SWTX SpringWorks Therapeutics Inc.

73.36
+2.2  (+3%)
Previous Close 71.16
Open 71.58
52 Week Low 29.41
52 Week High 96.48
Market Cap $3,596,411,791
Shares 49,024,152
Float 22,874,058
Enterprise Value $2,849,462,962
Volume 239,328
Av. Daily Volume 370,848
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Upcoming Catalysts

Drug Stage Catalyst Date
Mirdametinib and lifirafenib
Solid tumors
Phase 1b
Phase 1b
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Nirogacestat and BLENREP (Belantamab)
Multiple Myeloma
Phase 1b
Phase 1b
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Mirdametinib - ReNeu
Neurofibromas
Phase 2b
Phase 2b
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Nirogacestat (DeFi)
Desmoid tumors
Phase 3
Phase 3
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PBCAR269A
Multiple Myeloma
Phase 1/2
Phase 1/2
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BGB-3245
Solid tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Nirogacestat and Teclistamab
Multiple myeloma
Phase 1b
Phase 1b
Phase 1b initiation of dosing announced April 1, 2021.
Nirogacestat
Desmoid tumors - children
Phase 2
Phase 2
Phase 2 trial commenced recruitment in September 2020.

Latest News

  1. – Reported Interim Data from Phase 2b ReNeu Trial of Mirdametinib in NF1-PN Demonstrating Encouraging Clinical Activity and Tolerability in the First 20 Adult Patients Enrolled –

    – Announced Achievement of First Patient Dosed in Allogene and Janssen Phase 1 Trials Evaluating Nirogacestat in Combination with BCMA Therapies –

    – Expanded Targeted Oncology Pipeline with Exclusive Worldwide License to TEAD Inhibitor Portfolio –

    STAMFORD, Conn., May 06, 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 first quarter financial results for the period ended March 31, 2021…

    – Reported Interim Data from Phase 2b ReNeu Trial of Mirdametinib in NF1-PN Demonstrating Encouraging Clinical Activity and Tolerability in the First 20 Adult Patients Enrolled –

    – Announced Achievement of First Patient Dosed in Allogene and Janssen Phase 1 Trials Evaluating Nirogacestat in Combination with BCMA Therapies –

    – Expanded Targeted Oncology Pipeline with Exclusive Worldwide License to TEAD Inhibitor Portfolio –

    STAMFORD, Conn., May 06, 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 first quarter financial results for the period ended March 31, 2021 and provided an update on recent company developments.

    "In the first quarter of 2021 we continued to execute on our 10 clinical programs and grew our portfolio of opportunities aimed at serving a broad group of patients across our three distinct oncology segments: late-stage rare oncology, hematological cancers and biomarker-defined metastatic solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "We are poised for multiple important data readouts this year, including topline data from our Phase 3 DeFi trial, initial clinical data from our BCMA combination trial of nirogacestat with GSK's BLENREP in multiple myeloma and initial clinical data from our metastatic solid tumor trials being conducted in collaboration with BeiGene. I look forward to reporting on our continued progress throughout 2021."

    Recent Business Highlights and Upcoming Milestones

    Late-Stage Rare Oncology

    • In February 2021, SpringWorks reported interim data from the adult stratum of the ongoing potentially registrational Phase 2b ReNeu trial evaluating mirdametinib in pediatric and adult patients with NF1-associated plexiform neurofibromas. Of the first 20 adult patients enrolled, 50% had achieved an objective response, the primary endpoint of the study, as assessed by blinded independent central review, and 16 of these 20 patients (80%) remained on study as of the January 22, 2021 data cutoff. In addition, mirdametinib was generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2 and only one Grade 3 TRAE reported; there have been no Grade 4 or 5 TRAEs reported. The Company expects to report additional clinical data from the ReNeu trial at a medical conference this year and to complete enrollment of the trial in the second half of 2021.
    • SpringWorks expects to report topline data from the Phase 3 DeFi trial in the second half of 2021, as previously disclosed.
    • Recruitment is ongoing in a Phase 2 study sponsored by the Children's Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.

