SpringWorks Therapeutics Expands Targeted Oncology Pipeline with Exclusive Worldwide License to TEAD Inhibitor Portfolio

Rhea-AI Summary

SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) has announced an exclusive licensing agreement with KU Leuven and VIB for novel small molecule inhibitors targeting the TEA Domain (TEAD) family, aimed at treating biomarker-defined solid tumors linked to the Hippo pathway. An upfront payment of $11 million will be made, along with potential future milestones totaling $285 million. The company plans to nominate a development candidate in 2022 and commence IND-enabling studies. This strategic advancement is expected to enhance SpringWorks' portfolio of targeted therapies for cancer patients.

Positive

• Exclusive licensing agreement expands SpringWorks' portfolio with TEAD inhibitors.
• Potential to address tumors linked to aberrant Hippo pathway signaling.
• Upfront payment of $11 million is manageable given the potential $285 million in future milestones.

Negative

• Success of development candidates is uncertain until clinical trials are completed.
• Dependence on regulatory approvals and collaboration partners' success introduces risk.

- 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: kdiamond@springworkstx.com

FAQ

What is the significance of the licensing agreement for SWTX?

The licensing agreement allows SpringWorks to develop TEAD inhibitors, targeting tumors related to the Hippo pathway, potentially enhancing its drug portfolio.

What are the financial terms of the licensing agreement for SpringWorks?

SpringWorks will pay an upfront fee of $11 million and up to $285 million in milestones, plus tiered royalties on future sales.

What is the expected timeline for SpringWorks to nominate a development candidate?

SpringWorks expects to nominate a development candidate and commence IND-enabling studies in 2022.

How does TEAD inhibition relate to cancer treatment?

TEAD inhibition targets the Hippo pathway, which is genetically altered in up to 10% of cancers, offering a potential new approach to treating these tumors.