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About Cargo Therapeutics (CRGX)
Cargo Therapeutics is a clinical-stage biotechnology company dedicated to advancing the field of cell therapies for cancer treatment. The company specializes in the development of next-generation chimeric antigen receptor (CAR) T-cell therapies, addressing critical limitations in existing treatments such as limited durability, suboptimal safety profiles, and unreliable supply chains. With a focus on hematologic malignancies, Cargo Therapeutics aims to provide potentially curative solutions for patients with high unmet medical needs.
Core Business and Lead Program
The company's flagship program, CRG-022 (firicabtagene autoleucel or firi-cel), is an autologous CD22-targeting CAR T-cell therapy designed to treat patients with large B-cell lymphoma (LBCL) who have relapsed or are refractory (R/R) to CD19 CAR T-cell therapies. CD22 is a tumor antigen expressed in the vast majority of B-cell malignancies, making it a compelling target for patients who have exhausted other treatment options. Firi-cel leverages Cargo's proprietary cell engineering technologies to enhance CAR T-cell persistence, mitigate resistance mechanisms, and improve patient outcomes.
Proprietary Platform Technologies
Cargo Therapeutics employs innovative platform technologies to overcome key challenges in CAR T-cell therapy, including T-cell exhaustion, tumor resistance, and limited trafficking to tumor sites. The company’s proprietary tri-cistronic CAR T technology allows for the expression of three independent CARs from a single vector, each with distinct co-stimulatory domains. This approach ensures sustained anti-tumor activity, preserves T-cell memory phenotype, and enhances long-term efficacy, even in heterogeneous tumor environments. These advancements position Cargo as a leader in the development of highly specialized and effective cell therapies.
Manufacturing and Scalability
Recognizing the importance of reliable supply chains in cell therapy, Cargo Therapeutics has invested in a commercial-ready manufacturing process. This strategy aims to ensure consistent product quality and scalability, which are critical for meeting the demands of clinical trials and eventual commercialization. The company's manufacturing approach integrates advanced technologies to streamline production while maintaining stringent safety and efficacy standards.
Market Position and Competitive Landscape
Cargo Therapeutics operates within the highly specialized field of oncology-focused cell therapies, particularly targeting hematologic malignancies like LBCL. The market for CAR T-cell therapies is competitive, with established players such as Gilead Sciences (Yescarta) and Novartis (Kymriah). However, Cargo differentiates itself through its focus on CD22 as an alternative target and its innovative engineering techniques designed to address the limitations of first-generation CAR T therapies. By targeting patients who have failed CD19-directed therapies, Cargo addresses a significant unmet need, positioning itself as a vital player in this therapeutic space.
Pipeline and Future Potential
Beyond its lead program, Cargo Therapeutics is developing a broader pipeline of CAR T-cell therapies that incorporate multiple transgene therapeutic "cargo" elements. These include enhancements to improve CAR T-cell trafficking, persistence, and resistance to tumor-induced immunosuppression. The company’s commitment to innovation is further demonstrated by its exploration of allogeneic CAR T-cell platforms, which aim to expand accessibility and reduce production timelines.
Expertise and Leadership
Cargo Therapeutics benefits from a team of pioneers and world-class experts in CAR T-cell therapy. The leadership team brings extensive experience in developing, manufacturing, and commercializing oncology and cell therapy products. This expertise underpins the company’s ability to navigate complex regulatory landscapes and deliver transformative therapies to patients.
Conclusion
With its focus on addressing the limitations of current CAR T-cell therapies, Cargo Therapeutics is poised to make a significant impact in the field of oncology. By leveraging cutting-edge technologies and targeting high-need patient populations, the company is advancing the boundaries of what is possible in cancer treatment. Cargo's innovative approach to cell therapy development positions it as a key player in the ongoing evolution of precision medicine and immuno-oncology.
CARGO Therapeutics (NASDAQ: CRGX) announced the discontinuation of FIRCE-1, its Phase 2 clinical study of firi-cel for large B-cell lymphoma patients resistant to CD19 CAR T-cell therapy. The decision follows an ad hoc analysis showing unfavorable benefit-risk profile, with data from 51 patients showing 77% overall response rate and 43% complete response rate, but only 18% durability at three months.
The study revealed concerning safety data, with 18% of patients developing severe immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), including grade 4 and 5 serious adverse events. In response, CARGO will implement a 50% workforce reduction to preserve cash. The company will continue advancing CRG-023, its tri-specific CAR T, into Phase 1 trials and develop its allogeneic platform while evaluating strategic options. With $368.1 million in preliminary cash as of December 31, 2024, CARGO expects to extend its runway into mid-2028.
CARGO Therapeutics has provided a corporate update and outlined anticipated milestones for 2025. As of December 31, 2024, 71 patients have been dosed in the potentially pivotal Phase 2 clinical study of firicabtagene autoleucel (firi-cel). Interim analysis results are expected in the first half of 2025. The FDA has cleared the IND application for CRG-023, CARGO’s tri-specific CAR T-cell therapy, with Phase 1 study enrollment expected to begin mid-2025. Additionally, CARGO has announced a novel allogeneic platform designed to limit immune-based rejection of CAR T-cell therapies. This platform aims to convert autologous CAR T-cell therapies into allogeneic products for broader patient benefit.
