lyndra-therapeutics-signs-manufacturing-agreement-with-thermo-for-long-acting-oral-therapies
Lyndra Therapeutics Signs Manufacturing Agreement with Thermo for Long-Acting Oral Therapies

Lyndra Therapeutics Signs Manufacturing Agreement with Thermo for Long-Acting Oral Therapies

Lyndra's LYNX® drug delivery platform consists of six arms connected to a flexible core. It fits into a standard-sized capsule when folded. The LYNX platform's shape prevents its passage through the pylorus (the opening between the stomach and the small intestine) during the dosing period. [Lyndra Therapeutics]
Lyndra’s LYNX® drug delivery platform consists of six arms connected to a flexible core. It fits into a standard-sized capsule when folded. The LYNX platform’s shape prevents its passage through the pylorus (the opening between the stomach and the small intestine) during the dosing period. [Lyndra Therapeutics]

Lyndra Therapeutics, a clinical-stage biopharma firm, entered into a strategic collaboration with Thermo Fisher Scientific in which Thermo will provide global clinical research and commercial manufacturing services to Lyndra for its long-acting oral therapies.

Lyndra’s long-acting oral therapies, including lead investigational product oral weekly risperidone (LYN-005), are designed to deliver medication for a week or longer with a single oral dose. LYN-005 met its primary endpoint in the Phase III pivotal STARLYNG-1 study, demonstrating efficacy compared to daily Risperdal. The Phase III pivotal safety study of oral weekly risperidone is planned to be initiated in early 2025.

“Lyndra’s clinical research and manufacturing collaboration with Thermo Fisher is a critical step in our mission to transform how patients take medicine, providing the capabilities and scale to bring long-acting oral therapies to broad markets,” said Richard Scranton, MD, president of global product development and CMO of Lyndra Therapeutics. “Thermo Fisher will be part of our ecosystem of best-in-class partners as we execute on our go-to-market strategy, allowing Lyndra to focus on what we do best—R&D for innovative long-acting oral therapeutic solutions–while ensuring reliable, scalable manufacturing and clinical trial operations.”

The collaboration leverages Thermo Fisher’s Accelerator™ Drug Development services, 360° CDMO and CRO drug development solutions. Accelerator Drug Development provides a customizable suite of manufacturing, clinical research, and clinical supply chain services for emerging biotechs and large pharmaceutical companies at every stage from preclinical to commercialization, according to Michael Shafer, EVP and president, Biopharma Services at Thermo.

As part of the collaboration, Lyndra plans to utilize Thermo Fisher’s end-to-end advanced pharmaceutical manufacturing capabilities in Cincinnati, OH, including Lyndra’s LYNX drug delivery platform commercial line, to manufacture commercial materials at scale.

“Thermo Fisher is pleased to collaborate with Lyndra on its revolutionary drug delivery platform, and we look forward to helping bring these groundbreaking, long-acting oral therapies to patients,” said Shafer.

The LYNX drug delivery platform, which aims to improve clinical outcomes by optimizing how oral medicines are delivered and taken, enables the stable and sustained delivery of medicine in a target therapeutic window for a week or longer in a single oral dose, said a Lyndra spokesperson.

The technology for the LYNX platform originated in the Traverso and Langer Laboratories at MIT, with which Lyndra has an exclusive technology license. With broad applicability across multiple therapeutic areas, the LYNX platform has the potential to revolutionize oral drug delivery, enhancing the patient experience and providing meaningful value to the healthcare system, maintains Scranton.