I-Mab has announced the dosing of the first subject in the Phase II clinical trial of efineptakin alfa (TJ107) plus pembrolizumab (Keytruda) in advanced solid tumour patients in China.

Claimed to be the first ever long-acting recombinant human interleukin-7 (rhIL-7), efineptakin alfa could improve T-lymphocytes by raising their functions and number.

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On combining with immune checkpoint inhibitors, such as programmed death ligand-1 (PD-L1) treatments, efineptakin alfa has a synergistic impact as it boosts the number of circulating anti-tumour T cells to suppress the tumour.

It was analysed as a single agent, as well as with checkpoint inhibitors for treating advanced solid tumours in the US, China and South Korea, with favourable clinical data.  

I-Mab obtained exclusive rights for efineptakin alfa from Genexine for its development and marketing in Greater China.

The trial will have a ‘basket’ design to incorporate particular tumour types such as triple-negative breast cancer (TNBC) and squamous cell cancer of the head and neck (SCCHN).

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I-Mab president Dr Andrew Zhu said: “The initiation of efineptakin alfa’s Phase II study is another example that I-Mab’s pipeline is not only innovative but also mature with a majority of clinical programmes being in the advanced clinical development stage.

“Efineptakin alfa is the world’s first rhIL-7 designed to cater to the therapeutic needs of cancer patients, so we are mindful of the importance of this therapy and are committed to expediting the clinical development of a potentially transformative solution for patients in need.”

Apart from this trial, efineptakin alfa is being analysed in another Phase II trial in lymphopenic patients with recently detected glioblastoma multiforme (GBM).

These subjects were already treated with standard concurrent chemoradiotherapy.

I-Mab plans to quickly progress the clinical development of efineptakin alfa to obtain approval in Greater China by leveraging these two trials.

Last December, the company dosed the first two participants in a Phase II dose expansion trial of its uliledlimab plus atezolizumab (Tecentriq) to treat ovarian cancer and other advanced or metastatic solid tumour patients in the US.