We continued to make encouraging clinical progress with our leading drug candidates this quarter and we are looking ahead to key readouts from our OPTIMIZE-1 and ATOR-1017 clinical trials due in the second half of the year. We also expanded our board with two new members whose appointments further strengthen the leadership of the Company. To preserve financial resources and optimize the chances of success of our upcoming mitazalimab OPTIMIZE-2 clinical trial, we decided to await the interim data of OPTIMIZE-1 to readout before initiating this additional clinical trial, which we now expect in H1 2023. The entire Alligator team has worked tirelessly to deliver the OPTIMIZE-1 interim data and ATOR-1017 data on time and is entirely dedicated to continue to generate industry-leading scientific data to further validate the quality of our three core platforms to deliver long-term returns to all our stakeholders.
We are excited to be able to present these very promising data at ASCO, outlining the strong safety profile and signs of efficacy of our ATOR-1017 drug candidate. 4-1BB antibodies have been plagued with poor efficacy or unacceptable safety profile, but ATOR-1017 is distinct from other 4-1BB antibodies, partly because of its unique binding profile but also because its immunostimulating function is dependent on cross-linking to Fc-gamma receptors on immune cells. This localizes the immunostimulation to the tumor region, where both 4-1BB and Fc-gamma receptors are expressed at high levels. This means that ATOR-1017 has the potential to address a significant unmet medical need, and we look forward to finalizing this study and selecting a recommended dose for the upcoming Phase 2 study.
It's a great pleasure to welcome Staffan and Denise to our Board of Directors. Staffan is a hugely experienced investor having led the growth and development of numerous companies, including start-ups and established businesses, over the last 30 years. Since 2015, he has taken a great interest in Alligator Bioscience, and we are delighted to have him assume a formal leadership role in the company. Denise brings with her a huge amount of insight and experience with a deep understanding of the pharmaceutical industry as well as financing, fundraising and business development. Their appointments will further strengthen the leadership of the company and underline our commitment to our mission of developing antibody-based treatments for cancer while creating outstanding value for our shareholders.
I see great potential in Alligator Bioscience, not only in the potential of mitazalimab to revolutionize the treatment paradigm in metastatic pancreatic cancer but also of Alligator’s broad product portfolio and its drug development platform. The company is rightly focused on improving the balance between R&D and commercialization and I look forward to working with Alligator's excellent management team to help them achieve this.
I am very pleased to be joining the Board at Alligator Bioscience at a very important time for the company. Alligator's innovative technologies have the chance to make a real contribution to the future of cancer therapy and a difference to those suffering from these hard-to-treat conditions.
With the capital injection from the rights issue, we secure the start of important efficacy studies for our focus projects mitazalimab and ATOR-1017. Just before year-end, we submitted a CTA for mitazalimab, an application to start Phase II in pancreatic cancer. For ATOR-1017, we plan to start Phase II studies in the second half of 2021, with gastric cancer as a prioritized indication. Based on strong data from preclinical models and clinical Phase I, we see great opportunities for both mitazalimab and ATOR-1017 to successfully treat patients with these cancers.
The CTA submission is an important milestone for Alligator, as we are now entering clinical Phase II for the first time. With best-in-class benchmark data presented for mitazalimab during the autumn, I believe that OPTIMIZE-1 has great potential to deliver robust efficacy results in pancreatic cancer.
While the upcoming clinical Phase Ib/II study in pancreatic cancer, OPTIMIZE-1, will be starting in Europe, the IND opens up for later expansion in the US. This is essential for the future success of the product. Our key focus right now is to complete the submission of the CTA for start of OPTIMIZE-1 in the EU.
The fact that three of our immuno-oncology projects have been selected for presentation at this year’s SITC is a clear confirmation of Alligator’s strong presence in the field. The presentations span from advanced clinical patient data to thrilling early data from our next generation drug concept Neo-X-Prime.
The solid clinical package from Phase I and the new favorable benchmark data to our key competitors further strengthen our belief in mitazalimab as a potent immunotherapy agent. Mitazalimab has demonstrated strong activity and superior tolerability, which probably reflects the fact that the antibody has been optimized for more tumor-selective effects.
