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Study of Ensartinib as Postoperative Adjuvant Therapy Published in The New England Journal of Medicine

On July 8, 2026 Betta Pharmaceuticals reported ensartinib as postoperative adjuvant therapy for patients with stage IB–IIIB (T3N2M0) ALK-positive non-small cell lung cancer (NSCLC), known as the ELEVATE study, was published online in full in The New England Journal of Medicine (NEJM; Impact Factor 84.5), a world-leading medical journal. The study provides important evidence for adjuvant therapy of ALK-positive NSCLC worldwide and has the potential to change current clinical practice.

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Lung cancer is the most common and deadliest malignancy both globally and in China. According to the statistical report issued by the National Cancer Center, in 2022, there were an estimated 1.06 million new cases of lung cancer and 733,300 related deaths in China. Of patients with lung cancer, NSCLC accounts for up to 85%. Approximately 5-7% of patients with NSCLC have ALK-positive disease. Although some patients with ALK-positive NSCLC are diagnosed at an early or intermediate stage amenable to surgical resection, they still face high risks of recurrence and death, and traditional postoperative adjuvant chemotherapy offers modest benefits. Therefore, reducing the risk of recurrence and prolonging survival after surgery remains an urgent unmet clinical need.

The ELEVATE study directly addresses this unmet need. In the ELEVATE study, a total of 274 patients from 56 medical centers across China were randomly assigned at a 1:1 ratio to receive oral ensartinib or placebo following complete surgical resection and any planned adjuvant chemotherapy. It is a phase 3, multicenter, randomized, placebo-controlled, double-blind registration study in the field of ALK-TKI adjuvant therapy for ALK-positive lung cancer. The results showed a 2-year disease-free survival rate of 86.4% in the ensartinib group compared with 53.5% in the placebo group, with a hazard ratio of 0.20 (95% CI: 0.11 to 0.38) in patients with stage II to IIIB NSCLC. This means that two years of adjuvant treatment with ensartinib reduces the risk of disease recurrence or death by 80%. A significant reduction in this risk was also observed in stage IB to IIIB population, with a hazard ratio of 0.20 (95% CI: 0.10 to 0.37).

Dr. Ding Lieming, Chairman and CEO of Betta Pharmaceuticals, stated: "The publication of the ELEVATE study in NEJM represents high recognition from the international medical community of the scientific value and clinical significance of this research. It is not only an important milestone for Betta but also a landmark achievement showcasing Chinese clinical oncology research on the global academic stage, with the potential to change postoperative adjuvant treatment strategies for patients with ALK-positive lung cancer. The marketing application for the adjuvant indication of ensartinib has already been accepted in China. Moving forward, we will continue to focus on unmet clinical needs, deepen independent innovation, and accelerate the development of more innovative products with core competitiveness and global impact, benefiting more patients."

It is known that ensartinib is a novel, potent, and highly selective next-generation ALK inhibitor. It is an innovative drug developed independently and wholly owned by Betta Pharmaceuticals and its subsidiary Xcovery. Its first-line and second-line indications have already been approved in China, offering good accessibility and a favorable safety profile, and it has received the First Prize for Scientific and Technological Progress in Zhejiang Province. In December 2024, ensartinib was approved for marketing in the United States and subsequently included in the NCCN Guidelines for Non-Small Cell Lung Cancer. Marketing authorization applications in other overseas markets, including the European Union, are progressing.

(Press release, Betta Pharmaceuticals, JUL 8, 2026, View Source [SID1234669108])

UroGen Announces FDA Clearance of the IND for UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer

On July 8, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug application (IND) for UGN-501, a next-generation investigational oncolytic virus. The IND clearance enables initiation of a planned Phase 1 clinical study in patients with non-muscle invasive bladder cancer (NMIBC). The Phase 1 study is expected to begin in Q4 2026 and will evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501.

"Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of the IND allows us to begin evaluating whether the encouraging nonclinical profile of UGN-501 can translate into a safe and meaningful therapeutic approach for patients with NMIBC. We look forward to initiating the Phase 1 study and advancing our efforts to develop innovative treatment options for patients with bladder cancer."

