Ascendis Pharma Oncology Program Update Highlights Latest Clinical Data for Product Candidates
– TransCon IL-2 β/γ in Phase 1 clinical trial showed monotherapy clinical activity in heavily pre-treated cancer patients with clear dose dependent response on cytotoxic immune cells
– TransCon IL-2 β/γ administered every 3 weeks was generally well tolerated, with no meaningful effect on Tregs and eosinophils.
– At the TransCon IL-2 β/γ recommended Phase 2 dose (RP2D), no dose limiting toxicity (DLT), vascular leak syndrome, or grade 3/4 cytokine release syndrome observed
– Further follow-up for the TransCon TLR7/8 Agonist monotherapy cohort showed additional abscopal responses
– Webcast of Ascendis’ Oncology Program Update to begin at
“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
“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
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 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
About
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ ability to create well-tolerated immune-oncology product candidates without dosing complexity that limits use of current therapies; (ii) the timing of data from indication-specific cohorts for TransCon IL-2 β/γ and TransCon TLR7/8 Agonist; (iii) the timing of dose escalation combination therapy data from the Phase 1/2 IL-Believe trial and its presentation at a scientific congress; (iv) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated, global biopharma company, and (v) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in its development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on its business from the worldwide COVID-19 pandemic and ongoing conflicts such as that in the region surrounding
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Source: Ascendis Pharma