On September 7, 2026 Rznomics Inc.(KOSDAQ: 476830), a biopharmaceutical company specializing in the development of RNA-based gene therapies, reported a major breakthrough in the high-efficiency production of circular RNA (circRNA) – a rapidly emerging modality in next-generation RNA therapeutics.

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The research was published online in Nucleic Acids Research (NAR), a premier international journal in the fields of nucleic acid research and molecular biology, on September 4, 2026. The article is titled "Target Site Selection and P1 Engineering Enable Highly Efficient Circular RNA Production via End-to-End Self-Targeting and Splicing".

The study highlights a substantial enhancement in the circRNA production efficiency of Rznomics’ proprietary Self-Targeting and Splicing (STS) technology, which enables RNA molecules to spontaneously form a circular structure during in vitro transcription.

Unlike conventional linear RNA, circRNA features a covalently closed-loop structure, rendering it highly resistant to enzymatic degradation. This superior stability makes circRNA a highly promising platform for a broad spectrum of RNA-based medicines, including vaccines and protein therapeutics.

However, circularization efficiency generally decreases as RNA length increases. This limitation restricts the size of genes that can be practically accommodated and poses a challenge for efficient large-scale manufacturing.

To address this limitation, the Rznomics research team systematically screened target sites for self-circularization and implemented an engineering strategy to optimize the P1 construct involved in the self-circularization reaction.

The study revealed that self-circularization efficiency fluctuates significantly depending on the location of the target site, even within the same RNA sequence, demonstrating that optimal target site selection is a key factor for high-yield circRNA production. The researchers further engineered the P1 construct by sequentially introducing a short polyA10 sequence and an antisense sequence designed to strengthen interaction with the target site, improving self-circularization efficiency by up to approximately seven-fold compared with the original STS design.

Notably, in experiments using Factor VIII RNA approximately 7.8 kilo-nucleotides in length, the optimized STS method achieved approximately a two-fold higher circularization efficiency than the widely used Permuted Intron–Exon (PIE) method.

These findings demonstrate that integrating strategic target-site selection with P1 construct engineering enables efficient circRNA production not only for relatively short RNAs but also for large RNAs approaching 8 kilo-nucleotides. Rznomics anticipates that this technology could serve as a broadly applicable platform for the development of circRNA-based therapeutics and vaccines.

Dr. Kyung Hyun Lee, first and co-corresponding author of the study, stated, "By establishing a foundation for the efficient and robust production of circRNA even from large RNA molecules, we expect this technology to help broaden the potential horizons of circRNA application."

Dr. Seong-Wook Lee, CEO of Rznomics and co-corresponding author, added, "This milestone further advances our proprietary circRNA platform and strengthens its potential for practical applications. Moving forward, we plan to expand its utility across diverse therapeutic areas, including CAR-T therapies."

(Press release, Rznomics, SEP 7, 2026, View Source [SID1234670610])

On September 7, 2026 Nerviano Medical Sciences S.r.l. ("NMS"), a global oncology-focused biopharmaceutical company, reported its participation in the upcoming World Conference on Lung Cancer ("WCLC") of the International Association for the Study of Lung Cancer ("IASLC"), taking place in Seoul, Republic of Korea, from September 12 to 15, 2026.

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At the meeting, NMS will present a scientific poster featuring its proprietary PARP7 inhibitor, atamparib.

Title: "A Phase Ib/II Study of Atamparib, a PARP7 Inhibitor, in Patients with Advanced Solid Tumors"

Presenter: Dr. Xinru Chen, Shanghai East Hospital

Poster Section: Clinical Trials in Progress

Poster Board Number: P2-372

Abstract Control Number: 606

Date & Time: Monday, September 14, 2026 at 10:30 AM KST / UTC +9

Link to full poster abstract: View Source

This ongoing phase 1b/2 trial is evaluating atamparib, a potential, orally bioavailable, selective PARP7 inhibitor. Through its unique dual mechanism of action, atamparib disrupts KRAS-driven and other oncogenic signaling pathways, while activating innate immune responses. The study is currently exploring higher dose levels and generating proof-of-concept data in selected patients with advanced or metastatic NSCLC adenocarcinoma.

We look forward to engaging with the scientific community at the IASLC 2026 WCLC and sharing insights from our work.

About Atamparib

Atamparib was acquired by NMS from Ribon Therapeutics in November 2024 (previously RBN 2397/ONO 7119). It has demonstrated a favorable tolerability profile in prior Phase I/II clinical evaluation (NCT04053673, NCT05127590, JRCT2031210373). Supported by new preclinical data and early signs of clinical activity, NMS is advancing atamparib for the treatment of advanced or metastatic solid tumors, with the goal of addressing significant unmet medical needs as a single agent and in combination regimens.

20260912-NMS WCLC Poster Presentation

(Press release, Nerviano Medical Sciences, SEP 7, 2026, View Source [SID1234670609])

On September 4, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology and precision intracellular drug-delivery company, reported an update on its sharing agreement dated March 6, 2026 (the "Sharing Agreement") with Sorbie Bornholm LP ("SBLP") previously described in the Company’s news releases of March 9 and February 27, 2026.

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On March 6, 2026, the Company completed a non-brokered private placement in which it issued 17,445,455 units of the Company ("Units") at a price of $0.55 per unit for gross proceeds of $9,595,000.25 (the "Offering"). Of the Units issued under the Offering, 10,909,091 Units were subscribed for by SBLP and Sorbie Investments LLP for gross proceeds of $6,000,000 (the "Proceeds"). The common shares comprised in the Units (the "Placement Shares") were allotted to SBLP and Sorbie Investments LLP.

Pursuant to the Sharing Agreement, the Company would receive 18 monthly cash settlements (each, a "Settlement"), each determined by reference to a benchmark price of $0.7332 per common share. The amount payable to the Company under each Settlement is calculated based on a volume weighted average price for 20 trading days prior to each Settlement (the "20 Day VWAP") relative to the benchmark price, with the maximum permitted discount to the market price at the time. If the 20 Day VWAP is below the benchmark price, the Company will receive less than the monthly amount of $333,333; if the 20 Day VWAP exceeds the benchmark price, the Company will receive more than the monthly amount of $333,333. The final amount of each Settlement will depend on the Company’s future share price, which is subject to market fluctuations and may vary over time.

The Company has received the first Settlement in the amount of $182,623.49 as of the settlement date of August 14, 2026, against 606,060 Placement Shares released to SBLP. As of today, 10,303,031 Placement Shares are held in escrow in connection with the Sharing Agreement and there are 17 Settlement payments remaining.

(Press release, Defence Therapeutics, SEP 4, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-provides-updates-on-sharing-agreement [SID1234670605])

On September 4, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved Guardant360 CDx as a companion diagnostic (CDx) to identify patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer harboring tumors with ESR1 mutations before radiographic progression who may benefit from treatment with ETCAMAH (camizestrant), AstraZeneca’s next-generation oral selective estrogen receptor degrader (SERD). Guardant360 CDx is the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer, and this approval represents a major shift from therapy selection and switching post-radiographic progression to adaptive cancer management and early interception using pre-radiographic progression circulating tumor DNA (ctDNA) testing.

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The approval is based on data from the pivotal SERENA-6 clinical trial, which introduced a first-of-its-kind treatment strategy using ctDNA monitoring to detect emerging ESR1 resistance mutations before radiographic disease progression. Patients who switched to ETCAMAH in combination with continuing a cyclin-dependent kinase (CDK) 4/6 inhibitor versus continuing treatment with an aromatase inhibitor with a CDK4/6 inhibitor following ESR1 mutation detection experienced a 56% reduction in the risk of progression or death. The trial demonstrated the clinical value of proactively identifying disease progression earlier than radiographic imaging and adapting therapy earlier in the course of disease.

