US-based immuno-oncology company Aulos Bioscience has announced the first patients have been dosed as part of a trial investigating avelumab, marketed as Bavencio by its original developer Merck KgaA (Merck), as a combination therapy in non-small cell lung cancer (NSCLC).
Operated in collaboration with Merck’s Swiss subsidiary Ares Trading, the Phase I/II study (NCT05267626) is investigating Aulos Bioscience’s AU-007 as a combination therapy for second-line treatment.
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The announcement follows after Aulos and Merck disclose a collaboration and supply agreement, which saw the former provided with the rights to use the treatment as part of its efforts to address cancer care through best-in-class interleukin-2 (IL-2) therapeutics.
The third and final part of the Phase I/II trial is evaluating avelumab in combination with AU-007 and low-dose, subcutaneous aldesleukin, an IL-2 therapy. Avelumab is described as a human anti-programmed death ligand-1 (PD-L1) antibody approved for use in multiple tumour types.
Aulos say that pre-clinical results detail strong anti-cancer activity, including complete tumour eradication, from AU-007 and a single loading dose of human IL-2 and an anti-PD-L1 surrogate of avelumab.
The Phase I/II study is currently enrolling patients with unresectable locally advanced or metastatic cancer at multiple clinical trial site locations in the US and Australia.
Previously, the company has announced positive Phase I and preliminary Phase II data from the trial at the Society for Immunotherapy of Cancer (SITC) 39th annual meeting. This data showed AU-007 and low-dose, subcutaneous aldesleukin to be clinically active in tackling melanoma.
Aulos Bioscience CEO Aron Knickerbocker said: “We are excited to move forward with evaluating this combination therapy in a clinical setting after seeing encouraging synergy with AU-007 and a surrogate model of avelumab in preclinical studies including complete elimination of established solid tumours.
“Avelumab’s profile, coupled with AU-007 and low-dose, subcutaneous aldesleukin, could potentially offer a new therapeutic option for patients with advanced or metastatic PD-L1+ non-small cell lung cancer that has progressed following first-line therapy with a checkpoint inhibitor,” Knickerbocker added.
Elsewhere in treatments utilising avelumab, Transgene’s stock has dropped after a Phase II trial of its therapeutic vaccine candidate TG4001 (tipapkinogene sovacivec) in combination with avelumab failed to meet its primary endpoint of improvement in progression-free survival (PFS) in solid tumours.
Meanwhile, Immutep has received approval from the Paul-Ehrlich-Institut (PEI), German Federal Institute for Vaccines and Biomedicines, to start its INSIGHT-005 Phase I trial of eftilagimod alpha (efti), along with avelumab for the treatment of metastatic urothelial carcinoma.
