speaker
Jen
Conference Call Moderator

any forward-looking statements. Following this call, a replay will be available on the company's website, www.deciphera.com. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Deciphera. Steve?

speaker
Steve Herter
President and Chief Executive Officer, Deciphera

Thank you, Jen, and good morning, everyone. Thank you for joining us today as we provide an update from the second quarter, review our financial results, and outline our corporate milestones for the rest of 2022. We delivered a strong commercial performance with Kinloch in the second quarter, further entrenching this practice-changing medicine in the United States and building on our very successful initial launch in Germany, resulting in year-over-year quarter two product revenue growth of 43%. Beyond Kinloch, we continue to advance the development of our portfolio of product candidates with first-in-class and best-in-class potential. On today's call, Matt Sherman, our Chief Medical Officer, will review the progress we have made advancing our clinical stage pipeline, and highlight upcoming data milestones from the vinsultinib and DCC3116 programs. In the second quarter, we opened additional clinical study sites for the pivotal phase three motion study of vinsultinib as we focus our efforts on rapidly enrolling this registration-enabling study. We expect to present updated results from the phase one-two study of vinsultinib in tenosynovial giant cell tumor, or TGCT, at the ESMO Congress next month. We also announced today that we will present the initial clinical data from the phase one study of DCC3116, our first-in-class autophagy inhibitor, also at ESMO. This data presentation is the first report from our ongoing phase one study, and we're excited that the data was selected for an oral presentation as a proper paper. Finally, we anticipate nominating a potential best-in-class development candidate from our Pan-RAF research program by the fourth quarter. Dan Martin, our chief commercial officer, will share more details on the U.S. commercial performance for the quarter, and Margarita Duarte, our head of international, will provide an update on the momentum of Kenlock's fourth line launch in Europe, including, most notably, the recent major additional benefit rating Kenlock received in Germany and the successful post-approval paid access program in France. Both demonstrate the potential for Kenlock to transform the treatment of advanced JIS around the world. and underscore the sustained progress of our country-by-country market access strategy in Europe. This past quarter, we were also excited to welcome Kelly Deloy to our executive team as Chief Business Officer, who joined us from Novartis, where she served as the Vice President of Business Development for the Oncology Division. Kelly brings 20 years of life science leadership experience to the role, and her responsibilities will include developing and leading Decipher's business development efforts, as well as supporting corporate strategy initiatives. We're very excited to have Kelly at Deciphera, and I look forward to working with her to drive the company's next chapter of growth. I'll now turn the call over to Matt Sherman to provide an update on our R&D efforts. Matt?

speaker
Matt Sherman
Chief Medical Officer

Thanks, Steve. We continue to make excellent progress advancing our clinical and pre-clinical pipeline as we work to provide novel treatment options for patients with cancer. I'd like to start with DCC3116, our potential first-in-class O-conhibitor. We are leaders in exploring the role of autophagy as a broad resistance mechanism in cancer, and 3116 has the potential to benefit a significant number of cancer patients by targeting OAK, the initiating factor in the autophagy pathway. PCC 3116 is a potent and highly selective switch control inhibitor designed to inhibit the OAK1-2 kinases that activate the autophagy pathway. Autophagy is a key tumor survival mechanism and a potential mechanism of drug resistance in cancer cells. We've now generated a growing body of preclinical research, both independently and with academic collaborators, demonstrating the ability of BCC3116 to address autophagy-induced by a variety of RTK, RAS, and MAP kinase pathway inhibitors. And we have built an industry-leading position in targeting this pathway. BCC3116 is currently being investigated in the single-agent dose escalation portion of the Phase I study in patients with advanced or metastatic followed tumors with a RAS or RAS mutation. We are very excited that it was selected for an oral presentation at ESMO in September as a proffered paper, which is intended for original data of superior quality and includes expert discussion. The first readout will be focused on the overall safety and tolerability profile, as well as the pharmacokinetic and pharmacodynamic markers evaluated in the study. We expect to demonstrate targeted engagement through measuring levels of ACG14, a PD marker of ALT inhibition. Together with the initial PK and safety data, This will allow us to select the recommended dose that we will take forward into multiple combination dose exploration cohorts in the second half of this year. Based on our preclinical research and the mechanisms of action, we do not expect to see single agent activity as monotherapy. Our phase one study will include two cohorts in combination of MEK inhibitors, trimetinib and bidimetinib, as well as one cohort with dithoracin, an improved KRAS G12C inhibitor. Turning now to Vimseltamib, our CSF1 receptor kinase inhibitor that we believe has the potential to be a best-in-class treatment for tenosynovial giant cell tumor, or TPCT. With one approved treatment available for TPCT patients in the U.S. and none in Europe, there remains a significant unmet medical need for a highly effective therapy with a good safety and tolerability profile. We believe Vimseltamib is well-positioned to address this need. Based on the initial data from the ongoing Phase 1-2 study in GGCP patients, VinCeltinib has shown strong efficacy and durability with an excellent safety profile. We expect to provide updated results from the Phase 1-2 study next month and are delighted to have been selected for a closer presentation at ESMO. These results will include updated objective response rate data from the escalation and expansion phases of the study, longer-term safety, and initial secondary endpoint data based on patient-reported outcomes. We believe these results will continue to show that Zinfeltinib has the potential to become the standard of care drug treatment for patients with TTCP non-amenable to surgery. To that end, we continue to open sites and rapidly enroll our phase three registration-enabling motion study and plan to provide an estimate of timing of full enrollment in the coming months. Moving to our preclinical pipeline, We remain on track to nominate a development candidate from our pan-RAF research program later this year. This program is focused on developing a best-in-class dual inhibitor of BRAF and C-RAF kinases to address an unmet medical need in patients harboring class I, II, and III BRAF mutations, as well as BRAF fusions. Nomination of this development candidate highlights how our switch control kinase platform continues to drive portfolio growth through the discovery of innovative new molecules. We're proud to continue to expand our pipeline with potential best-in-class and first-in-class product candidates designed to improve the lives of people with cancer. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to provide an update on our U.S. commercial efforts. Dan?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-