On October 29, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported the first patient dosed with HB-202, a replicating arenavirus therapy based on the Pichinde Virus (PICV) (Press release, Hookipa Pharma, OCT 29, 2020, View Source [SID1234569371]). HB-202 is part of a sequential alternating regimen of HB-202/HB-201 for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers in the ongoing HB-201 Phase 1/2 trial (NCT04180215).
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"We are excited to expand our ongoing Phase 1/2 trial in HPV to explore the potential of combining HB-202 and HB-201 as an alternating two-vector therapy to enhance and focus the immune response against HPV16+ cancers," said Joern Aldag, Chief Executive Officer of HOOKIPA. "HPV-associated cancers remain an area of unmet need and a key focus for our oncology efforts. The start of this HB-202/HB-201 arm of our trial is an important achievement in our clinical development of improved therapeutics for people with HPV16+ cancers."
HB-202 and HB-201 are engineered using HOOKIPA’s replicating arenaviral vector platform. They are designed to use different arenavirus backbones (PICV for HB-202 and LCMV for HB- 201), while expressing the same antigen, an E7/E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-202 and HB-201 resulted in a ten-fold increase in immune response and better disease control than either compound alone.
The alternating, sequential HB-202/HB-201 two-vector therapy has been incorporated into the ongoing Phase 1/2 trial (NCT04180215). As such, the first patient dosed in the alternating HB-202/HB-201 arm received Dose Level 1 of HB-202 and is scheduled to receive Dose Level 2 of HB-201. This Phase 1/2 clinical trial is an open-label dose-escalation and dose-expansion trial in patients with treatment-refractory HPV16+ cancers. In addition to the newly added HB-202/HB-201 therapy option, patients will continue to be enrolled into the HB-201 dose groups.
The primary endpoint of the Phase 1 is a recommended Phase 2 dose based on safety and tolerability. Secondary endpoints include anti-tumor activity as defined by RECIST 1.1 and immunogenicity. Patients will receive HB-202/HB-201 via intravenous dosing or, for patients with an accessible lesion, the first dose of HB-201 will be delivered via intratumoral injection and the remaining doses of HB-202 and HB-201 will be administered intravenously.
The Phase 2 portion of the trial will investigate the efficacy of our arenaviral regimens alone and also in combination with a PD-1 inhibitor. While HOOKIPA intends to release preliminary data for the HB-201 arm of the trial in late 2020 or early 2021, the Company expects to provide interim safety, dose escalation, and efficacy data on the HB-202/HB-201 arm in mid-2021.
About Human Papillomavirus
Human Papillomavirus, or HPV, is estimated to cause about 5% of the worldwide burden of cancers. This includes approximately 99% of cases in cervical, up to 60% of head and neck, 70% of vaginal, and 88% of anal cancers.
The majority of these cancers are caused by the HPV serotype 16. Most infections with HPV are cleared from the body with no lasting consequences. However, 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. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.