ALIZE PHARMA II Pegcrisantaspase Program
|Company||Alize Pharma II SAS|
|Program||Pegcristantaspase (Asparec®, JZP-416), PEGylated recombinant Erwinia chrysanthemi L-asparaginase|
|Stage of development||Phase II/III in acute lymphoblastic leukemia|
|Status||Partnered (Jazz Pharmaceuticals, Nasdaq: JAZZ)|
Sham Innovation Santé
Pegcrisantaspase (Asparec®, JZP-416) is a new PEGylated recombinant L-asparaginase derived from Erwinia chrysanthemi, under development in acute lymphoblastic leukemia, in patients with hypersensitivity to E. coli-derived L-asparaginase. Preclinical data indicate that pegcrisantaspase is both longer acting and less immunogenic than Erwinaze® / Erwinase®, the currently available L-asparaginase derived from Erwinia chrysanthemi.
The product is protected by a patent filed internationally and was granted orphan drug designation from both the FDA and the EMA. The program is currently undergoing Phase I clinical trials in Europe. In 2013, it was granted Fast-Track designation by the FDA, and a pediatric US Phase II/III trial was launched in 2014.
It is partnered with Jazz Pharmaceuticals (Nasdaq: JAZZ). Under this license agreement that was announced in 2012, Jazz Pharmaceuticals is responsible for further development and worldwide commercialization of pegcrisantaspase. In return, Alizé Pharma II SAS received an upfront payment and is entitled to receive additional milestone payments and royalties on sales.
- Allas S et al. “Pharmacokinetics and pharmacodynamics in mice of a PEGylated recombinant Erwinia chrysanthemi-derived L-asparaginase”. Abstract #2033. 51st ASH annual meeting, December 5-8, 2009 (New-Orleans, LA). 2009.
- Allas S et al. “Immunogenicity profile in mice of a PEGylated recombinant Erwinia chrysanthemi-derived L-asparaginase”. Abstract #2034. 51st ASH annual meeting, December 5-8, 2009 (New-Orleans, LA). 2009.
- Chien WW, Allas S, Rachinel N, Sahakian P, Julien M, Le Beux C, Lacroix CE, Abribat T, Salles G. Pharmacology, immunogenicity and efficacy of novel pegylated recombinant Erwinia Chrysanthemi-derived L-asparaginase. Invest New Drugs. 2014 May 15. [Epub ahead of print].
- Chien WW, Le Beux C, Rachinel N, Julien M, Lacroix CE, Allas S, Sahakian P, Cornut-Thibaut A, Lionnard L, Kucharczak J, Aouacheria A, Abribat T, Salles G. Differential mechanisms of asparaginase resistance in B-type acute lymphoblastic leukemia and malignant natural killer cell lines. Sci Rep. 2015 Jan 28;5:8068.