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[{"orgOrder":0,"company":"Akari Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akari Therapeutics Announces Positive Topline Results from Fully Recruited Phase II Study of Nomacopan in Bullous Pemphigoid Patients","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Akari Therapeutics"},{"orgOrder":0,"company":"Akari Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akari Therapeutics Receives Positive EMA Opinion on Orphan Designation for Nomacopan for Bullous Pemphigoid","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New 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            Details:

            Sanofi gains Kymab's KY1005 (Amlitelimab) to its pipeline, a fully human monoclonal antibody targeting key immune system regulator OX40L. Kymab’s pipeline also includes the oncology asset KY1044.

            Lead Product(s): Amlitelimab

            Therapeutic Area: Dermatology Product Name: KY1005

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: $1,450.0 million Upfront Cash: $1,100.0 million

            Deal Type: Acquisition April 09, 2021

            Kymab cb

            TMF Summit 2024

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            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.

            Lead Product(s): Amlitelimab

            Therapeutic Area: Dermatology Product Name: KY1005

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: $1,450.0 million Upfront Cash: $1,100.0 million

            Deal Type: Acquisition January 11, 2021

            Kymab cb

            TMF Summit 2024

            Not Confirmed

            envelop Contact Supplier

            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.

            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

            Kymab cb

            TMF Summit 2024

            Not Confirmed

            envelop Contact Supplier

            Details:

            The capital raised will support Evommune’s three prioritised pipeline programs targeting highly prevalent inflammatory diseases, including EVO101, a novel small molecule inhibitor of the IRAK4.

            Lead Product(s): EVO101

            Therapeutic Area: Dermatology Product Name: EVO101

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: EQT Life Sciences

            Deal Size: $50.0 million Upfront Cash: Undisclosed

            Deal Type: Series B Financing April 27, 2023

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            Details:

            Seven of nine patients responded to rVA576 (nomacopan) with three, regarded as complete responders, showing >80% reduction in BPDAI (BP disease activity index)activity and four patients showing >70% reduction in pruritis by day 42; two of nine patients were non-responders.

            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 May 10, 2022

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            Details:

            Sonelokimab is a novel tri-specific Nanobody® targeting IL 17A and IL-17F that also has an extended half-life and enhanced biodistribution through engineered binding affinity to albumin.

            Lead Product(s): Sonelokimab

            Therapeutic Area: Dermatology Product Name: M1095

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Merck Group

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 23, 2021

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            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.

            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

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            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.

            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

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            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).

            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

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            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.

            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

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