Vaccine Info

HB-201 HPV16+ Cancer Monotherapy

Authored by
Staff
Last reviewed
April 12, 2021
Fact checked by
Robert Carlson, MD

HB-201 HPV16+ Cancer Monotherapy Description

HB-201 monotherapy treats HPV16+ cancers is based on HOOKIPA's proprietary arenavirus platform. HB201 is designed to use an arenavirus backbone (LCMV for HB- 201) while expressing the antigen, an E7/E6 fusion protein derived from HPV16.

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.

HOOKIPA Pharma Inc. is using non-replicating (VaxWave®) and replicating (TheraT®) technologies to elicit directly within patients a powerful and durable response of antigen-specific killer T cells and antibodies thereby activating essential immune defenses against infectious diseases and cancers. We believe that our technologies can meaningfully leverage the human immune system for prophylactic and therapeutic purposes by eliciting killer T cell response levels not achieved by other published immunotherapy approaches.

The 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.

“We’re excited to see the quantity and quality of a targeted immune response, particularly the directly measured increase in HPV16+-specific CD8+ T cells, generated by a single dose of our lead oncology candidates, HB-201 or HB-202. As we are still exploring optimal dosing, these early responses are particularly encouraging,” said Joern Aldag, CEO of HOOKIPA, in a press statement issued on April 10, 2021. “We believe our novel arenavirus platform has the potential to introduce a new class of immunotherapeutics that could considerably advance how physicians care for people with HPV16+ cancers. Building on the early clinical results reported on HB-201 in December, we look forward to additional data read-outs from our first clinical oncology program in the coming months.”

Vienna, Austria-based HOOKIPA Pharma Inc. is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on a proprietary arenavirus platform that is designed to reprogram the body’s immune system.

HB-201 HPV16+ Cancer Monotherapy Indication

HB-201 monotherapy is an experimental therapy for patients with advanced HPV16+ metastatic 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, says the company.

HB-201 HPV16+ Cancer Monotherapy News

April 10, 2021 - HOOKIPA Pharma Inc. announced positive preliminary Phase 1 immunogenicity data for its lead oncology candidates, HB-201 and HB-202, to treat Human Papillomavirus 16-positive (HPV16+) cancers. The results are from an ongoing Phase 1/2 study currently investigating HB-201 as a single-vector therapy and HB-201 and HB-202 as an alternating two-vector therapy to treat advanced metastatic HPV16+ cancers. Data showed a strong antigen-specific T cell response after one dose of HB-201 or HB-202, based on direct Enzyme-Linked ImmunoSpot T cell analysis. Also, an analysis of the antigen-specific T cell response showed an increase in CD8+ T cells specific to HPV16+ cancer after a single dose of HB-201 (baseline 0% to 2.8% two weeks later) and HB-202 (baseline 0% to 8.1% two weeks later). Other preliminary immunogenicity data highlight immune system activation following a single dose of HB-201.

December 7, 2020 - HOOKIPA Interim Phase 1 Monotherapy Data of HB-201 for the Treatment of Advanced HPV16+ Cancers Shows Promising Anti-Tumor Activity and Favorable Tolerability. By targeting an antigen common to Human Papillomavirus 16-positive (HPV16+), HB-201 can be a tumor-agnostic therapy for all HPV16+ cancers.

HB-201 HPV16+ Cancer Monotherapy Clinical Trial

Clinical Trial NCT04180215:  A Study of TheraT® Vector(s) Expressing HPV 16+ in Patients With HPV 16+ Confirmed Cancers. This is a First in Human (FIH) (140 participants) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion. End Date: June 01, 2022

Clinical Trials

No clinical trials found