Germany-based Affimed NV is turning its focus to prospective combination therapies for its bispecific antibody portfolio, highlighted by the start of a Phase 1b study in the US combining its lead product AFM13 with the Merck & Co Inc immunotherapy Keytruda (pembrolizumab).
Autifony Therapeutics Ltd, which has a technology for modulating ion channels, has reported the failure of a Phase 2a trial in patients with age-related hearing loss. However a second therapy based on the same technology passed a Phase 1 study in schizophrenia.
Adaptimmune Therapeutics Plc said it is ready to respond to the Food and Drug Administration’s partial hold on its proposed pivotal study of a T cell therapy for treating a rare cancer of connective tissue called myxoid round cell liposarcoma.
A Phase 3 trial of a drug being developed by AstraZeneca Plc for patients with a specific mutation in lung cancer has failed to meet its primary endpoint of progression free survival, the company announced on 9 August. The drug, selumetinib, is a MEK 1/2 inhibitor.
Ablynx NV has reported positive efficacy results from a second Phase 2b study of its biologic vobarilizumab in patients with moderate to severe rheumatoid arthritis, showing a strong decline in disease symptoms at 24 weeks of treatment.
The Bristol-Myers Squibb Company’s checkpoint antibody Opdivo (nivolumab) hit a roadblock on 5 August when a Phase 3 study failed to meet its primary endpoint in patients with previously untreated non-small cell lung cancer.
Netherlands-based Pharming Group NV has achieved positive results for its protease inhibitor replacement therapy Ruconest for the prevention of hereditary angioedema (HAE), a rare disorder caused by a deficiency of the C1 esterase inhibitor protein.
AstraZeneca Plc has received further evidence that its new personalised medicine for lung cancer is effective in patients with a specific genetic mutation. New Phase 3 data show that Tagrisso (osimertinib) increased progression-free survival compared with chemotherapy.
A Phase 3 study of the Roche therapy Gazyva (obinutuzumab) in patients with previously untreated diffuse large B-cell lymphoma failed to meet its primary endpoint, even though two previous studies of the same drug in different blood cancers succeeded.
Mesoblast Ltd is to do an early interim analysis of a Phase 3 trial of its cell therapy for heart failure in order to take a strategic view of the programme’s future. The analysis will take place in the first quarter of 2017, the Australian company announced on 1 July.