SWTX SpringWorks Therapeutics Inc.

68.48
-1.82  -3%
Previous Close 70.3
Open 68.85
52 Week Low 51.72
52 Week High 96.48
Market Cap $3,372,586,243
Shares 49,249,215
Float 23,099,121
Enterprise Value $3,035,931,814
Volume 307,308
Av. Daily Volume 327,678
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Upcoming Catalysts

Drug Stage Catalyst Date
Nirogacestat (DeFi)
Desmoid tumors
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Mirdametinib
Low-Grade Glioma
Phase 1/2
Phase 1/2
Phase 1/2 trial initiation announced June 15, 2021. Patients continue to be dosed.
Mirdametinib and FASLODEX (Fulvestrant)
ER+ breast cancer
Phase 2
Phase 2
Phase 2 trial initiated enrollment in September 2021.
Mirdametinib - ReNeu
Neurofibromas
Phase 2b
Phase 2b
Phase 2b enrollment to be completed 2H 2021. Interim data noted 10/20 Patients (50%) achieved an Objective Response
Mirdametinib and lifirafenib
Solid tumors
Phase 1/2
Phase 1/2
Phase 1b/2 trial initiated.
BGB-3245
Solid tumors
Phase 1/2
Phase 1/2
Phase 1 enrollment is ongoing.
Nirogacestat
Desmoid tumors - children (Children’s Oncology Group)
Phase 2
Phase 2
Phase 2 trial commenced recruitment in September 2020. Enrollment is ongoing.
Nirogacestat and BLENREP (Belantamab)
Multiple Myeloma
Phase 1/2
Phase 1/2
Phase 2 cohort expansion initiated October 27, 2021.
Nirogacestat and Teclistamab
Multiple myeloma
Phase 1b
Phase 1b
Phase 1b initiation of dosing announced April 1, 2021.

Latest News

  1. STAMFORD, Conn., Nov. 23, 2021 (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, today announced that management will participate in a Fireside Chat at the 4th Annual Evercore ISI HealthCONx Conference, taking place virtually on Tuesday, November 30, 2021, at 3:30 pm ET.

    A video webcast will be available on the Events & Presentations page within the Investors & Media section of the company's website at https://ir.springworkstx.com. A replay of the webcast will be available on SpringWorks' website for a limited time following the conference.

    About SpringWorks Therapeutics
    SpringWorks…

    STAMFORD, Conn., Nov. 23, 2021 (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, today announced that management will participate in a Fireside Chat at the 4th Annual Evercore ISI HealthCONx Conference, taking place virtually on Tuesday, November 30, 2021, at 3:30 pm ET.

    A video webcast will be available on the Events & Presentations page within the Investors & Media section of the company's website at https://ir.springworkstx.com. A replay of the webcast will be available on SpringWorks' website for a limited time following the conference.

    About SpringWorks Therapeutics

    SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology portfolio of small molecule product candidates and is advancing 16 development programs, including two potentially registrational clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to expand its portfolio and create more solutions for patients with cancer. For more information, visit http://www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.

    SpringWorks Contact:

    Kim Diamond

    Vice President, Communications and Investor Relations

    Phone: (203) 561-1646

    Email:



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  2. NEW YORK, Nov. 11, 2021 /PRNewswire/ -- Gilgamesh Pharmaceuticals, a mental health focused biotechnology company developing novel psychedelic-related medicines for the treatment of neuropsychiatric conditions, today announced the addition of several key additions to its leadership team and board of directors. The additions will enable Gilgamesh to rapidly advance its pipeline toward clinical trials beginning in late 2022 and further expand its IP portfolio.

    Key hires include:

    • Chief Medical Officer Gerard Marek, MD/Ph.D. is a renowned expert on serotonin system biology. Gerard is a former asst. professor at Yale University and was the Chief Scientific Officer of Psychiatric Disorders Discovery Biology at Eli Lilly and Company.
    • Chief Business

    NEW YORK, Nov. 11, 2021 /PRNewswire/ -- Gilgamesh Pharmaceuticals, a mental health focused biotechnology company developing novel psychedelic-related medicines for the treatment of neuropsychiatric conditions, today announced the addition of several key additions to its leadership team and board of directors. The additions will enable Gilgamesh to rapidly advance its pipeline toward clinical trials beginning in late 2022 and further expand its IP portfolio.

