Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q3 2023 Earnings Call Transcript
Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q3 2023 Earnings Call Transcript November 8, 2023
Operator: Good morning, ladies and gentlemen, and welcome to the Adaptimmune’s Q3 Financial and Business Update Conference Call. I would now like to turn the meeting over to Ms. Juli Miller. Please go ahead, Ms. Miller.
Juli Miller: Good morning, and welcome to Adaptimmune's conference call to discuss our third quarter 2023 financial results and business updates. I would ask you to 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 several factors, including those outlined in our latest filings with the SEC. Adrian Rawcliffe, our Chief Executive Officer; and Dennis Williams, our Senior Vice President of Late Stage Development, are here with me for the prepared portion of the call. Other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian Rawcliffe. Ad?
Adrian Rawcliffe: Good morning. Thanks, Juli, and thanks, everyone, for joining us. In the first part of 2023, we set out to transform Adaptimmune. Specifically, we set out to accomplish five key goals: one, create – complete a large organizational restructuring to significantly reduce our cost base; two, submit our BLA for Afami-cel, putting us on the path to being a commercial cell therapy company. Three, recover Lete-cel and PRAME from GSK; four, complete the strategic combination and subsequent integration of TCR2; and five, prioritize our clinical portfolio on the basis of data throughout the year. Midway through Q4 2023, we've made significant progress in each of these. In relation to the reorganization, whilst these things are always difficult, we achieved it with limited disruption to the company and to its momentum.
On the second goal, Afami-cel, we showed data last week at CTOS, demonstrating clear lasting benefit for people with synovial sarcoma who respond to Afami-cel, and we will complete the submission of the BLA this quarter. I want to ask Dr. Dennis Williams, who's been responsible for the development of the Afami-cel program to comment on its current status. Dennis?
Dennis Williams: Thank you, Ad. I want to echo Ad's excitement for our Afami-cel data. I attended the Annual Meeting of the Connective Tissue Oncology Society, or CTOS, where Dr. Brian Van Tine presented updated data, and they are transformational for people with synovial sarcoma. One of the primary goals of CTOS is to advance the care of people with sarcoma, and doctors who treat people with synovial sarcoma are eager to have Afami-cel as a therapeutic option. We share this eagerness and completion of the BLA has been our top priority. As part of the rolling submission, we submitted the first of three modules, the preclinical module at the end of last year. In quarter one, we completed submission of the clinical module. Since that time, we have been focused on completing submission of the CMC module.
All BLA CMC validation work is complete, including assay method validation and process performance qualification, completion of the final section of the BLA is imminent. We are in the final stages of dossier preparation. This includes activities such as the comprehensive review of the dossier, labeling and summary document finalization and regulatory submission publishing. We have RMAT designation and have been – and we have taken advantage of frequent interactions with the FDA. Meetings have been positive, and we have taken significant steps to derisk our file. Last year at the pre-BLA meeting, Adaptimmune and FDA agreed on the planned content of the BLA. We have also received what we believe is favorable FDA feedback in July, on the commercial T cell potency assay, including agreement on the potency data set for inclusion in the submission.
The agency also agreed that data from Cohort 2 of the SPEARHEAD-1 trial can serve as confirmatory evidence for full approval. This cohort is fully enrolled with mature data readouts expected late next year. We know that Afami-cel has the potential to transform the way synovial sarcoma is treated and bringing this product to market is very important to us and the sarcoma community. With that, I will turn it back over to Ad. Ad?
Adrian Rawcliffe: Thanks, Dennis. Returning to the other accomplishments in 2023. The third one relates to the recovery of Lete-cel and PRAME from GSK. The rights to PRAME are fully recovered and the Lete-cel transfer is in an advanced stage with the IND set to transition shortly. We recently reported data from a planned interim analysis of the pivotal IGNYTE-ESO trial with Lete-cel showing 18 responses by independent review out of 45 people with synovial sarcoma or MRCLS. And therefore, the trial will meet its primary endpoint for efficacy, which required only 16 responders, out of 60 patients in this cohort. I would note that all 60 patients have been treated, and we will have further data readouts next year. We're excited about how Lete-cel and Afami-cel complement one another.
Our initial assessment is that Lete-cel could increase the addressable market by 2x to 3x and could be delivered with essentially the same commercial organization. We will continue to evaluate how Lete-cel fits into our pipeline, and I'll update you on our plans for our expanded sarcoma franchise early next year after the transition from GSK is complete and after we have submitted the BLA for Afami-cel. For the fourth goal related to the combination with TCR2, we completed the transaction in Q2 and the business integration is now also complete. And on the fifth goal, the prioritization of the clinical pipeline based on data. Today, we announced we are stopping further development of the two mesothelin-directed TRuC programs, Gavo-cel and TC-510.
We have reviewed the data from the Phase 2 trial of Gavo-cel and the Phase 1 trial of TC-510 and the magnitude of the clinical benefit in either program does not justify further development. Although, it's difficult to stop a program when it is evident some patients are getting benefit, we do not see a rapid route to market with either of these assets, and we are committed to focus our resources on cell therapies where this path is clear. With respect to other pipeline priorities, we are narrowing our next-gen ADP-A2M4CD8 SURPASS trials, to focus on ovarian, head and neck and bladder cancer, and we showed data supporting this prioritization at ESMO. In our focus indications, there was a 50% response rate, which improved to 75% in patients who received three or fewer prior lines of therapy.
Based on this encouraging data, the SURPASS Phase 1 trial will only enroll patients with head and neck and urothelial cancer in earlier lines of treatment and in combination with checkpoint inhibitors. Enrollment of patients with other indications in this trial has been discontinued. And we have also initiated the Phase 2 SURPASS-3 trial in platinum-resistant ovarian cancer, which we intend to be registrational. This has been a transformational year for the company, and we will achieve each of the goals we set out in 2023. Data readouts demonstrate that our engineered cell therapies work across multiple solid tumors and we continue to prioritize our resources on those products that have the greatest chance of commercial success. In closing, I want to focus attention on three events in the short-term.
One, the completion of the submission of the Afami-cel BLA this year; two, transfer of Lete-cel IND from GSK this year; and three, updating you in the New Year on the path to deliver our expanded sarcoma franchise. And with that, I'd like to turn it over to the operator for questions. Operator?
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