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Lead Product(s): KY1005
Therapeutic Area: Dermatology Product Name: KY1005
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Sanofi Pasteur SA
Deal Size: $1,450.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition January 11, 2021
Details:
The transaction will result in Sanofi having full global rights to KY1005, a fully human monoclonal antibody that has a novel mechanism of action. KY1005 binds to OX40-Ligand and has the potential to treat a varieties of immune-mediated diseases and inflammatory disorders.
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Lead Product(s): Sonelokinab
Therapeutic Area: Dermatology Product Name: M1095
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
Sonelokinab is a novel investigational IL-17 A/F Nanobody® that neutralizes both IL-17A and IL-17F. The trial met its primary endpoint based on Investigator's Global Assessment at week 12 with clinically meaningful and statistically significant results for all tested doses.
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Lead Product(s): Nomacopan
Therapeutic Area: Dermatology Product Name: rVA576
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
The poster presentation will describe the safety & efficacy data from Akari’s Phase II clinical trial of nomacopan in adult patients with mild-moderate bullous pemphigoid. The PhII data was the basis for the agreement of the FDA & EMA that Akari may proceed to a PhIII study.
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Lead Product(s): Nomacopan
Therapeutic Area: Dermatology Product Name: rVA576
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2020
Details:
The EMA and the FDA have both agreed to a Phase III randomized placebo-controlled study with nomacopan in moderate to severe bullous pemphigoid (BP) patients with a primary endpoint of disease remission on minimal oral corticosteroids (OCS).
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Lead Product(s): Nomacopan,Prednisone
Therapeutic Area: Dermatology Product Name: Coversin
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2020
Details:
Treatment arms will be tapered to minimal OCS and an important secondary endpoint is reduction in cumulative OCS on nomacopan as high dose OCS are regarded as unsafe in this vulnerable patient population.
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Lead Product(s): KY1005
Therapeutic Area: Dermatology Product Name: KY1005
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
A clinically meaningful improvement in disease activity was found compared to placebo, as measured by percentage of change from baseline in the Eczema Area and Severity Index (EASI) in patients inadequately controlled by topical corticosteroids from baseline to week 16.
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Lead Product(s): Nomacopan
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Details:
The positive opinion comes at the heels of successful completion of a Phase II study in BP where the combined therapeutic role of both complement (C5) and leukotriene (LTB4) has been well documented.
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Lead Product(s): Nomacopan
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2020
Details:
Akari Therapeutics achieved the primary and secondary endpoints for nomacopan in its Phase II trial in BP and is planning to discuss Phase III pivotal study designs with the FDA and EMA.
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