FDA clears MannKind MKC1106-PP immunotherapy IND
US drug discovery firm MannKind Corp says that an Investigational New Drug application for its range of MKC1106-PP-based immunotherapy in solid tumors has been cleared by the US Food and Drug Administration. The company said that the FDA's decision allows it to proceed with trials of two of the synthetic peptides developed during the program, in the treatment of patients with solid malignancies.
MannKind said that the agents are designed to target both the preferential antigen of melanoma (PRAME) as well as the prostate specific membrane antigen (PSMA).The firm added that the study will assess the two proteins in terms of the immune response they elicit, as well as their safety and tolerability when delivered via a DNA vector. The firm said that it expects to begin enrollment of subjects before the end of the year.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze