Histopathologic image illustrating well differentiated squamous cell carcinoma in the excisional biopsy specimen. Credit: KGH via Wikipedia.

GlaxoSmithKline (GSK) has decided to stop the enrolment of patients in Phase II INDUCE-3 trial of feladilimab for PD-L1 positive recurrent locally advanced or metastatic head and neck squamous cell carcinoma (PD-L1 HNSCC) treatment.

Feladilimab is an investigational inducible T cell co-stimulatory (ICOS) agonist.

The latest move follows a recommendation from the Independent Data Monitoring Committee and will also include discontinuation of the treatment with feladilimab.

The INDUCE-3 study is evaluating feladilimab plus pembrolizumab as compared with placebo plus pembrolizumab in PD-L1 HNSCC patients.

GSK will also stop the INDUCE-4 phase II trial analysing feladilimab versus placebo plus pembrolizumab and chemotherapy.

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The company will analyse the totality of the data for understanding the impact on feladilimab’s overall clinical development programme.

The INDUCE-3 and INDUCE-4 trials are carried out as part of an agreement between GSK and Merck.

In a separate development, RegenxBio has dosed the first patient in Cohort 3 of the ongoing Phase I/II trial of RGX-121 for treating Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome, in patients aged up to five years old.

An investigational one-time gene therapy, RGX-121 can potentially deliver the gene that encodes the iduronate-2-sulfatase (I2S) enzyme using the AAV9 vector.

In the open-label, dose-escalation trial being carried out at four clinical centres in the US and Brazil, three dose levels of RGX-121 administered directly to the cerebrospinal fluid (CSF) will be analysed.

Safety and tolerability of RGX-121 will form the study’s primary endpoint, while additional endpoints include the effect of RGX-121 on biomarkers of I2S enzyme activity in the CSF, serum and urine; neurocognitive development; and other outcome measures.

REGENXBIO chief medical officer Steve Pakola said: “We are pleased with our continued progress in the Phase I/II trial of RGX-121 as we increase the dose level to further our understanding of the potential treatment effects, including potential systemic benefit for patients.”

Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.

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