HOOKIPA Pharma Inc.

HOOKIPA is pleased to announce the appointment of Directors Malte Peters as CEO and Terry Coelho as Executive Vice President and CFO. We also welcome Sean Cassidy, an experienced biotech and life sciences executive, to our Board of Directors.   To learn more about these leadership changes and our plans to advance potential commercialization of HB-200, read our full press release here: https://lnkd.in/dY_HGMW7

HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that the first person has been dosed in a Phase 1b clinical trial of HB-500, an investigational therapeutic vaccine for the treatment of HIV. As a result, HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead. The Phase 1b clinical trial (NCT06430905) will evaluate the safety and tolerability, reactogenicity, and immunogenicity to repeated doses of HB-500 in participants with HIV on suppressive antiretroviral treatment. The Phase 1b design comprises two dose escalation cohorts that will be randomized to receive HB-500 or placebo. The first participant was dosed on July 1, 2024, and enrollment is ongoing. HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial. Gilead has the exclusive right to assume further development of the program thereafter. HB-500 is one of two separate developmental programs in HOOKIPA’s collaboration and license agreement with Gilead. Read the release: https://lnkd.in/eGEXpfvZ

HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive updated results from its Phase 2 clinical trial of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic human papillomavirus 16 positive (HPV16+) head and neck cancer. The updated data presented at the ASCO 2024 Annual Meeting is as of March 29, 2024 (cutoff date) and includes 46 patients treated with HB-200 plus pembrolizumab in the first line setting. Results showed rapid and durable activation of antigen-specific CD8+ T cells and promising clinical activity. Among 35 evaluable patients data showed a 37 percent confirmed objective response rate (ORR), 11 percent complete response (CR) rate, and 69% disease control rate (DCR), per RECIST 1.1 criteria. Duration of response was not yet mature with 62 percent of responders still on treatment as of the cutoff date. In a subset of 17 evaluable patients with CPS of 20 or higher, the updated data showed a 53 percent confirmed ORR, 18 percent CR rate, and 82 percent DCR. These patients are representative of the Company’s planned pivotal Phase 2/3 trial population, which is targeted to begin enrolling patients in the fourth quarter of 2024. Additionally, preliminary PFS for the CPS 20 or higher subgroup was 16.3 months and is encouraging based on the historical PFS data of 3.4 months reported for pembrolizumab alone1. The preliminary OS rate was 88% at 9 months, and median OS was unreached as of the cutoff date with 16 of 19 patients still alive. Median follow-up for these patients was 8.4 months. Full Press Release: https://lnkd.in/dv_7JxHt

Join the HOOKIPA team at #ASCO24 to discuss three accepted abstracts presenting data from HOOKIPA programs including presentations during the Head and Neck Cancer oral abstract and rapid oral abstract sessions. Abstract Number: 6005 Title: HB-200 arenavirus-based immunotherapy plus pembrolizumab as first-line treatment of patients with recurrent/metastatic HPV16-positive head and neck cancer: Updated results Presenter: Dr. Alan L. Ho, Head and Neck Oncologist at Memorial Sloan Kettering Cancer Center and a trial investigator Abstract Type: Oral abstract Session Name: Head and Neck Cancer Session Date and Time: June 4, 2024; 9:45 AM-12:45 PM CDT Abstract Number: 6017 Title: Neoadjuvant HPV16-specific arenavirus-based immunotherapy HB-200 plus chemotherapy followed by response-stratified de-intensification in HPV16+ oropharyngeal cancer: TARGET-HPV Presenter:  Dr. Ari Rosenberg, Principal Investigator, TARGET-HPV Trial, University of Chicago Medicine Abstract Type: Rapid oral abstract Session Name: Head and Neck Cancer Session Date and Time:  June 3, 2024; 8:00 AM-9:30 AM CDT Trial Sponsor: UChicago Medicine   Abstract Number: e14672 Title: Development of an arenavirus-based immunotherapy for treatment of KRAS mutant cancer Abstract Type: Abstract only Read more: https://lnkd.in/eTqr3fnY

