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AstraZeneca to Acquire EsoBiotec...

By engineering immune cells directly within the patient’s body, EsoBiotec is eliminating the barriers of traditional cell therapies and unlocking new possibilities for oncology and immune-mediated diseases.

Signal12 gears up for...

BOSTON, March 18, 2025: Signal12, a clinical-stage ophthalmic pharmaceutical company has announced the...
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AstraZeneca to Acquire EsoBiotec for $1B. Aims to advance cell therapy ambition

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Mont-Saint-Guibert, Belgium, March 17, 2025: AstraZeneca has entered into a definitive agreement to acquire EsoBiotec, a biotechnology company pioneering in vivo cell therapies that has demonstrated promising early clinical activity.

EsoBiotec is a leading in vivo cell therapy company with the mission to make these innovative treatments more accessible, effective and affordable. By engineering immune cells directly within the patient’s body, EsoBiotec is eliminating the barriers of traditional cell therapies and unlocking new possibilities for oncology and immune-mediated diseases.

The EsoBiotec Engineered NanoBody Lentiviral (ENaBL) platform empowers the immune system to attack cancers and could offer many more patients access to transformative cell therapy treatments delivered in just minutes rather than the current process which takes weeks.

ENaBL uses highly targeted lentiviruses to deliver genetic instructions to specific immune cells, such as T cells, which programme them to recognise and destroy tumour cells for cancer treatment or autoreactive cells for potential use in immune-mediated diseases. This approach enables cell therapies to be administered through a simple IV injection and without the need for immune cell depletion.

Traditional cell therapies require cells to be removed from a patient, genetically modified outside the body, and then readministered to the patient as a medicine after immune cell depletion, typically taking weeks. By engineering immune cells directly within the patient’s body, the EsoBiotec in vivo approach has the potential to address many of the barriers associated with traditional cell therapies, reducing complexities and manufacturing timelines, thereby increasing access for patients.

AstraZeneca will acquire all outstanding equity of EsoBiotec for a total consideration of up to $1bn, on a cash and debt free basis. This will include an initial payment of $425m on deal closing, and up to $575m in contingent consideration based on development and regulatory milestones.

The transaction is expected to close in the second quarter of 2025, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2025.

The acquisition is part of AstraZeneca’s ambition to realise the full potential of cell therapies. Towards this it is also building world-class cell therapy capabilities and advancing a broad pipeline of cell therapies, enabled by technologies including chimeric antigen receptor T-cells (CAR T), T-cell receptor therapies (TCR T) and CAR T regulatory (CAR Tregs) cells.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “We are excited about the acquisition of EsoBiotec and the opportunity to rapidly advance their promising in vivo platform. We believe it has the potential to transform cell therapy and will enable us to scale these innovative treatments so that many more patients around the world can access them. EsoBiotec will accelerate and expand the impact of our recent investments and marks a major step forward in realising our ambition to harness the full potential of cell therapy.”

Jean-Pierre Latere, CEO, EsoBiotec, said: “We look forward to working with AstraZeneca, a global leader in drug development, to advance our shared goal of bringing transformative cost-effective cell therapies to more patients globally. By combining our expertise and resources, we can accelerate the development of our in vivo platform which has a novel delivery technology we believe will have broad therapeutic applicability.”

EsoBiotec will become a wholly owned subsidiary of AstraZeneca, with operations in Belgium.

Signal12 gears up for phase 3 clinical trials for ocular graft-versus-host disease

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BOSTON, March 18, 2025: Signal12, a clinical-stage ophthalmic pharmaceutical company has announced the alignment of its Phase 3 clinical trial strategy for Pro-ocular™ with the U.S. Food and Drug Administration (FDA).

The novel drop-free therapy is poised to revolutionize the treatment of ocular Graft-versus-Host Disease (oGvHD). This key regulatory milestone, achieved following a highly productive Type C meeting, sets the stage for Signal12’s transformative Phase 3 clinical research in an area of high unmet medical need.

Ocular Graft-versus-Host Disease, an orphan condition impacting roughly 50,000 patients annually in the United States, currently has no FDA-approved treatment. Pro-ocular has demonstrated its potential to not only boost tear production but also deliver significant relief from ocular pain, offering a promising new lifeline for patients debilitated by this severe condition.

“This alignment on the Phase 3 requirements with the FDA represents a major step forward for patients suffering from oGvHD,” said Tom Mitro, Chief Executive Officer at Signal12. “We believe Pro-ocular can significantly improve patient’s quality of life by providing sustainable relief from the signs and symptoms of this highly debilitating disease. Our team looks forward to initiating our Phase 3 trial as soon as possible.”

In a robust Phase 2 trial conducted over 10 weeks—a double-masked, placebo-controlled study involving 33 patients randomized 2:1 to Pro-ocular 1% or placebo—results revealed statistically significant and clinically meaningful improvements across multiple efficacy endpoints.

These improvements, which included improved corneal staining and ocular symptom scores , were sustained over a two-year open-label extension without any drug-related serious adverse events. The trial, executed in collaboration with Harvard Medical School’s renowned Mass Eye and Ear Infirmary, reinforces Pro-ocular’s potential as a breakthroughr therapy in oGvHD management.

“The FDA’s positive feedback on our Phase 3 trial design underscores the urgent need for new and effective interventions for oGvHD,” stated Marv Garrett, Senior Vice President of Regulatory Affairs at Signal12. “Our Phase 2 results, showing meaningful improvements in corneal staining and ocular dryness, highlight the disruptive potential of Pro-ocular as a potential treatment for this disease. We’re highly enthusiastic about advancing to the next stage of clinical research.”

Having achieved this important regulatory milestone, Signal12 is now strategically positioned to drive forward a Phase 3 clinical program that could redefine the treatment landscape for oGvHD. This development underscores the company’s commitment to addressing critical therapeutic gaps.

Detailed study outcomes are accessible at https://signal12inc.com/clinical-trials/.