Lund, Sweden, December 4, 2020 – Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced an approved IND (Investigational new Drug) for the CD40 targeting antibody mitazalimab. IND approval by the US Food and Drug Administration (FDA) is a prerequisite to start clinical trials in the USA. Recently, new benchmark data was published showing that mitazalimab has the potential to be best-in-class in the CD40 field. The comparison demonstrated the potent immune-activating properties and anti-tumor effects of mitazalimab.
“While the upcoming clinical Phase Ib/II study in pancreatic cancer, OPTIMIZE-1, will be starting in Europe, the IND opens up for later expansion in the US. This is essential for the future success of the product”, said Per Norlén, CEO of Alligator Bioscience.”, said Per Norlén, CEO of Alligator Bioscience. “Our key focus right now is to complete the submission of the CTA for start of OPTIMIZE-1 in the EU”, he added.
The mitazalimab drug candidate has previously reported positive clinical data from a Phase I study performed by Janssen Biotech Inc., displaying a manageable safety profile as well as early signs of efficacy.
For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
The information was submitted for publication, through the agency of the contact person set out above, at 9:00 a.m. CET on December 4, 2020.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s pipeline includes the two key assets ATOR-1017 and mitazalimab. Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc.). In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden. For more information, please visit www.alligatorbioscience.com.