    Key hires include:

    • Chief Medical Officer Gerard Marek, MD/Ph.D. is a renowned expert on serotonin system biology. Gerard is a former asst. professor at Yale University and was the Chief Scientific Officer of Psychiatric Disorders Discovery Biology at Eli Lilly and Company.
    • Chief Business Officer/Head of Research Laszlo Kiss, Ph.D. brings more than 20 years of experience in drug discovery and development (Merck, Bristol-Myers Squibb), leadership roles in corporate venture and business development (Pfizer, Biogen).
    • Chief Operating Officer Yoni Falkson, MBA joins Gilgamesh after spending more than 15 years focused on commercial development, payer strategy, and product launches at Pfizer and Regeneron. He is also the co-founder of SpringWorks Therapeutics (NASDAQ:SWTX).
    • Head of Clinical Development Daniel Umbricht, M.D. most recently was the Head of Early Clinical Research in Neuroscience at Roche and a former academic at Zurich University, bringing years of expertise in electrophysiology of psychedelic medicines and industry experience in experimental and translational medicine in neuroscience.
    • Translational Medicine Scientist Ed Christian, Ph.D. is an accomplished clinical and preclinical neurophysiologist, who served most recently as Executive Director of Translational Medicine at Cadent Therapeutics and for two decades as a Senior Principal Neuroscientist at AstraZeneca.

    The company also added three strategic members to its board of directors, including:

    • Amy Kruse, Ph.D. is a General Partner at Prime Movers Lab (Gilgamesh Series A lead investor), neuroscientist/biologist entrepreneur, and a former program manager at the Defense Advanced Research Projects Agency.
    • Robert Berman, M.D. was the lead author of the seminal study of ketamine in depressed patients (Berman et al 2000) and led clinical antidepressant development of aripiprazole (Abilify). He is a co-founder of Biohaven Pharmaceuticals (NYSE:BHVN) and an adjunct professor at Yale University.
    • Phil Skolnick, Ph.D. is a former director of the Division of Therapeutics and Medical Consequences at the National Institute on Drug Abuse, NIH. He was a Lilly Fellow in Neuroscience and served as the CSO and President of DOV Pharmaceutical, Inc.  He is currently CSO of Opiant Pharmaceuticals (NASDAQ:OPMT).

    "These additions to our team bring more than a century of experience in drug development and cutting-edge medical research that will help Gilgamesh advance our unique pipeline of novel and transformational medicines for people with debilitating neuropsychiatric disorders such as depression, ADHD, PTSD, and substance use disorders," said CEO and co-founder Dr. Jonathan Sporn.

    Founded in 2019, Gilgamesh is a cutting-edge biopharma focused on discovering and developing novel compounds that harness the pharmacology of psychedelic drugs and show incredible promise for the treatment of highly underserved patients with depression, anxiety, substance use, and stress-related disorders.

    About Gilgamesh Pharmaceuticals

    Gilgamesh is a pioneering mental health science-focused, early-stage biotechnology company. We have a disciplined focus on developing innovative new chemical entities (NCE's) leveraging a unique combination of medicinal chemistry, intellectual property strategy, neuroscience & neurobiology, and drug development expertise. We are an experienced team, with proven success in biotech exits and inventions. For more information, visit: www.gilgameshpharmaceutical.com.

