Only a few weeks into the new year Alligator updated the market on the progression of the phase Ib/II study OPTIMIZE-1, a new research collaboration, and about a new major shareholder joining Alligator’s nomination committee. BioStock reached out to CEO Søren Bregenholt to get his view on the latest developments.
Immuno-oncology company Alligator Bioscience develops tumour-directed antibody therapies and has two assets in clinical development, the CD40 agonist mitazalimab and ATOR-1017, a 4-1BB receptor agonist.
OPTIMIZE-1 is well underway
Mitazalimab is currently undergoing a phase Ib/II trial in metastatic pancreatic cancer. The study is conducted in France and Belgium and is planned to include up to 67 patients. The company has recently carried out an oversubscribed rights issue of 257 MSEK, to fund the OPTIMIZE-1 study.
In January, Alligator announced that all patients in the 450 µg/kg cohort have been dosed and that no adverse dosing effects have been reported. The dosing of the 900 µg/kg cohort has been initiated and the company expects to present safety data from the phase Ib part during the first quarter 2022. The interim data read-out is expected during the fourth quarter 2022.
Collaboration with UPENN
Alligator updated the market about a new sponsored research collaboration in connection with the phase Ib/II trial. Dr. Gregory Beatty, assistant professor at University of Pennsylvania’s (UPENN) Pancreatic Cancer Research Center, will lead a group of researchers to conduct analysis of biomarker data from the OPTIMIZE-1 study. Dr. Beatty will also support Alligator as a scientific advisor.
New representative in the nomination committee
In connection with the rights issue in November 2021, a new major shareholder emerged in Alligator. California-based investment fund Allegro Investment Fund, chaired by Staffan Encrantz, has been a long-time shareholder in Alligator. During the fourth quarter 2021, Allegro Investment Fund increased its ownership substantially and now holds 22,2 per cent of the shares.
Being the largest shareholder, Allegro Investment Fund will be represented in Alligator’s nomination committee, together with Anders Ekbom, the chair of Alligator and representatives from the second and third largest shareholders.
CEO comments on the latest developments
BioStock reached out to CEO Søren Bregenholt to get his comments on the latest news.
Søren, the OPTIMIZE-1 trial seems to be running as planned. Has the pandemic impacted the trial in any way?
– Yes, OPTIMIZE-1 is on track, running as planned and currently, there has been no impact from the pandemic.
What are the next steps with OPTIMIZE-1?
– Patient recruitment is continuing in both France and Belgium and dosing of the 900 µg/kg cohort has already begun. We plan to announce safety data from the Phase Ib part of the study in Q1 of this year and the interim readout on Q4.
Dr Gregory Beatty will lead a research collaboration with UPENN and OPTIMIZE-1. Can you tell us more about him?
– Gregory Beatty, MD, PhD, like you mentioned above, is an assistant professor of Medicine in the Division of Hematology/Oncology, UPENN. Dr. Beatty also runs The Beatty Laboratory which incorporates both basic science research and clinical investigation to define strategies for leveraging the immune system for the treatment of especially pancreatic cancer.
What do you hope Dr Beatty and his team will find in their research?
– The priority of Dr. Beatty’s study will be to apply their analytical capabilities on data collected from patients receiving our best-in-class agonistic CD40 antibody mitazalimab in combination with FOLFIRINOX. The UPENN study is a part of our OPTIMIZE-1 clinical trial, which is an open-label, multi-center phase Ib/II trial assessing the clinical efficacy of mitazalimab in combination with chemotherapy (FOLFIRINOX) in patients with metastatic pancreatic cancer.
– Of course, we expect the data generated will confirm and add to our understanding of mitazalimabs mechanisms-of action-in human and support the safety and efficacy profile.
Finally, Alligator has a new major shareholder since the rights issue – what do you think this will mean for the company?
– It is great to have a new cornerstone investor based in the US that knows Alligator well. Long-term investors like Allegro provide stability for the company as we develop the pipeline for the benefit of cancer patients and all stakeholders in the company.
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