COPENHAGEN - Ascendis Pharma A/S (NASDAQ:ASND) has reported encouraging outcomes from its ongoing Phase 1/2 IL-Believe Trial, evaluating TransCon IL-2 β/γ therapy for patients with melanoma who have not responded to prior treatments. The trial results were shared during a poster presentation at the American Society of Clinical Oncology’s annual meeting in Chicago.
The study revealed that 40% of efficacy-evaluable patients treated with TransCon IL-2 β/γ in combination with TransCon TLR7/8 Agonist showed confirmed clinical responses. Additionally, 45% of patients whose disease progressed on checkpoint inhibitors responded to TransCon IL-2 β/γ as a monotherapy or in combination treatment. These findings suggest potential benefits for patients with treatment-resistant melanoma.
The IL-Believe Trial includes participants with advanced or metastatic solid tumors, exploring the safety and tolerability of TransCon IL-2 β/γ alone or in combination with other agents. The recommended Phase 2 dose for this therapy is 120 µg/kg administered intravenously every three weeks.
Biomarker analysis indicated that TransCon IL-2 β/γ, whether used alone or in combination with pembrolizumab, expands cytotoxic lymphocytes without increasing markers of toxicity. A statistically significant correlation between clinical benefit and CD8+ T cell expansion and activation was also observed.
According to Stina Singel, M.D., Ph.D., Executive Vice President and Head of Clinical Development, Oncology at Ascendis Pharma, the data demonstrate the therapy’s capability to recruit and amplify the body’s immune response with sustained immune activation. She highlighted the absence of increased toxicity markers and the direct correlation between clinical benefit and expansion of CD8+ T cells.
TransCon IL-2 β/γ is a long-acting prodrug designed to overcome the limitations of interleukin-2 (IL-2) cancer immunotherapy by enabling prolonged activation of IL-2Rβ/γ with low Cmax. The therapy has been generally well tolerated with no new safety signals reported.
The promising results support the potential of TransCon IL-2 β/γ as a biased IL-2 cytokine therapy, and further data from larger, indication-specific cohorts are expected later in the year. This information is based on a press release statement from Ascendis Pharma.
InvestingPro Insights
In light of Ascendis Pharma A/S's (NASDAQ:ASND) recent updates on their Phase 1/2 IL-Believe Trial, investors may be keen to understand the financial health and market position of the company. InvestingPro provides a detailed snapshot of Ascendis Pharma's current financial metrics and analyst insights, which can be crucial for evaluating the company's prospects.
Ascendis Pharma's market capitalization stands at a robust $7.75 billion, reflecting significant investor confidence in the company’s potential. Despite this, the company's revenue for the last twelve months as of Q1 2024 shows a staggering growth of 322.18%, indicating a strong upward trajectory in their financial performance.
InvestingPro Tips highlight that while analysts have revised their earnings upwards for the upcoming period, they do not expect the company to be profitable this year. This is consistent with the reported adjusted P/E ratio of -14.22, underscoring the company's current lack of profitability. Additionally, the company operates with a moderate level of debt and has experienced a large price uptick over the last six months, with a 29.84% return, signaling investor optimism about its future.
Investors should note that Ascendis Pharma does not pay dividends, which could be a consideration for those seeking regular income streams. For those interested in diving deeper into Ascendis Pharma’s financials and future outlook, InvestingPro offers additional insights. There are currently 6 more InvestingPro Tips available for Ascendis Pharma, which can be accessed at https://www.investing.com/pro/ASND. Remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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