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Find Clinical Drug Pipeline Developments & Deals by Provention Bio

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            Lead Product(s): PRV-3279

            Therapeutic Area: Immunology Product Name: PRV-3279

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Huadong Pharmaceutical

            Deal Size: $293.0 million Upfront Cash: $6.0 million

            Deal Type: Collaboration February 17, 2021

            Details:

            Provention Bio plans to begin a Phase 2a trial of PRV-3279 in systemic lupus erythematosus (SLE) in the second half of 2021 and expects a portion of such trial to be conducted in China.

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            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: SVB Leerink

            Deal Size: $100.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering January 13, 2021

            Details:

            Provention Bio intends to use its net proceeds from the public offering for (i) pre-commercial activities, potential commercial activities, potential milestone or royalty payments, clinical development, and regulatory and manufacturing activities for PRV-031

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            Lead Product(s): PRV-101

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRV-101

            Highest Development Status: Phase I Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2020

            Details:

            The PRV-101 vaccine is specifically designed to prevent autoimmunity by primary prevention of a putative infectious trigger. Provention is developing PRV-101 for the prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes and celiac disease.

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            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            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 02, 2020

            Details:

            Teplizumab is an anti-CD3 monoclonal antibody (mAb). The BLA has been submitted for Teplizumab for prevention of clinical type one diabetes (T1D) in at-risk individuals with the submission of the chemistry, manufacturing and controls and administrative information modules.

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            Lead Product(s): PRV-015

            Therapeutic Area: Immunology Product Name: PRV-015

            Highest Development Status: Phase II Product Type: Large molecule

            Recipient: Celiac Disease Foundation

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership October 07, 2020

            Details:

            Provention Bio will provide clinical trial recruitment for the biopharmaceutical company's Phase 2b PROACTIVE (PROvention Amgen Celiac ProtecTIVE) Celiac Study testing the safety and effects of PRV-015 (an anti-interleukin-15 monoclonal antibody).

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            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            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 September 30, 2020

            Details:

            Teplizumab is an anti-CD3 monoclonal antibody (mAb) being developed for the interception, delay, or prevention of type 1 diabetes (T1D).

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            Lead Product(s): PRV-015

            Therapeutic Area: Immunology Product Name: PRV-015

            Highest Development Status: Phase II Product Type: Large molecule

            Recipient: Beyond Celiac

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership September 22, 2020

            Details:

            Beyond Celiac has partnered with Provention Bio to provide clinical trial recruitment for the biopharmaceutical company’s Phase 2b PROACTIVE study of PRV-015.

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            Lead Product(s): PRV-015

            Therapeutic Area: Gastroenterology Product Name: AMG 714

            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 31, 2020

            Details:

            PRV-015 (anti-interleukin-15) is the first investigational product to show both a reduction in gluten-induced symptoms and in markers of intestinal inflammation in a placebo-controlled trial in celiac subjects .

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            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: SVB Leerink

            Deal Size: $95.7 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 17, 2020

            Details:

            Provention Bio intends to use its net proceeds from the public offering for funding of the clinical development of PRV-031, development activities for PRV-015, development activities for PRV-3279 and PRV-101.

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            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology 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 15, 2020

            Details:

            Provention Bio announced extended follow-up data showing a single 14-day course of teplizumab (PRV-031) significantly delayed the onset of insulin-dependent type 1 diabetes (T1D) in presymptomatic patients by a median of approximately three years compared to placebo.

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