An Open-label, Multicenter, Two-cohort, Phase II Study to Evaluate the Efficacy and Safety of Neratinib (NLX) Combined with Vinorelbine Capsules (NVB) in Patients with HER2-positive Metastatic Breast Cancer

Start Date15 Jul 2026

Sponsor / Collaborator-

NCT07366840

/ Not yet recruitingPhase 2/3IIT

A Phase 3, Randomized Advanced Breast Cancer Study Investigating RC48 Combined With Chemotherapy Versus Guideline-recommended Trastuzumab/Inetetamab Plus Chemotherapy in HER2-Positive Patients With Prior TOP1i-ADC Failure

The purpose of this study is to assess the safety and efficacy of RC48 (a HER2 antibody drug conjugate with MMAE payload) in combination with gemcitabine or capecitabine (with or without trastuzumab/inetetamab), for treatment of patients with HER2-positive advanced breast cancer (ABC) who have developed disease progression or intolerance to prior therapy with a topoisomerase I inhibitor antibody-drug conjugate (TOP1i-ADC).

Start Date16 Jan 2026

Sponsor / Collaborator

Fudan University

NCT07182721

/ RecruitingPhase 2IIT

A Phase II, Single-Arm, Single-Center, Prospective Study of SKB264 Plus Inetetamab in HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients Progressing After T-DXd Treatment

This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy.

Start Date30 Sep 2025

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Inetetamab

100 Translational Medicine associated with Inetetamab

100 Patents (Medical) associated with Inetetamab

Literatures (Medical) associated with Inetetamab

01 Dec 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

SMP-656: A self-catalyzed ring-opening hydrolysis linker-based ADC with enhanced stability and antitumor efficacy

Article

Author: Li, Xiaoli ; Geng, Jiahao ; Feng, Chaoyang ; Heng, Xiaojie ; Huang, Jinkun ; Luo, Ding ; Wu, Chenglong ; Yang, Tingting ; Wang, Shouping

Maleimide-based conjugation, the predominant strategy in approved antibody-drug conjugates (ADCs), is susceptible to retro-Michael deconjugation, resulting in premature transfer of the linker-payload moiety to serum proteins rather than free payload release and reduced therapeutic index. Here, we report SuperHydra, a self-hydrolyzing maleimide linker that undergoes rapid post-conjugation ring-opening hydrolysis to irreversibly stabilize the thiosuccinimide linkage and suppress retro-Michael deconjugation. Incorporation of SuperHydra into the HER2-targeting ADC SMP-656, comprising the antibody Inetetamab and the microtubule inhibitor Eribulin, resulted in markedly enhanced plasma stability while preserving HER2 binding, internalization, Fc-mediated effector function, and bystander killing. SMP-656 exhibited potent antigen-dependent cytotoxicity, retained activity in DS-8201a-resistant tumor models, and achieved durable antitumor efficacy in multiple HER2-positive xenograft models. In cynomolgus monkeys, SMP-656 demonstrated favorable pharmacokinetic properties and an acceptable safety profile. Collectively, these findings establish SMP-656 as a promising HER2-targeting ADC, support its ongoing clinical evaluation in HER2-expressing solid tumors, and highlight the potential of the SuperHydra linker as a versatile platform for improving the stability and overall performance of maleimide-based ADCs.

01 Nov 2026·BIOORGANIC CHEMISTRY

A 177Lu-labeled Inetetamab theranostic conjugate with dual cytotoxic and stromal-depleting activities for targeted radionuclide therapy of HER2-positive breast cancer

Article

Author: Zheng, Jianping ; Zheng, Yan ; Li, Xiao ; Liu, Zhenhua ; Xue, Shuai ; Cai, Boyu ; Chen, Qiao ; Zhang, Yu ; Li, Qingqing ; Chen, Wenxin

PURPOSE:

HER2-positive breast cancer requires targeted therapies that overcome resistance and desmoplastic barriers. This study aimed to develop and biologically evaluate a ¹⁷⁷Lu-labeled Inetetamab conjugate (¹⁷⁷Lu-Inetetamab) with dual cytotoxic and stromal-depleting activities for targeted radionuclide therapy.

