On August 4, 2026 CEL-SCI Corporation (NYSE American: CVM) reported the publication of its study, "A Novel Neoadjuvant Immunotherapy Confers Improved Overall Survival in Oral Cancer Patients with Low Tumor PD-L1 Expression: The IT-MATTERS Clinical Trial – Prognostic Role of Tumor PD-L1 Expression," in the internationally recognized journal Oral Oncology.

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The peer-reviewed publication provides scientific evidence supporting the biomarker strategy that forms the foundation for selecting patients in CEL-SCI’s upcoming global Confirmatory Registration Study of Multikine (Leukocyte Interleukin, Injection)*. The Oral Oncology published study identifies low and zero tumor PD-L1 expression (TPS <10%) and the absence of lymph node involvement (N0) as prognostic biomarkers for selecting patients most likely to achieve substantial survival benefit from Multikine administered before surgery.

In this biomarker-selected patient population, patients receiving the Multikine treatment regimen prior to surgery followed by standard of care achieved a 73.4% five-year overall survival (OS) rate compared with 45.8% for patients receiving surgery followed by standard of care alone, corresponding to a hazard ratio of 0.34 (p=0.0012) and a 28.6% absolute improvement in five-year survival. The published study also demonstrated a statistically significant improvement in progression-free survival (PFS), with a 49% reduction in the risk of disease progression or death (PFS hazard ratio 0.51; p=0.0197) compared to control in the same patient population.

Importantly, the peer-reviewed publication concludes that these biomarkers can be used prospectively to identify patients most likely to benefit from Multikine and guide future clinical studies in head and neck (squamous cell carcinoma) cancer.

"Publication of these findings in Oral Oncology represents an important peer-reviewed acceptance of the science behind our Multikine development program," said Geert Kersten, CEO of CEL-SCI. "The results not only confirm the remarkable overall and progression free survival benefit observed in the selected population analyzed in our Phase 3 trial, but they also provide strong support for the biomarker selection strategy we are implementing for our Confirmatory Registration Study. It is important to note that when Keytruda was approved by the FDA in the same indication, based on event free survival, it had not established overall survival benefit. As awareness of the Multikine data grows within the global oncology community, we believe Multikine will become increasingly recognized as a differentiated immunotherapy."

The publication in Oral Oncology notes that currently approved checkpoint inhibitor therapies are generally directed toward patients with higher PD-L1 expression, while Multikine’s unique mechanism of action enables it to benefit patients whose tumors express low (TPS <10%), as well as zero (0%) PD-L1. This creates the potential for a treatment approach that specifically targets the underserved low and zero PD-L1 patient population.

CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study, which will evaluate Multikine in newly diagnosed, previously untreated, locally advanced resectable head and neck oral cancer patients with low and zero (TPS <10%) PD-L1 tumor expression and no lymph node involvement—the same patient population reported on in the newly published study in Oral Oncology. The trial is designed with approximately 97% statistical power to confirm the previously observed overall survival benefit.

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

(Press release, Cel-Sci, AUG 4, 2026, View Source [SID1234669678])

On August 4, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported study results demonstrating that PRISM2, a multimodal slide-level pathology foundation model developed in collaboration with researchers from Microsoft, can perform clinically important diagnostic tasks using simple prompts and can be leveraged for a variety of downstream applications. The results were published in Nature Medicine.

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PRISM2 outperformed or matched existing slide-level foundation models across a comprehensive set of diagnostic, biomarker and patient outcome prediction tasks. Additionally, when further tuned to specifically predict long-term outcomes, PRISM2 outperformed standalone models, including achieving high performance predicting colorectal cancer recurrence-free survival.

"PRISM2 represents a true leap forward both in terms of scale and multi-modal AI capabilities," said Razik Yousfi, Senior Vice President and General Manager of AI Products at Tempus. "Our Pathology Foundation Models allow us to have a detailed understanding of tissue, unlocking clinical-grade precision and novel research applications capable of predicting patient outcomes and biomarker status. PRISM2 builds on this by aligning whole-slide pathology images with the language of clinical diagnosis through clinical dialogue training. It can seamlessly handle complex diagnostic and prognostic research tasks without requiring specialized fine-tuning, offering a powerful tool to advance precision oncology."

As part of Tempus’ proprietary Pathology Foundation Models, PRISM2 turns routine hematoxylin and eosin (H&E) slides into deep biological insights. By combining large vision models built from pathology images with large language models, it unlocks diagnostic-grade precision in research involving cancer detection, biomarker identification and prognosis prediction.

