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Multiple Sacituzumab Tirumotecan (sac-TMT) Studies Selected as LBAs at ESMO 2026, OptiTROP-Lung04 and OptiTROP-Lung06 to be Presented in the Lung Cancer Session

On September 22, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported multiple Phase III clinical studies of the TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) have been selected as Late-Breaking Abstracts (LBAs) and the study results will be presented as oral reports at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress to be held in Madrid, Spain, from October 23 to 27. Abstract titles of these studies have been published on the official website of ESMO (Free ESMO Whitepaper). Among them, the Phase III studies of OptiTROP-Lung04 and OptiTROP-Lung06 have both been selected for the "Non-Small Cell Lung Cancer (NSCLC), Metastatic" session and will be presented in the same time slot as proffered paper presentations, as follows:

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Title: Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: randomized phase 3 OptiTROP-Lung06 study
Presentation Type: Proffered paper | NSCLC, metastatic
Presentation #: LBA66
Date and Time: October 25, 10:15 to 11:45 local time

Title: Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: phase III OptiTROP-Lung04 study
Presentation Type: Proffered paper | NSCLC, metastatic
Presentation #: LBA67
Date and Time: October 25, 10:15 to 11:45 local time

A Phase III study, TroFuse-005, evaluating sac-TMT in patients with previously treated advanced or recurrent endometrial cancer (EC), has also been selected as an LBA at this Congress and will be presented in an oral report in the Presidential Symposium.

Title: Sacituzumab Tirumotecan in Previously Treated Advanced or Recurrent Endometrial Cancer: Results from the Phase 3 TroFuse-005/ENGOT-en23/GOG-3095 Study
Presentation Type: Presidential Symposium
Presentation #: LBA11
Date and Time: October 26, 16:30 to 18:15 local time

Other sac-TMT studies to be presented at this Congress are as follows:

Title

Presentation Type

Final OS analysis of sacituzumab tirumotecan versus
chemotherapy in previously treated locally recurrent or metastatic
triple-negative breast cancer: Phase 3 OptiTROP-Breast01

Rapid oral

Sacituzumab Tirumotecan (Sac-TMT) + Pembrolizumab (Pembro)
for Locally Advanced or Metastatic Urothelial Carcinoma (la/m
UC): Results from a Phase 2 Study (2870-002/SKB264-II-06)

Rapid oral

Sacituzumab Tirumotecan (Sac-TMT) + Pembrolizumab (Pembro)
in Post-Platinum Advanced Mismatch Repair Proficient (pMMR)
Endometrial Cancer (EC): Results from a Phase 2 Study (2870-
002/SKB264-II-06)

Poster

About sac-TMT(佳泰莱)

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from KL610023, a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023 induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. Two new indication applications have been accepted for review by the NMPA and have been included in the priority review and approval process: 1) sac-TMT in combination with pembrolizumab (KEYTRUDA) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and ALK-negative; 2) sac‑TMT as first‑line treatment for patients with recurrent or metastatic TNBC who have a PD‑L1 combined positive score (CPS) <10 or have recurred after prior PD‑1/PD‑L1 inhibitor therapy in the early stage, two applications have been included in the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 18 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, SEP 22, 2026, View Source [SID1234671005])

Biocon’s Pertuzumab Becomes First Biosimilar to Secure EMA CHMP Approval Recommendation Under New Tailored Clinical Approach

On September 22, 2026 Biocon Biologics Limited, a wholly-owned subsidiary of Biocon Limited (BSE: 532523) (NSE: BIOCON), reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the granting of a marketing authorisation to its Pertuzumab biosimilar as 420 mg concentrate solution for infusion, under the brand name Pebrilzo, for the treatment of HER2–positive breast cancer across multiple disease stages.

The positive opinion follows the review of the marketing authorization application submitted by Biocon Biologics Ireland Limited (formerly Biosimilar Collaborations Ireland Limited), an indirect wholly-owned subsidiary of Biocon Biologics Limited.

Shreehas Tambe, CEO & Managing Director, Biocon, said: "The positive CHMP opinion for our Pertuzumab biosimilar marks an important step toward expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe. As the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA’s tailored clinical development approach, it reflects an important milestone in the evolution of biosimilar science and greater regulatory confidence on advanced analytical and clinical pharmacology evidence to establish biosimilarity."

