On June 23, 2026 PharmaMar (MSE: PHM), reported that Merck (MRK.DE) has submitted a marketing application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Zepzelca (lurbinectedin) regarding the first line maintenance treatment of small cell lung cancer (SCLC). Merck´s New Drug Application (NDA) was granted priority review.

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In April 2025, PharmaMar and Merck announced an exclusive licensing agreement for the development and commercialization in Japan of lurbinectedin for the treatment of SCLC.

In addition, on March 19th, 2026, Japan’s MHLW designated lurbinectedin as an orphan drug, a category granted to drugs intended for the treatment of diseases affecting fewer than 50,000 patients and for which there is a particularly high unmet medical need.

Lurbinectedin in combination with atezolizumab has already been approved in Europe and in 14 other countries, including the United States, for first-line maintenance treatment of this disease.

(Press release, PharmaMar, JUN 23, 2026, View Source [SID1234668907])

On June 23, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the successful treatment with Alpha DaRT of the first glioblastoma patient in Israel, and the first ever outside of the United States, performed at Hadassah University Medical Center in Jerusalem. The procedure was carried out by a multidisciplinary team led by Prof. Yigal Shoshan, Professor of Neurosurgery at Hadassah University Medical Center. Using the Company’s proprietary brain applicator under real-time stereotactic neuro-navigation, Alpha DaRT sources were precisely delivered to the recurrent tumor through a single, minimally-invasive burr hole entry point into the brain. The procedure was completed safely and without unexpected complications.

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Glioblastoma (GBM) is the most common and most lethal primary brain tumor in adults, with approximately 160,000 new cases diagnosed globally each year. Following standard first-line treatment, typically consisting of a combination of surgery, radiation, and chemotherapy, recurrence is virtually inevitable, occurring in nearly all GBM patients within 6 to 9 months of initial treatment. It is at this stage that the disease becomes most unforgiving: median overall survival from the time of recurrence is only an additional 6 to 9 months, there is no standard of care, and the majority of patients are ineligible for repeat surgical resection – leaving them with severely limited therapeutic options. It is precisely this population, facing progression with nowhere left to turn, that Alpha DaRT aims to reach.

Uzi Sofer, CEO of Alpha Tau, stated: "Today’s announcement marks a significant milestone for Alpha Tau’s glioblastoma program: the first-ever treatment of a GBM patient outside of the United States, delivered at an institution as scientifically rigorous and globally respected as Hadassah. Israel is the birthplace of Alpha DaRT, and bringing this technology to Israeli brain tumor patients, patients who today have so few options, is a moment of deep pride and significance for our entire team."

Prof. Yigal Shoshan, Professor of Neurosurgery at Hadassah University Medical Center, stated: "I am proud that this first Israeli case has advanced the field not just by a geography, but by a genuine technical step forward. My involvement in Alpha DaRT for brain tumors began in the laboratory, through our preclinical study, in which we demonstrated that stereotactic implantation of Alpha DaRT sources in the swine brain was both safe and technically feasible. That work laid the scientific and procedural groundwork for today’s clinical milestone. The procedure was completed successfully, without unexpected complications, and represents an important proof of concept for how the flexibility of Alpha DaRT’s delivery system can be adapted to the complexity of individual brain tumor anatomy. The patient – male 77 years old, with recurrent glioblastoma following surgery and radiation therapy – tolerated the procedure well."

Dr. Robert Den, CMO of Alpha Tau, commented: "Treating a patient with glioblastoma who has no remaining standard of care – under a protocol designed precisely to reach that population – is exactly what this program is built for. The treatment of the first patient in Israel adds to the momentum of our multicenter US Recurrent GBM REGAIN trial, which is continuing to recruit patients swiftly following the fantastic interim results last month and the FDA clearance to proceed to full enrollment with the addition of two new leading U.S. academic centers. Together, these milestones are building a genuine clinical foundation for Alpha DaRT in one of oncology’s most challenging and underserved diseases. We look forward with genuine anticipation to learning from Prof. Shoshan and his team as this work progresses, and above all, we look forward to following this patient’s progress."

(Press release, Alpha Tau Medical, JUN 23, 2026, View Source [SID1234668904])

On June 23, 2026 Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, reported that the first patient has been dosed in a Phase Ib combination clinical trial evaluating VVD-214, an investigational oral inhibitor of Werner helicase (WRN). The study is evaluating VVD-214 in combination with bevacizumab in patients with microsatellite instability-high (MSI-high) or deficient mismatch repair (dMMR) colorectal cancer whose disease has progressed following prior lines of therapy.

