SAGA Diagnostics enters into Agreement with Alligator Bioscience in the phase 1b/2 OPTIMIZE-1 trial

LUND, Sweden — /February 25, 2021/ — SAGA Diagnostics AB, a cancer liquid biopsy and genomic testing company focused on precision oncology and non-invasive ultrasensitive monitoring of cancer patients, has entered into a service agreement with Alligator Bioscience, a Swedish clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs.


SAGA will be involved in Alligator’s clinical trial OPTIMIZE-1, a phase 1b/2, open-label, multicenter study designed to assess the clinical efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic cancer.


OPTIMIZE-1 is a phase 1b/2 trial in patients with pancreatic cancer, that follows on two successful phase 1 studies with our innovative CD40 targeting antibody mitazalimab. By monitoring the patient’s ctDNA, we hope to gain additional insights into the kinetics of response and potentially see changes earlier and more quantitatively than with imaging alone.
Malin Carlsson, COO at Alligator Bioscience


SAGA Diagnostics will in the course of this agreement develop SAGAsafe® dPCR assays that will be used to monitor the circulating tumor DNA (ctDNA) in patients at baseline and during treatment. SAGAsafe® technology is a patented enhancement of digital PCR offering a limit of detection that is up to 100x increased in comparison with competitor methods. SAGAsafe® can be used to detect and quantify mutations in tissue samples as well as liquid biopsies such as blood plasma.


We at SAGA are very much looking forward to be part of the development of this innovative and promising immuno-oncology antibody therapy. We are certain that the ultrasensitivity of the SAGAsafe® approach will provide important insights into the therapy response.
Anthony George, CTO at SAGA Diagnostics


The OPTIMIZE-1 trial will start in the first half of 2021 and run for two years.




Operations Director Johanna Asklin, PhD.  Phone: +46 (0) 733 01 7242


About SAGA Diagnostics AB
SAGA Diagnostics is a personalized cancer genomics and disease monitoring company that offers molecular genetic testing of tissue biopsies and non-invasive “liquid biopsies” such as blood samples. SAGA helps pharmaceutical companies, scientists, and healthcare providers to detect actionable mutations, stratify patient groups, and monitor treatment response more accurately and to an industry-leading lower limit of detection of 0.001%. Analysis of circulating tumor DNA using its proprietary technologies gives SAGA unique ultrasensitivity, and provides the basis for optimal decision-making.

Follow SAGA on Twitter @SAGAdiagnostics and LinkedIn.


About Alligator Bioscience AB
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