Pipeline

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Preclinical Phase 1 Phase 2 Phase 3 Regulatory Submission Approved Collaborators

Nirogacestat (Gamma Secretase Inhibitor)

Monotherapy

Adult desmoid tumors

Approved in the U.S.

Approved in the U.S. for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.

Monotherapy

Pediatric desmoid tumors

In collaboration with Children’s Oncology Group (COG), a Phase 2 clinical trial is evaluating nirogacestat in children and adolescents with progressive, surgically unresectable desmoid tumors.

Monotherapy

Ovarian Granulosa Cell Tumors

Ovarian granulosa cell tumors are a rare ovarian cancer subtype for which there are currently no FDA-approved therapies. SpringWorks is conducting a Phase 2 study of nirogacestat in recurrent ovarian granulosa cell tumors.

+ BCMA-Targeting Agents

Relapsed/refractory multiple myeloma

The word "Several" with footnote indicator reading "1"

SpringWorks is evaluating nirogacestat as a potential treatment for patients with multiple myeloma as part of several B-cell maturation agent (BCMA) combination therapy regimens in collaboration with industry leaders.

Mirdametinib (MEK Inhibitor)

Monotherapy

Adult and pediatric NF1-associated plexiform neurofibromas

Approved in the U.S.

Approved in the U.S. for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.

Monotherapy

Pediatric low-grade gliomas

In collaboration with St. Jude Children’s Research Hospital, a Phase 2 clinical trial is evaluating mirdametinib in children, adolescents, and young adults with low-grade glioma.

Brimarafenib (RAF Fusion and Dimer Inhibitor)

+ Panitumumab

MAPK mutant solid tumors

MapKure is conducting a Phase 1b study of brimarafenib with panitumumab, a monoclonal antibody targeting EGFR, in colorectal and pancreatic cancer patients with known MAPK pathway mutations.

SW-682 (TEAD Inhibitor)

Monotherapy

Hippo mutant tumors

SpringWorks is developing SW-682 , a novel small molecule inhibitor of the TEA Domain (TEAD) family of transcription factors, for the potential treatment of biomarker-defined solid tumors driven by Hippo pathway mutations.

SW-3431 (PP2A Activator)

Monotherapy

Rare Uterine Cancers

SW-3431 is a first-in-class small molecule activator of specific Protein Phosphatase 2A (PP2A) complexes in preclinical development. PP2A mutations represent a class of targetable oncogenic drivers in molecularly defined subsets of uterine cancer patients with high unmet need.

Nirogacestat (Gamma Secretase Inhibitor)

Monotherapy

Adult desmoid tumors

Regulatory Approval

Approved in the U.S. for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.

Monotherapy

Pediatric desmoid tumors

Phase 2 In Progress:

Collaborators:

In collaboration with Children’s Oncology Group (COG), a Phase 2 clinical trial is evaluating nirogacestat in children and adolescents with progressive, surgically unresectable desmoid tumors.

Monotherapy

Ovarian Granulosa Cell Tumors

Phase 2 In Progress:

Ovarian granulosa cell tumors are a rare ovarian cancer subtype for which there are currently no FDA-approved therapies. SpringWorks is conducting a Phase 2 study of nirogacestat in recurrent ovarian granulosa cell tumors.

+ BCMA-Targeting Agents

Relapsed/refractory multiple myeloma

Phase 2 In Progress:

Collaborators:

The word "Several" with footnote indicator reading "1"

SpringWorks is evaluating nirogacestat as a potential treatment for patients with multiple myeloma as part of several B-cell maturation agent (BCMA) combination therapy regimens in collaboration with industry leaders.

Mirdametinib (MEK Inhibitor)

Monotherapy

Adult and pediatric NF1-associated plexiform neurofibromas

Regulatory Approval

Approved in the U.S. for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.

Monotherapy

Pediatric low-grade gliomas

Phase 2 In Progress:

Collaborators:

In collaboration with St. Jude Children’s Research Hospital, a Phase 2 clinical trial is evaluating mirdametinib in children, adolescents, and young adults with low-grade glioma.

Brimarafenib (RAF Fusion and Dimer Inhibitor)

+ Panitumumab

MAPK mutant solid tumors

Phase 1 In Progress:

Collaborators:

MapKure is conducting a Phase 1b study of brimarafenib with panitumumab, a monoclonal antibody targeting EGFR, in colorectal and pancreatic cancer patients with known MAPK pathway mutations.

SW-682 (TEAD Inhibitor)

Monotherapy

Hippo mutant tumors

Phase 1 In Progress:

SpringWorks is developing SW-682 , a novel small molecule inhibitor of the TEA Domain (TEAD) family of transcription factors, for the potential treatment of biomarker-defined solid tumors driven by Hippo pathway mutations.

SW-3431 (PP2A Activator)

Monotherapy

Rare Uterine Cancers

Pre-Clinical:

SW-3431 is a first-in-class small molecule activator of specific Protein Phosphatase 2A (PP2A) complexes in preclinical development. PP2A mutations represent a class of targetable oncogenic drivers in molecularly defined subsets of uterine cancer patients with high unmet need.

(1) Indicated for adult patients with progressing desmoid tumors who require systemic treatment. (2) Includes preclinical, Phase 1, and Phase 2 studies planned or ongoing with GSK, Janssen, Pfizer, and Regeneron. On June 6, 2024, GSK notified SpringWorks that it is terminating the collaboration agreement and winding down the study; no further enrollment is expected, though the study will continue for the patients enrolled at the time of termination notice. (3) Indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. (4) Being developed by MapKure, LLC, jointly owned by SpringWorks and BeiGene.

Our pipeline

SpringWorks Therapeutics is advancing a diversified pipeline of targeted oncology programs as both standalone and combination therapies. Our development programs include late-stage rare oncology programs as well as multiple programs addressing highly prevalent, genetically defined cancers. Our team is working with urgency on behalf of the patients living with these devastating illnesses.

Let’s unlock the future of targeted oncology

We are meticulous about the science and passionate about its possibilities. This leads us to dig deeper – to explore the full potential of our molecules. You can see that approach in our pipeline. We have a diversified targeted oncology portfolio that includes standalone and combination therapies across various stages of development, including late-stage clinical trials in rare tumor types and multiple programs addressing highly prevalent, genetically defined cancers.