Sierra Q1 Results.8 May 2019 13:58
SRA737:
•SRA737 is currently being evaluated in two Phase 1/2 clinical trials in patients with advanced cancer across multiple indications. The SRA737-01 trial is intended to evaluate SRA737's potential to induce synthetic lethality as monotherapy, while the SRA737-02 trial is intended to evaluate the combination of SRA737 potentiated by non-cytotoxic LDG. Sierra expects to report preliminary data from both trials at the 2019 ASCO Annual Meeting being held in early June 2019 .
•In addition, Sierra has designed clinical trials and has conducted preclinical research evaluating SRA737 in combination with other DDR-targeted agents, including poly ADP-ribose polymerase (PARP) inhibitors, as well as with immuno-oncology therapeutics, that could potentially guide the next planned wave of clinical development for this asset. Sierra has an agreement with Janssen Research & Development, LLC (Janssen), under which Janssen has agreed to supply the PARP inhibitor niraparib, facilitating the potential initiation of a PARP inhibitor combination trial with SRA737 for the treatment of prostate cancer. Sierra is currently evaluating the optimal timing to commence this trial within the context of its recently expanded portfolio.
•During the first quarter of 2019, Sierra reported preclinical data for SRA737+LDG, in combination with immunotherapy, in a late-breaking oral presentation at the AACR Annual Meeting 2019. In the study, SRA737+LDG demonstrated significant anti-tumor activity when combined with anti-PD-L1 in a mouse model of SCLC, resulting in durable tumor regressions. These findings provide a mechanistic basis for the growing body of evidence demonstrating a synergistic interplay between replication stress and anti-tumor immune responses and afford a compelling rationale for evaluating SRA737+LDG with immunotherapy in the clinic.