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Lead Product(s): IPP-201101
Therapeutic Area: Immunology Product Name: Lupuzor
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2020
Details:
As part of the Type ‘A’ Meeting, Avion has asked the FDA for guidance on the Key aspects of the study design, clinical end points and approval process for Lupuzor™; and Consideration by the FDA for a conditional approval of Lupuzor™, whilst the Phase 3 trial is underway.
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Lead Product(s): Grass MATA MPL
Therapeutic Area: Immunology Product Name: Grass MATA MPL
Highest Development Status: Phase III Product Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Allergy Therapeutics announces start of key exploratory field study in advance of pivotal Phase III Grass trial;Breakthrough study design to deliver for the first time cutting edge scientific concepts in the Allergy field to optimize SCIT trial results.
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Lead Product(s): Tree MATA MPL
Therapeutic Area: Immunology Product Name: Tree MATA MPL
Highest Development Status: Phase III Product Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2020
Details:
Technical issues in the study made it difficult to reconstruct the primary endpoint data and the PEI agreed that B301 cannot be considered for assessment of clinical efficacy and a new pivotal Phase III study will be conducted within the therapy allergens ordinance time frame.
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Lead Product(s): Rigerimod
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Avion Pharmaceuticals
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Agreement February 06, 2020
Details:
Avion and ImmuPharma to meet with the FDA in Q1 2020 to discuss guidance on a new optimised international Phase III trial protocol.
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