On January 9, 2023 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, will present today at the 41st Annual J.P. Morgan Healthcare Conference at 7:30 a.m. PT (10:30 a.m. ET), and a live webcast will be available at ir.springworkstx.com. Ahead of the presentation, the Company highlighted its 2022 accomplishments and reported its anticipated key milestones for 2023 (Press release, SpringWorks Therapeutics, JAN 9, 2023, View Source [SID1234626110]).
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2022 Accomplishments
Presented positive Phase 3 DeFi data of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with desmoid tumors at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
Submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for nirogacestat for the treatment of adults with desmoid tumors, which is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program.
Expanded and strengthened its intellectual property portfolio, including a new patent issued by the United States Patent and Trademark Office in the fourth quarter of 2022 directed to pharmaceutical compositions of nirogacestat (U.S. Patent No. 11,504,354), which expires in 2042 and represents what is expected to be the seventh Orange Book-listable patent for nirogacestat.
Participated in a Type C meeting with the FDA to align on the statistical analysis plan for the Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) and expectations for an anticipated NDA submission in this indication.
Initiated a Phase 2 trial evaluating nirogacestat in patients with ovarian granulosa cell tumors (OvGCT).
Expanded global, non-exclusive license and collaboration agreement with GSK plc (GSK) to evaluate nirogacestat in combination with belantamab mafodotin in patients with multiple myeloma, including in earlier lines of treatment.
Demonstrated clinical proof of concept for BGB-3245, a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene, as well as for the combination of mirdametinib and BeiGene’s RAF dimer inhibitor, lifirafenib.
Advanced BGB-3245 monotherapy into dose expansion cohorts and announced plans for a new Phase 1/2a study evaluating BGB-3245 in combination with mirdametinib.
Nominated TEAD inhibitor development candidate (SW-682).
Strengthened financial position to over $650 million in cash, cash equivalents and marketable securities, as of September 30, 2022, which is expected to provide runway into 2026.
Established commercial infrastructure to support anticipated first U.S. product launch for nirogacestat in patients with desmoid tumors.
Anticipated 2023 Key Milestones
Obtain regulatory approval from the FDA for nirogacestat in adults with desmoid tumors and launch nirogacestat as the first approved therapy for these patients in the second half of 2023.
Highlight publication of Phase 3 DeFi trial data in a peer-reviewed journal and present additional analyses from the study at upcoming medical meetings.
Present topline data from the pediatric and adult cohorts of the Phase 2b ReNeu trial in NF1-PN in the second half of 2023. Pending these data, SpringWorks anticipates submitting an NDA for mirdametinib as a treatment for NF1-PN in the first half of 2024.
Continue enrollment in the Phase 2 trial of nirogacestat in patients with OvGCT.
Expand data set with additional clinical data of nirogacestat in combination with BCMA-directed therapies and initiate additional planned Phase 1 collaborator studies.
Present additional clinical data from the Phase 1 trial evaluating BGB-3245 in adult patients with RAF mutant solid tumors at a medical conference in the first half of 2023.
Present additional data from BeiGene-sponsored Phase 1b/2 trial evaluating mirdametinib in combination with lifirafenib in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors at a medical conference in the first half of 2023.
Dose first patient in BGB-3245 + mirdametinib combination study in MAPK-mutant solid tumors in the first half of 2023.
File Investigational New Drug Application for TEAD inhibitor SW-682.
"We expect 2023 to not only mark SpringWorks’ transition into a commercial-stage company, but also to be a year of continued development execution and value-creating data readouts across our portfolio," said Saqib Islam, Chief Executive Officer of SpringWorks. "We are very pleased with our progress towards our goal of having two marketed products by 2025, given the overwhelmingly positive Phase 3 DeFi data for nirogacestat in desmoid tumors that were disclosed last year and our expectations for a successful topline readout for the Phase 2b ReNeu trial in children and adults with NF1-PN. Our strong execution in 2022, coupled with a financial position that funds us well into 2026 and durable IP protections for our lead assets, positions us well for continued performance on behalf of patients with devastating diseases."
Presentation at the 41st Annual J.P. Morgan Healthcare Conference
SpringWorks will webcast its presentation from the 41st Annual J.P. Morgan Healthcare Conference today, Monday, January 9, 2023 at 7:30 a.m. PT (10:30 a.m. ET). To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.