Advanced Accelerator Applications

Emerging Company in the Spotlight sponsored by JFK Communications.

BioNJ is pleased to shine the spotlight on one of our Innovation Members each month featuring their progress and work on behalf of Patients and their impact on the New Jersey life sciences ecosystem. This month’s Emerging Company in the Spotlight is Admera Health.

So many of our Members are making a dramatic impact on our State’s innovation ecosystem. We celebrate you! Admera Health is one such company.

Advanced Accelerator Applications (AAA) is a radiopharmaceutical company that develops, produces and commercializes molecular nuclear medicine, or MNM, diagnostic and therapeutic products. AAA is a global leader in the development of predictive, preventive and personalized tools that may transform healthcare for patients and physicians. AAA is merging therapeutic and diagnostic technologies to advance the early detection, treatment and monitoring of diseases. AAA, headquartered in Saint-Genis-Pouilly, France was founded in 2002 by Stefano Buono. Today, AAA has over 21 production and research & development facilities in Europe and the U.S. that manufacture both diagnostic and therapeutic MNM products. AAA employs over 500 employees in 13 countries (Belgium, Canada, France, Germany, Israel, Italy, the Netherlands, Poland, Portugal, Spain, Switzerland, the UK and the U.S.) and currently markets nine radiopharmaceuticals (8 in Europe and 1 in the U.S.) for diagnosis in oncology, cardiology and neurology. AAA is also developing a pipeline of theragnostic pairings for oncology indications.

Prior to founding AAA, Stefano Buono was a physicist at The European Organization for Nuclear Research (CERN) in Switzerland, working with Physics Nobel Laureate Carlo Rubbia. The team’s research produced a patent, which had applications in nuclear medicine, and Buono saw an opportunity to create a company to commercialize this patent and further develop the technology for theragnostic applications.

In line with AAA’s growth strategy, the company has built a substantial beachhead in the United States. AAA established its first U.S. office in New York City in 2014, and listed on the NASDAQ in 2015. In 2016, AAA officially opened its first production and distribution site in Milburn, New Jersey. The facility is undergoing validation to produce AAA’s investigational therapy, lutetium Lu 177 dotatate (Lutathera®)*, and currently serves as a distribution center for its NETSPOT® diagnostic drug and Oxygen-18 enriched water, an important precursor for the production of fluorodeoxyglucose (FDG) used in PET. The site is conveniently located near Newark airport, enabling future delivery of lutetium Lu 177 dotatate (Lutathera®)* directly to hospitals and treatment centers around the country. “New Jersey was our first choice of location for our U.S. operating site,” said James Cook, Chief Operating Officer for AAA USA. “We are grateful for BioNJ’s support, as well as their commitment to the development of the pharmaceutical and biotechnology community in New Jersey.”

 

Portfolio

AAA manufactures and commercializes a broad portfolio of PET and SPECT products for several indications, primarily in Europe. Currently, most of AAA’s global revenues are driven by GLUSCAN®, an FDG PET tracer for oncology, cardiology, neurology and infectious/inflammatory disease marketed in nine European countries. In 2016, AAA received its very first FDA approval for NETSPOT® (gallium Ga 68 dotatate), a PET imaging drug for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. SomaKit TOC™ (gallium Ga 68 edotreotide) was approved in Europe for localization of primary tumors and metastases in patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in December 2016.

 

Pipeline

AAA continues to develop innovative PET/SPECT diagnostics, while expanding its pipeline of theragnostic pairings for oncology indications. The company’s theragnostic platform involves radiolabeling a targeting molecule with either gallium Ga 68 for diagnostic use, or lutetium Lu 177 for therapy. AAA’s first theragnostic pairing addresses neuroendocrine tumors (NETs), an orphan indication. The diagnostic drugs in this pairing, marketed as NETSPOT® in the U.S. or SomaKit TOC™ in Europe, are already approved for use. The therapeutic drug in this pairing, lutetium Lu 177dotatate (Lutathera®)* recently received a positive CHMP opinion from the EMA for treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults, and is under review for registration with the FDA. Lutetium Lu 177dotatate* has been administered to more than 1,800 patients on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in ten European countries and in the U.S. under an Expanded Access Program (EAP).

AAA collaborated with numerous principal investigators throughout Europe and the United States on NETTER-1, a landmark phase III trial for lutetium Lu 177 dotatate*. This study compared lutetium Lu 177 dotatate* to Octreotide LAR 60mg in patients with advanced midgut NETs which progressed under the standard of care. As published in The New England Journal of Medicine, this study met its primary endpoint and demonstrated a significant increase in PFS.1 Preliminary NETTER-1 Quality of Life analysis suggests evidence of benefit in key domains that are pertinent to midgut NETs, including global health and diarrhea.2,3

Additional theragnostic pairings in the AAA pipeline include PSMA-R2, a unique, selective, second-generation PSMA-targeted molecule selective for the PSMA receptor expressed on the majority of prostate tumor cells; and NeoBOMB1, a new generation antagonist bombesin analogue targeting gastrin-releasing peptide receptor (GRPR)-expressing malignancies, such as gastrointestinal stromal tumors (GIST), prostate cancer and breast cancer.

 

The Next 5-10 Years

AAA is committed to being the leading theragnostic radiopharmaceutical company in oncology. The company will continue to expand its global footprint, as well as its pipeline, and remains open to partnerships with other leading physicians, industry, or academic partners, especially as it moves into more mainstream indications for its theragnostic pairings, such as prostate and breast cancer.

“I believe that nuclear medicine, and in particular, theragnostics, will become a key aspect of patient management in the future,” noted Stefano Buono, CEO of AAA. “There are few, if any, other technologies with the ability to diagnose, monitor, treat and evaluate therapy using the same molecule, with only a difference in the radioisotope attached. We see a very bright future for nuclear medicine, and think theragnostics is the innovative push needed to bring a revolution to the sector. As with all new medical paradigms, there is a cycle of interest and adoption. We saw this recently with the impact of check-point inhibitors on immuno-oncology. We believe theragnostics will bring new excitement and appreciation for the relevance of nuclear medicine in oncology.”

 

For more information about Advanced Accelerator Applications, please visit http://www.adacap.com.

* USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide (Lutathera®)
1 Strosberg JR, Wolin EM, Chasen B, et al. NETTER-1 phase III: Efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177Lu-DOTATATE. J Clin Oncol. 2016;34 (suppl; abstr 4005).
2 Highlights Lecture of 2016 Meeting of European Society for Medical Oncology, Copenhagen, Denmark.
3 “NETTER-1 Phase III: Efficacy, Safety, Subgroup Analysis, and QOL Results,” 2016 Meeting of North American Neuroendocrine Tumor Society, Jackson, Wyoming