Merck to Acquire US Biopharma Company SpringWorks Therapeutics to Accelerate Sustainable Growth of Healthcare Business

On April 28, 2025 Merck (DAX: MRK), a leading science and technology company, and SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a Stamford, Connecticut-based commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported the companies have entered into a definitive agreement for Merck to acquire SpringWorks (Press release, Merck KGaA, APR 28, 2025, View Source [SID1234654400]). The purchase price of $47 per share in cash represents an equity value of approximately $3.9 billion, or an enterprise value of $3.4 billion (€3.0 billion) based on SpringWorks’ cash balance as of December 31, 2024, and a premium of 26% to SpringWorks’ unaffected 20-day volume-weighted average price of $37.38 on February 7, 2025, the day prior to the first market speculation of a potential transaction between Merck and SpringWorks.

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"The agreed acquisition of SpringWorks is a major step in our active portfolio strategy to position Merck as a globally diversified, innovation and technology powerhouse. For our Healthcare sector, it sharpens the focus on rare tumors, accelerates growth, and strengthens our presence in the U.S.," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "Beyond this planned transaction, we will continue to explore M&A opportunities across our three complementary business sectors, always with a firm focus on strategic fit, financial robustness, and long-term value creation."

The planned transaction is fully aligned with the business development/M&A priorities of Merck’s Healthcare business as outlined during the company’s Capital Markets Day in October 2024: to continue to pursue external innovation via in-licensing of high-quality compounds at various stages of development and focused acquisitions that promise early value creation. It also fits with the strategic objective of strengthening Merck’s Healthcare presence in the United States, the world’s largest pharmaceutical market.

Upon closing, the business combination will immediately contribute to Merck’s revenues and is expected to be accretive to Merck’s earnings per share pre (EPS pre) in 2027. The acquisition will be funded with available cash and new debt. Beyond this planned transaction, Merck will retain the ability to pursue larger transactions and continue to evaluate opportunities across its three sectors, with Life Science a priority. Merck is committed to preserving its strong investment grade credit rating.

SpringWorks’ rare tumor portfolio, including a marketed first-in-class, systemic standard-of-care therapy for adults with desmoid tumors and the first and only approved therapy for adults and children with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection, will accelerate immediate and sustainable revenue growth for Merck. SpringWorks’ portfolio complements Merck’s progress in rare tumors, with Merck recently exercising an option for worldwide commercialization rights for pimicotinib, an investigational therapy developed by Abbisko Therapeutics Co., Ltd. for patients with tenosynovial giant cell tumor (TGCT).

"We have the unique opportunity with SpringWorks to establish a leadership position in rare tumors and build a strong foundation for further investments in this area, where a large unmet medical need exists," said Peter Guenter, member of the Executive Board and CEO of Healthcare at Merck. "Together, Merck and SpringWorks are the perfect combination to improve outcomes for patients with rare tumors and bring therapeutic innovations to more patients worldwide while building on and reinforcing the early success of SpringWorks in the United States. For Merck, the planned acquisition will create long term, sustainable growth for our Healthcare business. Along with my successor Danny Bar-Zohar, we look forward to completing this strategic transaction and making a meaningful difference for patients whose lives are so profoundly affected by these complex and challenging tumors."

The agreed acquisition provides SpringWorks with an opportunity to expand its reach into markets beyond the U.S. and leverage the breadth of resources of Merck’s global Healthcare organization.

"From the outset, our focus at SpringWorks has been to create transformative solutions for patients suffering from serious diseases. We have successfully launched two best-in-class medicines in the United States, and with the aspiration to deliver our therapies worldwide, our journey is at a pivotal juncture. It became clear during our discussions with the Merck team that we share many core values, including a commitment to help more patients with rare tumors live longer, better lives," said Saqib Islam, CEO of SpringWorks Therapeutics. "We believe that by joining forces with Merck, we are not only creating significant, immediate value for our stakeholders, but we will also be able to leverage their resources and expertise to build a brighter future for the patient communities we seek to serve while also creating new opportunities for SpringWorks employees as part of a global organization."