NMIBC continues to present significant clinical challenges, particularly among patients whose disease recurs following standard treatment. Despite available therapies, recurrence rates remain substantial, underscoring the need for novel bladder-sparing therapeutic approaches. UroGen believes UGN-501’s differentiated mechanism of action and local administration strategy may offer a promising new approach for addressing this unmet need.

About UGN-501

UGN-501 is an investigational, next-generation oncolytic virus being investigated for the treatment of non-muscle invasive bladder cancer (NMIBC). UGN-501 is designed to selectively replicate within tumor cells, resulting in direct tumor cell destruction and an anti-tumor immune response. The program is supported by nonclinical data demonstrating cytotoxic activity across a broad panel of bladder cancer cell lines representing multiple stages and grades of disease. While UGN-501 is initially being developed for bladder cancer, the Company believes UGN-501’s underlying properties may have broader applicability across additional solid tumor indications and intends to evaluate future development opportunities based on emerging clinical and translational data.

(Press release, UroGen Pharma, JUL 8, 2026, View Source [SID1234669107])

Quest Diagnostics Now the Largest Clinical Reference Lab to Extend Oncology Test Access Through OncoEMR MPI

On July 8, 2026 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported it is integrating its Haystack MRD ctDNA test and Comprehensive Genomic Profiling services for solid tumor cancers within OncoEMR, an electronic health record (EHR) from Flatiron Health, via a pilot program with American Oncology Network (AON) and other community oncology providers. Flatiron Health is a leading healthtech company dedicated to expanding the possibilities of point-of-care solutions in oncology.

Quest is the largest clinical reference lab to integrate oncology tests in OncoEMR using the opt-in OncoEMR Molecular Profiling Integration (MPI) ordering feature, which is designed to support the specialized test ordering requirements of comprehensive molecular tests. Once completed, the integration will enable 4,700 clinicians across the Flatiron network of 1,600 community-based cancer care locations in the United States to quickly access the Quest services.

"At Flatiron, we’re focused on helping oncology teams get the answers they need to deliver the best possible care," said Quincy Weatherspoon, Chief Network Officer, US Point of Care, Flatiron Health. "By integrating Quest’s advanced oncology services directly into existing workflows, we’re making it easier for physicians to access critical testing insights without adding complexity to their day. This collaboration helps reduce administrative burden so clinicians can spend less time navigating processes and more time focused on caring for patients with cancer."

Molecular oncology testing often involves dozens or even hundreds of individual genetic biomarkers, which can complicate ordering workflows and producing long, complex results reports. The use of OncoEMR MPI will enable providers to set up accounts for Quest services faster, order tests with fewer steps, and receive easy-to-understand reports within their daily EHR workflows.

Select providers can now order and receive results from Quest using the OncoEMR MPI capability as part of a pilot program. Among the pilot customers is American Oncology Network (AON), a leader in community oncology with more than 350 providers practicing across 21 states. Nearly 200 AON sites now have access to OncoEMR MPI and can use it to order the Quest tests. Quest plans to launch the full OncoEMR MPI integration to providers nationwide in the second half of the year.

"At AON, our aim is to provide comprehensive support, ancillary services and practice management benefits to help community physicians to make cancer care better. Empowering them to use OncoEMR MPI via Quest Diagnostics is an important step in that mission," said Dr. Brian Mulherin, Medical Director at AON. "Under this arrangement, our rapidly growing network of physicians can quickly and easily order Quest’s innovative cancer tests, such as Haystack MRD, to help guide patient care."

Providers in the pilot now have access to some of Quest’s most innovative cancer tests, including Haystack MRD, a highly accurate circulating-tumor DNA (ctDNA) minimal residual disease (MRD) test for solid tumor cancers. In addition, the company’s Comprehensive Genomic Profiling portfolio includes several panels that use advanced sequencing to identify up to 530 genes associated with therapy response, providing physicians with necessary insights to determine appropriate treatment for their patients.

