Almac Discovery granted Orphan Drug Designation for ALM201 programme in ovarian cancer
ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL.
FDA has granted Orphan Drug Designation to Almac Discovery's drug candidate ALM201 in the treatment of ovarian cancer.
ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL. The development of ALM201 by Almac Discovery builds upon initial research work by Professor Tracy Robson who has shown that FKBPL is a naturally secreted protein with effects on a number of important tumour biology processes including cancer stem cells and angiogenesis.
Ovarian cancer ranks among the top ten diagnosed and top five deadliest cancers in most countries. Unfortunately, approximately 80% of patients present with advanced disease, therefore it is critical that clinicians are provided with as many treatment options as possible which can target this disease, either as a monotherapy or in combination with other treatments.
Dr Stephen Barr, Managing Director & President, Almac Discovery commented: “The FDA’s Orphan Drug Designation of ALM201 in the treatment of ovarian cancer will allow for valuable assistance from the FDA during clinical development for either ourselves or our partners for this difficult to treat patient population.”
Related News
-
News Introducing the Pharmaceutical Sustainability Ecosystem from CPHI
The Sustainability Collective from CPHI unveils the groundbreaking Pharmaceutical Sustainability Ecosystem to drive pharmaceutical knowledge sharing, connection, and collaboration in order to change the face of sustainability in pharmceutical... -
News US Government shutdown leads to the FDA grinding to a halt
The US Congress reached a deadlock after not being able to come to an agreement regarding funding, specifically reaching an impasse when Republicans and Democrats were unable to reach an agreement regarding Obamacare subsidies. The resulting shutdown o... -
News Biosimilars for the better: an expert view from Ecolab
Ecolab expert Renato Azevedo shares his insights on the current state of the biosimilars market in pharmaceuticals, after a high number of biosimilar drug approvals throughout the year confirming the shift of focus in this field. -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News CPHI Podcast Series: US drug policy – exploring the executive orders
The latest episode of the CPHI Podcast Series provides a timely overview of the recent policy changes in the USA, with President Trump signing excecutive orders to change drug pricing under a 'Most Favoured Nation' scheme.
-
News PhRMA trade association issues comments on Section 232 investigation
The Pharmaceutical Research and Manufacturers of America (PhRMA), an American trade association representing groups in the pharmaceutical industry, issued a letter on May 6, 2026 to the Department of Commerce regarding the Section 232 National Security... -
News Pharmaceutical Packaging Market Prospects: Shifting regional policies
The pharmaceutical packaging industry is experiencing significant transformation in 2025, driven by regulatory changes, supply chain challenges, and sustainability initiatives. The US BIOSECURE Act, passed through the House of Representatives in Septem... -
News The next 15 drugs up for negotiation with Medicare include several blockbusters
By now, everyone is quite familiar with the drug price negotiations taking place between drug companies and the Centres for Medicare & Medicaid Services (CMS) in the USA as part of measures being taken to reduce the cost of drugs for patients, to make ...