CGT CDMO roundup: News from CRL, NorthX, and Avirmax

Charles River signs two gene therapy deals, NorthX inks cell therapy manufacturing deal with Mendus, and Avirmax has opened a gene therapy facility in California. Welcome to our CGT focused CDMO roundup.

First up in our contract development and manufacturing organization (CDMO) roundup is Charles River Laboratories (CRL). The firm has signed a deal with Korean biotechnology company Curigin to manufacture adenoviral vectors.

Curigin, a firm focused on developing oncolytic ribonucleic acid interference (RNAi) gene therapies, will use CRL’s CDMO solutions to assist its preclinical and clinical trials. Curigin’s lead candidate is CA102, which is a genetically engineered adenovirus that aims to treat bladder cancer. The firm said it anticipates submitting an Investigational New Drug (IND) application the US Food and Drug Administration (FDA) at some point this year.

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“Developing innovative therapeutics is our mission and we are steadily working towards that goal. We are excited to work with Charles River in the manufacturing phase as we continue to race on the path to drug development for oncology patients,” said Jae-Gyun Jeong, president at Curigin.

A few days earlier, the CDMO signed a plasmid DNA (pDNA) manufacturing collaboration with non-profit organization INADcure Foundation. The organization aims to support the advancement of treatments for forms of PLA2G6-related neurodegeneration (PLAN) and Infantile Neuroaxonal Dystrophy (INAD).

INADcure will use the CDMO’s pDNA knowledge to produce its leading candidate for Phase I/II clinical trials. “Our collaboration with CRL brings us closer to accomplishing our goal of delivering breakthrough treatments for INAD,” said Lenna Panwala, founder, and executive director at INADcure.

“We are excited to begin […] pDNA manufacturing to further develop our treatment with their experienced team.”

NorthX Biologics

Up next we have CDMO NorthX Biologics, which has entered into a manufacturing agreement with Mendus. Both firms will co-establish cell therapy manufacturing capabilities in Sweden, which will then be used for late-stage advancement and commercial production of Mendus’ lead asset vididencel.

Vididencel is an intradermal allogeneic cell-based vaccine, which aims to treat acute myeloid leukemia (AML), myelodysplastic syndrome, high-grade ovarian cancer, and multiple myeloma.

To support this deal, Swedish investment firm, Flerie Invest will initially provide Mendus with SEK 90 million ($8.4 million) in funding to support the NorthX partnership. The investment will cover all required activities until Q2 2025, as well as adjusting NorthX facilities, tech transfer of the vididencel production process and the manufacturing of it for clinical batches.

“This strategic alliance not only paves Mendus’ path to commercializing vididencel for the benefit of cancer patients but ensures NorthX strengthens its positioning as the premier GMP manufacturing hub for advanced therapies in the Nordics, attracting regenerative medicine innovators worldwide” said Helena Strigård, CEO of NorthX.

Avirmax

Last in our roundup is Avirmax, a spin off entity of Avirmax Inc, which has opened an adeno-associated virus vector (AAV) CDMO facility in Hayward, California. The 20,000 square-foot plant includes development and testing laboratories equipped with single-use bioreactors at 50 L, 200 L and 100 L production scales.

According to the firm, the production scales can produce rAAV drug product at a specific rate within 200 days starting from a transgene plasmid DNA.

“Our team has good experience and knowledge in rAAV technology development and rAAV manufacturing. With our new facility, Avirmax can deliver high yield and quality vectors efficiently, timely and cost effectively,” CEO of Avirmax, Shengjiang (Shawn) Liu, said at the opening of the facility.