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This month we've been watching how different companies are managing their pipelines, and keeping Eyes On other hot news topics. What do you have Eyes On?
AbbVie has returned to modality after beginning the year with a T-cell engager deal. This time, Xilio Therapeutics is receiving $52 million upfront from the pharmaceutical company to develop antibody-based immunotherapies. Having recently made agreements with Simcere Zaiming and Evolvelmmune, AbbVie is no stranger to T-cell engagers. The goal of the multi-program partnership is to create innovative immunotherapies, such as masked T-cell engagers, by fusing Xilio's exclusive tumor-activation technology with AbbVie's oncology knowledge.
AbbVie is responsible for paying up to $2.1 billion in option-related fees and milestones, in addition to the $52 million upfront cost, which includes a $10 million equity investment in Waltham, Massachusetts-based Xilio. This is in addition to any prospective royalties.
Bispecific antibodies known as T-cell engagers attach to both T cells and a molecule on a target cell, forcing the T-cells to attack the target. In recent months, the modality has been at the centre of a number of biotech announcements, such as the launch of GSK-backed Ouro Medicines, the $925 million deal between Candid Therapeutics and WuXi Biologics, and the excitement surrounding Janux Therapeutics' phase 1 prostate cancer asset.
With an upfront payment of $65 million in October 2024 to license EvolveImmune's multispecific biologics for a variety of targets in solid and haematologic cancers, AbbVie is no stranger to this market. The Big Pharma then announced one of the most substantial agreements at the J.P. Morgan Healthcare conference last month when it gave China's Simcere Zaiming an undisclosed upfront payment for a phase 1-stage trispecific antibody, with the possibility of up to $1.05 billion in milestone payments.
Xilio also announced three preclinical T-cell engager initiatives targeting the tumor-associated antigens PSMA, CLDN18.2, and STEAP1 in conjunction with AbbVie's partnership.
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The Connecticut-based cancer and rare illness medication developer SpringWorks Therapeutics has caught the interest of Germany’s Merck KGaA as it approaches a significant regulatory decision in the United States. Although Merck KGaA acknowledged the advanced talks, there is no guarantee that an agreement would be reached at present. The market value of SpringWorks was approximately $3 billion. In response, investors caused the company's share price to soar 34%, bringing its market capitalisation above $4 billion.
This comes as SpringWorks is waiting for the FDA to approve its MEK inhibitor mirdametinib by the end of this month. Mirdametinib, which is expected to be SpringWorks' second commercial medication after the desmoid tumour drug Ogsiveo, would be the first FDA-approved treatment for adults and children with neurofibromatosis type 1 (NF1) who have symptomatic plexifor neurofibromas (PN) if it is approved with the company's desired label.
Mirdametinib will have to compete with AstraZeneca's Koselugo in the U.S. market if SpringWorks' medication is approved by the FDA. Given Ogsiveo's launch trajectory and the company's ability to grow into a multi-product narrative, SpringWorks is of strategic value.The company's two main medications have the potential to reach $1 billion in sales at their peak.
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Novartis has reinstated abelacimab. In order to add the clot-busting potential to its late-phase pipeline, Novartis has agreed to pay $925 million up front to acquire Anthso, six years after spinning out the asset to become Anthos Therapeutics.
The purpose of the anti-factor XI/XIa antibody abelacimab is to prevent blood clots without increasing the risk of bleeding and bruises. The benefits of preventing clots are outweighed by the increased risk of bleeding because modern anticoagulants, like Bayer and Johnson & Johnson's Xarelto, affect both thrombosis and haemostasis.
Anthos has demonstrated that abelacimab is superior to the current medications by associating the drug candidate with lower rates of bleeding than Xarelto and an 80% decrease in venous thromboembolism when compared to enoxaparin in phase 2 trials. Three phase 3 trials were initiated by the biotech in 2022.
It appears that Novartis will be responsible for concluding the phase 3 investigations, which are scheduled to be completed in 2026. The pharmaceutical company anticipates closing the deal in the first half of 2025 and has agreed to pay $925 million up front, plus up to $2.15 billion in regulatory and sales milestones. In 2019, Novartis and Blackstone Life Sciences agreed on a $250 million Anthos setup.
