On July 28, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) (Press release, Akeso Biopharma, JUL 28, 2025, View Source [SID1234654555]).

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This submission represents the third accepted application for ivonescimab in China, following previous filings for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC.

PD-1 combined with chemotherapy has become a cornerstone in cancer therapy. The sNDA for ivonescimab’s new indication is based on the strong positive outcomes from its Phase III trial (AK112-306/HARMONi-6 study), which showed that ivonescimab combined with chemotherapy is superior to tislelizumab plus chemotherapy. Building on the success of its head-to-head comparison with pembrolizumab, ivonescimab’s ability to outperform PD-1 combination therapy marks a significant step forward in the evolution of global cancer immunotherapy.

Currently, ivonescimab is involved in over 12 registrational/Phase III clinical trials worldwide, including six head-to-head studies with PD-1/L1 inhibitors. These trials span a diverse range of malignancies, such as various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others. Ivonescimab has established a broad and strategic footprint across key cancer immunotherapy indications. As part of the company’s "IO+ADC" 2.0 oncology strategy, ivonescimab is positioned as a cornerstone agent in immuno-oncology, being evaluated in combination with innovative therapies targeting novel mechanisms and pathways.

On July 28, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative treatments for urothelial and specialty cancers, reported the publication in Reviews in Urology of results from a Phase 3b study evaluating the feasibility of administering ZUSDURI (mitomycin) for intravesical solution (formerly known as UGN-102) in the home setting (Press release, UroGen Pharma, JUL 28, 2025, View Source [SID1234654575]). The study, titled "Home Instillation of UGN-102 for Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: A Single-Arm, Open-Label, Phase 3b Trial," demonstrated that trained home health professionals (HHPs) can safely and effectively administer ZUSDURI outside of a traditional clinical setting.

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"The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources," said David Morris, MD, lead investigator and practicing urologist at Urology Associates, PC, Nashville, TN. "As physicians, we’re always looking for ways to provide effective care with greater comfort and convenience. These findings represent an important step in that direction."

The study assessed the feasibility, safety, and early efficacy of at-home instillations of ZUSDURI in patients with recurrent LG-IR-NMIBC. Six of eight patients (75%) completed all six scheduled treatments, with five of those six patients indicating they would recommend the home-based approach to others. A 75% complete response (CR) rate was observed at three months (95% CI: 34.9, 96.8), and no new safety concerns were identified. Feasibility questionnaires were completed by patients, and HHPs throughout the study. After each home instillation, patients rated their experience based on comfort, safety, communication, preference compared to office instillation, and overall satisfaction. At study end, they were also asked whether they would recommend home instillation of ZUSDURI to other patients and as an alternative to undergoing TURBT. Investigators assessed the clinical comparability of home versus in-office administration. HHPs provided feedback after each visit and at the study’s conclusion, reporting on their comfort with the procedure, perceived difficulty, and adequacy of training and support.

"This patient-centered approach to care reflects our commitment to redefining how urologic cancers are treated, offering patients access to effective and convenient treatment options," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "The ability to potentially administer ZUSDURI safely in the home represents a meaningful advancement for patients and caregivers alike, especially those who may face challenges traveling to frequent clinic visits."

In this study, ZUSDURI was administered via urinary catheter once weekly for six weeks, with the first dose administered in the clinic, followed by five at-home instillations by HHPs. Investigators found no meaningful differences between home and office instillation for most patients. The safety profile was consistent with previous studies, with most adverse events being mild-to-moderate urinary symptoms.

Study limitations include, among others, the small sample size of eight patients, and the open-label and single-arm design.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. Patients can visit ZUSDURI.com for more information.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

On July 28, 2025 Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via intratumorally administration, for primary and metastatic breast cancers, reported they have successfully secured the foundational Composition-of-Matter patents and claims from the USPTO for their proprietary breast cancer platform (Press release, Zetagen Therapeutics, JUL 28, 2025, View Source [SID1234654576]).

