On June 23, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO100, the Company’s lead candidate, an intranasally administered formulation of purified perillyl alcohol designed for non-invasive nose-to-brain delivery. The authorization covers the Company’s NEO100-01, NEO100-02, and NEO100-03 protocols across Phase 1, Phase 1b, and Phase 2 studies in adults, together with pediatric studies authorized for Phase 1 and Phase 1b pending further protocol review. The authorized indication is progressive or recurrent Grade III or IV gliomas.

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The breadth of the UAE authorization, spanning three protocols and adult studies from Phase 1 through Phase 2 alongside a defined pediatric pathway, is intended to allow NeOnc to advance multiple stages of clinical development in parallel. The authorization follows the DOH’s recent IND clearance for the Company’s NEO212 program, announced in June 2026, and extends NeOnc’s clinical development footprint in the UAE across both of its lead platforms, the intranasal delivery platform represented by NEO100 and the drug-conjugation platform represented by NEO212.

In the United States, NEO100 has received FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, and its lead clinical study, the NEO100-01 Phase 2a trial in recurrent IDH1-mutant high-grade glioma, is fully enrolled.

The Company expects to report top-line data from the fully enrolled NEO100-01 Phase 2a trial by the end of July 2026, representing what NeOnc believes may be one of the most important clinical milestones in the Company’s history. Based on the strength of the data observed to date and ongoing interactions with regulators, NeOnc believes the upcoming results may support one or more important regulatory pathways, including potential Breakthrough Therapy designation, expansion of existing Fast Track benefits, and enhanced development opportunities under the program’s existing Orphan Drug designation. While no assurance can be given regarding regulatory outcomes, the Company believes the upcoming data represent a significant milestone in the continued development of NEO100.

"This authorization is significant because it comes at a pivotal moment for NeOnc and the NEO100 program," said Amir Heshmatpour, Chief Executive Officer, Executive Chairman and President of NeOnc. "NEO100 has already received FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, and we are now approaching what we believe could be one of the most important clinical milestones in our Company’s history. We anticipate reporting top-line Phase 2a data by the end of July and believe those results may position NEO100 for additional regulatory opportunities, including potential Breakthrough Therapy designation. If the data continue to reflect the encouraging trends observed to date, we believe NEO100 has the potential to meaningfully alter the treatment paradigm for patients suffering from recurrent high-grade gliomas. While regulatory decisions are ultimately made by the FDA, we are encouraged by the progress of the program and remain focused on bringing a non-invasive treatment option to patients facing devastating brain cancers. Our objective is not simply to advance another oncology drug candidate, but to establish a new paradigm for non-invasive delivery of therapeutics to the brain, potentially changing how CNS diseases are treated worldwide."

"NEO100 uses intranasal delivery to reach the brain directly, a practical route that circumvents the blood-brain barrier without surgery or systemic chemotherapy," said Thomas Chen, MD, Ph.D., Founder, Chief Medical Officer and Chief Scientific Officer of NeOnc. "Because it is non-invasive, this approach can enable studies in difficult groups, including children with high-grade gliomas that have few options today. An authorization spanning Phase 1 through Phase 2 with a pediatric pathway lets us pursue that work where it is needed most."

The upcoming Phase 2a readout represents the first controlled evaluation of NEO100 in recurrent IDH1-mutant high-grade glioma following encouraging earlier clinical observations. If the study meets its objectives, NeOnc believes the data could support discussions with regulators regarding accelerated development pathways and potentially serve as the foundation for future registrational planning.

High-grade gliomas, including WHO Grade III and IV disease, are among the most aggressive brain cancers, with limited treatment options after recurrence. The Company expects to work with healthcare institutions, investigators, and regulatory authorities in the UAE as clinical development activities advance.

The UAE authorization further positions NeOnc to rapidly expand clinical development activities internationally as the Company prepares for multiple anticipated regulatory and clinical milestones throughout the second half of 2026.

(Press release, Neonc, JUN 23, 2026, View Source [SID1234668924])

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 23, 2026 Verastem presented its corporate presentation.

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(Presentation, Verastem, JUN 23, 2026, View Source [SID1234668909])

On June 23, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported that it has received formal approval from Germany’s Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) to initiate its planned Phase 2/3 clinical trial of SIL204, the Company’s lead small interfering RNA (siRNA) product candidate, in patients with locally advanced pancreatic cancer (LAPC). The trial has been approved without conditions, with both Part I and Part II of the assessment determined to be justifiable, following the positive opinion of the Ethics Committee of the North Rhine Medical Association regarding the conduct of the trial in Germany.

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The decision was issued under Articles 5 and 8 of EU Regulation No. 536/2014 in conjunction with the German Medicines Act (AMG), with Germany serving as the Reporting Member State (rMS) leading the scientific assessment of the trial under the EU Clinical Trials Regulation. The approval follows the Company’s April 2026 submission of its Clinical Trial Application (CTA) through the EU Clinical Trials Information System (CTIS), which was informed by the positive written Scientific Advice from BfArM received in December 2025, the previously announced completion of two-species toxicology studies confirming no systemic organ toxicity, and the Company’s broader preclinical package. The decision also builds on the March 24, 2026 approval from the Israeli Ministry of Health, which authorized initiation of the same Phase 2/3 trial in Israel. With the assessment in Germany complete, Silexion is now positioned to potentially expand its Phase 2/3 program across additional EU member states under the harmonized CTIS framework.

"With this BfArM approval, Silexion has now secured clinical trial authorizations in the two leading regulatory jurisdictions where we sought to initiate the Phase 2/3 trial of SIL204," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Germany is widely regarded as one of the most rigorous regulatory environments globally, and an unconditional approval as Reporting Member State under the EU Clinical Trials Regulation is, for us, a strong external validation of the SIL204 preclinical and safety package and a meaningful endorsement of the trial design we developed in close engagement with the agency. With Israeli and German authorizations now in hand, our focus shifts entirely to clinical execution, and we expect to dose our first patient in the coming weeks at one of the activated sites in Israel or Germany."

With both regulatory authorizations now obtained, Silexion is finalizing site activation procedures at participating medical centers in Israel and Germany, including the contracting and budget arrangements customary for multi-site international trials of this scale. The Company expects first-patient dosing to occur in the coming weeks, with the initial dosing site to be determined by the timing of site activation across the participating centers. Site activation in Israel is led by Sheba Medical Center and Tel Aviv Sourasky Medical Center, both of which previously received local ethics approvals for the trial, with leading German oncology centers being brought into the program under the EU CTIS framework.

The Phase 2/3 trial is designed to evaluate SIL204 in combination with standard-of-care chemotherapy in patients with LAPC, using Silexion’s innovative dual-route administration strategy – combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate below 13%, and more than 80% of pancreatic cancer mortality driven by metastatic disease. KRAS mutations are present in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 30–35% of lung adenocarcinomas, representing one of the largest and most persistent unmet needs in oncology.

(Press release, Silexion Therapeutics, JUN 23, 2026, View Source [SID1234668925])

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 [SID1234668910])