Nykode Therapeutics has designed a two-year plan to turn its fortunes around. Having lost a deal with Genentech—and with the future of a Regeneron pact uncertain—the Norwegian biotech is focusing on delivering phase 2 data in head and neck cancer before its cash runway runs out.
Genentech walked away from Nykode’s individualized cancer vaccine, VB10.NEO, in November. Nykode responded by setting out plans to lay off up to 60% of its employees. After cutting its costs, the biotech assessed how to use its remaining cash, concluding that a phase 2 trial of DNA-based vaccine VB10.16 in first-line recurrent or metastatic head and neck cancer is the best route to an inflection point.
VB10.16, also known as abipapogene suvaplasmid, is designed to turn the immune system against cancer cells that express two oncoproteins associated with the HPV16 virus. The virus accounts for most cases of HPV-positive head and neck cancer.
Nykode plans to randomize up to 100 patients to receive VB10.16 in combination with Keytruda or the Merck & Co. blockbuster as a monotherapy. An interim analysis of the first 33% of patients is planned for 2027.
The timeline positions Nykode to generate data by the end of its cash runway, which is forecast to run to 2028 or 2029, depending on the outcome of a tax case.
Oslo-based Nykode has studied VB10.16 in cervical cancer and has other programs in its pipeline, but its circumstances have forced a focus on how to generate value-driving data quickly.
“It's no secret ... that it has been a tough last 12 months for the ... Nykode company and the team,” Nykode CEO Michael Engsig said on an earnings call with investors Wednesday. “On the one hand, we were left with great technology, good data and a strong cash position. On the other hand, we had a disconnect between plans, inflection points and our cash runway.”
While the axing of the Genentech deal was the initial blow, Nykode is also contending with the potential loss of future revenues from Regeneron. The biotech has removed Regeneron-partnered programs from its updated strategy and financial forecasts and has entered into talks about the future of the alliance. Nykode has received no income from Regeneron this year.
The companies first joined forces in a multi-target license and collaboration agreement back in 2021.
Meanwhile, Nykode is paring back spending on VB10.NEO, the asset that Genentech dropped. The biotech plans to carry out “selected activities” to make the asset more attractive to potential buyers while relying on data drops from rivals to drum up interest in individualized neoantigen therapies.
The company says it has identified rival readouts in the next 18 months that could spur drugmakers to take another look at VB10.NEO.