NEW YORK – BridgeBio Pharma on Thursday said it is planning to file an investigational new drug application this year seeking permission from the US Food and Drug Administration to begin human trials of BBO-8520, its first therapeutic candidate targeting RAS.
In a release on its Q2 2023 financial performance, Palo Alto, California-based BridgeBio said it is on track to file an IND for BBO-8520 and take it into the clinic later this year. The drug, a KRASG12C(ON) inhibitor that blocks both the GTP-bound "on" and GDP-bound "off" conformations of KRAS, is one of three investigational drugs targeting the RAS pathway in BridgeBio's pipeline.
Additionally, the firm has selected a therapeutic candidate from within its PI3Kα:RAS breaker program to take into the clinic. BridgeBio expects to file an IND for that candidate, which blocks RAS driven by PI3Kα, in 2024. It also expects to select a clinical development candidate from its pan-KRAS program in late 2023 or early 2024.
Bristol Myers Squibb last year exclusively licensed BridgeBio's SHP2 inhibitor BBP-398, which is under development in MAPK- and RAS-driven cancers, in a deal worth up to $905 million. BBP-398 is being tested in several ongoing Phase I/II trials, including with BMS's checkpoint inhibitor Opdivo (nivolumab) and Amgen's KRAS inhibitor Lumakras (sotorasib) in KRAS-mutant tumors.
BridgeBio doesn't have any commercialized products, and its revenues are largely attributable to license fees and services it provides under its agreement with BMS for BBP-398. For the three months ending June 30, BridgeBio reported $1.64 million in revenue compared to $73.7 million in Q2 2022. In Q2 2023, the company made money mostly from services it provided in the BMS deal, while during the same period last year, the company made money from both licensing and services in this deal. The firm reported a net loss in Q2 2023 of $160.7 million, or $.98 per share, compared to $2.6 million, or $.07 per share. At the end of Q2, BridgeBio had $353.2 million in cash, cash equivalents, marketable securities, and short-term restricted cash.