Monalizumab is under clinical development by Innate Pharma and currently in Phase II for Small-Cell Lung Cancer. According to GlobalData, Phase II drugs for Small-Cell Lung Cancer have a 26% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Monalizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Monalizumab overview

Monalizumab (NN-8765, IPH-2201) is under development for the treatment of HER2-positive breast cancer, solid cancers including non-small cell lung cancer, small-cell lung cancer and coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The drug candidate is administered through intravenous and subcutaneous route. It is a first-in-class humanized IgG4 antibody that targets killer cell lectin-like receptor subfamily C member 1 (KLRC1, NKG2A). It was under development for the treatment of squamous cell carcinoma of the oral cavity, gastro-esophageal junction carcinoma and rheumatoid arthritis, high grade ovarian cancer, endometrial cancer, fallopian tube cancer, cervical cancer, esophageal and peritoneal cancer, hematological cancers like relapsed/refractory chronic lymphocytic leukemia (CLL), recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, or larynx) colorectal cancer.

Innate Pharma overview

Innate Pharma develops antibodies to treat cancer by harnessing the immune system. It offers Lumoxiti, a CD22-directed immunotoxin for the treatment of relapsed or refractory (r/r) hairy cell leukemia. The company is investigating Lacutamab, an anti-KIR3DL2 humanized cytotoxicity-inducing antibody for cutaneous T-cell lymphoma (CTCL), Monalizumab, an immune checkpoint inhibitor targeting solid tumors. Innate Pharma is also evaluating IPH5201, IPH5301, IPH6101, IPH6401, IPH6501 and IPH62 antibodies for the treatment of various tumors. It works in partnership with Sanofi SA, AstraZeneca Plc and other biopharmaceutical companies to develop its products. Innate Pharma is headquartered in Marseille, Provence Alpes Cote d’Azur, France.

For a complete picture of Monalizumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.