Ascend launches with $130m to tackle manufacturability of AAVs

Ascend Gene & Cell Therapies has launched to feed the demand for adeno-associated virus (AAV) vectors.

Having raised $132.5 million in a Series A funding led by Abingworth and Petrichor, newly-formed contract development and manufacturing organization (CDMO) Ascend hopes to support cell and gene therapy players in the development and production of their products.

Specifically, the firm is focusing on the development and manufacture of AAV by leveraging its split two-plasmid transfection system, something it says differentiates it from other vector suppliers in this demand-heavy market.

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“AAVs are a validated modality with commercially approved products, regulatory understanding and they fulfil a role of constitutive expression at clinically meaningful levels of protein that other modalities are not yet providing,” an Ascend spokesperson tells BioProcess Insider.

“The number of new AAV programs emerging from academic institutions continues to expand with novel capsid engineering a major theme at this year’s ASGCT conference. However, the process and manufacturability of AAV is still a challenge, and we see increasing demand for qualified experts who can produce high quality batches, work adaptably with customers and provide detailed analytical characterization of the product.”

Beyond the yield and quality improvements the firm says it has seen with the two-plasmid system, Ascend has further innovations emerging from its site in Alameda, California, “which show a step-change improvement in yield and potency. Ultimately this will bring down cost-of-goods enabling further expansion of the AAV field into larger indications.”

A team of industry veterans – CEO Mike Stella comes from Cognate Bioservices, CFO Wes McConnell joined from Bavarian Nordic, etc. – will also make Ascend stand out in the space, especially when it comes to competing with some of the larger players on the market.

“Ultimately, quality of product and quality of service will win out,” the spokesperson says. “Large CDMOs can provide capacity and scale, whereas smaller players like Ascend can provide nimble service, dedicated attention and talented specialists with deep expertise who do not want to work for large CDMOs.

Furthermore, the company has recently boosted its footprint by acquiring the CMC-focused German subsidiary of Freeline Therapeutics for $25 million. Freeline will be a customer of Ascend, with flexible access to analytical and process development capabilities and dedicated personnel for a period of 18 months following the closing of the transaction. No other customers have been divulged.

“Our sites are situated at centers of high innovation – our Alameda site is well connected with Bay Area institutions and businesses; Munich represents a hub of biotech activity in continental Europe and our UK facility sits within the cell and gene therapy infrastructure of the Oxford-Cambridge-London triangle. This enables our model of high-touchpoint service provision, partnership and adaptability.”