On August 26, 2026 Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, reported the publication of a landmark independent systematic review and meta-analysis of probe-based confocal laser endomicroscopy (pCLE) in upper gastrointestinal cancer, conducted and funded by Korea’s national health technology assessment agency.

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Published as an original research article in Endoscopy International Open1, the meta-analysis pools data from 33 studies involving 2,350 patients, of which 15 focused on esophageal lesions, 16 on gastric lesions and two covering both sites.

The study was conducted and funded by the Division of Health Technology Assessment Research of Korea’s National Evidence-Based Healthcare Collaborating Agency (NECA), the country’s national health technology assessment organization. Its protocol was defined in advance by a dedicated evaluation committee assembled by the agency, comprising pathologists, gastroenterologists, methodological experts and biostatisticians, and the work followed Cochrane and PRISMA methodology, with QUADAS-2 quality assessment, bivariate random-effects modelling of pooled diagnostic accuracy, pre-specified sensitivity analyses and formal testing for publication bias.

Co-authors are affiliated with NECA, CHA University School of Medicine, Asan Medical Center (University of Ulsan College of Medicine), Yonsei University College of Medicine and Seoul St. Mary’s Hospital (The Catholic University of Korea College of Medicine). The authors declare no conflicts of interest. Mauna Kea Technologies played no role in the design, conduct, funding, or interpretation of the review.

Enhanced lesion detection and reduced biopsy burden

In Barrett’s esophagus surveillance, adding pCLE to high-definition white-light endoscopy increased per-patient dysplasia detection to 28% of patients (14 of 50) from 10% (5 of 50) (p = 0.04). Among patients with poorly cohesive gastric adenocarcinoma, pCLE-guided biopsies identified malignant tissue in 65% of patients (19 of 29), versus 30% (10 of 32) with standard white-light-directed biopsies (p = 0.01). In a randomized trial in suspected gastric precancerous lesions, combining pCLE with flexible spectral imaging color enhancement (FICE) produced a diagnostic yield per biopsy of 75.1%, versus 31.5% with FICE alone (p < 0.001).

The same randomized study found that pCLE-guided targeting reduced the mean number of biopsies per patient by 48.5%, from 6.8 to 3.5 (p < 0.001). In a selected cohort of 13 patients with Barrett’s esophagus and subtle mucosal irregularities without a discrete macroscopic lesion, adjunctive pCLE altered real-time therapeutic management in 69.2% of cases (9 of 13) either prompting endoscopic resection where higher-grade disease was suspected or avoiding unnecessary resection or ablation where neoplasia was not supported.

Diagnostic performance

The authors conclude that pCLE is a safe and accurate adjunct to standard upper gastrointestinal endoscopy, particularly when lesion conspicuity is low or histologic confirmation is important. In studies comparing the two directly, adjunctive pCLE consistently showed higher sensitivity than white-light endoscopy alone with comparable or modestly improved specificity, underscoring its role as an adjunctive characterization tool rather than a replacement for high-quality conventional endoscopy.

Compared with histopathology, pooled sensitivity was 89% for both esophageal and gastric neoplasia; pooled specificity was 79% for esophageal lesions and 95% for gastric lesions. Discrimination was strong and consistent for high-grade dysplasia and overtly neoplastic lesions, with pooled sensitivity of 88% and specificity of 87%. The authors note that pooled estimates, particularly the high specificity observed for gastric lesions, should be interpreted with appropriate caution given potential small-study effects, and that the evidence base is drawn largely from high-volume academic centers.

Regulatory and reimbursement status

Confocal laser endomicroscopy is already established in the indications covered by this meta-analysis. In Korea, the technology received a positive health technology assessment from NECA in 2018, and coverage of the GastroFlex UHD probe and of the confocal endomicroscopy procedure in esophageal and gastric indications was ratified by the Ministry of Health and Welfare in February 2020. In the United States, optical endomicroscopy (OE) is performed and reported under dedicated Category I CPT codes, and upper gastrointestinal applications represent the core of the Company’s recurring per-procedure revenue.

Systematic reviews with meta-analyses are among the strongest clinical evidence used by clinical guideline committees and by payers assessing coverage.

Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies, said: "The incidence of esophageal adenocarcinoma in the United States has had a dramatic 5- to 6-fold increase in the past decades, and millions of Americans with non-diagnosed Barrett’s esophagus are at risk. We have designed and developed Cellvizio to empower physicians with cellular vision, enabling them to see what really matters; this is our purpose. For nearly fifteen years, well designed clinical trials have shown that the use of Cellvizio as an adjunct to regular and advanced endoscopy considerably enhanced diagnostic performance and patient management. Today, this landmark independent review and meta-analysis of 33 studies and 2,350 patients, funded by a national assessment agency with no industry involvement, reinforces that value proposition and details the major clinical impact that the use of Cellvizio provides. I believe this will help broaden reimbursement coverage and clinical adoption for Cellvizio in the United States, our primary market."

(Press release, Mauna Kea Technologies, AUG 26, 2026, View Source [SID1234670369])

On August 26, 2026 Arcus Biosciences (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, reported that its management team will participate in the following upcoming investor conferences in September:

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Citi’s 2026 Biotech Back to School Conference
Date: Wednesday, September 9th, 2026
Location: New York, NY
Format: Fireside chat & 1×1 meetings
Time: 10:40 a.m. ET

Cantor Fitzgerald Global Healthcare Conference 2026
Date: Thursday, September 10th, 2026
Location: New York, NY
Format: Fireside chat & 1×1 meetings
Time: 9:45 a.m. ET

Morgan Stanley 24th Annual Global Healthcare Conference
Date: Tuesday, September 15th, 2026
Location: New York, NY
Format: Fireside chat & 1×1 meetings
Time: 12:20 p.m. ET

Live webcasts of the fireside chats will be available by visiting the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. Replays will be available following the live event.

(Press release, Arcus Biosciences, AUG 26, 2026, View Source [SID1234670368])

On August 26, 2026 Noetik, an AI company building foundation models of human biology to redefine clinical outcomes in oncology, reported that it has met the first near-term milestone under its five-year strategic collaboration and licensing agreement with GSK, first announced in January 2026.

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The milestone was triggered by Noetik delivering and deploying the OCTO-VC model inference and fine-tuning capabilities, thereby meeting testing criteria. Under the terms of the original agreement, GSK holds a non-exclusive license to Noetik’s OCTO-VC models in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), backed by $50 million in upfront capital and near-term milestone payments.

"We built OCTO-VC to close the gap between science that is promising in the lab and therapeutics with the potential to work in patients," said Ron Alfa, M.D., Ph.D., CEO and Co-founder of Noetik. "AI approaches have come a long way in enabling molecular design for early stage drug discovery. We founded Noetik to extend the gains of AI to fundamental challenges in biology and patient selection, for better therapeutic decisions. The momentum we’re seeing now is incredible."

Noetik’s OCTO-VC models are biological foundation models trained on hundreds of millions of spatially resolved human cells, part of the largest spatial biology dataset in oncology. Because the models can simulate gene expression, cell states, and tumor-immune interactions, GSK researchers are able to generate data for hypothesis exploration instantly speeding their learning cycles.

"This milestone demonstrates that Noetik’s models are truly foundational and using a small amount of GSK’s unique data can be fine-tuned to generate high accuracy and specific predictions," said Kim Branson, Chief AI Officer at GSK. "The integration of these models into GSK’s learning system deepens our understanding of disease mechanism and accelerates our ability to potentially identify new targets for medicine development. The use of this tech enables us to accelerate the discovery and development of potential new medicines which ultimately means we can bring innovative treatments to patients faster."

GSK’s teams are using OCTO-VC to perform virtual cell experiments, investigate patient stratification, and enrich their H&E data with multi-modal predictions. The milestone reinforces the licensing structure Noetik and GSK established in January: a subscription-based framework in which GSK pays upfront capital and ongoing fees to access Noetik’s models, rather than acquiring individual drug candidates.

"We’re pleased that the partnership is producing results, and we’re looking forward to hitting additional milestones with GSK," said Shafique Virani, M.D., Chief Business Officer of Noetik.

