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Denali Therapeutics Announces Publication in Cell on New Approach to Treat FTD-GRN

SOUTH SAN FRANCISCO, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- 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 publication of preclinical proof of concept for using its Protein Transport Vehicle (PTV) to enhance brain uptake of peripherally administered progranulin (PTV:PGRN). This approach may have utility in treating certain types of frontotemporal dementia (FTD), especially FTD-GRN caused by progranulin deficiency.

Published online Thursday, August 26th, ahead of print in the September 2nd issue of Cell, the preclinical research showed that progranulin replacement therapy with Denali’s PTV:PGRN rescued both neurodegeneration and microglial dysfunction in progranulin-deficient mice. The research also provides new insight into the molecular and cellular mechanisms that may contribute to FTD, identifying novel roles of progranulin in lysosomal function and lipid metabolism, as well as lysosome biomarkers with potential clinical utility.

“This preclinical research demonstrates that our Protein Transport Vehicle can enhance the uptake of peripherally administered progranulin by multiple cell types in the brain, including neurons and microglia,” said Denali’s Chief Scientific Officer Joseph Lewcock, Ph.D. “In addition, the improved mechanistic understanding of progranulin’s role in lysosomal function indicates that our therapeutic strategy with PTV:PGRN may be the most direct and effective way to increase progranulin levels in lysosomes for the potential treatment of people with FTD-GRN.”

PTV:PGRN is engineered to bind transferrin receptor molecules, which are present in large amounts on endothelial cells of the BBB and normally function to transport iron into the brain. This approach enables PTV:PGRN to be actively transported into the brain, potentially overcoming a long-standing challenge to the field of delivering protein therapeutics across the BBB.

New insights on the role of progranulin and effects of PTV:PGRN in preclinical models of FTD

Mutations in the GRN gene, which encodes the progranulin protein, generally result in reduced protein levels of progranulin and are amongst the most common genetic causes of FTD. The studies published in Cell used two common models of FTD-GRN, genetically engineered progranulin-deficient mice as well as iPSC-derived human microglial cells, to investigate the role of progranulin and effects of PTV:PGRN treatment on disease pathology.

The preclinical research showed that lysosomes – which function as the “digestive system” of cells – are the primary cellular organelles impacted by progranulin deficiency. A new finding revealed in the preclinical studies was that progranulin regulates lysosomal function through binding to and stabilizing a lysosome-specific lipid, bis(monoacylglycero)phosphate (BMP), which is critical for normal lysosomal function.

In the progranulin-deficient mice, BMP lipid levels were profoundly decreased, which resulted in reduced activity of the lipid-metabolizing enzyme glucocerebrosidase (GCase) and accumulation of the GCase substrate glucosylsphingosine (GlcSph); GCase is known to be involved in Gaucher disease and GBA-linked Parkinson’s disease. A mild decrease in BMP and an increase in GlcSph was also found in biofluid samples from patients with FTD, with or without GRN mutations.

Treatment of progranulin-deficient mice or human cells with PTV:PGRN was sufficient to rescue a range of lysosomal defects, including BMP deficiency, GlcSph accumulation, lysosomal vacuolization and lysosomal membrane damage. In addition, PTV:PGRN corrected lipofuscinosis, microgliosis and astrogliosis, which are common disease-relevant brain pathologies in progranulin-deficient mice that are also present in patients with FTD-GRN.

“Collectively, these new insights from our preclinical research suggest that FTD-GRN may be an atypical lysosomal storage disorder, and that lysosomal function can be restored by PTV:PGRN,” said Dr. Lewcock. “Our work also identified candidate clinical biomarkers indicative of lysosomal dysfunction, such as BMP and GlcSph, which may help to evaluate the future therapeutic efficacy of PTV:PGRN and other therapeutics in people with FTD-GRN.”

