Milestone payment further bolsters Innate’s cash position
INTERLINK-1 represents first Phase 3 study examining IO approach in R/M SCCHN patients who have been treatedwith a platinum-based therapy and PD-(L)1 inhibitor
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 Phase 3 with our partner, AstraZeneca. The launch of INTERLINK-1 represents an important financial milestone for Innate, as it triggers a
"Patients with head and neck cancer previously treated with a checkpoint inhibitor are a newly-defined patient population that is currently underserved. We look forward to evaluating the novel combination of monalizumab and cetuximab in the Phase 3 INTERLINK-1 study," said
Presented at the ESMO 2019
During the ASCO20 Virtual Scientific Program, Innate presented preliminary data from its Phase 2 expansion cohort evaluating monalizumab and cetuximab in IO-pretreated patients (cohort 2), which confirmed an overall response rate (ORR) of 20% across 40 patients enrolled. Overall, the combination therapy data to date supports the expedited development of monalizumab and cetuximab in this indication. Innate intends to provide an update on this data at an upcoming scientific meeting.
About INTERLINK-1:
INTERLINK-1 is a global, multi-center, randomized, double-blind Phase 3 study of monalizumab and cetuximab vs. placebo and cetuximab that will enroll approximately 600 patients with recurrent or metastatic head and neck squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors (“IO-pretreated”).
The primary endpoint is overall survival (OS) with secondary endpoints including progression-free survival (PFS), ORR, duration of response (DoR), safety and quality of life. Additional details on the INTERLINK-1 clinical trial can be found here.
About the Innate-AstraZeneca monalizumab agreement:
On
The financial terms of the agreement include potential cash payments up to
AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in
About Monalizumab:
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 re-establish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies (André et al, Cell 2018).
AstraZeneca obtained full oncology rights to monalizumab in
About Cetuximab:
Cetuximab is an anti-EGFR monoclonal antibody. NK cells mediate cetuximab-induced antibody dependent cellular cytotoxicity (ADCC) against SCCHN. Genetic and preclinical experiments suggest that ADCC can be enhanced by NK-stimulators.
The activity of cetuximab as a single agent in recurrent and/or metastatic SCCHN is limited, with a 12.6% overall response rate, a median time to progression of 2.3 months and a median overall survival of 5.8 months (Vermorken et al, JCO 2007).
About
Innate Pharma’s commercial-stage product, Lumoxiti, in-licensed from AstraZeneca in the US, EU and
Innate has been 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 AstraZeneca.
Based in
Learn more about
Information about
ISIN code Ticker code LEI | FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 |
Disclaimer on forward-looking information and risk factors:
This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995.The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts, the Company’s continued ability to raise capital to fund its development and the overall impact of the COVID-19 outbreak on the global healthcare system as well as the Company’s business, financial condition and results of operations. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in
For additional information, please contact:
Investors Tel.: +33 (0)4 30 30 30 30 investors@innate-pharma.com | Media Tel.: +1 240 801 0076 Tracy.Rossin@innate-pharma.com Marie Puvieux ( Tel.: +33 (0)9 81 87 46 72 innate-pharma@atcg-partners.com |
Source:
2020 GlobeNewswire, Inc., source