ATLyphe

From left to right - Maddalena Marconato, MD, Danielle Villars, PhD, and Renier Myburgh, PhD - co-founders of ATLyphe

What problems does ATLyphe tackle?

“Current conditioning prior to allogeneic stem cell transplantation (allo-HSCT) is done by a combination of chemotherapy plus/minus radiation. This treatment is highly toxic for the patient, as it exhibits a systemic effect and is not specific towards the cells that need to be eliminated.” - shares in an interview with us Danielle Villars

“This not only results in serious side effects for the patient, but ultimately also impacts the success of the stem cell process. For the patient, this can be devastating, as they are promised a long-term cure by stem cell transplantation but ultimately may face even more side effects and health problems from this process than from the primary disease.

Additionally, because the current conditioning practice is too toxic, a large proportion of patients are currently excluded from the overall stem cell transplantation process and thus have no chance to access this potentially long-term cure. These patients are only treated with symptom-alleviating therapy, which not only has a significant impact on the health care costs, but also puts serious constraints on these patients and impacts their emotional health.

Changing the process of conditioning represent a pathway to help these patients on all levels, as it could alleviate the serious health issues that are caused by the current practice and also help the patients on an emotional level, as they can finally believe again in the promise of stem cell transplantation and regain the strength and motivation to undergo the lengthy process of stem cell transplantation.

ALY117 represents a precision conditioning agent that can counteract the caveats of current, chemotherapy-based conditioning regimens, acting at the sweet spot between safety and efficacy. ALY117 exhibits specificity towards hematopoietic stem cells, based on the expression of CD117 (a receptor that is described as the ideal conditioning target), and links them to CD3+ T cells. Thereby, it triggers an efficient immune response towards the stem cells that subsequently will be eliminated. In this way, ALY117 can prepare patients for stem cell transplantation in a safe and efficient way, reduce side effects and eventually increase eligibility of patients for stem cell transplantation

ALY117 triggers an efficient immune response towards the stem cells that subsequently will be eliminated, can prepare patients for stem cell transplantation in a safe and efficient way, reduce side effects, and eventually increase eligibility of patients for stem cell transplantation”

Market Potential and Visions for the Future

“ALY117 has the potential to serve as a conditioning agent for allo-HSCT in various indications. These include Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), lymphoproliferative disorders, as well as non-malignant conditions like hemoglobinopathies and bone marrow failures. The overall market for these applications is approximately $3.3 billion annually (65’000 patients), assuming a product price of CHF 50’000.

ALY117 is anticipated to provide a significant added benefit through Minimal Residual Disease (MRD) reduction, particularly in AML and MDS, which are the primary indications for allo-HSCT. These two indications alone represent a market of $2.1 billion per year (42’000 patients). Additionally, about 25% of patients currently excluded from transplantation (~ 14’000 patients) could benefit from ALY117's safer conditioning profile.

We project capturing approximately 30% of the existing AML and MDS market within five years of market approval, along with 50% of the newly accessible market of frail patients. This equates to a market potential of $0.97 billion (PP: $50’000, 30% of existing AML/MDS patients: 12’500, 50% of newly accessible market: 7’000 patients) for AML and MDS alone. Including the other indications, ALY117's total market potential exceeds $1 billion annually, highlighting its substantial commercial promise.”

How it all Began

“Recognizing that treating the active AML disease offers only a partial solution, the aim was shifted to focus on stem cell transplantation, the only intervention with the potential to provide a long-term cure for AML patients. To improve the conditioning process for stem cell transplantation, two research projects were initiated simultaneously in Prof. Dr. Markus Manz's lab, in collaboration with Prof. Dr. Dario Neri. Through this work, the invention was patented and a proposal was submitted to Wyss Zurich.”

Once accepted, the operational team at ATLyphe, now led by Danielle Villars, have been working hard over the last few years to realize the bench to bedside translation of the product. With the incorporation of the company in July 2023, the team fully embarked on this start-up journey.

And Finally