming presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting taking place from May 31- June 4, 2024, in Chicago, IL."

Trial status • Solid Tumor

Carisma Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results (PRNewswire) - P1 | N=48 | NCT04660929 | Sponsor: Carisma Therapeutics Inc | "In Study 101, CT-0508...was well-tolerated, remodeled the tumor microenvironment (TME), and induced anti-tumor T cell immunity in patients with HER2 3+ tumors that achieved stable disease, despite suboptimal dose and a patient population with exhausted T cells; In late March 2024, Carisma made the decision to prioritize CT-0525, a chimeric antigen receptor monocyte (CAR-Monocyte), as the development candidate in its anti-HER2 program due to the potential for a CAR-Monocyte to have an approximately 2,000-fold increase in total exposure compared to a CAR-Macrophage. As a result, the Company believes that CT-0525 will be able to build on CT-0508's observed clinical anti-tumor activity....The Company expects to treat the first patient in the CT-0525 Phase 1 clinical study in the second quarter of 2024 and to report initial data from the study by year-end 2024."

P1 data • Pipeline update • Trial status • Oncology • Solid Tumor

Carisma Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results (PRNewswire) - "The increase of $17.5 million year-over-year was primarily due to a $8.4 million increase in direct costs associated with pre-clinical development of CT-0525, a $4.4 million increase in personnel costs due to growth in research and development employee headcount, a $2.7 million increase in the Company's facilities and other expenses resulting from increased laboratory space and laboratory supplies from expanded clinical and pre-clinical work, a $1.3 million increase due to costs associated with growth and expansion of pre-clinical activities towards submission of an IND for CT-0525, and a $0.9 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. The Company expects its research and development expenses to decrease in 2024 as it implements the revised operating plan, including a reduction in workforce, prioritization of CT-0525..."

Commercial • Oncology • Solid Tumor

CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Carisma Therapeutics Inc

New P1 trial • Oncology • Solid Tumor • HER-2

Carisma Therapeutics Announces FDA Clearance of IND Application for CT-0525, a Novel HER2-Targeting CAR-Monocyte (PRNewswire) - "Carisma Therapeutics Inc...announced the clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). Having received a Study May Proceed notification from the FDA, Carisma expects to initiate a Phase 1 study in the coming months and to treat the first patient in the first half of 2024."

IND • New P1 trial • Oncology • Solid Tumor

Carisma Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights (PRNewswire) - "Upcoming Milestones: (i) 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; (ii) 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; (iii) The Company is targeting an IND for CT-1119 in 2025."

IND • New trial • P1 data • Solid Tumor

Carisma Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights (PRNewswire) - "Anticipated Upcoming Milestones: Data from Group 2 of Phase 1 clinical trial of CT-0508 expected in the second half of 2023; Initial data from Phase 1 clinical trial of CT-0508 in combination with KEYTRUDA^® (pembrolizumab) expected in the second half of 2023; Submission of Investigational New Drug (IND) application to the U.S. Food and Drug Administration for CT-0525, Carisma's first anti-HER2 CAR-Monocyte product candidate, expected in the second half of 2023; Selection of next-generation candidate for CT-1119 expected in the first half of 2024."

IND • P1 data • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Carisma Therapeutics Reports Fiscal 2022 Financial Results and Recent Business Highlights (PRNewswire) - "Anticipated Upcoming Milestones: Additional data from Group 2 of Carisma's Phase 1 CT-0508 study expected in the second half of 2023; Initial data from clinical trial sub-study of CT-0508 in combination with KEYTRUDA® (pembrolizumab) expected in the second half of 2023; Submission of IND application to the FDA for CT-0525, Carisma's first anti-HER2 CAR-Mono product candidate, expected in the second half of 2023."

Clinical data • IND • P1 data • Oncology • Solid Tumor