Since securing a European patent for their proprietary cancer vaccine HER-Vaxx, Imugene (ASX: IMU) have been busy. The Company has now announced the initiation of new clinical trials  in collaboration with global pharmaceutical company, Merck & Co (NYSE: MRK).

The USD $46 billion company will support Imugene in evaluating the efficacy and safety of HER-Vaxx in combination with Merck’s emerging anti cancer drug, pembrolizumab, in patients with HER-2 positive gastric cancer. 

Under the name nextHORIZON, the Phase 2 study will aim to not only evaluate safety, but will look at the duration of patient response, the rate of cancer progression after treatment, overall survival and biomarker evaluation. 

Merck promotes pembrolizumab under the brand name KEYTRUDA as a medicine that “may help treat certain cancers by working with your immune system.” The immunotherapy is already approved for use by the FDA. 

Last year, the FDA granted accelerated approval for a combination treatment for gastric cancer sufferers comprising Merck’s KEYTRUDA and Genentech’s trastuzumab, a herceptin medication used to treat cancer that is HER-2 receptor positive. Patients who have previously failed on this combination may see good results when switching to Imugene’s vaccine. 

Imugene aren’t reinventing the wheel here, they’re making it better. Cancer vaccines like HER-Vaxx have been proven to achieve a greater effect than monoclonal antibody immunotherapies (like trastuzumab) by harnessing the power of the body’s own immune system and training it to display an anti-cancer response.

HER-Vaxx is designed to activate immune cells against tumours that over-express the HER-2/neu receptor, a clinically validated cancer target. This receptor overexpression is common in gastric, breast, ovarian, lung and pancreatic cancers. 

Gastric cancers are of particular interest to Imugene due to significant unmet need for targeted treatments. Gastrointestinal cancers are often diagnosed at more advanced stages due to the lack of symptoms in the early stages. The treatment window is relatively small so doctors need specialised and effective treatment options to neutralise the cancer quickly, an option Imugene hopes to give soon. 

Managing Director and CEO of the Company, Leslie Chong says “Imugene is excited to announce this collaboration with MSD, one of the world’s leading immuno-oncology companies. HER-Vaxx has already shown a tolerable safety profile and encouraging efficacy in patients with metastatic HER-2 positive gastric cancer, and we look forward to further evaluating HER-Vaxx with pembrolizumab in a relapsed/ refractory metastatic setting.

“This collaboration with MSD is significant for our company as it provides the opportunity to optimise and enhance our formulations and utility in an additional setting in an effort to improve outcomes for more patients. We are committed to finding ways to address the unmet needs of patients living with cancer.”

The nextHORIZON trial will be funded by Imugene who as at December 31st 2021 had $118.4 million in cash reserves. Merck will supply their drug for the duration of the study which is expected to run for 24 months, with results expected soon after. 

The last six months saw the Company ramp up clinical trials and research which resulted in Imugene posting a higher loss than last year of $14.8 million. The Company did however report revenue of over $5.3 million, up $4.11 million from the prior corresponding period.