SpringWorks’ U.S. Food and Drug Administration (FDA)-approved therapy, OGSIVEO (nirogacestat) is a first-in-class therapy that is the systemic standard of care for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. SpringWorks’ marketing authorization application (MAA) for nirogacestat is under review with the European Medicines Agency (EMA), with a Committee for Medicinal Products for Human Use (CHMP) decision expected in Q2 2025.

GOMEKLI (mirdametinib) is the first and only FDA-approved therapy for the treatment of adult and pediatric patients 2 years of age and older with NF1-PN not amenable to complete resection. The FDA’s February 2025 approval of GOMEKLI was based on positive data from SpringWorks’ Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in a robust objective response rate, deep and durable reductions in tumor volume, and a manageable safety profile. With the approval, SpringWorks was granted a rare pediatric disease priority review voucher by the FDA. The marketing authorisation application for mirdametinib has been validated by the European Medicines Agency (EMA) with a potential approval in 2025. In addition, SpringWorks is advancing its pipeline with additional programs in other tumor settings that are currently underserved.

The transaction has been unanimously approved, by all those in attendance, by both the Merck and SpringWorks Boards of Directors and is expected to close in the second half of 2025, subject to satisfaction of customary closing conditions, including approval of SpringWorks’ shareholders and receipt of required regulatory approvals.

J.P. Morgan is acting as exclusive financial advisor and Sullivan & Cromwell LLP is acting as legal counsel to Merck. Centerview Partners LLC and Goldman Sachs & Co. LLC are acting as joint financial advisors to SpringWorks, and Goodwin Procter LLP is acting as SpringWorks’ legal counsel.

Financial Results for the Fiscal Year Ended March 31, 2025

On April 28, 2025 NEC reported Financial Results for the Fiscal Year Ended March 31, 2025 (Presentation, NEC, APR 28, 2025, View Source [SID1234654110]).

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Calidi Biotherapeutics Announces IL15 Superagonist as First Payload to be Delivered by Systemic Antitumor Virotherapy  Platform at AACR Annual Meeting

On April 28, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, reported the selection of IL15 superagonist (Il15-IL15Ra) as the first payload to be delivered into tumors using its systemic antitumor virotherapy platform, RTNova (Press release, Calidi Biotherapeutics, APR 28, 2025, View Source [SID1234653211]). New preclinical data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 27, 2025, in Chicago, IL.

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The first candidate developed using RTNova is a vaccinia virus (virotherapy) that is engineered to be tumor selective and produced in an enveloped form that allows the virus to survive bloodstream circulation and reach metastatic tumor sites where viral replication can destroy cancer cells while also activating an immune response. RTNova can be further engineered to deliver transgenes or gene medicines for expression in tumor cells. Data presented at AACR (Free AACR Whitepaper) demonstrates that the ability of the enveloped virotherapy to express IL15 superagonist specifically in the tumor microenvironment measurably increases the number of complete responses, or tumor eliminations, in preclinical models after a single systemic administration.

"IL15 superagonist is a potent cytokine capable of generating robust and durable immune responses against tumors but can induce severe toxicity when administered systemically" said Antonio F. Santidrian, PhD, Chief Scientific Officer at Calidi. "By using tumor-targeted virotherapies systemically delivered to express therapeutic proteins like IL-15 superagonist directly into the tumor microenvironment, we believe we can effectively boost immune response against the tumors precisely where it is needed while minimizing systemic toxicity".

"While intratumoral use of oncolytic viruses has shown positive clinical results, their applicability has been limited to injectable cancers," said Eric Poma, PhD, Chief Executive Officer at Calidi. "Our RTNova platform builds on the clinical success of current intratumoral oncolytic viruses but is designed for systemic administration, allowing us to target metastatic disease patients with high unmet need. RTNova also allows for the delivery of payloads like IL-15 superagonist to the tumor microenvironment, inducing a profound anti-tumor immune activation."

