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Pharma & Biotech

Imugene flags strong azer-cel response rates and ASCO milestone in March quarter update

Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) has highlighted encouraging early clinical data and fresh funding in its March 2026 quarterly report, as the company sharpens its focus on its lead CAR T therapy, azer-cel.

The clinical-stage immuno-oncology company highlighted positive results from its Phase 1b trial, alongside a $16 million capital raising and upcoming exposure at a major global oncology conference.

Strong early responses in azer-cel trial

Updated data from the CAR T-naïve cohort of the Phase 1b study showed high response rates across multiple blood cancer indications, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and marginal zone lymphoma (MZL):

  • CLL/SLL: 100% overall response rate (4/4 patients), all partial responses
  • MZL: 80% overall response rate (4/5 patients), including three complete responses
  • Patients were heavily pre-treated, with multiple prior lines of therapy

The trial is being conducted across 10 sites in the US and five in Australia and is designed as a multi-indication “basket” study, allowing the company to prioritise the most promising disease areas.

Imugene has also expanded the trial protocol to include a combination arm with Bruton Tyrosine Kinase inhibitors (BTKi) and added mantle cell lymphoma as a new indication, targeting patients who have previously failed standard therapies.

Further validation could come soon, with azer-cel data selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting — one of the sector’s most prominent events.

Strategic focus narrows to lead asset

During the quarter, Imugene completed a strategic review and elected to cease active development of its CF33 (VAXINIA) program, redirecting resources towards azer-cel.

Management said the decision reflects a disciplined capital allocation strategy focused on assets with the strongest near-term clinical and commercial potential.

Funding boost supports trial expansion

The company raised $16 million through a placement and share purchase plan, with proceeds earmarked to:

  • Expand the Phase 1b trial, including new cohorts
  • Advance the BTKi combination arm
  • Extend the funding runway into the fourth quarter of 2026

Imugene also received a $2.74 million R&D tax refund during the quarter, providing additional support for ongoing clinical development.

Cash position and outlook

Cash at the end of March stood at $5.96 million, with net operating cash outflows of $9.67 million for the quarter, largely driven by research and development, which accounted for 76% of operating costs.

While the reported cash balance implies less than one quarter of funding based on current burn rates, the company noted that proceeds from the second tranche of the placement and the share purchase plan were received after quarter end, strengthening liquidity.

Looking ahead, key near-term catalysts include:

  • Publication of the ASCO abstract in May
  • Oral presentation of azer-cel data at ASCO in late May/early June
  • Additional clinical data as more patients become evaluable

With clinical momentum building and broader exposure on the global stage approaching, the next phase of data readouts will be critical in shaping the program’s outlook.

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