CRBU - Caribou Biosciences Appoints Tim Kelly as Chief Technology Officer and Highlights Multiple Clinical Catalysts Expected in 2024 | Benzinga
-- 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 to present at 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, at 11:15 am PST --
BERKELEY, Calif., Jan. 07, 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 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."
2023 clinical highlights and corporate accomplishments
Clinical highlights
CB-010, an allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
- Caribou reported encouraging data from the dose escalation portion of the ANTLER Phase 1 trial evaluating CB-010 in 16 patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). Dose escalation data showed CB-010's response rates and safety profile have the potential to rival those of the approved autologous CAR-T cell therapies.
- In the ongoing ANTLER Phase 1 trial, Caribou is enrolling second-line relapsed or refractory large B cell lymphoma (r/r LBCL) patients in the dose expansion portion. Currently, 22 U.S. and 3 international sites are active, with additional site activation underway.
- Caribou provided a regulatory update based on feedback from the U.S. Food and Drug Administration (FDA) following a Type B clinical meeting. The company received the FDA's feedback on a Phase 3 randomized pivotal trial for CB-010 in second-line r/r LBCL stating that Caribou's proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is acceptable.
- To Caribou's knowledge, CB-010 is the first anti-CD19 allogeneic CAR-T cell therapy to be evaluated in the second-line LBCL setting and it has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations by the FDA for specific indications.
"My enthusiasm for the potential of off-the-shelf cell therapies combined with the encouraging CB-010 dose escalation data prompted me to establish Westmead Hospital ...