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"Securing these allowances and composition-of-matter patents for our intratumorally administered breast cancer therapeutics represents a strategic leap forward in our mission to redefine oncologic care," said Joe C. Loy, CEO of Zetagen Therapeutics. "This latest patent protects the molecular uniqueness of our drug ZetaPrime and affirms the disruptive potential in our pursuit to minimize off target side effects of conventional chemotherapeutics. We are proud to advance precision therapies designed to target tumors directly and deliver meaningful hope to patients with limited options."

Zetagen Therapeutics has built a robust intellectual property portfolio anchored in its groundbreaking discoveries in intratumorally drug administration for both primary and metastatic breast cancer. The company’s IP estate—which now includes multiple composition-of-matter patents—focuses on proprietary and established molecules designed to be delivered directly into tumors, reducing systemic toxicity and off-target side effects. This precision method not only protects healthy tissue but also holds the potential to significantly improve survival outcomes by enhancing therapeutic efficacy at the site of disease. Zetagen’ s growing suite of patents underscores its commitment to redefining standards of care and advancing targeted oncology innovation.

"Receiving multiple composition-of-matter patents for our breast oncology candidates is a transformative milestone for our scientific and clinical mission," said Bryan S. Margulies, Ph.D., CSO of Zetagen Therapeutics. "By securing these patents, we validate the unique molecular design of our compounds and strengthen our pursuit of transformative therapies for underserved patient populations."

Zetagen has enlisted Foley & Lardner LLP as its intellectual property counsel and maintains a collaborative professional relationship with Steve Maebius, Esq. Foley & Lardner LLP is a prominent law firm with global reach and specialized expertise in Life Sciences intellectual property and strategic counsel.

About ZetaMet (Zeta-BC-003) – Lead Drug Candidate:
ZetaMet is a groundbreaking molecular pathway drug, targets metastatic breast cancer in bone, ceasing lytic activity, inhibits pain, and regenerates new bone all via locoregional administration, 30-minute outpatient procedure, without systemic limitation, minimizing skeletal related events (SRE) while increasing survival rates.

ZetaMet has been awarded 2x FDA Breakthrough Designations and has been approved in the treatment of 8x Compassionate Use stage 4 cancer patients in the US and Canada. ZetaMet has demonstrated cross-species efficacy at consistent concentrations, with findings published in several peer-reviewed journals—underscoring its translational promise from lab to clinic. Notably, these individuals had previously failed to respond to standard treatments such as chemotherapy, surgery, and radiation.

Zetagen has successfully completed enrollment of phase 2a clinical trial for the treatment of metastatic breast cancer to the spine, University of British Columbia, preliminary results available upon request and full study results anticipated November 2025.

About ZetaMast (Zeta-MBC-005)
ZetaMast is a proprietarydrug-eluting hydrogel carrier designed for locoregional administration, controlled releaseof small molecules in treatment of multifocal, unresectable, liver metastases from breast cancer with potential to increase survival rates.

Zetagen has completed preclinical studies, drug elution refinement, toxicity testing and a dose optimization study, results published in peer-review journal PLOS-One.

Zetagen plans to file an IND with the FDA this fall and upon approval conduct a Phase 1b dose escalation study early 2026.

About ZetaPrime (Zeta-PBC-007)
ZetaPrime is a neo-adjuvant treatment for primary HR+ breast cancer, engineered for a locoregional administration following diagnosis. Utilizing a proprietary hydrogel-like lipid carrier, formulation enables controlled release of two small molecules— one being our novel molecular entity, and the ability to deliver other companies CDK4 or CDK4/6 protein inhibitor and any anticancer therapeutic. Designed for solubility within adipose tissue, approach targets primary breast cancer, aiming to mitigate off-target effects, reduce necessity for lumpectomies and mastectomies, postpone radiation exposure, and enhance patient survival.

