Adapatimmune has announced a partnership with Roche’s Genentech in a deal potentially worth more than $3bn that will combine their expertise in cell therapy to develop new cancer treatments.

The deal will see Adaptimmune receive $150m upfront, another $150m over the next five years and then milestone payments potentially exceeding $3bn in aggregate sales, as well as royalties.

Unlike other leaders in next-generation cell therapies, the partners will use allogenic T-cells rather than immune cells taken from and returned to an individual’s body as with many CAR-T therapies including Kymriah (tisagenlecleucel).

In addition to ‘off-the-shelf’ cell therapies for up to five cancer targets, the deal includes the development of a personalised cell therapy platform.

“We believe allogeneic cell therapies could be a game-changing approach for developing personalised therapy platforms based on individual cancer patients’ unique needs,” said James Sabry, global head of partnering at Genentech parent, Roche. The partnership, he said, “holds the promise to change how we treat cancer and brings us another step closer to making personalised healthcare a reality.”

Adaptimmune CEO, Adrian Rawcliffe, said: “Through this collaboration, our platform will form the basis of a personalised allogeneic cell therapy vision, where any patient can receive a T-cell product for their cancer; a significant step towards our goal of making cell therapies both curative and mainstream.”

Sanofi has announced it will acquire Kadmon Holdings after the Food and Drug Administration approved Kadmon’s Rezurock (belumosudil).

The “definitive merger agreement” will see Kadmon shareholders receive $9.50 per share in cash – a 79% premium on its closing price – in a deal worth $1.9 billion in total equity. Markets reacted positively to the news, with Kadmon shares rising more than 70%.

The boards of both Sanofi and New York-based Kadmon unanimously approved the transaction.

In July, the FDA approved Rezurock for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. cGVHD is a serious complication of transplant procedures where transplanted immune cells (graft) attack the patient’s cells (host), leading to inflammation and fibrosis in multiple tissues, resulting in significant morbidity and mortality. Approximately 14,000 patients are living with cGVHD in the US.

Rezurock is the first and only approved small molecule therapy that inhibits the Rho-associated coiled-coil kinase 2 (ROCK2), a signalling pathway that modulates inflammatory response and fibrotic processes.
The drug will join Sanofi’s Thymoglobulin (antithymocyte globulin) and Mozobil (plerixafor) in the company’s transplant portfolio, with analysts at Jefferies predicting it could achieve peak sales of $1bn annually.
Sanofi said it would work closely with other regulatory authorities to secure approval for the drug.
Kadmon is Sanofi’s third acquisition this year. In July it acquired Translate Bio and its mRNA technology while in April it completed it acquisition of Kiadis and its immune-oncology technology platform.

Respiratory syncytial virus (RSV) is a common and pervasive seasonal respiratory illness that feels like a common cold for most young adults, but for infants, the immunocompromised and older adults, it can be life-threatening.

RSV leads to the death of more than 24,000 older people a year in developed countries and 60,000 children under five each year and a number of pharmaceutical companies are working on vaccines and antibodies to combat the infection.

Last month, Pfizer began a phase 3 trial for its new RSV bivalent prefusion F subunit vaccine in adults aged 60 or over. The RENOIR phase 3 trial will study the efficacy, immunogenicity and safety of a single dose in 30,000 participants during the upcoming winter season.

“RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly contagious disease,” said Pfizer vaccine R&D head Kathrin Jansen.

GlaxoSmithKline dosed its first patient in a phase 3 trial for its candidate in February. In a recent financial update, the company stated it expected sales of the vaccine to peak at $4bn.

Earlier this year, AstraZeneca and Sanofi’s long-acting antibody nirsevimab met the primary endpoint in a late-stage respiratory syncytial virus trial in healthy infants. Janssen also has a phase 3 trial looking at its RSV vaccine candidate.

The Committee for Medicinal Products for Human Use (CHMP) has recommended Vumerity (diroximel fumarate) for patients with relapsing-remitting multiple sclerosis (RRMS) in the European Union.

Vumerity is a next-generation oral fumarate that has the same active ingredient as Biogen’s blockbuster MS drug Tecfidera (dimethyl fumarate), which faces generic competition.

The active ingredient, monomethyl fumarate, reduces the rate of MS relapses, slows the progression of disability and impacts the number of MS brain lesions. Approved in 69 countries, Tecfidera is the most prescribed oral medication for relapsing MS in the world, with more than 500,000 patients treated.

The CHMP positive opinion is based on the well established long-term safety and efficacy profile of Tecfidera plus data from pharmacokinetic bridging studies comparing the two drugs.

Vumerity has been available in the US for nearly two years, after gaining approval from the Food and Drug Administration for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease. Vumerity has since overtaken Tecfidera to become the number one prescribed oral MS therapy in the country.

In 2020, Biogen reported sales of $3.84bn of Tecfidera but the past year has seen its revenues drop, with GlobalData forecasting that Tecfidera will only generate $1.12bn in 2026 due to generic competition.

An estimated 2.8 million people live with MS across the globe, with some European countries demonstrating the highest prevalence.

Given the important role played by the Medicines and Healthcare products Regulation Agency (MHRA) within the European Medicines Agency (EMA) prior to the UK leaving the European Union, it is no surprise that adjustments would be needed.

However, the future of the agency and the prime minister’s ambition to make the UK a ‘science superpower’ are now in question if budget cuts force the MHRA to lay off 300 of 1,200 employees, say five UK trade unions.

After Brexit, the EMA moved its headquarters from London to Amsterdam, with the unions saying “fewer staff will therefore be asked to cover more ground with fewer resources, all while operating under a pay freeze”.

The budget cuts are driven by Brexit, which had seen the MHRA lose millions of pounds of funding from the European regulatory system. The agency has said it will be making savings in its operating costs, as well as redeploying and retraining staff in new areas of regulation and science.

Regulatory experts believe the cuts are more likely to restrict the MHRA’s ability to keep up with developments in the EU and force it to simply rubber-stamp approvals from larger regulators.

Concerns have been building since early August when senior members of the agency’s drug approval team wrote to the MHRA chief executive June Raine, expressing ‘deep concern at an emerging narrative’ over the future of the agency.