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Dose Escalation Data from transcendIT-101, Ascendis Pharma’s Phase 1/2 Trial of TransCon™
TLR7/8 Agonist
TLR7/8
Agonist in Patients with Advanced Solid Tumors, Presented at SITC 2022
2022-11-11
·
BioSpace
临床1期
临床结果
免疫疗法
- Early signs of clinical activity were observed in patients receiving
TransCon TLR7/8 Agonist
TransCon TLR7/8
Agonist as monotherapy or in combination with
pembrolizumab
; abscopal effect observed with monotherapy - With a single injection,
TransCon TLR7/8 Agonist
TransCon TLR7/8
Agonist demonstrated sustained target immune system engagement over weeks in injected and non-injected
tumors
, with no signs of systemic toxicity COPENHAGEN, Denmark, Nov. 11, 2022 (GLOBE NEWSWIRE) --
Ascendis Pharma, Inc.
(Nasdaq: ASND) today disclosed new data from the dose-escalation portion of transcendIT-101, the company’s Phase 1/2 open-label, multi-center trial of
TransCon TLR7/8 Agonist
TransCon TLR7/8
Agonist in patients with advanced solid tumors. TransCon
TLR7/8 Agonist
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. The dose escalation data from transcendIT-101, presented by Diwakar Davar, M.D. of the
University of Pittsburgh
Medical Center
during the annual meeting of the Society for Immunotherapy of
Cancer
(SITC 2022), suggests that intratumoral
TransCon TLR7/8 Agonist
TransCon TLR7/8
Agonist was safe and well-tolerated alone or in combination with
pembrolizumab
; that it demonstrated target immune system engagement in injected and non-injected
tumors
along with a systemic immune response; and that it showed early signs of clinical activity alone or in combination with
pembrolizumab
. “We are very pleased to see intratumoral TransCon
TLR7/8 Agonist
TLR7/8
Agonist administration working as designed to deliver prolonged, high local concentrations of
resiquimod
, steadily activating and intensifying the body’s innate and adaptive immune responses over weeks with a single injection,” said Stina Singel, Senior Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. “With these early signs of clinical activity, including monotherapy abscopal activity, and no signs of systemic toxicity, we look forward to continuing our work with investigators and patients to further assess TransCon
TLR7/8 Agonist
TLR7/8
Agonist’s ability to promote potent anti-tumoral responses while minimizing toxic systemic exposures.” All 23 of the patients enrolled in the dose escalation portion of the trial had
advanced or metastatic solid tumors
that had progressed on prior treatments, 9 in the monotherapy cohort (intratumoral TransCon
TLR7/8 Agonist
TLR7/8
Agonist alone) and 14 in the combination therapy cohort (intratumoral TransCon
TLR7/8 Agonist
TLR7/8
Agonist plus the check-point inhibitor
pembrolizumab
). Two dose levels were evaluated: 0.3 mg/lesion and 0.5 mg/lesion. The recommended Phase 2 dose was declared at 0.5 mg/lesion for up to two lesions. The Phase 1/2 transcendIT-101 trial (NCT04799054) is continuing to enroll patients, with dose expansion focused on investigating TransCon
TLR7/8 Agonist
TLR7/8
Agonist in combination with
pembrolizumab
in 4
cancer
types where increased
Toll-like receptor (TLR)
activity has potential to improve adaptive immune activation and host defense against
cancers
:
head and neck squamous cell carcinomas (SCC)
; other
HPV-associated cancers
;
melanoma
; and
cutaneous squamous cell carcinomas (cSCC)
. SITC 2022 registrants can obtain the poster (#763) and oral presentation slides, both titled “Phase 1/2, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study of TransCon
TLR7/8 Agonist
TLR7/8
Agonist Alone or in Combination With
Pembrolizumab
in Patients With
Locally Advanced or Metastatic Solid Tumor Malignancies
: Initial Results From Phase 1 Dose Escalation (transcendIT-101) Trial,” from the SITC 2022 event website: . About
TransCon
TLR7/8 Agonist
TLR7/8
Agonist Immunotherapies can stimulate, intensify, and sustain the immune system’s natural ability to recognize and eliminate
cancer
cells, yet many patients do not respond to immunotherapies currently on the market, most of which are designed for intravenous administration and many of which have significant toxicity profiles at therapeutically effective doses. TransCon
TLR7/8 Agonist
TLR7/8
Agonist is an investigational long-acting prodrug of
resiquimod
(a potent immune response modifier with clinically demonstrated anti-
tumor
activity) designed to provide sustained activation of intratumoral antigen-presenting cells driving
tumor
antigen presentation and induction of immune-stimulatory cytokines for weeks with a single intratumoral injection. Based on
Ascendis Pharma
’s innovative TransCon technology platform, TransCon
TLR7/8 Agonist
TLR7/8
Agonist is comprised of 3 main components:
resiquimod
a small molecule agonist of Toll-like receptors (TLRs) 7 and 8, a TransCon hydrogel microparticle carrier, and a linker bound permanently to the hydrogel microparticle carrier on one end and transiently to
resiquimod
on the other.
TransCon
TLR7/8 Agonist
TLR7/8
Agonist leverages TransCon hydrogel to achieve sustained, localized release of
resiquimod
in the injected
tumor
over weeks, where it is designed to steadily activate and intensify the body’s innate and adaptive immune responses to eradicate
cancer
cells in both injected and distal
tumors
, while maintaining low systemic drug exposure. About
Ascendis Pharma A/S
Ascendis Pharma
is applying its innovative
TransCon
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 Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit 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) TransCon
TLR7/8 Agonist
TLR7/8
Agonist’s ability to provide sustained, localized release over weeks of
resiquimod
with low systemic exposure and steadily activate and intensify the body’s innate and adaptive immune responses over weeks with a single injection, (ii) Ascendis’ plan to work with investigators and patients to further assess TransCon
TLR7/8 Agonist
TLR7/8
Agonist’s ability to promote potent anti-tumoral responses while minimizing toxic systemic exposures, (iii) Ascendis’ plans and expectations with respect to the ongoing Phase 1/2 transcendIT-101 trial, (iv)
TransCon TLR7/8 Agonist
TransCon TLR7/8
Agonist’s potential to improve adaptive immune activation and host defense against SCC, other
HPV-associated cancers
,
melanoma
and cSCC in combination with
pembrolizumab
, (v) TransCon
TLR7/8 Agonist
TLR7/8
Agonist’s ability to provide sustained activation of intratumoral antigen-presenting cells driving
tumor
antigen presentation and induction of immune-stimulatory cytokines for weeks with a single intratumoral injection, (vi) TransCon
TLR7/8 Agonist
TLR7/8
Agonist’s ability to leverage TransCon hydrogel to achieve sustained, localized release of
resiquimod
to eradicate
cancer
cells in both injected and distal
tumors
, while maintaining low systemic drug exposure, and (vii) Ascendis’ use of its TransCon technologies and platform to create new and potentially best-in-class therapies and build a leading, fully integrated, global biopharma company.
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; 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 the ongoing conflict 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 March 2, 2022 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
. © November 2022
Ascendis Pharma A/S
. Investor Contacts: Media Contact: 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 Patti Bank ICR Westwicke +1 (415) 513-1284 patti.bank@westwicke.com
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机构
Ascendis Pharma A/S
Transcon Valladolid SA
Athens Medical Center SA
[+2]
适应症
肿瘤
转移性实体瘤
头颈部鳞状细胞癌
[+3]
靶点
TLR7
TLR
药物
TransCon-TLR-7/8-agonist(Ascendis Pharma A/S)
帕博利珠单抗
Resiquimod
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