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

    • Enrollment is ongoing in three Phase 1 studies evaluating nirogacestat in combination with anti-B-cell maturation antigen (BCMA) therapies in adult patients with relapsed or refractory multiple myeloma: a Phase 1b trial sponsored by GSK evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), a Phase 1 study sponsored by Allogene evaluating nirogacestat in combination with ALLO-715, and a Phase 1 study sponsored by Janssen Research & Development, LLC (Janssen) evaluating nirogacestat in combination with teclistamab. Initial data from the GSK-sponsored study are expected in 2021. SpringWorks also expects that two additional collaborator-sponsored trials will initiate in the first half of 2021, as previously disclosed: nirogacestat + Pfizer's elranatamab and nirogacestat + Precision Biosciences' PBCAR269A.
    • In March 2021, SpringWorks entered into a services agreement with ONCOtracker, Inc., a leading innovation center for novel cancer treatment and testing with a focus on the diagnosis and treatment of multiple myeloma, other B-cell malignancies, and related disorders, to explore the effect of nirogacestat on soluble BCMA release and membrane-bound BCMA receptor density in primary bone marrow samples collected from multiple myeloma patients. This research is intended to further confirm nirogacestat's ability to potentiate BCMA by using ex vivo patient-derived models with associated longitudinal clinical characterization for each sample.

    Biomarker-Defined Metastatic Solid Tumors

    • In May 2021, SpringWorks entered into an exclusive worldwide license agreement with Katholieke Universiteit Leuven (KU Leuven) and the Flanders Institute for Biotechnology (VIB) for the in-license of a portfolio of novel small molecule inhibitors of the TEA Domain (TEAD) family of transcription factors, designed for the potential treatment of biomarker-defined solid tumors driven by aberrant Hippo pathway signaling. The licensed portfolio includes advanced lead compounds and multiple backup compounds from diverse chemical series, which were discovered at KU Leuven's Center for Drug Design and Discovery (CD3) in collaboration with Professor Georg Halder of the VIB-KU Leuven Center for Cancer Biology. SpringWorks expects to nominate a development candidate from this portfolio and move into IND-enabling studies in 2022.
    • 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. BeiGene is sponsoring this trial and SpringWorks and BeiGene expect to report initial clinical data in 2021, as previously disclosed.
    • 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 Phase 1 trial are expected in 2021, as previously disclosed.
    • In March 2021, SpringWorks entered into a research collaboration agreement with Inserm Transfert, the private subsidiary of Inserm, acting as a delegatee of the French National Institute of Health and Medical Research (Inserm) to explore the ability of nirogacestat to delay the development of resistance to the EGFR inhibitor osimertinib in preclinical models of non-small cell lung cancer (NSCLC) driven by the EGFR C797S gatekeeper mutation. This research, which will be led by Antonio Maraver, Ph.D. at Montpellier Cancer Research Institute (IRCM U1194), is intended to build on previous in vivo work from Dr. Maraver's lab demonstrating the potential for gamma secretase inhibition to enhance the activity of osimertinib in EGFR-driven models of NSCLC.1

    General Corporate

    • In March 2021, Bhavesh Ashar was appointed Chief Commercial Officer of SpringWorks. Mr. Ashar has more than 20 years of global pharmaceutical and biotechnology experience, most recently having served as Senior Vice President, General Manager of U.S. Oncology at Bayer Healthcare where he was responsible for a broad portfolio in prostate, liver, colorectal, GIST, hematologic and tumor-agnostic biomarker driven cancers.

    First Quarter 2021 Financial Results

    • Research and Development (R&D) Expenses: R&D expenses were $17.4 million for the first quarter, compared to $9.7 million for the comparable period of 2020. The increases in R&D expenses were primarily attributable to an increase in external costs related to drug manufacturing and trial costs, and 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.
    • General and Administrative (G&A) Expenses: G&A expenses were $12.4 million for the first quarter, compared to $6.4 million for the comparable period of 2020. The increases in G&A expenses were primarily attributable to the hiring of additional personnel in G&A functions supporting the growth of the organization, as well as an increase in stock-based compensation expense.
    • Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $29.8 million, or $0.62 per share, for the first quarter of 2021. This compares to a net loss of $15.3 million, or $0.37 per share, for the comparable period of 2020.
    • Cash Position: Cash, cash equivalents and marketable securities were $541.0 million as of March 31, 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 underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing 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 industry leaders to expand its portfolio. 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 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 March 31,
    (in thousands, except share and per-share data)2021 2020
    Operating expenses:   
    Research and development$17,375  $9,727 
    General and administrative12,381  6,403 
    Total operating expenses29,756  16,130 
       
