HPV 16+ Vaccine Launches Immuno-Oncology Study

An Austria based immunotherapeutics company announced that the 1st patient has been dosed in a Phase 1/2 clinical trial of HB-201, an immunotherapy for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers.

HOOKIPA Pharma said in a press release published on December 30, 2019, that it ‘believes that HB-201 has the potential to provide therapeutic benefit to patients across the HPV16+ cancer setting.’

This is good news since HPV is the cause of about 5 percent of the worldwide burden of cancer, and there is a reported inventory shortage of HPV vaccines in certain countries.

HB-201 is a TheraT® platform-based vector (replication attenuated) from the arenavirus family expressing a non-oncogenic, but highly antigenic E6/E7 fusion protein from HPV16. 

In preclinical studies, HB-201 was observed to be highly immunogenic, resulting in a robust CD8+ T cell response as compared to the levels induced by other approaches including adoptive cell therapies. 

In addition to strong immunogenicity, HOOKIPA observed robust anti-tumor activity in mouse models. 

Joern Aldag, Chief Executive Officer at HOOKIPA, commented: “We believe HOOKIPA’s approach can supercharge the natural defense mechanisms by inducing strong T cell responses to the benefit of patients affected by cancer and infectious diseases.”

The HB-201 Phase 1/2 trial is an open-label dose-escalation and dose-expansion trial in 100 patients with treatment-refractory HPV16+ cancers. It is designed to evaluate the safety and tolerability and preliminary efficacy of HB-201 as monotherapy and in combination with an immune checkpoint inhibitor.

For Phase 1 dose-escalation, the patient population will be divided into 2 groups of 20 patients, each: the first group will include patients with progressing HPV16+ tumors who will receive monthly intravenous (IV) administration of HB-201.

The 2nd group will include patients with progressing HPV16+ tumors and an accessible tumor site who will receive one intratumoral (IT) administration of HB-201 followed by monthly IV administration of HB-201.

The primary endpoint of the Phase 1 portion of this trial will be to evaluate safety and tolerability to determine the recommended dose for the Phase 2 portion.

The Phase 2 portion of the trial will also investigate the efficacy of HB-201 alone and in combination with a PD-1 inhibitor. 

HOOKIPA said it expects to provide interim safety, dose-escalation, and efficacy data from HB-201 in late 2020 or early 2021.

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The purpose of cancer-targeting immunotherapy is to modify the immune system to recognize that the cancer is foreign to the body and needs to be attacked. This can be difficult because the differences between cancer cells and healthy cells are often quite small and hard to detect.

The majority of HPV 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, reported a 2017 study. 

When host cells take up this DNA, they express the HPV E6 and E7 proteins. 

This can potentially lead to cancer since the expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.

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

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