LUND, Sweden I June 4, 2021 I Alligator Bioscience (Nasdaq Stockholm: ATORX) today presents novel supportive data from the ongoing Phase I clinical trial with the 4-1BB (CD137) drug candidate ATOR-1017 developed as tumor-directed therapy for metastatic cancer. The results, presented in a poster presentation at the 2021 ASCO Annual Meeting, validate the therapeutic potential of ATOR-1017 demonstrating a very favorable safety profile combined with clear signs of proof of mechanism, as activation of T cells in the circulation was observed across active dose levels of ATOR-1017.  

“ATOR-1017 is the first of the second generation monospecific 4-1BB antibodies to report proof of mechanism by showing increase in number of activated T cells in the circulation. Safety data show that ATOR-1017 is safe and well tolerable at doses up to 200 mg and no dose limiting toxicity has occurred. We are encouraged by these data validating the potential of ATOR-1017.  and we are  now focused on completing the study and determining the dose for the subsequent Phase II program,” said Søren Bregenholt, CEO of Alligator Bioscience.

The Phase I study with ATOR-1017 is a dose escalation study in patients with advanced solid cancer (NCT04144842). The primary endpoint of the study is to investigate the safety and tolerability of ATOR-1017 and to determine the recommended dose for subsequent Phase II studies. The first patient was dosed in December 2019. As of data cut-off March 31, 2021, a total of 13 patients with varying advanced solid malignancies had been included. 4 patients (31%) remained on treatment, 3 (23%) of whom had confirmed stable disease for a period of 3.5-12.5 months.

The results from the evaluation of doses up to and including 200 mg demonstrate that ATOR-1017 has an encouraging safety profile as the drug related adverse events in the study have generally been mild and transient. No dose-limiting toxicity or severe immune-related adverse events have been reported. The results further demonstrate that ATOR-1017 exhibits a favorable pharmacokinetic profile with linear elimination and no accumulation. Activation of T cells in the circulation was observed across therapeutic dose levels of ATOR-1017 demonstrating biological activity and proof of mechanism.

The ASCO poster presentation with the title “A first-in-human, multicenter, open-label, phase 1 study of ATOR-1017, a 4-1BB antibody, in patients with advanced solid malignancies” will be available at 03.00 p.m. CEST today, June 4, on the company website http://www.alligatorbioscience.com.

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.

SOURCE: Alligator Bioscience