CRG-023 / CARGO Therap - LARVOL DELTA

CRG-023 Is a Novel Tri-Specific CAR T Product Candidate Engineered to Prevent Antigen Escape and Sustain Durable Anti-Tumor Functionality Against B-Cell Malignancies (ASH 2024) - "CRG-023 demonstrated durable potency across a range of antigen levels in stringent in vitro and in vivo models, with each of the three CARs contributing to its functionality. By addressing factors known to be associated with inferior CAR T-cell response, CRG-023 may improve outcomes for patients afflicted with B-cell malignancies, paving the way for further clinical development and translation into the clinic."

Trispecific • B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD2 • CD22 • CD4 • CD58 • CD8

CRG-023, A Tri-specific CAR T-cell Product Candidate, Demonstrates Strong and Durable Anti-Tumor Activity In Vivo Across Lymphoma Models (ASGCT 2025) - "The FDA recently cleared an Investigational New Drug (IND) application for this product candidate. A Phase 1 dose-finding study will enroll R/R LBCL patients who have received at least two prior lines of therapy, including both CAR T-naïve and CAR T-exposed patients."

CAR T-Cell Therapy • Preclinical • Trispecific • B Cell Lymphoma • Burkitt Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD2 • CD20 • CD22

CARGO Therapeutics Provides Corporate Update (GlobeNewswire) - "CARGO Therapeutics, Inc...provided an update regarding its ongoing evaluation of strategic options following the discontinuation of FIRCE-1, a Phase 2 study of firicabtagene autoleucel (firi-cel). The Company’s Board of Directors has made the decision to suspend development efforts of both CRG-023 and CARGO’s allogeneic platform..."

Discontinued • Trial termination • Large B Cell Lymphoma

CARGO Therapeutics…Advances Remaining Programs While Evaluating Strategic Options (GlobeNewswire) - "...The Company will reduce its workforce to extend cash runway and prioritize the advancement of CRG-023 to Phase 1 proof-of-concept data as well as its novel allogeneic platform....CARGO to implement a workforce reduction of approximately 50%. Phase 1 dose escalation study enrollment for CRG-023 on track to initiate in Q2 2025."

Commercial • New P1 trial • Large B Cell Lymphoma

CARGO Therapeutics Provides Corporate Update and Anticipated Milestones for 2025 (GlobeNewswire) - "In January, the FDA cleared the Investigational New Drug (IND) application for CRG-023...CRG-023, CARGO intends to demonstrate the product candidate’s best-in-class potential through a Phase 1 dose escalation study in 3L+ LBCL including CAR T-naïve patients....The Phase 1, open-label, multi-center, dose escalation and dose expansion study is expected to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CRG-023 and to establish the recommended Phase 2 dose of CRG-023. Dose escalation will begin at a dose level of 25 million cells, which was informed by preclinical data that demonstrated in vivo tumor clearance at low dose levels. Enrollment for the Phase 1 study, including CAR T-naïve patients, is expected to initiate mid-year 2025. CARGO plans to leverage its established manufacturing and supply chain infrastructure to accelerate readiness for its Phase 1 study."

IND • New P1 trial • Large B Cell Lymphoma

CARGO Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Firi-cel:...CARGO expects to complete its interim analysis and report the results in the first half of 2025...IND application submission for CRG-023 in Non-Hodgkin’s lymphoma anticipated in the first quarter of 2025; first patient dosed planned for 2025."

IND • New trial • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

CARGO Therapeutics Announces ASH 2024 Abstract on CRG-023, a Tri-specific CAR T, Highlighting Innovative Construct Design and Durable Anti-B-Cell Lymphoma Activity (GlobeNewswire) - "The abstract reviews the CRG-023 construct design, including the discovery of novel CD19 and CD20 scFv binders, selected for enhanced CAR performance, that were combined with the existing CD22 scFv binder used in firicabtagene autoleucel (firi-cel). The iterative engineering of the construct allowed for the selection of the optimal costimulatory domain configuration and optimal assemblage in a unique tri-cistronic lentiviral vector designed to maximize durable anti-tumor response. Importantly, in these mouse models, CRG-023 CAR T cells were able to sustain durable in vitro anti-tumor activity despite repeated tumor challenge against tumor cells expressing all or any one of the three antigens. Superior tumor control was observed as compared to benchmark CAR T cells, without increased cytokine secretion and while sustaining a less effector-differentiated phenotype."

Preclinical • Hematological Malignancies • Lymphoma • Oncology

CARGO Therapeutics Announces $110.0 Million Private Placement Equity Financing (GlobeNewswire) - "CARGO Therapeutics, Inc...today announced that it has entered into a securities purchase agreement for a private investment in public equity financing that is expected to result in gross proceeds of approximately $110.0 million, before deducting placement agent fees and other expenses...'As we continue to make great progress on our potentially pivotal Phase 2 study of firi-cel in LBCL patients who have R/R from CD19 CAR T therapy, this financing will be key in supporting BLA preparations in addition to advancing our CRG-023 program, which is a novel tri-specific CAR T designed to overcome multiple mechanisms of resistance.'"

Financing • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology