On September 4, 2025 Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, reported it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution (Press release, Ibex Medical Analytics, SEP 4, 2025, View Source [SID1234655784]). Ibex’s fully automated "zero-click" AI-enhanced decision support tool for pathologists efficiently increases the accuracy and consistency of HER2 immunohistochemistry (IHC) scoring, including HER2-low cases. Ibex’s breast HER2 solution was developed and validated by Ibex in collaboration with AstraZeneca and Daiichi Sankyo.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Using digitized images of HER2 IHC stained breast cancer samples, Ibex’s breast HER2 solution detects invasive tumor cell staining patterns and classifies HER2 expression into four standard scores: 0, 1+, 2+ and 3+ (based on ASCO (Free ASCO Whitepaper)/CAP guidelines). It can assist pathologists in the detection and interpretation of cases with HER2 ultralow expression (defined as IHC 0 with membrane staining present). The AI-powered computational tool automates and optimizes case review with:

"Zero-click" invasive tumor detection (automatically excluding ductal carcinoma in situ)
Automated tumor cell identification and cell staining pattern classification
Editable invasive contours and score recalculation
Visualization of AI findings and cell staining pattern percentages for better understanding of score result
Pathologists supported by Ibex’s breast HER2 solution showed improvement in scoring accuracy and consistency, as demonstrated by two clinical studies; one spanning 14 international cancer centers and an additional multi-reader validation study.

The IVDR certificate was received following a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product. Ibex’s breast HER2 solution has been shown to be exceptionally robust, with high performance across multiple labs, scanners, anti-HER2 antibodies, and patient demographics during IVDR clinical studies:

Improved Accuracy (relative to experts): Pathologists supported by AI demonstrated improved sensitivity, when scoring HER2 0 and 1+ slides (91.2% manual score vs. 97.4% with AI) and overall accuracy for all HER2 scores (77.5% manual score vs. 86.6% with AI).
Increased Consistency: Pathologists’ average inter-observer agreement was significantly higher when assisted by AI (94.1%) than with manual scoring (77.3%), in all slides, and specifically for HER2 0 and 1+ slides (97.2% with AI vs. 87.4% for manual score).
"AI can be a valuable decision support tool, aiding pathologists to improve HER2 scoring accuracy and align more closely with expert breast pathologists, as well as enhancing consistency among pathologists, particularly in challenging cases at the lower end of the HER2 expression spectrum," says Dr. Elena Provenzano, lead breast histopathologist at Cambridge University Hospitals NHS Foundation Trust. "Ibex’s HER2 tool could be extremely valuable in today’s clinical landscape, where there is increasing pressure to identify low-expressing HER2 cases in a more reproducible and objective manner."

Ibex’s HER2 biomarker solution is part of Ibex Breast, an integrated AI solution offering a streamlined diagnostic workflow that detects 54 tissue morphologies in breast H&E slides, which has been widely adopted by leading pathology labs worldwide.2,3 Pathologists can review H&E and IHC-stained slides with AI support, facilitating rapid, consistent and objective diagnosis, scoring, and reporting of breast biopsies and excisions.

"Our AI-powered solutions are designed with pathologists, for pathologists, enabling them to leverage cutting-edge technology to make more confident diagnoses," remarked Dr. Manuela Vecsler, VP of Clinical and Scientific Affairs at Ibex Medical Analytics. "We are thrilled to see our HER2 IHC scoring solution’s high performance during IVDR clinical studies, with pathologists noting its ease of use, confidence boost, and smooth workflow integration—underscoring its real-world diagnostic impact. This certification reaffirms our commitment to providing the most accurate and reliable tools for pathologists, ultimately improving patient care."

On September 4, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a positive clinical readout update assessing the performance of the latest colorectal cancer (CRC) screening algorithm (V2) for its Shield blood test (Press release, Guardant Health, SEP 4, 2025, View Source [SID1234655783]). The study met all primary endpoints and the sensitivity of this new screening algorithm for detecting CRC was 84% with 90% specificity. Sensitivity for detection of stage I CRC was 62%.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with the performance of the new algorithm in detecting stage I CRCs. Today’s update shows yet again that Shield delivers best-in-class performance," said AmirAli Talasaz, Guardant Health co-CEO. "We will continue to leverage our first mover advantage, rapidly growing database and innovation engine to push Shield to higher levels of performance over time."

