Innate Pharma: First Patient Dosed in Monalizumab Phase 3 Lung Cancer Clinical Trial Triggers $50M Payment From AstraZeneca
- First patient dosed in Phase 3 trial, PACIFIC-9, evaluating durvalumab in combination with monalizumab or oleclumab in patients with unresectable, Stage III non-small cell lung cancer
- Milestone payment further bolsters Innate’s cash position
Second Phase 3 monalizumab trial now initiated by
The purpose of the study, which is sponsored by
Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.
Dosing of the first patient in this trial has triggered a
“We are very pleased that our key late-stage asset, monalizumab, has progressed into a second Phase 3 trial with our partner,
Detailed results from the randomized COAST Phase 2 trial were published in the
“Durvalumab has transformed the treatment of patients with unresectable, Stage III NSCLC, and we’re excited by the promise of extending its benefit through novel combinations with two potential first-in-class monoclonal antibodies demonstrating strong clinical activity. Based on the stand-out results from COAST, we are pleased that the Phase 3 trial is underway, which we hope will bring new treatment options to patients and further increase the potential for long-term survival benefit in this setting,”
PACIFIC-9 is a Phase 3, randomised, double-blind, multicenter global study to determine the efficacy and safety of durvalumab alone or in combination with oleclumab or monalizumab+ in patients with unresectable, Stage III NSCLC
The first patient has been dosed in
Stage III NSCLC:
In 2020, an estimated 2.2 million people were diagnosed with lung cancer worldwide1. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2,3,4 Stage III NSCLC represents approximately one quarter of NSCLC incidence5.
Stage III (locally advanced) NSCLC is commonly divided into three subcategories (
The majority of Stage III NSCLC patients are diagnosed with unresectable tumours2,5.
Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.
NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies7.
The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies, including the Phase 2 NeoCOAST trial in the neoadjuvant early-stage setting.
About the Innate-AstraZeneca monalizumab agreement:
The financial terms of the agreement include potential cash payments up to
For any commercialized oncology indication,
Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.
Innate is a pioneer in the understanding of natural killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with
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2 Provencio M, et al. Inoperable Stage III Non-Small Cell
3 Cheema PK, et al. Perspectives on Treatment Advances for Stage III Locally Advanced Unresectable Non-Small-Cell
5 EpiCast Report: NSCLC Epidemiology Forecast to 2025. GlobalData. 2016.
6 ASCO. Cancer.net.
7 André et al, Cell 2018