Financially, CARGO reported preliminary cash, cash equivalents, and marketable securities of $368.1 million as of December 31, 2024, which is expected to fund operations through 2026. Gina Chapman, President and CEO, emphasized the company’s progress and future potential at the 43rd Annual J.P. Morgan Healthcare Conference.
CARGO Therapeutics (NASDAQ: CRGX), a clinical-stage biotech company focused on developing next-generation cell therapies for cancer patients, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The conference will take place from January 13-16, 2025, in San Francisco, California.
President and CEO Gina Chapman will deliver a presentation on Monday, January 13, at 10:30 a.m. PT. The presentation will be accessible via live webcast in the Investors section of CARGO's website under News & Events, with a replay available for approximately 30 days following the presentation.
CARGO Therapeutics (NASDAQ: CRGX) reported Q3 2024 financial results and business updates. The company has dosed 57 patients in its Phase 2 FIRCE-1 study of firi-cel, with interim analysis expected in 1H25. Their cash position stands at $404.8 million, projected to fund operations through 2026. Q3 financial results show R&D expenses of $35.9 million and G&A expenses of $11.2 million, with a net loss of $41.9 million ($0.88 per share). The company plans to submit an IND for CRG-023 in Q1'25 and will present pre-clinical data at ASH 2024. CFO Anup Radhakrishnan has been appointed as COO while retaining his CFO role.
CARGO Therapeutics (NASDAQ: CRGX), a clinical-stage biotechnology company focused on developing next-generation cell therapies for cancer patients, has announced its participation in two upcoming investor conferences. Gina Chapman, President and CEO, will participate in fireside chats at the Jefferies London Healthcare Conference on November 20 at 11:00 a.m. GMT, and at the Piper Sandler 36th Annual Healthcare Conference on December 4 at 10:30 a.m. EST. Live webcasts will be available in the Investors section of CARGO's website, with replays accessible for approximately 90 days after the presentations.
CARGO Therapeutics announced its first abstract on CRG-023, a novel tri-specific CAR T-cell therapy targeting CD19, CD20, and CD22 B-cell antigens, will be presented at ASH 2024. CRG-023 is designed to provide durable responses by addressing common relapse causes in existing CAR T therapies.
The preclinical data demonstrated sustained anti-tumor activity, resistance to exhaustion during repeated tumor challenges, and robust anti-lymphoma activity at low doses. The therapy features a unique tri-cistronic design expressing three independent CARs from a single vector, each with distinct co-stimulatory domains. The company is actively preparing for an IND submission based on encouraging results.
CARGO Therapeutics (NASDAQ: CRGX) reported Q2 2024 financial results and provided a business update. Key highlights include:
- 38 patients dosed in the potentially pivotal Phase 2 FIRCE-1 study of firicabtagene autoleucel (firi-cel)
- Completed a $110 million private placement equity financing, extending cash runway through 2026
- $443.5 million in cash, cash equivalents, and marketable securities as of June 30, 2024
- Q2 2024 net loss of $44.3 million, or $1.02 per share
- R&D expenses of $37.5 million and G&A expenses of $11.9 million for Q2 2024
The company expects to complete its interim analysis and report results for the FIRCE-1 study in H1 2025.
CARGO Therapeutics announced that data from their Phase 1 clinical study of Firi-cel CAR T-cell therapy has been published in The Lancet. The study focused on patients with relapsed or refractory large B-cell lymphoma (LBCL) who did not respond to CD19 CAR T-cell therapy. Results showed a 68% overall response rate (ORR) and a 53% complete response (CR) rate, with a median follow-up of 23.3 months.
Notably, 36% of patients previously refractory to all therapies achieved CR. The selected dose for the Phase 2 study, DL1, had a 66% ORR and a 52% CR rate, showing an estimated one- and two-year survival rate of 57% and 52%, respectively. The therapy showed no severe cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome.
These results underscore the promising efficacy and safety profile of firi-cel, which has received Breakthrough Therapy Designation from the FDA. The ongoing Phase 2 study, FIRCE-1, is on track for interim analysis in the first half of 2025.
CARGO Therapeutics has appointed Jane Pritchett Henderson as an Independent Director to its Board. Henderson brings extensive experience in healthcare investment banking and executive leadership in biotech companies.
She will also serve on the audit and compensation committees. This appointment comes as CARGO advances its Phase 2 clinical study for the CAR T-cell therapy candidate, firicabtagene autoleucel (firi-cel), and progresses the CRG-023 program incorporating tri-specific CAR T-cells with CD2 co-stimulation.
Henderson has a strong background in finance and operations, having held key roles at Apogee Therapeutics, Adagio Therapeutics, Turnstone Biologics, and Voyager Therapeutics. Her current board positions include Akero Therapeutics and Ventus Therapeutics.
CARGO Therapeutics (NASDAQ: CRGX) announced its participation in two major investor conferences: the TD Cowen 5th Annual Oncology Innovation Summit and the Jefferies Global Healthcare Conference. Gina Chapman, President and CEO, will take part in virtual fireside chats on May 28 and June 5, respectively. These events will provide insights into the company's advancements in next-generation cell therapies for cancer. Webcasts of the presentations will be available on CARGO's website under the News & Events section, with replays accessible for 30 days post-event.
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