Lipid Nanoparticle (LNP) News Summary (April 14–21, 2025)

News Summaries

Arbor Biotechnologies: Unveiled FDA approval of an IND filing for their LNP-mediated treatment for primary hyperoxaluria type 1.

Rothwell Figg (Dan Shores): Led a workshop on intellectual property challenges for LNP-based therapies at the LNP Summit.

NOF CORPORATION: Presented biodegradable LNPs with tunable immunogenicity for vaccine and gene therapy applications.

Serina Therapeutics: Introduced immune-silent POZ-lipid technology as a PEG alternative for LNPs at the LNP Summit.

Verve Therapeutics: Reported positive Phase 1b clinical trial data for VERVE-102, an LNP-delivered base-editing therapy targeting PCSK9.

Detailed News Summaries

Arbor Biotechnologies Arbor Biotechnologies announced FDA approval of its Investigational New Drug (IND) application for an LNP-based therapy targeting primary hyperoxaluria type 1, a rare genetic disorder. The therapy utilizes LNPs to deliver gene-editing payloads to hepatocytes, aiming to address the underlying metabolic dysfunction.

Release Date: April 14, 2025

Website Link: https://lnp-formulation-process-development-pharma.com/

Location: Boston, MA, USA

Rothwell Figg (Dan Shores) Dan Shores, a partner at Rothwell Figg, conducted a workshop titled “Navigating IP Challenges for Companies Utilizing Lipid Nanoparticle Delivery Systems” at the LNP Summit. The session focused on strategies to avoid patent infringement and strengthen freedom-to-operate positions for LNP developers.

Release Date: April 14, 2025

Website Link: https://www.rothwellfigg.com/event-dan-shores-at-4th-annual-lnp-formulation-process-development-summit

Authors: Dan Shores

Location: Boston, MA, USA

NOF CORPORATION NOF CORPORATION presented research on biodegradable LNPs at the LNP Summit, highlighting their COATSOME® SS Series lipids. These lipids enable tunable immunogenicity, with applications ranging from vaccines (immunogenic formulations) to gene therapies (non-immunogenic formulations).

Release Date: April 15, 2025

Website Link: https://nofeurope.com/news/nof-to-exhibit-and-present-at-4th-annual-lnp-formulation-process-development-summit-2025/

Authors: Syed Reza, Drug Delivery Consultant

Location: Tokyo, Japan (company headquarters); Boston, MA, USA (event location)

Serina Therapeutics Serina Therapeutics presented preclinical data on its POZ-lipid technology, a PEG-free alternative for LNPs, at the LNP Summit. Studies in rats showed no anti-POZ antibody generation, addressing safety concerns associated with PEGylated LNPs used in mRNA vaccines.

Release Date: April 15, 2025

Website Link: https://www.stocktitan.net/news/SER/serina-therapeutics-to-present-at-the-4th-lnp-formulation-process-u9dp0mpyhj4n.html

Authors: Dr. Randall Moreadith, Chief Development Officer

Location: Boston, MA, USA

Verve Therapeutics Verve Therapeutics reported a mean 53% reduction in LDL cholesterol in patients treated with VERVE-102, an LNP-delivered base-editing therapy targeting the PCSK9 gene. The therapy’s GalNAc-LNP formulation demonstrated no serious adverse events in Phase 1b trials.

Release Date: April 14, 2025

Website Link: https://www.globenewswire.com/news-release/2025/04/14/3060774/0/en/Verve-Therapeutics-Announces-Positive-Initial-Data-from-the-Heart-2-Phase-1b-Clinical-Trial-of-VERVE-102.html

Authors: Eugene Braunwald (quoted spokesperson)

Location: Boston, MA, USA