HB-202

HB-200 in combination with pembrolizumab doubled the objective response rate of 1st-line pembrolizumab for patients with recurrent/metastatic head and neck cancer HOOKIPA is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ head and neck cancer in 2024 Initial cohort of heavily pre-treated patients who received HB-200 monotherapy showed preliminary median overall survival of 14.2 months in the intent-to-treat population HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive preliminary data from its ongoing Phase 2 study of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head and neck cancer. New data show a 43 percent objective response rate (ORR) with HB-200 in combination with pembrolizumab in checkpoint inhibitor (CPI)-naïve patients, doubling the 19 percent response rate for pembrolizumab alone. HOOKIPA plans to share the full data at a medical conference later this year and is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab in the 1st-line setting in 2024. The company will host a webcast call June 1st at 8:00 a.m. EDT. “Given the unmet medical need for patients with recurrent/metastatic HPV16+ head and neck cancers, we are thrilled to share the preliminary data on HB-200 in combination with pembrolizumab as they show a robust improvement in objective response rate and prolonged tumor control compared to pembrolizumab alone,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “Efficacy, immunogenicity and safety data observed in our HB-200 program to-date support our decision to progress to a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment for these patients. The data also underscore the scalability of our arenaviral platform across a range of cancers.” HB-200 results (NCT04180215) As of March 31, 2023, 35 patients with HPV16+ recurrent/metastatic head and neck cancers received HB-200 in combination with pembrolizumab as part of the Phase 2 study: 20 patients were treated with HB-200 and pembrolizumab in the 1st-line setting and 15 in the 2nd-line setting. All received HB-200 intravenously every three weeks for the first five doses and every six weeks thereafter. HB-200 means 2-vector therapy with alternating application of HB-201 (LCMV), HB-202 (PICV) vectors, encoding HPV16 E6/E7 antigens. 1st-line combination data HB-200 in combination with pembrolizumab demonstrated promising anti-tumor activity with a 43 percent objective response rate (6 of 14 patients with confirmed responses by investigator assessment under RECIST 1.1) among CPI-naïve patients with recurrent/metastatic HPV16+ PD-L1+ head and neck cancer. These data represent a doubling of the 19 percent objective response rate reported with pembrolizumab alone.1 As of March 31, 2023, 14 patients with at least two imaging assessments were included in the interim efficacy analysis. Six patients responded (one with confirmed complete response and five with confirmed partial responses), with a 71 percent disease control rate (10 of 14 patients), meaning stable disease or a complete or partial response. While recruitment is ongoing, based on these data, HOOKIPA is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ PD-L1+ head and neck cancers in 2024. 2nd-line plus combination data Data on HB-200 in combination with pembrolizumab in the 2nd-line plus setting are trending positively in this small initial cohort, but they are preliminary and need further maturation. As of March 31, 2023, five patients with at least two imaging assessments were included in the interim efficacy analysis based on RECIST 1.1. Preliminary results show one confirmed partial response and three patients with stable disease. Preliminary median progression-free survival in this small cohort was 5.3 months. Enrollment is ongoing, and a decision on a potential path forward in the 2nd-line plus setting will be made in 2024. Monotherapy data Given the limited options for heavily pre-treated patients with recurrent/metastatic HPV16+ head and neck cancers, HOOKIPA continues to evaluate HB-200 as monotherapy among these patients in the ongoing Phase 1/2 trial. Follow-up data show HB-200 monotherapy demonstrated a preliminary median overall survival of 14.2 months in the intent-to-treat population, indicating potential for prolonged clinical benefit in this heavily pre-treated population. These data are based on 11 patients who received HB-200 as monotherapy at the same dose being evaluated in combination with pembrolizumab, with a median follow-up period of 12.8 months. Additional patients are also being followed to continue to assess median overall survival in a larger cohort. Immunogenicity Importantly, new follow-up data from heavily pre-treated patients show an association between the induction of unprecedented levels of functional T cells after treatment with HB-200 monotherapy and clinical benefit. T cell increases were rapid and sustained for at least 8 months, as of data cut-off. Patients who achieved disease control after treatment with HB-200 monotherapy generally had greater CD8+ T cell infiltration in tumors compared to patients whose disease progressed, suggesting an association of HB-200-induced T cells and clinical benefit. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at https://ir.hookipapharma.com/events. An archived replay will be accessible for 30 days following the event. About HB-200 HB-200 is HOOKIPA’s lead oncology candidate engineered with the company’s proprietary replicating arenaviral vector platform. It comprises two single-vector compounds with arenaviral backbones based on lymphocytic choriomeningitis virus and pichinde virus. Both express the same transgene encoding an E7E6 fusion protein derived from HPV16. HB-200 is an alternating 2-vector immunotherapy designed to further focus the immune response against the encoded antigen. HB-200 in combination with pembrolizumab received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of 1st-line recurrent/metastatic HPV16+ head and neck cancers. About the HB-200 trial (NCT04180215) This Phase 1/2 clinical trial is an open-label trial evaluating HB-200 for the treatment of advanced HPV16+ cancers. Phase 1 assessed various dose levels, regimen, and modes of administration in a post-standard of care setting. Based on safety and tolerability, initial anti-tumor activity and T cell response data, HB-200 advanced for further development in Phase 2. The Phase 2 part of the trial is open-label with primary endpoints of efficacy based on objective response and disease control rate as defined by RECIST 1.1 and iRECIST. The trial is evaluating HB-200 in combination with pembrolizumab in the 1st-line and 2nd-line plus settings, as well as HB-200 alone in the post-standard of care setting. HOOKIPA anticipates sharing an additional data update at an upcoming medical conference. About Human Papillomavirus-driven Cancers Human Papillomavirus, or HPV, is a common viral infection estimated to cause about 5 percent of the worldwide cancer burden. This includes up to 60 percent of head and neck, 89 percent of cervical, 78 percent of vaginal, 88 percent of anal, 67 percent of vulvar and 50 percent of penile cancers. While there are numerous HPV types associated with cancer, HPV16 is the most common cause of cancer. Most HPV infections 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. About HOOKIPA HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, prostate cancers, and other undisclosed programs. HOOKIPA is collaborating with Roche on an arenaviral immunotherapeutic for KRAS-mutated cancers. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead. 1 Harrington et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Journal of Clinical Oncology. 2023;41(4);790-802. The content above comes from the network. if any infringement, please contact us to modify.

确定了！【药时代创新药BD高阶研讨会（苏州站）】将在4月22-23日举办！编者按：Hepatitis B Foundation网站乙肝新药表单近几月未见更新，为帮助大家更准确地获取全球乙肝新药最前沿信息，肝霖君查询各大药企官网更新的产品管线信息和相关网络资料中的乙肝新药报道做了系统地整理，并汇总了慢乙肝新药与新药联合、新药与现有药物联合治疗的临床研究进展。本期表单更新有：新增处于临床I期的反义RNA药物AHB-137。siRNA药物STSG-0002进入II期临床；治疗性疫苗GS-2829/6779、单克隆抗体KW-027以及HBV RNA去稳定剂AB-161均进入I期临床。新药联合治疗的探索明显加速，包括新药与新药联合、新药与现有药物的联合。许多新药单药在I期或II期研究中未达到主要疗效目标，企业便积极开始了不同联合治疗方案的探索。这也将是未来乙肝全面临床治愈的必要策略。部分新药进展01STSG-0002舒泰神（北京）生物制药股份有限公司研发的siRNA药物STSG-0002注射液进入临床II期（CTR20230448），该项多中心、非随机化、开放性研究主要为了评价STSG-0002对慢乙肝经治患者的安全性和耐受性，次要目的为评价产品的初步有效性；完成该试验未退出的受试者将开展给药后5年的长期随访研究（CTR20230449）。02AHB-137AHB-137是杭州浩博医药有限公司研发的一款注射用反义寡核苷酸（ASO），靶向所有HBV RNA，可引发所有HBV RNA的降解，并在临床前研究中证明能有效减少HBsAg水平，具有良好的安全性。当前处于I期临床阶段，旨在评估健康志愿者和慢乙肝患者经单次和多次给药后的安全性、耐受性、PK特性以及初步疗效（NCT05717686），目前已在新西兰完成首个队列给药。03GS-2829/6779（HB-400）GS-2829/6779是Gilead Sciences使用Hookipa Pharma公司基于沙粒病毒载体的专有TheraT®和Vaxwave®免疫技术研发的两款治疗性乙肝疫苗，也即Hookipa Pharma公司的慢乙肝项目HB-400。近日Gilead Sciences注册了一项在健康成人和慢乙肝患者中进行的Ia/Ib期临床试验（NCT05770895），旨在评估GS-2829/6779治疗的安全性和耐受性，目前暂未招募。04KW-027KW-027是北京凯因科技股份有限公司研发的注射用单克隆抗体，据公司宣布，该产品用于慢性乙型肝炎治疗的I期临床试验已获得国家药品监督管理局药品审评中心的默示许可（CXSL2300038）。05AB-161Arbutus Biopharma研发的口服HBV RNA去稳定剂AB-161进入临床I期（ACTRN12623000074695），这是一项随机双盲、安慰剂对照的单剂量研究，旨在评估健康受试者口服AB-161的安全性、耐受性和药代动力学。封面图来源：pixabay推荐阅读沙利文发布《诱导多能干细胞（iPSC）产业现状与未来发展蓝皮书》国内企业能否在siRNA药物领域分一杯羹？勃林格殷格翰的“三驾马车”，驰骋中国市场点击在看，共济新药研发浪潮