News

GSK to acquire asset from China

Country
United Kingdom

GSK Plc is to acquire a candidate immunotherapy from Chimagen Biosciences Ltd of Shanghai, China in order to strengthen its portfolio of candidate products for autoimmune diseases. Announced on 29 October, the agreement involves an upfront payment of $300 million by GSK for full global rights to the asset, CMG1A46, which is a clinical-stage dual CD19 and CD20-targeted T cell engager. In addition, Chimagen will be eligible for development and commercial milestone payments totalling $550 million.

Novartis acquires Kate Therapeutics

Country
Switzerland

Novartis is to spend up to $1.1 billion to acquire Kate Therapeutics Inc, a San Diego, US-based company which is developing adeno-associated virus gene therapies for neuromuscular diseases. The deal value includes an upfront payment and potential milestone payments. The company’s technology platforms integrate capsid and cargo technologies that are expected to deliver payloads to the appropriate tissues while potentially mitigating off-target effects to tissues such as the liver.

Sanofi invests in Resalis Therapeutics

Country
Italy

Sanofi SA has branched out into RNA therapeutics with an equity investment in Italy-based Resalis Therapeutics which has an antisense oligonucleotide drug in development as a potential treatment for obesity. Announced on 28 October, the size of the investment wasn’t disclosed. Resalis will use the funds to accelerate development of its product, RES-010, through a Phase 2 proof-of-concept trial. The drug targets miR-22, a non-coding RNA that is understood to play a pivotal role in the molecular pathways underlying obesity.

AC Immune extends cash runway

Country
Switzerland

AC Immune SA of Switzerland has extended its cash runway into 2027 following receipt of a milestone payment from partner Janssen Pharmaceutical Inc and contract revenue from other collaborations for its portfolio of medicines and diagnostics for Alzheimer’s and Parkinson’s diseases. Cash and cash equivalents on 30 September was CHF 157.9 million ($178.78), up from CHF 103.1 million on 31 December 2023. This was bumped up in October with a CHF 24.6 million payment from Janssen. 

Autolus cell therapy approved

Country
United States

Autolus Therapeutics Plc, a UK-based cell therapy company, reached its first regulatory milestone on 8 November when the US Food and Drug Administration approved its chimeric antigen receptor (CAR) T cell therapy for cancer. The therapy, Aucatzyl (obecabtagene autoleucel), targets the CD19 antigen on B cells. The approval is to treat B cell acute lymphoblastic leukaemia (ALL), an aggressive type of blood cancer. It was based on evidence from a single-arm trial in adults whose disease had relapsed after two or more prior lines of therapy.

Positive opinion for InflaRx

Country
Netherlands

A new treatment for acute respiratory distress syndrome (ARDS) received a positive opinion from the European Medicines Agency on 15 November paving the way for its use in patients with a coronavirus infection. The treatment, Gohibic (vilobelimab), is a monoclonal antibody directed against a component of the complement system which is part of the body’s immune system. By targeting the complement component C5a, the antibody is believed to block an inflammatory response induced by severe SARS-CoV-2 infection. The treatment has been developed by InflaRx NV of Germany. 

Rare disease gets therapy

Country
United States

A new gene therapy has been given an accelerated approval in the US for an inherited disorder affecting the way neurons transmit information to other cells in the body. The therapy, Kebilidi (eladocagene exuparvovec), has been shown to be effective in treating aromatic L-amino acid decarboxylase (AADC) deficiency, a rare disease. It is caused by mutations in the DDC gene leading to shortages of the AADC enzyme which plays an important role in the nervous system.

Leqembi given clearance

Country
Netherlands

After a second review, the main scientific committee of the European Medicines Agency has recommended approval of Leqembi (lecanemab) for the treatment of mild cognitive impairment due to early Alzheimer's disease in patients who have only one, or no copy, of the ApoE4 gene. The EMA opinion, announced on 14 November, will be forwarded to the European Commission for a decision. 

Syncona recalibrates, affirms target

Syncona Ltd, the UK investment group, has reaffirmed its goal of achieving £5 billion in net assets by 2032, but only after significant changes in the structure of its portfolio. With net assets per share down by 5.2% at the half year ended 30 September, the company has embarked on a two-pronged strategy. The first part of the plan is to rebalance the portfolio with an emphasis on companies with assets in clinical and late clinical-stage development.

AZ raises investment in US

Country
United Kingdom

AstraZeneca Plc is to increase its R&D and manufacturing presence in the US with a new investment of $2 billion at multiple sites across the country. Coupled with existing financial commitments, this will deliver total capital of $3.5 billion to the country by the end of 2026. The money will be invested in an R&D centre in Cambridge, Massachusetts; a biologics manufacturing plant in Maryland; specialty manufacturing in Texas; and cell therapy manufacturing at locations on the country’s west and east coasts.