On October 7, 2025 Eradivir Inc., a clinical-stage biotechnology company that harnesses the power of the immune system to target and treat disease, reported the recent closing of a $10 million private financing round (Press release, Eradivir, OCT 7, 2025, View Source [SID1234656498]). The investment will support continued clinical development of the company’s lead antiviral therapeutic for influenza, EV25, and advancement of a second molecule, EV148, for the treatment of respiratory syncytial virus (RSV).

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A significant amount of the $10 million raised came from previous investors, reflecting their continued confidence in Eradivir’s platform and vision.

"The funding marks a pivotal moment for Eradivir as we prepare to share EV25 Phase 2a results and underscores the confidence investors have in our ability to build out our toolkit of small molecule immunotherapies," said Martin Low, Chief Executive Officer of Eradivir. "We’ve minimized dilution by raising our first $30 million in milestone-based tranches. This disciplined financing strategy has preserved shareholder value while driving meaningful progress in our lead programs."

The funds have been used to complete the EV25 Phase 2a influenza challenge study and will also support IND-enabling studies of Eradivir’s RSV development candidate, EV148. The results from the EV25 Phase 2a challenge study will be publicly released in the coming weeks.

EV25 and EV148 were built on Eradivir’s BAiT (Bispecific Antigenic immuno-Therapy) platform that combines the simplicity of small molecules with the efficacy of antibodies. The simplicity of the platform’s technology provides the opportunity to address multiple diseases, including additional viruses and cancer, by switching the targeting ligand to another that binds specifically to a pathological cell.

On October 7, 2025 Daiichi Sankyo (TSE: 4568) reported it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab for the treatment of patients with HER2 positive unresectable or recurrent breast cancer.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

HER2 targeted therapies have improved outcomes in HER2 positive metastatic breast cancer; however, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with taxane, trastuzumab and pertuzumab (THP), which has been the standard of care for more than a decade.

The sNDA is based on data from the DESTINY-Breast09 phase 3 trial presented during a special latebreaking oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting.

"In DESTINY-Breast09, ENHERTU plus pertuzumab demonstrated a median progression-free survival of more than three years, which represents an impressive improvement over the current standard of care," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "Following the recent approval of ENHERTU in Japan for the treatment of HER2 low or HER2 ultralow metastatic breast cancer, this new submission of ENHERTU plus pertuzumab for the first-line treatment of patients with HER2 positive disease underscores the commitment of Daiichi Sankyo to bring ENHERTU to as many patients as possible in this region across certain subtypes of metastatic breast cancer."

A supplemental Biologics License Application for ENHERTU plus pertuzumab based on data from DESTINY-Breast09 was granted Priority Review in the U.S. under the Real-Time Oncology Review program. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in July 2025.

About DESTINY-Breast09

DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is progression-free survival (PFS) as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America, and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Metastatic Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.5 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.5 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed and 17,600 deaths in 2022. 6 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or progress to metastatic disease are expected to live five years following diagnosis.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.8 HER2 protein overexpression may occur as a result of HER2 gene amplification.1 Approximately one in five cases of breast cancer are considered HER2 positive.9 3 HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.10 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.1,2,3,4 Further, approximately 25% to 30% of patients do not receive any treatment following first-line therapy due to discontinuation or death.

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, OCT 7, 2025, View Source [SID1234665027])

On October 7, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that the independent Data Safety Monitoring Board (DSMB) has completed the second pre-planned safety interim analysis of the ongoing PHOEBUS trial, a Phase 2b randomized controlled trial designed to be pivotal, evaluate the efficacy and safety of MaaT033 versus placebo in patients undergoing an Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) (Press release, MaaT Pharma, OCT 7, 2025, View Source [SID1234656483]). The PHOEBUS trial is the world’s largest randomized controlled trial evaluating microbiome therapy in oncology to date.

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"We are pleased to report another positive safety review for MaaT033 with the DSMB’s recommendation to continue the trial without modification marking a key milestone in its development. We remain fully committed to advancing this Phase 2b trial and to delivering a much-needed therapeutic option for patients fighting blood cancers and undergoing allo-HSCT and to shaping a future where microbiome-based therapies become an integral part of hematology-oncology treatment," said Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma.

The DSMB reviewed unblinded safety data on 120 enrolled patients (including 60 patients randomized to receive MaaT033) and monitored patients for 90 days after allo-HSCT as per the trial protocol. Patients are especially vulnerable in the early phase after allo-HSCT, with a heightened risk of non-relapse mortality. To ensure patient safety, the study protocol includes a predefined safety review, with a stopping rule if an excess of mortality is detected in the experimental group.