On July 27, 2025 Elpis Biopharmaceuticals, a clinical-stage cell therapy company developing bispecific armored CAR-T therapies for solid tumors, reported the signing of a Memorandum of Understanding (MOU) with the National Cancer Centre Singapore (NCCS) (Press release, Elpis Biopharmaceuticals, JUL 27, 2025, View Source [SID1234654557]). The partnership aims to support collaborative cell therapy research and clinical trials for the treatment of a variety of cancers, including colorectal, pancreatic and ovarian cancers. CAR-T cell therapy is a form of immunotherapy that is currently only approved for use to treat blood cancers, such as certain types of lymphomas and multiple myeloma.

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As part of the agreement, Elpis will contribute clinically validated technologies for cancer treatment, including multi-mechanism armor, bispecific targeting antibodies, cytokine cocktails, and a rapid mRNA display discovery engine, to drive the development of next-generation cell therapies. These technologies are already being investigated in Elpis’ global clinical trials of EPC-002 and EPC-003, with the goal of expanding their translational relevance across multiple tumor types. Plans are also underway for Elpis to establish a laboratory space at NCCS and co-share its equipment to enable more integrated and efficient collaboration.

"This partnership reflects our commitment to rapidly advancing innovative immunotherapies from discovery to clinical development through to regulatory review and, hopefully saving patients’ lives," said Yan Chen, MD, PhD, Founder and CEO of Elpis Biopharmaceuticals. "By combining Elpis’s proprietary technology with NCCS’s clinical expertise, we look forward to accelerating the delivery of these potential groundbreaking new cancer therapies to patients in Singapore and beyond."

NCCS will contribute its expertise in clinical research and access to clinical trial infrastructure to support the evaluation of novel cell therapy candidates.

"The potential of using cell therapies for solid tumors is still being explored, and this collaboration will enable us to evaluate promising new technologies in a clinical context to address current unmet needs and improve patient outcomes," said Professor Lim Soon Thye, CEO of NCCS.

"This is a key collaboration with NCCS’ precision immunotherapy program. With our respective strengths and the shared goal of transforming clinical care through translational science, we look forward to offering clinical trials and developing novel cell therapies to better meet the needs of patients in Singapore and the region," added Professor Daniel Tan, Head, Division of Clinical Trials and Epidemiological Sciences and Senior Consultant, NCCS.

The collaboration will support the development of bispecific armored CAR-T cell therapies for solid tumors, while Elpis’s global leading mRNA display technology will support NCCS in the rapid discovery of human antibodies to novel targets and enable novel modalities to cell therapy and beyond.

"The MOU represents an expansion of Elpis’s living drug strategy and a key step toward enabling broader clinical translation of our cutting-edge cell therapy technologies," said Chee-Yong Lim, Co-Founder, Co-CEO & Chief Strategy Officer, Elpis Biopharmaceuticals. "Together, we are working to make living drugs a reality for patients with cancers that currently lack effective treatment options."

On July 27, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercialising first-in-class and/or best-in-class medicines for cancer, reported that an abstract featuring the latest data from a Phase I/II study of the Claudin 18.2 antibody-drug conjugate (ADC), ATG-022, has been accepted for poster presentation at the 2025 European Society for Medical Oncology Annual Congress (ESMO 2025), taking place from October 17th to October 21st at the Messe Berlin in Berlin, Germany (Press release, Antengene, JUL 27, 2025, View Source;302514585.html [SID1234654553]).

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Details of the Poster Presentation:

ATG-022 (Claudin 18.2 antibody-drug conjugate)
Title: Phase I/II study of Claudin 18.2 ADC ATG-022 in patients with advanced gastric/ gastroesophageal junction cancer (CLINCH)
Abstract Number: 2907
Presentation Number: 2113P
Date: October 19, 2025

About ATG-022

ATG-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, and pancreatic cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATG-022, for gastric and pancreatic cancers.

Data from the ongoing CLINCH study demonstrated that ATG-022 delivers robust efficacy across all levels of CLDN18.2 expression in gastric cancer patients, including those with high, low, and ultra-low expression. This broad activity positions ATG-022 as a potential market leader, capable of addressing the largest patient population with CLDN18.2-positive tumors. Furthermore, the strong efficacy observed in patients with low CLDN18.2 expression suggests promise for treating other tumor types with similar expression profiles.