Innate Pharma to Present Additional Efficacy Data for Monalizumab in Combination With Cetuximab in Head and Neck Cancer at the ESMO Immuno-Oncology Virtual Congress

Rhea-AI Summary

Innate Pharma (Euronext: IPH, Nasdaq: IPHA) announced upcoming data presentation for its lead candidate, monalizumab, at the ESMO Immuno-oncology Virtual Congress from Dec. 9-12, 2020. The presentation will focus on a Phase 2 study of monalizumab in combination with cetuximab for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M SCCHN) previously treated with platinum-based chemotherapy. AstraZeneca recently initiated a Phase 3 trial, INTERLINK-1, for the same combination. The agreement with AstraZeneca includes potential payments of up to $1.275 billion.

Phase 2 expansion cohort data supports ongoing Phase 3 trial

MARSEILLE, France, Dec. 03, 2020 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that it will present additional data on its lead partnered asset, monalizumab, at the ESMO Immuno-oncology Virtual Congress being held from Dec. 9-12, 2020. Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8⁺ T cells and NK cells.

The presentation will include updated results from a Phase 2 study investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) who have been previously treated with a platinum-based chemotherapy and PD-(L)1 inhibitor.

The e-poster presentation (#81P, abstract #235) entitled, “Monalizumab in combination with cetuximab post platinum and anti-PD-(L)1 in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Updated results from a phase 2 trial” will be available on Dec. 9^th.

As recently announced, AstraZeneca dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in R/M SCCHN patients who have been previously treated with a platinum-based chemotherapy and PD-(L)1 inhibitors.

About INTERLINK-1:
Sponsored by AstraZeneca, 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 a platinum-based chemotherapy and PD-(L)1 inhibitor (“IO-pretreated”).

The primary endpoint is overall survival (OS) with secondary endpoints including progression-free survival (PFS), overall response rate (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 April 24, 2015, the Company signed a codevelopment and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab.

The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma. Including the $50 million payment triggered by dosing the first patient in the Phase 3 INTERLINK-1 clinical trial, Innate Pharma has received $400 million to date.

AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

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 October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies.

About Cetuximab:
Cetuximab (Erbitux^®) 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:
Innate Pharma S.A. is a commercial stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.

Innate Pharma’s commercial-stage product, Lumoxiti, in-licensed from AstraZeneca in the US, EU and Switzerland, was approved by the FDA in September 2018. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia. 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 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 Marseille, France, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.
Learn more about Innate Pharma at www.innate-pharma.com

Information about Innate Pharma shares:

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 French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

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 Innate Pharma in any country.

For additional information, please contact:

Investors Innate Pharma         Tel.: +33 (0)4 30 30 30 30 investors@innate-pharma.com

Media Innate Pharma Tracy Rossin (Global/US) Tel.: +1 240 801 0076 Tracy.Rossin@innate-pharma.com ATCG Press Marie Puvieux (France) Tel.: +33 (0)9 81 87 46 72 innate-pharma@atcg-partners.com

FAQ

What is the significance of the upcoming presentation by Innate Pharma at the ESMO congress?

Innate Pharma will present updated data on monalizumab combined with cetuximab for R/M SCCHN, highlighting its potential effectiveness.

What are the details of the INTERLINK-1 clinical trial?

INTERLINK-1 is a Phase 3 trial evaluating monalizumab with cetuximab for R/M SCCHN patients previously treated with platinum-based agents, enrolling about 600 participants.

When will the monalizumab presentation take place at the ESMO Congress?

The presentation is scheduled for December 9, 2020, as part of the ESMO Immuno-oncology Virtual Congress.

How much has Innate Pharma received from AstraZeneca to date?

Innate Pharma has received $400 million to date from AstraZeneca, which includes a $50 million payment triggered by the initiation of the Phase 3 trial.

What potential financial terms are included in the agreement between Innate Pharma and AstraZeneca?

The agreement could yield up to $1.275 billion in potential cash payments, with Innate receiving royalties on net sales globally.