On July 9, 2025 Radiant Biotherapeutics, a biotechnology company committed to advancing and delivering transformative MULTi-specific, multi-Affinity antiBODY (Multabody) therapeutics for patients with cancer and autoimmune diseases, reported the appointments of seasoned biotechnology executive Deborah Geraghty, Ph.D., as President and Chief Executive Officer, entrepreneur and venture investor Stefan Larson, Ph.D., as Chair of the Board of Directors, and distinguished physician-scientist Ingmar Bruns, M.D., Ph.D., as Board Member (Press release, Radiant Biotherapeutics, JUL 9, 2025, View Source [SID1234654320]).

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Stefan Larson, Ph.D., incoming Chair of Radiant Biotherapeutics, commented: "Dr. Geraghty brings a proven track record of building and transforming innovative biotechnology companies and we are delighted to welcome her to Radiant. Her deep industry expertise and strategic vision make her the ideal CEO to lead Radiant through this next phase of growth as we advance our lead clinical candidate, a 4-1BB agonist, toward clinical trials and expand our preclinical pipeline more broadly across oncology and autoimmunity."

Dion Madsen, outgoing Chair and continuing Board Member of Radiant Biotherapeutics, noted: "We are thrilled to welcome Stefan and Ingmar to our board of directors as we move towards the clinic with our lead program. The addition of Dr. Larson and Dr. Bruns brings relevant expertise necessary for us to successfully deliver our next-generation biologics to patients with cancer and autoimmune diseases. We appreciate Arthur Fratamico’s leadership and foundational contributions to the Company during his four-year tenure as CEO."

These appointments follow the company’s successful $35 million Series A financing and build upon the recent progress by founding Chief Scientific Officer, Jo Hulme, Ph.D. Multabody, Radiant’s proprietary, best-in-class antibody platform, leverages remarkable avidity on intended targets while exploiting specificity to address multiple epitopes and different disease-modifying proteins. Antibodies developed using the Radiant platform are designed to deliver exceptional potency against both solid tumors and blood cancers, immunological targets, and infectious disease pathogens.

Deborah Geraghty, Ph.D., President and Chief Executive Officer of Radiant Biotherapeutics, added: "What drew me to this role are the compelling preclinical data based on the strong scientific foundation of Radiant’s unique biologic platform and the team that shepherded it this far. The opportunity to drive innovation for patients and realize the value of its application for devastating cancer and autoimmune diseases is energizing and I look forward to bringing these breakthrough therapies into the clinic."

Deborah Geraghty, Ph.D., is an accomplished life sciences executive with over 20 years of experience having built a strong foundation of financial, operational and strategic expertise throughout her career leading innovative biopharmaceutical companies. She most recently served as President and CEO of Anokion SA, a Phase 2 clinical-stage Swiss biotech company focused on developing a new class of immune tolerance therapies for autoimmune disease. Prior to that, she was Senior Vice President of Corporate Strategy at Dimension Therapeutics, where she led Dimension’s initial public offering and subsequent acquisition by Ultragenyx in 2017. Her earlier roles include co-founder and Vice President of Project and Portfolio Development at Cydan Development and leadership positions at Aileron Therapeutics as Head of Portfolio Advancement and Infinity Pharmaceuticals as Director of New Product Marketing. Dr. Geraghty holds a B.S. in Biology from Union College, an MBA from Boston College, and a Ph.D. in Molecular Biology from the University of Vermont.

Stefan Larson, Ph.D., is a Venture Partner at Sectoral Asset Management and serves on several biotech boards including Prilenia Therapeutics, Apnimed, and Stratus Therapeutics. He previously was an Entrepreneur-in-Residence and later Venture Partner at Versant Ventures, where he led the establishment of their Toronto-based Discovery Engine and served as founding CEO of Northern Biologics. Dr. Larson co-founded two medical device companies, Perimeter Medical Imaging and Tornado Spectral Systems, and began his career at McKinsey & Company. He holds a B.Sc. in Biology from McGill University, an M.Sc. in Molecular and Medical Genetics from University of Toronto, and a Ph.D. in Biophysics from Stanford University.

Ingmar Bruns, M.D., Ph.D., is a physician-scientist with two decades of hematology and oncology expertise who currently serves as Chief Medical Officer of Zentalis. He previously served as Chief Medical Officer of Trillium Therapeutics through its acquisition by Pfizer, then held senior clinical development roles at Pfizer, including head of the hematologic malignancies franchise. Earlier positions include Senior Vice President and Head of Clinical Development at Pieris Pharmaceuticals and clinical development leadership at Bayer Pharmaceuticals. Dr. Bruns served as an attending hematologist and oncologist as well as a physician-scientist at the University Hospital of Dusseldorf and Albert Einstein College of Medicine. He has authored over 50 publications in leading journals and holds an M.D. and Ph.D. from the University of Lubeck in Germany.

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 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 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 8, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported a landmark study published in Scientific Reports, a Nature journal, demonstrating the accuracy and clinical utility of the Caris Assure blood-based biopsy assay across the cancer continuum (Press release, Caris Life Sciences, JUL 8, 2025, View Source [SID1234654291]).

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The Caris Assure platform is a breakthrough single assay that combines comprehensive, highly sophisticated molecular profiling of all 23,000+ genes across DNA and RNA in plasma, setting a new blood-based testing standard and revolutionizing management of the cancer care journey. Additionally, Caris sequences DNA in the "buffy coat," the layer of centrifuged blood between the red blood cells and plasma, which contains white blood cells and platelets. Caris Assure combines Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) with advanced machine learning on a single platform. Caris Assure is currently used for therapy selection and is capable of enabling accurate early detection and highly sensitive disease monitoring.

"We designed Caris Assure to be more than a liquid biopsy test. This assay takes advantage of advanced sequencing and computing technology to capture genetic information available from the whole exome and whole transcriptome from the tumor material circulating in the blood and DNA from the patient’s white blood cells," said David Spetzler, MS, PhD, MBA, President of Caris. "This enables us to provide a very comprehensive individualized picture of a patient’s specific disease state. This is the first time so much molecular information has been available from a single blood test, allowing for increased accuracy and additional insights to inform physicians in helping to make cancer care decisions."

The Caris Assure liquid biopsy platform, powered by the Assure Blood-based Cancer Detection AI (ABCDai), was trained on over 376,000 whole exome and whole transcriptome tissue profiles and over 7,000 matched blood and tissue samples. In addition to therapy selection, the study validates the performance of Caris Assure in:

Multi-Cancer Early Detection (MCED): Achieved sensitivities of 83.1% to 95.7% across cancer stages I–IV at 99.6% specificity.
Diagnostic Pathway Predictor: Accurately identified the diagnostic pathway for MCED-positive cancers using the ABCDai-GPS model.
MRD and Recurrence Monitoring: Demonstrated significant predictive power for recurrence, with hazard ratios of 33.4 (p < 0.005) for MRD and 4.39 (p = 0.008) for therapeutic monitoring.
Caris Assure does not require a prior tissue biopsy. Instead, its AI model identifies tumor-derived signals based on patterns learned from hundreds of thousands of tumors. This enables a tissue-agnostic, highly sensitive approach to cancer detection and monitoring.

While Caris Assure is currently commercially available for therapy selection in advanced cancers, this study lays the groundwork for expanding into early detection, MRD and therapeutic monitoring. Caris is actively pursuing reimbursement and regulatory pathways to bring these applications to market.

"This is more than a validation study; it is a blueprint for the future of cancer diagnostics," added Spetzler. "Our goal is to create a seamless ecosystem where patients and clinicians can rely on one platform throughout the entire cancer journey."