    Loss from operations(29,756) (16,130)
    Interest and other income:   
    Other income3   
    Interest income, net227  936 
    Total interest and other income230  936 
    Equity investment loss(261) (100)
    Net loss$(29,787) $(15,294)
       
    Net loss per share, basic and diluted$(0.62) $(0.37)
    Weighted average common shares outstanding, basic and diluted48,229,539  41,789,120 



     
    SpringWorks Therapeutics, Inc.

    Selected Balance Sheet Data


    (Unaudited)
        
     March 31, 2021 December 31, 2020
    (in thousands)   
    Cash, cash equivalents and marketable securities$541,042  $561,820 
    Working Capital (1)462,785  495,788 
    Total assets554,588  576,191 
    Total liabilities19,891  19,133 
    Accumulated deficit(148,390) (118,603)
    Total stockholders' equity534,697  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:

    References

    1 Bousquet E, Quantin X, Pujol J, et al. Notch Inhibition Overcomes Resistance to Tyrosine Kinase Inhibitors Promoted by Gate-Keeper Mutations in EGFR-Driven Lung Adenocarcinoma. J Clin Invest. 2020;130(2):612-624. //doi.org/10.1172/JCI126896.



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  2. - TEAD Inhibition Represents an Emerging Approach for Addressing Multiple Biomarker-Defined Cancers Characterized by Aberrant Hippo Pathway Signaling, which is Genetically Altered in up to 10% of Cancers -

    - SpringWorks Expects to Nominate a Development Candidate and Commence IND-Enabling Studies in 2022 -

    STAMFORD, Conn., May 06, 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 an exclusive worldwide license agreement with Katholieke Universiteit Leuven (KU Leuven) and the Flanders Institute for Biotechnology (VIB) for the in-license of…

    - TEAD Inhibition Represents an Emerging Approach for Addressing Multiple Biomarker-Defined Cancers Characterized by Aberrant Hippo Pathway Signaling, which is Genetically Altered in up to 10% of Cancers -

    - SpringWorks Expects to Nominate a Development Candidate and Commence IND-Enabling Studies in 2022 -

    STAMFORD, Conn., May 06, 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 an exclusive worldwide license agreement with Katholieke Universiteit Leuven (KU Leuven) and the Flanders Institute for Biotechnology (VIB) for the in-license of a portfolio of novel small molecule inhibitors of the TEA Domain (TEAD) family of transcription factors, designed for the potential treatment of biomarker-defined solid tumors driven by aberrant Hippo pathway signaling.

    "We are very pleased to expand our portfolio with the in-licensing of these selective and potent TEAD inhibitors, which are highly complementary to our strategy of developing novel targeted therapies for patients with biomarker-defined tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "Based on the compelling in vitro and in vivo data generated to date, we believe that the CD3 and VIB team has created unique and differentiated chemical matter that lays the foundation for SpringWorks to advance a potentially best-in-class targeted oncology opportunity on behalf of patients with devastating cancers. We look forward to nominating a development candidate from this portfolio and commencing IND-enabling activities next year."

    "Since first identified by our group and others in the fruit fly Drosophila almost 20 years ago, the Hippo pathway has come to be recognized as a central regulator of cell proliferation and organ growth. Given that the Hippo pathway is genetically altered in up to 10% of cancers, TEAD inhibition holds great promise as a therapeutic approach," said Professor Halder. Patrick Chaltin, Ph.D., Managing Director of CD3 at KU Leuven, added: "This agreement demonstrates CD3's strong drive to translate promising scientific insights into novel therapies that improve patients' lives, and we are very proud and excited to collaborate with SpringWorks given their success in rapidly advancing new targeted oncology treatments on behalf of patients."

    Under the terms of the agreement, SpringWorks will pay KU Leuven and VIB an upfront payment of $11 million. KU Leuven and VIB are also eligible to receive up to $285 million in development, regulatory and commercial milestones from SpringWorks and tiered single-digit percentage royalties based on any future net sales.

