Lund, Sweden, June 4, 2021 – 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.
For further information, please contact:
Søren Bregenholt, CEO
Phone: +46 46-540 82 00This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CEST on June 4, 2021.
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 http://www.alligatorbioscience.com.