eseba-vec (HB-200) / Hookipa Pharma - LARVOL DELTA

H-200-001: A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers (clinicaltrials.gov) - P1/2 | N=198 | Completed | Sponsor: Hookipa Biotech GmbH | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Jan 2025 | Trial primary completion date: Jun 2025 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

HB-200: A novel viral vector vaccine platform that can improve immunotherapy treatment in HPV16+ HNSCC (AACR 2025) - "This study addresses the central question of how viral immunotherapy can induce stronger immune responses than standard immune checkpoint immunotherapy and better enable T cells to achieve tumor control in HPV-associated cancer, providing an important mechanistic understanding of the HB-200 vaccine platform. Thus, findings from this study give critical insights for optimizing HPV-specific immunotherapy with the exciting potential to translate into novel clinical interventions for HPV+ OSCC patients."

Viral vector • Head and Neck Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • CD8

A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Phase classification: P2 ➔ P1

Phase classification • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov) - P2 | N=3 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Active, not recruiting | N=51 ➔ 3

Enrollment change • Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

H-200-004: A Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Hookipa Biotech GmbH | N=450 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Metastases • Trial withdrawal • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

H-200-001: A Phase 1/2 Study in Patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers (clinicaltrials.gov) - P1/2 | N=200 | Active, not recruiting | Sponsor: Hookipa Biotech GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Eseba-vec (HB-200) plus pembrolizumab as first-line treatment of recurrent/metastatic HPV16-positive head and neck cancer: updated results in PD-L1 CPS ≥20 patients (SITC 2024) - P1/2 | "Clinical trial# NCT04180215 Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. 20-165A(5) (Memorial Sloan Kettering Cancer Center), 1282128 (University of Alabama at Birmingham Heersink School of Medicine), 1273311 (University of Kansas Medical Center), IRB22-1121 (Cleveland Clinic), 202101073 (University of Iowa), 1266389 (Banner MD Anderson Cancer Center), STUDY-19-01049 (Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute), HS-19-00931 (University of Southern California, Norris Cancer Center), 'BUA-2023-034-001' (University of California Los Angeles), H-200-001 (RM 662) (Stephenson Cancer Center at University of Oklahoma Health Sciences Center), 1346811 (University of Virginia Health System), IRB19-1294 (University of Chicago), PRO00036737 (Medical College of Wisconsin), i21-00729 (Grossman School of Medicine), EC/21/252/6495 ( R) (Hospital Virgen del Rocio), 1353073 (Rutgers Cancer..."

Clinical • Late-breaking abstract • Metastases • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • PD-L1

HOOKIPA Pharma Reports Third Quarter 2024 Financial Results and Provides Recent Business Updates (GlobeNewswire) - "Recent Developments: Oncology:...Enrollment completed in the Phase 2 H200-001 study for eseba-vec in combination with pembrolizumab in HPV+ HNSCC with 68 patients enrolled as of October 2024."

Enrollment status • Squamous Cell Carcinoma of Head and Neck

HOOKIPA Pharma’s Eseba-vec Highlighted in SITC Late-Breaker (GlobeNewswire) - P1/2 | N=200 | NCT04180215 | Sponsor: Hookipa Biotech GmbH | "HOOKIPA Pharma...announced that clinical collaborator Alan Ho...presented updated Phase 2 data from a study evaluating eseba-vec in combination with pembrolizumab as front line (1L) therapy in the setting of human papillomavirus type 16 positive (HPV16+) relapsed or metastatic head and neck squamous cell carcinoma (R/M HNSCC)....The late-breaking poster presentation focused on results from a subset of patients (PD-L1 CPS >20, n=27, with 25 response evaluable patients). The data showed an overall response rate (ORR) of 52% for all eseba-vec doses tested, with a disease control rate (DCR) of 80%, as of the September 30, 2024 data cut-off. While progression free survival (PFS) and overall survival (OS) data are still maturing, preliminary median PFS is greater than 16 months, with a 12-month OS rate of 83%, and 66.7% of confirmed responders ongoing."

Late-breaking abstract • P2 data • Squamous Cell Carcinoma of Head and Neck

HOOKIPA Pharma to Present Eseba-vec Combo in Frontline HNSCC as a Late-Breaker Poster Presentation at SITC 2024 (GlobeNewswire) - "HOOKIPA Pharma Inc...today announced that updated Phase 2 data for eseba-vec (HB200) plus pembrolizumab in first-line recurrent/metastatic HPV16-positive head and neck cancer will be presented as a late-breaking poster presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024), taking place in Houston, Texas from November 8-10, 2024."

P2 data • Head and Neck Cancer • Oncology

HOOKIPA Pharma Doses First Patients with Eseba-vec as Adjuvant Therapy in Phase 2 Investigator Lead Trial for Head & Neck Cancer (GlobeNewswire) - "HOOKIPA Pharma Inc...announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) have dosed the first patients in an investigator initiated trial (IIT) of eseba-vec, HOOKIPA’s human papillomavirus type 16 (HPV16+)-targeted investigational immunotherapeutic agent, in patients with minimal residual disease positive (MRD+) HPV-driven head and neck cancer....The Phase 2, randomized, double-blind, placebo-controlled study (NCT06373380) will evaluate the use of eseba-vec in patients with minimal residual disease positive (MRD+) HPV-driven head and neck cancer."

Trial status • Squamous Cell Carcinoma of Head and Neck

Phase II multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of HB-200 in patients with detectable TTMV-HPV DNA after definitive treatment for HPV16 + HNSCC (ESMO 2024) - P2 | "The primary objective is to assess the disease-free survival (DFS) for pts enrolled in the study receiving either HB-200 or placebo. The secondary objectives include overall survival, and safety."