The clinical validation of the algorithm was conducted on an expanded cohort of subjects enrolled in the landmark ECLIPSE study. ECLIPSE is a 20,000+ person registrational study evaluating the performance of Shield for detecting CRC in average-risk adults that was published in The New England Journal of Medicine. Sensitivity for early-stage CRC was 62% for stage I and 100% for stage II. Sensitivity was 96% for stage III and 100% for stage IV. Sensitivity in detecting advanced adenomas was 13%.

The National Comprehensive Cancer Network (NCCN) recently updated its CRC Screening Guidelines to add Shield as the first blood test that is FDA approved for primary screening of CRC. Shield has also received numerous awards recognizing its innovation and power to change lives, including Fast Company’s World Changing Ideas, TIME’s list of the Best Inventions of 2024 and was selected as a Grand Award Winner in Popular Science’s Best of What’s New 2024.

Beyond CRC screening, Guardant Health has a pipeline of activities around the Shield platform, including the Shield multi-cancer detection (MCD) test which was recently granted Breakthrough Device Designation by the FDA and included in the National Cancer Institute’s Vanguard study.

Shield is the first and only blood test that has received full FDA approval as a primary screening option for CRC in average-risk adults aged 45 and older and can be ordered by any prescribing healthcare provider. For more information, visit www.ShieldCancerScreen.com.

On September 4, 2025 Vaxiion Therapeutics reported completion of the dose escalation segment of its ongoing multicenter Phase 1 study evaluating the safety and efficacy of VAX014 as monotherapy along with initiation of the Phase 1b dose expansion segment of the study (Press release, Vaxiion Therapeutics, SEP 4, 2025, View Source [SID1234655782]). The dose expansion segment will implement an adaptive trial design to evaluate the safety and efficacy of VAX014 in combination with investigator’s choice of pembrolizumab or nivolumab in patients with solid tumors that have progressed on prior PD-1 blockade.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

VAX014 is a novel, first-in-class, pan-tumor targeted, oncolytic immunotherapy using bacterial minicells and was specifically designed for optimal activity in STING and/or RIG-I positive tumors to overcome this biological limitation of oncolytic virus-based therapies. Provided as a sterile product, VAX014 eliminates the need for BSL-2 biocontainment, dramatically increasing patient access in comparison to oncolytic viruses.

Eighteen heavily pretreated solid tumor patients were treated with VAX014 across five dose levels in the dose escalation segment of the study. In the first nine patients, a single tumor was injected with a fixed dose volume whereas the last nine patients were allowed to have multiple tumors injected. Across dose levels, VAX014 was well tolerated as monotherapy and provided strong evidence of immune-mediated antitumor activity in both injected and non-injected tumors.

The Phase 1b dose expansion study (NCT05901285) is open and enrolling at eight sites across the United States and utilizes an adaptive trial design in patients with solid tumors who have progressed after prior PD-1 directed immune checkpoint blockade. Based on current enrollment rates, the Company anticipates enrolling up to 30 patients in the next 12 months.

"The monotherapy data with VAX014 is promising and I am eager to see how it performs in combination with pembrolizumab or nivolumab," said study Principal Investigator Dr. Elizabeth Buchbinder of the Dana-Farber Cancer Institute. "Having a locally administered oncolytic immunotherapy option that doesn’t require special handling and biocontainment considerations has been really nice."

"We are happy to report the initiation of the dose expansion segment of this ongoing study and are encouraged by the safety and efficacy data as well as the positive investigator and patient feedback from the dose escalation study." said Vaxiion CEO, Matt Giacalone. "The Phase 1b dose expansion will continue to build on our hypothesis that VAX014 facilitates development of robust antitumor T cell responses to potentiate the effectiveness of immune checkpoint blockade."