The European Commission will now proceed with the final review of the application and issue its decision. Following a positive decision, the Summary of Product Characteristics (SmPC) will be available in all official European Union languages, while the European Public Assessment Report (EPAR) will be published on the EMA website in the weeks following the decision.

Until marketing authorisation is granted by the European Commission, the product is not authorised for use in the European Union.

About the Product:

Pebrilzo is a biosimilar medicinal product and the active substance is Pertuzumab, a monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumour cells that overexpress HER2.

It is indicated for use in combination with Trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2–positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence, as well as in the adjuvant treatment of adult patients with HER2–positive early breast cancer at high risk of recurrence.

In addition, it is indicated for use in combination with Trastuzumab and Docetaxel in adult patients with HER2 positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Extensive orthogonal, state-of-the-art structural and functional analytical characterization, together with comparative clinical pharmacokinetic data, demonstrated that Pebrilzo, a Pertuzumab biosimilar, is highly similar to the reference biologic, with no clinically meaningful differences in quality, safety, or efficacy.

(Press release, Biocon, SEP 22, 2026, View Source [SID1234671004])

TransCode Therapeutics Announces Patent Advancements in Australia and Japan Strengthening Global IP Position in RNA-Based Immuno-Oncology

On September 22, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, reported significant advancements in its global intellectual property portfolio, highlighted by (i) the acceptance of an Australian patent application and (ii) the issuance of a Notice of Allowance from the Japan Patent Office (JPO) for key technologies underpinning its RNA-based therapeutic platform.

IP Australia issued a Notice of Acceptance for Patent Application No. 2019349817, titled "Compositions and Methods for Immune Checkpoint Inhibition". The application covers therapeutic nanoparticle compositions designed to deliver small interfering RNA (siRNA) molecules for the treatment of cancer.

The allowed claims encompass nanoparticles comprising an iron oxide core, a dextran polymer coating, and a recited covalently linked siRNA, along with pharmaceutical compositions and methods of use across a broad range of cancers, including colon, lung, breast, pancreatic, and ovarian cancers.

In Japan, the Japan Patent Office (JPO) issued a Notice of Allowance, and subsequently granted and issued Japanese Patent No. 7886877, for Patent Application No. 2023-540752, titled "Template Directed Immunomodulation for Cancer Therapy." The application is directed to novel RNA-based immunomodulatory compositions, including single-stranded 5′ triphosphate-modified RNA oligonucleotides designed to selectively activate innate immune pathways such as RIG-I within tumors and the tumor microenvironment.

The allowed Japanese claims are related to compositions targeting cancers expressing miR-21, as well as nanoparticle-enabled delivery approaches incorporating magnetic or polymer-coated systems to enhance tumor targeting and cellular uptake.

"These milestones reflect the continued expansion and strengthening of our intellectual property portfolio in strategically important global markets," said Philippe P. Calais, Ph.D., Chairman and CEO of TransCode Therapeutics. "This provides additional support to our delivery platform and our emerging immuno-oncology capabilities, reinforcing our ability to develop differentiated RNA therapeutics designed to address critical unmet needs in cancer."

"These patent developments highlight the breadth of innovation underlying our platform," said Zdravka Medarova, Ph.D., Co-founder and CSO. "By integrating precise RNA design with targeted delivery technologies, we are advancing a new class of therapeutics designed to silence oncogenic drivers and activate innate immune pathways directly within tumors. We believe this dual approach represents a powerful potential to improve outcomes for patients with difficult-to-treat cancers."

The Australian patent application is expected to proceed to grant with a projected expiry date of September 6, 2039.

Collectively, these developments further strengthen TransCode’s global IP estate which encompasses its RNA-based therapeutic candidates, including TTX-MC138, and underscore the Company’s commitment to advancing innovative approaches that combine gene silencing and immune activation to treat cancer.

