The trial will enrol 12 to 24 subjects with immune checkpoint inhibitor refractory non-small cell lung cancer. Credit: Atlas of Pulmonary Pathology / Flickr (Creative Commons).

TILT Biotherapeutics and MSD (Merck) have entered a clinical trial collaboration and supply agreement for an oncolytic immunotherapy candidate, TILT-123, for non-small cell lung cancer (NSCLC).

Under the alliance, the companies will carry out a Phase I trial of TILT-123 plus Keytruda (pembrolizumab) in immune checkpoint inhibitor refractory NSCLC patients.

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The dose escalation, open-label trial will enrol 12 to 24 subjects.

This trial is built on emerging findings on TILT-123 presently in trials for various indications, where it showed promising intravenous usability results.

A lead asset of TILT, TILT-123 is a 5/3 chimeric serotype oncolytic adenovirus with two human cytokines, TNF alpha and IL-2.

In pre-clinical cancer models in vivo, the therapy candidate was found to offer a complete response rate.

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Keytruda is an anti-PD-1 therapy of MSD.

TILT Biotherapeutics CEO Akseli Hemminki said: “We already have clinical trials running in Europe and the USA in several cancer types, including ovarian cancer, head and neck cancer, and melanoma.

“We are planning several more, one of which is this new collaboration in NSCLC with our collaborator MSD.

“Overall, our armed oncolytic viruses are showing potential in the clinic to increase the anti-tumour benefits of checkpoint inhibitors for a range of cancers where there is a pressing need for better therapies.”

Apart from NSCLC, the companies are assessing TILT-123 plus Keytruda for ovarian cancer.

Merck KGaA and Pfizer Alliance are also assessing the therapeutic impact of TILT-123 plus Avelumab (Bavencio) for head and neck cancer.

TILT and Biotheus entered another collaboration in 2019 to develop and market TILT-123 in Greater China.

In December last year, the US Food and Drug Administration placed a hold on clinical trials of Merck’s (MSD) islatravir for human immunodeficiency virus 1 (HIV-1) treatment.

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