Immunology | Phase III Developments | FRANCE

Sanofi

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Sanofi Gets Priority FDA Review for Sutimlimab Product

Lead Product(s): Sutimlimab

Therapeutic Area: Immunology Product Name: Undisclosed

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 May 14, 2020

Details:

Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. If approved, sutimlimab would be the first and only approved treatment for these patients.

DBV Technologies

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Long Journey for DBV Peanut Patch Ends in Rejection by FDA

Lead Product(s): Viaskin peanut

Therapeutic Area: Immunology Product Name: DBV712

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 August 04, 2020

Details:

Food and Drug Administration has issued a Complete Response Letter regarding the Company’s Biologics License Application for investigational Viaskin™ Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.

ElsaLys Biotech

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ElsaLys Biotech Submits Biologics License Application to FDA for LEUKOTAC for the treatment of graft-versus-host disease in adult patients

Lead Product(s): Inolimomab

Therapeutic Area: Immunology Product Name: Leukotac

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 July 23, 2020

Details:

Inolimomab has shown a robust and long-lasting response Rate in steroid-refractory acute graft versus host disease (SR-aGvHD) in a randomized multicentre controlled parallel-group Phase 3 study (INO-107 - EUDRACT 2007-005009-24).

DBV Technologies

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DBV Technologies Publishes PEOPLE Phase III Open-Label Extension Study Evaluating Viaskin Peanut

Lead Product(s): Viaskin peanut

Therapeutic Area: Immunology Product Name: DBV712

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 July 10, 2020

Details:

Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment with Viaskin™ Peanut (compound name DBV712 250 μg), with low discontinuations due to adverse events.

DBV Technologies

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DBV Technologies to Present Data on Epicutaneous Immunotherapy and Food Allergy Quality of Life at EAACI Digital Congress 2020

Lead Product(s): Viaskin peanut

Therapeutic Area: Immunology Product Name: Undisclosed

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 June 04, 2020

Details:

Virtual presentations will include data about children with and without multiple food allergies from the pivotal Phase III peanut allergy immunotherapy trial PEPITES.

ElsaLys Biotech

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Mediolanum Farmaceutici Acquires the French Company ElsaLys Biotech to Develop Next Generation Immuno-oncology Therapies

Lead Product(s): Inolimomab

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Mediolanum Farmaceutici

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition May 07, 2020

Details:

Acquisition of ElsaLys Biotech adds drugs like Inolimomab and ELB011 to Mediolanum Farmaceutici's pipeline paving the way for its international expansion and increasing the Group's R&D capabilities.

DBV Technologies

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DBV Technologies Provides Update on Viaskin Peanut BLA for Children Ages 4-11 Years

Lead Product(s): Viaskin peanut

Therapeutic Area: Immunology Product Name: Undisclosed

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 March 16, 2020

Details:

FDA has informed the Company that during its ongoing review of the Biologics License Application for Viaskin™ Peanut and has identified questions regarding efficacy of patch-site adhesion.

DBV Technologies

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DBV Technologies Reports Positive Three-Year, Long-Term Data from the PEOPLE Phase III Open-Label Extension Study of Viaskin Peanut in Child...

Lead Product(s): Viaskin peanut

Therapeutic Area: Immunology Product Name: Undisclosed

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 January 08, 2020

Details:

These studies have been instrumental in highlighting CRV431's therapeutic strengths and have helped guideHepion Pharmaceutical'scurrent planning of NASH clinical trials.

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Find Immunology Drugs in Phase III Clinical Development in FRANCE

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Sanofi

Sanofi Gets Priority FDA Review for Sutimlimab Product

DBV Technologies

Long Journey for DBV Peanut Patch Ends in Rejection by FDA

ElsaLys Biotech

ElsaLys Biotech Submits Biologics License Application to FDA for LEUKOTAC for the treatment of graft-versus-host disease in adult patients

DBV Technologies

DBV Technologies Publishes PEOPLE Phase III Open-Label Extension Study Evaluating Viaskin Peanut

DBV Technologies

DBV Technologies to Present Data on Epicutaneous Immunotherapy and Food Allergy Quality of Life at EAACI Digital Congress 2020

ElsaLys Biotech

Mediolanum Farmaceutici Acquires the French Company ElsaLys Biotech to Develop Next Generation Immuno-oncology Therapies

DBV Technologies

DBV Technologies Provides Update on Viaskin Peanut BLA for Children Ages 4-11 Years

DBV Technologies

DBV Technologies Reports Positive Three-Year, Long-Term Data from the PEOPLE Phase III Open-Label Extension Study of Viaskin Peanut in Child...