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.
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.
Retrieved on:
Wednesday, 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.”
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.
Retrieved on:
Wednesday, April 10, 2024
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.
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.
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
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.
Retrieved on:
Tuesday, January 16, 2024
Bristol Myers Squibb,
Partnership,
Standard of care,
Heidelberg University,
Arenavirus,
Head,
MorphoSys,
Drug development,
Doctor of Philosophy,
Master of Science,
Max Planck Society,
Management Dr. Winderlich has rich experience leading multiple candidates through the drug development process to product approval in the United States and in Europe.
Key Points:
- Dr. Winderlich has rich experience leading multiple candidates through the drug development process to product approval in the United States and in Europe.
- “We are pleased to bring our search for a capable clinical development leader to such a swift, successful resolution and welcome Mark to the team,” said Joern Aldag, Chief Executive Officer at HOOKIPA.
- “Mark is a tremendous talent with rich experience across the drug development lifecycle.
- Prior to Evotec, Dr. Winderlich spent more than 12 years in drug development at MorphoSys AG across various roles of increasing responsibility.
Retrieved on:
Thursday, December 21, 2023
Partnership,
Food,
Antigen,
Hoʻokipa,
Sale,
Arenavirus,
The Mark of Gideon,
Common stock,
Investigational New Drug,
Equity,
HIV,
LCMV,
Prospectus,
Gilead Sciences,
Security (finance),
Pharmaceutical industry In addition, HOOKIPA has the right, subject to certain terms and conditions, to sell an additional approximately $8.75 million of common stock to Gilead as pro-rata participation in potential future equity raises.
Key Points:
- In addition, HOOKIPA has the right, subject to certain terms and conditions, to sell an additional approximately $8.75 million of common stock to Gilead as pro-rata participation in potential future equity raises.
- The agreement with Gilead replaces the stock purchase agreement that Hookipa entered into with Gilead in 2022.
- Following the completion of the stock purchase, Gilead’s ownership in HOOKIPA increased to 18,759,465 shares, or approximately 19.4% of HOOKIPA’s outstanding shares of Common Stock.
- HB-500 is one of two separate development programs in HOOKIPA’s collaboration and license agreement with Gilead.
