Our platform technology is based on engineering arenaviruses to carry and deliver virus-specific or tumor-specific genes to dendritic cells, which are natural activators of killer T cells, also known as cytotoxic T cells, or CD8+ T cells. We believe we are the first to reengineer arenaviruses for therapeutic purposes.

Our lead oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papillomavirus-16 positive (HPV16+) cancers. The Phase 1/2 clinical trial for HB-201 in patients with treatment-refractory HPV16+ cancers was initiated in December 2019; in October 2020, the alternating, sequential HB-202/HB-201 two-vector therapy was incorporated into the ongoing HB-201 Phase 1/2 trial. We expect to provide the next comprehensive Phase 1 program update including ongoing translational, biomarker, safety, dose escalation, and efficacy data in mid-2022; and initial Phase 2 HPV16+ combination data in head and neck squamous cell carcinoma (HNSCC) in 1st and 2nd line treatments arms in the second half of 2022. In November 2021, the U.S. Food and Drug Administration granted Fast Track designation to a combination of HB-201 or HB-201/HB-202 with pembrolizumab for the treatment of 1st-line advanced HPV16+ HNSCC.

Our lead infectious disease product candidate HB-101, a non-replicating-based prophylactic Cytomegalovirus (CMV) vaccine, is currently in a Phase 2 clinical trial in CMV-negative patients awaiting kidney transplantation from living CMV-positive donors as well as CMV-positive patients awaiting kidney transplantation from CMV-positive or -negative donors.

We have entered into a strategic partnership with Gilead Sciences, Inc., to accelerate development of additional infectious disease product candidates.

Hepatitis B Virus (HBV) Therapy Services

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