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"Colorectal cancer remains one of the most common and challenging cancers to treat worldwide, and a substantial proportion of cases are driven by underlying defects in DNA repair," said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. "VVD-214 reflects Vividion’s continued focus on uncovering and advancing therapies against critical cancer dependencies that have historically been difficult to target, including WRN, with the potential to deliver new precision medicines that address this urgent need."

VVD-214 is an investigational oral small-molecule inhibitor of WRN, a DNA repair enzyme that has emerged as a highly sought-after synthetic lethal target for cancers with microsatellite instability. Tumors that are MSI-high or dMMR rely on WRN to maintain DNA replication and repair despite their underlying genomic instability. By inhibiting WRN, VVD-214 is intended to cause lethal DNA damage in cancer cells while minimizing harm to normal cells, offering a potential precision medicine approach for patients with cancers such as colorectal, endometrial, ovarian and gastric tumors.

"Advancing precision oncology therapies for cancers driven by specific molecular vulnerabilities is a key focus of Bayer’s oncology strategy," said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer’s Pharmaceuticals Division. "Targeting WRN represents a promising new therapeutic approach for genetically distinct subsets of some of the most common cancers worldwide, and we are encouraged to see VVD-214 continue to advance through clinical development."

The global Phase Ib clinical trial (NCT06004245) is planned to enroll patients at clinical sites across the U.S., Australia, Belgium, Canada, China, Denmark, France, Malaysia, South Korea, Spain, and the U.K. Preliminary data from the Phase Ia study presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting showed that VVD-214 was well tolerated with early signals of activity.

(Press release, Vividion Therapeutics, JUN 23, 2026, View Source [SID1234668896])

On June 23, 2026 AnHorn Medicines reported that its lead neuroprotective candidate AH-008, being developed for the prevention of chemotherapy-induced peripheral neuropathy (CIPN), has achieved two major regulatory milestones: Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) and Index Case designation by the Taiwan Center for Drug Evaluation (CDE).

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These milestones validate the scientific and translational strategy behind AH-008 and mark a significant step toward advancing a first-in-class preventive therapy for CIPN into clinical development.

Addressing a Critical Unmet Need in Oncology

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common and dose-limiting toxicities associated with widely used cancer treatments, including taxanes, platinum-based agents, vinca alkaloids, and antibody-drug conjugates (ADCs). CIPN can cause irreversible nerve damage, leading to pain, sensory dysfunction, and long-term impairment that severely impacts patients’ quality of life.

Beyond patient suffering, CIPN often forces chemotherapy dose reductions, delays, or discontinuation – compromising treatment outcomes. Despite its prevalence and burden, no approved therapies currently exist to prevent CIPN, highlighting a major unmet need in oncology supportive care.

Regulatory Milestones: IND Clearance and Index Case Designation

The U.S. FDA IND clearance authorizes AH-008 to advance into human clinical trials, following a comprehensive review of its preclinical pharmacology, toxicology, and manufacturing data. This clearance affirms the robustness of the program’s safety package and development strategy.

The Taiwan CDE Index Case designation recognizes AH-008 as a reference program for novel drug development in its category. This designation reflects the candidate’s scientific innovation and potential to address an unmet clinical need, while facilitating efficient regulatory interaction and advancement of innovative therapies.

Together, these milestones demonstrate strong regulatory alignment across major agencies and reinforce the translational strength of the AH-008 program.

Regulatory and Translational Validation

Preclinical studies for AH-008 were designed in accordance with the U.S. FDA Draft Guidance (January 2025), "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." This guidance outlines FDA expectations for CIPN preventive therapies, emphasizing the use of clinically relevant neurotoxicity models and translational endpoints that connect nerve protection to meaningful functional outcomes.

AH-008 consistently demonstrated robust neuroprotective effects across multiple chemotherapy-induced neuropathy models, preserving peripheral nerve integrity while maintaining chemotherapy efficacy. These prevention-first studies were designed to halt the onset of neuropathy rather than treating established symptoms, underscoring AH-008’s potential as a proactive therapeutic approach.

Coupled with U.S. FDA IND clearance, these data validate AH-008 as a first-in-class neuroprotective candidate ready for clinical evaluation under current regulatory expectations.

