Lund, Sweden, May 29, 2020 – Alligator Bioscience (Nasdaq Stockholm: ATORX), announces that the company today presents additional novel data from the ongoing Phase I clinical trial with the bispecific drug candidate ATOR-1015 developed as tumor-directed therapy for metastatic cancer, which further validates the potential of the drug. The presentation will be held at the ASCO (American Society of Clinical Oncology) Annual Meeting, which this year is being held virtually.
The results from the evaluation of doses up and including 600 mg (about 10 mg/kg) show that ATOR-1015 is well tolerated, and dose-escalation has continued to 750 mg (12.5 mg/kg). In this presentation, 21 patients with varying cancer types (colon cancer, eye melanoma, pancreatic cancer, ovarian cancer, gallbladder cancer, gastric cancer, and melanoma) are included and evaluated in terms of safety. 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 presented at ASCO truly support the fact that ATOR-1015 could be a safer and more efficacious drug than current treatment options for spread cancer disease. We are consequently very much looking forward to moving ATOR-1015 into efficacy studies,” said Per Norlén, CEO of Alligator Bioscience.
Due to the positive tolerability profile of ATOR-1015, dose escalation will continue at even higher doses than expected but still allows for a preliminary efficacy readout in melanoma patients already towards the end of 2021.
The ASCO poster presentation with the title “A first-in-human phase I study in patients with advanced and/or refractory solid malignancies to evaluate the safety of ATOR-1015, a CTLA-4 x OX40 bispecific antibody” is available on the company website http://www.alligatorbioscience.com.
This 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 2:00 p.m. CEST on May 29, 2020.
About the ATOR-1015 Phase I study
The Phase I study with ATOR-1015 is a dose escalation study in patients with metastatic cancer (NCT03782467). The primary endpoint of the study is to investigate the safety and tolerability of ATOR-1015 and to determine the recommended dose for subsequent Phase II studies. The first patient was dosed in March 2019 and following the establishment of the maximum tolerable dose or recommended dose for Phase II, further clinical development of ATOR-1015 is planned, primarily for the treatment of malignant melanoma.
ATOR-1015, wholly owned by Alligator, is a bispecific CTLA-4 antibody developed as tumor targeted immunotherapy with increased capacity for killing regulatory T cells. ATOR-1015 binds to two different immune receptors – the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which can lead to reduced side effects.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s growing pipeline includes five lead clinical and preclinical drug candidates: mitazalimab, ATOR-1015, ATOR-1017, ALG.APV-527 (co-developed with Aptevo Therapeutics Inc.) and AC101 (in clinical development by Shanghai Henlius Biotech Inc.). 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.