    CONTACT: Gavin Mathis, , 406-539-7277

     

    Cision View original content:https://www.prnewswire.com/news-releases/gilgamesh-builds-team-of-pharmaceutical-industry-leaders-and-appoints-new-members-to-board-of-directors-301422097.html

    SOURCE Gilgamesh Pharmaceuticals

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  3. – Announced Advancement into Randomized Phase 2 Expansion and Addition of New Sub-studies to Existing Clinical Collaboration with GlaxoSmithKline Evaluating Nirogacestat in Combination with BLENREP in Patients with Relapsed or Refractory Multiple Myeloma –

    – Expanded Targeted Oncology Pipeline with In-License of Portfolio of Next-Generation Mutation-Selective EGFR Inhibitors –

    – Initiated Mirdametinib Phase 1/2 Basket Study in ER+ Metastatic Breast Cancer and MEK 1/2 Mutant Solid Tumors –

    – Announced Issuance of New U.S. Composition of Matter Patents to Polymorphic Form of Mirdametinib, Extending Patent Protection Into 2041 –

    STAMFORD, Conn., Nov. 04, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-stage…

    – Announced Advancement into Randomized Phase 2 Expansion and Addition of New Sub-studies to Existing Clinical Collaboration with GlaxoSmithKline Evaluating Nirogacestat in Combination with BLENREP in Patients with Relapsed or Refractory Multiple Myeloma –

    – Expanded Targeted Oncology Pipeline with In-License of Portfolio of Next-Generation Mutation-Selective EGFR Inhibitors –

    – Initiated Mirdametinib Phase 1/2 Basket Study in ER+ Metastatic Breast Cancer and MEK 1/2 Mutant Solid Tumors –

    – Announced Issuance of New U.S. Composition of Matter Patents to Polymorphic Form of Mirdametinib, Extending Patent Protection Into 2041 –

    STAMFORD, Conn., Nov. 04, 2021 (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, today reported financial results for the third quarter and year-to-date periods ended September 30, 2021 and provided an update on recent company developments.

    "In the third quarter of 2021, we continued to execute across our diversified portfolio of targeted oncology programs being evaluated as standalone and combination therapies for patients with rare tumors, hematological cancers and biomarker-defined metastatic solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our team remains focused on advancing our 16 development programs on behalf of oncology patients while simultaneously building our commercial organization in anticipation of serving patients with desmoid tumors as well as expanding our drug discovery capabilities to continue growing our early-stage pipeline."

    Recent Business Highlights and Upcoming Milestones

    Late-Stage Rare Oncology

    • SpringWorks is conducting the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors. DeFi is an event-driven trial with a primary endpoint of progression-free survival. SpringWorks expects to reach the 51 events required for the study analysis by the end of the year. The Company expects to report topline results from the study, after data validation and analysis, by the end of the fourth quarter of 2021 or in early 2022.
    • Recruitment is ongoing in a Phase 2 study sponsored by the Children's Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
    • SpringWorks expects to complete enrollment in the Phase 2b ReNeu trial evaluating mirdametinib in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) in the second half of 2021, as previously disclosed.
    • Patients continue to be dosed in a Phase 1/2 clinical trial evaluating mirdametinib in children and young adults with low-grade glioma.

    B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

    • In October 2021, SpringWorks announced an update from its ongoing clinical collaboration with GlaxoSmithKline evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf) in patients with relapsed or refractory multiple myeloma. The first combination dose level, which is evaluating 0.95 mg/kg Q3W BLENREP plus nirogacestat, has been expanded based on encouraging preliminary data observed in the dose exploration Phase 1 portion of the nirogacestat DREAMM-5 sub-study. This dose level has advanced into a randomized Phase 2 cohort expansion and is now enrolling patients to further explore the safety and efficacy profile compared to a 2.5 mg/kg Q3W BLENREP monotherapy control arm, which is the same as the FDA approved monotherapy dose and schedule of BLENREP. In parallel, additional dose levels and schedules of BLENREP plus nirogacestat continue to be evaluated in the Phase 1 portion of the study. In addition, two new sub-studies will evaluate the BLENREP plus nirogacestat combination with standard-of-care multiple myeloma therapies in the DREAMM-5 trial (pomalidomide plus dexamethasone and lenalidomide plus dexamethasone). Data from these two new sub-studies may enable future clinical trials in earlier lines of multiple myeloma.
    • SpringWorks continues to evaluate nirogacestat as a potential cornerstone of BCMA-directed therapy across modalities in collaboration with six industry leaders. In addition to the current ongoing studies, SpringWorks expects that a Pfizer-sponsored trial of nirogacestat + elranatamab (PF-0686313) will initiate enrollment in the second half of 2021, as previously disclosed, and a Seagen-sponsored trial of nirogacestat + SEA-BCMA will initiate enrollment in the first quarter of 2022.
    • In August 2021, SpringWorks entered into a research collaboration agreement with Dana-Farber Cancer Institute to further investigate nirogacestat with anti-BCMA agents in a variety of preclinical multiple myeloma models.