(Press release, Noetik AI, AUG 26, 2026, View Source [SID1234670367])

On August 26, 2026 Cizzle Bio Inc., a biotechnology company advancing biomarker blood tests for early cancer detection, reported its participation in the 18th Annual Next Generation Dx Summit in Washington, D.C. On Monday, Aug. 24, Dr. Lary A. Robinson, director of the Lung Cancer Early Detection (LEAD) Center at Moffitt Cancer Center, presented "Potential of the CIZ1B Biomarker to Redefine Early Lung Cancer Detection," examining the potential role of CIZ1B in lung cancer detection and patient management and providing an overview of the clinical study underway at Moffitt.

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Robinson discussed challenges in early lung cancer detection, including limited participation in low-dose CT (LDCT) screening and uncertainty associated with indeterminate pulmonary nodules. Approximately 1.6 million lung nodules are identified annually in the United States, underscoring the need for tools to help clinicians determine which nodules warrant further evaluation.

"A reliable blood test could help assess indeterminate lung nodules and reduce unnecessary invasive procedures," Robinson said. He also noted the potential for blood-based biomarkers to provide additional information for monitoring patients following treatment.

Developed from 30 years of research at the University of York, CIZ1B is a blood-based biomarker associated with early-stage lung cancer. A recently published study in The Journal of Applied Laboratory Medicine evaluating the scalable ELISA assay reported sensitivity of approximately 94% and a negative predictive value of 97%.

Moffitt Cancer Center Clinical Study

CIZ1B is being evaluated at Moffitt Cancer Center in patients with identified lung nodules. The study is assessing its potential to distinguish malignant from benign nodules, stratify recurrence risk after curative treatment and support surveillance for recurrence or second primary lung cancers. Results from blood collected at initial evaluation are compared with clinical diagnoses, with serial testing also studied during follow-up.

"Dr. Robinson’s presentation provided an important clinical perspective on the challenges physicians face in detecting lung cancer earlier and the research needed to determine how biomarkers such as CIZ1B may complement existing diagnostic approaches," said Bill Behnke, CEO of Cizzle Bio. "The Moffitt study is helping build the clinical evidence needed to understand where CIZ1B may provide meaningful information in the lung cancer care pathway."

Cizzle Bio commercially launched the CIZ1B Biomarker Blood Test for licensed healthcare providers in the Dallas-Fort Worth and San Antonio markets in July 2026, marking the first phase of the company’s planned national rollout strategy.

(Press release, Cizzle Bio, AUG 26, 2026, View Source [SID1234670366])

On August 26, 2026 Vivace Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class cancer therapies that target the Hippo signaling pathway, reported a series of leadership appointments that position the company for its next phase of growth as it prepares to advance its lead candidate, VT3989, into the pivotal Phase 3 sTEADfast registrational trial in mesothelioma patients previously treated with both combination immunotherapy and combination chemotherapy. Craig Gibbs, Ph.D. has been appointed President and Chief Executive Officer, Ellen Lubman has joined as Chief Business and Strategy Officer, and industry veteran Tim Clackson, Ph.D., has been appointed to the company’s Board of Directors.

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The appointments come at an inflection point for Vivace. VT3989, a first-in-class TEAD autopalmitoylation inhibitor that inhibits transcription by YAP/TAZ/TEAD which is activated in mesothelioma tumor cells, has generated impressive overall response (ORR) and progression-free survival (PFS) and tolerability data in patients with refractory mesothelioma as a monotherapy. In addition to the safe to proceed for the Phase 3 sTEADfast clinical study from the FDA, VT3989 has also been granted both Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration. With the new team capable of advancing VT3989 through late-stage development and toward commercialization, Vivace is now poised to initiate the registrational Phase 3 study in 2L/3L mesothelioma later this year.

"This is an exciting moment for Vivace," said Craig Gibbs, President and Chief Executive Officer of Vivace Therapeutics. "The company has translated novel biology into a differentiated clinical asset, and the data we’ve seen with VT3989 gives us real conviction as we prepare for the Phase 3 sTEADfast study. Despite the approval of over 35 targeted agents for other forms of lung cancer, current treatments for mesothelioma are limited to non-tumor specific agents. We have a huge responsibility to deliver this meaningful new targeted agent to patients who have very few options today."

