Caribou Biosciences Inc CRBU reported long-term follow-up data from the dose escalation portion of the ongoing ANTLER Phase 1 trial of CB-010, an allogeneic anti-CD19 CAR-T cell therapy for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).
Concurrently, Caribou priced an upsized underwritten public offering of 19.2 million shares at $6.50 per share, with gross proceeds of $125 million.
Last week, Caribou received an equity investment of $25 million from Pfizer Inc PFE to advance CB-011 development.
The data set includes all 16 patients treated in dose escalation.
In ANTLER dose escalation, three dose levels of CB-010 were evaluated (40x106, 80x106, and 120x106 CAR-T cells) in patients with multiple subtypes of aggressive r/r B-NHL.
CB-010 was generally well tolerated with adverse events consistent with autologous or allogeneic anti-CD19 CAR-T cell therapies; as previously reported, no dose-limiting toxicities (DLTs) were observed at dose levels 2 or 3 following a single DLT at dose level 1.
A 94% overall response rate (ORR; 15 of 16 patients) was observed following a single dose of CB-010. 69% of patients (11 of 16) achieved a complete response (CR).
44% of patients (7 of 16) had a CR at ≥6 months; 24 months is the longest CR maintained to date.
For the subset of patients with large B cell lymphoma (LBCL) (N=10):
- A 90% ORR (9 of 10) was observed.
- 70% (7 of 10) achieved a CR.
- 50% (5 of 10) had a CR at ≥6 months; 18 months is the longest CR maintained to date.
Caribou is enrolling second-line patients with LBCL in the ongoing dose expansion portion of the ANTLER clinical trial.
In expansion, the mid-dose and the high dose from escalation (80x106 and 120x106 CAR-T cells) are being evaluated in approximately 30 second-line patients to determine the recommended Phase 2 dose.
Caribou plans to report initial dose expansion data from the ongoing ANTLER trial in 1H 2024.
Price Action: CRBU shares are down 15.60% at $6.87 during the premarket session on the last check Friday.
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