Arenavirus

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

Retrieved on: 
torsdag, maj 30, 2024
Patient, Progression-free survival, CPS, Overalls, Arenavirus, Survival, Head

NEW YORK and VIENNA, May 30, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA or the Company), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that members of HOOKIPA’s Executive Team will host an investor call on June 4, 2024, at 4:15 p.m.

Key Points: 
  • NEW YORK and VIENNA, May 30, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA or the Company), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that members of HOOKIPA’s Executive Team will host an investor call on June 4, 2024, at 4:15 p.m.
  • ET.
  • Complete details and registration information are included below.
  • 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.

HOOKIPA Pharma Announces Positive Clinical Data to be Presented at the American Society for Clinical Oncology 2024 Annual Meeting

Retrieved on: 
torsdag, maj 23, 2024
HLA, Patient, Progression-free survival, Abstract (summary), Survival, Arenavirus, Pembrolizumab, IIT, Neck, OPC, University, CDT, Overalls, Neoplasm, Head, Safety, Disease, CPS, Cancer, ASCO, Mutation, Chemoradiotherapy, Peptide, CD8, PD-L1, DCR, Annual general meeting, Oropharyngeal cancer, Pharmaceutical industry

The abstract reported data as of January 12, 2024, and included 42 patients treated with HB-200 plus pembrolizumab.

Key Points: 
  • The abstract reported data as of January 12, 2024, and included 42 patients treated with HB-200 plus pembrolizumab.
  • 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.

HOOKIPA Pharma Reports First Quarter 2024 Financial Results and Recent Business Highlights

Retrieved on: 
torsdag, maj 9, 2024
FDA, Probability, Gilead Sciences, Food, Pembrolizumab, OPSCC, Partnership, IND, Roche, ASCO, Arenavirus, PRIME, Patient, EMA, Lung, Hepatitis B, HIV, Clinical trial, Annual general meeting, Food and Drug Administration, HBV, Pharmaceutical industry

The Company anticipates the first patient will be enrolled in the fourth quarter of 2024.

Key Points: 
  • The Company anticipates the first patient will be enrolled in the fourth quarter of 2024.
  • Effective April 25, 2024, HOOKIPA regained full control of the associated intellectual property portfolio and has full collaboration and licensing rights for this program.
  • HOOKIPA received FDA clearance of its IND application in the fourth quarter of 2023 and expects to initiate a Phase 1 clinical trial of HB-500 in people with HIV in the second quarter of 2024.
  • On January 29, 2024, HOOKIPA provided an update on its business priorities and oncology partnership programs.

HOOKIPA Pharma Announces Pivotal Phase 2/3 Trial Design for HB-200 in Combination with Pembrolizumab

Retrieved on: 
torsdag, april 25, 2024
FDA, Patient, Cancer, Food, Pembrolizumab, Infection, ASCO, Arenavirus, PRIME, Society, Head, Annual general meeting, European Medicines Agency, OPSCC, Pharmaceutical industry

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.

Key Points: 
  • 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 presentation will include data for approximately 40 head and neck cancer patients treated with HB-200 in combination with pembrolizumab.
  • We believe our trial design and alignment with our primary regulators can help us reach a potential registration more quickly.
  • The trial is expected to enroll approximately 250 patients across the seamless Phase 2/3 design.

HOOKIPA Pharma Announces FDA Clearance of its Investigational New Drug Application for HB-700 for the Treatment of KRAS-Mutated Cancers

Retrieved on: 
onsdag, april 24, 2024
FDA, Food, Partnership, IND, ASCO, Arenavirus, Patient, Society, Annual general meeting, Cancer, Pharmaceutical industry

This program has the potential to benefit more patients than single mutation inhibitors.

Key Points: 
  • This program has the potential to benefit more patients than single mutation inhibitors.
  • The Company will publish preclinical data in an abstract at the American Society for Clinical Oncology (ASCO) 2024 Annual Meeting.
  • Our HB-700 program targets five KRAS-mutations found in multiple cancer indications with a single product candidate,” said Joern Aldag, Chief Executive Officer at HOOKIPA.
  • We continue to define our clinical development strategy which includes the possibility of collaboration or partnership for this program.”

