UK-based gene therapy company Gyroscope Therapeutics is set to be bought by Swiss pharma Novartis for an upfront cost of $800m, followed by another $700m in milestone increments.

Gyroscope is a clinical-stage gene therapy company researching eye diseases that cause vision loss and blindness. Its lead investigational gene therapy, GT005, is currently in phase 2 trials for the treatment of geographic atrophy (GA), a leading cause of blindness.

GA is an advanced form of dry age-related macular degeneration (AMD) that leads to progressive and irreversible vision loss. There are no approved treatments, making it ‘one of the most significant unmet needs remaining in retinal diseases’, according to Novartis.

GT005 – which was granted fast track designation from the US Food and Drug Administration (FDA) in September 2020 – is a one-time gene therapy that is delivered under the retina to treat GA that is secondary to AMD.

The therapy is believed to restore ‘balance to an overactive complement system’, a part of the immune system, reducing inflammation with the goal of preserving vision.

Novartis said the acquisition complemented its already established portfolio in retinal diseases and gene therapy and further built its position in ophthalmology gene therapy and optogenetics, following acquisitions of Vedere Bio and Arctos Medical.

The focus of the deal is to strengthen Pfizer’s inflammation and immunology capabilities and expertise.

Analysts across the industry have been predicting a spending spree in 2022 as big pharmas spend some of their COVID-19 cash but Pfizer is ahead of the game, announcing an agreement to acquire US-based Arena Pharmaceuticals.

Clinical stage company Arena is currently developing several innovative potential therapies for immuno-inflammatory diseases. Its lead candidate, etrasimod – an oral, selective sphingosine 1-phosphate (S1P) receptor modulator – is in development across a range of immuno-inflammatory diseases including ulcerative colitis and Crohn’s disease.

Both boards of directors have approved the move, which will see Pfizer spend $6.7bn of its cash buying Arena at $100 per share.

Arena has a robust development programme for etrasimod, said Pfizer, listing two Phase 3 studies in ulcerative colitis (UC), a Phase 2/3 programme in Crohn’s Disease, a planned Phase 3 programme in atopic dermatitis and ongoing Phase 2 studies in eosinophilic oesophagitis and alopecia areata.

Arena’s pipeline also includes two development-stage cardiovascular candidates, temanogrel and APD418. Temanogrel is in phase 2 for the treatment of microvascular obstruction and Raynaud’s phenomenon secondary to systemic sclerosis, while APD418 is in phase 2 for acute heart failure.

Sanofi has agreed to buy US-based immuno-oncology company Amunix Pharmaceuticals for $1bn upfront and another $225m in milestones.

The deal brings with it Amunix’s proprietary ‘stealth’ technology XTEN and masking technology platform Pro-XTENTM, with the aim of developing and producing ‘transformative T-cell engagers (TCE) and cytokine therapies for patients living with cancer.

“The Amunix technology platform utilises a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumour tissues while sparing normal tissues, thus bringing the promise of more effective and safer treatment options for cancer patients,” said Dr John Reed, Sanofi’s head of R&D.

Sanofi’s oncology efforts will be boosted with the acquisition of Amunix’s pipeline, including lead candidate AMX-818.

AMX-818 is a masked T-cell engager targeting HER2, a receptor tyrosine kinase expressed on a wide variety of solid tumours including breast, gastric, non-small cell lung and colorectal cancers.

Integral to the deal is Amunix’s XTEN next-generation protein engineering technology that allows biologics to circulate in ‘stealth’ mode and only become active in ‘disease-specific micro-environments’. By converting in disease tissues to short half-life agents, the active molecule is rapidly cleared from the body, potentially enabling safer and more efficacious medicines.

Sanofi’s acquisition of Amunix is expected to be completed in the first quarter of 2022.

Novartis has signed an expanded deal with Beijing-based biotech BeiGene that will strengthen its immunotherapy pipeline with the addition of late-stage TIGIT inhibitor, ociperlimab.

Under the terms of the agreement, Novartis will make an upfront payment of $300m to obtain the development and commercialisation rights to ociperlimab in the US, EU, Japan, Canada, Mexico and several European countries.

The two companies are already working together since Novartis signed an in-licensing agreement for BeiGene’s anti-PD-1 monoclonal antibody, tislelizumab.

Basel-based Novartis will also pay a fee of up to $700m if the option is exercised before late 2023.

Ociperlimab is a late-stage TIGIT inhibitor – a novel class of anticancer therapies that blocks the TIGIT protein receptor – that is currently being evaluated in two phase 3 lung cancer trials as well as studies in a wide range of solid tumours. Early research suggests TIGIT inhibitors may be active against a broad range of tumours including lung, oesophageal, gastric and breast cancers and melanoma.

Susanne Schaffert, president of Novartis Oncology, commented on the agreement and its potential to add a “transformative new therapy” to Novartis Oncology. She added: “Ociperlimab is a promising late-stage compound in non-small cell lung cancer, with potential in a wide range of solid tumours.”

During the option period, Novartis and BeiGene will also collaborate on the clinical development of ociperlimab in combination with tislelizumab.

Pfizer/BioNTech have announced the start of a new collaboration to develop a potential first mRNA-based prophylactic shingles vaccine.

The collaboration will see the two companies exploring new R&D and commercialisation in the hope of producing a preventative treatment for shingles – herpes zoster virus (HZV) – which is believed to impact around one in three people in the US during their lifetime.

According to the terms of the agreement, Pfizer will pay BioNTech $225m in upfront costs, while BioNTech will pay Pfizer $25m for the company’s proprietary antigen technology.

HZV is a chronic type of varicella zoster virus (VZV), more commonly known as chickenpox. After contracting VZV, the virus lies dormant in the human nervous system with the potential to reactivate later in life.

Reactivation of the virus means it can re-emerge as shingles, which is often triggered due to stress or in those who are immunocompromised. In some cases, patients can experience a condition known as post-herpetic neuralgia, while in rarer cases, shingles can produce facial paralysis, blindness and deafness.

Although approved vaccines are already available for shingles, Pfizer/BioNTech are looking to develop an improved vaccine, with the potential for better tolerability and a more efficient global production by using mRNA technology.

The companies aim to begin clinical trials for the vaccine in the second half of 2022.