Imugene Limited (ASX:IMU, OTC:IUGNF) has obtained US Food and Drug Administration (FDA) consent for clinical trials for two of its oncology treatments, securing Investigational New Drug (IND) approval to initiate a Phase I clinical trial for oncolytic virotherapy candidate VAXINIA (CF33-hNIS, HOV2) and a Phase II trial of immunotherapy candidate HER-Vaxx.
The FDA approval of the INDs were received on December 10, 2021, and allows Imugene to start patient recruitment and dosing for the two trials.
IMU's Phase I trial involves the use of oncolytic virotherapy candidate VAXINIA in a study for treatment of metastatic or advanced solid tumours (MAST) in multiple solid tumour-type patients.
The Phase II trial, the nextHERIZON study, concerns treating HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction, also known as Advanced Gastric Cancer (AGC) with Imugene’s immunotherapy candidate, HER-Vaxx.
VAXINIA Oncolytic Virus study
Imugene managing director and CEO Leslie Chong said: “Imugene receiving this IND approval for VAXINIA from the FDA is a crucial step forward.
“The start of our VAXINIA OV study is a significant milestone for clinicians treating patients faced with the challenge of solid tumour cancers.
“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s and City of Hope’s research and development teams as we continue to build on our clinical and commercial potential.”
Shares were as much as 3.9% higher intraday at A$0.535 while IMU's market cap is approximately A$2.96 billion.
CF33-hNIS is a chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and an expert in the oncolytic virus field.
Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.
The clinical trial is titled 'A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumors (MAST)'.
This is an open-label, dose-escalation, multi-centre phase I study evaluating the safety of CF33-hNIS (hNIS – human sodium iodide symporter) administered via two routes of administration.
The treatment will be delivered intratumorally (IT) or intravenously (IV), either as a monotherapy or in combination with pembrolizumab administered intravenously in patients with metastatic or advanced solid tumours.
The trial will involve a dose escalation before the trial expands to up to 10 patients at the final monotherapy and combination dose.
NextHERIZON B cell study
“Imugene receiving this IND approval for HER-Vaxx from the FDA is another important step forward,” Chong said.
“To achieve two IND’s for our programs (OV and B Cell) concurrently is an outstanding result for the team.”
The second clinical trial is titled 'nextHERIZON: An open-label, signal generating, phase 2 study of HER-Vaxx in combination with chemotherapy or pembrolizumab in patients with metastatic HER2/neu overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinomas who have previously received trastuzumab and progressed on this treatment'.
Gastrointestinal cancer is often resistant to immunotherapy, one of the novel treatments currently emerging into the Oncology market space. One promising strategy to overcome this resistance involves increasing the number of cytotoxic immune cells within the tumour microenvironment (TME) with immunotherapies such as HER-Vaxx.
Active immunization with HER-Vaxx has induced high and long-lasting antibody levels and expanded lymphocytes’ subpopulations, such as interferon-gamma (IFNγ) producing CD4 and CD8 T cells.
Therefore, the introduction of HER-Vaxx after first-line treatment in patients that have progressed under trastuzumab may overcome potential resistance.
Based on pre-clinical data, HER-Vaxx may also synergise with PD-1 targeting immune checkpoint inhibitor pembrolizumab (sold and marketed as KEYTRUDA by Merck), and therefore serve as a potentially better tolerated and chemotherapy-free treatment opportunity in metastatic patients.
About Imugene
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.
The company’s platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies.
Imugene’s product pipeline includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T’s for solid tumours.
The company is supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.