On May 20, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the first data on HB-201/HB-202 alternating 2-vector therapy and expanded data on HB-201 will be featured as an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 4-8, 2021 (Press release, Hookipa Biotech, MAY 20, 2021, View Source [SID1234580342]). HB-201 and HB-202, novel arenaviral therapeutics and HOOKIPA’s lead oncology candidates, are being evaluated in an ongoing, first-in-human Phase 1/2 clinical trial (NCT04180215) for the treatment of advanced Human Papillomavirus 16-positive (HPV16+) cancers. The oral presentation will highlight safety, tolerability, immunogenicity and preliminary anti-tumor activity data from about 40 evaluable patients as of March 31.
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"We’re thrilled that our novel arenaviral immunotherapeutics for HPV16+ cancers, HB-201 and HB-202, are being featured at ASCO (Free ASCO Whitepaper). We believe our selection as an oral presentation speaks to the strength of the data and the potential of our arenaviral therapeutics to redefine success in cancer treatment," said Joern Aldag, Chief Executive Officer at HOOKIPA. "Following the preliminary HB-201 data shared in December and our translational data presentation at AACR (Free AACR Whitepaper), we’re excited to share expanded data from more patients and additional doses, including first results on HB-201/HB-202 alternating 2-vector therapy, as well as detailed safety, tolerability, translational data and preliminary anti-tumor activity results. We believe these data are very encouraging for such an early-stage program."
The abstract, outlined below, is available on the ASCO (Free ASCO Whitepaper) website:
First report of the safety/tolerability and preliminary anti-tumor activity of HB-201 and HB-202, an arenavirus-based cancer immunotherapy, in patients with HPV16+ cancers
Abstract # 2502, oral presentation
Monday, June 7, 3:00 – 6:00pm EDT
Presenter: Alan L. Ho, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
Investor Event
At the conclusion of the planned ASCO (Free ASCO Whitepaper) conference events on June 7, 2021, HOOKIPA will host a live webcast event "Advancing Novel Immunotherapies: HOOKIPA ASCO (Free ASCO Whitepaper) Data Review" at 6:30 p.m. EDT. Joern Aldag, Chief Executive Officer, and Igor Matushansky, Chief Medical Officer, will provide an overview of the ASCO (Free ASCO Whitepaper) oral data and future plans for HOOKIPA’s oncology program. Dmitriy Zamarin, M.D., Ph.D., Translational Research Director in Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center and co-investigator in this study, will also offer commentary on the significance and implications of the translational findings. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source To participate in a live Q&A at the end of the prepared remarks, please register here. An archived replay will be accessible for 30 days following the event.
About HB-201/HB-202
HB-201 and HB-202 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (LCMV for HB-201 and PICV for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone.
About the trial
This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ cancers who progressed on standard of care, including check point inhibitors. 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.
The trial is evaluating HB-201 as a single-vector monotherapy, as an alternating two-vector therapy with HB-202, and in combination with a PD-1 inhibitor. Participants receive HB-201/HB-202 intravenously or, for patients with an accessible lesion, the first dose can be delivered via intratumoral injection followed by intravenous dosing. Dosing every three weeks and every two weeks is being explored, as well as different dose levels.
About Human Papillomavirus
Human Papillomavirus, or HPV, is estimated to cause about 5 percent of the worldwide burden of cancers. This includes approximately 99 percent of cases in cervical, up to 60 percent of head and neck, 70 percent of vaginal and 88 percent 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.