"This approval represents a landmark shift in how we define disease progression and reinforces the transformative role of liquid biopsy in guiding therapy decisions earlier at a critical moment in a breast cancer patient’s treatment journey," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "The SERENA-6 paradigm opens a new frontier in how cancer is managed, with potential application across different diseases and therapies."

Approximately 37,000 women in the U.S. living with advanced HR-positive breast cancer being treated with an aromatase inhibitor could potentially benefit from this new therapeutic approach leading to better progression-free survival and outcomes.

Advancing a New Precision Medicine Paradigm

Historically, biomarker testing in advanced cancer most often occurred after clinical or radiographic progression. The SERENA-6 study demonstrated the value in a fundamentally different approach: ctDNA surveillance during first-line endocrine therapy to identify the emergence of resistance before overt disease progression.

Patients enrolled in the study underwent serial testing with Guardant360 CDx every three months while receiving an aromatase inhibitor with a CDK4/6 inhibitor. Upon detection of an ESR1 mutation before radiographic progression, eligible patients were transitioned to camizestrant-based treatment. Patients treated under this new paradigm experienced 74% longer median progression-free survival (16.0 vs. 9.2 months) with a 47% reduction in risk of deterioration in global health status and quality of life.

Strategic Collaboration with AstraZeneca

The approval reflects a multi-year collaboration between Guardant Health and AstraZeneca focused on integrating Guardant Health products and capabilities into clinical development.

Guardant Health supported the study through its FDA-approved Guardant360 CDx platform, providing high-sensitivity ESR1 mutation detection capabilities across serial testing timepoints. The collaboration enabled accessible, scalable biomarker testing designed to support rapid clinical decision-making and broad patient access.

This latest FDA approval for Guardant360 CDx marks the 29th CDx indication across multiple tumor types globally, building on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.

About Guardant360 CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.

(Press release, Guardant Health, SEP 4, 2026, View Source [SID1234670603])

On September 4, 2026 Acepodia (6976: TT), a clinical-stage biotechnology company developing next-generation cell therapies and antibody-drug conjugates, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ACE723, a GPC3-targeted dual-payload antibody-drug conjugate (ADC) developed using Acepodia’s proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC). The clearance enables Acepodia to advance ACE723 into Phase 1 clinical development.

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"The FDA clearance of ACE723 marks an important milestone for our AD2C platform and brings our first AD2C-generated candidate into clinical development," said Sonny Hsiao, Ph.D., Chief Executive Officer and Chairman of Acepodia. "ACE723 is designed to deliver two cytotoxic payloads to GPC3-expressing tumor cells, with the goal of addressing tumor heterogeneity and potential resistance to single-payload therapies. We look forward to evaluating its safety, pharmacokinetics and preliminary anti-tumor activity in patients with unresectable or metastatic HCC."

ACE723 is an investigational GPC3-targeted dual-payload ADC developed through Acepodia’s proprietary AD2C platform, which integrates expertise in antibody engineering, medicinal chemistry and tumor biology. GPC3 is a tumor-associated antigen frequently expressed in HCC, providing a potential target for selective delivery of cytotoxic payloads to tumor cells.

HCC accounts for more than 70% of liver cancer cases worldwide. Although immunotherapy-based combination regimens have improved first-line treatment for patients with unresectable or metastatic disease, significant unmet medical need remains for patients whose disease progresses or becomes resistant to treatment, underscoring the need for therapies with differentiated mechanisms of action.

The planned Phase 1 study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics and preliminary anti-tumor activity of ACE723 in patients with unresectable or metastatic HCC. The dose-escalation portion of the study is expected to characterize the safety profile and establish a recommended dose for subsequent clinical development and potential expansion cohorts.

Acepodia also submitted an IND application for ACE723 to China’s National Medical Products Administration (NMPA) in August 2026 as part of the Company’s global development strategy for the program.

(Press release, Acepodia, SEP 4, 2026, View Source [SID1234670602])