Ascendis Pharma Presents New Data and Updated Results from Phase 1/2 IL-Believe Trial at ASCO 2024
June 03 2024 - 4:01PM
Ascendis Pharma A/S (Nasdaq: ASND) reported new and updated results
from its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β⁄γ in
a poster presentation at ASCO 2024, the annual meeting of the
American Society of Clinical Oncology being held in Chicago May
31–June 4, 2024. Data included the first presentation of Phase 2
dose expansion Cohort 4 (TransCon IL-2 β⁄γ in combination with
TransCon TLR7/8 Agonist) in post anti-PD-1 melanoma and new
analyses of patients from dose escalation cohorts with prior
disease progression on checkpoint inhibitors, along with biomarker
studies correlating cytotoxic immune cell expansion and clinical
benefit.
As of the April 16, 2024 data cutoff, confirmed clinical
responses were observed in 40% (two out of five) of
efficacy-evaluable patients from Cohort 4, suggesting potential
synergy of Ascendis Pharma’s two novel immunotherapy agents.
Of efficacy-evaluable patients with prior disease progression on
checkpoint inhibitors to date in the IL-Believe Trial, confirmed
clinical responses (per RECIST v1.1) were observed in 45% (five out
of eleven) administered TransCon IL-2 β/γ doses ≥80 μg/kg every 3
weeks, suggesting clinical benefit in treatment-resistant
settings.
- Monotherapy (n=4): 1 confirmed partial response (PR) in
colorectal cancer
- Combination with pembrolizumab (n=2): 1 confirmed complete
response and 1 confirmed PR in small-cell lung cancer
- Combination with TransCon TLR7/8 Agonist (n=5): 2 confirmed PRs
in melanoma
Biomarker analysis demonstrated comparable, cytotoxic immune
expansion between TransCon IL-2 β/γ monotherapy and combination
therapy with pembrolizumab, indicating that administration of
TransCon IL-2 β⁄γ expands cytotoxic lymphocytes and elevates levels
of cytokines and chemokines in the blood without the corresponding
expansion of Tregs or eosinophils (markers of toxicity). A
statistically significant correlation of clinical benefit with both
CD8+ T cell expansion and activation was observed, directly linking
this pharmacodynamic effect to clinical activity.
In this trial, TransCon IL-2 β⁄γ alone or in combination with
pembrolizumab or TransCon TLR7/8 Agonist was generally well
tolerated with no new safety signals.
“We are very encouraged by the clinical response and safety
profile for TransCon IL-2 β⁄γ and are pleased to see it working as
designed to recruit and amplify the body’s immune response with
sustained immune activation without a corresponding increase in
markers of toxicity,” said Stina Singel, M.D., Ph.D., Ascendis
Pharma’s Executive Vice President and Head of Clinical Development,
Oncology. “These new data in a heavily pre-treated population who
progressed on or did not benefit from prior checkpoint inhibitors
support TransCon IL-2 β⁄γ as the first biased IL-2 cytokine
therapy to show not only monotherapy activity in a convenient
outpatient setting every 3 weeks but also a direct correlation
between clinical benefit and expansion of CD8+ T cells. We look
forward to additional data readouts expected later this year from
larger, 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. The Phase 1/2 IL-Believe Trial is investigating the
safety and tolerability of TransCon IL-2 β⁄γ alone or in
combination with the checkpoint inhibitor pembrolizumab and/or
chemotherapy or TransCon TLR7/8 Agonist in participants with
locally advanced or metastatic solid tumors. The recommended Phase
2 dose (RP2D) for TransCon IL-2 β⁄γ in the IL-Believe trial is 120
µg/kg administered intravenously every three weeks in an outpatient
setting in both the monotherapy and combination-therapy arms.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform 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, Ascendis uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Europe and the United States. 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) the potential
synergy of TransCon IL-2 β⁄γ and TransCon TLR7/8 Agonist; (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 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
Ascendis’ 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. 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 7, 2024 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. © June 2024 Ascendis Pharma A/S.
Investor Contacts: |
Media
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Tim Lee |
Melinda Baker |
Ascendis Pharma |
Ascendis Pharma |
+1 (650) 374-6343 |
+1 (650) 709-8875 |
tle@ascendispharma.com |
media@ascendispharma.com |
ir@ascendispharma.com |
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Patti Bank |
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