The FDA expanded Fast Track status for invikafusp alfa, Marengo Therapeutics’ TCR Vβ-targeting antibody-IL-2 fusion protein, from TMB-H colorectal cancer to TMB-H solid tumors regardless of tissue of origin.
Feature|Videos|March 13, 2024
Top Tips for Successful Development of Antibody Chromatography Processes
Author(s)Cytiva
In this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific antibodies. Then, he shares his top tips for addressing challenges associated with mAb aggregates removal and separation of homo and heterodimers.
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Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA launches a new rare disease development initiative, BioNTech’s BNT113 misses a progression-free survival endpoint, and Viking Therapeutics begins Phase III trials of its oral obesity candidate.
As ArsenalBio, TScan, Bristol Myers Squibb, and others abandon ex vivo programs for in vivo engineering, early clinical data and platform differences point to both the promise and the unresolved safety, manufacturing, and regulatory questions of generating CAR-T cells inside the body.
FDA’s rare disease framework effort will revisit evidence expectations and manufacturing review, with public input starting Oct. 28.
BNT113 plus pembrolizumab failed to significantly extend progression-free survival in a 285-patient HPV16-positive head and neck cancer trial.
Viking Therapeutics has started two Phase 3 trials of once-daily oral VK2735, a dual GLP-1/GIP receptor agonist, in adults with obesity, with and without type 2 diabetes.
Gilead will develop up to three PRO-XTEN T-cell engagers discovered by Vir Biotechnology for solid tumors in a deal worth up to $1.74 billion.
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