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EyesOn Clinical Assets
- Jana Chisholm
- 21 hours ago
- 10 min read
We still have EyesOn Clinical Asset updates. This week we cover GSK's FDA approval for Jideytro, Royalty's ATTR royalty deal, plus the Sanofi and Roche portfolio adjustments that include discontinuation of some assets.
GSK has received FDA approval for Jideytro (zidesamtinib), the first commercial lung cancer medication in the company’s history, marking a significant milestone for its oncology goals.
GSK’s recent $10.6 billion acquisition of Nuvlaent enabled the milestone. Approximately two months before the FDA’s anticipated decision date of September 18th, and only one week after the British pharmaceutical company concluded the acquisition, Jideytro was approved.
Adult patients with advanced ROS1-positive non-small cell lung cancer who have previously received a ROS1 inhibitor can now receive treatment with Jideytro. According to the business, Jideytro’s quick development to clearance is a testament to the strength of the underlying research as well as the pressing need for more safe and effective treatments for ROS1-positive lung cancer.
GSK estimates that 50,000 new instances of ROS1-positive NSCLC are diagnosed globally each year, primarily in nonsmokers in their 40s and 50s who may require years of treatment.
Given that none of the current ROS1 NSCLC medications - made by Pfizer, Roche, Bristol Myers Squibb, and most recently, Nuvation Bio - have even approached that goal, GSK has made the bold prediction that Jideytro has multi-blockbuster potential.
Jideytro’s distinct molecular structure sets it apart from other treatments like BMS’ Augtyro and Pfizer’s Xalkori. Jideytro was created by Nuvalent to minimise off-target toxicity by overcoming treatment-emergent ROS1 mutations while protecting the structurally related TRK family. In order to address brain metastases, a frequent consequence of ROS1-positive NSCLC, it has strong central nervous system penetration.
Jideytro recorded an objective response rate of 44% in 117 patients with ROS1 inhibitor-pretreated NSCLC in the single-arm Arros-1 phase 1/2 clinical trial. At six months and twelve months, respectively, 82% and 69% of responders were still in remission.
According to the medication’s label, responses were seen in 48% of 50 patients with detectable brain metastases, including 22% with a full response. The 42 patients with ROS1 resistance mutations also had a 50% ORR rate.
Even with the encouraging statistics, GSK still has a way to go before Jideytro becomes a blockbuster. David Hung’s Ibtrozi (taletrectinib) of Nuvation Bio is one of its main rivals. Ibtrozi, which similarly has intracranial activity and TRK sparing, brought in $18.5 million in the first quarter of 2026 after receiving a line-agnostic FDA approval for ROS1-positive NSCLC in June 2025.
Only individuals who have already taken a ROS1 inhibitor are permitted to utilise the GSK medication under the current Jideytro label. The business cited Nuvalent’s earlier statement that it will look to expand its first-line label this year.
Nuvalent also presented encouraging preliminary data for zidesamtinib in non-NSCLC solid tumours at the 2026 American Society of Clinical Oncology annual meeting, suggesting the medication may have pan-tumor potential with a 40% ORR across 10 tumour types.
The first product to come out of GSK’s acquisition of Nuvalent is Jideytro. With an FDA target action date of November 27th, 2026, neladalkib, a fourth-generation ALK inhibitor, may be the next treatment for advanced ALK-positive NSCLC. For such medication, GSK has also expressed aspirations for many blockbusters.
In addition to the Nuvalent assets, GSK is developing a phase 3 extensive-stage small-cell lung cancer research for risvutatug rezetecan (ris-rez), an antibody-drug combination that targets B7-H3. Hanson Pharma, the drug’s initial originator, recently announced a phase 3 success in SCLC in China.
Side Note: GSK has revealed plans to relocate roughly 1,000 employees to a new research and development (R&D) facility on the Cambridge Biomedical Campus and shut down its Stevenage location.
Although the company has been in Stevenage for fifty years, it claims that the new location in the UK’s Golden Triangle for life sciences will speed up research and development and help produce new, competitive goods.
Employees will relocate gradually, and the Stevenage location is scheduled to close in 2029.
GSK aims to enhance its current R&D laboratories in Ware, Hertfordshire, and relocate some personnel there as part of the £400 million investment plans.
The MP for Stevenage, Kevin Bonavia, expressed his profound dissatisfaction with GSK’s lack of meaningful involvement prior to the announcement of these plans, saying it was unfortunate for the town and creating needless uncertainty for workers and the community at large. He is worried about all GSK employees and the impacted families in Stevenage. Even if jobs are scheduled to relocate to areas that are accessible from Stevenage, many residents will still experience inconvenience. He went on to say that after 2029, he will put in a lot of effort to secure new funding for the prior location.
Modern labs and infrastructure will support research in GSK’s key areas of oncology, respiratory, hepatology, vaccines, and HIV at its new Cambridge location, which is now under development, according to the company.
