• The agreement covers the cGMP clinical manufacturing of a next-generation ADC drug candidate
• Novasep’s Le Mans site, in France, has already manufactured the ADC for Exelixis’ ongoing phase 1 clinical trial
• Novasep leverages its ADC bioconjugation expertise and process development capabilities in support of promising new cancer treatments
Lyon, France – July 06, 2021 - Novasep, a leading supplier of services and technologies for the life sciences industry, is pleased to announce the signature of a manufacturing services agreement with Exelixis, a commercially successful, oncology-focused US biotechnology company, for the cGMP clinical production of XB002, a next-generation tissue factor-targeting antibody-drug conjugate (ADC) for oncology applications.
XB002 is a novel ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent and leverages proprietary linker-payload technology. After binding to tissue factor on tumor cells, XB002 is internalized, and the cytotoxic agent is released, resulting in targeted tumor cell death. Following the U.S. Food and Drug Administration’s acceptance of Exelixis’ Investigational New Drug filing in April 2021, Exelixis initiated a phase 1 clinical trial of XB002 in patients with advanced solid tumors in the second quarter of 2021.
Novasep performs process development and cGMP bioconjugation of the XB002 ADC at its state-of-the-art ADC manufacturing unit on its Le Mans site, in France. This site, which now has more than 15 years’ experience in supporting ADC drug innovators, is utilizing its specialized technologies and expertise to support Exelixis’ XB002 clinical supply needs.
“As the first ADC in our growing biologics pipeline to enter clinical development, XB002 is an important program for Exelixis,” said Khalid Shah, Ph.D., Senior Vice President, Pharmaceutical Operations and Supply Chain, Exelixis. “Novasep’s ADC process development and manufacturing capabilities were integral to our ability to initiate XB002’s first phase 1 study on an aggressive timeline this spring. We look forward to leveraging Novasep’s highly specialized ADC expertise as work on the XB002 clinical development program continues.”
“The Antibody Drug Conjugate clinical pipeline continues to strengthen thanks to innovators such as Exelixis. These therapies have the potential to serve as new treatment options for patients around the world and our aim is to accompany their development,” said Dr. Michel Spagnol, Chairman and CEO of Novasep. “We are proud to support Exelixis with our manufacturing services.
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune’s 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
Novasep offers flexible contract development & manufacturing (CDMO) solutions for small molecule APIs & biopharmaceuticals to innovators. We propose a wide range of flexible cGMP manufacturing assets on multiple sites with an outstanding regulatory track record. We are a world leader in a number of specialized technologies including HPAPIs, ADCs, hazardous & cryogenic chemistry & industrial chromatography (batch and continuous).
Following a series of investments in both payload and bioconjugation manufacturing (the latest expansion will involve the creation of an additional 30 full time jobs), Novasep has evolved to become a leading CDMO provider in the ADC arena, working closely with our innovator partners, to supply their clinical and commercial needs. The bioconjugation facility was successfully inspected by the ANSM (French regulatory drug authorities) in 2021.
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