ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.
|Articles|April 22, 2021
Bristol Myers Squibb Plans Cell Therapy Manufacturing Site in the Netherlands
Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.
Advertisement
Bristol Myers Squibb (BMS) has selected Leiden, Netherlands, as a new cell therapy manufacturing site in Europe, the company announced in an April 22, 2021 press release. The site is in the growing life sciences region near Amsterdam and convenient to transportation for shipping patient cells. According to the press release, Leiden will be the company’s fifth cell therapy manufacturing facility and first in Europe, in addition to contract manufacturing partnerships globally.
“A key element of BMS’ commitment to cell therapy is our continuous investment in advanced manufacturing capabilities, from the expansion of our global network and capacity to treat patients to reduced turn-around time and optimized costs,” said Ann Lee, senior vice-president, Cell Therapy Development & Operations, Bristol Myers Squibb, in the release. “We continue to grow our presence in Europe and the Netherlands, which offers an innovative life sciences hub and world class industry talent, and we look forward to hiring several hundred talented people over the coming years to join our global team and participate in our cell therapy journey.”
The facility will focus on commercial capabilities for multi-product cell therapy manufacturing, using advanced digital systems. Planning for site design and development is underway, with construction slated to begin later in 2021.
Source:
Advertisement
Related to this article
As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial
4
Beam's Risto-cel Meets Primary Endpoint in Sickle Cell Trial
5