Scancell Holdngs Plc said that its lead cancer vaccine that targets dendritic cells has generated a disease-specific immune response in a Phase 1/2 study of patients with late-stage melanoma. There were no reports of serious drug-related side effects.
GlaxoSmithKline Plc and its partner, Theravance Inc, have announced positive Phase 3 results in asthma for their combination corticosteroid and long-acting beta2 agonist, Breo Ellipta. The companies plan to discuss an asthma filing with the FDA.
Eli Lilly and Company said that its experimental add-on therapy for depression, edivoxetine, failed to meet the primary endpoint of three Phase 3 studies and that it is ending development of the drug. This will result in a fourth quarter charge of $15 million.
Sanofi SA said it is stopping clinical development of the JAK2 inhibitor, fedratinib, following reports of cases consistent with Wernicke’s encephalopathy in patients participating in the trials. Wernicke’s encephalopathy is caused by biochemical lesions of the CNS and is related to vitamin B1 insufficiency.
The first of two Phase 3 studies of a new treatment for chronic coronary heart disease, darapladib, has failed to meet its primary endpoint, GlaxoSmithKline Plc said. The endpoint was time to first occurrence of any major adverse cardiovascular event.
Anergis SA of Switzerland has provided further data on its lead vaccine for birch pollen allergy which showed that the treatment increased allergen-specific antibody levels by a factor of 20, indicating an immunological response.
Network pharmacology is an approach to drug discovery and development that is gaining increasing attention from the medical community.
At a time when investors are shying away from technology platform companies, one UK biotech with a platform focus continues to enjoy the support of several large funders. Circassia Ltd recently reported positive data from Phase 2 studies of its immunotherapy technology in patients with grass and house dust mite allergies. A third product against cat allergy is now in Phase 3.
Immatics Biotechnologies GmbH of Germany has raised €34 million from its existing investors in a Series D financing round, enabling it to conclude development of a therapeutic cancer vaccine intended as a first-line treatment for patients with renal cell carcinoma in combination with the current standard of care, Sutent (sunitinib).
The US Food and Drug Administration has agreed to give Alkermes Plc’s candidate drug for the adjunctive treatment of major depressive disorder a ‘fast track’ designation which means the company can have more frequent interactions with the regulator.