Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010, an Allogeneic Anti-CD19 CAR-T Cell Therapy - Marketscreener.com

-- RMAT and Fast Track designations travel CB-010’s durable implicit responses at dose level 1 successful the ANTLER Phase 1 proceedings --

-- CB-010 is the 1^st allogeneic CAR-T compartment therapy successful the session with a PD-1 knockout --

BERKELEY, CA, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a starring clinical-stage CRISPR genome-editing biopharmaceutical company, contiguous announced that the U.S. Food and Drug Administration (FDA) has granted CB-010 Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed oregon refractory ample B compartment lymphoma (LBCL) and Fast Track designation for relapsed oregon refractory B compartment non-Hodgkin lymphoma (r/r B-NHL). CB-010, an allogeneic anti-CD19 CAR-T compartment therapy with a PD-1 knockout, is being evaluated successful the company’s ongoing ANTLER Phase 1 objective proceedings successful patients with r/r B-NHL, which tin enroll 3 LBCL subtypes: diffuse ample B compartment lymphoma (DLBCL), superior mediastinal ample B compartment lymphoma (PMBCL), and high-grade B compartment lymphoma (HGBL). CB-010 is the archetypal allogeneic anti-CD19 CAR-T compartment therapy successful the session with a PD-1 knockout, a genome-editing strategy designed to amended the persistence of antitumor enactment by limiting premature CAR-T compartment exhaustion.

“RMAT and Fast Track designations for CB-010 are important recognitions of the important unmet diligent request for an off-the-shelf compartment therapy successful the attraction of assertive B-NHL,” said Rachel Haurwitz, Ph.D., Caribou’s president and main enforcement officer. “Through genome editing with our precision CRISPR chRDNA genome-editing technology, CB-010 has been designed with a PD-1 knockout strategy to amended the persistence of antitumor enactment by limiting premature CAR-T compartment exhaustion. In our ANTLER Phase 1 trial, 3 of 6 patients treated with CB-010 astatine dose level 1 maintained a durable implicit effect astatine 6 months. We are encouraged that CB-010 has demonstrated aboriginal imaginable arsenic an off-the-shelf compartment therapy that whitethorn meaningfully rival autologous compartment therapies.”

Encouraging information information and antitumor enactment for CB-010 astatine dose level 1 (40x10⁶ CAR-T cells) person been reported from the ANTLER trial. As presented astatine the European Hematology Association (EHA) 2022 Congress, 6 of 6 patients (100%) achieved a implicit effect (CR) arsenic champion effect aft attraction with CB-010 astatine dose level 1 (40x10⁶ CAR-T cells). Subsequently, astatine 6 months, 3 of 6 patients (50%) maintained a CR. Fifteen months is the longest CR maintained to date, observed successful the archetypal diligent dosed successful the ANTLER trial. CB-010 was mostly good tolerated astatine dose level 1.

Both RMAT and Fast Track designations are dedicated programs designed to expedite the improvement and reappraisal processes for promising therapeutic candidates intended to code an unmet aesculapian request successful patients with superior conditions. These designations supply important benefits successful the cause improvement process and are designed to facilitate and expedite improvement and regulatory review, including providing eligibility for Priority and Rolling Reviews, and Accelerated Approval, if applicable criteria are satisfied.

About CB-010
CB-010 is the pb merchandise campaigner from Caribou’s allogeneic CAR-T compartment therapy level and is being evaluated successful patients with relapsed oregon refractory B compartment non-Hodgkin lymphoma (r/r B-NHL) successful the ongoing ANTLER Phase 1 trial. CB-010 is an allogeneic anti-CD19 CAR-T compartment therapy engineered utilizing Cas9 CRISPR hybrid RNA-DNA (chRDNA) exertion to insert a CD19-specific CAR into the TRAC cistron and sound retired PD-1 to boost the persistence of antitumor activity. CB-010 is the archetypal allogeneic CAR-T compartment therapy successful the session with a PD-1 knockout. CB-010 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations. Additional accusation connected the ANTLER proceedings tin beryllium recovered astatine https://clinicaltrials.gov/ utilizing identifier NCT04637763.

About Caribou’s Novel Next-Generation CRISPR Platform
CRISPR genome editing uses easy designed, modular biologic tools to marque DNA changes successful surviving cells. There are 2 basal components of Class 2 CRISPR systems: the nuclease macromolecule that cuts DNA and the RNA molecule(s) that usher the nuclease to make a site-specific, double-stranded break, starring to an edit astatine the targeted genomic site. CRISPR systems are susceptible of editing unintended genomic sites, known arsenic off-target editing, which whitethorn pb to harmful effects connected cellular relation and phenotype. In effect to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced “chardonnays”) that nonstop substantially much precise genome editing compared to all-RNA guides. Caribou is deploying the powerfulness of its Cas12a chRDNA exertion to transportation retired aggregate edits astatine precocious efficiency, including multiplex cistron insertions, to make CRISPR-edited therapies.

About Caribou Biosciences, Inc.
Caribou Biosciences is simply a clinical-stage CRISPR genome-editing biopharmaceutical institution dedicated to processing transformative therapies for patients with devastating diseases. The company’s genome-editing platform, including its proprietary Cas12a chRDNA technology, enables superior precision to make compartment therapies that are specifically engineered for enhanced persistence. Caribou is advancing a pipeline of off-the-shelf CAR-T and CAR-NK compartment therapies for the attraction of patients with hematologic malignancies and coagulated tumors.

For much accusation astir Caribou, sojourn www.cariboubio.com and travel the institution @CaribouBio.

“Caribou Biosciences” and the Caribou logo are registered trademarks of Caribou Biosciences, Inc.

Forward-Looking Statements
This property merchandise contains forward-looking statements, wrong the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements related to Caribou’s strategy, plans, and objectives, and expectations regarding its objective and preclinical improvement programs, including its timing and expectations relating to the merchandise of diligent information from its ongoing ANTLER Phase 1 objective proceedings for CB-010, arsenic good arsenic the timing of regulatory reappraisal and approval. Management believes that these forward-looking statements are tenable arsenic and erstwhile made. However, specified forward-looking statements are taxable to risks and uncertainties, and existent results whitethorn disagree materially from immoderate aboriginal results expressed oregon implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent successful improvement of compartment therapy products; uncertainties related to the initiation, cost, timing, progress, and results of existent and aboriginal probe and improvement programs, preclinical studies, and objective trials; and the hazard that archetypal oregon interim objective proceedings information volition not yet beryllium predictive of the information and efficacy of Caribou’s merchandise candidates oregon that objective outcomes whitethorn disagree arsenic much diligent information becomes available; arsenic good arsenic different hazard factors described from clip to clip successful Caribou’s filings with the Securities and Exchange Commission, including its Annual Report connected Form 10-K for the twelvemonth ended December 31, 2021 and consequent filings. In airy of the important uncertainties successful these forward-looking statements, you should not trust upon forward-looking statements arsenic predictions of aboriginal events. Except arsenic required by law, Caribou undertakes nary work to update publically immoderate forward-looking statements for immoderate reason.

Caribou Biosciences, Inc. Contacts:
Investors:
Amy Figueroa, CFA
afigueroa@cariboubio.com

Media:
Peggy Vorwald, Ph.D.
pvorwald@cariboubio.com

Investors and Media:
Elizabeth Wolffe, Ph.D., and Sylvia Wheeler
Wheelhouse LSA
lwolffe@wheelhouselsa.com
swheeler@wheelhouselsa.com

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