On August 25, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it will give status updates and details on the recent clinical development plans for the clinical drug candidates mitazalimab, ATOR-1015 and ATOR-1017 on a virtual R&D Day on August 27 (Press release, Alligator Bioscience, AUG 25, 2020, View Source [SID1234563992]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These clinical plans provide an excellent opportunity for Alligator to have two or even three competitive cancer therapeutics in clinical efficacy studies by the end of 2021", commented Per Norlén, CEO of Alligator Bioscience.

Mitazalimab is Alligator’s most advanced immunotherapy candidate intended for the treatment of different types of cancer. It activates CD40, a receptor on the dendritic cells which allows the immune system to selectively attack the cancer.

Next step in the development of mitazalimab is the submission of a Phase II clinical trial application (CTA) which is planned for December 2020. The study (OPTIMIZE-1) is an open-label, multi-center trial assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFolfirinox) in patients with metastatic pancreatic cancer. The OPTIMIZE study will be performed at several clinics in Europe, with inclusion of the first patient H1 2021.

Clinical data previously communicated from mitazalimab’s Phase I development program demonstrated that mitazalimab is safe and tolerated at clinically relevant dose levels, with early signs of clinical activity identified, including a partial response in a patient with renal cell cancer and prolonged stable disease ≥6 months in 10 patients. There is still one patient in the Phase I study, now treated with mitazalimab for more than 30 months.

ATOR-1015, wholly owned by Alligator, is a tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer. The first indication will be skin cancer (malignant melanoma) where the target molecule CTLA-4 has been proven effective but associated with significant toxicity.

Promising data from the ongoing ATOR-1015 Phase I clinical trial was presented in June 2020 and dose escalation has continued at high doses. The positive tolerability profile of ATOR-1015 has led to the frontloading of a Phase Ib study for demonstration of single-agent activity. This allows for an efficacy readout as early as H2 2021 in malignant melanoma. This could significantly increase the value of the concept and will be followed by a Phase II combination study with anti-PD-1.

The interim data include doses up to 600 mg (about 10 mg/kg) and show that ATOR-1015 is well tolerated, thus supporting for the concept. Dose-escalation is currently at 750 mg (12.5 mg/kg). 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.

ATOR-1017 is Alligator’s wholly owned 4-1BB antibody in clinical Phase I development for the treatment of metastatic cancer. ATOR-1017 activates 4-1BB receptors on T cells which increases the ability of the immune system to detect and kill tumor cells. ATOR-1017 has a unique profile which creates an opportunity for a strong and tumor-directed immune activation that can increase efficacy and reduce side effects for the patient.

The ongoing Phase I study is a dose escalation study in patients with advanced cancer. The study is conducted at three different clinics in Sweden and is planned to include up to 50 patients. The objectives of the study are to assess the safety and tolerability of ATOR-1017, to determine the recommended dose for the subsequent Phase II studies, but also to assess initial signs of efficacy.

A more detailed invitation to the R&D Day on August 27 will be distributed shortly.

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 11:00 a.m. CEST on August 25, 2020.