Imugene (IMU: $0.065) has announced it will acquire its fourth technology platform in cancer immunotherapy. The company is in-licensing an allogeneic CAR-T program, called Azer-Cel, from US company Precision Biosciences.
As part of the agreement, Imugene will also take over an existing R&D facility lease together with a 50 person manufacturing team based in North Carolina.
The appeal of the technology is the clinical data that has been generated with the allogeneic approach, which is an off-the-shelf therapy not requiring the extraction and processing of a patient’s own T-cells. Another appeal is that this is the first-in-class allogeneic CAR-T cell therapy, and has the potential to be the first allogeneic CAR-T treatment to enter the market.
Imugene will pay US$8 million in cash upfront with a US$13 million payment in cash or Imugene shares in 12 months time. A further US$8 million is payable when the Phase Ib study has been completed. And there are up to US$198 million in milestone payments and royalties payable from product sales.
Imugene will also pay ASX-listed Chimeric Therapeutics a US$3 million introductory fee for sourcing the technology.
Imugene is raising $35 million through a private placement at $0.084 a share, and is seeking to raise an additional $30 million through a share purchase plan.
Data Achieved to Date
In 2019, Precision Biosciences started a Phase Ib study seeking to recruit 120 patients with non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia who were failing other treatments (relapsing/refractory).
Of the 61 evaluable patients with NHL, the overall response rate was 58% with 41% achieving a complete response. Importantly there were no Grade 3 (or greater) adverse events, such as cytokine release syndrome, reported in the most recent cohort.
In the 18 patients in the study with diffuse large B-cell lymphoma (DLBCL) who had all failed CAR-T therapy, the complete response rate was even better, at 61%, with 55% having a sustained complete response at six months or longer after treatment.
The Azer-Cel Technology
The Azer-Cel therapy targets CD-19 on blood-based cancer cells. All of the current six approved CAR-T therapies are approved for the treatment of blood-based cancers, with most using CD-19 as the target. The first of these was approved in 2017. However all are autologous, meaning that the patient’s T-cells need to be extracted and re-engineered.
The technology behind Azer-Cel stems from the core expertise of Precision Biosciences in gene editing. With Azer-Cel, the company replaced the endogenous T-cell receptor with the chimeric antigen receptor (CAR). The aim is to achieve an antitumour effect with an allogeneic approach by removing the graft-versus-host rejection through the above gene editing.
A registration study (Phase II) is expected to start in early 2025 as a third and fourth line therapy in patients with DLBCL. It will include one of the five different doses explored in the Phase Ib study.
There is a good synergy with the technology acquisition for Imugene. One of Imugene's technology platforms, OnCARlytics, uses the company's oncolytic virus, CF33, to infect cancer cells with CD-19 on solid tumours. The combination of the Azer-Cel technology with OnCARlytics has the potential to generate a powerful allogeneic CAR-T therapy for solid tumours.
For Precision Biosciences, the company will now focus on in vivo gene editing to tackle diseases such as Duchenne muscular dystrophy and sickle cell disease, with two programs partnered with Eli Lilly and one with Novartis. Another allogeneic (ex-vivo) CAR-T program, called PBCAR19B Stealth Cell, has not been licensed by Imugene, although Imugene has three other targets included in the license deal with Precision Biosciences.
Imugene is capitalised at $444 million.
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