PRISM2 was trained on a diverse set of 2.3 million whole-slide images and 14 million diagnostic question−answer pairs derived from nearly 700,000 pathology reports, making it the largest multimodal slide-level pathology datasets to date.

To support ongoing research, open science, and other non-commercial and non-clinical use cases, the full PRISM2 model weights are publicly available through Hugging Face at View Source and View Source-survival.

(Press release, Tempus, AUG 4, 2026, View Source [SID1234669677])

On August 4, 2026 SOPHiA GENETICS (NASDAQ: SOPH) reported a new global collaboration to develop, validate, and deploy two companion diagnostics (CDx) supporting precision oncology therapies with AstraZeneca (LSE/STO/NYSE: AZN).

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This multi-year collaboration agreement will advance the development and commercialization of two companion diagnostic programs, bringing SOPHiA GENETICS’s decentralized clinical trial assays and companion diagnostic capabilities to AstraZeneca therapies.

As part of the collaboration, SOPHiA GENETICS will develop its Solid Tumor application into a decentralized companion diagnostic. In addition, the company will develop and validate its Hematological Oncology application to support a companion diagnostic program for patients with blood cancer.

"A breakthrough therapy only matters to the patients we can find in time to treat. We are moving towards a future that no longer depends on geography, where any laboratory can run the same test to the same high standard on day one of a launch. We believe these programs are what that future looks like in practice. Bringing the right therapy to the right patient, in any country and any laboratory, is the work that will define the next generation of precision medicine," said Ross Muken, CEO, SOPHiA GENETICS.

By combining accurate biomarker detection with rapid deployment, SOPHiA GENETICS aims to shorten the distance between a new therapy and the patients who need it. Through its global data-driven platform, insights generated from patient populations can help advance informed clinical decision-making across healthcare systems. This vision of connected, data-driven medicine underpins these programs, with the goal of expanding access to innovative treatments and improving outcomes for patients worldwide.

About SOPHiA GENETICS Companion Diagnostics

SOPHiA GENETICS end-to-end diagnostic capabilities span the drug development and launch continuum:

Clinical Trial Assay (CTA) development, to identify, screen, and enroll the right patients quickly and accurately during a trial.
Companion Diagnostic (CDx) development, validation, and regulatory submission, taking an assay from research use through analytical and clinical validation to approval in the US, EU, Japan, and beyond.
Deployment through the SOPHiA DDMTM Platform and the SOPHiA DDMTM MaxCare Program, enabling laboratories to bring testing in-house and adopt new genomic applications with confidence, reaching larger populations around the globe.
SOPHiA GENETICS’s technology-agnostic, cloud-based platform lets healthcare institutions run the same validated, AI-powered analysis locally, while sharing and benefiting from the collective intelligence of a global network of more than 1,000 connected institutions across over 75 countries. For a pharmaceutical partner preparing a global launch, that means a companion diagnostic that can be available in the local lab on day one of drug approval.

(Press release, AstraZeneca, AUG 4, 2026, View Source [SID1234669676])

On August 4, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy approaches for cancer and autoimmune diseases, reported two important milestones reflecting the advancement of its TriSTAR platform: the nomination of the first development candidate under its TriSTAR strategic collaboration with Ipsen and the appointment of Saso Cemerski, Ph.D., as Senior Vice President, Head of Immunology.

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This drug candidate nomination marks the successful advancement of the first program developed through the strategic collaboration established by Marengo and Ipsen in June 2024. It is the second candidate from Marengo’s proprietary TriSTAR platform to enter IND-enabling development.

"Nominating a development candidate under our TriSTAR collaboration with Ipsen is a testament to the strength of our partnership and underscores the dedication and ingenuity of Marengo’s research team," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "Our first-in-class precision TriSTAR trispecific T-cell engagers are designed to deliver on the promise of precision immuno-oncology by bringing the right T cells to the right tumors. We look forward to continuing our work with Ipsen to translate this innovation into meaningful clinical benefit for patients."

TriSTAR is a precision "armed" T-cell engager platform with a differentiated two-in-one mechanism of action, combining selective T-cell activation and expansion with tumor-directed engagement in a single molecule. By integrating Vβ-directed T-cell activation, built-in costimulation and tumor-antigen targeting, TriSTAR candidates are designed to generate and redirect a new pool of highly active memory T cells against tumors. This precision approach has the potential to improve the therapeutic index of T-cell engagement by enhancing antitumor potency in solid tumors while limiting the broad, indiscriminate T-cell activation associated with traditional CD3-directed T-cell engagers.

