On August 15, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based in vivo gene editing therapies, reported completion of a strategic transaction with Imugene Limited (ASX: IMU) for global rights to Azercabtagene Zapreleucel (azer-cel), Precision’s lead allogeneic CAR T candidate, for cancer (Press release, Precision Biosciences, AUG 15, 2023, View Source [SID1234634428]). Imugene will assume ongoing clinical execution for azer-cel in the large B-cell lymphoma (LBCL) population who have relapsed following autologous CAR T treatment. The license also includes an option to develop up to three other cancer research programs in the future.
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"We are excited to reach this key inflection point for Precision BioSciences with the achievement of three milestones – first, the completion of a global deal with Imugene for azer-cel in cancer; second, the extension of our expected cash operating runway to greater than two years; and third, our pivot to focus exclusively on in vivo gene editing," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "We are very pleased to partner with Imugene as they plan to leverage azer-cel’s clinical data package and recent regulatory feedback to continue its path toward a pivotal trial in LBCL and potentially help patients in dire need. Our commercial and scientific interests are closely aligned, and we believe Precision’s allogeneic CAR T technology can complement the novel oncology approaches being pursued by Imugene, especially its OnCARlytics platform for solid tumors."
"After an extensive review of the allogeneic CAR T landscape, we are excited to progress what we believe is the most advanced allogeneic CAR T program – azer-cel, which has regulatory feedback and a broad data set. This is an important opportunity to develop a much-needed treatment for the growing number of lymphoma patients who have relapsed following CAR T treatment and is complementary to our pipeline, which is designed to unleash the immune system to fight cancer, including our OnCARlytics program," said Leslie Chong, Chief Executive Officer and Managing Director at Imugene Limited.
In exchange for global rights to azer-cel for cancer, as well as Precision BioSciences’ CAR T infrastructure and its experienced cell therapy teams, Precision will receive upfront economics valued at $21 million (all figures in USD) consisting of cash and equity. In addition, Precision is eligible for an $8 million near-term payment in cash and equity upon successful completion of the phase 1b dosing in the CAR T relapsed LBCL patient population. For azer-cel, Precision is eligible to receive up to $198 million in additional milestone payments and double-digit royalties on net sales. For each additional research program selected by Imugene, Precision is eligible for up to $145 million in milestone payments and tiered royalties on net sales.
Precision’s PBCAR19B stealth cell and its CAR T assets targeting multiple myeloma, as well as all rights to non-oncology indications for azer-cel, remain available for development through partnership only.
Corporate & Financial Update
As a result of this transaction, Precision expects to reduce its annual operating spend by approximately $20 million from the current base case and has right-sized the company to operate as a single platform company focused on in vivo gene editing. Upfront cash from this transaction, reduced CAR T operating expenses, and continued fiscal discipline are expected to extend Precision’s cash runway through the third quarter of 2025.
"As we pivot our full attention and resources to leveraging the core features of ARCUS for differentiated in vivo gene editing programs, we are prepared to capitalize on the utility of ARCUS to produce a profound impact on diseases in the liver and beyond, including those that are best suited for gene insertion or excision of large defective gene sequences. We look forward to providing additional updates about our in vivo gene editing progress at our upcoming R&D event on September 12, 2023," added Mr. Amoroso.