Adaptimmune Therapeutics plc

Ladies and gentlemen, thank you for standing by, and welcome to the ADAPT Immune Conference Call. With that, I'd like to turn the call over to Julie Miller. And you may begin.

Good morning, and welcome to ADAPT Immune's conference call to discuss our full year and fourth quarter 2020 financial results and business updates. I would ask you to please review the full text of our forward-looking statements from this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to a number of factors. including those outlined in our latest filings with the SEC. Adrian Rockliffe, our Chief Executive Officer, is with me for the prepared portion of this call. Other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian.

Thanks, Julie, and thank you, everyone, for joining us. Three months ago, during our Investor Day, I laid out plans to deliver transformative value for patients and for investors over the course of the next five years, our 2252 plan. In concrete terms, this means two products on the market targeting MAGE A4, two additional BLAs from our clinical pipeline, as well as five autologous and two other generic products entering the clinic in the next five years. All this is based on an integrated cell therapy company with the intent and capabilities to discover, develop, and deliver products that are both curative and mainstream. At the JP Morgan conference last month, we outlined the key catalysts for 2021 and beyond, which will be the mile markers on the road to our 2252 ambition. And I'm absolutely delighted every time I say this. We aim to launch our first product next year. As you know, not many biotechs get to this stage, and it is hugely motivating. for our research and development teams to know that ADPA2M4, the treatment they discovered and developed through clinical trials, may soon be delivered to transform the lives of people with sarcoma. The launch is our first building block of our 2252 plan. The next key dates when we aim to release data at ASCO and CTOS, and these data will be used to support the registration and approval of ADPA2M4. In 2021, beyond our BLA and launch readiness, we will also focus on, firstly, initiating a Phase II trial with our next-generation MAGE-A4 targeted product for people with either esophageal or esophagogastric junction cancers in the first half of this year. Secondly, treating patients in the ongoing Phase I SURPASS trial that also uses our next-generation MAGE-A4 targeted product. We're focused on indications where we've seen signs of efficacy with our MAI-J4 program, namely lung, head and neck, gastroesophageal, and bladder cancer. And we aim to report updated data from the SUPASS trial at ESMO this year. Thirdly, treating patients in our Phase I ADP A2 AFT trial, we planned to report data at ILCA. We will also determine the next steps for this product. And lastly, continuing our research work to bring new products to the clinic, including HLA-independent TCRs, next-generation TILs, and next-generation spear T-cells targeting additional HLAs. Looking back at 2020, you'll find a summary of our key achievements in our press release. I just want to pick up on a few points. When I became CEO, I committed to increasing our focus on speed and quality of execution. And last year, we demonstrated clear progress by completing enrollment in our Spearhead 1 trial in about 12 months, even with the challenges of the COVID-19 pandemic. Whilst we wait for data from Spearhead 1, we're working towards filing a BLA for ADPA2 and 4 for people with synovial sarcoma in the U.S. next year and shortly after that in Europe. The U.S. and EU regulatory designations granted based on compelling and durable response data from our Phase I trial, will help us with this approval process. We've also started to grow our commercial organization and plan for the launch of a companion diagnostic. When you compare our Phase I data to what can be achieved with available treatment options, ADPA2 and 4 has the potential to truly change the lives of people living with synovial sarcoma. And the synovial sarcoma community is incredibly excited about these data. We confirmed in 2020 that sarcoma is only the beginning for our MAGE-A4 targeted products. Last year, we reported responses from spear T-cells targeting MAGE-A4 in four different tumor types, including melanoma, esophagogastric junction, head and neck, and lung cancers. There were also meaningful tumor reductions in other indications. We also completed dose escalation in the surpassed trial with our next generation ADP A2 M4 CD8 product. We're recruiting in the expansion cohort of this trial. And as I said, we plan to report data at ESMO this year. 2020 was also the year where we showed we're building the cell therapy company in the future with our deep preclinical pipeline. Our research team has made great progress on multiple fronts, including identifying the first candidate, mesothelin, to take forward with our HLA-independent TCR platform in co-development with Astellas, products targeting HLAs beyond HLA-A2, and strengthening our toolkit of next-generation options, including a TIL therapy with IL-7 in collaboration with CCIT. This preclinical pipeline supports our ambition to bring five new products to the clinic by 2025. Finally, I want to bring up the progress with our allogeneic platform. We signed a major co-development and co-commercialization agreement with Astellas in 2020 and showed we could generate functional T cells from stem cells. We also demonstrated these T cells can kill cancer targets in vitro. And financially, we've confirmed that we are funded into 2023 and equipped to deliver on our ambition. With that, I'll open it up for questions. Operator?