Rapid Translation from Preclinical to IND

AnHorn Medicines advanced AH-008 from preclinical stage to FDA IND clearance in just 12 months, underscoring the company’s integrated development capabilities. This accelerated timeline reflects AnHorn’s ability to unify translational science, regulatory strategy, and CMC development into a streamlined execution framework—demonstrating its strength in efficiently advancing first-in-class programs that address urgent unmet medical needs.

About AH-008

AH-008 is a first-in-class neuroprotective therapeutic candidate designed to prevent chemotherapy-induced peripheral neuropathy by targeting the underlying mechanisms of chemotherapy-related nerve damage. Unlike symptomatic treatments, AH-008 intervenes early in the disease cascade to preserve peripheral nerve function during cancer therapy.

(Press release, AnHorn Medicines, JUN 23, 2026, View Source [SID1234668851])

On June 22, 2026 Oxford BioTherapeutics ("OBT"), a clinical-stage oncology company specialising in proteomics-driven target discovery for antibody-based therapies enabled by its OGAP-Verify platform, reported two new clinical milestones with Boehringer Ingelheim-partnered programmes, BI 3820768 (OB33) and obrixtamig (OBT620).

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BI 3820768 is the third programme from OBT’s multi-target collaboration with Boehringer Ingelheim to achieve first-patient dosing (A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours) – NCT07306559), triggering a milestone payment to OBT. The BI 3820768 target was identified using OBT’s proprietary OGAP-Verify platform and represents the second development milestone for this programme, following the initiation of IND-enabling studies one year earlier.

Further illustrating the strength and maturity of the collaboration, OBT also highlighted the advancement of obrixtamig (OBT620), an investigational DLL3-targeting bispecific T-cell engager originating from its discovery platform. Obrixtamig has entered global Phase 3 development in two trials: DAREON-Lung-1 is investigating obrixtamig in combination with chemotherapy and atezolizumab versus chemotherapy and atezolizumab in previously untreated extensive-stage small cell lung cancer, where the first patients have recently been dosed. DAREON-NEC-1 is evaluating obrixtamig in combination with chemotherapy versus chemotherapy alone as first-line treatment for patients with DLL3-positive unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma. A second Boehringer Ingelheim-partnered programme from OBT’s work, the investigational B7-H6-targeting T-cell engager BI 765049, is also in clinical development for advanced solid tumours.

DLL3 was originally identified by OBT using its OGAP-Verify platform as a tumour-selective T-cell engager target. The antigen is expressed in approximately 80–85% of small cell lung cancer and certain neuroendocrine carcinomas, supporting its potential as a promising therapeutic target in aggressive cancers with high unmet need.

The collaboration began in 2013 and was subsequently expanded in 2020 and 2023. OBT has applied its OGAP-Verify platform to identify novel oncology targets in solid tumours. The partnership has generated multiple development-stage assets, including three clinical programmes and a fourth target optioned in January 2025.

Christian Rohlff, PhD, Chief Executive Officer of OBT, said: "Establishing another clinical-stage programme with BI 3820768 further validates the robustness of our OGAP-Verify discovery platform and the quality of the oncology targets it delivers. The fact that three of the four programmes optioned by Boehringer Ingelheim have now entered the clinic underscores the strength and productivity of this longstanding collaboration. In parallel, the advancement of obrixtamig into Phase 3 highlights the long-term value-creation potential of our platform and our ability to translate novel targets into clinically advanced therapies for patients with high unmet need."

Vittoria Zinzalla, Global Head of Experimental Medicine at Boehringer Ingelheim, said: "Our long-standing collaboration with Oxford BioTherapeutics demonstrates the value of linking complementary scientific expertise to transform outcomes for people living with difficult-to-treat cancers. By combining OBT’s strength in target discovery with our expertise in therapeutic antibody development, we connect insights across the R&D continuum, advancing differentiated treatment approaches while strengthening a more efficient and connected oncology ecosystem to create unprecedented impact."

OBT’s OGAP-Verify platform enables highly sensitive and precise target identification, supporting the development of differentiated antibody-based therapies and the successful progression of multiple programmes into clinical development.

Under the collaboration, Boehringer Ingelheim is responsible for global development and commercialisation of all programmes.

(Press release, Oxford BioTherapeutics, JUN 22, 2026, View Source [SID1234668903])