Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 112

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 4
Chunk 112
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 with relapsed/refractory multiple myeloma (R/R MM) after ≥2 prior lines of therapy.
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The primary objective of the Phase 1 part of the PAPILIO-1 study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the study is to evaluate the efficacy of GLPG5301, as measured by the Objective Response Rate (ORR). Secondary objectives for both Phase 1 and Phase 2 include further assessment of the safety of GLPG5301, additional efficacy endpoints, including assessment of Minimal Residual Disease (MRD), as well as the feasibility of decentralized manufactured GLPG5301 in R/R MM patients. Each enrolled patient will be followed for 24 months. During Phase 1, up to 2 dose levels will be evaluated and at least 12 patients will be enrolled to establish the recommended Phase 2 dose. Approximately 30 additional patients will be enrolled in the Phase 2 part of the study to further evaluate the safety and efficacy of GLPG5301.
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The Phase 1 part of the PAPILIO-1 Phase 1/2 study is currently recruiting patients. In 2024, we submitted a protocol amendment to the European regulatory authorities following one observed case of Parkinsonism and resumed enrolment in the Phase 1 part of the PAPILIO-1 Phase 1/2. Upon completion of Phase 1 and analysis of the data, We will evaluate the most appropriate development strategy and next steps. 
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We aim to present Phase 1 data at a future medical conference.
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  4.    Uza-cel: MAGE-A4 directed TCR T-cell therapy candidate, co-expressing CD8α
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<{self.tag} alt="{self.alt}" src="{self.src}"><{self.tag} alt="{self.alt}" src="{self.src}">In May 2024, Galapagos signed a clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4, and co-expressing the CD8α co-receptor, for head and neck cancer, and potential future solid tumor indications, using Galapagos’ cell therapy manufacturing platform. Under the terms of the agreement, Adaptimmune will receive initial payments totaling $100 million, option exercise fees of up to $