Curia Global, Inc.

Fast Track Designation Highlights the Urgent Need for New Treatment Options and Potential Value of Liafensine SAN DIEGO, Oct. 9, 2024 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative drugs, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for DB104 (liafensine) being developed for treating patients with treatment-resistant depression (TRD). Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need for such a disease or condition. Continue Reading TRD is the most difficult depression to treat and TRD patients have limited treatment options that are often associated with significant treatment-related toxicities. Furthermore, clinicians have challenges identifying the appropriate therapies that most likely benefit these patients. Denovo's discovery of a novel pharmacogenomic biomarker, DGM4™, presents a new era for liafensine, a first-in-class triple reuptake inhibitor. The positive results from the biomarker-guided Phase 2b ENLIGHTEN clinical trial, which met all endpoints including the primary endpoint of the Montgomery-Åsberg Depression Rating Scale (MADRS) total score change from baseline at 6 weeks vs. control (p=0.0056), represent a major advance in TRD as well as the application of precision medicine to psychiatric diseases. Liafensine's safety profile was also favorable, without reports of side effects common for approved TRD drugs, such as dissociation, respiratory depression, movement disorders, and metabolic dysfunction with morbid weight gain. "This FDA Fast Track designation is an accelerator for liafensine's development," said Xiao-Xiong Lu PhD, Denovo's CTO. Post this "This FDA Fast Track designation is an accelerator for liafensine's development," said Xiao-Xiong Lu, PhD, Denovo's Chief Technical Officer. "We are pleased that FDA has recognized our innovative biomarker approach and will continue to work with the agency to bring this biomarker-based precision medicine to TRD patients." About Treatment-Resistant Depression More than 23 million people in the US alone suffer from major depressive disorder (MDD). Over 30% patients with MDD do not benefit from currently available antidepressants and are diagnosed with treatment-resistant depression (TRD). TRD remains a major unmet medical need as there are few approved pharmacological agents for TRD and overall outcomes remain poor. About DB104 (liafensine) Liafensine is a first‑in‑class triple reuptake inhibitor targeting transporters for serotonin, norepinephrine, and dopamine. It was licensed from Albany Molecular Research, Inc. (now Curia) and was previously developed by Bristol‑Myers Squibb (BMS: recently obtained FDA approval for Cobenfy™, a first-in-class treatment for schizophrenia), who had conducted two large Phase 2b clinical trials in TRD which failed in non-biomarker-selected patient population. Denovo's unique artificial intelligence (AI) and whole genome sequencing (WGS)-based Denovo Genomic Marker (DGM™) biomarker platform allowed discovery of a novel genetic biomarker, termed DGM4™, with strong correlation of DGM4-positive status with liafensine's efficacy in the BMS studies. The ENLIGHTEN study results prospectively demonstrated the use of DGM4 as a predictive biomarker for liafensine's efficacy in TRD patients, a first for genetic biomarkers in psychiatry. About Denovo Biopharma Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute efficient clinical trials in targeted patient subpopulations to increase the probability of success. Denovo has seven late-stage drugs in its pipeline addressing major unmet medical needs in central nervous system diseases and oncology, most of which are first‑in‑class drugs with global rights. Visit for additional information. Contact Michael F. Haller, PhD Chief Business Officer and Head of US Finance Denovo Biopharma LLC [email protected] SOURCE Denovo Biopharma LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

GSK and Touchlight signed a non-exclusive licensing deal that gives the pharma giant access to the CDMO’s manufacturing tech. Pharma giant GSK inked a licensing deal with Touchlight, giving the pharma giant non-exclusive access to the CDMO’s manufacturing tech dubbed "doggybone DNA." Although financial details of the agreement weren’t disclosed, the deal includes an upfront payment to Touchlight, ongoing access fees, clinical and regulatory milestone payments, and other financial considerations such as royalties on mRNA products produced with the CDMO’s enzymatic dbDNA, the company said in a July 23 press release. The doggybone DNA technology is a minimal, linear, covalently closed structure that eliminates bacterial sequences and accelerates speed and scale in manufacturing, according to Touchlight. It can be used to produce a variety of vaccines, therapeutics and gene therapies. “The adoption of Touchlight’s enzymatic DNA is gathering pace and becoming an important part of the advanced therapy supply chain,” Jonny Ohlson, founder and executive chair of Torchlight, said in the release. “Our technology delivers the speed, scalability and high-quality DNA products that are essential for the next generation of mRNA therapeutics,” Meanwhile, Touchlight also announced that it expects dbDNA will be used in an unnamed cancer vaccine and in several other investigational new drugs later this year. The company’s production facility in Hampton, England, came online last year. It was first announced in 2021 and was financed with $125 million in venture funding. Other players that have inked deals with Torchlight include Pfizer, Lonza and Curia.

By focusing on early-phase CDMO services, Siegfried aims to bolster its drug substance pipeline. Credit: H_Ko / Shutterstock. Switzerland-based Siegfried has announced the signing of binding agreements with Curia Global to acquire an early-phase contract development and manufacturing organisation (CDMO) site in Grafton, Wisconsin, US to strengthen its drug substances service offering. The strategic move will enhance Siegfried’s capabilities and geographical coverage in the sector. The Grafton site, which has 80 experienced employees, specialises in early-phase development and manufacturing services. Siegfried plans to transform the site into a top-tier hub for early-phase CDMO services for its international clientele, including the management of highly potent active pharmaceutical ingredients (APIs). The company’s expansion into the US pharmaceutical market will enable it to provide extensive support to customers throughout the pre-clinical and clinical development stages of drug substances. See Also: Monlunabant by Inversago Pharma for Obesity: Likelihood of Approval Monlunabant by Inversago Pharma for Metabolic Syndrome: Likelihood of Approval The acquisition could particularly be beneficial for small and medium-sized pharmaceutical companies, expanding Siegfried’s range of offerings. By focusing on early-phase CDMO services, Siegfried will bolster its drug substance pipeline, capturing promising opportunities at their inception. The deal will conclude in July 2024. The financial aspect of the acquisition will be managed using existing funds, and Siegfried has confirmed that the outlook for 2024 and mid-term financial targets will remain unaffected by this transaction. Siegfried interim CEO and chief financial officer Reto Suter stated: “With this acquisition, we enhance our offering with early-stage development services for drug substances and become even more relevant and attractive to our customers. “Siegfried now offers an integrated range of services from early-stage development to commercial production of APIs through to the manufacturing of fully formulated drug products. This transaction will generate attractive opportunities and will further accelerate our growth story.”