Lyndra, Thermo Fisher to Partner on R&D for Long-Acting Oral Therapies

Lyndra Therapeutics, of Watertown, Mass., announced on Jan. 15, 2025, a strategic collaboration with Thermo Fisher Scientific in which Thermo Fisher will provide global clinical research and commercial manufacturing services to Lyndra for its roster of long-acting oral therapies (1).

A press release from Lyndra said that the partnership leverages Thermo’s Accelerator Drug Development services, described as 360-degree contract development and manufacturing organization (CDMO) and contract research organization (CRO) drug development solutions that provide a customizable menu of options encompassing manufacturing, clinical research, and clinical supply chain services (1).

“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 chief medical officer of Lyndra Therapeutics, in the press release. “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 agreement stipulates that Lyndra will use Thermo Fisher’s end-to-end, advanced pharmaceutical manufacturing capabilities based out of Cincinnati, Ohio, to manufacture commercial materials at scale (1).

“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 Michael Shafer, executive vice president and president, biopharma services, at Thermo Fisher, in the release. “Leveraging Accelerator Drug Development, our comprehensive CDMO and CRO drug development solutions, exemplifies our commitment to help speed and simplify the complex journey of clinical development.”

Lyndra’s long-acting oral therapies include its lead investigational product, oral weekly risperdone (LYN-005) (1). It and others are designed to deliver medication for a week, or more, with a single dose.

Pharmaceutical Technology® has been following trends in oral therapies, specifically the oral solid dosage (OSD) market, making that a focal point of its October 2024 coverage of CPHI Milan. In addition, an episode of Pharmaceutical Technology’s Drug Solutions Podcast, from October 2024, encapsulates numerous experts’ perspectives from CPHI.

Dovetailing with that, Thermo Fisher used the occasion of CPHI Milan 2024 to launch its Accelerator Drug Development offering, as Shafer said at the time, “to support customers as they move critical programs forward to tackle global health challenges with speed, quality, and efficiency” (2). Thermo’s stated goal is for Accelerator Drug Development to impact the pharmaceutical value chain for biotech and large pharmaceutical companies with its customizable manufacturing, clinical research, and clinical supply chain services for small molecule, biologics, and cell and gene therapies.

Click here to listen to the October 2024 Drug Solutions Podcast.

References

1. Lyndra Therapeutics. Lyndra Therapeutics Announces Strategic Clinical Research and Commercial Manufacturing Services Collaboration with Thermo Fisher Scientific for Long-Acting Oral Therapies. Press Release. Jan. 15, 2025.
2. Thermo Fisher Scientific. Thermo Fisher Scientific Showcases Expanded Biopharma Services, Capabilities and Innovations at CPHI Milan 2024. Press Release. Oct. 7, 2024.