CARGO Therapeutics, Inc. (NASDAQ: CRGX) has announced key corporate updates and anticipated milestones for 2025, highlighting advancements in its pipeline of cell therapies for cancer. The company is focused on developing next-generation, potentially curative treatments, addressing limitations of current cell therapies.
Firi-cel Phase 2 Study and Manufacturing Progress
As of December 31, 2024, 71 patients have been dosed in the potentially pivotal Phase 2 study, FIRCE-1, evaluating firicabtagene autoleucel (firi-cel) in patients with large B-cell lymphoma (LBCL) whose disease has relapsed or is refractory to CD19 CAR T-cell therapy. CARGO continues to demonstrate strong manufacturing success with firi-cel, collaborating with National Resilience, Inc. and ElevateBio for drug product manufacturing. Interim analysis results from a meaningful patient sample size with at least 3 months of follow-up are expected in the first half of 2025.
CRG-023 IND Clearance and Phase 1 Trial
The FDA has cleared the Investigational New Drug (IND) application for CRG-023, CARGO's novel tri-specific CAR T-cell therapy. This therapy is designed to target multiple causes of relapse in B-cell malignancies by expressing three independent CARs (CD19, CD20, and CD22) from a single vector, each with a distinct co-stimulatory domain. A Phase 1 dose escalation study is planned to commence mid-year 2025, evaluating the safety, tolerability, pharmacokinetics, and efficacy of CRG-023 in patients with 3L+ LBCL, including CAR T-naive patients. The dose escalation will begin at 25 million cells, based on preclinical data demonstrating in vivo tumor clearance at low dose levels. "Rapid progression of CRG-023 from lead construct to IND submission in less than 12 months was enabled by our robust CMC and pre-clinical development capabilities," said Gina Chapman, President and Chief Executive Officer of CARGO.
Novel Allogeneic Platform for Off-the-Shelf CAR T Therapy
CARGO has unveiled a novel allogeneic platform designed to overcome immune-based rejection and enable durable responses in CAR T-cell therapy. This platform utilizes a universal vector that can be paired with new or existing CAR vectors, leveraging existing autologous drug product processes to create off-the-shelf allogeneic CAR T products. Michael Ports, Chief Scientific Officer of CARGO, stated, "The allogeneic CAR T platform is comprised of a universal vector with multiple transgene 'cargo' to limit T and NK rejection and downregulate TCR... We are encouraged by our preclinical results which suggest the potential of a universal approach to creating off-the-shelf allogeneic CAR T products to provide more life-saving therapies for patients." The company expects to select the lead vector candidate in the first half of 2025.
Financial Position
As of December 31, 2024, CARGO's preliminary cash, cash equivalents, and marketable securities were $368.1 million, which the company believes will be sufficient to fund operations through 2026.
