On May 31, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported that it will host an investor meeting highlighting the latest developments in the Company’s Oncology programs, including clinical data updates and a review of clinical development strategy for the Company’s two immuno-oncology product candidates, TransCon TLR7/8 Agonist and TransCon IL-2 β/γ (Press release, Ascendis Pharma, MAY 31, 2023, View Source [SID1234632258]). Both are designed to recruit innate and adaptive components of the immune system to maximize anti-cancer activity while reducing dose-limiting toxicities.

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"TransCon IL-2 β/γ was designed by applying the TransCon technology together with protein bioscience to solve problems with aldesleukin that have eluded industry for many decades – to create a well-tolerated IL-2 therapy that has the potential to effectively activate the immune system to drive anti-cancer activity without dosing complexity that limits aldesleukin use. Today we are reporting for the first-time clinical data supporting the successful design for TransCon IL-2 β/γ," said Jan Mikkelsen, Ascendis Pharma’s President and CEO.

"We are excited to highlight the progress we have made across our two immuno-oncology product candidate programs, TransCon IL-2 β/γ and TransCon TLR7/8 Agonist," said Stina Singel, M.D., Ph.D., Executive Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. "The clinical data shared today from both programs showed an acceptable safety profile and single-agent clinical activity. Data from indication-specific cohorts, including melanoma, head-and-neck, and non-small cell lung cancer are expected in 2024."

Today’s meeting highlights include:

TransCon IL-2 β/γ program update from the Phase 1/2 IL-Believe Trial

Phase 1 monotherapy dose escalation complete; 25 heavily pre-treated patients enrolled (median of 4 prior lines of systemic therapies).
120 µg/kg IV every three weeks selected as monotherapy recommended Phase 2 dose (RP2D).
Eight monotherapy patients dosed at RP2D; of the three efficacy evaluable patients to date, one partial response in a metastatic colorectal cancer patient, and one stable disease in a renal cell carcinoma patient (data cut April 28, 2023).
At RP2D, TransCon IL-2 β/γ was generally well-tolerated with no DLT observed, no vascular leak syndrome and no grade 3 or 4 cytokine release syndrome.
As designed, the non-alpha TransCon IL-2 β/γ expanded local and systemic cytotoxic immune effector cells (CD8+ T and NK cells) without clear effect on Tregs and eosinophils.
RP2D for combination therapy with checkpoint inhibitor dose escalation data expected in the third quarter of 2023 and will be presented at a scientific congress in the fourth quarter.
Enrollment continues in indication-specific cohorts for the Phase 2 portion of the IL-Believe trial.
TransCon TLR7/8 Agonist program update from the Phase 1/2 transcendIT-101 Trial

Additional follow-up indicates further clinical activity in patients receiving TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab. Results supporting selection of RP2D from transcendIT-101 were first reported at SITC (Free SITC Whitepaper) 2022 last November.
Preliminary results showed that TransCon TLR7/8 Agonist was well-tolerated both as a monotherapy and in combination with pembrolizumab.
Enrollment continues in the Phase 2 portion of transcendIT-101 at the RP2D of 0.5 mg/lesion for up to two lesions, which is being evaluated in four indication-specific cohorts.
TransCon IL-2 β/γ is an investigational long-acting prodrug with sustained release of an IL-2Rβ/γ-selective analog (IL-2 β/γ) designed to address the known limitations of interleukin-2 (IL-2) cancer immunotherapy through prolonged activation of IL-2Rβ/γ with low Cmax.

TransCon TLR7/8 Agonist is an investigational long-acting prodrug designed to provide sustained, localized release over weeks of resiquimod (a potent immune response modifier with clinically demonstrated anti-tumor activity) with low systemic exposure.

Oncology Program Update Meeting Webcast Information
Ascendis’ 2023 Oncology Program Update Meeting will take place today starting at 10:00 am Eastern Time (ET). Those who would like to participate may access the live webcast here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.