HOOKIPA Pharma (NASDAQ: HOOK) announced that members of HOOKIPA’s Executive Team will host an investor call on June 4, 2024, at 4:15 p.m. ET. The call will detail the Company’s Phase 2 clinical data of HB-200 in combination with pembrolizumab for the treatment of human papillomavirus 16 positive head and neck cancer, including preliminary progression-free survival and overall survival data for patients with CPS ≥20.   Call Details: HOOKIPA HB-200 ASCO Data Update Tuesday, June 4, 2024, 4:15 p.m. ET Webcast Registration: https://lnkd.in/e4hGqSi8 Dial-in Registration: https://lnkd.in/eaD_knhe Read the full release: https://lnkd.in/ed872bsJ

HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive updated results from its Phase 1/2 clinical trial of HB-200 for the treatment of human papillomavirus 16 positive (HPV16+) head and neck cancers. The data were published in the Company’s abstract for the ASCO 2024 Annual Meeting and support the Company’s pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab in the first line setting. Among a subpopulation of 17 evaluable patients with CPS of 20 or higher, the updated data showed confirmed ORR of 53 percent, CR rate of 18 percent, and DCR of 82 percent. This subpopulation is representative of patients eligible for the Company’s pivotal Phase 2/3 trial, which will begin enrolling patients in the fourth quarter of 2024. Additional data will be presented in the Head and Neck Oral Abstract Session at the ASCO 2024 Annual Meeting on June 4, at 11:09 a.m. CDT. During the presentation, preliminary progression-free survival and overall survival data will be shared for the first time. Read the full press release: https://lnkd.in/eTqr3fnY

HOOKIPA Pharma (NASDAQ: HOOK) announced its final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab. The Phase 2/3 trial design and protocol are based on alignment with the U.S. Food and Drug Administration (FDA) following the Company’s Type C meeting with the FDA. The seamless Phase 2/3 trial is for the investigational product HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS ≥ 20 oropharyngeal squamous cell carcinoma (OPSCC) in the first line setting. The Company anticipates the first patient will be enrolled in the fourth quarter of 2024. The Company also announced acceptance of its HB-200 study abstract as an oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in the head and neck cancer session to be held on June 4, 2024. The presentation will include data for approximately 40 head and neck cancer patients treated with HB-200 in combination with pembrolizumab. Full press release: https://lnkd.in/gbj2SR-K

HOOKIPA Pharma announced FDA Clearance of its investigational new drug application for HB-700 for the treatment of KRAS-mutated cancers. HOOKIPA’s HB-700 program is designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers by targeting the five most prevalent KRAS mutations in these disease indications: G12D, G12V, G12R, G12C and G13D. This program has the potential to benefit more patients than single mutation inhibitors. The IND submission achieves a final $10 million milestone payment. The Company will publish preclinical data in an abstract at the American Society for Clinical Oncology (ASCO) 2024 Annual Meeting. Read the Release: https://lnkd.in/eVpFddTS

HOOKIPA Pharma (NASDAQ: HOOK) announced that members of HOOKIPA’s Executive Team will host an investor call summarizing the Company’s constructive regulatory interactions with the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA). HOOKIPA and the FDA have aligned on the design and protocol of the Company’s upcoming pivotal Phase 2/3 clinical trial of HB-200 in combination with pembrolizumab. The investor call will be held on April 25, 2024, at 8:00 a.m. ET. Complete details and registration information are included below. The Company also announced that EMA has granted PRIME designation for the investigational product HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS ≥ 20 oropharyngeal squamous cell carcinoma (OPSCC) in the first line setting. PRIME designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs. Eligibility and approval are based on preliminary clinical evidence and indicate that the drug candidate may offer substantial improvement over existing therapies. Call Details: HOOKIPA HB-200 Phase 2/3 Clinical Trial Update Thursday, April 25, 2024, 8:00 a.m. ET Webcast Registration: https://lnkd.in/ejiBfyaT Dial-in Registration: https://lnkd.in/eWB4ywPx Full press release: https://lnkd.in/eieFi4Rd

April marks Head and Neck Cancer Awareness Month. The goal of awareness month is to educate our communities about head and neck cancer prevention, routine screening options, and research for better treatments. HOOKIPA is making an impact through our research with our HB-200 Program, committed to bringing new treatment options to head and neck cancer patients in need. We are preparing to start a randomized trial of HB-200 in combination with pembrolizumab in the 1st-line setting for patients with recurrent/metastatic HPV16+ head and neck cancers later this year. Help us make a difference for head and neck cancer patients! We encourage you to explore and share the helpful resources on the Head and Neck Cancer Alliance website: https://lnkd.in/dvXvXDg. #headandneckcancer