An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD).
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
HONG KONG – Taiho Pharmaceutical Co. Ltd. has signed an exclusive license agreement with Lung Therapeutics Inc., picking up the Japanese rights to Lung Tx’s LTI-01, a recombinant human single-chain urokinase plasminogen activator for loculated pleural effusion (LPE).
PERTH, Australia – With the approval of cystic fibrosis treatment Bronchitol (mannitol), Sydney-based Pharmaxis Ltd. joins a small group of elite Australian biotech companies to take their drugs all the way to FDA approval.
Gossamer Bio Inc.’s finding of a subset of especially good responders in the phase IIb study called Leda may have taken some of the edge off two failures with GB-001, an oral DP2 antagonist undergoing tests in asthma and chronic rhinosinusitis. But the Street still wasn’t happy, and shares (NASDAQ:GOSS) of the San Diego-based firm closed Oct. 13 at $10.09, down $3.50, or 26%.
LONDON – Enterprise Therapeutics Ltd. has sold its TMEM16A cystic fibrosis portfolio to Roche Holding AG for an up-front payment of £75 million (US$96.9 million), with more to come on achievement of predetermined milestones.
DUBLIN – Galecto Biotech Inc. raised $64 million in a series D funding round, which will enable the company to complete a phase IIb trial of its lead drug candidate, the inhaled galectin-3 inhibitor GB-0139, in idiopathic pulmonary fibrosis, and to move two other programs into phase II studies, in liver fibrosis and myelofibrosis, before year-end.
Immune Regulation Ltd., a U.S.-U.K. venture advancing peptide-based therapies for rheumatoid arthritis and allergic diseases, has closed a £40.6 million (US$53.4 million) series B financing that will support its preparation for multiple phase II studies next year, as well as an evaluation of one candidate in COVID-19-related acute respiratory distress syndrome. Morningside Ventures led the round, along with existing shareholders, including London-based 24Haymarket.
While its mRNA COVID-19 vaccination effort gets the most attention these days, Moderna Inc. is also moving in other directions as the company will lead mRNA discovery programs drawn from its early stage pipeline in new collaborations with Vertex Pharmaceuticals Inc. and Italy’s Chiesi Farmaceutici SpA. These two deals highlight the “huge opportunity for mRNA beyond SARS-CoV-2 and vaccines,” Piper Sandler analysts wrote Sept. 16.
LONDON – Redx Pharma plc is in the process of handing its RXC-006 program over to Astrazeneca plc, after signing a potential $377 million development and commercialization deal for the porcupine inhibitor in the treatment of fibrotic disease.