On September 4, 2025 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported that its latest research has been accepted for poster presentation at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC), taking place September 6–9 in Barcelona, Spain (Press release, OncoHost, SEP 4, 2025, View Source [SID1234655780]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study, "Distinct Clinical and Biological Features of Five SCLC Subtypes Identified by Plasma Proteomic Analysis," highlights the company’s innovative use of plasma proteomic profiling to advance precision medicine in small cell lung cancer (SCLC).

Poster Presentation
Title: Distinct Clinical and Biological Features of Five SCLC Subtypes Identified by Plasma Proteomic Analysis
Presenter: David Gandara, MD (UC Davis Medical Center, Sacramento, CA, USA) Session Date: September 8, 2025 | Poster Hall
Abstract Number: 3247

Study Highlights and Conclusions
SCLC is increasingly recognized as a heterogeneous disease, with distinct disease characteristics thought to reflect different mechanisms of therapeutic resistance. One strategy for patient stratification involves molecular subtyping based on transcription factor expression in tumor samples. These subtypes exhibit unique biological features and gene expression profiles that give rise to subtype-specific therapeutic vulnerabilities. Emerging evidence therefore suggests that integrating SCLC subtyping into clinical decision-making may support personalized treatment, improve biomarker-guided trial design, and ultimately enhance patient outcomes.

However, current subtyping approaches face two major limitations. First, tumor heterogeneity can lead to variability in test results across different biopsy sites. Second, recent studies indicate a significant risk of subtype shifting during treatment, reflecting tumor plasticity and therapeutic adaptation. Accordingly, there is a need for a non-invasive subtyping method that enables longitudinal monitoring of a patient’s subtype.

By analyzing pre-treatment plasma samples from 79 patients with extensive-stage SCLC treated with immune checkpoint inhibitors and chemotherapy, the research team at OncoHost identified five distinct proteomic subtypes, each marked by unique molecular features and clinical outcomes. The subtypes display differential survival profiles for ICI-based treatment.

Proteomic profiling uncovered 469 differentially expressed proteins between the patients’ subtypes, grouped into four major expression clusters enriched for pathways linked to cell cycle regulation, splicing, inflammation, and additional processes. The subtypes further differ in neuroendocrine and NOTCH signaling pathways, which play a critical role in SCLC progression and treatment response. These insights indicate that plasma proteomics-based subtyping can provide a minimally invasive approach to overcome the limitations of tissue biopsies, enable dynamic monitoring of disease, and identify new therapeutic opportunities – paving the way for more precise and personalized treatment strategies in SCLC.

"Small cell lung cancer remains one of the most challenging malignancies to treat due to its complexity and poor prognosis," said Michal Harel, PhD, VP Translational Medicine at OncoHost. "Our findings show that plasma proteomics can identify clinically meaningful SCLC subtypes and reveal new biological pathways that may serve as therapeutic targets."

Ofer Sharon, MD, CEO of OncoHost, added: "By integrating proteomic profiling and AI-driven capabilities to SCLC, we are uncovering actionable insights that have the potential to transform how we approach treatment decision-making. These results reinforce our mission to empower oncologists with predictive tools that improve patient outcomes in some of the most aggressive cancers."

On September 4, 2025 Aethlon Medical, Inc. ("Aethlon" or the "Company") (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported the pricing of a public offering of an aggregate of 5,000,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 5,000,000 shares of common stock at a combined public offering price of $0.90 per share (or pre-funded warrant) and accompanying warrant (Press release, Aethlon Medical, SEP 4, 2025, View Source [SID1234655779]). The warrants will have an exercise price of $0.90 per share, will be exercisable immediately upon issuance and will expire on the fifth anniversary of the original issuance date. The closing of the offering is expected to occur on or about September 5, 2025, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Maxim Group LLC is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $4.5 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include clinical trial expenses, research and development expenses, capital expenditures, and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-289745), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 4, 2024. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at www.sec.gov and may also be obtained by contacting Maxim Group LLC at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.