On November 7, 2025 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported pivotal clinical validation results from the ALTUS study (NCT: 05064553). The prospective, head-to-head trial demonstrated that the company’s Oncoguard Liver blood test delivers superior early-stage and overall sensitivity for hepatocellular carcinoma (HCC) — the most common form of liver cancer — compared to the current standard of care.1,2

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These findings will be presented as late-breaking data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting* on November 11, 2025, underscoring the Oncoguard Liver test’s potential to transform liver cancer surveillance for at-risk populations. The company intends to submit the data for publication in a peer-reviewed journal.

"Ultrasound surveillance has been the standard for liver cancer screening for decades, but it’s limited by image quality and inconsistent follow up, resulting in low detection rates and poor adherence," said Dr. Binu John, principal investigator for the ALTUS trial, associate professor at the University of Miami Miller School of Medicine, and chief of gastroenterology and hepatology at the Miami VA. "A highly sensitive blood-based alternative like Oncoguard Liver is a game changer that could make liver cancer screening more accessible, equitable, and effective for millions of at-risk patients."

Setting the new benchmark in liver cancer surveillance

The ALTUS study is the largest prospective, real-world trial of a blood test for liver cancer surveillance in the United States. More than 3,000 participants were enrolled across community practices, Veterans Affairs, and academic centers, representing the racial and ethnic diversity of high-risk patient populations.1

The Oncoguard Liver test achieved its primary endpoint, detecting three times more cancers defined as early-stage by Milan criteria compared to ultrasound (67% vs 22%).1 Milan criteria are a set of guidelines that describe eligibility for curative liver transplant.3†

Very early-stage HCC sensitivity: 64% for Oncoguard Liver vs 9% for ultrasound 1
Early-stage HCC sensitivity: 77% for Oncoguard Liver vs 36% for ultrasound 1
These findings demonstrate a seven-fold improvement in detecting liver cancers when they are most treatable and remain eligible for potentially curative options such as resection or transplant.1-3

The Oncoguard Liver test also demonstrated a specificity of 82% in the ALTUS study,1 exceeding the threshold established by experts for clinical utility.4

"These new data from the ALTUS study show that we can reliably detect liver cancer earlier, which is key to improving outcomes," said Dr. Paul Limburg, chief medical officer, screening at Exact Sciences. "With Cologuard, we have already seen what is possible, with more than 20 million tests completed and thousands of colorectal cancers prevented through early detection. The Oncoguard Liver test builds on that success, applying the same science-driven approach to another cancer in which finding disease early can help save lives."

Transforming surveillance for a growing and underserved population

Hepatocellular carcinoma is among the fastest-growing causes of cancer-related deaths in the United States.5-7 By 2040, liver cancer is expected to become the third-leading cause of cancer death, with more than 40,000 new cases and 30,000 deaths annually.5-7 Patients diagnosed at early stages of HCC experience 12 times greater survival rates than those diagnosed with distant disease,6 yet fewer than 30% of eligible individuals participate in regular surveillance, which is recommended by AASLD for people with specific risk factors, such as chronic liver disease or cirrhosis.8

The Oncoguard Liver test is a blood-based multiomics assay developed in collaboration with Mayo Clinic. It combines DNA methylation and protein markers to detect molecular signatures associated with liver cancer, using Exact Sciences’ proprietary PCR technology designed for accuracy, scalability, and broad clinical access.

The ALTUS study confirms that the Oncoguard Liver test meets consensus thresholds for blood-based surveillance established in 2025 and overcomes key barriers associated with ultrasound imaging, particularly in populations affected by obesity or other factors that limit image quality.

(Press release, Exact Sciences, NOV 7, 2025, View Source [SID1234659635])

On November 7, 2025 CREATE Medicines Inc. (formerly Myeloid Therapeutics), a biotechnology company advancing in vivo immune-cell programming with mRNA-LNP therapeutics, reported first-in-human results from its Phase 1 MYE Symphony trial (NCT05969041) evaluating MT-302, an mRNA-LNP-encoded TROP2-targeted in vivo CAR therapy in patients with advanced solid tumors, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting.

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"These data provide important mechanistic insights into how in vivo programmed myeloid cells behave within the tumor microenvironment," said Rasha Cosman BSc (Med), MBBS, FRACP, Head of the Early Phase Clinical Trials Unit at The Kinghorn Cancer Centre, St. Vincents Hospital Sydney, "The degree of remodeling observed, combined with a manageable safety profile and repeat-dose feasibility, and early signal of anti-tumor activity in a heavily pre-treated population, is highly encouraging in tumor settings where immune infiltration has been historically limited. Seeing immune cells effectively reprogrammed inside the body to mount a targeted anti-tumor response represents a meaningful milestone and supports continued clinical advancement."

Results
27 patients with advanced TROP2-positive solid tumors were treated with MT-302 across seven dose cohorts.

Manageable safety profile consistent with immune cell activation.
Dose and tumor burden dependent low grade cytokine release syndrome observed in 51.9% of participants with kinetics consistent with tumor target engagement. There were no events of grade 3 or higher CRS.
Maximum tolerated dose: 0.10 mg/kg without steroid premedication. One Grade 4 ICANS event was observed at the highest dose tested (0.15 mg/kg).
Pharmacokinetics: terminal half-life of pegylated and ionizable lipids 45–50 hours.
Biological activity: CAR⁺ myeloid cells observed within tumors with T-cell infiltration and cytokine induction (IFNγ, CXCL9/10); the CXCL9:SPP1 ratio correlated with tumor-burden change, indicating pro-inflammatory tumor-microenvironment remodeling.
Clinical signal: one confirmed partial response in HR⁺ breast cancer in a patient on treatment for 16 months (20 doses) with pharmacological activity observed at 0.015 mg/kg.
"These data represent the first demonstration of an in vivo CAR therapy achieving tumor penetration and measurable biological activity in patients with solid tumors," said Matt Maurer, MD, Chief Medical Officer of CREATE Medicines. "MT-302 showed proof-of-mechanism while maintaining a manageable safety profile and repeat dosing without preconditioning or immunosuppression."

Conclusions
In this first-in-human study, MT-302 demonstrated tolerable repeat dosing, robust immunologic activity, direct tumor penetration by CAR myeloid cells and broad immune activation in heavily pre-treated patients. These results provide clear proof-of-mechanism for in vivo CAR therapies in solid tumors and support advancement of MT-302 for front-line use. Dosing with MT-302 was recently initiated in the first ever front-line solid tumor trial with an in vivo CAR combined with a standard frontline regimen in the SPaCE-MT trial (EUCT 2024-520213-45-00).

"This is a foundational moment for our platform and for the field of in vivo cell therapy," added Daniel Getts PhD, Chief Executive Officer and co-founder of CREATE Medicines. "We have clinical evidence demonstrating that immune cells can be reprogrammed inside the body to mount a targeted anti-tumor response, paving the way for a new, highly versatile modality in the fight against solid tumors."

Presentation Details:
SITC 40th Anniversary Annual Meeting

Title: First-in-Human Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of mRNA-LNP MT-302 In Vivo CAR Therapy in Solid Tumors
Presenting Author: Dr. Rasha Cosman, The Kinghorn Cancer Centre, St. Vincent’s Hospital Darlinghurst NSW Australia
Category: Clinical Oral Abstract Session 1
Publication Number: LBA 1342
Session Date & Time: Friday, November 7, 2025: 11:30 AM ET- 12:15 PM
Location: Gaylord National Resort & Convention Center, Potomac Ballroom, National Harbor, MD
About MT-302
MT-302 is an investigational mRNA-LNP in vivo CAR therapy designed to program immune cells inside the body. Delivered systemically, MT-302 recognizes and eliminates TROP2-expressing solid tumors by encoding a TROP2-specific chimeric antigen receptor to transiently reprogram immune cells. This approach eliminates the need for ex vivo manipulation or preconditioning, while achieving repeatable dosing and controllable anti-tumor activity.

(Press release, Create Medicines, NOV 7, 2025, View Source [SID1234659651])

On November 7, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported it will host an R&D Day on Monday, November 10, 2025 at 8:00 a.m. ET in New York City featuring in-depth discussions with experts including principal investigators leading the Phase 3 OVATION 3 clinical trial and Phase 2 minimal residual disease (MRD) trial of IMNN-001, a novel IL-12 immunotherapy in development for the treatment of women with advanced ovarian cancer.

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"This is an opportunity to hear directly from the investigators driving IMNN-001 clinical progress forward—physicians who see firsthand the urgent need for new ovarian cancer treatment options and the potential clinical impact of our novel IMNN-001 immunotherapy," said Stacy R. Lindborg, Ph.D., president and chief executive officer of IMUNON. "The data and insights shared will be consequential for understanding the future of ovarian cancer treatment and how we are leading the effort to bring the first advance in the standard of care that could transform frontline treatment, which has not seen innovation for about 30 years."

The event will include presentations from:

Premal H. Thaker, M.D. (Washington University School of Medicine) – Unmet need and OVATION 2 trial data including survival benefits
Amir A. Jazaeri, M.D. (MD Anderson Cancer Center) – Phase 2 MRD study results and immune activation mechanism overview
Giorgio Paulon, Ph.D. (Berry Consultants, LLC) – Phase 3 trial statistical design and path to approval
Douglas V. Faller, M.D., Ph.D. (IMUNON) – Phase 3 trial enrollment momentum and clinical milestones

(Press release, IMUNON, NOV 7, 2025, View Source [SID1234659636])

On November 7, 2025 Akeso, Inc. (HKEX: 9926.HK) reported that the final Overall Survival (OS) analysis results from the HARMONi-A study, a Phase III study evaluating ivonescimab combined with chemotherapy for the treatment of EGFR-mutated non-squamous non-small cell lung cancer (nsq-NSCLC) following EGFR-TKI progression, were selected as a "Late-Breaking Abstract" (LBA) for the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held in National Harbor, Maryland, USA. Professor Xiuning Le from MD Anderson Cancer Center presented these findings to a global audience during an oral presentation session.

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HARMONi-A is the first global Phase III clinical trial of an immunotherapy in the EGFR-TKI resistant, EGFR-mutated nsq-NSCLC setting to demonstrate clinically meaningful and statistically significant benefits in both Progression-Free Survival (PFS) and Overall Survival (OS). This final OS analysis, the first from a Phase III trial of ivonescimab, confirms the breakthrough value of ivonescimab-based therapy in improving both PFS and OS. Historically, cancer immunotherapies have largely failed to demonstrate significant breakthroughs in this specific indication. Prior Phase III trials involving other regimens—such as PD-1 inhibitors combined with chemotherapy or immunotherapies combined with anti-angiogenic therapy, failed to show significant OS benefits. The significant positive outcomes in both PFS and OS in the HARMONi-A study underscore the substantial clinical benefit improvement of ivonescimab over PD-1 inhibitors.

Previously, the HARMONi-A study had already met its primary endpoint, demonstrating a statistically significant improvement in PFS at the interim analysis (PFS HR 0.46, P < 0.001). Previously, during the regulatory review for the approval of ivonescimab in first-line PD-L1-positive NSCLC in China, a descriptive analysis of OS from the HARMONi-A study was conducted in May 2024 at the request of the regulatory authorities. The final OS analysis results presented at SITC (Free SITC Whitepaper) 2025 represent the final and only pre-specified formal OS analysis for the HARMONi-A study, performed as a sequential test according to the pre-specified statistical analysis plan (SAP).

The final OS analysis, with a median follow-up period of 32.5 months, showed that the ivonescimab plus chemotherapy regimen provided a clinically meaningful and statistically significant improvement in OS compared to chemotherapy alone:

The median OS was 16.8 months in the ivonescimab treatment group compared to 14.1 months in the control group (OS HR=0.74, P=0.019), achieving statistical significance. The OS benefit increased with extended follow-up.
The ivonescimab combination regimen consistently demonstrated OS benefit over the control group across all subgroups:
In patients with brain metastases, OS HR=0.61;
In patients without brain metastases, OS HR=0.77;
In patients with EGFR 19Del mutations, OS HR=0.83;
In patients with EGFR L858R mutations, OS HR=0.60.
With a median follow-up of 32.5 months, the long-term safety profile of the ivonescimab combination therapy remained favorable, with no new safety signals identified. The incidence of common treatment-related adverse events (TRAEs) showed no significant difference between the two groups.

Based on the positive clinical data from the HARMONi-A study, ivonescimab received approval from the China National Medical Products Administration in May 2024 for this indication. In November 2024, Akeso announced that ivonescimab was successfully added to China’s National Reimbursement Drug List, effective January 1, 2025, ensuring widespread patient access to this life-saving treatment.

Additionally, Summit Therapeutics, Akeso’s global partner for ivonescimab, announced in October 2025 that it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025, seeking approval for ivonescimab in combination with chemotherapy for the treatment of EGFR-mutant, third-generation EGFR-TKI-resistant, non-squamous NSCLC.

(Press release, Akeso Biopharma, NOV 7, 2025, View Source;302608764.html [SID1234659652])

On November 7, 2025 Trained Therapeutix Discovery, Inc., a biotech company training immunity at its origin with nanomedicines, reported preclinical data on RIDE-001, a nanomedicine designed to program myeloid progenitor cells for an anticancer innate immune response, were presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The data demonstrated that RIDE-001 effectively induced trained immunity in vitro in primary human immune cells, induced anti-tumor immunity in mouse tumor models of melanoma and colorectal cancer, and safely induced innate immune responses in rats and non-human primates. RIDE-001 showed therapeutic activity against solid tumors as a single agent, and it also exhibited synergy in combination with immune checkpoint inhibition.

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"Myeloid cells can promote cancer by suppressing anti-tumor immune responses, enhancing tumor angiogenesis and facilitating metastasis, but due to their plasticity in the tumor microenvironment, they have been considered an unattractive therapeutic target," said Willem Mulder, PhD, Chief Scientific Officer of Trained Therapeutix Discovery. "Our approach with RIDE-001 is a breakthrough in immune-oncology, as it targets myeloid progenitor cells before they differentiate into immune cells. By programing myeloid cells at their naissance, we can deploy the power of the innate immune response against cancer. Based on these promising data demonstrating consistent myeloid cell training and antitumor activity across species, in addition to RIDE-001’s favorable safety profile, we have initiated GMP manufacturing in anticipation of the first clinical studies in patients with solid tumors."

RIDE-001 was developed using Trained Therapeutix Discovery’s proprietary ApoA1-based nanomedicines platform to target the bone marrow where it activates the intracellular pattern recognition receptor NOD2. This triggers epigenetic changes in myeloid progenitor cells, inducing the production of trained myeloid cells to generate durable, anti-tumor responses.

RIDE-001 preclinical data showed:

A dose-dependent rise in NOD2 activation;
Trained immunity as assessed by peripheral blood mononuclear cells (PBMCs);
Trained myeloid cells in rats demonstrating a shift in monocyte phenotype and increased blood neutrophil counts;
Trained myeloid cells in non-human primates with a consistent increase in intermediate monocytes in both males and females following each administered dose;
Single-agent anti-tumor efficacy in the highly immunosuppressive B16F10 melanoma mouse model;
Synergy with a subtherapeutic dose of anti-PD1 in the MC38 colorectal cancer mouse model;
And a favorable safety profile.
A copy of the poster titled "RIDE-001: A well-tolerated innate immunotherapy to treat cancer by targeting and reprogramming bone marrow progenitor cells" (abstract number 1178) is available on the company’s website.

(Press release, Trained Therapeutix Discovery, NOV 7, 2025, View Source [SID1234660997])