BeiGene pulls out of Leap of faith, letting option on immuno-oncology candidate lapse

Three years with a front-row seat for the development of DKN-01 have failed to persuade BeiGene to pull the trigger on a deal for the oncology drug candidate, leaving Leap Therapeutics looking for a new partner for the anti-DKK1 monoclonal antibody.

BeiGene secured an option to license the asset in Australia, New Zealand and Asia, excluding Japan, in return for $3 million upfront at the start of 2020. Since then, Leap has kicked off a clutch of clinical trials of DKN-01, including a BeiGene-partnered study that is testing the drug candidate in combination with the checkpoint inhibitor tislelizumab. But BeiGene has now pulled back from the program.

The agreement has expired, depriving Leap of a partnership that could have netted it up to $132,000 in option exercise fees and milestone payments. Leap “will look to identify a new strategic partner,” its CEO Douglas Onsi said in a statement.

While BeiGene has opted against licensing DKN-01, it is continuing to support the ongoing clinical trial that is testing the candidate in combination with its anti-PD-1 antibody tislelizumab. The new agreement positions BeiGene and Leap to keep collaborating on the first-line gastric cancer study. BeiGene will keep supplying tislelizumab for however long it takes to complete the phase 2 clinical trial.

Leap expects to complete enrollment in the 160-patient study toward the end of the year, with the initial response rate data scheduled for release as 2023 rolls into 2024. Progression-free survival results are due to be published later in 2024. Data from two other trials of DKN-01, which are testing the candidate with Avastin and Keytruda in other settings, are on the roster for release in 2023 and 2024.

The schedule gives Leap a shot at increasing enthusiasm for DKN-01 before it runs out of road. By buying Flame Biosciences, the biotech recently secured itself enough money to keep going into mid-2025, plus a clinical-phase antibody against the hot target CLDN18.2.

Shares in Leap fell 20% to 35 cents in premarket trading this morning.