The investment trust co-founded Freeline alongside University College London in 2015, with Syncona currently owning 57.9% of company shares, according to an SEC filing. But the trust has now placed an offer to buy the rest for $5 apiece, according to another SEC filing.
The bid represents a 20% premium on Freeline’s weighted average share price of $4.16 since the data release on Oct. 4 through Oct. 16. Syncona said it plans to further discuss the offer with the UK biotech. Freeline’s stock $FRLN surged by as much as 12% to $5 on Wednesday in response to the news.
Freeline’s Gaucher therapy, dubbed FLT201, is under investigation in the Phase I/II GALILEO-1 trial. FLT201 uses an AAVS3 capsid to deliver a transgene to the liver to produce an engineered version of the glucocerebrosidase (GCase) enzyme, which is missing in Gaucher disease patients.
Results from two patients in GALILEO-1 shared earlier this month hinted at favorable tolerability, with no cases of liver transaminase elevations or infusion reactions observed at the data cutoff. One patient was 13 weeks post-treatment administration, while the second patient was six weeks in.
Both patients also saw an increase in plasma GCase levels. The first patient had an almost 700-fold increase from baseline to more than 70 μmol/L/h GCase at 12 weeks. The second patient had more than a 300-fold increase from baseline to around 30 μmol/L/h at four weeks.
These recent developments mark a welcome change for Freeline, which was forced to hit the brakes on its early-stage gene therapy program for hemophilia B in 2021 due to CMC concerns raised by the FDA.
In July last year, the company published long-term data from a Phase I/II dose-finding trial of the bleeding disorder treatment named FLT180a. But, as part of a broader strategic reprioritization, Freeline stopped investing in the FLT180a program in November 2022, per an earnings report.
PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.
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