Cargo Therapeutics, Inc. has provided a corporate update and anticipated milestones for 2025, highlighting significant progress and developments in its clinical-stage biotechnology programs. Let's take a closer look at the key metrics and changes since the last period:
- Firi-cel Clinical Study Progress:
- As of December 31, 2024, 71 patients have been dosed in the potentially pivotal phase 2 study of Firi-cel, Firce-1.
- The company continues to achieve strong manufacturing success of Firi-cel, partnering with National Resilience, Inc. and ElevateBio for drug product manufacturing for the Firce-1 study.
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Cargo expects to share topline data from an interim analysis for a meaningful patient sample size with at least 3 months of follow-up in 1H’25.
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CRG-023 IND Clearance and Phase 1 Study Plans:
- In January, the FDA cleared the Investigational New Drug (IND) application for CRG-023, Cargo’s novel tri-specific CAR T-cell therapy designed to address various causes of relapse across a broad range of B-cell malignancies.
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The phase 1, open-label, multi-center, dose escalation and dose expansion study for CRG-023, including CAR T-naïve patients, is expected to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CRG-023. Enrollment is anticipated to initiate mid-year 2025.
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Novel Allogeneic Platform Advancements:
- Cargo has advanced several lead allogeneic constructs and demonstrated proof of concept in limiting immune rejection, preventing graft vs. host disease (GVHD), and preserving comparable CAR activity when co-transduced with CAR vector utilized for autologous CAR T-cell therapy.
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The company expects to select the lead vector candidate in 1H’25.
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Financial Outlook:
- As of December 31, 2024, the company’s preliminary cash, cash equivalents, and marketable securities were $368.1 million, anticipated to be sufficient to fund expected operations through 2026.
These metrics and developments underscore Cargo Therapeutics' progress in advancing potentially curative cell therapies for cancer patients, including advancements in clinical studies, IND clearance, and the development of novel allogeneic platforms.
Gina Chapman, President and Chief Executive Officer of Cargo, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference to provide further insights into the company's achievements and future plans.
Cargo Therapeutics, Inc. is focused on addressing the limitations of approved cell therapies through its growing pipeline, platform technologies, and manufacturing strategy, aiming to provide more patients with durable and potentially curative responses to cancer.
This update showcases the company's commitment to innovation and execution in the field of biotechnology and cell therapies, positioning it for significant milestones in 2025. Following these announcements, the company's shares moved -4.9%, and are now trading at a price of $13.5. Check out the company's full 8-K submission here.