Imugene Ltd (ASX:IMU, OTC:IUGNF) has dosed its first combination patient in the PD1-Vaxx and Immune Checkpoint Inhibitor lung cancer clinical trial.
The clinical-stage immuno-oncology company is conducting the IMPRINTER (adults with non-small cell lung cancer) study, to evaluate the safety and efficacy of Imugene’s PD1- Vaxx, a B-cell activating immunotherapy alone or in combination with atezolizumab (Tecentriq®), an immune checkpoint inhibitor targeting PD-L1 from Roche, in patients with non-small cell lung cancer (NSCLC).
The objectives of the open-label, multi-centre, dose escalation/expansion, phase 1/1b study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or without chemotherapy, are to determine safety, efficacy, and optimal dose of PD1-Vaxx together with atezolizumab as therapy in ICI treatment-naïve (those yet to be exposed) NSCLC patients or ICI pre-treated patients.
As way of explanation, immunotherapy drugs called immune checkpoint inhibitors work by blocking checkpoint proteins from binding with their partner proteins. This prevents the “off” signal from being sent, allowing the T cells to kill cancer cells.
The study will take place in the USA and Australia.
Cancer treatment options
Dual targeting of the PD-1/PD-L1 axis is an area of considerable interest, providing treatment options for patients with cancer.
Combination with PD1-Vaxx may overcome treatment resistance to ICIs with dual inhibition of the PD-1/PD-L1 axis extending the treatment benefit of atezolizumab.
In contrast to the combination of two monoclonal antibodies, PD1-Vaxx induces a unique polyclonal immune response which may increase response rates for the combination therapy.
Tecentriq® has previously shown that it has meaningful clinical benefit in various types of lung cancer, with six currently approved indications in the US.
It was the first approved cancer immunotherapy for adjuvant (an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine) NSCLC and the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy).
Tecentriq® also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.
"Outstanding accomplishment"
Imugene is working closely with Roche and is the sponsor of the clinical study, funding it from existing budgets and resources.
“It’s an outstanding accomplishment to see Imugene collaborate with Roche, in combination with our PD1-Vaxx drug,” Imugene managing director and CEO Leslie Chong said.
“PD1-Vaxx has shown a tolerable safety profile and encouraging efficacy in patients with NSCLC, and with the first patient being dosed today, we are looking forward to evaluating PD1-Vaxx with atezolizumab in ICI treatment naïve and pre-treated NSCLC patients.”
While IMU will take care of funding, Roche will provide atezolizumab for the duration of the study without preconditions.
The supply agreement is for a period of up to five years.
All data generated will remain the property of Imugene as the sponsor of the study, while the rights to all inventions and discoveries made or conceived in the course of the study relating to the combination of atezolizumab and PD1-Vaxx will belong to Roche and Imugene.