Imugene’s Cost Cuts and Patent Wins Set Stage Amid Clinical Trial Risks

Clinical Breakthroughs in CAR T Therapy

Imugene Limited (ASX, IMU) has delivered encouraging clinical data from its Phase 1b trial of azer-cel, an allogeneic, off-the-shelf CAR T therapy targeting CD19 for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The trial reported a 75% overall response rate, including six complete responses, marking a significant advance in treating a patient population that has exhausted multiple prior therapies.

Unlike autologous CAR T therapies that require patient-specific manufacturing, azer-cel’s off-the-shelf design promises faster, broader patient access. The durability of responses is notable, with some patients remaining cancer-free for over a year. Imugene plans to engage with the US FDA in Q4 2025 to discuss pivotal trial design, aiming to accelerate regulatory approval.

Expanding Clinical Horizons and New Trials

Beyond DLBCL, the azer-cel trial is expanding to include other B-cell lymphomas such as primary central nervous system lymphoma and chronic lymphocytic leukemia, addressing rare and underserved cancers. Meanwhile, the onCARlytics Phase 1 OASIS trial has cleared its first intravenous dose level, progressing the evaluation of an engineered oncolytic virus designed to sensitize solid tumors to CD19-targeted therapies.

In Australia, the first patient has been dosed in the PD1-Vaxx Phase II Neo-POLEM trial targeting mismatch repair-deficient colorectal cancer. This neoadjuvant study aims to harness the immune system to reduce tumors before surgery, potentially improving outcomes in early-stage disease.

Strengthening Intellectual Property and Leadership

Imugene secured key US patents for its onCARlytics platform and PD1-Vaxx vaccine, both with extended patent terms into the late 2030s and early 2040s, respectively. These protections bolster the company’s competitive position in immuno-oncology.

Leadership was reinforced with the appointment of Dr John Byon as Chief Medical Officer. Dr Byon brings extensive experience in CAR T clinical development, having previously held senior roles at Fate Therapeutics and Genentech, and has been instrumental in advancing azer-cel’s combination strategy with interleukin-2.

Robust Financial Position to Support Growth

Financially, Imugene completed a $22.5 million institutional placement and launched a $15 million share purchase plan, both strongly supported by international investors. The company also received a $5.8 million R&D tax refund, extending its cash runway into 2027. Operational efficiencies have been achieved through a 40% reduction in expenses and a streamlined workforce now under 23 full-time employees.

These funds are earmarked primarily for advancing azer-cel into pivotal trials planned for 2026, alongside supporting ongoing clinical programs and corporate operations. Imugene’s strategic focus remains on clinical development and delivering transformative immuno-oncology therapies.