Imugene Raises A$37.5m to Advance Off-the-Shelf CAR T Therapy with 75% Response Rate
Imugene Limited has launched a A$37.5 million capital raising to advance its promising off-the-shelf CAR T therapy, azer-cel, following encouraging Phase 1b data showing a 75% overall response rate in lymphoma patients.
- A$37.5 million capital raise via Placement and Share Purchase Plan
- Azer-cel Phase 1b trial reports 75% overall and 55% complete response rates
- Plans for pivotal Phase 2 registrational trial in 2026 targeting rare lymphomas
- Funding runway extended into mid-2027 with potential options exercise
- Imugene’s pipeline includes onCARlytics and CF33 VAXINIA solid tumor programs
Capital Raise to Accelerate Clinical Progress
Imugene Limited (ASX – IMU), a clinical-stage immuno-oncology company, has announced a capital raising of up to A$37.5 million to fund the development of its lead asset, azer-cel. This allogeneic, off-the-shelf CD19 CAR T therapy is currently in Phase 1b clinical trials targeting Diffuse Large B-Cell Lymphoma (DLBCL), a fast-growing blood cancer with significant unmet medical need.
The raise comprises a A$22.5 million Placement and a A$15 million Share Purchase Plan (SPP), priced at A$0.33 per share, representing a discount to recent trading prices. Attaching options exercisable at A$0.43 and piggyback options exercisable at A$0.86 accompany the new shares, potentially extending the company’s funding runway into mid-2027.
Promising Phase 1b Data Bolsters Confidence
Azer-cel’s allogeneic approach, derived from healthy donor T-cells, offers a scalable, on-demand alternative to personalized autologous CAR T therapies, which require lengthy manufacturing times and are limited to single-patient use. This positions azer-cel as a potential first-in-class off-the-shelf CAR T therapy with broad commercial appeal.
Strategic Pathway Towards Regulatory Approval
Imugene plans to expand the Phase 1b trial to include CAR T-naïve niche lymphoma patients and aims to initiate a pivotal Phase 2 registrational trial in 2026, subject to regulatory approvals and positive data. The company anticipates an FDA End-of-Phase meeting in late 2025 to confirm the registration pathway, with potential Fast Track and Orphan Drug designations enhancing regulatory engagement.
The targeted market opportunity is substantial, with rare lymphomas and relapsed CAR T therapy patients representing a US$2 billion annual market in the United States alone. Imugene’s strategy focuses on high-need indications suitable for accelerated approval pathways, potentially enabling faster patient access.
Broader Pipeline and Experienced Leadership
Beyond azer-cel, Imugene’s pipeline includes two other clinical-stage immunotherapies – onCARlytics, a CD19-expressing virus designed to make solid tumors susceptible to CAR T therapies, and CF33 VAXINIA, an oncolytic virus targeting late-stage solid cancers. These programs offer additional avenues for growth and value creation.
The company is led by a seasoned management team with extensive experience in oncology drug development and commercialization, having contributed to bringing over 18 FDA-approved drugs to market. This expertise underpins Imugene’s clinical and regulatory ambitions.
Funding and Operational Efficiency
Pro-forma cash post-raise is expected to be approximately A$64 million, sufficient to fund operations through the initiation of the pivotal trial. Imugene has also implemented cost-saving measures, including headcount reductions and out-licensing manufacturing facilities, to preserve capital while maintaining focus on its core programs.
With a robust patent portfolio and a clear clinical development roadmap, Imugene is positioning itself to capitalize on the growing CAR T therapy market, which has seen significant deal activity and investment from major pharmaceutical players.
Bottom Line?
Imugene’s capital raise and promising clinical data set the stage for a pivotal trial that could redefine CAR T therapy accessibility and scalability.
Questions in the middle?
- Will the FDA grant Fast Track or Orphan Drug designation to azer-cel, accelerating approval timelines?
- How will Imugene’s allogeneic CAR T therapy compete against established autologous CAR T products commercially?
- What are the prospects and timelines for clinical readouts from the onCARlytics and CF33 VAXINIA programs?