A Differentiated Program Approaching a Pivotal Milestone

VT3989 targets the Hippo pathway, a fundamental regulator of cell growth that has long been considered difficult to drug. In its Phase 1/2 study, VT3989 demonstrated durable antitumor activity and a favorable safety profile in heavily pretreated patients with mesothelioma, a cancer with limited treatment options after standard chemotherapy and immunotherapy. Building on these results, Vivace is preparing to initiate a Phase 3 registrational trial, marking the company’s transition from an emerging clinical-stage innovator to a late-stage oncology company.

Leadership Built for the Next Chapter

The new leadership team brings deep experience in oncology drug development, corporate strategy, and value creation across the biotech landscape.

Craig Gibbs, PhD, MBA, President and Chief Executive Officer

Dr. Gibbs is a seasoned biopharmaceutical leader with more than three decades of experience spanning research, corporate development, and commercial strategy. He most recently served as Chief Executive Officer of Asher Biotherapeutics and previously was Chief Business Officer of Forty Seven, Inc., which was acquired by Gilead Sciences. Earlier in his career, he spent more than 20 years at Gilead Sciences in leadership roles across biology research, corporate development, and commercial planning and operations after beginning his career in industry as a post-doc at Genentech Inc. He holds a Ph.D. in molecular biology from the University of Glasgow and an M.B.A. from Golden Gate University.

Ellen Lubman, MBA, Chief Business and Strategy Officer

Ms. Lubman is an accomplished business and strategy executive with a track record of building partnerships, financings, and corporate strategy across the biopharmaceutical industry. She previously served as Chief Business Officer of Werewolf Therapeutics and has held senior business development and strategy roles across oncology and immunology, in addition to serving on the boards of multiple life sciences companies. At Vivace, she will lead the company’s corporate strategy, business development, and partnering efforts as it advances VT3989 toward the market. She holds an M.B.A. and brings extensive experience shaping strategy at pivotal moments in a company’s evolution.

Tim Clackson, PhD, Member of the Board of Directors

Dr. Clackson is a highly regarded oncology drug developer and executive whose leadership has helped shape multiple successful precision-oncology companies. He most recently served as Chief Executive Officer of IDRx, a private, clinical-stage precision oncology company developing velzatinib, a potential best-in-class therapy for gastrointestinal stromal tumor (GIST). Under his leadership, IDRx advanced through key development, financial, and strategic inflection points, culminating in its acquisition by GSK for up to $1.15 billion. Earlier, he served as Chief Executive Officer of Theseus Pharmaceuticals, President of Xilio Therapeutics, and as President of Research and Development at ARIAD Pharmaceuticals. He holds a Ph.D. in biochemistry and brings deep scientific and operational expertise to the Vivace Board.

Aligned Around a Clear Strategy

"Vivace sits at the intersection of exceptional science, impactful clinical response and genuine commercial opportunity," said Ellen Lubman, Chief Business and Strategy Officer. "First-in-class assets like VT3989 don’t come along often, and my priority is to make sure we build the partnerships, resources, and strategy to realize its full potential for patients and shareholders. It’s a privilege to help advance this molecule to benefit as many patients as possible, including patients in earlier lines of treatment and patients at risk of resistance to other anti-tumor agents. "

The biology around TEAD is compelling, and VT3989 translates that potential into a derisked first-in-class asset with substantial clinical data," said Tim Clackson, PhD "Vivace has a rare opportunity to bring a truly differentiated medicine to patients, and I look forward to working with Craig, Ellen, and the rest of the team as the company enters this pivotal stage."

About VT3989

VT3989 is a first-in-class, orally administered TEAD autopalmitoylation inhibitor designed to inhibit transcription by YAP/TAZ/TEAD on the Hippo signaling pathway, a central driver of tumor growth. VT3989 has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for the treatment of mesothelioma. VT3989 has demonstrated encouraging antitumor activity and tolerability in patients with refractory mesothelioma and other solid tumors with activated YAP/TAZ/TEAD signaling, and in preclinical tumor models where activated YAP/TAZ/TEAD signaling drives resistance to other targeted anti-tumor agents.

(Press release, Vivace Therapeutics, AUG 26, 2026, View Source [SID1234670365])