Ascendis Presents Updated and New TransCon™ IL-2 β⁄γ Monotherapy and Combination Therapy Data Confirming Clinical Activity Across Tumor Types at ESMO 2023
26 Octobre 2023 - 2:30PM
Ascendis Pharma A/S (Nasdaq: ASND) reported updated and new data
from its ongoing Phase 1/2 IL-Believe Trial of TransCon
IL-2 β⁄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 β⁄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 β⁄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 β⁄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 β⁄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 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. IL-Believe is
investigating the safety and tolerability of TransCon
IL-2 β⁄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 β⁄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.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative platform technology to build a leading,
fully integrated biopharma company focused on making a meaningful
difference in patients’ lives. Guided by its core values of
patients, science and passion, the company uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Germany (Heidelberg and Munich) and the United States
(Palo Alto and Redwood City, California, and Princeton, New
Jersey). Please visit ascendispharma.com to learn more.
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’ belief
of the best-in-class potential of TransCon IL-2 ß/γ; (ii) the
timing of data from indication-specific cohorts for TransCon IL-2
β⁄γ; (iii) the ability of TransCon IL-2 β⁄γ to address
the known limitations of interleukin-2 (IL-2) cancer immunotherapy
through prolonged activation of IL-2Rβ⁄γ; (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 Ukraine and Russia. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to Ascendis’ business in
general, see Ascendis’ Annual Report on Form 20-F filed with the
U.S. Securities and Exchange Commission (SEC) on February 16, 2023
and Ascendis’ other future reports filed with, or submitted to, the
SEC. Forward-looking statements do not reflect the potential impact
of any future licensing, collaborations, acquisitions, mergers,
dispositions, joint ventures, or investments that Ascendis may
enter into or make. Ascendis does not assume any obligation to
update any forward-looking statements, except as required by
law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company
logo, and TransCon are trademarks owned by the Ascendis Pharma
group. © October 2023 Ascendis Pharma A/S.
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Ascendis Pharma |
Ascendis Pharma |
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+1 (650) 709-8875 |
tle@ascendispharma.com |
media@ascendispharma.com |
ir@ascendispharma.com |
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