On June 1, 2023 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported the first patient dosed in the combination cohort of the IMPRINTER study, a clinical trial 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) (Press release, Imugene, JUN 1, 2023, View Source [SID1234632299]).
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The objectives of the open label, multi-center, 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, in adults with non-small cell lung cancer (IMPRINTER), are to determine safety, efficacy, and optimal dose of PD1-Vaxx in combination with atezolizumab as therapy in ICI treatment-naïve NSCLC patients or ICI pretreated patients. The study will be conducted at sites in USA and Australia.
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 clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the US. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also 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.
Imugene MD & CEO Leslie Chong said "It’s an outstanding accomplishment to see Imugene collaborate with Roche, in combination with our PD1-Vaxx drug. 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."
Imugene is the sponsor of the study and is funding the clinical study from existing budgets and resources. Roche will provide atezolizumab for the duration of the study. There are no preconditions to this supply agreement. The supply agreement is for a period of up to five years unless agreed otherwise by either party with industry standard cancellation provisions including termination without penalty. All data generated in the performance of the study in accordance with the supply agreement shall be the property of Imugene as
the sponsor of the study. All rights to all inventions and discoveries made or conceived in the course of the study relating to the combination of atezolizumab and PD1-Vaxx shall belong jointly to Roche and Imugene.