Denmark-based Novo Nordisk has announced its intention to acquire Massachusetts-based biopharmaceutical company Dicerna Pharmaceuticals for $3.3bn.

The two companies have been collaborating since 2019 and the tender offer takes place just ahead of their first clinical development programme, which is due to start in 2022.
Dicerna – a publicly held company based in Lexington, Massachusetts – focuses on therapeutics stemming from its ribonucleic acid interference (RNAi) platform that selectively silence genes that cause or contribute to disease.

The ‘strategic addition’ of Dicerna supports Novo Nordisk’s strategy of using a broad range of technology platforms, said the company.

Professor Marcus Schindler, chief scientific officer at Novo Nordisk said the combined expertise of the two companies would “deliver life-changing precision medicines” for chronic diseases including diabetes, obesity, cardiovascular disease and non-alcoholic steatohepatitis (NASH), as well as rare diseases such as endocrine and bleeding disorders.

Dicerna believes its proprietary GalXC and GalXC-Plus RNAi technologies will lead to the development of RNAi-based therapies to treat both rare and more prevalent diseases. Its platform has attracted attention from several pharma companies and Dicerna has ongoing partnerships with Roche, Eli Lilly, Alexion and Boehringer Ingelheim.

Collectively, they have more than 20 active discovery, preclinical or clinical programmes focused on cardiometabolic, viral, chronic liver and complement-mediated diseases, as well as neurodegenerative diseases and pain.

After receiving a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), Gilead Science’s Trodelvy (sacituzumab govitecan) has been approved in Europe.

The therapy is now indicated as monotherapy for the treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies with at least one of them used for advanced disease.

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate that is directed to the Trop-2 receptor, a protein that is overexpressed in several tumours including metastatic TNBC and is associated with poor survival and relapse.

The approval is based on results from the phase 3 ASCENT trial of more than 500 patients randomised on either Trodelvy or chemotherapy. Gilead’s therapy improved both progression-free and overall survival.

Trodelvy is approved in second-line metastatic TNBC in multiple countries worldwide, including Australia, Canada, Great Britain and Switzerland as well as the United States where it is also approved for metastatic urothelial cancer.

TNBC is the most aggressive type of breast cancer and is diagnosed more frequently in younger and premenopausal women, as well as in Black and Hispanic women.

Effective treatment options are extremely limited in TNBC compared with other breast cancer types and the chance of recurrence and metastases is higher.

Norwegian clinical-stage biopharmaceutical company, previously known as Vaccibody, has announced that it will now be known as Nykode Therapeutics, a name inspired by the company’s Norwegian roots and translates as ‘new code’.

Along with its new name, Nykode has announced its deal with Regeneron that is worth up to $900m. The deal is composed of an upfront payment of $30m and an equity investment of $20m, plus additional payments based on potential future developments and commercial achievements of up to $875m and royalties.

The company already has several strategic agreements with Roche’s Genentech and Nektar in cancer vaccines as well as Adaptive on new vaccines against emerging variants of SARS-CoV-2.

The collaboration with Regeneron covers multiple targets across five programmes, two focused on vaccines against infectious disease and three against cancer. Each of the vaccine candidates would be eligible for milestone and royalty payments.

The vaccines will combine Regeneron’s antigen selection expertise and VelociSuite in vivo models with Nykode’s modular vaccine platform and expertise in vaccine design, said the company.

Nykode’s new name will be doing a lot of heavy lifting for the company. According to the company, it links to ‘the potential of our technology to generate novel codes and create innovative patient therapies’ and will ‘reflect its exciting development’. Not only will it also ‘mark a milestone in our journey of growth and transformation’, it ‘conveys how we are truly starting to realise our vision of being a leading immunotherapy platform company, breaking down the boundaries of conventional drug design to unlock the future of medicine’.

Roche has acquired its long-term partner, diagnostics company TIB Molbiol in order to expand its test portfolio and bolster ‘the fight against new infectious diseases’.

Roche announced its intention to acquire the company in September and has now completed its share purchase agreement, acquiring all of TIB Molbiol Group’s outstanding shares.

The company will operate under the Roche umbrella as a subsidiary of the Diagnostics division, adding its 45+ CE-marked in vitro diagnostics assays and 100+ research-use assays to the Roche portfolio.

The two companies have collaborated for more than 20 years ‘to rapidly address critical healthcare needs including biological threats’ that include SARS, anthrax, avian influenza virus H5N1, MERS, the novel influenza virus H1N1 swine, Ebola virus, Zika virus and most recently, SARS-CoV-2 virus and its variants, said Roche.

For more than 30 years TIB Molbiol has supplied reagents for research and medical diagnostics including custom oligonucleotides with which the company partnered in the development of molecular diagnostics. The resulting broad portfolio of diagnostic assays covers inherited genetic as well as somatic mutation testing, quantitative assays for haematology and transplantation medicine.

However, the company’s greatest focus has been on assays to test for infectious diseases. Its assays are available as modular kits that allow ‘symptomatic panels’ to be created by combining assays, which is especially valuable when faced with emerging pathogens.

Following the success of the Pfizer-BioNTech and Moderna COVID-19 vaccines, mRNA technology is increasingly being seen as the future of immunotherapy, with many pharmaceutical companies investing in the area.

Sanofi is the latest to get out its chequebook with the announcement that it is to acquire Austrian skin disease specialist Origimm Biotechnology and its promising ORI-001 vaccine against acne vulgaris. The deal will also allow Paris-based Sanofi to leverage the company’s next-generation mRNA platform to unlock the potential of vaccine-candidates.

Origimm (Origins of Immunity) specialises in the skin microbiome, the large and diverse collection of bacteria, fungi and viruses that inhabit the human skin. Since 2012 it has focused on vaccine antigens and drug targets for the prevention and treatment of diseases and infections associated with skin-colonising microbes.

Its first therapeutic vaccine candidate, ORI-001, based on recombinant proteins, entered preliminary clinical studies for acne vulgaris earlier this year. Sanofi has also announced that it is ‘working to develop additional antigen versions’ and expects to ‘leverage its next-generation mRNA platform’ in a phase1/2 trial in 2023.

Acne is a widespread and stigmatising condition for millions of people globally, causing substantial psychological burden for teenagers but also adults, over 10% of whom are still experiencing acne after age 50, said Roche. The Cutibacterium acnes bacterium plays a central role in the development of moderate to severe acne.