SAN CARLOS, Calif. - CARGO Therapeutics, Inc. (NASDAQ:CRGX), a biotechnology firm focused on advancing cell therapies for cancer, disclosed favorable outcomes from a Phase 1 study of firicabtagene autoleucel (firi-cel) in treating large B-cell lymphoma (LBCL). The study, published in The Lancet, showed a complete response rate of 53% in patients with relapsed or refractory LBCL.
The research, conducted by Stanford Medicine, evaluated the safety and efficacy of firi-cel, a CD22 CAR T-cell therapy, in 38 LBCL patients who had previously not responded to CD19 CAR T-cell therapy. With a median follow-up of 23.3 months, the overall response rate stood at 68%. Notably, the study indicated that 36% of patients with a history of refractory disease to all prior therapies achieved a complete response.
The selected dose for the ongoing Phase 2 clinical study FIRCE-1, Dose Level 1 (DL1), showed similar response rates with no severe cases of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome reported. The estimated one-year and two-year survival rates at DL1 were 57% and 52%, respectively.
CARGO's CEO, Gina Chapman, expressed confidence in the study's findings, highlighting the durable responses in a patient population with advanced disease and limited treatment options. The Phase 2 study is progressing with an interim analysis expected in the first half of 2025.
The longer-term follow-up data presented at the 2024 European Hematology Association Congress reinforced the Phase 1 results. At DL1, the median overall survival was 25.7 months, and the two-year survival rate remained at 52%. No additional patient relapses were reported among the 20 patients who achieved a complete response since the previous data cut.
Stanford has received Breakthrough Therapy Designation from the FDA for firi-cel for LBCL patients whose disease is resistant after CD19-directed CAR T-cell therapy. LBCL is a rapidly growing lymphoma, most common in people over 60, representing about 85% of non-Hodgkin lymphomas in the U.S.
CARGO Therapeutics aims to address the unmet needs in LBCL treatment, including for those who have failed prior CD19 CAR T-cell therapies. The company is also planning to explore firi-cel's potential in earlier stages of the disease and other hematologic malignancies.
The data presented in The Lancet is based on a press release statement from CARGO Therapeutics.
In other recent news, CARGO Therapeutics has seen a flurry of activity. The company has secured approximately $110 million from a private investment in public equity financing, a move that will support the preparation of a Biologics License Application for its Phase 2 study, FIRCE-1, and further development of its CRG-023 program.
In addition, CARGO Therapeutics has entered into a significant sublease agreement with Vaxcyte, Inc. aimed at maximizing the utility of its headquarters in San Carlos, California.
In analyst coverage, Piper Sandler has initiated coverage on CARGO Therapeutics with an Overweight rating, expressing optimism based on promising data from an early-stage clinical trial for CRG-022, the company's investigational therapy for certain types of lymphoma. Meanwhile, Truist Securities has adjusted its price target for CARGO Therapeutics to $32 from $34, maintaining a Buy rating on the company's stock.
In other developments, CARGO Therapeutics recently announced the appointment of Dr. Kapil Dhingra, a medical oncologist with over 25 years of experience, to its Board of Directors. This appointment comes as the company continues to advance its lead CAR T-cell therapy candidate, firi-cel (CRG-022). These developments highlight the company's ongoing efforts in the biotech sector.
InvestingPro Insights
In the midst of advancing its cell therapies for cancer, CARGO Therapeutics, Inc. (NASDAQ:CRGX) has shown promising clinical outcomes, yet the financial health of the company, as reflected by real-time data from InvestingPro, presents a more nuanced picture.
With a market capitalization of $751.67 million, CRGX's current Price to Earnings (P/E) Ratio stands at a negative -2.06, indicating that the company is not currently profitable. This aligns with an InvestingPro Tip that analysts do not expect CRGX to be profitable this year, which is crucial for investors to consider when assessing the company's short-term financial outlook.
Another noteworthy InvestingPro Tip is that CRGX holds more cash than debt on its balance sheet, which can be a sign of financial resilience, especially for a biotech firm that is in the critical stage of developing new therapies. Moreover, the company's liquid assets exceed its short-term obligations, suggesting a solid position to manage its immediate financial responsibilities.
Despite the challenging financial metrics, such as a negative EBITDA growth in the last twelve months as of Q1 2024, standing at -182.69%, and an adjusted operating income of -$122.27 million USD, CRGX's research progress could be a pivotal factor for its future. The company's commitment to addressing unmet needs in LBCL treatment is evident in its clinical advancements and may play a significant role in its long-term valuation.
For more detailed analysis and additional InvestingPro Tips on CRGX, which can further guide investment decisions, visit https://www.investing.com/pro/CRGX. There are 6 more tips available on InvestingPro, and by using the coupon code PRONEWS24, readers can get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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