    About the Hippo Pathway and TEAD

    The Hippo pathway is an evolutionarily conserved signaling cascade that regulates organ development and tissue growth and regeneration. The TEA Domain (TEAD) family is a group of four homologous transcription factors whose activity is regulated by the Hippo pathway. The TEAD family is the terminal component of the Hippo pathway and transcriptional activity of this family has been implicated in a variety of tumors characterized by aberrant Hippo signaling. Transcription of TEAD target genes requires TEAD to form a transcriptional complex with the co-activators YAP or TAZ. Activation of the Hippo pathway prevents YAP and TAZ from translocating to the nucleus, preventing TEAD-dependent transcription. Aberrations and genetic mutations that limit Hippo pathway activation can result in significant increases in TEAD dependent transcription and have been identified as key drivers in several tumor types, including subsets of mesothelioma, non-small cell lung cancer, head and neck cancer, and kidney cancer.

    About SpringWorks Therapeutics

    SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing 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 industry leaders to expand its portfolio. For more information, 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, the interim data of the ReNeu clinical trial, including its interim primary efficacy, safety and tolerability data, 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 presentation 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 presentation, including, without limitation, risks relating to: (i) the success and timing of our ongoing DeFi and ReNeu 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 product development activities and initiating clinical trials, (iv) the success and timing of our collaboration partners' ongoing and planned clinical trials, (v) our ability to obtain and maintain regulatory approval of any of our product candidates, (vi) our plans to research, discover and develop additional product candidates, (vii) our ability to enter into collaborations for the development of new product candidates, (viii) our ability to establish manufacturing capabilities, and our and our collaboration partners' abilities to manufacture our product candidates and scale production, (ix) our ability to meet any specific milestones set forth herein, and (x) 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" section(s) of our filings with the Securities and Exchange Commission. ​

    SpringWorks Media/Investor Contact:

    Kim Diamond

    Vice President, Communications and Investor Relations

    Phone: 203-561-1646

    Email:



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  3. SOUTH SAN FRANCISCO, Calif. and STAMFORD, Conn., April 12, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer, and 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 the first patient has been dosed in a Phase 1 trial evaluating ALLO-715, Allogene's investigational anti-B-cell maturation antigen (BCMA) AlloCAR T therapy, in combination with nirogacestat, SpringWorks' investigational gamma secretase inhibitor (GSI), in patients…

    SOUTH SAN FRANCISCO, Calif. and STAMFORD, Conn., April 12, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer, and 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 the first patient has been dosed in a Phase 1 trial evaluating ALLO-715, Allogene's investigational anti-B-cell maturation antigen (BCMA) AlloCAR T therapy, in combination with nirogacestat, SpringWorks' investigational gamma secretase inhibitor (GSI), in patients with relapsed or refractory multiple myeloma.

    "We are pleased to have initiated this portion of the UNIVERSAL trial and look forward to investigating ALLO-715 in combination with nirogacestat as part of our comprehensive anti-BCMA strategy aimed at bringing an off-the-shelf cell therapy to patients with relapsed or refractory multiple myeloma," said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene Therapeutics.

    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, which may enhance the activity of BCMA-targeted therapies.1 In addition, emerging clinical data suggest that a GSI may increase antitumor efficacy of BCMA-targeted autologous CAR T therapy in patients with relapsed and refractory multiple myeloma.2,3

    "Multiple myeloma is incurable for the overwhelming majority of patients diagnosed with this cancer and those who have relapsed or are refractory to current treatments have very limited therapeutic options available to them," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "SpringWorks is advancing nirogacestat as a cornerstone of BCMA combination therapy across modalities, with the goal of potentiating BCMA therapies to provide better outcomes for patients. This study represents the first clinical trial combining nirogacestat with a CAR T therapy and we are delighted that the milestone of dosing the first patient has been achieved."

