On June 1, 2026 Servier reported promising new Phase 1 clinical data for Emi-Le, an investigational antibody drug conjugate (ADC) directed against B7-H4, during an oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago, Illinois.

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Emi-Le is an advanced engineered ADC that is directed against B7-H4, an immune checkpoint protein that is highly expressed in ACC along with several other cancers. As part of an ongoing Phase 1 trial, a dose escalation and backfill cohort enrolled adult patients with advanced or metastatic solid tumors (n=180), including those with ACC (n=48) defined by an aggressive clinicopathologic phenotype and/or molecular features consistent with poor prognosis.

"Emi-Le represents a novel, targeted therapeutic approach for patients who suffer from recurrent, advanced or metastatic ACC. The recent FDA Breakthrough Designation further validates the critical unmet need for a targeted systemic therapy to address the challenging effects of this disease for affected individuals," said Elly Barry, MD, Chief Medical Officer, Day One Biopharmaceuticals, now part of Servier Group. "These encouraging data at ASCO (Free ASCO Whitepaper) indicate strong promise to support a population distinctly in need of effective therapies and will help inform the pivotal Phase 2 study we will undertake in a larger set of participants."

The analysis presented at ASCO (Free ASCO Whitepaper) found:

Emi-Le was well-tolerated demonstrating a distinct and potentially differentiated emerging safety profile:
Most treatment-related adverse events (TRAEs) were transient laboratory-based and/or low-grade. The most common TRAEs were transient AST increase (56%) generally asymptomatic and reversible proteinuria (54%), predominantly low-grade fatigue (42%) and nausea (33%).
The only Grade 3 TRAEs in ≥10% of pts were transient AST increase (20%) and proteinuria (23%). No Grade 4 or 5 TRAEs reported.
TRAEs leading to treatment discontinuation occurred in 3.9% of patients and no treatment-related deaths were reported.
Promising signals of efficacy among 45 evaluable participants with ACC.
Objective response rate (ORR) was 35.6%, including one complete response.
Disease control rate was 82.2%.
Further, a post-hoc analysis was conducted in a more clearly defined aggressive ACC subtype reflecting clinical features used in practice by clinicians and pathologists, including solid histology or high-grade transformation. This analysis (n=32 evaluable participants) reported promising signals:
Consistent tumor shrinkage, with an ORR of 46.9%, DCR of 81.3% and median PFS of 7.8 months.
"These data provide important insights into the use of a targeted ADC for the difficult-to-treat rare cancer ACC, most notably demonstrating favorable tolerability and a potentially differentiated safety profile," said Glenn J. Hanna, M.D., study investigator and Director, Center for Cancer Therapeutic Innovation at Dana Farber Cancer Institute. "The encouraging anti-tumor activity observed to date supports continued investigation of this program, particularly given the poor prognosis for patients with ACC and the lack of approved or preferred systemic therapies in the advanced or metastatic setting. If confirmed in further studies, this profile could potentially represent a paradigm shift in treatment."

(Press release, Servier, JUN 1, 2026, View Source [SID1234666328])

On June 1, 2026 Qurient Co., Ltd. (KRX: 115180) reported that the first patient has been dosed in a Phase 2 clinical study evaluating mocaciclib (Q901) in combination with fulvestrant for treatment of hormone receptor-positive (HR+) breast cancer. The trial specifically targets patients who have stopped responding to prior treatments containing CDK4/6 inhibitors. Mocaciclib is a highly selective and potent covalent inhibitor of cyclin-dependent kinase 7 (CDK7), developed to address significant unmet medical needs in advanced solid tumors, including treatment-resistant breast cancer.

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The dosing of the first patient with CDK4/6 inhibitor-resistant HR+ breast cancer marks a significant milestone in development of mocaciclib as a new therapeutic option. While CDK4/6 inhibitors combined with endocrine therapy have proven highly effective for treatment of HR-positive, HER2-negative metastatic breast cancer, many patients eventually experience disease progression due to innate non-responsiveness or acquired resistance. Mocaciclib is being investigated as a targeted solution to overcome the refractory conditions through cell cycle control and transcriptional regulation of key refractory mechanisms, such as PTEN-PI3K/AKT pathway activation.

