BERKELEY, Calif. - Caribou Biosciences, Inc. (NASDAQ:CRBU), a biopharmaceutical company specializing in CRISPR genome-editing, has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for CB-010 in lupus nephritis and extrarenal lupus. The company announced its Phase 1 GALLOP clinical trial is slated to commence by the end of 2024.
CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, has shown initial safety and efficacy in the ANTLER Phase 1 trial for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). Based on these results, Caribou is expanding CB-010's clinical development to autoimmune diseases.
The GALLOP trial will explore the safety and initial efficacy of CB-010 following a lymphodepletion regimen. The trial incorporates partial HLA matching, which may improve outcomes, as suggested by data from the ANTLER trial. This approach is based on the premise that closer HLA matches between patients and donors can reduce therapy rejection.
CB-010's distinct manufacturing process does not rely on lentiviral or retroviral vectors, which have been associated with secondary malignancy risks. Instead, Caribou uses chRDNA technology for precise CAR insertion into the T cell genome.
The ANTLER trial continues to enroll second-line patients with large B cell lymphoma (LBCL) and is expected to present initial dose expansion data at a medical congress in Q2 2024.
Lupus is an autoimmune disease where the immune system attacks healthy tissues, leading to widespread inflammation and organ damage. CB-010 targets CD19, a protein on B cells' surface, and is engineered to reduce CAR-T cell exhaustion, potentially leading to sustained remission.
Caribou anticipates its current cash reserves to fund operations into Q1 2026. The company will discuss the clinical development expansion of CB-010 and the GALLOP trial plans in a webcast conference call scheduled for today at 5:00 pm ET.
This news is based on a press release statement from Caribou Biosciences, Inc.
InvestingPro Insights
As Caribou Biosciences, Inc. (NASDAQ:CRBU) gears up for the commencement of its GALLOP clinical trial by the end of 2024, investors and industry observers are closely monitoring the company's financial health and stock performance. An analysis using InvestingPro provides a snapshot of Caribou's current market situation:
- The company's market capitalization stands at $410.03 million, reflecting its valuation in the biopharmaceutical market.
- With a negative price-to-earnings (P/E) ratio of -3.31, Caribou's earnings are currently not keeping pace with the company's share price, a common scenario for growth-stage biotech firms investing heavily in research and development.
- Despite a substantial year-over-year revenue growth of 148.91% as of the last twelve months of Q4 2023, the company's gross profit margin is deeply negative at -225.07%, indicating significant costs outweighing revenues in the same period.
InvestingPro Tips for Caribou Biosciences highlight several critical points for potential investors:
- The company holds more cash than debt on its balance sheet, which is a positive sign for its financial stability and its ability to fund ongoing operations and research.
- Caribou's stock is currently in oversold territory according to the Relative Strength Index (RSI), suggesting that the recent sell-off could be overextended and that the stock might be due for a rebound.
It is important to note that while analysts anticipate a sales decline in the current year and do not expect the company to be profitable this year, Caribou's innovative CRISPR genome-editing technology positions it as a key player in the field with potential for long-term growth.
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