On July 9, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical company focused on respiratory diseases, reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Verona Pharma for $107 per American Depository Share (ADS), each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately $10 billion (Press release, Merck & Co, JUL 9, 2025, View Source [SID1234654308]).

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Through this acquisition Merck will add Ohtuvayre (ensifentrine), a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio. The U.S. Food and Drug Administration approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first novel inhaled mechanism for the treatment of COPD in more than 20 years and combines bronchodilator and non-steroidal anti-inflammatory effects. Ohtuvayre is also being evaluated in clinical trials for the treatment of non-cystic fibrosis bronchiectasis.

"This acquisition of Verona Pharma reflects the commitment we have to delivering innovative treatments to patients and our ability to execute on our science-led and value-driven business development strategy," said Robert M. Davis, chairman and chief executive officer, Merck. "Ohtuvayre complements and expands our pipeline and portfolio of treatments for cardio-pulmonary diseases while delivering near- and long-term growth as well as value for shareholders. This novel, first-in-class treatment addresses an important unmet need for COPD patients persistently symptomatic based on its unique combination of bronchodilatory and non-steroidal anti-inflammatory effects. We look forward to welcoming the talented Verona Pharma team to Merck."

"Today’s announced agreement with Merck is the culmination of years of focus and determination by the Verona Pharma team advancing Ohtuvayre, the first novel inhaled mechanism for the maintenance treatment of COPD in two decades," said David Zaccardelli, president and chief executive officer, Verona Pharma. "Since launching Ohtuvayre in August 2024 we have seen rapid and accelerating uptake in the U.S. We believe Merck’s commercial footprint and industry-leading clinical capabilities will help accelerate the potential of Ohtuvayre to reach more patients living with COPD. This agreement will enable the strong launch trajectory of this important medicine and provides value to Verona Pharma shareholders."

The transaction was unanimously approved by both the Merck and Verona Pharma Boards of Directors and is intended to be effected by way of a scheme of arrangement under UK law. Closing of the proposed acquisition is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act, approval of Verona Pharma shareholders, sanction by the High Court of Justice of England and Wales and other customary conditions. The transaction is expected to close in the fourth quarter of 2025 and will result in the capitalization of most of the purchase price as an intangible asset for Ohtuvayre (which will be amortized as a GAAP-only charge over the life of the product).

Investor Call

Merck will hold an investor call today, July 9, 2025 at 8 a.m. ET to discuss the proposed transaction. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call. Investors, journalists and the general public may access a live audio webcast of the call via this weblink.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 2398172.

Advisors

Citi and Morgan Stanley & Co. LLC acted as financial advisors to Merck in this transaction and Freshfields LLP acted as Merck’s legal advisor. Centerview Partners LLC acted as exclusive financial advisor to Verona Pharma and Latham & Watkins LLP as Verona Pharma’s legal advisor.

Ohtuvayre Indication and Important Safety Information

INDICATION

Ohtuvayre is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

IMPORTANT SAFETY INFORMATION

Contraindication: Ohtuvayre is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

Warnings and Precautions:

Acute Episodes of Bronchospasm Ohtuvayre should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.

Paradoxical Bronchospasm As with other inhaled medicines, Ohtuvayre may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Ohtuvayre, it should be treated immediately with an inhaled, short-acting bronchodilator. Ohtuvayre should be discontinued immediately and alternative therapy should be instituted.

Psychiatric Events Including Suicidality Before initiating treatment with Ohtuvayre, healthcare providers should carefully weigh the risk and benefits of treatment with Ohtuvayre in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with Ohtuvayre if such events occur.

Treatment with Ohtuvayre is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received Ohtuvayre (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] Ohtuvayre 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] Ohtuvayre 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients [0.4%] receiving Ohtuvayre and no patients receiving placebo.

Adverse Reactions: The most common adverse reactions ≥1% in Ohtuvayre and greater than placebo in the pooled population were back pain 1.8%, hypertension 1.7%, urinary tract infection 1.3%, and diarrhea 1.0%.