    The Phase 1 trial (NCT04093596), which is part of the ongoing UNIVERSAL trial being conducted by Allogene, is an open-label study evaluating the safety, tolerability and preliminary efficacy of ALLO-715 in combination with nirogacestat in patients with relapsed or refractory multiple myeloma. The trial is being advanced pursuant to a clinical trial collaboration agreement between Allogene and SpringWorks. Under the terms of the agreement, Allogene is sponsoring and conducting the Phase 1 study. Allogene and SpringWorks have formed a joint development committee to oversee this portion of the clinical study.

    About ALLO-715

    ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies. Multiple myeloma originates in the bone marrow and it is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow and other disease sites.4 Multiple myeloma is incurable for most patients, as relapses occur despite most treatments available.5 Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the American Society of Hematology (ASH) annual meeting in December 2020. This study also uses ALLO-647, Allogene's anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen.

    ALLO-715 utilizes the TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the BCMA target. Allogene holds the global development and commercial rights for this investigational candidate.

    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 five collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies and two bispecific antibodies. In addition, SpringWorks and Fred Hutchinson Cancer Research Center have entered into a sponsored research agreement to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA directed therapies using a variety of preclinical and patient-derived multiple myeloma models developed by researchers at Fred Hutch.

    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 Allogene Therapeutics

    Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

    About SpringWorks Therapeutics

    SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing 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 industry leaders to expand its portfolio. For more information, please visit www.springworkstx.com, and follow @SpringWorksTx on Twitter and LinkedIn.

    Allogene Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to progress the UNIVERSAL trial and combination of ALLO-715 with nirogacestat; the ability of ALLO-715 in combination with nirogacestat to provide better outcomes for patients; the ability to develop allogeneic CAR T therapies for cancer and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogene's expectations and actual results as discussed in greater detail in Allogene's filings with the Securities and Exchange Commission (SEC), including without limitation in its Form 10-K for the year ended December 31, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

    AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

    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' Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks' subsequent filings.

    Allogene Media/Investor Contact:

    Christine Cassiano

    Chief Communications Officer

    (714) 552-0326

    SpringWorks Media/Investor Contact:

    Kim Diamond

    Vice President, Communications and Investor Relations

    203-561-1646

    References:

    1 Eastman et al., Abstract #4401 "Synergistic Activity of Belantamab Mafodotin (anti-BCMA immuno-conjugate) with Nirogacestat (PF-03084014, gamma-secretase inhibitor) in BCMA-Expressing Cancer Cell Lines", ASH 2019.

    2 Cowan et al., Abstract #204 "Efficacy and Safety of Fully Human BCMA CAR T Cells in Combination with a Gamma Secretase Inhibitor to Increase Bcma Surface Expression in Patients with Relapsed or Refractory Multiple Myeloma", ASH 2019.

    3 Blood. 2019 Nov 7;134(19):1585-1597. doi: 10.1182/blood.2019000050

    4 Multiple myeloma - Genetics Home Reference - NIH. Retrieved from https://ghr.nlm.nih.gov/condition/multiple-myeloma#

    5 Sonneveld P, Broijl A. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396-406



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  4. STAMFORD, Conn., April 01, 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 the first patient has been dosed in a Phase 1b clinical trial evaluating nirogacestat, an investigational gamma secretase inhibitor (GSI) being developed by SpringWorks, in combination with teclistamab, an investigational bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3 being developed by Janssen Research & Development, LLC (Janssen), in patients with relapsed or refractory multiple myeloma.

    Gamma secretase inhibition prevents the cleavage and shedding of BCMA from…

    STAMFORD, Conn., April 01, 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 the first patient has been dosed in a Phase 1b clinical trial evaluating nirogacestat, an investigational gamma secretase inhibitor (GSI) being developed by SpringWorks, in combination with teclistamab, an investigational bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3 being developed by Janssen Research & Development, LLC (Janssen), in patients with relapsed or refractory multiple myeloma.

    Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, which may enhance the activity of BCMA-targeted therapies.

    "We are very pleased that patients have been dosed in this study, which represents the first clinical study combining nirogacestat with a bispecific antibody in patients with multiple myeloma," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We are advancing nirogacestat as a cornerstone of BCMA combination therapy across modalities and look forward to the enrollment of patients into multiple Phase 1 studies and generating data with our BCMA collaborators in 2021."