"Dosing the first HR-positive breast cancer patient with mocaciclib is an important step forward in our mission to provide new therapeutic options for patients who have exhausted standard-of-care treatments," said Kiyean Nam, Ph.D., Chief Executive Officer of Qurient. "Because of its unique mechanism of action in cell cycle control and transcriptional regulation, mocaciclib holds promise for patients whose tumors have developed bypass mechanisms to evade CDK4/6 inhibition. We are highly encouraged by our latest findings in CDK7 biology and look forward to translating this science into meaningful clinical outcomes."

Mechanism of Action Rationale in HR+ Breast Cancer

Mocaciclib (Q901) provides a novel therapeutic strategy for HR+ breast cancer by targeting CDK7, a dual-function kinase essential for both cell cycle progression and transcriptional regulation:

Master Regulation of the Cell Cycle (CAK Inhibition): CDK7 acts as the CDK-activating kinase (CAK), responsible for phosphorylating the T-loop of other key cell cycle kinases, including CDK1, CDK2, CDK4, and CDK6. In HR+ breast cancer, resistance to CDK4/6 inhibitors frequently occurs through the loss of retinoblastoma (RB) protein function or the over-activation of the Cyclin E-CDK2 axis. This allows cancer cells to bypass the CDK4/6 blockade and re-enter the S-phase of division. By potently inhibiting CDK7, mocaciclib suppresses the activation of CDK2 and other downstream kinases, effectively shutting down these alternative escape routes and halting tumor proliferation.
Targeted Transcriptional Repression: Beyond cell cycle control, CDK7 is a core component of the transcription factor II H (TFIIH) complex. Mocaciclib selectively disrupts the transcription of heavily relied-upon oncogenic transcription factors (such as MYC and E2F) and suppresses the expression of genes that are activated by the PTEN-PI3K/AKT pathway, effectively neutralizing another mechanism of CDK4/6 inhibitor resistance.
About Mocaciclib (Q901)

Mocaciclib (Q901) is an intravenously administered, highly selective covalent CDK7 inhibitor currently advancing through Phase 1/2 clinical trials (NCT05394103). In addition to its potential as a monotherapy in HR+ breast cancer and other advanced solid tumors, mocaciclib has demonstrated profound synergy in preclinical models when used in combination with Topoisomerase 1 inhibitor-based antibody-drug conjugates (TOP1i-ADCs) and immune checkpoint inhibitors.

(Press release, Qurient Therapeutics, JUN 1, 2026, View Source [SID1234666344])

On June 1, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported the presentation of a poster "Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)" on May 30 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 annual meeting, taking place in Chicago, Illinois.

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APR-1051 is an orally bioavailable, potent, and selective small molecule WEE1 inhibitor with in vivo anti-tumor activity in several cancer models. It exhibits low off-target inhibition of PLK kinases (PLK1, PLK2, PLK3), a property that differentiates it from prior WEE1 inhibitors and may contribute to an improved safety profile. ACESOT-1051 is the ongoing first-in-human Phase 1 study evaluating once-daily APR-1051 in advanced solid tumors harboring cancer-associated gene alterations.

"We are pleased to have the opportunity to present the updated ACESOT-1051 data to the oncology community at this year’s ASCO (Free ASCO Whitepaper) meeting," said Gene Kennedy, M.D., Chief Medical Advisor of Aprea. "The partial responses and disease stabilizations we have observed in this heavily pretreated, biomarker-selected patient population reinforce our confidence in APR-1051’s differentiated profile and the potential of our precision medicine strategy. With enrollment now expanding into uterine serous carcinoma and platinum-resistant ovarian cancer, dose escalation and backfill expansion is on track to complete in the second quarter of 2027. Importantly, we believe that we are on a clear path to generating the data that will demonstrate APR-1051’s potential."

