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Company: 

HOOKIPA Pharma

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HOOKIPA Pharma

Services Niche provided to HOOKIPA Pharma included:

  • Compilation of a set of preclinical reports and lab data in preparation of the clinical trial application
  • Writing of the Investigator’s Brochure
  • Writing of the Investigational Medicinal Product Dossier (including CMC, clinical and non-clinical components)
What our client said

"As a small company with limited resources, we had to outsource our regulatory package. The documentation produced was to a high quality and very tight timeline and resulted in a positive recommendation from the health authority."

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Heidi Feik

HOOKIPA Pharma




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Project background
HOOKIPA Pharma is a clinical-stage biopharmaceutical company developing a proprietary arenavirus immunotherapy platform to mobilise and amplify targeted T-cells and antibodies, 'supercharging'” the ability of the immune system to combat serious diseases. Their proprietary platform is based on a replication-deficient lymphocytic choriomeningitis virus (LCMV). Currently, the delivery pipeline is focused on two broad areas, immuno-oncology and infectious diseases. Immuno-oncologic indications includes targeting human papillomavirus (HPV)-associated head and neck cancers, and KRAS-mutated cancers. HOOKIPA has partnered with Gilead to leverage their adenavirus platform on an ambitious programme for the prevention or treatment of HIV and Hepatitis B Virus.
Delivery

In order to realise their pioneering vision for the arenavirus platform, Hookipa Pharma have worked with a number of trusted partners. HOOKIPA began a fruitful collaboration with Niche for regulatory documentation preparation, on the recommendation from a business partner. Niche was given accountability for clinical trial application documents, pivotal to the early development of the LCMV technology. Niche writers assisted in the preparation of regulatory documents, leading to the first first-in-human studies exploring the safety and immunogenicity of a LCMV-based vaccination vector. These included the Investigator’s Brochure and IMPD (including a challenging CMC, clinical and non-clinical components for this groundbreaking technology). These documents, produced efficiently to a high quality, resulted in a positive recommendation from the health authority.

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