We are now completing the clinical file for the submission of the CTA for the upcoming Phase Ib/II efficacy study in pancreatic cancer.
ATOR-1017 is now administered at the dose levels we aimed for when designing the study: we are in fact more than 20 times higher in dose than the benchmark product urelumab. This is an important milestone for the program and for the upcoming Phase II efficacy study. ATOR-1017 was designed to overcome the challenges of the first generation 4-1BB antibodies, in particular severe immune-related adverse events. The emerging safety profile, based om data seen this far, suggests that we have been successful.
ATOR-1017 and mitazalimab are frontrunners worldwide and Alligator must prioritize and focus investments on these assets to maximize their value. They both have potential in large cancer indications with high medical need and billion-dollar markets. They also target important immune mechanisms where clinical validation is now emerging and has attracted significant interest already. Under the revised plan, resources will be concentrated to the upcoming phase Ib/II efficacy studies for ATOR-1017 and mitazalimab.
The new concept may be viewed as a patient specific therapeutic vaccination with the aim of curing cancer. The early data are extremely promising and show that Neo-X-Prime antibodies have the potential to induce anti-tumor effects superior to any current treatment option.
ATOR-1015 constitutes a new concept, a tumor-localizing bispecific CTLA-4 antibody. Our invention addresses one of the key challenges within immuno-oncology, i.e. the narrow therapeutic window of CTLA-4 drugs. This is now protected by a granted US patent.
We are now regaining the exclusive, global rights to develop and commercialize ADC-1013 and at the same time receive enough ADC-1013 substance to, with or without a new partner, bring ADC-1013 into Phase II clinical trials next year. In total, we now have three projects in clinical development, and soon another one where the first patient in Phase I will be dosed.
Engaging Theradex is a key step towards starting our clinical phase I study with ATOR-1015 later this year. We have worked previously with Theradex on the ADC-1013 clinical phase I trial and, based on their robust delivery and extensive expertise in clinical oncology research, we are confident in their ability to assist us in executing high-quality studies and we look forward to continuing our successful collaboration.
With three preclinical projects approaching clinical development and our business model to out-license projects after proof-of-concept in cancer patients, we are very pleased to make this important appointment to the management team. We look forward to welcoming Anu to Alligator. He brings extensive international experience in drug licensing and collaboration, complementing the growing team at Alligator.
We are pleased that our collaboration with Janssen is continuing to progress according to plan. The upcoming combination is a very important step in the continued clinical development. Synergy between ADC-1013 and PD-1 blocking antibodies is supported by pre-clinical data. If this translates to the clinic, it could create new treatment opportunities for many cancer patients.
We are very excited about the continued progress and promising early data of ADC-1013. The data indicate that it is well tolerated at clinically relevant doses. There is clear evidence supporting activation of CD40 receptors, which together with the clinical observations gives us increased confidence for the continued clinical development of ADC-1013.
I am very enthusiastic about the extended collaboration with Alligator. Its 4-1BB drug candidates provide great new treatment opportunities within immuno-oncology. The fact that 4-1BB is upregulated on tumor-specific T cells, together with its capacity to promote survival, expansion and functional activity of several immune cells involved in tumor eradication, makes 4-1BB a uniquely appealing target for immunotherapy of cancer.
We are very fortunate to have Professor Melero as a research collaborator. He is a world leading expert in the field of 4-1BB and immunotherapy and his scientific guidance will be extremely valuable both for our pipeline projects, and to help fulfill our ambition to deliver first and best-in-class products to patients.
With CMC and IND enabling activities underway, our partnership with Aptevo is moving ahead rapidly. Having worked collaboratively to design and engineer ALG.APV-527, we are pleased to now announce its advancement into preclinical development. This bispecific antibody brings tumor directed immunotherapy to the next level. By making the immune activation dependent on binding to a tumor antigen we have created a candidate drug with potential for improved efficacy and fewer side effects.