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Freenome Delivers Improved Performance in Its Colorectal Cancer Blood Test with Sensitivity of 85% for CRC and 22% for Advanced Precancerous Lesions

On January 6, 2026 Freenome, an early cancer detection company developing blood-based screening tests, reported the improved clinical performance of an updated version of its SimpleScreen CRC test. In data being shown at this week’s ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, the updated colorectal cancer (CRC) test detected 85% of CRC cases and 22% of advanced precancerous lesions (APLs) at 90% specificity.

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The increased clinical sensitivity – higher than previously reported from Freenome’s PREEMPT CRC Study1 – reflects improvements made to the assay, including optimizing key aspects of the reagents, workflow and automation of the testing platform. The original test and the updated version were compared head-to-head by evaluating all study subjects with both versions, which controls for biological variation and cohort effects. For both CRC and APL, the PREEMPT CRC clinical performance results were within the confidence intervals of the original test in this study, which helps validate the credibility of the improvements made to the underlying platform.

Additional improvements in the updated test included increased sensitivity of 44% for APLs with high-grade dysplasia, a 2.6-fold reduction in the limit of detection, and meaningful improvements in projected patient outcomes (9% reduction in lifetime CRC cases and 10% reduction in CRC deaths). A total of 966 samples were tested from an average-risk cohort, with results adjusted to the intended-use population using U.S. Census and PREEMPT CRC cohort information.

"The results Freenome is presenting at ASCO (Free ASCO Whitepaper) GI this week for an updated CRC screening test – utilizing our personalized multi-cancer detection platform – demonstrate that we can deliver a versioning strategy to generate significant improvements in test performance," said Aaron Elliott, Ph.D., CEO of Freenome. "As we look ahead to 2026 and the planned launch of multiple blood-based cancer screening tests, we are confident in our potential to systematically improve the detection of cancer at its earliest, most treatable stages."

Data for Freenome’s updated CRC test will be presented at ASCO (Free ASCO Whitepaper) GI in a poster session at 7:00 a.m. PT on Saturday, Jan. 10, 2026. The presenting author will be Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study.

Freenome’s multiomics discovery platform evaluates multiple biomarker classes, including genomics, epigenomics and proteomics, to identify the early biological signals of disease in the bloodstream. SimpleScreen CRC was built using this platform and applies an AI/ML-based model to detect specific methylation signatures in tumor-derived cell-free DNA (cfDNA) at single-base resolution.

Freenome has also been working on upgrades to the AI/ML learning algorithm; these improvements will be described in future work.

In August, Freenome completed its Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for the initial version of its SimpleScreen CRC test. The company intends to submit a supplemental PMA application for the updated test following expected approval of SimpleScreen CRC and completion of a larger, independent clinical validation study in 2026.

(Press release, Freenome, JAN 6, 2026, View Source [SID1234661776])

Ivonescimab’s Updated Label Shows Positive Dual Results in PFS and OS from HARMONi-A Study

On January 6, 2026 Akeso, Inc. (9926.HK) reported that the National Medical Products Administration has approved a significant label update in China for its internally developed, first-in-class PD-1/VEGF bispecific antibody, ivonescimab. The updated label incorporates final analysis data from the AK112-301/HARMONi-A study, which demonstrated statistically significant and clinically meaningful dual benefits in both progression-free survival (PFS) and overall survival (OS) for ivonescimab combination therapy in patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) who had progressed after EGFR-TKI therapy.

This update highlights how the HARMONi-A trial stands as the world’s first Phase III immunotherapy study in EGFR-TKI-resistant nsq-NSCLC to deliver clinically meaningful and statistically significant improvements in both co‑primary endpoints, PFS and OS. It is also the first randomized, double‑blind Phase III trial in this setting to report positive outcomes for both survival endpoints concurrently, supporting the exceptional benefits for patients from Akeso’s combination of immunotherapy and anti-angiogenic approach.

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:

At 77% data maturity, ivonescimab combination lowered the risk of death by 26% (OS HR=0.74, P=0.019), with the survival benefit becoming more evident over time. It also reduced the risk of disease progression or death by 54% (PFS HR=0.46, P＜0.001), extending median PFS from 4.8 to 7.1 months.
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, ivonescimab was added to China’s National Reimbursement Drug List (NRDL), effective January 1, 2025, ensuring widespread patient access to this life-saving treatment.