    Biomarker-Defined Metastatic Solid Tumors

    • Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene's RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. Initial clinical data from the BeiGene-sponsored trial are expected to be presented at an upcoming SpringWorks-sponsored R&D Day.
    • Enrollment is ongoing in a Phase 1 trial of BGB-3245 in adult patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene. Initial clinical data from the MapKure-sponsored trial are expected to be presented at an upcoming SpringWorks-sponsored R&D Day.
    • In August 2021, SpringWorks announced a platform study sponsored by Memorial Sloan Kettering Cancer Center to evaluate mirdametinib both as a monotherapy and as a combination therapy in advanced solid tumors harboring selected MAPK-activating mutations. This trial initiated enrollment in September 2021 and is exploring mirdametinib in two patient cohorts: the first in combination with fulvestrant, a selective estrogen receptor degrader, in patients with estrogen receptor-positive metastatic breast cancer with MAPK alterations, and the second as a monotherapy in advanced solid tumors harboring oncogenic MEK1 or MEK2 mutations.
    • In October 2021, SpringWorks entered into an exclusive worldwide license agreement with Dana-Farber Cancer Institute (Dana-Farber) and a sponsored research agreement with Stanford Medicine for a portfolio of novel small molecule inhibitors of Epidermal Growth Factor Receptor (EGFR) designed for the treatment of EGFR-mutant cancers. In addition, SpringWorks entered into a collaboration agreement with Ab Magnitude Ventures Group, LLC and Ab Magnitude Fund, LP (collectively, "Ab Magnitude") to collaborate on target discovery and initial hit finding to advance next generation oncology therapeutics. SpringWorks and Ab Magnitude will also collaborate on the portfolio of EGFR inhibitors in-licensed by SpringWorks from Dana-Farber, with Ab Magnitude supporting optimization and characterization of the portfolio using its computational structural biology platform.

    General Corporate

    • In the second half of 2021, the United States Patent and Trademark Office issued two new composition of matter patents, U.S. Patent Nos. 11,066,358 and 11,084,780, covering several polymorphic forms of mirdametinib, including the polymorphic form that is currently in clinical development. These patents expire in 2041.

    Third Quarter 2021 Financial Results

    • Research and Development (R&D) Expenses: R&D expenses were $22.9 million for the third quarter, compared to $13.9 million for the comparable period of 2020. The increases in R&D expenses were attributable to an increase in internal costs driven by the growth in employee costs associated with increases in the number of R&D personnel and an increase in stock-based compensation expense as well as an increase in external costs related to drug manufacturing and trial costs.
    • General and Administrative (G&A) Expenses: G&A expenses were $18.0 million for the third quarter, compared to $7.7 million for the comparable period of 2020. The increases in G&A expenses were primarily attributable to the hiring of additional personnel in our G&A functions, as we continued to expand our operations to support the organization, including commercialization preparation efforts that are underway, and an increase in stock-based compensation expense. In addition, G&A expenses included an increase in information technology costs, and consulting and professional services, including legal, regulatory and compliance.
    • Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $41.0 million, or $0.84 per share, for the third quarter of 2021. This compares to a net loss of $21.7 million, or $0.51 per share, for the comparable period of 2020.
    • Cash Position: Cash, cash equivalents and marketable securities were $480.6 million as of September 30, 2021.

    COVID-19 Update

    To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks' business operations, in particular on SpringWorks' clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks' periodic filings with the Securities and Exchange Commission and refer to the Forward-Looking Statements section in this press release.

    About SpringWorks Therapeutics

    SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology portfolio of small molecule product candidates and is advancing 16 development programs, including two potentially registrational clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to expand its portfolio and create more solutions for patients with cancer. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.