With the RTNova platform, Calidi Biotherapeutics is pioneering the systemic delivery of virotherapies, a major step forward in treating metastatic cancers. This adaptable platform can also deliver different therapeutic payloads, allowing a bespoke approach to candidate design determined by the intrinsic properties of different tumor types.

A copy of the poster presented at AACR (Free AACR Whitepaper) featuring data on delivering IL15 superagonist is available here.

BriaCell Presents Benchmark Beating Survival and Clinical Benefit at AACR 2025; Advancements in Next Generation Bria-OTS+(TM) Development

On April 28, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported positive data from its Phase 2 study of lead product candidate, Bria-IMT, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL (Press release, BriaCell Therapeutics, APR 28, 2025, View Source [SID1234652433]). In addition, Phase 3 early biomarker data will be presented as a late breaking abstract.

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The posters are summarized below and linked here: View Source

Title: Survival outcomes in a randomized phase 2 of Bria-IMT : An allogeneic whole cell cancer vaccine
Session Title: Phase II and Phase III Clinical Trials
Session Start: 4/28/2025 2:00 PM – 5:00 PM CST
Location: Poster Section 50
Poster Board Number: 18
Abstract Presentation Number: CT100

"The excellent survival responses reported in patients with different tumor types in the Phase 2 study is very exciting, and we look forward to seeing these promising data replicate in the pivotal Phase 3 study," stated Dr. William V. Williams, BriaCell’s President & CEO.

Of 54 metastatic breast cancer patients in the Phase 2 study, 37 patients received Bria-IMT formulation that is currently being used in BriaCell’s ongoing pivotal Phase 3 study (ClinicalTrials.gov as NCT06072612 ). Patients have been heavily pre-treated a median of 6 prior treatments — including Antibody-Drug Conjugates (ADCs) and check point inhibitors (CPIs).

Clinical benefit rates [CR, PR, SD] ranged from 45% to 100% based on subtype
Decrease in size or no change in all tumors noted in 83% of patients receiving Phase 3 formulation
Overall survival (OS) with the Phase 3 formulation was 17.3 months for HR+ patients and 11.44 months for patients with triple negative breast cancer (TNBC)
Overall response rate (ORR) for patients with intracranial metastases was 50% with a 75% clinical benefit rate
Safety profile: No unexpected adverse events, no treatment related discontinuation of therapy
Title: Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunity
Session Category: Immunology
Session Title: Vaccines, In Situ Vaccines, and Vaccine Combinations
Session Date and Time: 4/28/2025 2:00 – 5:00 PM CST
Location: Poster Section 39
Poster Board Number: 29
Published Abstract Number: 3553

Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, "We are very excited with the anti-cancer activity of Bria-OTS+ and expect the platform will enable the delivery of powerful and long-lasting immune activity against cancer."

"This data further validates the mechanism of action of our next-generation Bria-OTS+ platform. Additional immune activating factors are expected to enhance efficacy, and we look forward to replicating these results clinically as we advance our next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs," stated Dr. William V. Williams, BriaCell’s President and CEO.

Bria-OTS+ is an immunotherapy platform and enhanced version of Bria-OTS, BriaCell’s personalized pre-manufactured immunotherapy already demonstrating tremendous results as announced on April 24 2025 . Bria-OTS+ immunotherapy expresses multiple immune-activating cytokines and co-stimulatory molecules in addition to immune-boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer are expected to be investigated in BriaCell’s upcoming Phase 1/2a clinical studies.

enGene to Participate in Upcoming Investor Conferences

On April 28, 2025 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that management will present at upcoming investor conferences in May 2025. Details of the conferences are below (Press release, enGene, APR 28, 2025, View Source [SID1234652291]):

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Conference: 2025 Bloom Burton & Co. Healthcare Investor Conference
Date: Monday, May 5, 2025
Time: 2:30 p.m. ET
Format: Corporate Presentation

Conference: The Citizens Life Sciences Conference
Date: Wednesday, May 7, 2025
Time: 11:30 a.m. ET
Format: Fireside Chat

A live webcast of these presentations can be accessed under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.