SELLAS Life Sciences Group, Inc. announced results from a preplanned analysis of immunologic responses in the cohort of patients with triple negative breast cancer (TNBC) from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of nelipepimut-S (NPS) +/- trastuzumab (Herceptin®) targeting HER2 low-expressing breast cancer patients. 

"Effective adjuvant/maintenance therapy strategies are urgently needed to prevent recurrence or to prolong remission in patients with TNBC after successful frontline standard therapy for early-stage disease. In this setting, immune-directed therapy with NPS, a peptide vaccine targeting HER2, a protein expressed at low levels in TNBC, along with trastuzumab, led to high rates of antigen-specific immunization by both ex vivo and in vivo validated measures, corroborating the immunobiological synergy between these two agents," said Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Phase 2b study.

"These ex vivo and in vivo resultsin TNBC patients, particularly the newly discovered correlation between mounting an immune response and remaining clinically relapse-free over time, provide a solid mechanistic rationale for the previously observed clinically meaningful and statistically significant prolongation in disease-free survival (DFS), and the significant decrease in the frequency of relapses identified by standard clinical follow-up, in favor of NPS plus trastuzumab," said Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. 

"As we continue discussions with potential partners and the FDA on this promising program, we remain excited with these data demonstrated in the TNBC population," added Dr. Stergiou.

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