    SpringWorks uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company's website in the ‘Investors & Media' section. Accordingly, investors should monitor such portions of the SpringWorks website, in addition to following press releases, SEC filings and public conference calls and webcasts.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding SpringWorks' clinical trials and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to SpringWorks' financial results, the timing for initiation, progress and completion of SpringWorks' clinical trials or third-party clinical trials of its product candidates, the timing for expected data readouts from partners and partners' clinical trials, the expected benefits of collaborations, the fact that interim results from a clinical study may not be predictive of the final results of such study or the results of other ongoing or future studies, whether and when, if at all, SpringWorks' product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks' business, operations, clinical trials involving its product candidates, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in SpringWorks' SEC filings. SpringWorks cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. SpringWorks disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent SpringWorks' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.



    SpringWorks Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)



    Three Months Ended September 30, Nine Months Ended September 30,
    (in thousands, except share and per-share data)2021 2020 2021 2020
    Operating expenses:       
    Research and development$22,866   $13,923   $72,332   $36,597  
    General and administrative18,029   7,669   45,340   20,946  
    Total operating expenses40,895   21,592   117,672   57,543  
           
    Loss from operations(40,895)  (21,592)  (117,672)  (57,543) 
    Interest and other income:       
    Other income(58)     (96)    
    Interest income, net179   63   617   1,156  
    Total interest and other income121   63   521   1,156  
    Equity investment loss(267)  (130)  (687)  (459) 
    Net loss$(41,041)  $(21,659)  $(117,838)  $(56,846) 
           
    Net loss per share, basic and diluted$(0.84)  $(0.51)  $(2.43)  $(1.35) 
    Weighted average common shares outstanding, basic and diluted48,595,420   42,148,837   48,417,300   41,961,691  
                    



    SpringWorks Therapeutics, Inc.

    Selected Balance Sheet Data

    (Unaudited)



     September 30, 2021 December 31, 2020
    (in thousands)   
    Cash, cash equivalents and marketable securities$480,643   $561,820  
    Working Capital (1)404,914   495,788  
    Total assets495,275   576,191  
    Total liabilities28,597   19,133  
    Accumulated deficit(236,441)  (118,603) 
    Total stockholders' equity466,678   557,058  

    (1)   We define Working Capital as current assets less current liabilities.





    Contact:

    Kim Diamond

    Vice President, Communications and Investor Relations

    Phone: 203-561-1646

    Email:  



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  4. -- Based on Encouraging Preliminary Data Observed with the First Dose Exploration Cohort (0.95 mg/kg BLENREP Q3W + Nirogacestat) a Randomized Phase 2 Cohort Expansion to Compare Against 2.5 mg/kg Q3W BLENREP Monotherapy Has Been Initiated --

    -- Two New Sub-Studies of BLENREP + Nirogacestat Combined with Standard-of-Care Therapies Now Planned --

    STAMFORD, Conn., Oct. 27, 2021 (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, today announced an update from its ongoing clinical collaboration with GlaxoSmithKline (GSK) evaluating nirogacestat, SpringWorks' investigational gamma secretase…

    -- Based on Encouraging Preliminary Data Observed with the First Dose Exploration Cohort (0.95 mg/kg BLENREP Q3W + Nirogacestat) a Randomized Phase 2 Cohort Expansion to Compare Against 2.5 mg/kg Q3W BLENREP Monotherapy Has Been Initiated --

    -- Two New Sub-Studies of BLENREP + Nirogacestat Combined with Standard-of-Care Therapies Now Planned --

    STAMFORD, Conn., Oct. 27, 2021 (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, today announced an update from its ongoing clinical collaboration with GlaxoSmithKline (GSK) evaluating nirogacestat, SpringWorks' investigational gamma secretase inhibitor, in combination with BLENREP (belantamab mafodotin-blmf), GSK's antibody-drug conjugate targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma. The nirogacestat and BLENREP combination is being evaluated as a sub-study of GSK's ongoing DREAMM-5 platform trial.