“Publication of this research in Cell marks a significant milestone in the development of therapeutics enabled by our Transport Vehicle technology,” said Denali’s Chief Executive Officer Ryan Watts, Ph.D. “We are making great progress towards our goal of initiating clinical testing of our lead PTV:PGRN molecule (DNL593) and believe that our unique brain-penetrant progranulin replacement approach has the potential to make a difference for individuals and their families affected by FTD-GRN.”

About Denali’s TV Platform

The BBB is essential in maintaining the brain’s microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for CNS diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali’s Transport Vehicle (TV) platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes, proteins, and oligonucleotides across the BBB after intravenous administration. The TV technology is based on engineered Fc fragments that bind to specific natural transport receptors, such as transferrin receptor, which are expressed at the BBB and deliver TV and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered to the TV technology demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates.

About Denali Therapeutics

Denali 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 PTV:PGRN, plans regarding planned future clinical studies of PTV:PGRN (DNL593), expectations regarding Denali’s TV technology platform, the therapeutic potential of PTV:PGRN (DNL593) and Denali’s TV platform, and statements made by Denali’s Chief Scientific Officer and Chief Executive Officer. 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 PTV:PGRN (DNL593); 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 PTV:PGRN (DNL593) to differ from preclinical or expected results, the risk that results from early preclinical biomarker studies will not translate to clinical benefit in clinical studies; and that PTV:PGRN (DNL593) may not receive regulatory approval as a treatment of FTD-GRN 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 on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 26, 2021, and August 4, 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) 452-2747
[email protected]

Media Contacts:
Lizzie Hyland
(646) 495-2706
[email protected]
or
Morgan Warners
(202) 295-0124
[email protected]


Sours: https://www.globenewswire.com/news-release/2021/08/26/2287248/0/en/Denali-Therapeutics-Announces-Publication-in-Cell-on-New-Approach-to-Treat-FTD-GRN.html

Biogen and Denali to Collaborate on LRRK2 Program for Parkinson’s Disease and Certain TV Platform-Enabled Programs for Neurodegenerative Diseases

  • Biogen to receive license to co-develop and co-commercialize Denali’s small molecule LRRK2 inhibitor program, expanding pipeline of potential therapies in Parkinson’s disease and other movement disorders
  • Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s blood-brain barrier crossing TV technology platform, including for amyloid beta, plus right of first negotiation for two additional unnamed TV platform programs
  • Denali to receive a $560 million upfront payment, a $465 million equity investment and potential milestone payments, profit sharing and royalties

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that they have signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease. Biogen will also receive rights to opt into two programs and a right of first negotiation for two additional programs, in each case for neurodegenerative diseases leveraging Denali’s Transport Vehicle (TV) technology platform to cross the blood-brain barrier (BBB).

“Our collaboration with Denali represents an opportunity to advance the development of a potential first-in-class oral therapy that may slow the progression of Parkinson’s disease,” said Michel Vounatsos, Biogen’s Chief Executive Officer. “Denali’s LRRK2 program is highly complementary to our existing Parkinson’s disease pipeline and its successful development would enhance Biogen’s portfolio of medicines for treating serious neurological and neurodegenerative diseases. We look forward to leveraging our neurology capabilities and infrastructure with Denali’s scientific expertise to accelerate advancement of this program.”

“We are very excited to collaborate with Biogen, a company with an impressive history in inventing and developing medicines for neurological diseases,” said Ryan Watts, Ph.D., Denali’s Chief Executive Officer. “This collaboration will allow us to accelerate the development of our LRRK2 program and gives us the resources to build a fully integrated company with the goal of bringing transformative medicines to patients suffering from neurodegenerative diseases.”

Under the agreement, Biogen will collaborate with Denali to co-develop and co-commercialize Denali’s small molecule inhibitors of LRRK2 for Parkinson’s disease. Biogen and Denali will co-commercialize the LRRK2 product in the U.S. and China, and Biogen will commercialize in all other markets. DNL151 has been selected to progress into late stage clinical studies expected to commence in 2021.