    The Phase 1b trial (NCT04722146), which is part of a multi-arm trial being conducted by Janssen, is an open-label study to evaluate the safety, tolerability and preliminary efficacy of nirogacestat in combination with teclistamab in patients with relapsed or refractory multiple myeloma. The trial is being advanced pursuant to a clinical collaboration and supply agreement that SpringWorks entered into with Janssen Biotech, Inc. in September 2020. Under the terms of the agreement, Janssen is assuming all costs associated with the Phase 1b study, other than expenses related to the supply of nirogacestat. SpringWorks has formed a joint oversight committee with Janssen to coordinate the sharing of study results, regulatory and other activities in connection with the study.

    In addition to its ongoing clinical collaborations with BCMA-directed therapies, SpringWorks is conducting a global Phase 3, double-blind, randomized, placebo-controlled clinical trial (the DeFi Trial) to evaluate nirogacestat as a monotherapy in adults with progressing desmoid tumors.

    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 five collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies and two bispecific antibodies. In addition, SpringWorks and Fred Hutchinson Cancer Research Center have entered into a sponsored research agreement to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA directed therapies using a variety of preclinical and patient-derived multiple myeloma models developed by researchers at Fred Hutch.

    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 underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing 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 industry leaders to expand its portfolio. For more information, please 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' Annual Report on Form 10-K for the year ended December 31, 2020, 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



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  5. STAMFORD, Conn., March 22, 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, announced today that Bhavesh Ashar has been appointed Chief Commercial Officer. Mr. Ashar has more than 20 years of global pharmaceutical and biotechnology experience, most recently having served as Senior Vice President, General Manager of U.S. Oncology at Bayer Healthcare. Mr. Ashar will build and lead commercial operations at SpringWorks as the company continues to advance its diversified targeted oncology portfolio, which includes two potentially registrational rare oncology programs.

    "We are very happy…

    STAMFORD, Conn., March 22, 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, announced today that Bhavesh Ashar has been appointed Chief Commercial Officer. Mr. Ashar has more than 20 years of global pharmaceutical and biotechnology experience, most recently having served as Senior Vice President, General Manager of U.S. Oncology at Bayer Healthcare. Mr. Ashar will build and lead commercial operations at SpringWorks as the company continues to advance its diversified targeted oncology portfolio, which includes two potentially registrational rare oncology programs.

    "We are very happy to be welcoming Bhavesh to the SpringWorks team. His deep knowledge and experience in oncology product launches and proven record of building high-performing commercial teams will be instrumental as we prepare to serve patients with various forms of cancer," said Saqib Islam, Chief Executive Officer of SpringWorks. "SpringWorks has made great progress in developing nirogacestat for patients with desmoid tumors and mirdametinib for patients with NF1-associated plexiform neurofibromas. We look forward to reporting data from our two registrational trials in these devastating tumors later this year, including topline data from our Phase 3 DeFi trial and additional data from our Phase 2b ReNeu trial."

    "What attracted me to SpringWorks was the breadth of opportunities across the company's rare oncology programs and larger opportunities in genetically defined cancers," said Mr. Ashar. "I look forward to joining this team of passionate and driven people who share a deep commitment to bringing life-changing medicines to patients and families suffering from severe rare diseases and cancer."

    As Senior Vice President, General Manager of U.S. Oncology at Bayer, Mr. Ashar served as Business Unit head for the U.S. Oncology franchise and was responsible for a broad portfolio in prostate, liver, colorectal, GIST, hematologic and tumor-agnostic biomarker driven cancers. Before joining Bayer in 2017, he held roles of increasing responsibility at Sanofi Genzyme over a 15-year tenure, including Vice President, General Manager of U.S. Oncology and Vice President, Global Head of Transplant. Prior to Sanofi Genzyme, Mr. Ashar was a consultant with McKinsey & Company where he served clients in the biopharmaceutical space. Mr. Ashar received an MBA from the University of Chicago and a BS in Mathematics from the Imperial College in London.

    About SpringWorks Therapeutics

    SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing 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 industry leaders to expand its portfolio. For more information, 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' Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks' subsequent filings.

    Contact

    Kim Diamond

    Vice President Communications and Investor Relations

    Phone: 203-561-1646

    Email: 



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