Denali Therapeutics to Present Interim Data from Phase 1/2 Study of ETV:IDS (DNL310) for the Potential Treatment of Hunter Sy...
July 15 2021 - 9:00AM
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical
company developing a broad portfolio of product candidates
engineered to cross the blood-brain barrier (BBB) for
neurodegenerative diseases, today announced its participation at
MPS 2021, the 16th Annual International Symposium of MPS and
Related Diseases, a research conference dedicated to the exchange
of knowledge on mucopolysaccharidoses and related syndromes, taking
place virtually July 23-25, 2021. Details related to Denali’s oral
presentation at MPS 2021 and a webinar hosted by Denali management
following the presentation are provided below.
Oral Presentation at MPS 2021
Session Title: Late Breaking News / Oral
CommunicationsPresentation Title: Interim 24-Week
Results of Cohort A in a Ph I/II Study of Intravenous DNL310
(brain-penetrant enzyme replacement therapy) in MPS
IIDate: Sunday, July 25thSession Start
Time: 16:05 p.m. CEST / 10:05 a.m. EDT / 7:05 a.m. PDT
Denali’s presentation is the fifth presentation during the
session and is slated to start at approximately 17:05 p.m. CEST /
11:05 a.m. EDT / 8:05 a.m. PDT.
Denali Webinar for Analysts and Investors
Following the presentation, Denali will host a webinar for
analysts and investors to present the interim data from the Phase
1/2 study of DNL310. The webinar will begin at approximately 11:30
a.m. EDT / 8:30 a.m. PDT on Sunday, July 25, 2021, and will be
available on Denali’s corporate website on the Events page under
the Investor section
at https://www.denalitherapeutics.com/investors/events. An
archived replay of the webinar will be available for at least 30
days following the event. Preregistration for the webinar can be
accessed here.
Families interested in learning more about Denali’s efforts
related to the discovery and development of therapeutics for the
potential treatment of Hunter syndrome are invited to visit
EngageHunter.com, the Denali Hunter syndrome community engagement
website.
About DNL310 and Hunter Syndrome (MPS II)
Hunter syndrome (MPS II) is a rare neurodegenerative lysosomal
storage disorder caused by a mutation in the gene that encodes for
the enzyme iduronate-2-sulfatase (IDS). The resultant reduction or
loss of IDS enzyme activity leads to accumulation of
glycosaminoglycans, which causes lysosomal dysfunction and
neurodegeneration as well as progressive damage to multiple organs
including bone, cartilage, heart and lung. Current standard of care
enzyme replacement treatment does not address neuronopathic
manifestations of the disease as it does not sufficiently cross the
blood-brain barrier (BBB). DNL310 is a fusion protein composed of
IDS fused to Denali’s proprietary Enzyme Transport Vehicle (ETV),
which is engineered to cross the BBB via receptor-mediated
transcytosis into the brain. Denali previously announced human
biomarker proof-of-concept for its Transport Vehicle (TV)
technology from Cohort A (n=5) of an ongoing Phase I/2 study of
DNL310 in patients with Hunter syndrome. The study is currently
enrolling Cohort B, and a Cohort C is planned to further explore
clinical endpoints. More information about the ongoing Phase 1/2
study of DNL310 in patients with Hunter syndrome can be found on
ClinicalTrials.gov by following this link.
About the EngageHunter.com
WebsiteEngageHunter.com — the Denali Hunter syndrome
(MPS II) community engagement website — is an online destination
for emerging information on Denali’s scientific advances in Hunter
syndrome research and Denali’s clinical trials. Visitors who
register on the Engage Hunter website will receive updates on
Denali’s research and future Denali investigational studies.
About Denali TherapeuticsDenali Therapeutics is
a biopharmaceutical company developing a broad portfolio of product
candidates engineered to cross the blood-brain barrier (BBB) for
neurodegenerative diseases. Denali pursues new treatments by
rigorously assessing genetically validated targets, engineering
delivery across the BBB and guiding development through biomarkers
that demonstrate target and pathway engagement. Denali is based in
South San Francisco. For additional information, please visit
www.denalitherapeutics.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements expressed or implied in this press
release include, but are not limited to, statements regarding
Denali's plans, timelines and expectations related to DNL310, the
DNL310 ongoing Phase 1/2 study, and planned future studies,
Denali’s TV technology platform, and the therapeutic potential of
DNL310 and Denali’s TV platform. Actual results are subject to
risks and uncertainties and may differ materially from those
indicated by these forward-looking statements as a result of these
risks and uncertainties, including but not limited to, risks
related to: Denali’s early stages of clinical drug development;
Denali’s and its partners’ ability to complete the development and,
if approved, commercialization of DNL310; Denali’s and its
partners’ ability to enroll patients in its ongoing and future
clinical trials; Denali’s reliance on third parties for the
manufacture and supply of its product candidates for clinical
trials; the potential for clinical trial results of DNL310 to
differ from preclinical, preliminary or expected results, the risk
that Denali will be able to continue dose escalation in the Phase
1/2 study, whether DNL310 will cause any serious adverse events,
whether DNL310 will impact downstream biomarkers of
neurodegeneration, and that DNL310 may not receive regulatory
approval as a treatment of Hunter syndrome necessary to be
commercialized. In light of these risks, uncertainties and
assumptions, the forward-looking statements in this press release
are inherently uncertain and may not occur, and actual results
could differ materially and adversely from those anticipated or
implied in the forward-looking statements. Accordingly, you should
not rely upon forward-looking statements as predictions of future
events. Information regarding additional risks and uncertainties
may be found in Denali’s Annual and Quarterly Reports filed on
Forms 10-K and 10-Q filed with the Securities and Exchange
Commission (SEC) on February 26, 2021, and May 5, 2021,
respectively, and Denali’s future reports to be filed with the SEC.
Denali does not undertake any obligation to update or revise any
forward-looking statements, to conform these statements to actual
results or to make changes in Denali’s expectations, except as
required by law.
Investor Relations Contact:Laura Hansen,
Ph.D.Vice President, Investor Relations(650)
452-2747hansen@dnli.com
Media Contacts:Lizzie Hyland(646)
495-2706Lizzie.Hyland@FGH.com
or
Morgan Warners(202) 295-0124Morgan.Warners@FGH.com
Denali Therapeutics (NASDAQ:DNLI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Denali Therapeutics (NASDAQ:DNLI)
Historical Stock Chart
From Apr 2023 to Apr 2024