Last week, Imugene (IMU: $0.035) announced that it had achieved two additional complete responses (CRs) in the combination and dose expansion part of its Phase Ib study for lymphoma with its Azer-Cel technology. This brings the CR rate to 57% (four out of seven patients) in Cohort B, which is the dose expansion segment of the trial. All four patients who responded had previously failed four lines of therapy, including autologous (CD-19 directed) CAR-T therapy. Azer-Cel (azercabtagene zapreleucel) is an allogeneic CD19 CAR T-cell therapy (i.e. cells from donors), currently being investigated in a Phase 1b study for relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
In Cohort A – monotherapy without IL-2 – the CR rate was 16.7% (two out of 12 participants), with the monotherapy was not durable beyond two months. These patients had previously failed four to five lines of therapy, including autologous CAR T-cell therapy. Also beneficial, the combination of Azer-Cel (after chemotherapy) and IL-2 produced fewer adverse events (AEs) compared to the group without IL-2 (after chemotherapy), with no Grade 3 (serious) AEs reported. Pharmacokinetic data showed that the addition of low-concentration IL-2 expanded CD8+ CAR+ T-cells, and allo-CAR rejection – which could provoke graft-versus-host disease (GvHD) – did not occur. Imugene also reported that the longest duration of response achieved is still ongoing, at 10 months.
Ongoing trials
The Azer-Cel allogeneic CAR T-cell trial is still enrolling patients with DLBCL who have relapsed after treatment with autologous CAR T-cell therapies. The company aims to become the first-in-class allogeneic (off-the-shelf) CD19 CAR T-cell therapy for cancer. The current study is a precursor to a registration study, if results are successful.
Addressable Market of Azer-Cel
Imugene estimates that 60-70% of patients treated with currently approved autologous CAR T-cell therapies will experience progression or recurrence. Imugene exclusively licensed Azer-Cel from Precision Biosciences in August 2023, paying an upfront fee of US$8 million. Imugene may pay up to $198 million in performance-based milestones over the life of Azer-Cel.
Funded Through 2025
Imugene holds around $65.4 million in cash, providing a runway through to the end of 2025. This includes its cash balance of $33.7 million at the end of last year, $11.7 million received in January from its R&D tax rebate (for FY2023), and $20 million received in January from CVI Investments from a convertible note facility signed in December last year. The convertible notes can be converted into shares at $0.0475 per share for the first six months, then at 90% of the prevailing share price, but no lower than a floor price of $0.019.
CVI Investments also received warrants that may raise an additional $26 million for Imugene. These warrants have a period of five years to expiry with an exercise price of $0.0494 per share for CVI. Imugene is capitalised at $265 million.
Bioshares recommendation: Speculative Hold Class B.
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