Mutations in the LRRK2 gene can cause Parkinson’s disease. LRRK2 is a regulator of lysosomal function, which is impaired in Parkinson’s disease and may contribute to neurodegeneration. Inhibition of LRRK2 activity may slow the progression of Parkinson’s disease in patients with and without known genetic risks based on restoration of lysosomal function. People who have Parkinson’s disease experience numerous symptoms, including tremors, slow movement, muscle stiffness and impaired balance. As these symptoms become progressively worse, patients have difficulty walking, talking or completing other simple tasks. Parkinson’s disease is the second most common neurodegenerative disease with significant unmet medical needs due to the absence of approved therapies that may slow disease progression.

In addition to the LRRK2 program, Biogen will also receive an exclusive option to license two preclinical programs from Denali’s TV platform, which aims to improve brain uptake of biotherapeutics, including its Antibody Transport Vehicle (ATV): Abeta program (ATV enabled anti-amyloid beta program) and a second program utilizing its TV technology. Further, Biogen will have right of first negotiation on two additional TV-enabled therapeutics, currently at a preclinical stage, should Denali decide to seek a collaboration for such programs. Denali’s TV platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes, proteins and oligonucleotides across the BBB after intravenous administration.

Terms of the Collaboration

Under the terms of the agreement, Biogen will make an upfront payment to Denali of $560 million and make a $465 million equity investment in Denali from the purchase of 13.3 million newly issued shares of Denali common stock at approximately $34.94 per share, representing 11.2 percent of Denali’s pro-forma outstanding stock.

Should the LRRK2 program achieve certain development and commercial milestones, Denali will be eligible to receive up to $1.125 billion in potential milestone payments.

In the LRRK2 collaboration, Biogen and Denali will share responsibility and costs for global development (60 percent Biogen; 40 percent Denali), and will share responsibility and costs as well as profits and losses for commercialization in the U.S. (50 percent Biogen; 50 percent Denali) and China (60 percent Biogen; 40 percent Denali). Outside the U.S. and China, Biogen will be responsible for commercialization and pay Denali tiered royalties.

Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

About Denali’s LRRK2 DNL151 Program

DNL151 is a small molecule inhibitor of LRRK2 invented at Denali which has completed dosing of 162 healthy volunteers in an ongoing Phase 1 clinical study and completed dosing in 25 Parkinson’s patients in a Phase 1b clinical study. Denali is currently completing further dose escalation cohorts in an expanded Phase 1 and an additional cohort in the Phase 1b study to define the full therapeutic window of the molecule. Based on the clinical data to date that has been generated in Europe, DNL151 appears to have an acceptable safety and tolerability profile and has met desired target engagement goals. An Investigational New Drug application for DNL151 was cleared by the U.S. Food and Drug Administration in July 2020 and enables expansion of Denali clinical trials for DNL151 globally.

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

About Denali Therapeutics

Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the BBB for neurodegenerative diseases. Denali Therapeutics 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 Therapeutics is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

Biogen Safe Harbor

This press release contains forward-looking statements, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits and results that may be achieved through Biogen’s proposed collaboration with Denali; the anticipated completion of the proposed transaction; the potential benefits, safety and efficacy of DNL151 and other LRRK2 inhibitor molecules; the clinical development program for DNL151 and other LRRK2 inhibitor molecules; the potential benefits of Denali’s TV technology platform and TV programs including its ATV: anti-amyloid beta program; the treatment of Parkinson’s disease; the potential of Biogen’s commercial business and pipeline programs; Biogen’s strategy and plans; the potential treatment of neurological and neurodegenerative diseases; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risks factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this press release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Denali 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, plans, timelines and expectations related to DNL151 and other LRRK2 inhibitor molecules, Denali’s TV technology platform and TV programs including its ATV: anti-amyloid beta program; LRRK2 inhibitors as modifying therapy for Parkinson’s disease; the ability of the TV technology to effectively deliver large therapeutic molecules across the BBB; expectations regarding the proposed transaction with Biogen, including all financial aspects of the collaboration and equity investment; the potential benefits and results of the proposed transaction with Biogen; the anticipated completion of the transaction; plans to conduct clinical development activities and commercialize products; and statements made by Denali’s CEO and Biogen’s CEO.

