BioNTech SE (BNTX)

[jondoeuk]

Data from the ongoing PhI/II in patients with advanced solid tumours were presented at SITC in 2022 [1] and 2021, where it showed clinical activity, either as a single agent or in combination with Keytruda, particularly in those who progressed on prior checkpoint blockade.

ONC-392 received Fast Track designation from the FDA as a monotherapy for immunotherapy-resistant NSCLC. The data as a monotherapy for anti-PD-1 resistant NSCLC supports the initiation of a randomised PhIII trial which will evaluate ONC-392 as monotherapy against the current SOC (docetaxel) in that that could open in the next few months. Also, it is currently also being evaluated in an additional PhII trial as a combination therapy with Keytruda in platinum-resistant ovarian.

Refs:
1 https://www.globenewswire.com/news-release/2022/11/07/2549654/0/en/OncoC4-to-Present-Positive-Data-from-Ongoing-Phase-1-2-PRESERVE-001-Trial-of-ONC-392-in-Combination-with-pembrolizumab-at-SITC-2022.html
2 https://www.globenewswire.com/en/news-release/2021/11/09/2330344/0/en/OncoC4-Inc-Reports-Phase-Ia-Data-on-Safety-and-Clinical-Activities-of-ONC-392-Nextgen-Anti-CTLA-4-Monotherapy-for-Stage-IV-Solid-Tumors.html