(Press release, TransCode Therapeutics, SEP 22, 2026, View Source [SID1234671003])

Blue Earth Diagnostics to Present New Research Advancing Precision Molecular Imaging at ASTRO 2026

On September 22, 2026 Blue Earth Diagnostics, part of the Bracco Group and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, reported new research examining how precision molecular imaging may provide clinically meaningful insights in cancer care when conventional measures or imaging alone may leave uncertainty about the location or extent of disease. The data, spanning recurrent prostate cancer and brain metastases, will be presented at the upcoming American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting, September 26–30, in Boston, MA.

The presentations highlight two distinct clinical settings in which clinicians may face uncertainty. In recurrent prostate cancer, rising prostate-specific antigen (PSA) levels may indicate cancer has returned without showing where it is located. The first presentation showcases an analysis from the first intra-patient, head-to-head comparator study of POSLUMA (flotufolastat F 18) and piflufolastat F 18, examining detection rates in men with biochemical recurrence. For patients with brain metastases, the second study evaluated fluciclovine F 18 PET/CT alongside magnetic resonance imaging (MRI) following surgery, when post-operative changes can make it difficult to distinguish treatment-related changes from tumor necrosis or pseudoprogression.

Previously presented results from the head-to-head study, including data shared at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, showed significantly lower urinary radioactivity with POSLUMA compared with piflufolastat F 18. Lower urinary activity may mean less interference when looking for recurrent disease, particularly at very low PSA levels.

At ASTRO 2026, the new analysis explores how clinical factors may influence detection with POSLUMA and piflufolastat F 18 in men with biochemical recurrence and low PSA levels (≤0.5 ng/mL) following radical prostatectomy. Factors include baseline PSA level, time since radical prostatectomy, initial disease stage and International Society of Urological Pathology (ISUP) Grade Group.

"Biochemical recurrence after radical prostatectomy presents an important clinical challenge because a rising PSA level can signal recurrent disease without identifying where it is located," said Jack R. Andrews, M.D., Urologic Oncologist and Assistant Professor of Urology, Mayo Clinic. "This first head-to-head PSMA PET trial allows us to compare two PSMA PET imaging agents in the same patients and better understand how clinical factors may affect detection rates, particularly at low PSA levels. These insights can help inform how molecular imaging is used in the evaluation of patients with biochemically recurrent prostate cancer."

The brain metastases presentation draws from a prospective, single-institution trial evaluating fluciclovine F 18 PET/CT in adults undergoing resection followed by post-operative fractionated stereotactic radiosurgery. The study examined whether PET imaging alongside MRI can provide additional information to assess the extent of resection, refine target volume delineation – defining the area to be treated with radiation – and monitor for signs of recurrence over time.

"In multidisciplinary cancer care, connecting the right imaging insights with the treatment decisions that follow is critical," said Marco Campione, President and CEO of Blue Earth Diagnostics. "Our presence at ASTRO 2026 reflects our continued commitment to advancing the field of precision molecular imaging through focused science and clinical research. From identifying suspected recurrent prostate cancer when PSA levels are low to exploring how PET imaging may help better define and monitor brain metastases following surgery, this research builds on our experience in molecular imaging while helping expand what these technologies can reveal to inform patient care."

Blue Earth Diagnostics also invites ASTRO attendees to the Satellite Symposium, "Precision in PSMA: Why Agent Selection Matters More Than Ever," on Sunday, September 27, from 12:00 to 1:00 p.m. ET, in Theater 2 on the ASTRO Exhibit Floor. This program will examine the evolving role of PSMA radiopharmaceutical imaging agents and their potential impact on patient care. Experts in nuclear medicine and urology, including Sean Collins, MD, PhD, Professor of Radiation Oncology at the University of South Florida, will review emerging clinical evidence, including recent head-to-head study data, and discuss implications for precision oncology. Attendees can also visit Blue Earth Diagnostics at Booth #2147.

For complete details on the sessions and a list of scientific presentations, please refer to the ASTRO 2026 Annual Meeting online program.

