SELLAS Life Sciences Group Inc (NASDAQ:SLS) announced on Friday that an independent data safety monitoring board has concluded that the final data from the Phase 2b study of trastuzumab in breast cancer patients showed that there was an incremental improvement in the outcomes and statistics with a longer median follow-up.
The final analysis showed no new safety signals and continued to show no difference in cardiotoxicity. The DSMB confirmed that the final analysis continues to identify patients with triple negative breast cancer (TNBC) as the key target patient population for the drug.
The DSMB had previously recommended to expeditiously seek regulatory guidance by the US Food and Drug Administration (FDA) for further development of the combination drugs in TNBC, a population with a large unmet medical need.
Shares of SELLAS fell 6.39% to $1.685 by midsession on Friday, having touched a session peak of $1.90.
READ: Maxim reiterates Buy rating after SELLAS Life Sciences' cancer vaccine gets Fast Track designation
The company will host a call on October 22 following its presentation at the European Society for Medical Oncology’s 2019 annual meeting.
The FDA has granted Fast Track designation to its second lead product candidate, galinpepimut-S (GPS), which is licensed from the Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT-1) protein present in an array of tumor types.
SELLAS is a clinical-stage biopharmaceutical company focused on novel cancer immunotherapeutics for a broad range of cancer indications.
Reporting by Rene Pastor, contact him at rene.pastor@proactiveinvestors.com