1. Scrip
  2. >>Advanced Therapies

Sweden’s Mendus Clears Regulatory Path For Vididencel Registration Trial

 
• By Kevin Grogan

Following promising Phase II data presented at ASH on the company's allogenic leukemia-derived dendritic cell vaccine, Mendus has secured support from the FDA and the EMA for pivotal studies starting later this year.

New pathway
• Source: Shutterstock

The high hopes that Mendus has for vididencel have been raised further following positive regulatory interactions on late-stage plans for the off-the-shelf cell-based vaccine in acute myeloid leukemia (AML).

The Swedish biotech, which also has operations in the Netherlands, sought advice in the fourth quarter from the US Food and Drug Administration and the European Medicines Agency on preparations...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Cell Therapies

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Atara Does An About Face As FDA Lifts Ebvallo Hold

 
• By Alaric DeArment

The biotech said it will have a type A meeting with the agency to resubmit for the cell therapy’s approval in EBV+ PTLD.

Zelluna Believes Its TCR Tech Can Unlock Natural Killer Cell Potential

 
• By Andrew McConaghie

While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology

Gilead Pipeline Progress Offsets Oncology Sales Slowdown

 
• By Alaric DeArment

Sales of the company’s approved cancer therapies were weaker or down, but Trodelvy is likely to see a label expansion and cell therapies are making progress.

More from Therapy Areas

PureTech’s IPF Candidate Ready For Phase III After Efficacy Win

 
• By Andrew McConaghie

Coming one day after Boehringer’s underwhelming data, PureTech’s tweaked molecule, deupirfenidone, shows promise in slowing idiopathic pulmonary fibrosis.

End Is Nigh For 4SC After EMA’s No For Kinselby

 
• By Kevin Grogan

The German biotech has discontinued the oral HDAC inhibitor for cutaneous T-cell lymphoma.

In Brief: Tourmaline Reports Positive Topline Phase II Results for Pacibekitug In CKD

 
• By Sushmita Panda

Based on first positive results for any quarterly IL-6 inhibitor, company plans to initiate Phase III cardiovascular outcomes trial.