Beyond Cancer Ltd, the exempted company registered in Bermuda that is focused on developing ultra-high concentration nitric oxide for the treatment of solid tumours, has announced that the first patient was treated in a first-in-human phase one study to assess the safety and immune biomarkers of UNO therapy.

Ido Wolf, MD, head, oncology division, Tel Aviv Sourasky Medical Centre; professor of oncology, faculty of medicine, Tel Aviv University; and head, National Israeli Council for Prevention, Diagnosis and Treatment of Malignant Diseases, said: “UNO therapy is very promising given the local delivery and surprising speed and ease of administration.

“I am looking forward to completing this phase one study and assessing the potential for efficacy.”

Selena Chaisson, CEO of Beyond Cancer, said: “We are proud to announce today the important milestone of advancing our UNO therapy into the clinic.

“This is a critical step in our mission to provide cancer patients a therapeutic option that may prevent metastases and end relapse. We anticipate initial clinical data from this trial in early 2023.”

Jedidiah Monson, MD, chief medical officer of Beyond Cancer, added: “This open-label, first-in-human, single administration, phase one study is a promising advancement as a new approach towards treating solid tumours with nitric oxide.

“The study will evaluate the maximum tolerated dose (MTD), safety and immune biomarkers of UNO injection into solid tumours that are not amenable to, or have failed, standard treatment.”

Steve Lisi, chairman and CEO of affiliate Beyond Air Inc and chairman of Beyond Cancer, said: "Once again the Beyond Air team executes, this time in collaboration with our Beyond Cancer colleagues. The team’s tireless efforts over the past three years have led us to this day.

“We will continue our rapid development to determine what role UNO therapy may play in the fight against solid tumours.”

The company said the primary endpoints of the phase one study are the incidence and characteristics of adverse events, serious adverse events, dose-limiting toxicities and changes in safety parameters.

It said the dose for future studies will be determined based on the MTD with additional consideration for all available safety and biomarker data.

The company added that the secondary endpoints include standard efficacy measures of stable disease, partial response, complete response, overall response rate or confirmed disease progression status at the treatment site, as well as survival.