Employees at the Cambridge Centre for Data-Driven Discovery, Cambridge-GSK Translational Immunology Collaboration, Cambridge Immune Ageing, the GSK-Teichmann Lab, and the company’s clinical unit at Addenbrooke’s Hospital are just a few of the more than 22,000 life sciences professionals who work at the Cambridge Biomedical Campus, according to GSK.
Along with Addenbrooke’s and Royal Papworth hospitals, the property also houses AstraZeneca, a rival pharmaceutical company, and a new Cambridge Cancer Hospital is being built.
With top universities, hospitals, and biotech firms, Cambridge has created one of the best life sciences ecosystems in the world, according to Tony Wood, chief scientific officer of GSK. The campus offers outstanding chances for teamwork. This action accelerates the science that is most important for GSK’s next wave of medications, which is a catalyst for quicker, bolder drug development thanks to the company’s current relationships and experience.
GSK declared five years ago that it intended to grow its Stevenage facility, stating that by the end of the decade, Stevenage would become a premier location for scientific and medical research. It appears that Cambridge is becoming too alluring supported by direct services to Stevenage from the recently opened Cambridge South Station.
According to the organization, it hopes that the majority of its employees will relocate with them.
The Cambridge location will be a part of GSK’s larger UK network of partnerships with top universities and cutting-edge scientific institutions, such as the University of Oxford, King’s College London, Imperial College, the University of Manchester, Wellcome, and the Crick Institute.
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Royalty Pharma has acquired another transthyeritn-mediated (ATTR) amyloidosis medication. They previously paid Neurimmune $125 million up front in exchange for a portion of the revenues of its AstraZeneca-partnered medication.
The candidate, known as cliramitug or NI006, was licensed by AstraZeneca from Neurimmune in 2022. With the possibility of up to $730 million in development, regulatory, and commercial milestones, as well as low-to-mid teen royalty on net sales should cliramitug get it to market, the contract paid the Swiss biotech $30 million up front.
Those payments are the focus of royalty. In exchange for royalties of 3% to 4% on global sales of cliramitug, the company, the biggest buyer of biopharma royalties worldwide, has agreed to pay $125 million up front and another $125 million in the first quarter of the following year. Neurimmune may potentially receive $425 million in total because the transaction also includes up to $175 million linked to clinical and regulatory milestones.
The Swiss company has released findings from a phase 1 study of cliramitug in transthyretin amyloid cardiomyopathy (ATTR-CM) since Neurimmune’s 2022 agreement with AstraZeneca, claiming that the results demonstrated significant decreases in cardiac amyloid deposition at higher doses. The treatment is currently undergoing a phase 3 trial at AstraZeneca’s Alexion rare disease unit, scheduled for read out in 2028.
The protein at the core of ATTR, misfolded transthyretin, is the target of cliramitug. The protein’s capacity to attach to other molecules is compromised by structural changes, which can result in deposits in the heart or neurones.
Currently, medications such as Pfizer’s Vyndaqel and Vyndamax, Alnylam’s Onpattro and Amvuttra, and AstraZeneca’s Wainua are used to treat the resultant cardiomyopathy and polyneuropathy, known as ATTR-CM and transthyretin amyloid polyneuropathy (ATTR-PN).
Earlier this month, Wainua encountered difficulties when the Ionis-partnered antisense oligonucleotide (ASO) inhibitor, which was authorised to treat ATTR-PN polyneuropathy, failed a phase 3 trial for ATTR-CM. Although analysts at the time pointed out that AstraZeneca still had a chance with cliramitug, the unexpected outcome cast doubt on the company’s ATTR strategy.
Analysts pointed out that because the depleter is developed to directly attack amyloid accumulation, it may be able to reverse disease biology rather than slow its advancement. Although amyloid load and cardiac biomarkers have decreased in early-stage burden, cliramitug’s clinical utility will rely on showing significant improvements in cardiovascular outcomes in the ongoing phase 3 trial.
It is obvious that Royalty Pharma thinks the medication has promise. Eight months ago, the business joined the ATTR market by paying $310 million up front in exchange for a 1% royalty on Amvuttra sales over the following nine years.
According to the business, the ATTR-CM market exceeded $7 billion in sales last year, growing by more than 40%.
Pablo Legorreta, CEO of Royalty Pharma, highlighted cliramitug’s unique mechanism, promising clinical outcomes and commercial potential in a sector with unmet treatment needs. The company’s second recent investment in this indication, cliramitug, has the potential to change the direction of ATTR-CM. The company’s development-stage pipeline is further strengthened by this therapy, which has the potential to eventually contribute significantly to its portfolio.
Neurimmune stated that while keeping the majority of its royalty and milestone interests in cliramitug, the biotech will use the profits to further its internal pipeline, which is headed by a phase 2 SOD1-targeting therapy for amyotrophic lateral sclerosis.
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Sanofi's portfolio optimization has impacted several clinical assets including amlitelimab for use in treating atopic dermatitis (AD). Management acknowledges that the medication that was once predicted to be a big hit will not significantly enhance current therapies.