The forward-looking statements in this press release are based on information available to Denali as of the date hereof. Denali disclaims any obligation to update any forward-looking statements, except as required by law.

Sours: https://investors.biogen.com/news-releases/news-release-details/biogen-and-denali-collaborate-lrrk2-program-parkinsons-disease
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Denali Therapeutics Announces Positive Clinical Results and Regulatory Progress for Development Programs in Amyotrophic Lateral Sclerosis (ALS)

  • eIF2B activator DNL343 achieved safety and biomarker goals in a Phase 1 study in healthy volunteers; a Phase 1b study began in individuals with ALS in Q3 2021
  • Fast Track designation granted by the U.S. Food and Drug Administration (FDA) to SAR443820/DNL788, a RIPK1 inhibitor, for the treatment of ALS; Sanofi to initiate Phase 2 study in individuals with ALS in Q1 2022
  • Denali to host webinar for analysts and investors today, October 6, at 4:30 p.m. Eastern Time  

SOUTH SAN FRANCISCO, Calif., Oct. 06, 2021 (GLOBE NEWSWIRE) -- 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 positive Phase 1 clinical results and regulatory progress for two investigational small molecule therapeutics in development for the treatment of amyotrophic lateral sclerosis (ALS) at the 2021 Annual Northeast ALS (NEALS) Meeting being held virtually, October 6-7.

“Effective treatment options are a critical unmet medical need for people living with ALS,” said Carole Ho, M.D., Denali’s Chief Medical Officer. “DNL343 and SAR443820 are designed to modulate distinct biological pathways implicated in ALS, including the integrated stress response and inflammation, respectively. We are pleased that the data generated preclinically and in Phase 1 studies support clinical investigation of both molecules as potential treatments for individuals with ALS.”

“We’re very encouraged by the initial results of the Phase 1 study of SAR443820 for the treatment of ALS,” said Nazem Atassi, M.D., Sanofi’s Global Head of Early Neurodevelopment. “ALS is a devastating disease for patients and their families, with no available cure or effective treatment for slowing its progression. We look forward to launching the Phase 2 HIMALAYA trial in adults with ALS in early 2022 and to achieving our ultimate goal of helping people living with ALS.”

Highlights from eIF2B activator DNL343 clinical and preclinical data presented at NEALS

Denali presented positive results from a Phase 1 study in healthy volunteers (n=95) in which safety, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of DNL343 were evaluated. The results demonstrated that DNL343 was generally well tolerated for up to 14 days of dosing, with robust distribution in the central nervous system (CNS) and predictable dose-related increases in DNL343 exposure with a PK profile supporting once daily dosing. Biomarker assessments were also made as related to the cellular integrated stress response (ISR). The ISR is a biological pathway implicated in ALS and other diseases. After healthy volunteers were treated with DNL343, samples of their blood cells were subjected to stress ex vivo, and robust changes in biomarkers of the ISR were observed, confirming pathway engagement.

Denali also presented preclinical data in a mouse model of vanishing white matter (VWM) disease, a genetic and progressive disorder that causes severe neurological symptoms after exposure to certain stressors. eIF2B activity is reduced in the VMW disease model leading to chronic activation of the ISR, making this a relevant model for demonstrating target engagement and ISR modulation by DNL343. After treatment with DNL343, body weight and motor function were normalized in these mice. Furthermore, ISR gene expression and stress response protein levels were reduced in both peripheral tissues as well as the brain. A similar PK/PD relationship was observed in mice and in humans, supporting DNL343 dose selection in the ongoing Phase 1b study in participants with ALS.

The Phase 1b study (NCT05006352) is a multicenter, randomized, placebo-controlled, double-blind, 28-day study followed by an 18-month open-label extension, designed to evaluate the safety, PK and PD of DNL343 in approximately 30 participants with ALS. Dosing in this study began in the third quarter of 2021.