Clinical • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

HOOKIPA Pharma Reports Second Quarter 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "Eseba-vec: HOOKIPA is on track to start a seamless pivotal Phase 2/3 trial of eseba-vec in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS ≥ 20 OPSCC in the first line setting....The Company anticipates the trial will start in the fourth quarter of 2024."

Trial status • Oropharyngeal Cancer • Squamous Cell Carcinoma

A Phase 2/3 Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer (clinicaltrials.gov) - P2/3 | N=450 | Not yet recruiting | Sponsor: Hookipa Biotech GmbH

Metastases • New P2/3 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

HOOKIPA Pharma Announces Leadership Changes to Intensify Focus on HB-200 (GlobeNewswire) - "HOOKIPA Pharma Inc...today announced the appointment of Directors Dr. Malte Peters as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer, effective July 22, 2024. They will both retain their positions on the Board of Directors ('Board')....Dr. Peters and Ms. Coelho, in close collaboration with the Board, will lead a review of HOOKIPA’s business strategy and operations to determine the best path to realize the full potential of HB-200 and create shareholder value. The review process will not impact HOOKIPA’s operations or clinical trials."

Clinical • Oncology

HB-200 arenavirus-based immunotherapy plus pembrolizumab as first-line treatment of patients with recurrent/metastatic HPV16-positive head and neck cancer: Updated results. (ASCO 2024) - P1/2 | "HB-200 comprises an alternating sequence of two replicating attenuated arenavirus vectors derived from LCMV (HB-201) and Pichinde virus (HB-202), respectively. Updated data of HB-200 arenavirus-based immunotherapy plus pembrolizumab continued to demonstrate a favorable safety profile and promising clinical activity as 1L treatment in patients with HPV16+ PD-L1+ R/M HNSCC and confirms previously reported data. The results suggest that the subgroup of patients with PD-L1 CPS ≥20 may benefit more from this treatment, which warrants further development in a randomized pivotal study. Clinical trial# NCT04180215."

Clinical • IO biomarker • Metastases • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • PD-L1

Neoadjuvant HPV16-specific arenavirus-based immunotherapy HB-200 plus chemotherapy followed by response-stratified de-intensification in HPV16+ oropharyngeal cancer: TARGET-HPV. (ASCO 2024) - P1/2 | "Building on our OPTIMA II results demonstrating that neoadjuvant chemotherapy/nivolumab led to deep responses in 71% of patients who went on to receive reduced radiation (RT), we hypothesized that adding HB-200 to chemotherapy to drive HPV16-specific anti-tumor immunity would be safe and effective to further deepen responses and facilitate more de-escalation. In this Phase 1 dose escalation investigator-initiated study, patients with non-metastatic HPV16+ OPC were treated with escalating doses of HB-201 single vector (Arm A) or HB-202/201 alternating vector (Arm B) x3 with neoadjuvant carboplatin AUC5 on day 1 and paclitaxel 100mg/m2 on days 1/8/15 of a 21-day cycle for 3 cycles. Deep responders (≥50% tumor shrinkage) received transoral robotic surgery (TORS) alone or RT to 50Gy +/- cisplatin, while non-responders (<50% shrinkage) received 50 or 70Gy of RT with cisplatin... Neoadjuvant HB-200/chemotherapy is safe and feasible with early efficacy signal in this..."

Clinical • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • CD8

TARGET-HPV: HB-200, a HPV16-specific immunotherapy, in oropharyngeal cancer (YouTube)

Interview • Video

HOOKIPA Pharma Announces Updated Phase 2 Clinical Data at the American Society of Clinical Oncology 2024 Annual Meeting (GlobeNewswire) - P1/2 | N=200 | NCT04180215 | Sponsor: Hookipa Biotech GmbH | "HOOKIPA Pharma...announced positive updated results from its Phase 2 clinical trial of HB-200...in patients with recurrent/metastatic...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."

P2 data • Head and Neck Cancer

HOOKIPA Pharma to Host Investor Call on HB-200 Data Presented at American Society of Clinical Oncology 2024 Annual Meeting (GlobeNewswire) - "HOOKIPA Pharma...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."

P2 data • Head and Neck Cancer

HOOKIPA Pharma Announces Positive Clinical Data to be Presented at the American Society for Clinical Oncology 2024 Annual Meeting (GlobeNewswire) - P1/2 | N=200 | NCT04180215 | Sponsor: Hookipa Biotech GmbH | "The abstract reported data as of January 12, 2024..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...During the presentation, preliminary progression-free survival and overall survival data will be shared for the first time...HB-200 + pembrolizumab were generally well tolerated. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 6 (14%) patients...No treatment-related deaths were reported...Notably, among patients with PD-L1 CPS ≥20 (N=17), ORR, based on confirmed responses, was 53%, CR rate was 18%, and DCR was 82%."

New P2/3 trial • P1/2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

HOOKIPA Pharma Reports First Quarter 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "HOOKIPA is preparing to start a seamless pivotal Phase 2/3 trial of 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. HB-200 was accepted for an oral abstract presentation at the ASCO 2024 Annual Meeting with data from approximately 40 patients treated with HB-200 in combination with pembrolizumab."

New P2/3 trial • P2 data • Gastrointestinal Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma of Head and Neck

A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Hookipa Biotech GmbH | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2024 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Naveris Announces Launch of Phase II Clinical Study in MRD+ Head and Neck Cancer (Businesswire) - "'This study will propose a novel intervention for patients with MRD+ HPV-driven head and neck cancer and will assess the ability of NavDx to identify MRD in these patients,' said Alan L. Ho, MD, PhD...'The findings from this study will provide critical insights into the utility of treating patients identified at the early stage of molecular relapse.'"

Media quote