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Human Papillomavirus (HPV) - associated head and neck cancers

Human Papillomavirus, or HPV, is estimated to cause about 5% of the worldwide burden of cancer including approximately 99% of cervical cancers, 25% to 60% of head and neck cancers, 70% of vaginal cancers and 88% of anal cancers. The majority of these cancers are caused by the HPV serotype 16. While most infections with HPV are cleared from the body with no lasting consequences, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. The expression of these proteins can lead to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.

Our solution: HB-201 and HB-202
Both HB-201 (LCMV) and HB-202 (PICV) are replicating product candidates expressing a non-oncogenic but highly antigenic E6/E7 fusion protein from HPV16. In animal models, HB-201 was observed to be highly immunogenic, resulting in a robust CD8+ T cell response. Based on the levels of antigen-specific CD8+ T cells induced by HB-201 in preclinical models, notably when compared to the levels induced by other approaches including adoptive cell therapies, as observed in separately designed and conducted third-party clinical trials, we believe that HB-201 monotherapy has the potential to provide therapeutic benefit to patients across the broader HPV16+ cancer setting. We have observed strong immunogenicity and robust anti-tumor activity in mouse models for HB-201 alone as well as for the sequential administration of HB-201 and HB-202.

We initiated a Phase 1/2 clinical trial for HB-201 in people with treatment-refractory HPV16+ cancers in December 2019 and expect the next data read-out by mid-2021. In October, 2020 we dosed our first patient with HB-202, which is part of a sequential alternating regimen of HB-202/HB-201 for the treatment of HPV16+ cancers in the ongoing HB-201 Phase 1/2 trial. We expect to provide interim safety, dose escalation, and efficacy data on the HB-202/HB-201 arm in mid-2021.

* Identifier: NCT04180215

Prostate Cancer

Prostate Cancer is the most common cancer in American men. In 2018 in the US alone there were 164,000 men diagnosed with prostate cancer. An estimated 1.1 million men worldwide were diagnosed with prostate cancer in 2012, accounting for 15% of all cancers diagnosed in men, with almost 70% of the cases (759,000) occurring in more developed regions. With an estimated 307,000 deaths in 2012, prostate cancer is the fifth leading cause of death from cancer in men (6.6% of the total men deaths).  In 2018 in the US alone there were 164,000 men diagnosed with prostate cancer with 30,000 deaths, representing an annual mortality rate close to 10%. Despite significant progress in the treatment of prostate cancer, mainly through the targeting of the androgen pathway, significant work remains. Metastatic hormone resistant prostate cancer (mHRPC) is defined as prostate cancer that has spread from its original location to other parts of the body.

Our solution: HB-300

We are developing our most advanced self-antigen project in this area, HB-300, as a replicating technology based product candidate in metastatic, hormone-resistant prostate cancer. Prostate cancer provides a unique treatment opportunity for immunotherapy because prostate cancer cells express a number of tumor-specific antigens that serve as potential targets. HB-300 targets three of these antigens: prostatic acid phosphatase (PAP), prostate specific antigen (PSA), and prostate specific membrane antigen (PSMA).