    The first combination dose level that evaluated 0.95 mg/kg Q3W BLENREP plus nirogacestat has been expanded based on encouraging preliminary data observed in the dose exploration Phase 1 portion of the nirogacestat DREAMM-5 sub-study. The expanded Phase 2 cohort is further exploring the safety and efficacy profile compared to a 2.5 mg/kg Q3W BLENREP monotherapy control arm, which is the same as the FDA approved monotherapy dose and schedule of BLENREP. In parallel, additional dose levels and schedules of BLENREP plus nirogacestat continue to be evaluated in the Phase 1 portion of the study.

    In addition, two new sub-studies will evaluate the BLENREP plus nirogacestat combination with standard-of-care multiple myeloma therapies in the DREAMM-5 trial. These two new sub-studies will explore BLENREP plus nirogacestat in combination with pomalidomide and dexamethasone and in combination with lenalidomide plus dexamethasone. Data from these sub-studies may enable future clinical trials in earlier lines of multiple myeloma. 

    "We continue to remain intensely focused on advancing nirogacestat as a potential best-in-class cornerstone of BCMA combination therapy for patients with multiple myeloma and are pleased with the progress that has been made with our collaborator GSK," said Saqib Islam, Chief Executive Officer of SpringWorks. "We believe in the emerging role of nirogacestat as a BCMA potentiator and we look forward to working with GSK to advance the expanded program."

    Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of multiple myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.1 To date, SpringWorks has entered into clinical collaborations with six industry partners, including GSK, to evaluate nirogacestat in combination with BCMA therapies across modalities.

    The platform study is being advanced pursuant to a non-exclusive global clinical trial collaboration agreement that SpringWorks and GSK entered into in June 2019 and that was amended in October 2021 to enable additional sub-studies to be conducted. Under the terms of the agreement, GSK is sponsoring and conducting the platform study to evaluate the safety, tolerability and preliminary efficacy of the combination and is assuming all development costs associated with the study other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. SpringWorks and GSK have formed a joint development committee to help manage and oversee the clinical study.

    About Nirogacestat

    Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

    In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two bispecific antibodies and a monoclonal antibody. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA therapies using a variety of preclinical multiple myeloma models.

    Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

    About SpringWorks Therapeutics

    SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology portfolio of small molecule product candidates and is advancing 16 development programs, including two potentially registrational clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to expand its portfolio and create more solutions for patients with cancer. For more information, please visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development plans, our preclinical and clinical results, and other future conditions. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "would," "should" and "could," and similar expressions or words, identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks relating to: (i) the success and timing of our product development activities, including the initiation and completion of SpringWorks' clinical trials, (ii) the fact that interim data from a clinical study may not be predictive of the final results of such study or the results of other ongoing or future studies, (iii) the success and timing of our collaboration partners' ongoing and planned clinical trials, (iv) our ability to obtain and maintain regulatory approval of any of our product candidates, (v) our plans to research, discover and develop additional product candidates, (vi) our ability to enter into collaborations for the development of new product candidates, (vii) our ability to establish manufacturing capabilities, and our and our collaboration partners' abilities to manufacture our product candidates and scale production, (viii) our ability to meet any specific milestones set forth herein, and (ix) uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks' business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines.

    Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements.

    For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks' expectations and actual results, you should review the "Risk Factors" in Item 1A of Part I of SpringWorks' Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks' subsequent filings.

    SpringWorks Media/Investor Contact:

    Kim Diamond

    Vice President, Communications and Investor Relations

    203-561-1646

    References

    1Eastman S, Shelton C, Gupta I, Krueger J, Blackwell C, Bojczuk P. Synergistic Activity of Belantamab Mafodotin (anti-BCMA immuno-conjugate) with PF-03084014 (gamma-secretase inhibitor) in BCMA-Expressing Cancer Cell Lines. Blood. 2019;134(supplement_1):4401. doi:10.1182/blood-2019-123705.

