Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1063 |
| INN | Monalizumab |
| Status | Clinical |
| Drug code(s) | NN8765, IPH-2201, NNC141-0100 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | NKG2A |
| Indications of clinical studies | Breast cancer, Non-small cell lung cancer, head & neck cancer (Phase 1/2), Chronic lymphocytic leukemia (Phase 1/2), Squamous Cell Carcinoma of the Oral Cavity (Phase 1/2), ovarian cancer, Rheumatoid Arthritis |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2011 |
| Start of Phase 2 | December 15, 2014 |
| Start of Phase 3 | October 02, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Novo Nordisk |
| Licensee/Partner | AstraZeneca, Innate Pharma |
| Comments about company or candidate | Nov 2024: The Phase 3 PACIFIC-9 trial (NCT05221840) run by AstraZeneca evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. This follows the Independent Data Monitoring Committee recommendation for the continuation of the Phase 3 PACIFIC-9 trial based on a pre-planned analysis. NCT05221840 Phase 3 study in NSCLC started in Feb 2022 recruting as of last update in May 2023. August 01, 2022 I Innate Pharma SA announced that a planned futility interim analysis of the INTERLINK-1 Phase 3 study sponsored by AstraZeneca did not meet a pre-defined threshold for efficacy. Based on this result and the recommendation of an Independent Data Monitoring Committee, AstraZeneca has informed Innate that the study will be discontinued. The INTERLINK-1 study, sponsored by AstraZeneca, evaluated monalizumab in combination with cetuximab vs. cetuximab in patients with recurrent or metastatic 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. April 2022: AstraZeneca has now dosed the first patient in its Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (PD-L1) in combination with monalizumab (NKG2A) or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy. NCT04590963 Phase 3 in Recurrent or Metastatic Head and Neck Cancer started in Oct 2020 On September 26, 2019 Innate Pharma SA announced that AstraZeneca will advance monalizumab into a Phase 3 randomized clinical trial evaluating monalizumab in combination with cetuximab in patients suffering from recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), and the companies will co-fund the trial. The trial initiation is expected in 2020, subject to regulatory and compliance approvals. NCT03822351 Phase 2 COAST study on NSCLC (combo with durvalumab) started in Dec 2018. Oct 2018: AZ exercised an option under its 2015 deal with Innate to gain full rights to checkpoint inhibitor monalizumab for oncology indications; the pharma also gained new options to license rights to Innate's preclinical anti-CD39 mAb IPH5201 and four yet-to-be-determined preclinical candidates. NCT02643550 Phase 1/2 study in head and neck cancer and NCT02671435 Phase 1 study in advanced solid tumors recruiting as of Aug 2018. NCT02557516 Phase 1/2 study in CLL recruiting as of Nov 2015. NCT02331875 Phase 1/2 study started in Dec 2014. As of Feb 2014, Innate Pharma has acquired full development and commercialization rights to the anti-NKG2A antibody. |
| Full address of company | Novo Alle 1, 2880 Bagsværd, Denmark Europe Denmark https://www.novonordisk.com/contact-us.html |
Immune checkpoint inhibitor. Monalizumab, a humanized IgG4, blocks the binding of NKG2A to HLA-E allowing activation of NK and cytotoxic T cell responses
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |