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Artera Debuts ArteraAI Prostate Test (Post‑RP), Expanding its Oncology Portfolio

On December 9, 2025 Artera, a developer of multimodal AI-based prognostic and predictive cancer tests, reported the commercial launch of the ArteraAI Prostate Test (Post‑RP) for patients experiencing biochemical recurrence (BCR) following radical prostatectomy.

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The test builds on the established ArteraAI platform and delivers prognostic results and insights into short-term ADT benefit to optimize decision-making in the salvage therapy setting, where additional treatment is given if cancer returns after surgery.

After radical prostatectomy, PSA should be undetectable. A rising PSA after surgery can indicate biochemical recurrence, suggesting residual cancer cells may remain. With an estimated 20% to 40% of patients affected, the test now delivers personalized, AI-driven data to this previously underserved population, expanding access to advanced precision medicine.

"The launch of the ArteraAI Prostate Test (Post-RP) is a significant milestone in Artera’s continued growth," said Andre Esteva, CEO of Artera. "This expansion broadens our portfolio, extends our reach to an underserved patient population, and strengthens our partnerships across the healthcare ecosystem. As demand for responsible AI in oncology accelerates, we remain focused on scaling access, delivering measurable value to clinicians, and ensuring our technology reaches the patients who need it most."

This test is based on the robust data presented at the 2024 AUA Annual Meeting, which showed that ArteraAI’s MMAI-based prostate biomarker can accurately estimate the risk of metastasis and help predict which men may benefit from intensified salvage therapy, including hormone therapy plus radiation.

"There is a continued need to optimize treatment for men with post-prostatectomy BCR, especially in understanding which patients benefit from ADT when undergoing salvage radiation," said Todd Morgan, urological surgeon and Chief of Urologic Oncology at Michigan Medicine. "This test has substantial promise for helping individualize these treatment decisions."

As with all Artera products, the ArteraAI Prostate Test (Post‑RP) integrates seamlessly into standard pathology workflows, enabling rapid turnaround and broad accessibility. The test relies on the digitized image of the surgical specimen, preserving the resected tissue while delivering actionable insights to guide personalized treatment decisions.

The launch of the ArteraAI Prostate Test (Post-RP) reinforces Artera’s mission to advance the frontier of precision oncology, offering a timely, cost-effective tool that complements clinical assessments for patients with recurrent prostate cancer.

The ArteraAI Prostate Test (Post‑RP) is now available for commercial ordering nationwide. For more information, visit artera.ai.

(Press release, Artera, DEC 9, 2025, View Source [SID1234661334])

CytoAgents to Present New CTO1681 Data at the ESMO Immuno-Oncology Congress 2025

On December 9, 2025 CytoAgents, Inc., a clinical-stage biotechnology company developing CTO1681, a novel, steroid-sparing inhibitor of prostaglandin-mediated inflammation reported that data from two of its Investigational New Drug (IND) application enabling studies will be presented at the European Society for Medical Oncolgy (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2025, taking place December 10-12, 2025 in London, United Kingdom.

CTO1681 is an orally administered immune modulator that targets inflammation in the tumor microenvironment and mitigates cell therapy induced toxicities frequently seen in lymphoma patients receiving CAR T-Cell Therapy. CytoAgents is currently enrolling patients in a Phase 1b/2a clinical trial evaluating CTO1681 in lymphoma patients receiving CAR T-Cell Therapy at risk for inflammatory driven toxicities.

At ESMO (Free ESMO Whitepaper), the company will present data from two non-clinical studies demonstrating that CTO1681 attenuates key cytokines known to drive Cytokine Release Syndrome (CRS) without compromising the CAR T-Cell mediated tumor killing in vitro and in vivo. These studies demonstrate that CTO1681 does not interfere with CD19 CAR T-Cell expansion and anti-tumor activity in vivo while reducing the inflammatory cytokines associated with CRS and ICANS.

"These data suggest CTO1681 could enable safer CAR T-Cell Therapy administration, support outpatient treatment paradigms and broaden patient access without compromising anti-tumor efficacy," said Teresa Whalen, Chief Executive Officer at CytoAgents. "We look forward to sharing these data at ESMO (Free ESMO Whitepaper) and to continuing our advancement of CTO1681."