     



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  5. – SpringWorks to Utilize Pioneering Computational Modeling Approaches Developed by Yibing Shan, Ph.D., Previously Founding Member of DE Shaw Research and Leading Computational Structural Biologist –

    – Collaboration Designed to Expand SpringWorks' Drug Discovery Capabilities and to Support Buildout of Early-Stage Pipeline -

    STAMFORD, Conn., Oct. 20, 2021 (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, today announced that it has entered into a collaboration agreement with Ab Magnitude Ventures Group, LLC and Ab Magnitude Fund, LP (collectively, "Ab Magnitude") for the development…

    – SpringWorks to Utilize Pioneering Computational Modeling Approaches Developed by Yibing Shan, Ph.D., Previously Founding Member of DE Shaw Research and Leading Computational Structural Biologist –

    – Collaboration Designed to Expand SpringWorks' Drug Discovery Capabilities and to Support Buildout of Early-Stage Pipeline -

    STAMFORD, Conn., Oct. 20, 2021 (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, today announced that it has entered into a collaboration agreement with Ab Magnitude Ventures Group, LLC and Ab Magnitude Fund, LP (collectively, "Ab Magnitude") for the development of next-generation targeted oncology therapeutics. Ab Magnitude is led by Yibing Shan, Ph.D., a leading structural computational biologist who was a founding member of D.E. Shaw Research, a pioneering computational biochemistry research company. Dr. Shan's simulations of protein structural dynamics have previously yielded important insights on the activity of key oncogenic proteins and the identification of novel binding sites suitable for small molecule therapies. SpringWorks and Ab Magnitude will collaborate on target discovery and initial hit finding to advance next generation oncology therapeutics. In addition, the parties will also collaborate on a portfolio of novel EGFR inhibitors recently in-licensed by SpringWorks from the Dana-Farber Cancer Institute with Ab Magnitude supporting optimization and characterization of the portfolio using its computational platform.

    "We believe that Dr. Shan's track record of identifying novel druggable targets for the design of new cancer therapies is unparalleled and represents a natural complement to our strategy of developing differentiated targeted therapies on behalf of cancer patients," said Badreddin Edris, Ph.D., Chief Operating Officer of SpringWorks. "We look forward to collaborating with Ab Magnitude and we believe that by incorporating these cutting-edge computational approaches into our early-stage drug discovery and development capabilities, we will be well positioned to continue expanding our emerging preclinical pipeline and advancing promising candidates into the clinic."

    "I am excited to collaborate with SpringWorks on discovering novel oncology therapeutics using computational molecular and structural modeling approaches and to further optimizing the portfolio of novel EGFR inhibitors that SpringWorks recently in-licensed," said Dr. Shan. "This collaboration has the potential to expedite discovery of novel oncology therapeutics and advancement of promising therapeutic candidates by integrating Ab Magnitude's computational modeling and target identification expertise with a vertically-integrated biopharmaceutical partner that has the capital resources and expertise to optimize promising candidates to development candidate stage and into clinical studies."

    Under the terms of this agreement, Ab Magnitude is eligible for low single-digit percentage royalties on future net sales of products or other realizations of value arising from the collaboration.

    About SpringWorks Therapeutics

    SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology portfolio of small molecule product candidates and is advancing 15 development programs, including two potentially registrational clinical trials in rare tumor types as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to expand its portfolio and create more solutions for patients with cancer. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.

    SpringWorks Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development plans, our preclinical and clinical results, and other future conditions. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "would," "should" and "could," and similar expressions or words, identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks relating to: (i) the success and timing of our product development activities, including the initiation and completion of SpringWorks' clinical trials, (ii) the fact that interim data from a clinical study may not be predictive of the final results of such study or the results of other ongoing or future studies, (iii) the success and timing of our collaboration partners' ongoing and planned clinical trials, (iv) our ability to obtain and maintain regulatory approval of any of our product candidates, (v) our plans to research, discover and develop additional product candidates, (vi) our ability to enter into collaborations for the development of new product candidates, (vii) our ability to establish manufacturing capabilities, and our and our collaboration partners' abilities to manufacture our product candidates and scale production, (viii) our ability to meet any specific milestones set forth herein, and (ix) uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks' business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks' expectations and actual results, you should review the "Risk Factors" in Item 1A of Part I of SpringWorks' Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks' subsequent filings.

    SpringWorks Media/Investor Contact:

    Kim Diamond

    203-561-1646



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