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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. 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.

Based on safety, anti-tumor activity and T cell response data observed in the Phase 1 portion of the Phase 1/2 clinical trial ( Identifier: NCT04180215), we are currently evaluating HB-202/HB-201 in combination with pembrolizumab in 1st line and 2nd line patients with advanced/metastatic head and neck cancer. In addition, we are evaluating HB-200 in a small number of patients at the RP2D as a stand-alone therapy, in patients who have progressed on standard of care. We plan to provide a data update in the first half of 2023.

Prostate Cancer

Prostate cancer is the most diagnosed cancer and fifth leading cause of death from cancer in men. There are several stages of prostate cancer, and prostate cancer cells usually need androgen hormones, such as testosterone, to grow. Treatment for early-stage prostate cancer often aims to lower testosterone levels to stop or slow growth. Metastatic castration-resistant prostate cancer is when the cancer has spread, or metastasized, to other parts of the body including the lymph nodes, bones, rectum, liver and lungs. Metastatic castration-resistant prostate cancer does not respond to hormone therapy. Currently, there are limited treatment options for people with metastatic castration-resistant prostate cancer and only 30 percent will survive beyond five years.

Our solution: HB-300

HB-300 is an alternating, 2-vector replicating arenaviral immunotherapy for metastatic castration-resistant prostate cancer. It uses the Lymphocytic Choriomeningitis Virus and Pichinde Virus as arenaviral backbones, with each expressing two well-defined antigens of prostate cancer, PAP and PSA. Subsequent clinical development may include addition of arenaviral therapeutics expressing a third antigen, PSMA. HOOKIPA’s approach is designed to focus the immune response against the target antigens. The technology has demonstrated the ability to induce potent antigen-specific T cell responses and anti-tumor activity in preclinical tumor models.

On July 25, 2022, HOOKIPA announced that the US FDA accepted the Company's Investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer.  The Phase 1 portion of the Phase 1/2 trial opened for enrollment in the first quarter of 2023.

KRAS-mutated Cancers

KRAS is a gene that acts as an on/off switch for cell growth. When there is a mutation, or error, in the gene, cells can grow out of control. KRAS mutations are among the most common mutations that cause cancer. While KRAS-mutated, tumor-specific treatments exist, there remains an opportunity to target a broader range of KRAS-mutations simultaneously to potentially help more people impacted by these cancers.

KRAS mutations can be associated with poor prognosis and are common in many cancers, including pancreatic (≥60%), colorectal (30%-40%) and lung cancers (15%-20%).  Until recently, there has been no significant clinical success targeting KRAS in cancer; however, several therapies specifically targeting the KRAS G12C mutation have shown promising activity in lung cancer.  There is a need to improve upon the efficacy of current KRAS-targeted therapies while maintaining treatment tolerability and to expand KRAS-targeted therapy to other tumor types with high rates of KRAS mutations beyond lung cancer, including pancreatic and colorectal cancers.  Immunotherapeutic approaches and treatments that are able to target a broader range of KRAS mutations may help improve upon current KRAS-targeted therapy and provide new therapeutic options for patients with KRAS-mutated cancers.

Our solution: HB-700

HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most common KRAS mutations: (G12D, G12V, G12R, G12C and G13D) and thereby benefits more patients than single mutation inhibitors.

HOOKIPA is collaborating with Roche on an arenaviral immunotherapeutic for KRAS-mutated cancers and intends to file an IND in the first half of 2024.