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Ascendis Pharma’s Initial Dose Escalation Results Accepted for Online Publication at ASCO 2023


Ascendis Pharma’s Initial Dose Escalation Results from the Ongoing Phase 1/2 Trial of TransCon™ IL-2 β/γ Accepted for Online Publication at ASCO 2023


COPENHAGEN, Denmark, April 03, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that initial dose escalation data from the Company’s ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ alone or in combination with pembrolizumab has been accepted for online publication at ASCO 2023, the annual meeting of the American Society of Clinical Oncology being held June 2-6 in Chicago.


TransCon IL-2 β/γ is an investigational novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective analog (IL-2β/γ) designed to address the drawbacks of interleukin-2 (IL-2) cancer immunotherapy through prolonged activation of IL-2Rβ/γ with low Cmax.


“We look forward to sharing this initial dose escalation data, which will guide our selection of the recommended Phase 2 dose of monotherapy TransCon IL-2 β/γ in this ongoing Phase 1/2 trial,” said Stina Singel, Executive Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. “Our goal is to address the known shortcomings of current IL-2 immunotherapy, such as short half-life and high Cmax. We believe that our novel approach to achieving sustained activation and expansion of the cytotoxic immune cell types while avoiding upregulation of immunosuppressive cells could, if successful, lead to a potentially best-in-class cancer immunotherapy product.”


The primary objectives of the Phase 1 portion of the ongoing Phase 1/2 IL-Believe Trial are to evaluate the safety and tolerability and to define the maximum tolerated dose and recommended Phase 2 dose of TransCon IL-2 β/γ alone or in combination with pembrolizumab in adults with locally advanced or metastatic solid tumors.


About TransCon IL-2 β/γ1 Recombinant interleukin-2 (IL-2, aldesleukin) is an approved cancer immunotherapy but may cause severe side effects including cytokine release syndrome (CRS) and vascular leak syndrome (VLS). This is believed to be due to activation of IL-2Rα+ endothelial cells and inflammatory eosinophils as well as high Cmax due to the short half-life requiring frequent high-dose administrations. Potent activation of immunosuppressive IL-2Rα+ regulatory T cells (Tregs) may also limit IL-2’s efficacy. TransCon IL-2 β/γ is a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 analog designed to address these shortcomings. In pre-clinical studies, TransCon IL-2 β/γ has demonstrated improved pharmacokinetics and profound expansion of cytotoxic immune cells in animal models.


About Ascendis Pharma A/S Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated, global biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Heidelberg, Munich, and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit ascendispharma.com to learn more.



Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma Group. © April 2023 Ascendis Pharma A/S.


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