Following its review, the DSMB recommended that the study continue as planned, having identified no safety concerns and no excessive mortality related to MaaT033 as of today.

In addition to this specific safety analysis, routine safety assessments are conducted every six months. All assessments to date have confirmed a favorable safety profile for MaaT033, and recommended continuation of the trial without modifications. These regular safety reviews further support MaaT033’s integration in the allo-HSCT treatment setting, without significant added risk of severe adverse events.

Patient enrollment for the PHOEBUS trial is ongoing in France, Germany, Belgium, Spain, Netherlands and the United Kingdom. The trial is expected to enroll 387 patients and is set to be conducted in up to 60 clinical investigational sites (NCT05762211). Next steps include the routine DSMB review for ongoing safety for MaaT033, conducted every six months, with the next analysis expected for the first quarter of 2026.

MaaT033 is designed to reach an expanded patient population through its oral capsule administration that could address approximately 6.000 patients per year, with an estimated potential market of €500 million (EU5, US). By enabling outpatient use, MaaT033 also supports optimized patient care.

About MaaT033

MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

On October 7, 2025 Kincell Bio, a leading US cell therapy CDMO, reported a partnership with Moonlight Bio, Inc., a Seattle-based biotech company pioneering advanced T cell therapies for solid tumors (Press release, Moonlight Bio, OCT 7, 2025, View Source [SID1234656499]). In this partnership, Kincell provides CMC development and GMP manufacturing services to advance Moonlight’s lead T cell therapy program into clinic trials.

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Under the agreement, Kincell is providing process and analytical transfer and GMP manufacturing services to support the scale-up and clinical supply of Moonlight’s lead T cell therapy product. The collaboration between Moonlight and Kincell is designed to accelerate clinical supply and meet the needs of patients, advancing Kincell’s mission to support innovators in the rapidly growing cell therapy sector.

"At Moonlight, we are dedicated to delivering T cell therapies that address barriers obstructing successful outcomes in solid tumors – the vast majority of the global cancer disease burden," said Jordan Jarjour, PhD, Moonlight’s CSO. "We are very excited to collaborate with Kincell to advance our lead program into the clinic."

"I am excited to partner with the team at Moonlight as they develop an innovative cell therapy that has the potential to make a significant impact on patient disease burden. Kincell has a strong and agile team that thrives on finding technical solutions to deliver for our clients and their patients," said Bruce Thompson, PhD.

"We are thrilled to partner with Moonlight, a technology leading cell therapy innovator," said Mark Bamforth. "Kincell excels at finding solutions for CMC development and clinical supply for product innovators, and we are demonstrating these capabilities for Moonlight’s clinical trial."

Kincell provides industry-leading process and analytical development, and early clinical and late-stage clinical and commercial cGMP manufacturing capabilities that are serving the needs of biotech and pharmaceutical companies and is committed to advancing the field of cell therapy with tailored solutions that empower innovators to bring their therapies to market efficiently and effectively.

On October 7, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the completion of the Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma") acquisition (Press release, Merck & Co, OCT 7, 2025, View Source [SID1234656484]). Verona Pharma is now a wholly-owned subsidiary of Merck and the American Depositary Shares (ADS) of Verona Pharma will no longer be listed or traded on the Nasdaq Global Market.

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"The Verona Pharma acquisition strengthens and complements our portfolio of treatments for patients with cardio-pulmonary diseases to include Ohtuvayre, while delivering near and long-term growth as well as value for shareholders," said Robert M. Davis, chairman and chief executive officer, Merck. "The addition of Ohtuvayre is another strong example of our business development strategy, which focuses on opportunities where compelling science and value align. Ohtuvayre is a novel, first-in-class maintenance treatment targeting an important unmet need for adult patients with COPD. We look forward to applying our commercial capabilities and working with our talented new colleagues from Verona Pharma to build on the strong uptake and performance to date to reach even more patients with this important medicine."

Through this acquisition Merck has added 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 maintenance 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.

Additional Transaction Details
Under the terms of the acquisition agreement, Merck, through a subsidiary, has acquired all outstanding shares of Verona Pharma for $107 per ADS, each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately $10 billion.

As previously disclosed, the acquisition 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). The transaction is expected to negatively impact non-GAAP EPS by approximately $0.16 in the first 12 months, representing costs associated with financing the transaction partially offset by Ohtuvayre performance.

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. More than 390 million people were estimated to be suffering 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.