Erasca Inc. (ERAS), a clinical-stage precision oncology company, on Monday released positive preliminary Phase 1 AURORAS-1 dose-escalation data evaluating ERAS-0015 for targeting RAS-mutant solid tumours.
ERAS-0015 is an investigational, oral, highly potent, pan-RAS molecular glue that inhibits RAS signalling to treat RAS-mutant solid tumors.
The Phase 1 AURORAS-1 dose-escalation trial and the JYP0015M101 Phase 1 dose-escalation trial in China evaluated the efficacy, safety, and tolerability of ERAS-0015.
Preliminary data indicated well-behaved pharmacokinetics with a pharmaceutical active dose (PAD) of 16-32 mg, and a maximum administered dose (MAD) of 40 mg. The pharmacodynamics study of the drug showed a substantial decrease in KRAS G12X circulating DNA (ctDNA).
ERAS-0015 showed good efficacy, with an objective response rate (ORR) of 62%-75% across varied dose cohorts in patients with KRAS G12X non-small cell lung cancer (NSCLC).
The ORR was 40%-50% across varied dose cohorts in patients with KRAS G12X pancreatic ductal carcinoma (PDAC).
Based on the preliminary Phase 1 dose escalation data, 24 mg and 32 mg QD were selected as the go-forward monotherapy recommended doses for expansion.
ERAS-0015 also demonstrated good safety and tolerability as monotherapy and shows potential for combination with Panitumumab.
The company plans to release complete data from the monotherapy expansion and combination AURORAS-1 dose escalation trial by the first half of 2027.
Preliminary data from the Phase 1 BOREALIS-1 trial of ERAS-4001 in KRAS-mutant solid tumours are expected in the second half of this year.
ERAS closed Monday at $19.15, down 10.93%. In the overnight market, shares are trading at $12.94, down 32.43%
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