In April 2025, ivonescimab’s new indication for the first-line treatment of PD-L1-positive NSCLC was also approved, and subsequently included in China’s NRDL later in the same year, effective January 2026. The first-line treatment approval and the NRDL inclusion provides a new, highly effective, well-tolerated, and durable chemotherapy-free therapeutic option for the first-line treatment of NSCLC in China.

(Press release, Akeso Biopharma, JAN 6, 2026, View Source [SID1234661775])

AbelZeta to Attend 44th Annual J.P. Morgan Healthcare Conference and Join Panel Discussion

On January 6, 2026 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, reported it will attend the 44th Annual J.P. Morgan Healthcare Conference on January 12-15, 2026 in San Francisco, CA, and host meetings showcasing the Company’s recent accomplishments and sharing strategic plans moving forward. The Company’s Chairman and CEO, Tony (Bizuo) Liu, has also been invited as a panel speaker at the Conference.

Session:

Emerging Biotechs from China

Time & Date:

January 14, 2026, 16:30 – 17:15 PST

Location:

Pacific Hall, Convene, 40 O’Farrell St, San Francisco

Description:

China is emerging as a hub of global biotech innovation. Leveraging on strong capability in early discovery
and clinical resources, China’s biotech companies are joining the global innovation in the next wave of oncology and
autoimmune assets. In this panel, J.P. Morgan invited CEOs with lead assets in cell therapy and other modalities and will
discuss differentiation of their assets and strategy for business developments

(Press release, AbelZeta, JAN 6, 2026, View Source [SID1234661774])

Atossa Therapeutics Receives FDA "Study May Proceed" Letter for (Z)-Endoxifen Investigational New Drug Application for Metastatic Breast Cancer

On January 6, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines for unmet medical needs, reported that the U.S. Food and Drug Administration ("FDA") issued a "Study May Proceed" letter for the Company’s study in metastatic breast cancer which was the subject of a recent investigational new drug application for (Z)-endoxifen.

"This letter marks an important regulatory milestone for Atossa and to potentially expand the use of (Z)-endoxifen for metastatic ER+/HER2- Breast Cancer. We believe its activity, even in tumors that have developed resistance to other endocrine therapies and in the oncogenic signaling pathway, protein kinase C beta 1 (PKCβ1), may offer a new tool in treating this disease.," said Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer. "We appreciate the FDA’s review and look forward to advancing this clinical investigation."

About (Z)-Endoxifen

(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company’s proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa’s (Z)-Endoxifen is not approved for any indication.

Atossa’s (Z)-Endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.

(Press release, Atossa Therapeutics, JAN 6, 2026, View Source [SID1234661773])

Astellas to Present at 44th Annual J.P. Morgan Healthcare Conference

On January 6, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12-15, 2026, in San Francisco, Calif. As a global leader in life sciences, Astellas will use this premier platform to highlight its key strategic focuses and the tangible progress achieved to date in support of delivering long-term impact for patients, partners, and shareholders.

During the conference, President and CEO Naoki Okamura will present Astellas’ key growth drivers and commitment to disciplined execution. Chief Research & Development Officer Tadaaki Taniguchi will also join the session, and together, they will emphasize how Astellas is advancing transformative scientific breakthroughs for diseases with high unmet medical need and reinforcing its leadership in healthcare innovation and shaping the future of patient care.

Naoki Okamura, President and CEO, Astellas
"Our focus is clear: we are working to turn innovative science into meaningful VALUE for patients and drive sustainable growth. The J.P. Morgan Healthcare Conference provides an exceptional opportunity to engage with the global investment and healthcare community and demonstrate how our strategy and execution position Astellas for long-term success."

Presentation Details

Event: 44th Annual J.P. Morgan Healthcare Conference
Date & Time: January 12, 2026, at 3:00 p.m. PT
Location: Westin St. Francis, San Francisco
The presentation materials and a live webcast link will be available on the Investor Relations page of Astellas.com on the day of the presentation. A link to the on-demand replay will be made available shortly after the presentation.

As a distinguished sponsor of Biotech Showcase held in San Francisco the same week, Astellas is furthering its visibility in the global life sciences community. Chief Strategy Officer Adam Pearson will join a plenary session on partnering trends that are advancing emerging technologies and drug development innovation—underscoring Astellas’ commitment to pioneering science and fostering collaborations to benefit patients worldwide.

(Press release, Astellas Pharma, JAN 6, 2026, View Source [SID1234661772])