Poster Presentation Details:

Title: CTO1681 Does Not Interfere with CAR T-Cell Anti-Tumor Efficacy In Vivo

Presenter: Michael Howell, PhD, Founder and President Mountaineer Biosciences, San Diego, CA, USA

Final Poster Number (FPN): 109P

Session Date and Time: Wednesday, December 10, 2025, 5:15 PM – 6:30 PM GMT

Location: Queen Elizabeth II Centre – Churchill Room

Title: CTO1681 Attenuates CRS-Driving Cytokines Without Compromising CAR T-Cell-Mediated Tumor Killing In Vitro

Presenter: Michael Howell, PhD, Founder and President Mountaineer Biosciences, San Diego, CA, USA

Final Poster Number (FPN): 113P

Session Date and Time: Wednesday, December 10, 2025, 5:15 PM – 6:30 PM GMT

Location: Queen Elizabeth II Centre – Churchill Room

(Press release, CytoAgents, DEC 9, 2025, View Source [SID1234661333])

CREATE Medicines Doses First Patient in Frontline HCC Trial Evaluating MT-303, an In Vivo CAR Therapy, in Combination with Standard-of-Care Immunotherapy

On December 9, 2025 CREATE Medicines Inc., a clinical-stage biotechnology company pioneering in vivo multi-immune programming, reported that the first patient has been dosed in the frontline cohort of its metastatic hepatocellular carcinoma (HCC) clinical trial evaluating MT-303. The study is assessing MT-303, an investigational in vivo GPC3-targeted CAR therapy delivered by the company’s proprietary mRNA-LNP platform, in combination with atezolizumab and bevacizumab, the current global standard-of-care regimen for frontline HCC.

This milestone marks the first time MT-303 is being evaluated in systemic treatment-naïve patients, where immune fitness is better preserved and there is greater potential for deep, durable responses to immunotherapy. Clinical correlative data from CREATE’s ongoing monotherapy programs, including MT-302 and MT-303, have demonstrated in vivo CAR expression, immune activation, and tumor infiltration across more than 40 treated patients. These findings provide strong biological rationale for combination therapy and support the potential for additive or synergistic benefit when MT-303 is paired with atezolizumab and bevacizumab in the frontline setting.

In addition, MT-303 has shown a manageable and differentiated safety profile as a monotherapy, reinforcing the suitability of CREATE’s mRNA-LNP in vivo CAR approach for use alongside established immunotherapies. The platform’s flexibility, redosability, and absence of lymphodepletion requirements position MT-303 well for combination regimens in earlier-line settings where coordinated immune activation is essential.

"Advancing MT-303 into a frontline combination study represents an important evolution for the in vivo CAR field," said Matthew Maurer, M.D., Chief Medical Officer of CREATE Medicines. "Our monotherapy experience across MT-302 and MT-303 has generated compelling correlative evidence of immune activation, myeloid engagement, and tumor infiltration. These data, combined with MT-303’s favorable safety and tolerability profile, support our confidence in evaluating the therapy alongside atezolizumab and bevacizumab. We believe MT-303 is well-positioned to drive deeper and more durable responses for patients with HCC."

"New modalities capable of expanding the benefit of the current treatment options for hepatocellular carcinoma are urgently needed," said Vladimir Andelkovic, M.D., FRACP, Principal Investigator, ICON Cancer Centre, Brisbane, Australia. "Adding the immune engagement potential of MT-303 to atezolizumab and bevacizumab in frontline systemic therapy, where immune fitness is more preserved, is both scientifically compelling and potentially clinically meaningful."

About MT-303

MT-303 is an experimental, in vivo GPC3-targeted CAR therapy that selectively programs myeloid cells using CREATE’s redosable mRNA-LNP system. MT-303 is designed to produce:

CAR expression in circulating and tumor-infiltrating myeloid cells
Direct cytotoxicity against GPC3-positive tumor cells
Immune-modulating effects that recruit adaptive immunity
Repeat-dose capability with improved durability, requiring no lymphodepletion or ex vivo manufacturing
GPC3 is highly expressed across a majority of HCC cases and absent in normal adult tissue, making it an ideal target for directed immunotherapy. In the monotherapy dose escalation cohort of the MT-303 Phase 1/2 trial, the therapy demonstrated human proof-of-mechanism for in vivo CAR expression, myeloid-cell activation, tumor infiltration, evidence of clinical activity and the feasibility of repeat-dose regimens. These results provide the foundation for advancing MT-303 into combination and earlier-line settings.

About the Frontline HCC Study Evaluating MT-303

The frontline HCC study evaluating MT-303 (NCT06478693) is a multi-center, open-label, dose-escalation and expansion trial designed to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of MT-303 in combination with atezolizumab and bevacizumab. The trial will evaluate MT-303 in adults with unresectable or metastatic HCC who have not received prior systemic therapy.

The study will also characterize markers of immune activation, including CAR expression kinetics, cytokine/chemokine profiles, tumor infiltration by innate and adaptive immune cells, and early signs of antitumor activity. Data generated from this trial will inform recommended Phase 2 dose selection, further combination strategies, and potential expansion into additional earlier-line or biomarker-defined patient populations.

About Hepatocellular Carcinoma

Liver cancer is among the fastest-growing causes of cancer-related mortality globally, with more than 850,000 new cases diagnosed each year. Hepatocellular carcinoma accounts for most liver cancer cases and often arises in the context of chronic liver disease, viral hepatitis, metabolic syndrome, or cirrhosis. Although recent advances in targeted agents and immunotherapies have improved patient outcomes, durable, long-term benefit remains limited for most patients. Once frontline therapies fail, treatment options become scarce, and prognosis worsens sharply. Novel therapeutic approaches capable of generating coordinated and sustained immune responses represent an urgent and unmet need for the global HCC patient community.

(Press release, Create Medicines, DEC 9, 2025, View Source [SID1234661332])

Phase II Data of Cadonilimab Regimen as Neoadjuvant Therapy for Resectable Gastric Cancer Presented at ESMO Asia 2025

On December 9, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy for resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, was presented at the 2025 ESMO (Free ESMO Whitepaper) Asia Congress.

Currently, Akeso is running the pivotal Phase III study (AK104-310/COMPASSION-33) investigating cadonilimab combined with the SOX regimen for perioperative treatment of resectable G/GEJ adenocarcinoma. This regimen is expected to further push the efficacy boundaries beyond existing single-target immunotherapies and establish a new standard for perioperative immunotherapy in gastric cancer.

Promising Pathologic Complete Response (pCR) Rate

Among all evaluable patients, the overall pCR rate was 28.6%. Notably, in patients receiving the cadonilimab Q3W dosing regimen, the pCR rate reached 50.0%. pCR, defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes upon surgical resection, is considered the "gold standard" surrogate endpoint for evaluating neoadjuvant treatment efficacy and predicting long-term survival benefits.

High Rate of Major Pathologic Response (MPR)

The overall MPR rate (defined as ≤10% residual viable tumor cells) across all evaluable patients was 71.4%. For the cadonilimab Q3W regimen, the MPR rate was as high as 85.7%. This suggests that the cadonilimab-based regimen induces substantial tumor regression in the majority of patients.

100% R0 Resection Rate

All patients who underwent surgery achieved an R0 resection (microscopically margin-negative resection), providing a solid foundation for curative intent and potentially reducing the risk of recurrence.

Significant Tumor Downstaging

Among all evaluable patients, 85.7% achieved downstaging of the primary tumor (ypT), and 75.0% achieved nodal downstaging (ypN). These results confirm the efficacy of the cadonilimab regimen in reducing tumor burden and lowering the pathological stage, thereby improving the conditions for successful surgical intervention.

Manageable Safety Profile with Good Tolerability

Treatment-related adverse events were consistent with the known safety profiles of the SOX regimen and immune checkpoint inhibitors. No new or unexpected safety signals were observed, indicating an overall manageable and favorable safety profile.

In perioperative treatment of resectable G/GEJ adenocarcinoma, chemotherapy remains the standard therapy for locally advanced gastric cancer. However, chemotherapy has limited efficacy. Cadonilimab, the first PD-1/CTLA-4 bispecific antibody, works by synergistically activating the immune system, achieving a dual blockade of the tumor immune suppressive microenvironment. This mechanism provides a stronger anti-tumor effect compared to PD-1/L1 monotherapies.

Currently, cadonilimab’s clinical value in gastric cancer is scientifically well-established. Beyond its ongoing phase III clinical trial in the perioperative setting, cadonilimab combined with chemotherapy as a first-line treatment for advanced gastric cancer (with survival benefits across the PD-L1 expression levels) has been approved for commercialization in China. Additionally, a pivotal phase III trial exploring cadonilimab in combination with pulocimab (VEGFR-2) for immune therapy-resistant advanced gastric cancer is currently ongoing and is expected to offer a new therapeutic option for later-line gastric cancer. Collectively, these pivotal phase III studies will expand the use of cadonilimab, paving the way for a comprehensive gastric cancer treatment options that spans from advanced, unresectable gastric cancer to early-stage, resectable disease.

(Press release, Akeso Biopharma, DEC 9, 2025, View Source [SID1234661331])

GC Genome Study Identifies ‘Confounders’ Interfering with Cancer Signals to Improve Liquid Biopsy Accuracy

On December 9, 2025 GC Genome, a leading clinical genomics and liquid biopsy company, reported that its study analyzing cell-free DNA (cfDNA) fragmentation patterns in 1,154 healthy individuals has been published in Clinical Chemistry (Impact Factor 6.3, 2025). The findings reveal key physiological factors that can interfere with cancer-associated cfDNA signals, offering a foundation for improving the accuracy of liquid biopsy tests.

The study, conducted in collaboration with Professor Min-Jung Kwon and her team at Kangbuk Samsung Medical Center, examined correlations between cfDNA fragmentomic profiles and 65 clinical variables, including age and liver function markers. The goal was to identify potential confounders that could influence cfDNA-based cancer detection in individuals without cancer.

Study Overview

Healthy cohort: 1,154 noncancerous individuals who underwent routine health checkups
Clinical variables included: 65 demographic, hematologic, and biochemical parameters
Three fragmentomic features were derived: cfDNA concentration, short-fragment ratio (SFR), and frequency of cancer-enriched motifs(CEMs)
Key Findings

Liver enzymes(including AST, ALP, γ-GTP) and age were identified as major factors altering cfDNA fragmentation patterns.
Elevated AST or age closely resembled cancer-like fragmentomic signatures, blurring the distinction between noncancer and cancer profiles.
AST showed high similarity to fragmentation size patterns seen in lung cancer patients (cosine similarity = 0.98).
Age showed the highest similarity to cancer-like profiles among clinical variables (cosine similarity = 0.52).
Receiver Operating Characteristic (ROC) analysis confirmed that these physiological variables can act as confounders by reducing the specificity of cfDNA-based detection, potentially leading to false-positive results.
These findings demonstrate that non-cancer physiological factors can influence cfDNA signals, underscoring the need for confounder-aware modeling approaches in liquid biopsy development.

A GC Genome spokesperson stated:

"This study is significant because it uses large-scale data from healthy individuals to identify key confounders that influence cfDNA fragmentation patterns. These insights will play an important role in refining our Multi-Cancer Early Detection (MCED) test, ai-CANCERCH, particularly in reducing false-positive rates and improving test specificity."

About ai-CANCERCH

Launched in September 2023, ai-CANCERCH is an AI-based multi-cancer early detection(MCED) test powered by Lc-WGS. Using just 10 mL of blood, the test detects signals associated with multiple cancers. A major upgrade—expanding from 6 detectable cancers to 10 cancers (colorectal, lung, esophageal, liver, ovarian, pancreatic, biliary, breast, gastric, and head-and-neck)—is planned for January 2026.

(Press release, GC Genome, DEC 9, 2025, View Source [SID1234661330])