Archive for April, 2018

Pfizer pulls plug on Inlyta trial

Posted on April 12th, 2018 by Valorem Life Sciences

Pfizer is terminating a late-stage trial assessing Inlyta in patients at risk of kidney cancer recurrence after an interim analysis showed that it was highly unlikely the drug would offer any benefit in this setting.

The Phase III ATLAS trial was assessing Inlyta’s (axitinib) potential as an adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy.

However, a futility analysis by an independent Data Monitoring Committee found that the study failed to demonstrate a clear improvement in the primary endpoint of extending disease-free survival for patients treated with Pfizer’s drug compared to those given a placebo.

Source: Pharma Times

GSK hands rare disease gene therapies over to Orchard

Posted on April 12th, 2018 by Valorem Life Sciences

Orchard Therapeutics has snapped up GlaxoSmithKline’s portfolio of approved and investigational rare disease gene therapies.

The deal sees GSK become an investor in Orchard, with a 19.9 percent equity stake along with a seat on the firm’s board. The UK drugs giant also stands to receive royalties and commercial milestone payments related to the acquired portfolio.

The parties also noted that they intend to share manufacturing, technical and commercial insights and learnings on the development of gene therapy medicines to ensure the success of the assets.

The programmes acquired by Orchard includes Strimvelis, the first autologous ex vivo gene therapy for children with adenosine deaminase severe combined immunodeficiency (ADA-SCID), approved in Europe in 2016, and two late-stage clinical programmes in ongoing registrational studies for metachromatic leukodystrophy and Wiskott Aldrich syndrome, and one clinical programme for beta thalassaemia.

Orchard will also acquire rights to exclusively license three additional preclinical programmes from GSK partners Telethon/Ospedale San Raffaele upon completion of clinical proof of concept studies for mucopolysaccharidosis type 1 (MPS1 or Hurler syndrome), chronic granulomatous disease and globoid cell leukodystrophy.

Explaining the rationale behind the move, Orchard said the programmes complement its own pipeline of clinical and preclinical gene therapies.

“Acquiring this portfolio further advances Orchard’s vision to be a global, fully integrated company leading the field of gene therapy for rare diseases. The acquisition immediately expands our primary immune deficiency and inherited metabolic disorder franchises and adds the potential for other franchises in the future,” noted Mark Rothera, the group’s chief executive.

For GSK, the agreement follows a strategic review of its rare disease unit, under wider prioritisation of its pharmaceuticals pipeline with a focus on priority programmes in two current therapy areas, respiratory and HIV/infectious diseases, and two potential areas, oncology and immuno-inflammation.

GSK said it would continue to invest in the development of its platform capabilities in cell and gene therapies, but with a focus on oncology.

Source: Pharma Times