These are not all of the possible risks associated with Ohtuvayre.

Please see Prescribing Information for Ohtuvayre (ensifentrine) at: View Source, Patient Information for Ohtuvayre at: View Source

About Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a progressive respiratory condition that causes restricted airflow and breathing problems. Emphysema and chronic bronchitis are the two most common types of COPD. Common symptoms of COPD include shortness of breath an ongoing cough or a cough that produces a lot of mucus, wheezing, chest tightness or heaviness and fatigue. Smoking and air pollution are the most common causes of COPD. An estimated 390 million people suffer from COPD worldwide as of 2019 and COPD is the fourth leading cause of death worldwide. There is no cure for COPD.

About Ohtuvayre (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of adults with COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD.

On July 9, 2025 Kazia Therapeutics (NASDAQ: KZIA) reported preliminary results from the first patient in its Phase 1b trial evaluating a combination regimen of Paxalisib, pembrolizumab (Keytruda), and standard chemotherapy after completing Cycle 1 (21 days) of dosing (Press release, Kazia Therapeutics, JUL 9, 2025, View Source [SID1234654307]). The patient, a 61-year-old woman with metastatic triple-negative breast cancer localized to the left upper lobe of the lung, has shown highly encouraging preliminary results at 21 days, with a >50% reduction in circulating tumor cells (CTCs) and a notable decrease in CTC clusters.

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The early data in this first patient closely mirror the mechanistic preclinical findings published in Molecular Cancer Therapeutics (View Source), which highlight that Paxalisib, when combined with immunotherapy, significantly disrupted both single CTCs and multicellular clusters in preclinical models.

Key Highlights

– Patient Profile: 61-year-old female, metastatic triple-negative breast cancer (lung metastasis).

– Investigational Regimen: Paxalisib, pembrolizumab, and chemotherapy.

– Results at Day 21 (End-of-Cycle 1):

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>50% reduction in total CTC count.

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Comparable reduction in CTC clusters—these aggregates are associated with heightened metastatic potential.

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Reduction in the mesenchymal phenotype of the remaining CTCs; this phenotype is one of the hallmarks of aggressive metastatic seeding cancer cells.

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First-in-human data support potential for potent CTC mobilization suppression by this combination.

Clinical Significance of Patient Data

CTC clusters have long been recognized as critical mediators of metastasis and markers of poor prognosis. They are known to resist apoptosis, evade immune detection, and seed new tumor sites with exceptional efficiency. Notably, standard chemotherapy has been shown in some studies to transiently increase CTC and cluster counts within the first cycle, with levels sometimes doubling before normalizing after cycle two. In contrast, immunotherapy alone has demonstrated variable impact, often showing delayed or modest effects on CTCs, likely due to immune-mediated mechanisms over weeks to months.

In this case, the combination regimen of Paxalisib and immunotherapy achieved a rapid reduction in both CTC numbers and clusters as well as a reduction in the mesenchymal phenotype—an outcome not typically seen with chemotherapy or immunotherapy alone after only 21 days of treatment. This early clinical data reflects mechanistic synergy consistent with the preclinical data described in the MCT manuscript.

Dr. John Friend, MD, Chief Executive Officer of Kazia Therapeutics, said "It is very exciting to see our extensive preclinical research translate into such positive early data in this first patient receiving a combination of Paxalisib and immunotherapy. The degree of reduction in tumor cell dissemination markers in just 21 days gives us strong reason for optimism as we continue this clinical trial."

Dr. Friend continued "CTC clusters are emerging as key drivers of metastatic spread—they’re 20–100X more efficient at seeding than single CTCs—and the sharp decline we’re seeing is truly encouraging. We believe this combination may offer a meaningful early intervention against systemic disease progression."

