On September 22, 2026 Summit Therapeutics Inc. (Nasdaq: SMMT) reported that data from the Phase III HARMONi-GI1 trial, conducted in China and sponsored by Akeso, Inc., featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab, will be featured as part of the Presidential Symposium II at the European Society for Medical Oncology 2026 Congress (ESMO 2026) which takes place October 23–27, 2026, in Madrid, Spain. The presentation will take place on Sunday, October 25 during the Presidential Symposium from 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT).

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The HARMONi-GI1 study is evaluating ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC). HARMONi-GI1 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.

On August 25, 2026, Akeso announced topline results from HARMONi-GI1. Akeso reported that, at a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority in the primary endpoint of overall survival (OS) compared to the durvalumab-based regimen. The study also met the key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).

About the ESMO (Free ESMO Whitepaper) 2026 Presidential Symposium Presentation
Presidential Symposium Presentation
Presentation Title: Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double-blinded, phase 3 trial (HARMONi-GI1)
Presenter: Jian Zhou, MD (Shanghai, China)
ESMO Presentation No.: Presidential Symposium II, LBA8
Session Date & Time: Sunday, October 25, 2026, 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT)

In China, ivonescimab is approved and commercially available for indications in non-small cell lung cancer (NSCLC). Ivonescimab remains investigational and is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) and increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 5,000 patients have been treated with ivonescimab in clinical studies globally and over 100,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026.

Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

(Press release, Summit Therapeutics, SEP 22, 2026, View Source [SID1234671009])

On September 22, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that its Signatera test has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic (CDx) in muscle-invasive bladder cancer (MIBC).

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This approval supports the use of the Signatera test to guide adjuvant atezolizumab (Tecentriq) treatment decisions in patients with MIBC. Natera expects to commercially launch Signatera for MIBC in Japan in the first half of 2027, following the PMDA’s approval of atezolizumab in MIBC.

Regulatory approval was supported by data from IMvigor011, a randomized, double-blind phase III clinical trial that evaluated Signatera-guided adjuvant atezolizumab in patients with MIBC. The trial included more than 20 participating sites in Japan, giving Japanese clinicians firsthand experience with Signatera-guided treatment in this setting.

This marks Signatera’s second PMDA authorization in Japan, after receiving approval in colorectal cancer in June 2026. It follows the U.S. Food and Drug Administration’s (FDA) approval of Signatera as a CDx for adjuvant atezolizumab in MIBC (and the approval by the FDA of atezolizumab), as well as the recently published Category 1 recommendation for MRD-guided adjuvant atezolizumab in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Bladder Cancer.

Bladder cancer affects more than 34,000 people in Japan each year,1 with approximately 20–25% of newly diagnosed cases classified as muscle-invasive.2 MIBC carries a higher risk of recurrence and greater treatment complexity than earlier-stage disease, underscoring the need for precision tools that can help clinicians individualize treatment decisions in the adjuvant setting.

"We look forward to launching this second Signatera MRD indication in Japan, giving patients with muscle-invasive bladder cancer a proven diagnostic tool to guide treatment decisions in the first year after surgery," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology, Natera. "We value our growing partnership with the Japanese oncology community, which has been a leader in adopting MRD into clinical trials and into clinical practice."

(Press release, Natera, SEP 22, 2026, View Source [SID1234671008])

On September 22, 2026 Beactica Therapeutics AB, a Swedish precision medicine company, reported the initiation of IND-enabling studies for BEA-17, the Company’s wholly owned, first-in-class oral degrader of the epigenetic regulators LSD1 and CoREST, being developed as a precision immunotherapy for glioblastoma (GBM). The studies advance BEA-17 from preclinical proof-of-concept into the formal safety, manufacturing and regulatory programme required to support a Clinical Trial Application (CTA) in the EU and/or an Investigational New Drug (IND) application in the US, and the start of first-in-human clinical trials.

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Glioblastoma is the most common and most aggressive primary brain tumour, with a median overall survival of around 15 months and a standard of care that has remained essentially unchanged for more than two decades. Immunotherapies that have transformed other cancers have repeatedly failed in GBM, largely because the tumour maintains a profoundly immunosuppressive, immune-"cold" microenvironment. BEA-17 is designed to overcome this barrier: by degrading LSD1 and its scaffolding partner CoREST, BEA-17 enhances antigen presentation, induces viral mimicry and reprogrammes macrophages towards a pro-inflammatory state. In preclinical models of glioblastoma, BEA-17 in combination with standard of care substantially improved survival and produced durable tumour regression not observed with standard of care alone. BEA-17 has also potentiated anti-PD-1 checkpoint blockade in a preclinical model of colon cancer – effects not seen with catalytic LSD1 inhibitors. BEA-17 is orally bioavailable, brain-penetrant, and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of glioblastoma.

"Initiating IND-enabling studies is a defining milestone for Beactica and for the BEA-17 programme," said Dr Per Källblad, Chief Executive Officer of Beactica Therapeutics. "With a first-in-class mechanism and compelling preclinical efficacy in combination with standard of care, we are now executing the rigorous safety and manufacturing programme that will carry BEA-17 into first-in-human trials."

The IND-enabling programme comprises GLP-compliant repeat-dose toxicology in rodent and non-rodent species, safety pharmacology, pharmacokinetic studies, and manufacture of a traceable, fully documented batch of BEA-17 drug substance suitable for a Clinical Trial Application and a finalised oral clinical trial formulation.

The work is conducted under GLIOBREAK, a 30-month project supported by a EUR 2.5 million EIC Transition grant under Horizon Europe, announced in February 2026. Beactica expects to complete the IND-enabling programme and submit a Clinical Trial Application in the EU and/or an Investigational New Drug application to the US FDA in 2027.

(Press release, Beactica, SEP 22, 2026, View Source [SID1234671007])

On September 22, 2026 SystImmune Inc. (SystImmune), a clinical-stage biotechnology company advancing next-generation multi-specific antibodies and antibody-drug conjugates (ADCs), reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SI-B037, a bispecific antibody targeting immunosuppression and other synergistic mechanisms.

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The FDA clearance marks SystImmune’s first IND application utilizing New Approach Methodologies (NAMs) as part of its integrated nonclinical safety and translational assessment package. It also underscores the company’s role at the forefront of the global paradigm shift toward modern, human-centric, non-animal testing alternatives encouraged by regulatory authorities worldwide.

"We used human organ-on-chip systems and primary human tissue models, in place of conventional animal toxicology studies," said Dr. Jahan Khalili, Senior Vice President of Research at SystImmune. "Human-relevant models gave us a more direct read on a molecule designed to engage multiple human pathways in the nonclinical package, built around New Approach Methodologies."

"Patients with advanced solid tumors refractory to standard therapies remain in urgent need of novel therapeutic options with coordinated mechanisms of action," said Dr. Anand Achanta, Senior Vice President, Regulatory Affairs and Medical Writing. "We look forward to initiating the Phase 1/1b trial to determine optimal dosing and characterize the clinical activity of SI-B037, while continuing to collaborate closely with regulatory agencies to refine translational endpoints and human-relevant safety models in future studies."

(Press release, SystImmune, SEP 22, 2026, View Source [SID1234671006])

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])