Vaxcyte will file VAX-24 pneumococcal conjugate vaccine later than planned citing capacity constraints at CDMO Lonza and the COVID-19 pandemic.
The California biotech had intended to file the vaccine for US FDA review early this year, however, according to its Q4 results presentation, submission is now planned during the first half of 2022.
Vaxcyte said it expects to submit an IND application “between January and June 2022 and plans to announce top-line data from the ensuing Phase I/II clinical study between late 2022 and early 2023.”
CEO Grant Pickering said capacity constraints at Vaxcyte’s contract development and manufacturing organization (CDMO) Lonza and the impact of the COVID-19 pandemic prompted the delay.
This was expanded upon by COO James Wassil who told analysts on Vaxyte’s earnings call manufacture of the 24 conjugated drug substances at larger scale at Lonza’s site is taking longer than company had anticipated.
Wassil explained sizing and activating the polysaccharide (PS) is taking slightly longer than expected. He also said Vaxcyte had to vacate Lonza’s manufacturing suite for some time, adding that it has re-entered the suite.
He said “Before we were able to complete the final conjugation stage we encountered an interruption of the drug substance manufacturing campaign at Lonza.
“Working with a world class CMO such as Lonza has many benefits. However, they [Lonza] also have numerous clients with late-stage clinical and commercial products. As a result our GMP conjugate manufacturing campaign was unfortunately interrupted due to Lonza’s prior customer commitments.
“The good news is that we have resumed our manufacturing campaign the early data for which are encouraging and we are working towards completing the 24 conjugated drug substances.”
Disruption caused by the coronavirus also had an impact according to Wassil.
“The COVID-19 pandemic created some operational headwinds. Travel restrictions delayed the qualification of key analytical equipment and in-person CMO oversight. We also saw raw material supply chains slowed. Fortunately, we do believe these issues have now been resolved,” he said.
Wassil also outlined the next steps.
“Before we submit our IND we still have a few outstanding items, which include: GMP manufacturing, testing and release of the conjugated drug substances and drug product; second completion of the GLP toxicology study that is currently underway; and third generation and submission of stability data resulting from the drug product.”
Vaxyte entered into a strategic manufacturing agreement with Lonza for VAX-24 in 2016.
The deal obligated Lonza to perform process development and clinical manufacture and supply of components for VAX-24, including production of polysaccharide antigens, Vaxcyte’s proprietary eCRM protein carrier and conjugated drug substances.
The agreement was amended in 2018 to include manufacturing process development and clinical manufacture and supply of VAX-24 finished drug product.