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CellVax Therapeutics Announces FDA Clearance of IND Application for FK-PC101, a Novel Personalized Cancer Immunotherapy

ARCADIA, Calif., Jan. 29, 2024 – Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, has announced that its sponsor client, CellVax Therapeutics Inc., received clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for FK-PC101. Patient recruitment for the randomized Phase II trial will begin in March […]

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CellVax Submits IND Application for Individualized Cell-based Immunotherapy FK-PC101 with Support of Theragent

Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, announced that their sponsor client, CellVax Therapeutics Inc., has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for FK-PC101. CellVax and Theragent partnered in November of 2022, with CellVax seeking clearance to proceed with their Phase II adaptive design […]

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Theragent Welcomes Seasoned Cell Therapy Professional Brian Newsom as New Vice President of Business Development

Theragent, a comprehensive cell & gene therapy CDMO focused on advancing next-generation cancer and rare disease treatments, announced that Brian Newsom will be joining the team as their new Vice President of Business Development effective October 16th, 2023. Mr. Newsom will join Theragent from his latest role as Senior Director of Business Development at KBI […]

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Theragent Embraces Pharma 4.0 with AI Software Provider, Insight68

Theragent, a cell therapy CDMO focused on advancing next-generation cancer and rare disease treatments, has signed a multi-year exclusive contract with Insight68, an AI-driven software provider that aims to digitalize and streamline the cell therapy manufacturing process. This partnership reinforces Theragent’s commitment to 100% digital batch record compliance and elevates the company’s reputation as a […]

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Theragent Secures Novel Stem Cell Bank Production Contract with Accelerated Biosciences

Theragent has announced an agreement with Accelerated Biosciences, a regenerative medicine innovator, to produce the cGMP-grade master cell bank (MCB) for Accelerated Biosciences’ novel human Trophoblast Stem Cells (hTSCs). Accelerated Biosciences’ hTSCs are pluripotent and immune-privileged stem cells that are derived from an ethical source and can be differentiated into a number of cell therapies. […]

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CellVax Selects Theragent as Manufacturing Partner for Phase 2 Clinical Trial for Prostate Cancer Immunotherapy

Theragent, a cell therapy Contract Development and Manufacturing Organization (CDMO) focused on advancing next-generation cancer and rare disease treatments, has announced that they have been selected by CellVax Therapeutics to provide manufacturing and testing services for CellVax’s novel cancer immunotherapy candidate FK-PC101 entering Phase 2 clinical trials. FK-PC101 is a cell-based autologous cancer vaccine for […]

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