In 2021, Sanofi acquired Kymab for $1.1 billion, which included amlitelimab. However, the anti-OX40 ligand antibody was doomed as early as September 2025, when a phase 3 trial met the study’s primary goals but fell short of analyst expectations and the standard set by Sanofi and Regeneron’s Dupixent.
Even worse, in January, a different set of phase 3 research saw a primary endpoint hit but missed other important metrics. Sanofi promised to pursue approvals based on all available data in spite of the setback. However, a number of clinical disappointments, including amlitelimab, led to Paul Hudson’s dismissal as CEO of Sanofi.
The board of Sanofi has tasked Hudson’s successor, Belén Garijo, with organising the pharmaceutical company’s R&D strategy. She has already left her mark by selecting former Roche executive Paulo Fontoura, M.D., Ph.D., to succeed former R&D leader Houman Ashrafian, Ph.D..
Garijo is in charge of Sanofi’s announcement this morning that amlitelimab in AD will be phased out as part of a continuing strategic evaluation of the pipeline.
According to Sanofi, amlitelimab’s continued development in AD is not supported by the entirety of the efficacy and safety data that has been produced thus far.
Amlitelimab would not significantly improve the standard of care for patients with AD, according to Sanofi, even though the Estuary phase 3 long-term extension study demonstrated long-term maintenance of clinical response without relapse in patients aged 12 and older with moderate-to-severe AD and an emerging safety profile that builds on prior data.
Amlitelimab for AD was supposed to be approved in the second half of this year, according to the official schedule until recently. Following a phase 2 failure last year, the business had already chosen not to pursue the medication for asthma; however, a mid-stage research in coeliac disease is scheduled to come out later in 2026.
The decision does not force Sanofi to change its full-year 2026 guidance, according to the company, which is scheduled to release its second-quarter earnings next week.
The chief of pharma at Roche stated that the company still has a plan for creating cell treatments for autoimmune illnesses, despite having abandoned work on a T-cell engager (TCE) for lupus.
The Swiss pharmaceutical company reported that it had halted development of RG6382, a T-cell-engaging bispecific antibody that targets CD19 and CD3, as part of a larger pipeline clearout during its second-quarter earnings results, which were posted on July 23rd. In a phase 1 open-label study of patients with systemic lupus erythematosus (SLE), the business had been assessing the treatment.
However, a Roche representative clarified that after analysing the data thus far, it is evident that this molecule lacks the necessary qualities to proceed with this indication. The spokesperson continued, “This discontinuation marks the termination of its development because SLE was the lead indication for this asset.”
In recent years, autoimmune illnesses have gained popularity as targets for cell treatments, particularly CAR-T therapies. Kyverna Therapeutics may be the first to market with mivocabtagene autoleucel for stiff person syndrome.
Roche mentioned the possibility of utilising Poseida Therapeutics’ cell therapy pipeline, which includes a BCMAxCD19 CAR-T, to treat autoimmune diseases when it reached a $1.5 billion deal to acquire the firm in 2024.
Teresa Graham, CEO of Roche Pharmaceuticals, stated that autoimmune illness was a factor in the Poseida agreement. The business is currently investigating the possibility of cell therapies and plans to continue development with further updates in the near future.
Two medications under phase 2 development were part of the pipeline clearout. As part of its acquisition of Carmot Therapeutics, Roche purchased CT-868, a once-daily dual GLP-1/GIP receptor agonist for Type 1 diabetes.
Roche has chosen to give priority to another Carmot asset for T1D, enicepatide, a once-weekly GLP-1/GIP agonist, despite positive phase 2 data for CT-868.
Roche stated that it makes more sense to concentrate on this initiative because enicepatide is also being assessed for obesity. According to the business, enicepatide can provide patients with diabetes with optimum therapeutic differentiation and has the best-in-disease potential for glycaemic management. Later on, further information on plans for enicepatide in T1D will be disclosed.
An anti-Tie2 agonist known as RG6351 was the other mid-stage asset that was discarded. Roche has been evaluating the treatment for diabetic macular oedema (DME), both alone and in conjunction with Vabysmo or Eylea.
However, the corporation stated that a review of the data indicated a slim chance of defeating Vabysmo. The study confirmed that Vabysmo’s combination suppression of VEGF/Ang-2 is believed to give patients with DME strong Tie2 pathway activation.
A number of phase 1-stage medications were withdrawn by Roche further back in its development. These included mosperafenib, a BRAF inhibitor being tested for solid tumours, in addition to the TCE. According to the firm, that experiment ended in April.
Despite encouraging data from the phase 1a/b study, the company feels that the best course of action for this asset and the larger community would be to license it to a competent partner.
Another solid tumour candidate, RG6468, which was being evaluated in conjunction with Tecentriq, joined Mosperafenib on the trash pile. Roche admitted that the company had chosen to stop the development after examining the phase 1 data, but it did not confirm RG6468’s course of action.
Roche’s decision earlier this month to abandon two of its Huntington’s disease prospects, including the phase 2-stage tominersen, which was collaborated with Ionis Pharmaceuticals, was also confirmed by the company’s second-quarter earnings.
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