Tim Kelly to lead Caribou’s technical operations strategy and execution
CB-010 ANTLER Phase 1 trial initial dose expansion data and RP2D to be disclosed Q2 2024; Caribou plans to initiate pivotal Phase 3 trial in 2L LBCL by YE 2024.
CB-011 CaMMouflage Phase 1 trial enrolling patients at dose level 3; initial dose escalation data in r/r MM expected by YE 2024
CB-012 AMpLify Phase 1 trial first sites active; trial initiation in r/r AML expected H1 2024
Caribou is to present at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, at 11:15 a.m. PST.
BERKELEY, Calif., January 2024, (GLOBE NEWSWIRE): Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced the appointment of Tim Kelly to the newly created position of chief technology officer. Mr. Kelly brings over 25 years of experience in global clinical and commercial product development, manufacturing, and supply chain operations with large and small biopharmaceutical and cell and gene therapy companies in the US and Europe. In addition, Caribou highlighted successful execution across its allogeneic CAR-T cell therapy platform over the past year and provided an outlook on multiple clinical catalysts planned for 2024.
“2023 was a year of exceptional progress and leadership for Caribou as we advanced our three clinical programs and strengthened our balance sheet with a public offering and investment from Pfizer. We are excited to kick off 2024 by welcoming Tim Kelly as Caribou’s chief technology officer,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “Tim’s extensive experience in global pharmaceutical product development, manufacturing, and commercialization, combined with his proven leadership and strategic vision, will be instrumental as we advance our pipeline and plan for the future. We are pleased to have Tim join us on our mission of bringing transformative therapies to patients with devastating diseases.”
Mr. Kelly will lead the company’s technical operations strategy and execution and will report to Dr. Haurwitz. Tim joins Caribou from Oxford Biomedica Solutions, a spin-out of Homology Medicines, offering AAV product development and manufacturing services, where he was chief executive officer and board chair. Prior to Oxford Biomedica Solutions, he was chief operating officer at Homology Medicines, Inc., where he led operations, process and platform development strategy, and product manufacturing strategy for gene therapy and gene editing technology. Earlier, he led technical operations at Sarepta, Shire, UCB, and Biogen and was a fighter pilot in the US Air Force. Tim earned an MS/MBA from Troy State University and a BS, with an emphasis in engineering mechanics, from the United States Air Force Academy.
“I’m thrilled to join Caribou as the company prepares to initiate its first pivotal trial. The potential of genome editing to revolutionize medicine is undeniable, and Caribou’s innovative chRDNA technology has enabled the development of armored allogeneic CAR-T cell therapies that hold immense promise,” said Mr. Kelly. “I look forward to leveraging my experience in building and scaling global process and manufacturing operations to ensure provider support and rapid patient access for commercialization and delivery of these potentially transformative therapies.”
CB-011, an allogeneic anti-BMCA CAR-T cell therapy for multiple myeloma
- Caribou initiated the CaMMouflage Phase 1 trial evaluating CB-011 in patients with relapsed or refractory multiple myeloma (r/r MM).
- CB-011 was granted Fast Track and Orphan Drug designations by the FDA, which are designed to expedite the development and review processes for promising therapeutic candidates that may fill an unmet medical need.
- CaMMouflage trial enrollment has concluded for dose level 1 (50×106 CAR-T cells, N = 3) and dose level 2 (150×106 CAR-T cells, N = 3) without any dose-limiting toxicities (DLTs), and the trial is enrolling patients at dose level 3 (450×106 CAR-T cells).
CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy for acute myeloid leukemia
- The investigational new drug (IND) application for CB-012 was cleared by the FDA for evaluation in relapsed or refractory acute myeloid leukemia (r/r AML).
- The first clinical sites are active for the AMpLify Phase 1 trial for CB-012 in r/r AML, with additional site activation underway.
Corporate accomplishments
Expanded executive leadership team and scientific advisory board (SAB)
- Appointed Tim Kelly as Caribou’s chief technology officer, leading the company’s process development and manufacturing organizations.
- Appointed Reigin Zawadzki as Caribou’s chief people officer, leading the company’s people strategy.
- Expanded Caribou’s SAB with a renowned lymphoma expert and two leading multiple myeloma experts:
- Stephen Schuster, MD, Robert and Margarita Louis-Dreyfus professor of chronic lymphocytic leukemia and lymphoma and the director of the lymphoma program and lymphoma translational research at the Perelman School of Medicine at the University of Pennsylvania, with Penn Medicine’s Abramson Cancer Center.
- Sundar Jagannath, MD, director of the Center of Excellence for Multiple Myeloma and professor of medicine at the Tisch Cancer Institute of Mount Sinai.
- Sriram Krishnaswami, PhD, vice president and development head for multiple myeloma at Pfizer Oncology’s Global Product Development division.
Armored balance sheet for cash runway into Q4 2025
- Completed successful $134.4 million follow-on financing.
- Received a $25 million Pfizer investment with proceeds to advance CB-011.
- Reported $396.7 million in cash, cash equivalents, and marketable securities as of September 30, 2023, which is expected to fund the current operating plan into Q4 2025.
2024 anticipated milestones
CB-010: Caribou plans to report initial dose expansion data from the ANTLER trial and share the recommended Phase 2 dose (RP2D) for CB-010 in Q2 2024. The company plans to initiate a Phase 3 pivotal trial evaluating CB-010 in second-line LBCL by year-end 2024.
CB-011: Caribou plans to report initial dose escalation data by year-end 2024.
CB-012: Caribou plans to initiate patient enrollment in the AMpLify Phase 1 clinical trial in r/r AML in H1 2024.
Caribou to present at the 42nd Annual J.P. Morgan Healthcare Conference
Dr. Haurwitz is scheduled to present a corporate update at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024, at 11:15 a.m. PST.
A live webcast of the presentation will be accessible via Caribou’s website on the Events page. The archived webcast will be available on the Caribou website for 30 days after the event.
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