Heat Biologics Announces Strong Efficacy of HS-110 Combined with Opdivo in Lung Cancer Immunotherapy
Nov 25, 2019 14:14
CST Updated
14:14
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November 25, 2019 News /BioValleyBIOON/ -- Heat Biologics is a biopharmaceutical company dedicated to developing immunotherapies designed to activate patients’ immune systems against cancer by leveraging CD8+ “killer” T cells.
Recently, the company at the American Association for Cancer Research (AACR) oncologyImmunologyand immunotherapy specificallyMeetingannounced the T-cell activation cell therapy HS-110 in combination with Bristol-Myers SquibbTumorPhase II Study of Immunotherapy Opdivo (Opdivo, Generic Name: Nivolumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)Clinical TrialsTop-line Data for Cohort A.
HS-110 is Heat Company’s first biological candidate product in its portfolio of patented immunotherapies, designed to stimulate patients’ own T cells to attack cancer. HS-110 is an allogeneic cell-based immunotherapy that comprises a broad range of known targets prevalent in a high proportion of NSCLC patients.TumorAntigen; this cell system contains gp96 immunoglobulin and is designed to enable cells to express secretory gp96.
Secreted gp96, as a chaperone molecule, induces responses against those expressed by HS-110TumorCellular Immune Response to Antigens. gp96 is a unique chaperone molecule that can activate MHC, upregulate T-cell co-stimulation, and deliver chaperoned antigens to antigen-presenting cells (APCs), ultimately resulting in a CD8+ T cell-mediated immune response.
Cohort A enrolled only patients who had previously received treatment but had never received checkpoint inhibitors (CPIs). The results presented at the meeting are as follows:
The results presented at the conference showed that the median overall survival (mOS) was 16.9 months (with 50% of patients still alive at a median follow-up of 17 months), which is favorable compared to the mOS of 12.2 months reported for Opdivo monotherapy in the CheckMate-057 study conducted in a similar patient population.
Furthermore, the median overall survival (mOS) in patients who experienced injection site reactions (ISR) (i.e., ISR-positive patients) was 42.1 months (95% CI: 15.8–42.1), whereas the mOS in ISR-negative patients was 5.9 months (95% CI: 1.4–11.6). Compared with the ISR-negative group, the ISR-positive group showed statistically significant improvements in progression-free survival (PFS) and mOS (PFS: HR=0.51, p=0.042; mOS: HR=0.14, p<0.0001).
Prospective analysis of PD-L1-negative and PD-L1-positive patients showed mOS of 16.9 months (95% CI: 5.5–unk) and 42.1 months (95% CI: 1.6–42.1), respectively.
The objective response rate (ORR) assessed according to the immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) was 22%, the disease control rate (DCR) was 48%, and 46% of patients experiencedTumorReduction. During combination therapy, patients who achieved stable disease or disease improvement showed a statistically significant decrease in peripheral blood T-cell subsets relative to baseline levels.
Dr. Jeff Hutchins, Chief Scientific and Operating Officer of Heat Biologics, stated, “The data from Cohort A are highly encouraging and build upon our recently announced data from Cohort B, in which patients previously treated with checkpoint inhibitors were re-challenged with the combination of HS-110 and Opdivo. Of particular interest in Cohort A is a prospectively defined subset of PD-L1–positive patients, who demonstrated a median overall survival (mOS) of 42.1 months (95% CI: 15.8–42.1). This finding is especially notable when compared with overall survival rates reported in the literature for first- or second-line monotherapy with checkpoint inhibitors.”
Currently, Heat Biologics has completed the combination of HS-110 with Bristol-Myers Squibb’s oncology immunotherapy Opdivo (Opdivo, generic name: nivolumab) or Merck & Co.TumorPhase II Study of Immunotherapy Keytruda (Keytruda, generic name: pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)Clinical Trialpatients were enrolled. Its subsidiary, Pelican Therapeutics, focuses on the development of costimulatory monoclonal antibody and fusion protein therapies designed to activate the immune system. Heat Biologics also has multiple preclinical projects at various stages of development. (Bioon.com)