Iovance Biotherapeutics has dosed the first participant and completed the safety observation period in the Phase I/II IOV-GM1-201 trial of IOV-4001, a genetically modified, tumour-infiltrating lymphocyte (TIL) therapy.

The first-in-human study has been designed for evaluating IOV-4001’s efficacy and safety in patients with previously treated metastatic non-small cell lung cancer (NSCLC) or advanced melanoma.

It is enrolling adult participants with advanced NSCLC or unresectable or metastatic melanoma.

IOV-4001 uses a gene-editing technology called TALEN, which was licensed from Cellectis, for inactivating the gene coding for the PD-1 protein.

Iovance believes that inactivating the PD-1 protein could improve the TIL therapy’s antitumor activity, which enables the direct targeting and killing of tumour cells.

Found on T cells, the PD-1 protein normally works as an ‘off switch’ for preventing T cells from attacking other cells in the body.

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It binds to the PD-L1 protein, which is found on normal and cancerous cells, thereby shutting down a T cell attack.

Iovance chief medical officer Friedrich Graf Finckenstein said: “Dosing the first patient with IOV-4001 is an important first step in providing proof-of-concept for delivering genetically modified TIL therapy to solid tumour patients with significant unmet needs and few treatment options.

“We look forward to dosing the next patient. This trial may also support our broader platform of genetically modified Iovance TIL therapies to potentially address difficult-to-treat solid tumour cancers.”

The company stated that genetically modified IOV-4001 has the potential to become an optimised, next generation TIL therapy to treat several solid tumour cancers.

In 2020, Iovance entered into a research collaboration and exclusive worldwide license agreement with Cellectis for the TALEN technology to develop genetically edited TIL to create more effective therapeutics for cancer.