Next Steps

– Explore potential relationship between CTC kinetics and radiographic responses

– Enrollment continues in the Phase Ib study, expanding cohort size to assess safety, tolerability, and pharmacodynamics

– Planned comprehensive analysis of immune microenvironment and CTC kinetics across all patients through serial monitoring

– Longer-term follow-up will include imaging, progression-free survival, and assessment of correlation with molecular biomarkers

For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC, [email protected], +1-201-786-8795.

On July 9, 2025 Immuneering (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, reported that the United States Patent and Trademark Office (USPTO) granted the company a composition of matter patent for atebimetinib (IMM-1-104), an oral once-daily deep cyclic inhibitor of MEK (Press release, Immuneering, JUL 9, 2025, View Source [SID1234654306]). MEK is a key component of the signaling pathway that drives the majority of cancers, including pancreatic cancer.

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First-line pancreatic cancer patients treated with atebimetinib plus chemotherapy had a remarkable 94% probability of surviving 6 months, in data from Immuneering’s ongoing Phase 2a study announced in June, with few serious side effects observed. In prior studies of the most common global standard of care chemotherapy in first-line pancreatic cancer patients, the probability of surviving 6 months was only 67%.

U.S. Patent No. 12,351,566, titled: "MEK Inhibitors and Therapeutic Uses Thereof", includes claims to atebimetinib’s composition of matter. The patent’s term, which includes a patent term adjustment, is currently expected to expire in August 2042. The patent may also be eligible for patent term extension to recover a portion of the time required to fulfill regulatory approval requirements.

"Our priorities are to make medicines that keep working, so cancer patients keep living, and to make medicines that have fewer side effects, so cancer patients can feel like themselves and live normal lives. We have already observed exceptional durability and a markedly favorable tolerability profile in first-line pancreatic cancer patients treated with atebimetinib+mGnP, and this is just the beginning of the important impact that we believe atebimetinib and our entire pipeline of deep cyclic inhibitors will have on the treatment of cancer," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.

"We believe the granting of our composition of matter patent validates the novelty of our approach and secures key intellectual property around our lead product candidate, as part of a broader intellectual property strategy," Zeskind continued. "We expect that the long patent runway we are forging for atebimetinib will support our efforts to maximize its full therapeutic potential, starting with first-line pancreatic cancer and extending to many different cancer types and combinations."

Atebimetinib previously received FDA Fast Track designations for the treatment of first- and second-line pancreatic ductal adenocarcinoma (PDAC), as well as for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. The FDA also previously granted atebimetinib orphan drug designation for the treatment of pancreatic cancer. Immuneering has also announced plans to study atebimetinib in combination with other therapeutics – in a variety of additional cancers.

On July 9, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,357,593 on July 15, 2025 covering key aspects of its ovarian cancer vaccine technology (Press release, Anixa Biosciences, JUL 9, 2025, View Source [SID1234654304]). The patent includes broad claims related to methods of eliciting an immune response targeting anti-Müllerian hormone receptor, type II (AMHR2), a promising target for ovarian cancer prevention and treatment.

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Anixa’s ovarian cancer vaccine, being developed in a collaboration between Cleveland Clinic and the National Cancer Institute, represents a novel approach to preventing and treating ovarian cancer, particularly among high-risk populations such as those carrying BRCA mutations or with a family history of the disease.

The patent includes methods of administering an immunogenic composition comprising a nucleic acid encoding the AMHR2 polypeptide, specifically the extracellular domain of human AMHR2, to elicit an AMHR2-specific immune response. This patent was issued to Cleveland Clinic and Anixa exclusively holds the world-wide rights to the patent.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "The issuance of this patent by the USPTO continues to strengthen broad protection for the various components and delivery mechanisms of our vaccine technology. This patent supports the continued advancement of our program."

On July 9, 2025 Actithera, a radiopharmaceutical biotech company translating medicinal chemistry insights into next-generation radioligand therapies (RLTs), reported the close of an oversubscribed $75.5 million Series A financing round (Press release, Actithera, JUL 9, 2025, View Source [SID1234654293]). The financing will support the advancement of Actithera’s lead FAP asset into clinical development in multiple indications, while also enabling the continued development of its proprietary RLT discovery platform and preclinical pipeline.

