Item 7.01 Regulation FD Disclosure.
On November 21, 2022, Caribou Biosciences, Inc. (the “Company”) issued a press
release announcing that it has received clearance of its investigational new
drug (“IND”) application from the U.S. Food and Drug Administration (“FDA”) for
CB-011, a genome-edited allogeneic anti-BCMA CAR-T cell therapy with immune
cloaking. A copy of the press release is furnished as Exhibit 99.1 to this
Current Report on Form 8-K and also is incorporated by reference into this Item
The information contained in this Item 7.01 and in the accompanying Exhibit 99.1
shall not be deemed filed for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in
any filing or other document under the Exchange Act or the Securities Act of
1933, as amended (the “Securities Act”), regardless of any general incorporation
language in any such filing or document, except as shall be expressly set forth
by specific reference in any such filing or document.
Item 8.01 Other Events.
On November 21, 2022, the Company announced that it has received clearance of
its IND application from the FDA for CB-011, a genome-edited allogeneic
anti-BCMA CAR-T cell therapy with immune cloaking. The safety and efficacy of a
single dose of CB-011 in adult patients with relapsed or refractory multiple
myeloma (“r/r MM”) will be evaluated in the multicenter, open-label CaMMouflage
phase 1 clinical trial.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press Release Issued by Caribou Biosciences, Inc. on November 2 1 , 202 2 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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