HB-300 / Hookipa Pharma - LARVOL DELTA

HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=12 | Terminated | Sponsor: Hookipa Biotech GmbH | N=70 ➔ 12 | Trial completion date: Sep 2026 ➔ Apr 2024 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ Apr 2024; Decision by the company to terminate the H-300-001 study early for non-safety related reasons.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

HOOKIPA Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - P1/2 | N=70 | NCT05553639 | Sponsor: Hookipa Biotech GmbH | "The Study Safety Committee deemed that HB-300 was generally safe and well-tolerated in both dose escalation cohorts. Initial analysis of target antigen-specific T cell responses—using direct ELISPOT without pre-expansion of T cells—in ten patients between dose level 1 (N=5) and dose level 2 (N=5) indicated a 15- to 26-fold increase of target antigen specific T cells in 30 percent of patients (3/10). In line with its previously announced strategy to prioritize the development of HB-200, the Company has terminated the Phase 1/2 study of HB-300 and will utilize the associated capital and resources for the advancement of its HB-200 program. HOOKIPA will keep the IND open to allow the potential for further development of this program in the future. HOOKIPA will publish the final data at a scientific conference, once complete."

P1/2 data • Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

HOOKIPA Pharma Provides Update on Business Priorities and Oncology Partnership Programs (GlobeNewswire) - "At this time, the company will not pursue further preclinical programs into development and pause further development of its HB-300 to conserve capital and ensure pipeline success and operational efficiency."

Discontinued • Prostate Cancer

HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Hookipa Biotech GmbH

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

HOOKIPA Pharma Reports Third Quarter 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - "Anticipated Milestones: Phase 1 HB-300 in prostate cancer: Preliminary safety and immunogenicity data: H1 2024; HB-700 in KRAS-mutated cancers: IND filing H1 2024."

IND • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HOOKIPA Pharma Reports Second Quarter 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - "Phase 1 HB-300 in prostate cancer: Preliminary safety and immunogenicity data: H1 2024; HB-700 in KRAS-mutated cancers: IND filing H1 2024."

IND • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HB-300, a novel arenavirus-based cancer immunotherapy in patients with metastatic castration-resistant prostate cancer. (ASCO 2023) - P1/2 | "Sipuleucel-T, a cell-based therapy recognizing prostatic acid phosphatase (PAP) protein, is approved for treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and induced PAP-specific T cell responses correlating with overall survival (OS)...Trial inclusion criteria include male participants age ≥ 18; documented mCRPC (adenocarcinoma without neuroendocrine or small cell features); receipt of at least 1 androgen deprivation therapy and no prior chemotherapy regimens (docetaxel in the castration-sensitive setting is allowed); ≥1 measurable lesion; ECOG PS 0-1...Clinical trial# NCT05553639. Clinical trial information: NCT05553639."

Clinical • Metastases • Genito-urinary Cancer • Immunology • Infectious Disease • Neuroendocrine Tumor • Oncology • Pain • Prostate Cancer • Solid Tumor • ACPP • CD8 • PSAP

HOOKIPA to Present a Trial in Progress Poster on its Prostate Cancer Phase 1/2 Clinical Trial at ASCO (GlobeNewswire) - "HOOKIPA Pharma...announced that a Trial in Progress poster on its ongoing Phase 1/2 clinical study (NCT05553639) of HB-300 in prostate cancer has been accepted for presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HOOKIPA Reports Fourth Quarter and Full Year 2022 Financial Results and Provides 2023 Outlook (Yahoo News) - "Upcoming Milestones: Phase 2 HB-200 in HPV16+ head and neck cancers; 1st-line initial data in combination with pembrolizumab: 2Q 2023; 2nd+-line initial data in combination with pembrolizumab: 2Q 2023; Post-standard of care monotherapy: 2Q 2023; Randomized Phase 2 in 1st-line with pembrolizumab: study kick-off 2023 (Fast Track designation); HB-300 in prostate cancer: initial data expected 1H 2024; HB-700 in KRAS-mutated cancers: submit IND 2024..."

