Imugene Limited (ASX:IMU, OTC:IUGNF) has advanced another treatment in its development pipeline through a clinical trial supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc (NYSE:PFE) to evaluate the safety and efficacy of Imugene’s HER-Vaxx, in combination with avelumab, in patients with HER-2 positive gastric cancer.
HER-Vaxx is Imugene’s B-cell activating immunotherapy, which will be assessed in conjunction with avelumab, an immune checkpoint inhibitor targeting PD-L1 which is marketed as BAVENCIO® and co-developed and commercialised by Merck KGaA and Pfizer.
neoHERIZON is an open-label, multi-centre, randomized, Phase 2 clinical trial designed to assess the safety and efficacy of perioperative (surgery adjacent) HER-Vaxx combined with chemotherapy.
The trial will compare the use of HER-Vaxx with and without avelumab compared to chemotherapy alone in patients with HER-2 positive gastric or gastroesophageal junction adenocarcinomas (cancer of the stomach and/or oesophagus).
This study’s primary endpoint is pathologic complete response, in other words, a complete lack of cancer markers in tissue samples taken after treatment. Secondary endpoints include safety and biomarker evaluation (a study of the treatments’ characteristics).
Meeting unmet needs of cancer patients
“Imugene is excited to announce this collaboration with Merck KGaA, Darmstadt, Germany and Pfizer,” Imugene CEO and managing director, Leslie Chong said.
“HER-Vaxx has shown a tolerable safety profile and encouraging efficacy in patients with metastatic HER-2 positive gastric cancer, and we are looking forward to evaluating HER-Vaxx with avelumab in the perioperative clinical setting.
“Working together, we’re committed to finding ways to address the unmet needs of patients living with cancer.”
Effective immediately, under the terms of the agreement, Imugene will be the sponsor of the study and will fund the clinical study from existing budgets and resources. Merck KGaA, Darmstadt, Germany and Pfizer will provide avelumab for the duration of the study.
“We are very excited for the opportunity to treat patients with this new generation of HER-2 targeted Bcell immunotherapy, which has the potential to address significant unmet need in early HER-2 overexpressing gastric cancer that remains a challenging indication with poor prognosis,” director of the Asklepios Tumorzentrum in Hamburg, Dirk Arnold MD, PhD, said.
“The combination of chemotherapy and HER-Vaxx alone or in combination with avelumab in this type of gastric cancer may support a better treatment outcome for patients."
Gastric and gastro-oesophageal cancer
Perioperative (pre- and post-surgery) treatment in gastric or gastro-oesophageal cancer remains an unmet need for patients with HER-2 positive tumours.
HER-2 is a growth-promoting protein expressed on the surface of both healthy and cancerous cells.
Cancers with an increased level of HER-2 are called HER-2 positive, as they tend to grow and spread faster than other cancers but are much more likely to respond to treatment with drugs that target HER-2.
The current standard of care is limited to chemotherapy, radiotherapy and surgery when gastric cancer is diagnosed in its early stages. Immune checkpoint inhibitors have been successfully introduced to metastatic gastric cancer.
Immune checkpoints are another protein hosted on the surface of a cell, that in healthy cells protects them from being destroyed by the body’s immune system. Cancerous cells can co-opt this system to avoid destruction by the immune system.
Immune checkpoint inhibitors strip these proteins from the outside of cancer cells, allowing immune cells to attack the cancer as they normally would.
Imugene believes moving HER-Vaxx into earlier gastric cancer in combination with chemotherapy or an immune checkpoint inhibitor may improve treatment outcomes for patients with this difficult to treat cancer.
HER-Vaxx
Imugene is a clinical-stage immuno-oncology company developing a range of novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours.
Imugene’s HER-Vaxx is a B-cell peptide cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies and in Phase 1 and 2 studies to stimulate a potent polyclonal antibody (B-cell antibody) response to HER-2/neu, a well-known and validated cancer target.
Treatment pipeline