By purchasing Anthos, Novartis will once again be able to compete with other factor XI candidate developers. The target is being pursued by a number of drug developers who think they can enhance oral anticoagulants that do not include vitamin K. The market is dominated by that older medicine class, which includes Pfizer's Eliquis, Bristol Myers-Squibb, and Xarelto. However, in the upcoming years, leading companies will have to contend with broader competition.
Since Novartis sold off abelacimab, the factor XI field has experienced setbacks. Compared to Eliquis, Bayer discovered that around twice as many patients died from heart attacks, strokes, or other cardiovascular events when taking its factor XIa inhibitor asundexian. Despite failing a phase 2 study, BMS and J&J's milvexian entered three phase 3 trials in 2023.
Still, the industry remains competitive. Two antibodies targeting distinct domains of factor XI are being developed by Regeneron; one is intended to optimise anticoagulation, while the other may be less effective but less likely to result in bleeding. Late last year, the company released phase 2 data on the candidates.
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Large-scale biopharma M&A in 2025 has already brought about two significant deals. Johnson & Johnson paid $14.6 billion last month to acquire Intra-Cellular Therapies, a central nervous system biotech located in New York City, as an opening move at this year's J.P. Morgan Healthcare Conference. The investment firm Bain Capital just announced last week that it was paying $3.3 billion (510 billion Japanese yen) to buy Mitsubishi Tanabe Pharma from the parent company of the Japanese pharmaceutical manufacturer, Mitsubishi Chemical Group.
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The FDA placed a hold on Amgen's early-stage obesity asset. Amgen has not specified the mechanism of the asset, known as AMG 513, but did emphasise in its fourth-quarter and full-year earnings call that it still expects to continue going forward with the candidate and does not think the issue is related to the medicine.
Amgen has two clinical-stage obesity assets, including AMG 513. MariTide, the company's more well-known candidate, is presently enrolled in a phase 2 trial for diabetes and is also in a phase 2 trial for obesity. The first part of this year will see the start of a phase 3 trial with numerous indications. Apart with AMG 513 and MariTide, Amgen is also looking into a number of other possible obesity medications that might be administered orally or subcutaneously and target both integrins and non-integrins.
Another early-stage obesity asset, AMG 786, was discontinued by the company in May 2024. Fipaxalparant, a lysophosphatidic acid receptor 1 antagonist, was discontinued by Amgen in a phase 2 trial for diffuse cutaneous systemic sclerosis in addition to the AMG 513 revelation. This was due to the asset's failure to fulfil primary and secondary endpoints. In October, the same medication failed a second phase 2 trial, this time in idiopathic pulmonary fibrosis (a lung disease).
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President Donald Trump's administration has implemented a new initiative that will immediately reduce billions of dollars in funding for NIH’s "indirect costs" associated with biomedical research, including premises, equipment, and administrative costs. The reductions are expected to result in annual savings of almost $4 billion.
The National Institutes of Health is the largest public supporter of biomedical research in the world, with an annual budget of around $48 billion. The new policy, which will not be implemented retroactively, restricts the indirect cost rate on all NIH grants at 15%. This is in contrast to the agency's historical average of 28% to 29%.
The federal agency spent approximately $35 billion for roughly 50,000 grants to over 300,000 researchers in the United States for the fiscal year 2023. Of that amount, about $26 billion went towards direct research expenses, and the remaining $9 billion went into overhead. The NIH cited other indirect cost rates from private grant-making organisations, including the Chan Zuckerberg Initiative's 15% and the Grants Foundation's 10%.
The medical and research communities have been overwhelmingly opposed to the modifications since they were revealed. To halt the action, attorney generals from 22 states sued the government, claiming that the NIH modification violated the Administrative Procedure Act and was illegal. According to documents filed in a Massachusetts court, a federal judge temporarily banned the NIH plan in the 22 states that are part of the complaint. A temporary restraining order was issued by Judge Angel Kelley to stop the 15% cap from taking effect in those states.
The states included in the temporary restraining order are: Arizona, California, Connecticut, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Rhode Island, Vermont, Washington and Wisconsin.
A hearing on the issue is scheduled for February 21st. We will keep an eye on the proceedings and provide an update.
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