CT-1119 / CARISMA Therap - LARVOL DELTA

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 Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results (PRNewswire) - "Company to prioritize CT-0525 as its anti-HER2 CAR-M product candidate and will cease further development of CT-0508...The Company has also enrolled six patients in a Study 101 substudy evaluating the co-administration of CT-0508 and pembrolizumab, a programmed cell death protein 1 (PD-1) checkpoint inhibitor, evaluating the safety and tolerability of the co-administration, along with several customary secondary endpoints; While the Company will continue all study operations for subjects enrolled in Study 101, it plans to stop recruitment of new patients into the study and its substudies, and expects to report data from the substudy evaluating the co-administration of CT-0508 and pembrolizumab in the second quarter of 2024....The Company has elected to pause further development of CT-1119 as part of its reprioritization plan, pending additional financing."

Discontinued • Enrollment status • P1 data • 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

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

Pre-Clinical Development of CT-1119, a Mesothelin-Targeting Chimeric Antigen Receptor Macrophage (ASGCT 2023) - "Previously, we developed CT-0508, a HER2-targeted CAR-M, which showed efficacy in a variety of pre-clinical models and is currently in a Phase I clinical trial for patients with HER2+ solid tumors. In addition, Ad5f35 was utilized to generate functional anti-mesothelin CAR monocytes in a rapid single day process, yielding a population of myeloid progenitors restricted to M1-macrophage differentiation. In summary, these results show that the autologous human anti-mesothelin CAR-M are a targeted cell therapy capable of inducing a multi-modal anti-tumor mechanism of action."

Preclinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HER-2 • MSLN • TNFA

A mesothelin targeting chimeric antigen receptor macrophage (CAR-M) for solid tumor immunotherapy: pre-clinical development of CT-1119 (AACR 2023) - "We have previously developed CT-0508, a chimeric antigen receptor macrophage (CAR-M) targeting HER2 which showed efficacy in a variety of pre-clinical models and is currently in a Phase I clinical trial for patients with HER2+ solid tumors. The presented results demonstrate that CT-1119, an autologous human anti-mesothelin CAR-M, can cause phagocytosis, tumor cell killing, and pro-inflammatory cytokine release in response to stimulation with mesothelin. These results show that CAR-M is a feasible approach for the treatment of mesothelin expressing sold tumors via the potential for induction of a systemic anti-tumor response."

IO biomarker • Preclinical • Hematological Malignancies • Lung Cancer • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HER-2 • MSLN • TNFA

Carisma Therapeutics to Present at Upcoming Healthcare Industry and Investor Conferences in April 2023 (PRNewswire) - "American Association for Cancer Research (AACR) Annual Meeting 2023 - Carisma will present three data abstracts during the meeting: (i) Macrophages engineered with cytokine switch receptors: Development of a modular platform for rebalancing inflammation in microenvironments; (ii) A mesothelin targeting chimeric antigen receptor macrophage (CAR-M) for solid tumor immunotherapy: pre-clinical development of CT-1119; and (iii) A Phase 1, First-in-Human study of autologous anti-HER2 CAR-M in participants with HER2 overexpressing solid tumors."

P1 data • Preclinical • Oncology • Solid Tumor

Carisma Therapeutics Announces Clinical & Pre-Clinical Updates (BioSpace) - "The data is drawn from the ongoing clinical trial led by Kim A. Reiss, MD, principal investigator of the Phase 1 clinical trial and an...."

Pre-clinical development of CT-1119, a mesothelin targeting chimeric antigen receptor macrophage (CAR-M), for solid tumor immunotherapy (SITC 2022) - "Conclusions The presented results demonstrate that CT-1119, an autologous human anti-mesothelin CAR-M, can cause phagocytosis, tumor cell killing, and pro-inflammatory cytokine release in response to stimulation with mesothelin. These results show that CAR-M is a feasible approach for the treatment of mesothelin expressing sold tumors via the potential for induction of a systemic anti-tumor response."

IO biomarker • Preclinical • Hematological Malignancies • Lung Cancer • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HER-2 • MSLN • TNFA

Carisma Therapeutics Announces Clinical & Pre-Clinical Updates (PRNewswire) - "Early pre-clinical data on CT-1119 and preliminary insights from novel immunotherapy platform also presented...at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting....The presented data demonstrate that CT-1119, an autologous human anti-mesothelin CAR-M, can mediate phagocytosis, tumor cell killing, and pro-inflammatory cytokine release and control tumor growth in pre-clinical lung cancer models. This data demonstrates that CAR-M may be a feasible and differentiated approach that could be tested in the treatment of mesothelin expressing solid tumors such as lung cancer, mesothelioma, ovarian cancer, pancreatic cancer, and other solid tumors."

Preclinical • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Thoracic Cancer

Carisma Therapeutics Announces Multiple Abstracts Accepted for Presentation at the Society for Immunotherapy of Cancer 37th Anniversary Annual Meeting (PRNewswire) - "Carisma Therapeutics...announced today the acceptance of multiple abstracts to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Anniversary Annual Meeting in Boston, Massachusetts, which is being held November 8 to November 12, 2022. Accepted abstracts include: two abstracts of clinical trial data, including one for oral presentation; four abstracts of pre-clinical study data; and one abstract overviewing the design of a Phase 1 clinical trial for CT-0508."

Clinical data • Clinical protocol • Preclinical • Oncology • Solid Tumor

CARISMA Therapeutics to Present Data at The American Association for Cancer Research Annual Meeting (PRNewswire) - “CARISMA Therapeutics…announced study findings accepted for virtual presentation at The American Association for Cancer Research (AACR) Annual Meeting on Saturday, April 10 – Thursday, April 15…A phase 1, first in human (FIH) study of adenovirally transduced autologous macrophages engineered to contain an anti-HER2 chimeric antigen receptor (CAR) in subjects with HER2 overexpressing solid tumors. Anti-HER2 CAR monocytes demonstrate targeted anti-tumor activity and enable a single day cell manufacturing process…Chimeric antigen receptor macrophages (CAR-M) induce anti-tumor immunity and synergize with T cell checkpoint inhibitors in pre-clinical solid tumor models.”

P1 data • Preclinical • Oncology • Solid Tumor