HOOKIPA Pharma Announces Grant of Inducement Award Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
tisdag, april 16, 2024
Arenavirus, Compensated emancipation, Common stock, Employment

The award was granted as an inducement material to the employee’s acceptance of employment with HOOKIPA in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The award was granted as an inducement material to the employee’s acceptance of employment with HOOKIPA in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The options have an exercise price equal to $0.76 per share.
  • The options have a ten-year term and vest over four years, with 25% vesting on the one-year anniversary of the grant date and the remainder vesting in equal quarterly installments for three years thereafter, subject to the employee’s continued service with HOOKIPA on each such vesting date.
  • The options are subject to the terms and conditions of HOOKIPA’s 2023 Inducement Plan approved by the Board of Directors in April 2023 and the terms and conditions of award agreements covering the grants.

HOOKIPA Pharma to Host Investor Call on HB-200 and Planned Path to Registration

Retrieved on: 
onsdag, april 10, 2024
FDA, Pembrolizumab, Arenavirus, PRIME, Patient, EMA, European Medicines Agency, OPSCC, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • PRIME designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs.
  • “We have had positive conversations with our regulators as we have outlined our clinical trial plans for HB-200.

HOOKIPA Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
fredag, mars 22, 2024
SIV, Clinical trial, Hepatitis, Head, CPI, Serum, Hepatitis B, Partnership, HIV, Oncology, Gilead Sciences, Patient, Lung, Journal, Viral load, Pembrolizumab, HBV, Trial of the century, IND, Infection, Hepatocyte, Arenavirus, Antibody, Vaccination, Intellectual property, FDA, Liver, Animal, Pharmaceutical industry

“It was a defining year for HOOKIPA as we witnessed the powerful potential of our novel arenaviral immunotherapies in action.

Key Points: 
  • “It was a defining year for HOOKIPA as we witnessed the powerful potential of our novel arenaviral immunotherapies in action.
  • Data was initially presented in May 2023 and additional patient data was provided in October at the European Society for Medical Oncology Congress 2023.
  • HOOKIPA expects to initiate a Phase 1 clinical study of HB-500 in people with HIV in the second quarter of 2024.
  • In June 2023, the Company completed a $50.0 million public offering of common stock and non-voting convertible preferred stock.

HOOKIPA Pharma to Participate in Leerink Partners Global Biopharma Conference

Retrieved on: 
onsdag, mars 6, 2024
Conference, Arenavirus

NEW YORK and VIENNA, Austria, March 06, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that HOOKIPA’s Chief Financial Officer, Reinhard Kandera, will present at the Leerink Partners Global Biopharma Conference on March 13, 2024.

Key Points: 
  • NEW YORK and VIENNA, Austria, March 06, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that HOOKIPA’s Chief Financial Officer, Reinhard Kandera, will present at the Leerink Partners Global Biopharma Conference on March 13, 2024.
  • Webcast details are available below.
  • Leerink Partners Global Biopharma Conference 2024, Miami, Florida

HOOKIPA Pharma Provides Update on Business Priorities and Oncology Partnership Programs

Retrieved on: 
måndag, januari 29, 2024
Patient, Neck, HNSCC, Arenavirus, Head, IND, HIV, Investigational New Drug, Workforce, Hepatitis B, Pembrolizumab, Pharmaceutical industry

The totality of the HB-200 data presents a clear opportunity for HOOKIPA to advance this program in a randomized trial starting in mid-2024.

Key Points: 
  • The totality of the HB-200 data presents a clear opportunity for HOOKIPA to advance this program in a randomized trial starting in mid-2024.
  • “HOOKIPA has a tremendous opportunity to transform treatment of multiple disease areas using an entirely new class of medicines,” said Joern Aldag, Chief Executive Officer at HOOKIPA.
  • HOOKIPA will reduce its workforce by approximately 30 percent and rebalance its cost structure in alignment with the new prioritization of the Company’s programs.
  • The strategic priorities for HOOKIPA are to advance its clinical programs including HB-200 and its two Gilead-partnered infectious disease programs.