— Clinical responses with TransCon IL-2 βâ„γ demonstrated as monotherapy or in combination with checkpoint inhibitor, including in two of three small cell lung cancer patients treated with combination therapy
— TransCon IL-2 βâ„γ administered every three weeks was generally well tolerated as a monotherapy or in combination with pembrolizumab, with no meaningful effect on Tregs and eosinophils
— Enrollment continues in indication-specific cohorts for Phase 2 portion of the IL-Believe Trial
COPENHAGEN, Denmark, Oct. 26, 2023 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (NASDAQ:ASND) reported updated and new data from its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 βâ„γ in a poster presentation at ESMO 2023, the annual meeting of the European Society of Medical Oncology held in Madrid, Spain. The data included longer-term follow up of previously presented TransCon IL-2 βâ„γ monotherapy data from the IL-Believe Trial, and was the first presentation of dose escalation data informing recommended Phase 2 dose (RP2D) for TransCon IL-2 βâ„γ in combination with a checkpoint inhibitor.
As of the August 15, 2023 data cutoff, 46 patients were enrolled into dose escalation: 25 to monotherapy and 21 to combination therapy. Patients were heavily pretreated including some who previously progressed on checkpoint inhibitors. Anti-tumor clinical responses were observed with TransCon IL-2 βâ„γ both as monotherapy (colorectal cancer with confirmed partial response (PR)) and in combination with pembrolizumab (small cell lung cancer (SCLC), 1 with confirmed PR and, subsequent to the August 15, 2023 data cutoff, 1 ongoing with an unconfirmed complete response).
“These updated data reinforce the promising Phase 1 monotherapy data for TransCon IL-2 βâ„γ reported earlier this year, further strengthening our confidence in its best-in-class potential,” said Stina Singel, M.D., Ph.D., Executive Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. “In addition to previously reported monotherapy clinical activity, we are particularly encouraged to see anti-tumor responses in two of the three patients with SCLC in the combination portion of the trial who had previously progressed on checkpoint inhibitors. In the Phase 2 portion of IL-Believe, we continue enrolling into indication-specific cohorts and look forward to sharing preliminary data from these cohorts in the second half of 2024.”
TransCon IL-2 βâ„γ is an investigational long-acting prodrug with sustained release of an IL-2Rβâ„γ-selective analog (IL-2 βâ„γ) designed to address the known limitations of interleukin-2 (IL-2) cancer immunotherapy through prolonged activation of IL-2Rβâ„γ with low Cmax. IL-Believe is investigating the safety and tolerability of TransCon IL-2 βâ„γ alone or in combination with the check-point inhibitor pembrolizumab and/or chemotherapy or TransCon TLR7/8 Agonist in participants with locally advanced or metastatic solid tumors. RP2D for IL-Believe is 120 µg/kg of TransCon IL-2 βâ„γ administered intravenously every three weeks in both the monotherapy and combination therapy arms.
Additional details and highlights from the ESMO poster are available on the Investor & News section of the Ascendis Pharma website at https://investors.ascendispharma.com.
