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.
|Articles|April 1, 2022
Rentschler Biopharma and Vetter Unveil Xpert Alliance
Author(s)BioPharm International Editors
Rentschler Biopharma and Vetter are unveiling a strategic collaboration called Xpert Alliance.
Advertisement
Rentschler Biopharma and Vetter, two global contract development and manufacturing organizations, are unveiling a joint visualization of their strategic collaboration, Xpert Alliance. The collaboration is focused on delivering effective solutions to address clients’ changing and expanding needs in the biopharmaceutical industry.
Rentschler Biopharma and Vetter entered the alliance in mid-2020, aiming to allow clients to bring their complex products to patients in a faster and easier manner. The companies’ joint visualization Xpert Alliance is focused on the advancement of the alliance and the visibility of the collaborative services the companies offer to clients.
“It is exciting to see how our alliance has been steadily evolving and taking shape,” said Dr. Frank Mathias, CEO of Rentschler Biopharma, in a press release. “We and Vetter have ambitious goals for our collaboration and believe that our clients can greatly benefit from the complementary services and seamless interactions we offer, with the ultimate aim of bringing new, life-changing treatment options to patients.”
“With joint projects ongoing, the day-to-day workings of our strategic alliance are running smoothly, as we work together to create best-in-class solutions for our clients from early development stage through to the market,” added Peter Soelkner, managing director if Vetter, in the release. “We are pleased with the progress we have made so far and look forward to demonstrating the added value we are generating through our collaboration.”
Source:
Advertisement
Related to this article
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.
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.
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.
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
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