"At Quest Diagnostics, we strive to provide comprehensive cancer services that empower providers to work with patients to make optimal care decisions," said Asia Chang, Vice President and General Manager, Oncology at Quest Diagnostics. "We know that positive outcomes in oncology start with excellent diagnostics, but they don’t stop there. We’re looking forward to providing oncologists at AON and other organizations a single-source ordering and results solution via OncoEMR MPI, as well as the world-class expertise they’ve come to expect from Quest."

Quest’s integration of OncoEMR MPI reflects the company’s strategy to make testing simpler and smarter, including through the use of specialized IT and EHR technologies. Last summer, the company began to offer its Haystack MRD test through the Epic Aura platform and now provides a range of specialized tests, from prenatal screening to Alzheimer’s disease, through the platform.

(Press release, Quest Diagnostics, JUL 8, 2026, View Source [SID1234669106])

STEMCELL Technologies and CCRM Partner to Expand Access to Matched GMP and RUO iPSC Lines for Cell Therapy Development

On July 8, 2026 STEMCELL Technologies and the Centre for Commercialization of Regenerative Medicine (CCRM) reported a partnership to expand access to high-quality human induced pluripotent stem cell (iPSC) starting materials, giving cell therapy developers worldwide a faster, lower-risk path from research to the clinic. Under the agreement, STEMCELL will manufacture and distribute research-use-only (RUO) iPSC lines derived directly from LineaBio’s Good Manufacturing Practices (GMP) iPSC lines, and will offer the matched GMP lines to developers worldwide.

For developers of iPSC-derived cell therapies, the starting cell line is a foundational choice that shapes the entire path to the clinic. A 2026 review in Stem Cell Reports identified 126 human iPSC lines available for clinical applications, but few offer the full set of attributes that reduce development risk: donor consent for commercial and therapeutic use, cleanroom-based GMP manufacturing, comprehensive genomic characterization, and clear freedom to operate. A shortfall in any of these may not surface until late in development, when a change of starting material can trigger a new regulatory filing, adding significant time and cost.

"As a company of Scientists Helping Scientists, STEMCELL is committed to providing cell therapy developers with iPSC starting materials they can rely on as they move from research toward the clinic," said Dr. Allen Eaves, President and CEO, STEMCELL. "By offering LineaBio’s GMP iPSC lines alongside matched RUO lines manufactured from the same material, we are giving scientists a dependable foundation for their work and helping to accelerate the development of new cell therapies."

"LineaBio was founded to give cell therapy developers off-the-shelf GMP iPSC lines backed by the documentation, characterization, and regulatory support they need," said Dr. Michael May, President and CEO, CCRM. "Working with STEMCELL and its reach into research laboratories worldwide, we can expand access to these lines across the research community and help accelerate the next generation of cell therapies for patients. We are proud to advance this work with a fellow Canadian company, expanding access to these tools for scientists worldwide."

LineaBio’s iPSC lines are manufactured under controlled GMP conditions from donor-eligible source material and characterized extensively, including by whole genome sequencing. The flagship line, Linea 1, is certified by the Human Pluripotent Stem Cell Registry (hPSCreg) and supported by a U.S. FDA drug master file, giving developers a standardized chemistry, manufacturing, and controls (CMC) data package they can reference in their own regulatory submissions to shorten their path to GMP and reduce cell line development costs. STEMCELL generates matched RUO counterparts directly from this GMP material and qualifies them using established comparability and genomic assessment frameworks. Because the RUO and GMP lines share the same donor and origin, developers can begin their research on the RUO line with confidence that it is comparable to the GMP material. The partnership will expand to include future GMP iPSC lines, including a hypoimmune line for allogeneic therapies.

The companies will present comparability and genomic concordance data for Linea 1 during the STEMCELL and CCRM Innovation Showcase at the 2026 International Society for Stem Cell Research (ISSCR) Annual Meeting in Montréal, "Accelerating Cell Therapy Development with GMP-Manufactured Human iPSC Lines and Matched RUO Equivalents," presented by Dr. Andrew Gaffney (STEMCELL) and Dr. Janet Rothberg (CCRM) on Wednesday, July 8, at 12:30 p.m. ET in Room 511a, Palais des congrès de Montréal. To learn more about the iPSC lines, visit www.stemcell.com/gmp-ipscs.

