Kevin Boyle
Analyst · Cantor Fitzgerald. Your line is open. Please go ahead
Thanks, Danielle. Good morning, everyone. Welcome to the Alaunos second quarter 2022 earnings call. Apologies for the frog in my voice here, I hit back to Mr. Rossi, my seventh and eighth grade Latin teacher, and I remember the phrase, tempus fugit, time flies. And time flies when you're having fun. I approach the one-year anniversary of joining the company, and I'm just so proud of are progress that's been made by our dedicated team. The rebuild team has formed a strong operational, manufacturing, and clinical foundation over the past year. Our TCR-T Library Phase 1/2 trial is continuing to actively enroll, and I'm pleased to say that we're moving ahead at the second dose level after consulting with our investigators and safety review board. At the same time, we're working to expand our manufacturing capacity to support future clinical expansion, and are very pleased to welcome Abhi, as Vice President of Technical Operations, to lead this effort. You will hear from Abhi in just a couple of minutes, but I wanted to say that we're very excited to have him on the team as we seek to expand and optimize our manufacturing capabilities. Small world that Drew and Abhi worked together at the NCI, and both are beneficiaries of the world-class training it offers. This quarter, we are very privileged to extend our CRADA into 2025, working with Dr. Rosenberg and the NCI to develop personalized cancer therapies using our novel TCR-T cell platform. In partnership with Dr. Rosenberg's team, we look forward to continuing our collaboration, generating proof of concept in this personalized approach. When combined with the Alaunos TCR-T Library Phase 1/2 trial and our R&D efforts, we believe that we have the right approach, the right expertise, and in my mind most importantly the right team for Alaunos to be successful in the long-term and improve the lives of cancer patients with solid tumors. And to provide an update on our TCR-T Library trial, as a reminder, it's a Phase 1/2 basket trial, targeting hotspot mutations across six different solid tumor indications; non-small cell lung, colorectal, endometrium, pancreas, ovary, and bile duct cancers. We are currently enrolling patients down the street, at MD Anderson Cancer Center, with one of these six cancers based on matching mutation HLA pairings that are available in our TCR-T library, which consists of 10 TCRs; we have four KRAS, five TP53, and one EGFR. As you may recall, we announced that we dosed the first patient in the trial, in May, at a dose level 1 or approximately five billion TCR-T cells. This patient has non-small cell lung and the KRAS G12D mutation. The patient was treated with TCR-T cells targeting this driver mutation, manufactured in our very own in-house cGMP facility. Following discussion with our investigators as well as a review of safety data at MD Anderson, we're very pleased to be moving ahead at the second dose level of approximately 40 billion TCR-T cells. We remain encouraged by the progress in the trial, and look forward to providing an early look at data in a medical meeting in the third quarter of this year. And we believe we're on the right track, but instilling even greater confidence in our approach using TCR-T cells to target hotspot mutations were two recent papers published by leading academic institutions. One was published in the New England Journal of Medicine, and the other in Cancer Immunology Research. I'll let Drew go into more detail about the clinical findings of these papers, but I'd like to highlight that these case studies with patients with KRAS and TP53 mutations treated with TCR-T cells resulted in durable responses using TCRs that we have in our library. Now, we believe that we have a better more cost-effective and commercially scalable approach using our proprietary Sleeping Beauty technology, and we're actively testing these TCRs in our clinical trial. Now, as much like the old scout motto, to be prepared, we're working diligently to execute on a multi-pronged strategy to expand our manufacturing capabilities. Now, while we believe we have sufficient capacity to support our Phase 1/2 study for at least the next year, this expansion will serve us well in the long-term as we continue our R&D effort with membrane-bound IL-15, and expand our future clinical pipeline. First, we're implementing new SOPs that will allow for simultaneous production of multiple products in our cGMP suite. And this also includes work to further optimize our manufacturing process by introducing cryopreserved cell products. Secondly, we are continuing to hire additional staff to support increased manufacturing capability. And lastly, having already successfully built one cGMP suite, we will investigate physically expanding our GMP footprint as the need arises. Now, before I turn the call over to Drew to touch upon our R&D efforts, I wanted to briefly highlight a collaboration agreement that we have with Solasia Pharma. This collaboration was initially formed way back in 2011, and granted Solasia an exclusive worldwide license to develop and commercialize darinaparsin, also known as Darvias. As part of this license agreement, we are eligible for sales-based cash milestones and a percentage of any sub-license revenue generated by Solasia. Now, Solasia will continue to be responsible for all costs related to manufacturing and commercialization. In June of 2022, Solasia announced that Darvias has been approved for relapsed or refractory peripheral T-cell lymphoma by the Ministry of Health, Labor, and Welfare, in Japan. And we're excited for their team at Solasia as this represents a significant milestone for them. Now, we do not expect to receive significant capital for the royalties on these sales, but the additional non-dilutive capital will certainly help to further support our own internal development program. I'm going to now hand the call over to Drew to highlight our continued partnership with Dr. Rosenberg and the NCI, and also expand on those supportive academic papers that were recently published. Drew?