Gilead, Pionyr Immunotherapeutics change 2020 exclusive option agreements

Pionyr Immunotherapeutics announced that Pionyr and Gilead Sciences have mutually agreed to change their 2020 exclusive option agreements. Gilead has waived its exclusive option to acquire Pionyr and certain other rights under the 2020 agreements. Gilead will retain its 49% equity stake in Pionyr as well as its right, under certain conditions, to review new data as it emerges. Pionyr is now free to pursue fundraising and partnering opportunities as part of its ongoing strategy. Pionyr is continuing Phase 1b development of two monoclonal antibody drugs targeting TREM1 and TREM2 and is poised to file an IND this year for a third program targeting MARCO. TREM2, TREM1 and MARCO represent novel targets present on distinct populations of myeloid cells in the tumor microenvironment associated with suppression of the immune response to multiple tumor types. In Phase 1a and 1b studies, PY314 and PY159 have demonstrated encouraging safety and tolerability both alone and in combination with pembrolizumab warranting further clinical investigation. PY314, PY159 and PY265 are first-in-class assets that target these cellular populations to enhance anti-tumor immunity. In 2020, Gilead paid $275M for its equity stake in Pionyr and agreed to fund Pionyr’s clinical and research activities in exchange for an exclusive option to acquire Pionyr for a pre-set price and contingent payments. As part of this agreement, Gilead waives its exclusive option to acquire Pionyr. Pionyr will be responsible for ongoing development of its pipeline, which includes PY159, PY314 and PY265. The company has the resources to advance its pipeline for the next two years. Within that timeframe, Pionyr will continue enrollment in Phase 1b expansion cohorts for both PY159 and PY314 in the refractory setting and is planning to add new frontline cohorts for both candidates. Pionyr has also completed IND-enabling studies for PY265 and will be ready to file an IND for that program in 2023.