1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Mersana Back On Track After Speedy Changes To ADC Program

 
• By Jo Shorthouse

Following a clinical hold for its lead product, Mersana explains how it re-engineered the program and how it is developing its ADC platform further.

Train
Mersana hurtled toward its clinical hold lift in 60 days • Source: Shutterstock

When Mersana Therapeutics Inc.'s Phase I program for its lead candidate XMT-1522, an antibody drug conjugate (ADC) targeting HER2, was put on partial clinical hold in July following a patient death, the company acted quickly to change the study protocols to regulator's satisfaction. (Also see "Mersana's ADC Technology Faces A Setback With Partial Clinical Trial Hold " - Scrip, 19 July, 2018.)

“We worked through it with the FDA in under 60 days, which is very fast,” chief business officer Eva Jack told Scrip. Mersana is now excluding patients with hepatic impairment,...

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 Clinical Trials

InflaRx Stock Sinks As Vilobelimab Fails Phase III Skin Trial

 
• By Kevin Grogan

A study of the German biotech's intravenous complement factor C5a antibody for pyoderma gangrenosum was stopped for futility.

Angelini Advances Brain Health Ambitions With GRIN Pact

 
• By Kevin Grogan

The Italian drugmaker gets rights to Phase III-ready asset radiprodil.

Sweden’s Hansa Slims Down Ahead of Key Readouts

 
• By Kevin Grogan

New CEO Renée Aguiar-Lucander is marking her mark.

Gilead Ready To Go After Hepatitis D Again

 
• By Joseph Haas

Following an FDA complete response in 2022, Gilead is getting ready to refile bulevirtide for hepatitis D. The drug already is approved in the EU, UK and elsewhere.

More from R&D

Gilead Ready To Go After Hepatitis D Again

 
• By Joseph Haas

Following an FDA complete response in 2022, Gilead is getting ready to refile bulevirtide for hepatitis D. The drug already is approved in the EU, UK and elsewhere.

Progress In The Effort To Improve Outcomes In SCLC

 
• By Jessica Merrill

Several drug makers are working to bring new advances to small-cell lung cancer, a fast-growing cancer with limited treatment options.

Pipeline Watch: 12 Approvals And 26 Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.