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Gilead to advance first T cell engager for autoimmune diseases

Gilead Sciences has entered an agreement to acquire Ouro Medicines, a biotechnology company focused on developing T cell engager therapies for autoimmune diseases.
The acquisition adds OM336 (gamgertamig), a clinical‑stage BCMAxCD3 T cell engager, to Gilead’s inflammation portfolio.
OM336 is designed to enable rapid and deep B cell depletion following a limited subcutaneously administered treatment course. In ongoing Phase I/II clinical studies, OM336 has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune haemolytic anaemia (AIHA) and immune thrombocytopenia (ITP).
Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the US FDA for the treatment of AIHA and ITP and is expected to enter registrational studies in 2027.
“This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases,” said Dietmar Berger, Chief Medical Officer of Gilead. “BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control.”
Redefining treatment for immune-mediated diseases
BCMA‑targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA‑expressing plasma cells, clinical data suggests these agents may reduce inflammation, improve organ‑level disease, and, in some cases, enable an immune reset marked by durable, drug‑free remission without ongoing immunosuppression.
“From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases,” said Jaideep Dudani, Co-Founder and Chief Executive Officer of Ouro Medicines. “Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation—leveraging a proven track record in late stage development, launch, and commercialisation to accelerate our programmes and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences.”
Under the terms of the agreement Gilead will acquire all of the outstanding equity of Ouro Medicines for a total of $1,675 million in upfront cash consideration, subject to customary adjustments, which is payable at closing, and up to $500 million in contingent milestone payments.
Gilead is also currently in advanced discussions with Galapagos with respect to a potential research and development collaboration on the acquired Ouro Medicines assets.
The post Gilead to advance first T cell engager for autoimmune diseases appeared first on Drug Discovery World (DDW).
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New webinar: Tackling drug discovery challenges in cancer research

Hosted by Drug Discovery World and supported by Sartorius and BioIVT, this webinar will explore the opportunities and challenges that exist within cancer research drug discovery and development.
You will hear from Dr Sudha Rao, Chief Scientific Officer of Kazia Therapeutics, Karol Budzik, PhD, Business Development Associate at Vyriad Therapeutics and Lars van der Veen, Chief Scientific Officer at iOnctura.
Presentations will cover how cancer treatments have shifted towards reprogramming the biology driving tumour growth, immune escape and treatment resistance, the trajectory that in vivo CAR-T treatments are taking, and how challenging tumours burdened by stroma and immune-mediated resistance can be tackled.
Q&A with the speakers follows the presentations.
The post New webinar: Tackling drug discovery challenges in cancer research appeared first on Drug Discovery World (DDW).
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Psilocybin proves promising in neuropathic pain mouse study
Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.
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New Spectrometry Technique Could Aid Formulation Development
New Spectrometry Technique Could Aid Formulation Development
A new technique combining two forms of spectrometry could help biopharmaceutical companies improve their choice of formulation buffer for antibody manufacturing by revealing how molecular forms and three-dimensional shapes of complex biologics respond to their environment. That’s the view of Christian Bleiholder, PhD, a professor at Florida State University who helped develop the technique.
According to Bleiholder, what happens structurally when a complex biological molecule, such as an antibody or viral spike protein, binds to its target is currently poorly understood.
“This is where [this approach] can help with the bioprocessing and formulation,” he says, as structural changes “can affect the lifespan [of the product] and lead to issues, such as aggregation.”
Because antibodies are complex, existing techniques tend to be powerful at different levels of complexity, he explains. Mass spectrometry is particularly powerful for distinguishing molecular composition, while structural approaches such as X-ray crystallography and cryo-electron microscopy can provide high-resolution structural information.
The challenge is understanding the link between these things within a heterogeneous sample, he says.
To overcome this, Bleiholder and his team worked with Bruker Daltonics to develop Tandem-Trapped Ion Mobility Spectrometry (Tandem-TIMS). This combines tandem ion mobility spectrometry with tandem mass spectrometry to disentangle three overlapping layers of molecular complexity: molecular form, three-dimensional shape, and binding or assembly state, he says.
He explains that, if the proteins have different structures, they can be characterized with tandem ion mobility spectrometry, and then mass spectrometry can be used to look at their molecular forms and binding states.
Going forward, Bleiholder hopes the technique can be used for formulation development but also earlier, during drug discovery of new products, such as multi-specific antibodies, to determine which molecular states are important and how those change when a biologic engages its target. He also plans to look at automating the technique.
Bleiholder spoke about using Tandem-TIMS at the Bioprocessing Summit in Boston earlier this year.
The post New Spectrometry Technique Could Aid Formulation Development appeared first on GEN – Genetic Engineering and Biotechnology News.
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