HB-700 / Hookipa Pharma - LARVOL DELTA

Poolbeg Pharma plc (“Poolbeg” or the “Company”) Combination of Poolbeg and HOOKIPA Pharma Inc. (GlobeNewswire) - "The boards of directors (each a 'Board') of HOOKIPA Pharma Inc. ('HOOKIPA') and Poolbeg Pharma plc ('Poolbeg') are pleased to announce that they have entered into non-binding discussions for an all-share acquisition by HOOKIPA of Poolbeg (the 'Potential Combination') to create a strong clinical-stage biopharmaceutical company focused on developing and commercialising innovative medicines for critical unmet medical needs, with a special focus on next-generation immunotherapies for the treatment of cancer and other serious diseases (the 'Combined Group')....HOOKIPA is expected to undertake a 100% primary private placement fundraise of up to approximately $30 million (the 'Fundraise') which will be funded into HOOKIPA immediately following the completion of the Potential Combination in order to provide sufficient capital for the enlarged business to realize meaningful expected value inflection points, including (i) Phase 1 interim data for HB-700 in the first half of 2026."

Financing • P1 data • Oncology

HOOKIPA Pharma to Present Strong Preclinical HB-700 Dataset (GlobeNewswire) - "HOOKIPA Pharma Inc...announced that the Company will present preclinical data related to the HB-700 program for the treatment of KRAS mutated cancers at the 6th Annual RAS-Targeted Drug Development Summit being held in Boston, Massachusetts from September 24-26, 2024....The preclinical dataset has demonstrated safety, induction of target-specific CD8+ T-cells, and target cell killing in several different animal and translational models."

Preclinical • Oncology • Solid Tumor

HOOKIPA Pharma Announces Positive Clinical Data to be Presented at the American Society for Clinical Oncology 2024 Annual Meeting (GlobeNewswire) - "KRAS mutation specific CD8+ T cell expansion was evaluated in HLA transgenic mice treated with HB-700 and functionality of induced CD8+ T cells was evaluated by assessing CD8+ T cell mediated killing of mutant KRAS peptide loaded target cells in vivo...All treatment regimens were well tolerated, and no mortalities or major adverse events were observed. The results indicate efficient induction of KRAS mutation specific T cell responses in HLA transgenic mice...No specific cytotoxicity towards target cells pulsed with KRAS wild type peptides was observed in any of the groups."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

HOOKIPA Pharma Reports First Quarter 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "Financial Highlights...Total revenues of $36.6 million, mainly driven by the recognition of previously received upfront and milestone payments under the now-terminated Roche collaboration, as well as the recent HB-700 milestone achievement, led to a profitable first quarter of 2024."

Commercial • Oncology • Solid Tumor

HOOKIPA Pharma Announces Pivotal Phase 2/3 Trial Design for HB-200 in Combination with Pembrolizumab (GlobeNewswire) - "HOOKIPA Pharma Inc...today 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 Company anticipates the first patient will be enrolled in the fourth quarter of 2024....Two additional abstracts for HB-200 and HB-700 accepted for the ASCO 2024 Annual Meeting....Phase 2 primary analysis expected in 2026 with potential subsequent filing for accelerated approval."

Clinical data • Clinical protocol • P2 data • Trial status • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer

HOOKIPA Pharma Announces FDA Clearance of its Investigational New Drug Application for HB-700 for the Treatment of KRAS-Mutated Cancers (GlobeNewswire) - "HOOKIPA Pharma Inc...announced that the Company has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers....The IND submission achieves a final $10 million milestone payment from Roche. Effective April 25, 2024, the Company will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for the HB-700 program. The Company will publish preclinical data in an abstract at the American Society for Clinical Oncology (ASCO) 2024 Annual Meeting."

IND • Licensing / partnership • Preclinical • Oncology • Solid Tumor

HOOKIPA Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - "HOOKIPA is preparing to start a randomized Phase 2/3 trial of HB-200 in combination with pembrolizumab in the 1st-line setting for patients with recurrent/metastatic HPV16+ head and neck cancers....On January 25, 2024, the Company received notification from Roche of their decision to terminate the collaboration and licensing agreement for HOOKIPA’s HB-700 program. To date, HOOKIPA has met all go-forward criteria under the agreement and remains eligible for a final milestone payment associated with IND submission. HB-700 is on-track to an expected IND application filing by April 2024. Effective April 25, 2024, HOOKIPA will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for this program."

IND • Licensing / partnership • New P2/3 trial • Head and Neck Cancer • Oncology • Solid Tumor

HOOKIPA Pharma Provides Update on Business Priorities and Oncology Partnership Programs (GlobeNewswire) - "Upcoming Catalysts - Oncology Programs: HB-200 - HPV16+ HNSCC: (i) Additional first-line data for HB-200 in combination with pembrolizumab (1H 2024); (ii) Initiation of randomized trial (mid-2024); HB-700 - KRAS: (i) IND submission (1Q 2024); (ii) Publication of preclinical research (1H 2024)."

IND • New trial • P1/2 data • Preclinical • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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

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

HOOKIPA Achieves $10 Million Milestone Payment in Development of Immunotherapy for KRAS-Mutated Cancers (GlobeNewswire) - "HOOKIPA Pharma Inc...announced that it has achieved a $10 million non-dilutive milestone payment under its collaboration agreement with Roche to develop HB-700, a novel arenaviral immunotherapy for KRAS-mutated cancers. The success-based milestone payment reflects the start of the HB-700 manufacturing process to support a Phase 1 clinical trial. HOOKIPA plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration in the first half of 2024."

Financing • IND • Oncology

HOOKIPA announces strategic collaboration and license agreement with Roche to develop novel arenaviral immunotherapy for KRAS-mutated cancers (GlobeNewswire) - "HOOKIPA Pharma Inc...announced today a strategic collaboration and license agreement with Roche to develop HB-700 for KRAS-mutated cancers and a second undisclosed novel arenaviral immunotherapy. This represents HOOKIPA’s first oncology licensing collaboration. Through the collaboration, HOOKIPA will conduct research and early clinical development through Phase 1b for HB-700, a novel investigational arenaviral immunotherapy for the treatment of KRAS-mutated cancers....Under the terms of the agreement, HOOKIPA will receive an upfront payment of $25 million. Roche will have the option to expand the initial collaboration by adding an additional product candidate, whereafter HOOKIPA will receive an additional $15 million payment at option exercise. Including this option payment, HOOKIPA is eligible for research, development and commercialization milestone-based payments for HB-700 and the additional product candidate totaling up to approximately $930 million."

Licensing / partnership • Oncology