ACESOT-1051: A Biomarker-Focused, Phase 1 Trial of Oral WEE1 Inhibitor, APR-1051

The poster (Abstract #3107) provides an updated summary of ACESOT-1051 with a data cutoff of May 6, 2026. Key highlights from the presentation include:

Study objectives: The primary objective is to characterize the safety profile, dose-limiting toxicity (DLT), maximum tolerated dose or maximum administered dose, and recommended Phase 2 dose (RP2D) of APR-1051. Secondary objectives include characterization of the PK of APR-1051 and assessment of preliminary efficacy of APR-1051
Clinical activity: Two patients with endometrial cancers have achieved partial responses ("PR"). Six additional patients achieved stable disease, including those with colorectal cancer, HPV+ head and neck squamous cell carcinoma, and endometrial cancer.
Tolerability: APR-1051 has been well tolerated across all dose levels. Treatment-related adverse events were reported in 54% of patients, with nausea (36%) and fatigue (14%) the most common, nearly all Grade 1 or 2.
Pharmacokinetics: APR-1051 exposure is dose-proportional with a half-life of approximately 18 hours, supporting once-daily dosing.
Study status: 28 patients with advanced solid tumors harboring specific cancer-associated gene alterations have been enrolled at doses from 10 mg to 300 mg once daily. Dose escalation is ongoing, with enrollment currently underway in the 300 mg cohort (dose level 9). Aprea is expanding enrollment to include at least 50 patients with uterine serous carcinoma as well as patients with cyclin E-overexpressing, platinum-resistant ovarian cancer. Completion of dose escalation and backfill expansion is anticipated in the second quarter of 2027.

For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514. A copy of the poster will be available on Aprea’s corporate website, later today.

(Press release, Aprea, JUN 1, 2026, View Source [SID1234666297])

On June 1, 2026 Nouscom, a clinical-stage biotech company developing next-generation immunotherapies to treat cancer at all stages, from early cancer interception to late-stage metastatic disease, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NOUS-209 for the prevention of Lynch Syndrome (LS)-associated cancers in LS carriers with genetically confirmed mismatch repair (MMR) mutations.

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Fast Track Designation is granted to investigational therapies that have the potential to address serious conditions with significant unmet medical need. It is designed to expedite development and review through more frequent, direct interactions with the FDA, and confers eligibility for Accelerated Approval, Rolling Review of a Biologics License Application (BLA), and Priority Review at BLA submission.

"Lynch Syndrome carriers face up to 80% lifetime risk of developing cancer. Yet their only options today are intensive surveillance or prophylactic organ removal surgery," said Marina Udier, Ph.D., Chief Executive Officer of Nouscom. "Fast Track Designation from the FDA validates the urgency of the need and the strength of our NOUS-209 program. Building on promising Phase 1b/2 results published in Nature Medicine, we are now advancing NOUS-209 into a registration-enabling trial — with the goal of delivering the first cancer interception immunotherapy for Lynch Syndrome carriers."

The designation is supported by Phase 1b/2 data in LS carriers, published in Nature Medicine (D’Alise et al., 2026), demonstrating NOUS-209 monotherapy was safe and induced broad, potent, functional and durable T cell responses, boosted by annual retreatment. No new advanced adenomas were detected one-year post-treatment, providing first clinical evidence of cancer interception in LS carriers.

"Fast Track Designation will accelerate our dialogue with the FDA as we prepare for our registration-enabling study," said Sven Gogov, M.D., Chief Medical Officer of Nouscom. "Together with our prior FDA and EMA alignment on the registrational path, FTD provides both speed and regulatory clarity as we work to bring this transformative immunotherapy to Lynch Syndrome carriers."

About NOUS-209

NOUS-209 is an investigational off-the-shelf cancer immunotherapy that targets tumors with mismatch repair deficiency (dMMR) and microsatellite instability (MSI). These tumors produce unique markers known as frameshift peptide (FSP) neoantigens, which are unique to cancerous cells and absent in healthy cells. NOUS-209 is comprised of two proprietary viral vectors able to deliver 209 shared FSP neoantigens and train the immune system to recognize and attack cancerous and precancerous cells before tumors can develop.

Phase 1b/2 data demonstrated the safety of NOUS-209 and its ability to stimulate potent immune responses in LS carriers1,2, supporting its advancement into a registration-enabling Phase 2/3 trial in cancer interception. NOUS-209 is also being studied in Phase 2 studies in combination with pembrolizumab in a difficult-to-treat patient population of advanced dMMR and/or MSI-H metastatic CRC (mCRC) patients refractory to anti-PD-1 therapy3 and in first line treatment of advanced dMMR and/or MSI-H mCRC. Data from the successfully completed Phase 1b trial were published in Science Translational Medicine4.

