Sterling, Novasep in HPAPI advances
CDMOs Sterling Pharma Solutions and Novasep have both made announcements in the high potency arena in the past week. The former has signed a manufacturing deal with oncology specialist OncoTex, while the latter is expanding its main high potency API (HPAPI) site at Le Mans.
Under its deal with OncoTex, Sterling will produce clinical trial volumes of its novel platinum-resistant oncology drug candidate, OxaliTex, at the cGMP facility it acquired last year from Alcami in Germantown, Wisconsin (pictured). This can handle HPAPIs in fully contained manufacturing suites. No financial details were disclosed.
OxaliTex is a conjugate of oxaliplatin with a tumour-localising metallotexaphyrin for targeted drug delivery to cancerous tumours. OncoTex describes it as the first candidate to emerge from a new class of oncology drugs that are well-tolerated, overcome platinum resistance and are detectable by MRI.
Meanwhile, Novasep is investing more than €4 million and recruiting 30 more people at Le Mans, where it develops HPAPIs and antibody-drug conjugates (ADCs), mainly for cancer treatment. It said that the site “continues to exhibit strong growth as a result of longstanding collaborations with major pharmaceutical companies and new partnerships with biotechnology innovators”.
The company has been active in ADCs for 15 years and has offered integrated development and manufacturing services for both payloads and bioconjugation since 2017, when it opened its €12 million bioconjugation facility. This has recently had a successful inspection by the French regulatory authority, ANSM.