Kalkine: Imugene Expands Global Cancer Vaccine Trial, Adding Momentum to ASX200 Biotech Landscape

3 min read | June 02, 2025 11:43 AM AEST | By Team Kalkine Media

Highlights 

  • Imugene activates Australian site for Phase II bowel cancer vaccine trial 
  • PD1-Vaxx targets hard-to-treat genetic subtype of colorectal cancer 
  • Study focuses on pre-surgical immune response and long-term outcomes 

Imugene Ltd (ASX:IMU) has marked another milestone in its cancer immunotherapy journey by activating its first Australian site for the Phase II Neo-POLEM clinical trial. This expansion reinforces Imugene’s presence within the international oncology research space and adds momentum to the innovative biotech efforts represented in the S&P/ASX200 index. 

The Neo-POLEM trial evaluates Imugene’s PD1-Vaxx, a neoadjuvant B-cell vaccine designed to stimulate an immune response against the PD-1 protein in a challenging subset of bowel cancer patients – those with mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-high) colorectal cancer. This specific subtype accounts for approximately 15% of all bowel cancer cases and has shown to be more responsive to immunotherapy approaches. 

With clinical trial sites now open in both the United Kingdom and Australia, the study is recruiting patients to assess the effectiveness of PD1-Vaxx when administered prior to surgery. The key goal is to observe major pathological response, which measures the degree of tumour reduction following treatment. Secondary endpoints of the trial include overall survival, objective response rates, biomarker activity, and treatment safety. 

Led by the Cancer Research UK Southampton Clinical Trials Unit in collaboration with the Royal Surrey Hospital NHS Foundation Trust and Australasian Gastro-Intestinal Trials Group (AGITG), the trial builds on promising early research suggesting that immunotherapy may offer meaningful advantages for patients with this specific cancer profile. 

Imugene’s managing director and CEO, Leslie Chong, expressed optimism regarding the trial’s momentum, particularly in light of its expansion within Australia. According to the company, PD1-Vaxx holds the potential to induce a strong and lasting immune response that could shift treatment paradigms for dMMR/MSI-high colorectal cancer. 

Globally, colorectal cancer ranks as the third most common cancer, with more than 1.2 million new cases each year. Although most patients are diagnosed with resectable disease, mortality rates remain high, making the development of new therapeutic options an urgent priority. Imugene’s targeted immunotherapy approach aims to improve long-term outcomes compared to conventional chemoradiation. 

The Neo-POLEM study forms part of Imugene’s broader pipeline, which also includes B-cell vaccines, oncolytic virotherapy, and allogeneic CAR-T therapies such as azer-cel, designed to target CD19 in blood cancers. These platforms place the company among innovative biotech leaders on the ASX. 

As global interest in biotechnology and healthcare innovation continues to rise, companies like Imugene are increasingly catching the eye of investors exploring sectors beyond traditional ASX dividend stocks, offering long-term growth opportunities in breakthrough therapies. 


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