— NDA filing for Nirogacestat in Desmoid Tumors, Which Will Be Reviewed Under the FDA’s Real-Time Oncology Review (RTOR) Program, Expected in Second Half of 2022 —
— New Phase 2 Study Announced to Evaluate Nirogacestat in Patients with Ovarian Granulosa Cell Tumors —
— Eight Clinical Collaborations Evaluating Nirogacestat as a Cornerstone of BCMA Combination Therapy Ongoing; Nirogacestat in Combination with Low Dose of GSK’s BLENREP Being Evaluated in Phase 2 Trial and Advanced into Additional Sub-Studies with Standard of Care Agents —
— Mirdametinib Being Evaluated in Monotherapy and Combination Studies in Rare Oncology Indications and Biomarker-Defined Solid Tumors —
— BGB-3245 Monotherapy to Advance into Cohort Expansion Studies —
— Well Capitalized to Execute Across Current R&D Programs and Preparations to Serve Patients with Desmoid Tumors Starting in 2023 –
STAMFORD, Conn., June 10, 2022 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced that the Company will host a virtual R&D Day today, Friday, June 10th from 10:00 a.m. to 1:00 p.m. ET.
SpringWorks’ R&D Day will feature presentations by Saqib Islam, Chief Executive Officer; Badreddin Edris, PhD., Chief Operating Officer; L. Mary Smith, PhD, Chief Development Officer; Bhavesh Ashar, Chief Commercial Officer; Mike Burgess, MBChB, PhD, Head of R&D; and Jim Cassidy, MD, PhD, Chief Medical Officer. The event will also include presentations from two external key opinion leaders: Breelyn Wilky, MD, Director of Sarcoma Medical Oncology at the University of Colorado, Denver (CU Denver) and Neal Rosen, MD, PhD, Director of the Center for Mechanism-Based Therapy and the Enid A. Haupt Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center (MSKCC).
“SpringWorks is at an exciting juncture in terms of data generation, regulatory discussions, and launch preparations. Our goal is to provide the first approved therapy for patients with desmoid tumors in 2023, and we expect to have two approved products with the potential to serve patients across four distinct oncology indications by 2025,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We are confident that our strong execution across our R&D programs, our disciplined, rigorous approach to business development, and our focused commercial buildout will drive our success in 2022 and beyond.”
Agenda
- Introduction and Business Overview (Saqib Islam, Badreddin Edris, PhD)
- KOL Presentation: Unmet Need in Desmoid Tumors (Bree Wilky, MD, CU Denver)
- Nirogacestat
- Clinical Experience in Desmoid Tumors (L. Mary Smith, PhD)
- Desmoid Tumor Commercial Opportunity (Bhavesh Ashar)
- Additional Expansion Opportunity (Badreddin Edris, PhD)
- BCMA Therapy Combination Development (Mike Burgess, MBChB, PhD)
- Mirdametinib
- NF1-PN (L. Mary Smith, PhD)
- Additional Expansion Opportunities (Jim Cassidy, MD, PhD)
- Mirdametinib + Lifirafenib: Combination Development (Jim Cassidy, MD, PhD)
- KOL Presentation: Introduction to BGB-3245 (Neal Rosen, MD, PhD, MSKCC)
- BGB-3245
- Initial Clinical Data and Program Update (Jim Cassidy, MD, PhD)
- Preclinical
- TEAD and EGFR Inhibitor Program Overview (Mike Burgess, MBChB, PhD)
- Closing Remarks and Q&A (Saqib Islam)
Webcast and Conference Call Information:
The Company’s R&D Day will be held today, Friday, June 10th, from 10:00 a.m. to 1:00 p.m. ET. The webcast can be accessed here. Participants can also listen to the event by dialing + 1 (844) 946-0285 (domestic) or +1 (602) 585-9676 (international) and providing the conference ID 4453188. A replay will be available on the SpringWorks website for a limited period of time following the event.