About Lynch Syndrome

Lynch Syndrome (LS) is a common inherited condition that significantly increases a person’s risk of developing cancer over their lifetime, especially colorectal cancer (CRC) (up to 50% risk, compared to 2% for general population), endometrial cancer (up to 50% risk, compared to 1-2% for general population) and urothelial cancer (up to 25% risk, compared to 1-2% for general population)5,6,7,8. LS also elevates the risk of developing other cancers including gastric, ovarian, prostate and pancreatic. LS is caused by inherited mutations in specific genes responsible for repairing DNA, leading to the buildup of harmful genetic errors that can accumulate, triggering development of tumors. Currently, managing LS is limited to frequent screenings such as colonoscopy to catch cancer early, but is not shown to reduce cancer incidence9,and elective surgery, which is invasive, expensive, and negatively impacts quality of life. As a pioneering approach to cancer interception, Nouscom’s investigational immunotherapy, NOUS-209, is designed to train the immune system to recognize and stop cancer before it develops.

About Cancer Interception

Cancer interception is an innovative approach that aims to stop cancer in its earliest stages before tumors fully develop and spread. Unlike traditional therapies that target established cancers, interception strategies harness advancements in immuno-oncology that can train the immune system to recognize and eliminate precancerous and cancerous cells. This approach is particularly relevant for those with high-risk genetic conditions such as LS who have high predisposition to developing MSI-associated cancers.

(Press release, NousCom, JUN 1, 2026, View Source;utm_medium=rss&utm_campaign=nouscom-receives-u-s-fda-fast-track-designation-for-nous-209-a-novel-immunotherapy-for-the-prevention-of-lynch-syndrome-associated-cancers [SID1234666313])

On June 1, 2026 Sonire Therapeutics, a U.S.-based clinical-stage medical device company, reported the completion of patient enrollment in SUNRISE-I, a randomized controlled trial evaluating the safety and efficacy of its proprietary High-Intensity Focused Ultrasound (HIFU) therapy system for the treatment of pancreatic cancer.

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This multi-center study was conducted across seven leading clinical sites in Japan with a total of 90 patients with overall survival (OS) as the primary endpoint. The study represents one of the few randomized controlled trials (RCTs) conducted in the HIFU space for pancreatic cancer treatment, one of the most intractable cancers in the world today.

"Patients facing pancreatic cancer need treatment options that are less invasive, more accessible, and easier to integrate into real-world clinical practice," said Tohru Satoh, President and CEO of Sonire Therapeutics. "SUNRISE-I reflects our efforts to develop treatment approaches that reduce the burden on patients and address some of the limitations of existing treatment options. We believe the future of oncology will be shaped by therapies that are better suited to the needs of both patients and healthcare providers."

Sonire’s HIFU therapy system leverages real-time ultrasound guidance to deliver precise, non-invasive tumor ablation, allowing physicians to monitor treatment as it is administered without the need for general anesthesia. The approach is designed to reduce the procedural burden while expanding access to treatment in outpatient settings.

SUNRISE-I forms the basis of Sonire’s ongoing U.S.-based clinical development program, including SUNRISE-II, which is currently evaluating the company’s HIFU system in the United States. Together, these studies form a global clinical strategy aimed at advancing minimally invasive treatment options for pancreatic cancer.

Atsushi Sofuni, MD, Professor of Gastroenterology at Tokyo Medical University and physician who treated the first patient in the SUNRISE-I study, said, "Pancreatic cancer remains one of the most difficult cancers to treat, with a significant unmet medical need. HIFU therapy represents an innovative approach that is distinct from existing treatments. We hope the SUNRISE-I study will contribute to expanding future treatment options for patients with pancreatic cancer."

"The completion of enrollment in SUNRISE-I is a step forward for the broader field exploring ultrasound-based approaches for pancreatic cancer treatment and highlights the growing clinical interest in advancing new therapeutic options for patients," said Pejman Ghanouni, MD, PhD, Principal Investigator of Sonire Therapeutics’ U.S.-based SUNRISE-II study. Ghanouni is also a Professor of Radiology at Stanford Medicine.

By generating the clinical evidence from randomized, multi-center clinical trial with overall survival as a primary endpoint, Sonire aims to strengthen the body of data supporting the safety and efficacy of its HIFU platform and advance toward future regulatory submissions and global commercialization.

(Press release, SONIRE Therapeutics, JUN 1, 2026, View Source [SID1234666329])