Lyndra Therapeutics, Inc.

A New York City drug developer led by well-known executives and backed by some of the top names in biotech investing is shutting down, a blow to a company that was prepping for a pivotal trial in colorectal cancer. Inspirna is “winding down” after “10 years as a fantastic biotech company,” CEO Oz Azam wrote in a LinkedIn post on Monday morning. The cell and gene therapy veteran joined Inspirna in 2023 after leading Empyrean Neuroscience and Tmunity Therapeutics. Inspirna’s team decided to close the company after a Phase 2 trial of its oral small molecule, called ompenaclid, “did not read out positively” in KRAS colorectal cancer, according to a source familiar with the decision, who agreed to speak on the condition of anonymity. Merck KGaA paid $45 million upfront last year for the ex-US rights to the SLC6A8 inhibitor and had the option to co-develop and co-promote it in the US. The companies were also working on follow-up SLC6A8 compounds. Merck KGaA will “not pursue further development of ompenaclid” and will not exercise its option in the US, a spokesperson for the drugmaker told Endpoints News via email. Azam did not immediately respond to an inquiry from Endpoints. Inspirna is at least the seventh biotech to shutter so far in 2025, following last week’s news about Lyndra Therapeutics . Inspirna was putting together a global pivotal study of ompenaclid for patients with certain forms of colorectal cancer, but the trial “requires additional funding and is dependent on further FDA feedback,” according to the company’s first-quarter presentation . Inspirna last disclosed a $50 million Series D in July 2022. Its backers included blue-chip investors like Vivo Capital, Sands Capital, Novo Holdings, and Sofinnova Partners. The financing was expected to keep the R&D engine humming until the second half of 2024, a spokesperson told Endpoints at the time of the Series D. Inspirna also had a small molecule called abequolixron in its pipeline. The LXR-beta selective agonist was being tested in Phase 1b/2 for certain forms of lung cancer. GSK discovered the asset and originally intended for it to treat cardiovascular disease before licensing it out to Inspirna. Inspirna was formed more than a decade ago as Rgenix from the Tavazoie Lab at The Rockefeller University. The biotech’s platform focused on microRNA, or miRNA, dysregulation, which is thought to contribute to the development of cancer and its progression. Dieter Weinand, a former CEO of Bayer’s pharma division, chaired Inspirna’s board.

WATERTOWN, Mass.--( BUSINESS WIRE )-- Lyndra Therapeutics ® , a clinical-stage biopharmaceutical company pioneering long-acting oral therapies, today announced the Board of Directors has appointed Adam Sayer as President and Chief Executive Officer effective immediately. He will also serve on the company’s Board of Directors. Sayer was most recently Chief Transformation Officer at Envision Healthcare, overseeing strategy, transformation and payer negotiations. His deep understanding of the healthcare ecosystem and track record of operational excellence will be instrumental in advancing Lyndra’s pivotal program for oral weekly risperidone (LYN-005) and bringing the first long-acting oral therapeutics to patients. “I am excited to join Lyndra at this pivotal moment for the company,” said Sayer. “Lyndra’s LYNX ® platform technology has demonstrated remarkable potential to transform oral medicine delivery and make a meaningful impact on patient outcomes, and I look forward to leading this talented team as we bring the first-ever long-acting oral medicines to market.” Under the leadership of outgoing President and CEO Jessica Ballinger, Lyndra completed the pivotal efficacy study for lead asset oral weekly risperidone (LYN-005) and established a strategic collaboration with Thermo Fisher Scientific for global clinical research and commercial manufacturing. “We are grateful for Jess’ contributions and overall dedication to our mission,” said Amy Schulman, Lyndra Therapeutics co-founder and Executive Chair of the Board. “Now, under Adam’s leadership and with his focus on business execution, we are poised to achieve our goals and fundamentally change how oral medicines are delivered.” “As one of Lyndra’s first employees, I’m incredibly proud of the progress this team has made – from the development and testing of what is now the LYNX ® platform, to the successful first trial of our pivotal program and announcement of a strategic manufacturing collaboration with Thermo Fisher,” said Ballinger. “I am confident the company is well-positioned for continued success.” Lyndra’s pivotal safety study for lead asset oral weekly risperidone (LYN-005) is slated to begin in the first half of 2025. About Lyndra Therapeutics Lyndra Therapeutics is a clinical-stage biopharmaceutical company partnering to create and commercialize long-acting oral therapies. Lyndra’s LYNX ® drug delivery platform delivers medicine for a week or longer in a single oral dose. The LYNX drug delivery platform aims to optimize the way we take and deliver medicines: less frequent dosing with more stable drug exposure, enhancing the patient experience. The LYNX platform's versatility has been demonstrated through clinical proof-of-concept research across five therapeutic areas and 25 APIs. For more information on Lyndra and partnership opportunities, visit https://lyndra.com .

Lyndra’s drug delivery platform optimises the delivery of oral medicines. Credit: Stock-Asso/Shutterstock. Lyndra Therapeutics and Thermo Fisher Scientific have entered a strategic partnership to develop Lyndra’s long-acting oral therapies for conditions such as schizophrenia and bipolar disorder. Lyndra will utilise Thermo Fisher’s worldwide clinical research and commercial manufacturing services for its therapies, including its lead investigational product, oral weekly risperidone (LYN-005). LYN-005 recently achieved its primary endpoint in the pivotal Phase III STARLYNG-1 trial, showcasing its efficacy against daily risperdal. The partnership will leverage Thermo Fisher’s accelerator drug development services, which offer a suite of manufacturing, clinical research and clinical supply chain services. The services are tailored to support biotech and pharmaceutical companies from pre-clinical stages to commercialisation. Lyndra aims to harness Thermo Fisher’s pharmaceutical manufacturing capabilities in Cincinnati in the US state of Ohio. This includes the commercial line for Lyndra’s LYNX drug delivery platform, which will facilitate the manufacturing of commercial materials at scale. The platform is tailored to enhance clinical outcomes by optimising the delivery of oral medicines. The technology underpinning the LYNX platform was developed in the Traverso and Langer Laboratories, from which Lyndra has an exclusive technology licence. The partnership also opens opportunities for other pharmaceutical partners interested in creating long-acting oral therapies using LYNX platform technology. Lyndra Therapeutics global product development president and chief medical officer Dr Richard Scranton stated: “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. “Thermo Fisher will be part of our ecosystem of best-in-class partners as we execute our go-to-market strategy, allowing Lyndra to focus on what we do best – research and development for innovative long-acting oral therapeutic solutions – while ensuring reliable, scalable manufacturing and clinical trial operations.” In December 2023, Lyndra secured $101m in Series E financing to advance its pipeline of long-lasting oral therapy products.