News

September 2025

NAYA Therapeutics to partner with Atley Solutions to accelerate the development and commercialization of NAYA’s At-211 radiopharmeceuticals.

Gothenburg, Sweden and MIAMI, Florida, US – 2 September 2025 – NAYA Therapeutics (“NAYA”), a clinical-stage biopharmaceutical company pioneering next generation cancer therapies through the development of astatine-211 (At 211) targeted alpha therapies (TATs) and bifunctional antibodies today announced that it has selected Atley Solutions, global leader in commercial products (Atley C100) and services for At-211 related pharmaceutical development and manufacturing, as a partner and supplier to accelerate the development, pre-clinical and clinical translation, and commercialization of NAYA’s At-211 radiopharmaceuticals. NAYA will leverage Atley’s planned European network of clinical manufacturing and development partners as well as deploy additional GMP drug manufacturing sites using the Atley C100 for final clinical-dose manufacturing of At-211 TATs.

“We’re thrilled to partner with Atley Solutions, a leader in the advancement of At-211 as a preferred radionuclide,” commented NAYA CEO Dr. Daniel Teper. “This partnership will enable us to use Atley’s scalable and automated Atley C100 manufacturing module, which allows for the purification, conjugation, preparation of therapeutic doses in close proximity to outpatient treatments centers – a breakthrough in unlocking a scalable At-211 supply chain. In addition, we plan to leverage and expand on Atley’s planned decentralized manufacturing & clinical development network, allowing us to enroll patients in clinical trials globally, starting with NY-703, our GPC3-targeting At-211 TAT for the treatment of hepatocellular carcinoma.”

“At-211’s short half-life, clean decay, chelatorless chemistry, and ability to be produced using naturally abundant Bismuth-209 address key safety & supply limitations of other alpha and beta emitters and make it a highly promising radionuclide for multiple therapeutic applications,” added Milton Lönnroth, CEO of Atley Solutions. “We’re delighted to partner with NAYA, one of the pioneering biotech companies advancing At-211 therapeutics to clinical and commercial use and deliver the transformative potential of these therapies to patients.”

About Atley Solutions

Atley Solutions is the global leader in commercial products and services for the development and manufacturing of At-211 radiopharmaceuticals. The Atley C100 is the world’s only commercial module for automated manufacturing of At-211 radiopharmaceuticals. Atley also offers non-clinical radiopharmaceutical development services and At-211 related targetry.

About Atley C100

The Atley C100 is the world’s first and only commercial manufacturing system specifically designed for At-211 radiopharmaceuticals. This state-of-the-art platform addresses the critical challenges of At-211 radiopharmaceutical manufacturing, enabling reliable and scalable manufacturing from non-clinical R&D to full-scale commercial rollout. Its process involves two key stages: purification of At-211 from irradiated Bi-209 targets through dry distillation, followed by automated radiopharmaceutical synthesis and purification.

About NAYA Therapeutics

NAYA Therapeutics is pioneering the next generation of cancer therapies, aiming to unlock deeper, more durable responses in patients not responding to current standard-of-care. NAYA’s pipeline harnesses the transformational potential of two synergistic modalities: At-211 targeted alpha therapies & bifunctional antibodies, with an initial focus on hepatocellular carcinoma (HCC).

About NY-703

NY-703 is a GPC3-targeting At-211 targeted alpha therapy for the treatment of residual & metastatic hepatocellular carcinoma (HCC), aiming to achieve initial clinical data in 2026. It consists of a GPC3-antibody fragment F(ab’)2 conjugated to an At-211 isotope through an optimized proprietary linker. Hepatocellular Carcinoma is a rapidly growing cancer with an estimated one million new patients every year. Up to 75% of HCC patients treated with surgery and/or immunotherapy relapse within 5 years, often due to the presence of metastases and minimal residual disease (MRD).

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