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Details:
Through the acquisition of Provention Bio, Sanofi adds to its portfolio, TZIELD (teplizumab-mzwv), a CD3-directed antibody, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D).
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: Tzield
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: $2,900.0 million Upfront Cash: $2,900.0 million
Deal Type: Acquisition April 27, 2023
Details:
Through the acquisition of Provention Bio, Sanofi adds to its portfolio, TZIELD (teplizumab-mzwv), a CD3-directed antibody, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D).
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: Tzield
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: $2,900.0 million Upfront Cash: $2,900.0 million
Deal Type: Acquisition March 13, 2023
Details:
Tzield (teplizumab-mzwv) binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: Tzield
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
Teplizumab (PRV-031), is an investigational anti-CD3 monoclonal antibody that is being evaluated for the delay of clinical type 1 diabetes (T1D) in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: $55.0 million Upfront Cash: $20.0 million
Deal Type: Agreement October 06, 2022
Details:
Teplizumab, an investigational anti-CD3 mAb developed for delay of clinical type 1 diabetes at-risk individuals, company resubmitted BLA for teplizumab has been considered a complete, class 2 response by USFDA.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
FDA approved the Company proceeding to populate the popPK model with data collected from patients receiving therapeutic doses of teplizumab in a pharmacokinetic/pharmacodynamic substudy of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabetes patients.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
In the pivotal TN-10 Study, a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 T1D compared to placebo.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2021
Details:
Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) with a filed BLA under Priority Review by the FDA for the delay of clinical T1D in at-risk individuals. EMDAC of the U.S. Food and Drug Administration (FDA) voted 10 yes and 7 no on the question.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2021
Details:
Provention Bio took part in an informal meeting with the U.S. Food and Drug Administration (FDA) on April 23, 2021, in connection with the FDA's ongoing review of the teplizumab Biologic License Application (BLA) for the delay or prevention of clinical type 1 diabetes.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
Details:
As part of its ongoing review of the Company's BLA for teplizumab for the delay or prevention of clinical type 1 diabetes, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 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
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: SVB Leerink
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering January 13, 2021
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.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct 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) being developed for the interception, delay, or prevention of type 1 diabetes (T1D).
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 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.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase IIIProduct 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 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.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
The data from the 'At Risk' Study, published last year, underscores the transformative therapeutic potential of teplizumab to delay or prevent the onset of clinical-stage, insulin-dependent, T1D.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
Details:
PROTECT Study Randomization to be Paused Temporarily in Response to the Ongoing Public Health Crisis
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2020
Details:
Under the terms of the agreements held in 2018, Provention has acquired all rights to Tzield (teplizumab) to be further developed as PRV-031 and licensing rights to MGD010 for development as PRV-3279.
Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: Tzield
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Provention Bio
Deal Size: $395.0 million Upfront Cash: Undisclosed
Deal Type: Agreement November 17, 2022
Details:
The JDRF award will fund efforts to investigate the use of NexImmune’s AIM nanoparticles in combination with a murine surrogate of teplizumab. The investigation will test this hypothesis in a preclinical model by combining anti-CD3 mAb treatment.
Lead Product(s): T1D Antigen-specific Nanoparticle,Teplizumab
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: JDRF
Deal Size: $0.6 million Upfront Cash: Undisclosed
Deal Type: Partnership May 10, 2022
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