Adaptimmune Therapeutics plc

Good day, and thank you for standing by. Welcome to the afternoon second quarter earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Julie Miller, Investor Relations. Please go ahead.

Hello and welcome to Adaptimmune's conference call to discuss our second quarter 2021 financial results and business updates. Please review our forward-looking statements from this afternoon's press release as 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. Adrianne Rockless, our Chief Executive Officer, is 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 Rockliff.

Thanks, Julie. And thanks, everyone, for joining us. So last year, we set out our 2252 strategy for the next five years. And at the beginning of this year, we identified the milestones in 2021 to start to deliver that strategy. From a clinical perspective, these milestones were, one, to present initial data from our Pivotal Spearhead 1 trial with Afamacel at ASCO with a fuller data set to follow at CTOS. Two, present data from our AFP trial at ILCA. And three, present data from our Surpass trial with our NextGen program targeting MAI-J4 at ESMO. I'm pleased to say that in Q2, we delivered on the first of these with excellent Afamacel data at ASCO. and we're positioned to deliver on the next two in Q3 at ILCA and ESMO as anticipated. I want to say a little bit about each of these milestones in turn. As you can see from the press release, we had a busy Q2. In June, we presented initial data from our pivotal Spearhead 1 trial at ASCO. With a disease control rate of approximately 85%, an overall response rate of approximately 40%, and very encouraging initial durability. These data demonstrate that Afamacel has life-changing potential for people with synovial sarcoma and MR-CLS. We plan to update data from this trial at CTOS later this year. We're working hard to file our BLA next year and achieve the first element of our 2252 strategy to have a product on the market targeting MAJ-A4. we're preparing for a successful commercial launch working with key industry leaders, Agilent for companion diagnostic, Milteni for our lentiviral vector supply, as well as developing our in-house capabilities to support commercial delivery for a famicel. For the second and third clinical milestones this year, we are on track to update in Q3 on our AFP and surpass programs, at ILCA and ESMO, respectively. At ILCA, on September the 5th, Dr. Bruno Sangro will present data from our AFP Phase 1 trial. He'll present data on 13 patients who have been treated in Cohort 3 and Expansion, 11 of whom have had at least one post-baseline scan. We'll issue a full press release around these data, and we'll update regarding this program going forward. At ESMO, we'll present an update from the SURPASS trial with our NextGen program targeting May J4. You'll remember that last year, we reported data at CITSE from six patients in the dose escalation cohorts of this trial, with two confirmed responses in patients with EGJ and head and neck cancer, as well as tumor reductions in three other patients with esophageal, ovarian, and EGJ cancers. As I said in the Q1 call in May, enrollment in the first half of 2021 in this trial has gone very well. As of the data cut for the ESMO presentations, we've treated 25 patients in this trial, and 23 of these patients have at least one post-baseline scan. And we are very much looking forward to sharing this data update as planned at ESMO. The poster will be available online on September the 16th. Again, we'll issue a full press release, and provide an update on the future for the development of this therapy. A couple of other updates on this program. The SURPASS trial was initially in a wide range of MAGE-A4-expressing tumors, but was subsequently amended to recruit in four focus indications, lung, bladder, head and neck, and gastroesophageal cancers, where we had seen anti-tumor activity and responses with our MAGE-A4-targeted therapies previously. Based on emerging data in several patients with ovarian cancer treated in the SURPASS trial, we will add ovarian cancer back to the list of focus indications. So going forward, the SURPASS trial will continue to enroll patients with lung, bladder, head and neck, gastroesophageal, and ovarian cancer. In addition, our SURPASS II trial which is the phase two trial with the NextGen product targeting MAI-J4 for patients with esophageal and EGJ cancers, is on track to initiate as planned in Q3. We've designed a protocol to account for the evolving standard of care in this setting and identify a patient population that is most likely to benefit from this type of therapy. We are committed to identify more indications for late phase development with the 2252 goal of having an additional MAI-J4 marketed product in the next five years. Our clinical data, our translational learnings, as well as our preclinical pipeline, including our industry-leading allogeneic program, move us closer every day to our goal of cell therapy products that are both curative and mainstream. And with that, I'd like to turn it over to the operator for questions.