Boston Medical Center

Agomab’s lead candidate is being investigated as a treatment for patients with fibrostenosing Crohn’s disease (FSCD). Credit: Hananeko_Studio via Shutterstock. Agomab Therapeutics has secured $89m in Series D funding to support clinical trials of its fibrotic disease treatments, with some help from Sanofi . Belgium-based Agomab announced that Sanofi and Invus have joined as new investors in its latest funding round, following on from a $100m Series C round in October 2023, and a $114m Series B where Pfizer led an extension round. The funds will be used to advance the development of Agomab’s lead candidate AGMB-129, a treatment for patients with fibrostenosing Crohn’s disease (FSCD). The oral small molecule inhibitor of ALK5 (TGFβ1R) is currently being investigated in the Phase IIa STENOVA trial (NCT05843578). The company expects to share interim results from the 90-patient trial in early 2025. Positive data from the Phase I trial (NCT04933565) of AGMB-129 was reported in February 2023, where the candidate demonstrated high local exposure in the ileum, with no drug-related safety signals or dose-limiting toxicities. Patients with FSCD have strictures in the intestines caused by inflammation and scarring, for which there is no cure. The company also has an inhaled treatment for idiopathic pulmonary fibrosis (IPF), named AGMB-447, and a liver cirrhosis candidate AGMB-101. AGMB-447 is being investigated in a Phase I trial (NCT06181370) and Agomab plans to start clinical development of AGMB-101, which is “in the final stages of IND-enabling studies”. See Also: Dyno and Roche collaborate on neurological gene therapies Takeda and BMC partner to decarbonise US healthcare sector Sanofi continues to assert itself in the immunology space, signing deals with parties such as Recludix, Teva Pharmaceutical and IGM Biosciences . The company expanded its immunology pipeline further in June 2024, entering a $700m strategic partnership with Belharra Therapeutics to spur the development of small molecule therapies for immunological diseases. Sanofi and Regeneron’s immune-targeting biologic Dupixent (dupilumab) has been picking up label expansions since its 2017 US Food and Drug Administration (FDA) approval for atopic dermatitis. The drug earned $11.6bn last year, as per Regeneron’s financials, and is set to generate $23.6bn in 2030, according to GlobalData consensus forecasts. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the funding, Agomab’s CEO Tim Knotnerus said: “We are thrilled to have Sanofi and Invus joining our investor syndicate. Their investment as well as the continued support from our existing shareholders is another validation of the trailblazing work our team is conducting in the fields of fibrostenosing Crohn’s disease and idiopathic pulmonary fibrosis.”

The collaboration specifically targets GHGs from pharmaceutical packaging and single-use plastics. Credit: Mumemories/Shutterstock. Takeda and the Boston Medical Center (BMC) have announced a partnership aimed at tackling decarbonisation across the US healthcare ecosystem. Their collaboration specifically targets the reduction of greenhouse gas emissions (GHGs) due to regulated medical waste disposal, such as single-use plastics and pharmaceutical packaging. It is poised to identify and pilot solutions to reduce hard-to-abate emissions, and to share findings to facilitate adoption across the healthcare industry. By implementing waste audits and testing new technologies, BMC aims to pinpoint emission hotspots and address them effectively. BMC health system senior vice-president and chief sustainability and real estate officer Robert Biggio stated: “Increasing health risks exacerbated by climate change, such as extreme heat, pollution, biodiversity loss and other environmental impacts, are a real and direct threat to patient and community wellbeing. “Our collaboration with Takeda aims to drive meaningful change by tackling environmental challenges that contribute to health disparities in many communities. “This collaboration is a critical step in driving innovation in the medical supply chain that can be shared with other health care organisations for a healthier environment for all communities.” For Takeda, the initiative aligns with its commitment to achieving net zero GHG emissions by 2035 in its operations and by 2040 across its value chain. The Science Based Targets initiative (SBTi) validated Takeda’s GHG emission goals in 2024, confirming their alignment with the global effort to limit temperature rise to 1.5°C above pre-industrial levels. BMC is the first hospital in the US to utilise a rooftop solar array to aid patients with energy insecurity, and has established rooftop farms to supply fresh produce for its needs. It opened the first net-zero-ready behavioural health facility and issued sustainability bonds, raising $232m for campus renovations to enhance patient care. The collaboration between Takeda and BMC will involve engaging with industry stakeholders, including waste vendors and suppliers, to establish and disseminate new best practices.

Nitrosamine impurities in drugs. Credit: Linaimages via Shutterstock. Drug impurities such as nitrosamines can often contaminate drugs leading to recalls and regulatory actions given their carcinogenic nature. These nitrosamine-related recalls have significantly increased in the last three years as per data from the US Pharmacopeia (USP), said Harmony Biosciences quality assurance director Danita Broyles at a recent conference. At CPHI Europe, Broyles emphasised that “even having those ingredients in your product can compromise patient safety and product recalls or import alerts, or warning letters- that leads to drug shortages and loss of business revenue”. Nitrosamines are organic compounds formed from nitroso and amino groups, which were first detected in the 1800s but have gained significant attention in the 1950s. Now, companies need to be concerned with nitrosamines in both finished drug products and active ingredients, said Broyles. Risk assessment practices to avoid nitrosamine contamination The first step in managing nitrosamines involves the risk evaluation of API synthesis, drug product formulation, and potential for nitrosamine formation. Broyles said it is crucial to test for nitrosamines relevant to a specific product rather than following blanket statements applicable to a group of products. Confirmatory testing is essential if a risk is identified and documentation of all steps and testing is necessary, as it is important to maintain thorough records for quality assurance and regulatory compliance. Health authorities also expect companies to thoroughly understand their supply chains and manufacturing processes, and each time a new excipient is introduced, a risk assessment is required to comply with health authority guidelines. Risk assessment of API solvents is also essential according to the speaker while companies should evaluate all sources of tertiary, secondary, and nitrosating agents, as well as conditions that could facilitate nitrosamine formation. See Also: Takeda and BMC partner to decarbonise US healthcare sector AbbVie and Richter partner for neuropsychiatric treatments Changes in supply chains require risk assessments as well. Firstly, manufacturers need to proactively get an in-depth understanding of supplier histories, enhance supplier management systems, and use scavengers to prevent nitrosation, said Broyles. Or else, manufacturers should switch to alternative suppliers or optimise manufacturing processes to remove potential nitrosamine sources, which is a strategy that some pharmaceutical companies are adopting. The significance of remaining proactive and informed about new health authority guidelines while managing supplier relationships was a theme emphasised throughout her talk. Broyles encourages companies to use online resources to stay informed and proactive in managing nitrosamine risks, underlining the importance of collaboration and continuous learning. Some of the online tools she suggested were the Nitrosamines Exchange by USP, which provides a platform for sharing information and support; the Nitrosamines Exchange, which offers regulatory guidance updates and community support with translations in different languages; and the Lost Excipient database for information on nitrosating agents in excipients.