This milestone demonstrates continued progress across the collaboration’s multiple programs and further validates the ability of the TriSTAR platform to repeatedly generate differentiated therapeutic candidates suitable for global clinical development. Marengo has led research and preclinical development for this program in partnership with Ipsen and is eligible for milestone payments under the collaboration. Ipsen will assume responsibility for all activities following development candidate nomination.

Appointment of Saso Cemerski, Senior Vice President, Head of Immunology

Building on this momentum, Marengo is strengthening its scientific leadership with the appointment of Dr. Cemerski, an industry-leading expert in T-cell engager discovery and immune-cell activation Dr. Cemerski will lead immunology research across Marengo’s clinical and preclinical portfolio, help shape the company’s scientific strategy and accelerate expansion of its pipeline of precision Vβ-directed T-cell therapies.

"Saso is one of the industry’s foremost experts in T-cell engager discovery and immune-cell activation.," Dr. Su continued. "His experience building global research organizations and advancing multiple programs toward the clinic makes him uniquely suited to help us realize the full potential of TriSTAR. His appointment significantly strengthens our ability to expand what we believe is one of the industry’s most differentiated pipelines of precision Vβ-directed T-cell engagers."

"Marengo has built an exceptionally innovative immunology platform with the potential to redefine how T-cell engagers activate and redirect the immune system," said Saso Cemerski, Ph.D., Senior Vice President, Head of Immunology at Marengo Therapeutics. "The unique biology of selective Vβ T-cell activation creates an opportunity to overcome many of the limitations of existing T-cell engager approaches. I am excited to join this outstanding team and help translate the TriSTAR platform into a broad pipeline of next-generation therapies for patients."

Dr. Cemerski brings more than 15 years of experience leading immunology research and therapeutic discovery across biotechnology and pharmaceutical companies. Most recently, he served as Head of Discovery Immune Cell Engagement at AstraZeneca, where he led a global organization of more than 75 scientists, advanced multiple discovery programs toward clinical development, and helped evaluate and integrate externally sourced T-cell engager technologies. His prior experience includes a senior leadership role at Cue Biopharma, as well as positions at Merck, Bristol Myers Squibb and Xencor, where he contributed to the advancement of multiple antibody and small molecule therapeutics from discovery through clinical development.

(Press release, Marengo Therapeutics, AUG 4, 2026, View Source [SID1234669675])

On August 4, 2026 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported the nationwide availability of Roche’s VENTANA PTEN (SP218) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) to determine PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate adenocarcinoma. The assay helps identify patients who may be eligible for treatment with AstraZeneca’s TRUQAP (capivasertib) in combination with abiraterone acetate and prednisone.

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Addressing an Unmet Need in Prostate Cancer Care
Excluding skin cancer, prostate cancer is the most common cancer among men in the United States, with more than 330,000 new cases expected each year. PTEN is a tumor suppressor protein that plays a critical role in regulating cell growth. Loss of PTEN protein expression has been associated with more aggressive disease progression and reduced benefit from current standard-of-care therapies in prostate cancer. Until recently, there were no approved treatment options specifically targeting this biology.

The VENTANA PTEN (SP218) RxDx Assay is a companion diagnostic designed to detect PTEN protein loss in prostate cancer tissue specimens, providing clinicians with important biomarker information to help guide treatment decisions and support personalized patient care.

"Biomarker testing is essential to advancing precision oncology and helping connect patients with the therapies most appropriate for their disease," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "The launch of the VENTANA PTEN (SP218) RxDx Assay underscores how Labcorp is expanding access to innovative companion diagnostics and delivering the timely insights physicians need to make personalized treatment decisions."

Advancing Access to FDA-Approved Companion Diagnostics
Labcorp participated in Roche’s early access program to support Day 1 laboratory readiness for the assay, reinforcing the company’s commitment to helping patients gain timely access to newly approved targeted therapies and the companion diagnostics needed to identify eligible patients.

The VENTANA PTEN (SP218) RxDx Assay is now available through Labcorp’s national network of laboratories and complements the company’s comprehensive portfolio of genomic, molecular and companion diagnostic testing services that support precision oncology care. As one of the nation’s largest providers of oncology testing services, Labcorp enables physicians across community and academic settings to access FDA-approved companion diagnostics at scale, helping bring precision medicine to more patients regardless of where they receive care. The assay can also be ordered alongside Labcorp’s broader portfolio of oncology testing services, providing clinicians with comprehensive biomarker insights from a single laboratory partner.

To learn more about the assay, visit View Source

(Press release, LabCorp, AUG 4, 2026, View Source [SID1234669674])