News

Immunocore expands collaboration with Genentech

Country
United Kingdom

Immunocore Ltd is expanding a 2013 collaboration with Genentech (Roche) to co-develop a bi-specific biologic for cancer. The compound is based on soluble T cell receptors that have been designed to recognize intracellular cancer antigens, and then kill cancer cells through an anti-CD3 effector function.

In this case, the targets are tumours expressing the melanoma-associated antigen A4. Called IMC-C103C, the molecule is poised to enter clinical development in early 2019.

Treatment for sleeping sickness recommended

Country
United Kingdom

A new treatment for sleeping sickness, a life-threatening tropical disease, has received a positive review by the European Medicines Agency, paving the way for its approval in sub-Saharan Africa where the illness is endemic. The medicine, Fexinidazole Winthrop (fexinidazole), was developed through a collaboration between Sanofi SA and the non-profit organisation, Drugs for Neglected Diseases initiative (DNDi).

FDA accelerates Adcetris review

Country
United States

The antibody-drug conjugate Adcetris (brentuximab vedotin) has received a new lymphoma indication from the US Food and Drug Administration under a procedure that allows the agency to study key clinical data for the compound prior to its formal regulatory application.

AZ’s Mystic trial misses overall survival threshold

Country
United Kingdom

AstraZeneca Plc’s Phase 3 trial of the Imfinzi and tremelimumab checkpoint antibodies did not meet the primary endpoint of improving overall survival compared with standard-of-care chemotherapy in previously untreated patients with Stage IV metastatic non-small cell lung cancer, the company announced on 16 November. This follows the failure of the same combination in July 2017 to reach statistical significance in progression-free survival.

Exscientia acquires biophysics specialist

Country
United Kingdom

The UK artificial intelligence company Exscientia Ltd has expanded its drug discovery resource with the acquisition of Kinetic Discovery Ltd, a protein engineering specialist. The transaction follows Exscientia’s expansion in Oxford where it is bringing computer scientists, drug designers and biologists under one roof to work on algorithm development for drug discovery. Financial terms of the deal were not disclosed.

FDA proposes waiver for informed consent

Country
United States

The US Food and Drug Administration is proposing a waiver to the legal requirement on pharma companies to obtain informed patient consent for certain low-risk clinical trials. The proposal would amend a provision of the 21st Century Cures Act to add an exception to the consent requirement.

The proposed rule, if finalized, would allow the institutional review board (IRB) responsible for the review and approval of clinical research to waive or alter certain elements of informed consent, or to waive the requirement entirely, under limited circumstances.

Sobi acquires US rights to Synagis from AZ

Country
Sweden

Swedish Orphan Biovitrum AB (Sobi) has agreed to pay up to $1.5 billion upfront to AstraZeneca Plc for US rights to Synagis (palivizumab), an off-patent medicine for the prevention of serious lower respiratory tract infection caused by the respiratory syncytial virus (RSV) in infants and young children.

The upfront payment consists of cash and newly issued Sobi shares which will give AstraZeneca an equity interest in the Swedish company of about 8%.

Evotec powers ahead in first nine months

Country
Germany

Evotec AG powered ahead in the first nine months of 2018 as its contract service provision generated €254.3 million in revenue, up by 53% from a year earlier, and its discovery alliances produced €51.3 million, up by 55%. The discovery business realized more milestone payments during the period, including a €60 million payment from Sanofi SA for taking over development of the French’s company’s infectious disease portfolio.

AZ reports positive outcome data for Farxiga

Country
United Kingdom

AstraZeneca Plc has reported positive outcome data for its licensed diabetes medicine Farxiga (dapagliflozin) showing that the drug significantly reduces the risk of hospitalisation for heart failure or cardiovascular death among patients with Type 2 diabetes. In a Phase 3 trial, the reduction of risk was 17% compared with a placebo.

Lundbeck raises guidance

Country
Denmark

The neuroscience specialist H. Lundbeck A/S has raised its profit forecast for 2018 on the back of revenue and earnings gains in the first nine months and a significant improvement in its operating margin.

“Lundbeck remains on track to deliver the best-ever financial results, creating the foundation to work to strengthen the pipeline for future growth,” said Deborah Dunsire, the company’s new chief executive. Dr Dunsire joined Lundbeck on 1 September having previously managed biopharmaceutical companies in the areas of oncology and central nervous system disorders.