On January 28, 2022 Imugene (ASX: IMU) reported a new clinical trial supply agreement with Roche to evaluate the safety and efficacy of Imugene’s PD1-Vaxx, a B-cell activating immunotherapy, in combination with atezolizumab (Tecentriq), an immune checkpoint inhibitor targeting PD-L1, in patients with non-small cell lung cancer (NSCLC) (Press release, Imugene, JAN 28, 2022, View Source [SID1234607523]).
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The objectives of the phase 1b trial, "An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1 Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab, in Adults with Non-Small Cell Lung Cancer," are to determine safety, efficacy, and optimal dose of PD1-Vaxx in combination with atezolizumab as either first-line therapy in ICI treatmentnaïve 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 with ongoing clinical results 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 combination of two monoclonal antibodies, PD1-Vaxx has the advantage that it 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.
"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 we are looking forward to evaluating PD1-Vaxx with atezolizumab in ICI treatment-naïve and pretreated NSCLC patients." said Leslie Chong, Managing Director & Chief Executive Officer of Imugene.
Imugene and Roche have entered into a supply agreement for a period of up to five years for the supply of atezolizumab. Imugene will be the sponsor of the study and will fund the clinical study from existing budgets and resources. Roche will supply atezolizumab for the duration of the study. In accordance with the terms of the supply agreement, all data generated in the performance of the study shall be the property of Imugene as the sponsor and 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.
About NSCLC
Lung cancer is one of the leading causes of cancer death globally Each year 1.8 million people die as a
result of the disease; this translates into more than 4,900 deaths worldwide every day. Lung cancer
can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type,
accounting for around 85% of all cases.