POSLUMA (flotufolastat F 18)
Date: Tuesday, September 29, 2026
Title: Impact of Clinical Factors on 18F-Piflufolastat and 18F-Flotufolastat Detection Rates in Patients with Recurrent Prostate Cancer Post-prostatectomy: Results from an Intra-patient Head-to-head Study
Presenter: Alain Chaglassian, MD, MPH, Blue Earth Diagnostics Inc., Needham, MA, USA
Session Type: Poster presentation
Session Time: 2:15 – 3:30 PM ET
Abstract ID: 3320

Date: Wednesday, September 30, 2026
Title: A Prospective Single-Arm Study of POSLUMA PET in Very Low Prostate-Specific Antigen Recurrence Following Prostatectomy
Presenter: Jacob Hogan, MD, Harvard Radiation Oncology Program, Boston, MA, USA
Session Type: Poster presentation
Session Time: 8:30 – 8:35 AM ET
Abstract ID: 1222

Axumin (fluciclovine F 18)
Date: Sunday, September 27, 2026
Title: 18F Fluciclovine PET in Postoperative Target Delineation and Recurrence Detection in Resected Brain Metastasis: Pre-Planned Analysis of a Prospective Trial
Presenter: Hanan N. Hassan, MD, Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL, USA
Session Type: Poster presentation
Session Time: 3:00 – 4:00 PM ET
Abstract ID: 2085

(Press release, Blue Earth Diagnostics, SEP 22, 2026, View Source [SID1234671002])

Rise Therapeutics Completes Dose Escalation in R-5780 Phase 1 Cancer Trial, Advances to Dose Expansion

On September 22, 2026 Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, reported that it has completed the dose escalation portion of its ongoing Phase 1 clinical trial evaluating R-5780, the Company’s lead immuno-oncology candidate. Having established a recommended dose, the study will now move into its planned dose expansion stage to enroll additional cancer patients at the highest fixed dose.

"Completing dose escalation for R-5780 is a meaningful step in translating our novel immunotherapy approach into a potential option for people fighting cancer," stated Gary Fanger, President and CEO of Rise Therapeutics. "Following its review of the available safety data, the independent Data Monitoring Committee supported advancing the study into dose expansion, where we will further evaluate R-5780’s safety and tolerability and explore its potential to enhance the effectiveness of immune checkpoint inhibitor therapy."

R-5780 is being evaluated in a multi-dose Phase 1 clinical trial (NCT06398418) designed to assess the safety, drug exposure, and clinical activity of R-5780 in patients with cancer, enrolling up to 33 participants in total. This clinical study assesses the ability of R-5780 to reawaken an anti-tumor immune response in patients who are refractory to PD-1 immune checkpoint inhibitor therapy. With the dose escalation stage complete, the trial will enroll additional patients at the highest selected dose in the planned dose expansion stage to further characterize R-5780’s safety and its ability to enhance responses to immune checkpoint inhibitors, in tumors that are refractory to these therapies. R-5780 is one of three Rise Therapeutics programs, all based upon its proprietary oral biologics drug delivery platform, that are now in clinical testing, alongside ongoing studies in ulcerative colitis, rheumatoid arthritis, and Sjögren’s disease. This drug delivery platform was developed to enable medicine to tap into novel intestinal mechanisms that control systemic immune biology, opening a new era of treatments that correct the fundamental underlying immunological basis of cancer and autoimmune disease.

The clinical opportunity for R-5780 sits within a large and rapidly growing, yet still underserved, segment of oncology. The global immune checkpoint inhibitor market was valued at approximately $49.8 billion in 2026 and is projected to reach $154.3 billion by 2030, as immune checkpoint inhibitors remain a cornerstone of cancer treatment. However, only about one in five patients with advanced cancer responds to checkpoint inhibitor therapy, leaving roughly 80% of treated patients without benefit. R-5780 is designed to help close this gap by re-sensitizing checkpoint-refractory tumors to immune checkpoint inhibitor therapy, positioning it to address a substantial unmet need within an expanding market.

About R-5780
Immune checkpoint inhibitors have transformed the treatment of many types of cancers, yet most patients either do not respond or eventually become refractory to these therapies. R-5780 is an orally delivered, precision-directed synthetic biology medicine designed to control the patient’s immune system to drive a more robust anti-tumor T cell response. By resetting immunological repertoires, R-5780 can make immune checkpoint inhibitors like PD-1 therapy more effective. R-5780 is being developed to expand the population of cancer patients who can benefit from immune oncology treatment, including those who have become refractory to, or were never responsive to, existing checkpoint inhibitor therapies.

(Press release, Rise Therapeutics, SEP 22, 2026, View Source [SID1234671001])