Voyager Enters into License for Next-Generation Capsid, Bringing Partnered Portfolio of TRACER-Enabled Gene Therapies to 14

Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that Novartis AG (NYSE: NVS) has agreed to license a novel capsid generated from Voyager's TRACER™ capsid discovery platform for use in a gene therapy program against an undisclosed rare neurologic disease target. This capsid license is being granted pursuant to the agreement between Voyager and Novartis originally announced in March 2022.

"Novartis is a global leader in gene therapy, and we view their continued selection of our IV-delivered, blood-brain barrier-penetrant capsids as strong validation of our TRACER capsid discovery platform," said Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of Voyager. "We are proud of the continued success of the relationship between Voyager and Novartis, which now includes five gene therapy programs: Huntington's disease, spinal muscular atrophy, and three undisclosed indications."

In consideration for the current capsid license, Voyager will receive $15M upfront and is eligible to receive up to $305 million in associated potential development, regulatory, and commercial milestone payments, as well as tiered mid- to high-single digit royalties on a potential product incorporating the licensed capsid for this target.

About the TRACER™ Capsid Discovery Platform

Voyager's TRACER™ (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) capsid discovery platform is a broadly applicable, RNA-based screening platform that enables rapid discovery of novel AAV capsids to enable gene therapy. Voyager has leveraged TRACER to create multiple families of novel capsids that, following intravenous delivery in preclinical studies, harness the extensive vasculature of the central nervous system (CNS) to cross the blood-brain barrier and transduce a broad range of CNS regions and cell types. In cross-species preclinical studies (rodents and multiple non-human primate species), intravenous delivery of TRACER-generated capsids resulted in widespread payload expression across the CNS at relatively low doses, enabling selection of multiple development candidates in Voyager's wholly owned and partnered gene therapy programs for neurologic diseases.

About Voyager Therapeutics

Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com.

Voyager Therapeutics ® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "will," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements.

For example, all statements Voyager makes regarding Voyager's receipt of the fee for the Novartis license of the undisclosed rare neurologic disease target and Voyager's eligibility to receive development, regulatory, and commercial milestone payments, and tiered royalties under the 2022 Novartis option and license agreement are forward looking.

All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the expectations and decisions of regulatory authorities; the timing, initiation, conduct and outcomes of Voyager's preclinical and clinical studies; the availability of data from clinical trials; the availability or commercial potential of product candidates under collaborations; the willingness and ability of Voyager's collaboration partners to meet obligations under collaboration agreements with Voyager; the continued development of Voyager's technology platforms, including Voyager's TRACER platform and its antibody screening technology; Voyager's scientific approach and program development progress, and the restricted supply of critical research components; the development by third parties of capsid identification platforms that may be competitive to Voyager's TRACER capsid discovery platform; Voyager's ability to create and protect intellectual property rights associated with the TRACER capsid discovery platform, the capsids identified by the platform, and development candidates for Voyager's pipeline programs; the possibility or the timing of Voyager's receipt of program reimbursement, development or commercialization milestones, option exercise, and other payments under Voyager's existing licensing or collaboration agreements; the ability of Voyager to negotiate and complete licensing or collaboration agreements with other parties on terms acceptable to Voyager and the third parties; the success of programs controlled by third party collaboration partners in which Voyager retains a financial interest, and the success of Voyager's product candidates; the ability to attract and retain talented directors, employees, and contractors; and the sufficiency of cash resources to fund its operations and pursue its corporate objectives.

These statements are also subject to a number of material risks and uncertainties that are described in Voyager's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Trista Morrison, NACD.DC, tmorrison@vygr.com
Investors: Adam Bero, Ph.D., abero@kendallir.com
Media: Brooke Shenkin, brooke@scientpr.com


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

NVS
The Conversation (0)
Troy Minerals (CSE:TROY)

Troy Minerals Reports Drilling Results from the Lake Owen Project, Wyoming. Critical Minerals inclusive of Scandium (Rare Earths Element) Discovered

Troy Minerals Inc. ("Troy" or the "Company") (CSE:TROY)(OTCQB:TROYF)(FSE:VJ3) is pleased to announce that its two-hole maiden drilling program at Lake Owen Project has been completed and assays of the first pass of selective sampling have been received. The 100% owned Lake Owen Project (the "Project") is located 50 km southwest of Laramie, Wyoming, USA (see Figures 1,2).

The Project is a Proterozoic layered mafic intrusion complex with a long history of sporadic exploration primarily for Platinum Group Elements. Similar in style to the Stillwater Complex in USA and the Merensky Reef of South Africa, the Lake Owen Complex is a highly prospective North American based target with a strong potential for significant vanadium, titanium, PGE and associated metals mineralization.

Keep reading...Show less

Pfizer's Sasanlimab Combination Significantly Improves Event-Free Survival in BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer

  • Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or progression, with sasanlimab in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) regimen compared to SOC alone
  • Sasanlimab, a subcutaneously administered PD-1 inhibitor, in combination with BCG represents the first potential treatment advancement for BCG-naïve, high-risk non-muscle invasive bladder cancer in more than 30 years
  • Results have been shared with global health authorities to support potential regulatory filings

Pfizer Inc. (NYSE: PFE) today announced results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The trial met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance): Hazard Ratio (HR) of 0.68; 95% Confidence Interval (CI), 0.49-0.94; 2-sided p=0.019; median EFS not yet reached. These findings show a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. Pre-specified subgroup analyses for patients harboring higher risk disease showed consistent benefit with EFS HR of 0.63 (0.41, 0.96) for T1 disease, and EFS HR 0.53 (0.29, 0.98) for those with CIS disease.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Pfizer Declares Second-Quarter 2025 Dividend

Board of Directors approves quarterly cash dividend of $0.43 per share

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

ACIP Votes to Expand Recommendation for Pfizer's RSV Vaccine ABRYSVO® to Include Adults Aged 50 to 59 at Increased Risk of Disease

  • Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). This includes ABRYSVO ® (Respiratory Syncytial Virus Vaccine), which in October 2024, the U.S. Food and Drug Administration approved for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased risk of severe disease.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Pfizer Provides Update on Oral GLP-1 Receptor Agonist Danuglipron

Pfizer Inc. (NYSE: PFE) today announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management.

Pfizer's dose-optimization studies of once-daily formulations of danuglipron ( NCT06567327 and NCT06568731 ) met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase 3 testing, based on earlier studies of twice-daily danuglipron. While the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in-line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury which resolved after discontinuation of danuglipron. After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer has decided to discontinue development of the molecule.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Invion Limited (ASX:IVX)

Invion Limited

Keep reading...Show less

Latest Press Releases

Related News

×