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The round was co-led by founding investor M Ventures and new lead investors Hadean Ventures, Sofinnova Partners, and 4BIO Capital, with additional participation from Bioqube Ventures, Innovestor’s Life Science Fund, Investinor, Surveyor Capital (a Citadel company), and second founding investor, Arkin Bio Ventures II.

The Company’s discovery platform combines rational drug design with radiochemistry to create novel small molecule radioligands that overcome current limitations in radiopharmaceutical development. Its three-pillar platform includes first-in-class covalent targeting strategies, designed to optimize tumor residence time, while ensuring rapid systemic clearance – improving precision, safety, and efficacy. Two additional proprietary approaches further support compound differentiation and improve tumor residence time and selectivity. This platform was validated through Actithera’s work on FAP, a high-value theranostic target known for being difficult to drug with molecules that maintain prolonged tumor residency. These efforts have resulted in a FAP-directed RLT development candidate with best-in-class potential due to its optimal pharmacokinetic profile and tumor specificity.

Dr. Andreas Goutopoulos, founder and CEO, brings over 25 years of pharmaceutical and biotech industry experience, including a track record of more than a dozen development candidates. His background includes over a decade of discovery leadership at EMD Serono, where he led medicinal chemistry. In his role as Entrepreneur-in-Residence (EIR) at M Ventures, he led the scientific efforts of and supported a number of oncology small molecule biotechs. At Actithera, he is pioneering a chemistry-driven, precision approach to RLTs by integrating novel covalent-targeting chemistries, rational drug design principles and an isotope-agnostic philosophy.

"We set out to bring structure-based and kinetics-driven thinking from small molecule drug design into the world of radiopharmaceuticals," said Dr. Andreas Goutopoulos. "This oversubscribed Series A, backed by a truly global and experienced investor syndicate, is strong validation of our approach. We engineer our radioconjugates for extended retention within tumors, making them ideally suited for longer-lived radionuclides and ultimately delivering more convenient dosing schedules and enhanced efficacy and safety for patients."

Karl Naegler, incoming Board member and Partner at Sofinnova Partners, noted: "Actithera is applying Big Pharma discipline to an emerging field with enormous potential. Its radioligand therapies represent a meaningful shift in oncology, with the opportunity to redefine the therapeutic index. We’re excited to support that vision."

Roger Franklin, incoming Board member and Partner at Hadean Ventures, added: "Actithera stands out as one of the most thoughtfully constructed radiopharma platforms we’ve seen, combining smart molecular design with a deep understanding of tumor biology and clinical need. The team’s work to align pharmacokinetics with therapeutic effect could transform how patients experience and benefit from radioligand therapies."

Therese Liechtenstein, incoming Board member and Investment Director at 4BIO Capital, added: "We are honored to support Actithera, whose molecules address key challenges in the nascent radioligand therapies space; a large therapeutic window through high tumor retention and low systemic exposure, applied to a lead program that has significant pan-tumor therapeutic potential."

Hakan Goker, current Chairman of Actithera, and Managing Director at M Ventures, said: "We are excited to see Actithera evolve from the one-person ideation we seeded with Andreas and Arkin to the transatlantic company it has become today. The innovative chemistry platform built and the first-in-class approach on FAP have the potential for a large impact in the RLT field and a significant benefit for patients. We welcome the new investor group and Board members to the company aligned with this bold vision of building the next generation of RLTs."

As part of the Series A financing, Roger Franklin, Partner at Hadean Ventures, Karl Naegler, Partner at Sofinnova Partners, Therese Liechtenstein, Investment Director at 4BIO Capital, and Debbie Dumont, Managing Partner at Bioqube Ventures will join the Actithera Board of Directors, including Noga Yerushalmi, Investment Director at M Ventures, who is currently on the Board.