Ankyra Therapeutics contracts Lonza; Oculis selects AGC Biologics to manufacture its investigational drug candidate; BioVaxys signs a contract with BioElpida. Great to have you here for Bioprocess Insider’s CDMO round-up.
First up in our contract development manufacturing organization (CDMO) round-up is Swiss firm Lonza, which recently partnered with US-based Ankyra to support manufacturing of its cytokine-based immunotherapy for cancer patients.
The immunotherapy candidate is administered directly into the solid tumors and Jeetendra Vaghjiani, director of Commercial Mammalian Development, Lonza told BioProcess Insider “the process to make the fusion protein is broadly similar to monoclonal antibodies (mAbs) but requires additional activities in certain areas such as analytics and downstream processing.”
Image/iStock: metamorworks
Under the terms of the agreement, Lonza will provide Ankyra with cell line optimization, process development, and stability assessment from two of its manufacturing facilities.
“Lonza is utilising its network to deliver the services required for this project,” said Vaghjiani. “The drug substance development and manufacturing will take place at our Slough site in the UK while drug product development and manufacturing will be carried out in Switzerland.”
The transfer process will begin in Q2 2021, with clinical batches expected to be ready in 2022.
Secondly, we have CDMO AGC Biologics, which has been chosen by Swiss biopharmaceutical company Oculis to manufacture a Phase II drug candidate that targets dry eye disease and anterior uveitis, OCS-02 at its Heidelberg, Germany facility.
“We are very pleased that Oculis has chosen us to manufacture this treatment,” said AGC Biologics chief business officer, Mark Womack. He added: “Our Heidelberg site has the experience and expertise to deliver this program from early phase to market.”
According to AGC, OCS-02 is a ‘tumor necrosis factor-alpha (TNF alpha) inhibitor’ which is a biological target that can potentially cause anti-inflammation and anti-necrosis.
The candidate has already had its safety and efficacy evaluated in three clinical trials and two controlled studies under IND. The trials showcased a ‘promising profile’ for treating dry eye diseases and anterior uveitis.
Thirdly, we have BioElpida, which has entered an agreement to provide clinical-grade bioproduction and aseptic packaging for BioVaxys’ vaccine candidate BXV-0918A, which aims to treat stage three and four ovarian cancer.
Both firms previously signed a Term Sheet in February, which outlined their commercial relationship. However, this week BioElpida and BioVaxys have signed a definitive agreement that focuses on the facility build-out in Lyon, France.
BioVaxys anticipates it will prepare for regulatory submission for an EU Phase I study of the vaccine candidate at the end of this year, with vaccine supply for the clinical trial expected in early May 2022.
“Early on we made the decision to seek a bioproduction partner with the ability to quickly move from smaller-yield GMP-grade clinical study supplies to large-scale manufacturing if our clinical trials prove successful and EU regulatory approval is granted,” said Kenneth Kovan, co-founder, president and COO of BioVaxys.
“BioElpida’s technical experience and previous work on early generations of our cancer vaccine platform will be a significant advantage in our efforts to provide hope to those suffering from advanced ovarian cancer.”
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