Adaptimmune(US:ADAP)2023-11-08 16:45Financial Data and Key Metrics Changes - The company has made significant progress in reducing its cost base through organizational restructuring [3] - The submission of the Biologics License Application (BLA) for Afami-cel is expected to be completed within the quarter [4][6] - R&D expenses increased due to the inclusion of TCR2 R&D expenses and a reduction in R&D tax credits [27] Business Line Data and Key Metrics Changes - Afami-cel demonstrated clear lasting benefits for patients with synovial sarcoma, with data presented at the CTOS [4][5] - Lete-cel has shown 18 responses out of 45 patients in the pivotal IGNYTE-ESO trial, meeting its primary endpoint for efficacy [8] - The company has decided to discontinue the development of Gavo-cel and TC-510 due to insufficient clinical benefit [10] Market Data and Key Metrics Changes - The company is focusing on expanding its sarcoma franchise, with Lete-cel expected to increase the addressable market by 2x to 3x [8] - The SURPASS trials are now narrowed to focus on ovarian, head and neck, and bladder cancers, with promising response rates reported [11] Company Strategy and Development Direction - The company aims to transform into a commercial cell therapy company by achieving key goals set for 2023, including the completion of BLA submissions and strategic combinations [3] - The focus is on prioritizing clinical portfolios based on data, with a commitment to resources on cell therapies with clear paths to market [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of Afami-cel to transform treatment for synovial sarcoma and the importance of bringing it to market [6][7] - The competitive landscape for PRAME TCR therapies is viewed positively, with confidence in the company's position in the market [24][25] Other Important Information - The company has received RMAT designation and has had positive interactions with the FDA regarding the BLA submission [6] - The company plans to provide updates on its expanded sarcoma franchise in the New Year [12] Q&A Session Summary Question: Focus on SURPASS and ADP trial activity in earlier line patients - Management confirmed that the focus will be on patients with fewer prior lines of therapy in the SURPASS trials [16] Question: Pricing strategy for Afami-cel based on durability data - Management stated it is too early to comment on pricing but emphasized the importance of efficacy and duration of response for pricing strategy [20] Question: Competitive landscape for PRAME and confidence in addressing other cancer types - Management expressed confidence in the PRAME program and noted the validation of TCR-based therapies in solid tumors [24] Question: Context of interim data from IGNYTE-ESO trial for Lete-cel - Management indicated that the data from Lete-cel appears comparable to Afami-cel, with a 40% response rate [26] Question: R&D expense increase and future spending outlook - Management explained the increase in R&D expenses and indicated that spending will be aligned with the commercial launch of Afami-cel and ongoing development plans [27] Question: Enrollment goals and success metrics for ovarian cancer program - Management did not specify enrollment numbers but indicated that response rates above 35% would be necessary for later-stage programs [34] Question: Sensitivity of TCR to PRAME compared to MAGE-A4 - Management noted that PRAME TCR sensitivity is slightly better than MAGE-A4, allowing for treatment of tumors with lower antigen expression [39] Question: Positioning of T cell therapies in melanoma - Management discussed the broader context of cell therapies in solid tumors and the potential for multiple therapies to enter the market [40][41]