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Details:
Under the agreement, AGC Biologics is providing autologous production for MDG1015, a third generation TCR-T therapy, focused on the treatment of solid cancers, supporting Medigene’s IND filing and clinical trials.
Lead Product(s): MDG1015,PD1-41BB
Therapeutic Area: Oncology Product Name: MDG1015
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Medigene
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 25, 2023
Details:
Under the agreement, AGC Biologics will assume a technology transfer and feasibility study for a drug product focused on the treatment of Idiopathic pulmonary fibrosis at the CDMO's center of Cell and Gene Excellence in Milan.
Lead Product(s): Undisclosed
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: DiscoveryProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: The Jikei University
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 03, 2023
Details:
Under the agreement, AGC Biologics will manufacture TZIELD™ (teplizumab-mzwv), a new T1D treatment. TZIELD is the first and only immunomodulatory treatment that delays the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older.
Lead Product(s): Teplizumab-mzwv
Therapeutic Area: Endocrinology Product Name: Tzield
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Provention Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 24, 2023
Details:
Under the terms of the agreement, AGC Biologics is supporting the manufacturing and testing of Allergy Therapeutics’ VLP Peanut vaccine candidate, providing VLP material for Phase I supply.
Lead Product(s): VLP Peanut
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Vaccine
Recipient: Allergy Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 31, 2022
Details:
Under the terms of the agreement, AGC Biologics is supporting the manufacturing and testing of Allergy Therapeutics’ VLP Peanut vaccine candidate, providing VLP material for Phase I supply.
Lead Product(s): VLP-Based Peanut Allergy Vaccine
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Vaccine
Partner/Sponsor/Collaborator: Allergy Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 31, 2022
Details:
AGC Biologics will manufacture and supply BioNTech with pDNA starting material, an essential component of BioNTech’s mRNA-based vaccine (BNT162b2) manufacturing process.
Lead Product(s): BNT162b2
Therapeutic Area: Infections and Infectious Diseases Product Name: BNT162b2
Highest Development Status: ApprovedProduct Type: Vaccine
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 07, 2021
Details:
OCS-02 is a tumor necrosis factor-alpha (TNF alpha) inhibitor. TNF alpha is a proven biological target in ocular inflammation with possible dual actions: anti-inflammation and anti-necrosis.
Lead Product(s): OCS-02
Therapeutic Area: Ophthalmology Product Name: OCS-02
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Oculis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership May 06, 2021
Details:
Through the expanded partnership, AGC Biologics will bolster the security of supply of Rocket Pharmaceuticals across their entire lentiviral vector (LVV) pipeline, with the manufacture of LVV, which includes RP-L102 genetically modified with a lentiviral vector.
Lead Product(s): RP-L102
Therapeutic Area: Rare Diseases and Disorders Product Name: RP-L102
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Rocket Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 20, 2021
Details:
AGC Biologics will manufacture GMP material for the next stage of clinical trial. ER-004 is an intra-amniotic drug that will pioneer the treatment of a rare and debilitating genetic disorder.
Lead Product(s): ER-004
Therapeutic Area: Genetic Disease Product Name: EDI200
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pierre Fabre
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership December 21, 2020
Details:
Horizon’s TEPEZZA® (teprotumumab-trbw) treatment will be produced from AGC Biologics’ new facility in Boulder. The facility is well equipped for the production of TEPEZZA. Following approval, it is expected that the facility will produce the majority of the TEPEZZA supply.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Horizon Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 29, 2020
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