(Press release, CCRM, JUL 8, 2026, View Source [SID1234669105])

BioLineRx and Hemispherian Announce New Preclinical Data Demonstrating Strong
Synergistic Effect between GLIX1 and PARP Inhibitor in a Patient-Derived
Ovarian Cancer Xenograft Model

On July 8, 2026 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported highly encouraging new preclinical data demonstrating strong synergy between GLIX1 and PARP inhibitors in a patient-derived xenograft (PDX) model of ovarian cancer.

Ovarian cancer remains a major therapeutic challenge, particularly in homologous recombination (HR)-proficient disease where PARP inhibitors (PARPi) presently have limited efficacy, as well as for patients with platinum-resistance.

GLIX1 in combination with PARPi is expected to result in synthetic lethality, a mechanism in which GLIX1-induced single-stranded DNA breaks overcome PARP inhibitors’ requirement for HR-deficiency, enabling synergistic activity in HR-proficient cancers. This effect was first observed in vitro, where GLIX1 showed reproducible synergy across different PARP inhibitors and multiple HR-proficient ovarian cancer cell lines, with very high ZIP synergy scores.

"We are very excited to observe, in a patient-derived ovarian cancer model, the synergistic effect as we anticipated based on the mechanistic rationale and as demonstrated by in vitro data" said Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1 has the potential to sensitize patients to PARP inhibitors as well as to potentially address the huge unmet need for patients with platinum-resistance. Based on these highly encouraging data, we plan to include an ovarian cancer arm in the expansion part of our ongoing Phase 1/2a study."

Today’s results represent a compelling in vivo confirmation of GLIX1 and PARPi synergy from an HR-proficient ovarian cancer PDX model.

· The study included six arms: cisplatin, GLIX1 monotherapy and olaparib monotherapy (all at doses expected to be optimal), low-dose GLIX1, a low-dose GLIX1/olaparib combination arm, and a control arm

· Results show substantially better efficacy in the combination arm versus the control arm and versus the monotherapy arms, despite using lower doses in the combination arm

· The low-dose GLIX1/olaparib combination tumor reduction was similar to cisplatin, the current chemotherapy benchmark

BioLineRx and Hemispherian plan to present the data from this study at one or more future medical conferences.

About Ovarian Cancer

Ovarian cancer is the deadliest gynecologic malignancy in the United States, with an estimated approximately 21,000 new cases and 12,450 deaths projected in 2026. Standard first-line treatment consists of cytoreductive surgery and platinum-based chemotherapy, with PARP inhibitors used as maintenance therapy in selected patients, particularly those with BRCA-mutated or homologous recombination (HR)-deficient disease. However, PARP inhibitors are markedly less effective in patients with HR-proficient tumors, which account for approximately 50% of high-grade serous ovarian cancers and are associated with primary platinum resistance and shorter survival. This leaves a substantial and currently underserved patient population in need of new treatment strategies capable of extending the benefits of PARP inhibitors.

About GLIX1

GLIX1 is a first-in-class, orally administered, brain penetrating, small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway that is commonly inhibited in cancer. Activating the novel TET2 pathway by GLIX1 overwhelms the DNA repair capacity of cancer cells, resulting in apoptotic cancer cell death.

About the Phase 1/2a Trial with GLIX1

The Phase 1/2a trial is an open-label, multicenter trial. Part 1 of the trial is a dose escalation study where patients receive GLIX1 daily as monotherapy. This part is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Updates to the Phase 1/2a trial are anticipated during H2 2026, with full results on the dose escalation part expected in 2027.

The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers, with GLIX1 as monotherapy or in combination with standard of care (including in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.

For more information on the Phase 1/2a trial, please visit NCT07464925.

(Press release, BioLineRx, JUL 8, 2026, View Source [SID1234669104])