Precision BioSciences and Eli Lilly modify deal, shifting responsibilities and milestones

USA —Precision BioSciences, a leading gene editing company, has announced modifications to its deal with pharmaceutical giant Eli Lilly.

The changes, documented in an SEC filing, reveal that the companies revised the terms on June 30, following Lilly’s assignment of the Precision deal to its subsidiary, Prevail Therapeutics, in November.

Eli Lilly acquired Precision BioSciences in November 2020 and Prevail in December of the same year.

Precision BioSciences, Inc. specializes in clinical-stage gene editing and the development of in vivo gene editing and ex vivo allogeneic CAR-T therapies using its advanced ARCUS genome editing platform.

ARCUS utilizes highly precise and versatile sequence-specific DNA-cutting enzymes for gene knockout, as well as sophisticated gene insertion and repair techniques.

Precision’s pipeline includes preclinical candidates for primary hyperoxaluria type 1 (PBGENE-PH1), familial hypercholesterolemia, and chronic hepatitis B.

Under the modified agreement, Prevail Therapeutics will assume additional responsibilities in the $2.7 billion deal, including manufacturing products for clinical trials.

Previously, this responsibility rested with Precision at Prevail’s expense. As for Precision, the biotech company is now eligible for milestones ranging from approximately US$390 million to US$395 million per licensed product, instead of the originally agreed-upon US$420 million.

Eli Lilly’s involvement with Precision BioSciences initially indicated a shift toward genome editing, with a US$100 million upfront payment to the company for developing treatments targeting Duchenne muscular dystrophy and two other programs focused on the liver and CNS.

In addition, Eli Lilly purchased US$35 million worth of Precision’s stock.

Precision’s allogeneic CAR T pipeline includes several investigational candidates in early-stage clinical trials, such as PBCAR0191 and PBCAR19B, first and second-generation CD19 targeting candidates for patients with relapsed and/or refractory non-Hodgkin and B-cell lymphoma.

Precision is also prioritizing the development of PBCAR269A, a BCMA-targeted candidate in combination with a gamma-secretase inhibitor for patients with relapsed and/or refractory multiple myeloma.

The global genome editing market was valued at US$4.8 billion in 2020 and is projected to reach US$36.1 billion by 2030, with a compound annual growth rate (CAGR) of 22.30% from 2021 to 2030, according to Allied Markets Research.

Genome editing, also known as gene editing, encompasses a group of technologies that enable researchers to modify the DNA of organisms, allowing for additions, removals, or alterations of genetic material at specific locations in the genome.

Among the various approaches to genome editing, CRISPR-Cas9 has gained significant attention in the scientific community.

CRISPR-Cas9, which stands for clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9, is a faster, cheaper, and more efficient system compared to other existing genome editing methods.

In a related development, Pfizer has made a US$25 million investment to acquire a minority stake in Caribou Biosciences, a clinical-stage genome-editing biopharmaceutical firm specializing in clustered regularly interspaced short palindromic repeats (CRISPR) technology.

This investment will support the advancement of Caribou’s immune-cloaked allogeneic CAR-T cell therapy, CB-011.

Currently, CB-011 is undergoing evaluation in a Phase I CaMMouflage clinical trial for relapsed or refractory multiple myeloma, with the US Food and Drug Administration granting fast-track designation for the therapy in April 2023.

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