San Diego‐based start‐up Aspyrian has selected Goodwin to manufacture its ADC candidate using the near‐infrared Photoimmunotherapy (PIT) platform exclusively licensed from the National Cancer Institute.
Whilst conventional ADC platforms have been hindered by dose-limiting adverse effects to the payload, the PIT technology avoids this by ensuring the cytotoxin remains inert until the ADC is in the tumour itself, according to Aspyrian, when it is then activated by near‐infrared (NIR) light.
PIT is based, therefore, on the antibody itself which binds to cell-surface antigens, the NIR IR700DX dye which is conjugated to the antibody via a linker, and the light which commences the cell killing.
The firm says the selective binding and localised NIR activation is highly efficient in destroying diseased cells, whilst sparing to nearby healthy tissue and hopes to take its first product – for the treatment of neck and head cancer – into Phase I trials by the end of the year.
The deal with Goodwin – of which financial details were not divulged – will see Aspyrian use the CMO for the technology transfer, development, scale-up and cGMP manufacturing of the ADC.
“This important project is a testament to our experience and expertise in bioconjugation that has been developed and refined over more than a decade,” said Goodwin COO SooYoung Lee.
In May 2013, Goodwin teamed up with fellow US contract manufacturer Coldstream Laboratories to begin offering clients ADC capabilities, with the former providing pre-formulation development and the latter clinical and commercial.
Speaking with sister publication Outsourcing-Pharma.com last year, Goodwin’s Director of Marketing David Cunningham said “the economics and efficacy of ADCs have always been compelling,” with the firm seeing a “very high demand within the biopharmaceutical sector from small and virtual companies to large and established multinationals.”