Highlights from RIPK1 inhibitor SAR443820 clinical trial design presentation at NEALS and Fast Track Designation

Denali’s partner Sanofi presented plans for a Phase 2 study of RIPK1 inhibitor SAR443820 in participants with ALS based on positive results of a Phase 1 study in healthy volunteers. In that study, robust target engagement was demonstrated at doses that were generally well tolerated. The Phase 2 study, named HIMALAYA, is a multi-center, randomized, double-blind, placebo-controlled study, followed by an open-label long-term extension, to evaluate the efficacy and safety of SAR443820 in adult participants with ALS. This Phase 2 study is expected to commence in the first quarter of 2022.

The U.S. FDA has granted Fast Track designation to SAR443820 for the treatment of ALS. Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Fast Track designation may allow for early and frequent communication with the FDA regarding the development of SAR443820 for the treatment of ALS. This designation also enables rolling review of the marketing application.

About the eIF2B activator DNL343

Modulation of eIF2B activity with DNL343 is a novel and targeted investigational approach with first-in-class potential for the treatment of ALS. eIF2B is an intracellular protein complex that regulates protein synthesis and is required for neuronal health and function. When neurons experience stress, as occurs in ALS, eIF2B activity is suppressed. This leads to impaired protein synthesis and results in the formation of "stress granules," which are thought to be a precursor of TDP-43 aggregation, a hallmark pathology in ALS. DNL343 is designed to activate eIF2B and thereby restore protein synthesis, disperse TDP-43 aggregates, and improve neuronal survival. DNL343 is an investigational therapeutic and has not been approved by any regulatory authority for any commercial use.

About the RIPK1 Inhibitor SAR443820/DNL788

SAR443820/DNL788 is a novel, CNS-penetrant, small molecule inhibitor of RIPK1, a critical signaling mediator of necroptotic cell death, cytokine release, and inflammatory pathways. Denali and Sanofi entered into a broad collaboration in October 2018 for the global development and commercialization of RIPK1 inhibitors. This includes CNS-penetrant molecules such as SAR443820/DNL788, which was evaluated in a Phase 1 study in healthy volunteers, with potential development for neurological indications such as ALS, multiple sclerosis (MS) and Alzheimer’s disease (AD). Sanofi leads Phase 1 and Phase 2 development of SAR443820/DNL788 for ALS and MS and leads co-development of SAR443820/DNL788 with Denali in Phase 3 clinical trials for ALS, AD and MS. SAR443820/DNL788 is an investigational therapeutic that has not been approved by any regulatory authority for any commercial use.

Denali Webinar for analysts and investors on October 6, 2021, at 4:30 p.m. ET

Denali plans to host a webinar for analysts and investors to highlight development programs in ALS and frontotemporal dementia (FTD) on October 6, 2021, starting at approximately 4:30 p.m. Eastern Time. During the webinar, Denali will review the NEALS presentations related to its investigational small molecule therapeutics DNL343, an eIF2B activator, and SAR443820, a RIPK1 inhibitor. Denali will also review preclinical data on DNL593 (PTV:PGRN), its Transport Vehicle (TV)-enabled biotherapeutic in development for FTD-GRN, which was recently published in Cell. The webinar 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.

About Denali Therapeutics
Denali 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 plans, timelines and expectations related to DNL343, SAR443820/DNL788; the DNL343 ongoing Phase 1b study and the planned Phase 2 study of SAR443820/DNL788; expectations regarding Denali’s product candidates and the therapeutic potential of DNL343 and SAR443820/DNL788; statements made by Denali’s Chief Medical Officer; and statements made by Sanofi’s Global Head of Early Neurodevelopment. The forward-looking statements in this press release are based on information available to Denali as of the date hereof. Denali disclaims any obligation to update any forward-looking statements, except as required by law.


Sours: https://www.globenewswire.com/news-release/2021/10/06/2309876/0/en/Denali-Therapeutics-Announces-Positive-Clinical-Results-and-Regulatory-Progress-for-Development-Programs-in-Amyotrophic-Lateral-Sclerosis-ALS.html
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