Ascendis Pharma Oncology Program Update Highlights Latest Clinical Data for Product Candidates
31 Maio 2023 - 9:30AM
Ascendis Pharma A/S (Nasdaq: ASND) will today 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.
Both are designed to recruit innate and adaptive components of the
immune system to maximize anti-cancer activity while reducing
dose-limiting toxicities.
“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 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
InformationAscendis’ 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
https://investors.ascendispharma.com. A replay of the webcast will
be available on this section of our website shortly after
conclusion of the event for 30 days.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform to build a
leading, fully integrated, global 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, Berlin and
Munich) and the United States (Palo Alto and Redwood City,
California, and Princeton, New Jersey). 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’
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 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. © May 2023 Ascendis Pharma A/S.
Investor Contacts:Tim LeeAscendis Pharma+1 (650)
374-6343tle@ascendispharma.comir@ascendispharma.com |
Media Contact:Melinda BakerAscendis Pharma+1 (650)
709-8875media@ascendispharma.com |
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Patti BankICR Westwicke+1 (415)
513-1284patti.bank@westwicke.com |
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