Clinical data • IND • P1/2 data • Anal Carcinoma • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Oncology • Oropharyngeal Cancer • Pancreatic Cancer • Penile Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Vaginal Cancer • Vulvar Cancer

HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Hookipa Biotech GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

HOOKIPA Pharma Announces Third Quarter 2022 Financial Results and Provides a Business Update (GlobeNewswire) - "Upcoming Milestones: First patient enrolled in HB-300 Phase 1 study (prostate cancer) expected in the first quarter of 2023."

Enrollment status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: Hookipa Biotech GmbH

New P1/2 trial • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

FDA accepts HOOKIPA’s Investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer (GlobeNewswire) - "Novel arenaviral immunotherapy is directed against the prostate cancer targets PAP and PSA; Phase 1/2 trial to commence by early 2023; Drug Master File (DMF) accepted to support future FDA submissions...HOOKIPA Pharma Inc...has received U.S. Food and Drug Administration (FDA) acceptance of its Investigational New Drug (IND) application for HB-300, a novel arenaviral immunotherapy for the treatment of metastatic castration-resistant prostate cancer."

IND • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer

New data show HOOKIPA’s arenaviral immunotherapies induce potent T cell responses in novel combinations and against tumor self-antigens (GlobeNewswire) - "HOOKIPA Pharma...announced positive preclinical data demonstrating potent T cell responses, potential novel combination use beyond PD-1 inhibitors, and the ability to break immune tolerance to various self-antigens for targeting cancers....The data were shared as poster presentations at the 2022 American Association for Cancer Research Annual Meeting (AACR)....Preclinical data also expand evidence on arenaviral immunotherapy targeting tumor self-antigens, reinforcing scientific approach for HB-300 program in prostate cancer....'we prepare to file an IND for our HB-300 program in prostate cancer in the third quarter'....A clinical update on Phase 1 HB-200 monotherapy data is anticipated mid-year; preliminary data on HB-200 in combination with pembrolizumab as 1st-line and 2nd-line treatment for HNSCC is anticipated in the second half of 2022."

IND • P1 data • P1/2 data • Preclinical • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

HOOKIPA Pharma Reports Third Quarter 2021 Financial Results and Recent Highlights (GlobeNewswire) - "Upcoming Milestones: Phase 1 HB-200 HPV16+ HNSCC additional data: mid-year 2022; Phase 2 HB-201 + pembrolizumab HPV16+ HNSCC 1st-line initial data: second half of 2022; Phase 2 HB-201 + pembrolizumab HPV16+ HNSCC 2nd-line initial data: second half of 2022; Randomized Phase 2 HB-200 + pembrolizumab HPV16+ HNSCC 1st-line trial initiation: first half of 2023; Investigational New Drug application for HB-300 in metastatic prostate cancer: third quarter 2022."

Clinical data • IND • New P2 trial • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Prostate Cancer • Squamous Cell Carcinoma of Head and Neck

HOOKIPA Reports Fourth Quarter and Full Year 2020 Financial Results and Provides 2021 Outlook (GlobeNewswire) - “Upcoming Milestones; Translational data from the HB-201 program in Q2 2021; Additional HB-201 and initial HB-201/HB-202 Phase 1/2 efficacy data in HPV16+ cancers in mid-2021; Advancing HB-300 towards IND for the treatment of metastatic prostate cancer”

Clinical data • IND • P1/2 data • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Prostate Cancer • Solid Tumor

HOOKIPA Pharma Reports Second Quarter 2021 Financial Results and Recent Highlights (GlobeNewswire) - “Upcoming Milestones: Additional HB-201/HB-202 Phase 1/2 data in HPV16+ cancers and recommended Phase 2 dose for the HB-200 program in the fourth quarter of 2021….Advancing our HB-300 program to IND for the treatment of metastatic prostate cancer.”

P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer

HOOKIPA Pharma Reports First Quarter 2021 Financial Results and Recent Highlights (GlobeNewswire) - “Upcoming Milestones: Oral abstract presentation at ASCO (#2502 at 3:00pm EDT on June 7): First report of the safety/tolerability and preliminary antitumor activity of HB-201 and HB-202, an arenavirus-based cancer immunotherapy, in patients with HPV16+ cancers; Initial HB-201/HB-202 Phase 1/2 efficacy data in HPV16+ cancers in mid-2021; Advancing our HB-300 to IND for the treatment of metastatic prostate cancer.”

IND • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer