Xspray Pharma to present CML data supporting differentiation of Dasynoc and Nilopki
Xspray Pharma will present two posters at the ESH-iCMLf 28th Annual John Goldman Conference on Chronic Myeloid Leukemia, CML, held in Gothenburg, Sweden, on 2-4 October 2026. The posters focus on how much drug reaches the bloodstream and how predictably. The data quantifies a significantly more consistent blood level with Dasynoc and significantly lower levels of food-related interactions with Nilopki, which may make both drugs safer and easier to use. Together with a lower dose profile compared to the originator drugs, this reinforces the clinical profile differentiation potential of these HyNap™-based product candidates.
Xspray Pharma today announces that data on its two product candidates Dasynoc and Nilopki have been accepted for poster presentation at the ESH-iCMLf 28th Annual John Goldman Conference on Chronic Myeloid Leukemia, taking place in Gothenburg, Sweden, on 2-4 October 2026.
The two posters focus on clinically relevant limitations of today’s tyrosine kinase inhibitor, TKI, treatments in CML and how Xspray’s HyNap™ formulation technology may help address them. For patients and physicians, the findings point to the possibility of more predictable exposure and thereby improved management of safety risks. For Xspray, the data further support the differentiated profiles of Dasynoc and Nilopki and their potential roles as improved formulations of established CML therapies.
“Xspray is utilizing its HyNap™ technology platform and scientific capabilities to unlock the full potential of these molecules through strong collaboration with leading key opinion leaders. I am incredibly proud of Chief Scientific Officer Per Andersson and the entire Xspray team for their leadership and achievements as we execute on our strategy and advance our portfolio,” commented Xspray’s CEO Blake Leitch.
Two internationally renowned CML-specialists, Professor Michael J. Mauro and Professor Jorge Cortes, were co-authors of the poster abstracts and gave the following comments:
“The formulation technology utilised in Dasynoc/XS004 has the potential to provide an ideal basis for a low dose treatment algorithm with dasatinib; this could improve the management of CML patients substantially” said Professor Michael Mauro, director of the Chronic Myeloid Leukemia Program at Memorial Sloan Kettering Cancer Center in New York, USA and Professor of Medicine at Weill Cornell Medical College.
“The elimination of food effect can provide an improved safety profile, of nilotinib particularly the cardiac risk profile, and thereby reduce the risk to patients and the uncertainty for both patients and care givers,” said Professor Jorge Cortes, Chief of Hematology in the Division of Hematology and Oncology at the University of Alabama at Birmingham, UAB, and Deputy Director of the O’Neal Cancer Center at UAB.
The poster presentations add to the growing body of data supporting Xspray’s HyNap™ technology platform and its potential to create improved formulations of established targeted cancer therapies. For Dasynoc and Nilopki, the findings are relevant both from a clinical perspective, by addressing known safety and dosing challenges in CML treatment, and from a commercial perspective, by supporting differentiated product profiles in large and well-established treatment categories.
Dasynoc: a more predictable, lower-dose approach to dasatinib
The first poster sets out why Dasynoc may improve the tolerability of dasatinib while maintaining its effect. Tolerability and clinical effect depend on different pharmacokinetic parameters: trough concentration is linked to pleural effusion, a build-up of fluid around the lungs and effects tolerability. Whereas clinical efficacy tracks overall drug exposure in the blood. Because exposure varies widely with crystalline dasatinib, reducing the dose risks subtherapeutic levels in some patients.
Dasynoc's markedly lower variability may allow a lower dose that still works for the individual patient: fewer patients exposed to the high levels linked to pleural effusion, and fewer left below the level for desired clinical effect.
Nilopki: reduced food effect may lower cardiovascular safety uncertainty
The second poster concerns Nilopki/XS003, Xspray’s formulation of nilotinib. The abstract investigates the relationship between nilotinib plasma exposure and cardiovascular adverse events. The data indicate that Nilopki avoids the food-induced increase in plasma exposure seen with crystalline nilotinib. In addition, the estimated effect on the QTc interval decreases under fed conditions with Nilopki, while it increases with crystalline nilotinib.
This is clinically relevant because nilotinib treatment is associated with cardiovascular safety considerations, and food intake may contribute to increased plasma exposure with conventional crystalline nilotinib. Conventional crystalline nilotinib, either in the form of Tasigna or generic versions, patients must avoid food for two hours before and one hour after each twice-daily dose. By reducing the food effect, Nilopki may offer a more predictable treatment profile and reduce uncertainty in everyday use.
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Xspray will also present and discuss the two poster announcements at a live-streamed Investor Update in Gothenburg on 2 October 2026, starting 12.30 CET. The Investor Update will provide an opportunity to place the new data in the broader context of Xspray’s clinical, regulatory and commercial strategy for Dasynoc and Nilopki.
For further information, please contact:
Jacob Nyberg, IRO
Xspray Pharma AB (publ)
Tel: + 46 (0) 70 767 08 83
E-mail: ir@xspray.com
About Xspray Pharma
Xspray Pharma AB (publ) is a pharmaceutical company with several product candidates in clinical development utilizing its innovative, patent protected HyNap™ technology platform to create improved versions of marketed protein kinase inhibitors (PKI), the largest oncology market segment, often with high drug prices. The company’s goal is to become the market leader in improved PKI’s for cancer treatment. Xspray Pharma’s lead drug candidate, Dasynoc® and Nilopki® (an optimized version of Tasigna®) are currently undergoing FDA review. Dasynoc is an amorphous form of dasatinib, demonstrating bioequivalence at a 30% lower dose due to a better solubility profile. Its compatibility with proton pump inhibitors (PPIs), which are often co-prescribed to patients with CML and ALL, is a significant advantage. Xspray Pharma is building a robust product portfolio, including Nilopki and XS008-axitinib (an optimized version of Inlyta®) and XS025-cabozantinib (an optimized version of Cabometyx®).
The Xspray Pharma AB-share is trading at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY).
www.xspraypharma.com.