METHODS:

¹⁷⁷Lu-Inetetamab was synthesized using p-SCN-Bn-DOTA as the bifunctional chelator. Radiochemical purity, stability, and HER2-specific binding were assessed in vitro. In vivo SPECT/CT imaging, biodistribution, and therapeutic efficacy were evaluated in BT-474 xenograft-bearing mice. Tumor growth, survival, immunohistochemistry (Ki67, BCL-2, γ-H2AX, TNF-α), stromal remodeling (^99mTc-FAPI-04 SPECT/CT, Masson's trichrome), and transcriptomic profiling were performed.

RESULTS:

¹⁷⁷Lu-Inetetamab was successfully synthesized using p-SCN-Bn-DOTA as the bifunctional chelator, achieving a conjugation efficiency of 40.3 ± 2.5% at pH 9.0 and a chelate-to-antibody ratio of approximately 3.3 DOTA per antibody. The radiochemical purity (> 95%) was confirmed by radio-HPLC and radio-TLC and remained stable in PBS and mouse serum at 37 °C for up to 168 h. HER2-specific cellular uptake was confirmed, with an immunoreactive fraction of 75.5 ± 1.9% and a dissociation constant (K_D) of 0.772 nM. SPECT/CT showed sustained tumor retention (1.45 ± 0.96 %ID/mL at 168 h) and favorable hepatobiliary clearance. Treatment with ¹⁷⁷Lu-Inetetamab significantly suppressed tumor growth (no net growth by day 10, whereas control tumors increased by >150%) and prolonged survival compared to controls. IHC revealed reduced Ki67 and BCL-2, increased γ-H2AX and TNF-α. The reduced FAPI-04 uptake (1.05 ± 0.33 vs. 2.35 ± 0.45%ID/mL) and Masson's staining indicated CAF loss, to which β-emission cross-fire may have contributed. Transcriptomics showed activation of p53-mediated apoptosis and downregulation of profibrotic genes (TGFB2, CCN2, FN1).

CONCLUSION:

¹⁷⁷Lu-Inetetamab exhibits high HER2 specificity, potent antitumor efficacy, and stromal-modulating activity, supporting its potential as a theranostic agent for resistant or stroma-rich HER2-positive breast cancer.

01 Aug 2026·Therapeutic Advances in Medical Oncology

Real-world outcomes and safety of inetetamab plus pyrotinib and chemotherapy in HER2-positive metastatic breast cancer: A multicenter retrospective study

Article

Author: Chen, Biyin ; Huang, Weiwei ; Lin, Cailing ; Wu, Fan ; Li, Nani ; Chen, Xinhua ; Wu, Xiufeng ; Chen, Kan ; Yang, Qingmo ; Liu, Jian ; Lin, Zhiwu ; Wu, Xiuping ; Hong, Yi ; Zhang, Ruxue

Background:

Inetetamab and pyrotinib have shown promising activity in HER2-positive metastatic breast cancer (MBC). However, real-world data on their combination with chemotherapy (IPyC) across different treatment lines remain limited.

Objectives:

This multicenter retrospective study aimed to describe the outcomes associated with a dual HER2-targeting strategy IPyC in HER2-positive MBC across treatment lines in real-world clinical practice.

Design:

Multicenter retrospective study.

Methods:

Between July 2020 and August 2024, 301 patients with HER2-positive MBC from five tertiary centers in China received IPyC until disease progression or unacceptable toxicity. Key outcome measures included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Cox proportional hazards models were used to identify potential prognostic factors.

Results:

The median IPyC associated PFS and OS for the entire cohort were 12.0 months (95% CI: 10-15) and 33.0 months (95% CI: 28-42), respectively, with an ORR of 50.2% and a CBR of 80.4%. The IPyC associated PFS varied significantly by treatment line (23.0, 17.0, and 6.0 months for first-line, second-line, and ≥third-line, respectively; p<0.001). In first-line setting, baseline lymphovascular invasion (LVI) and multiple metastases were independent prognostic factors, and trastuzumab-naïve patients had a numerically longer median PFS of 27.0 months than those with prior trastuzumab exposure. In second-line setting, patients with secondary resistance to trastuzumab achieved a median PFS of 24.0 months. A new central nervous system (CNS) metastasis incidence was observed in 6.6% (5/76) of patients without baseline CNS metastases in the first-line IPyC treatment setting. The IPyC regimen was associated with manageable toxicity, with grade 3-4 diarrhea (26.2%), neutropenia (16.6%), and leukopenia (12.6%) as the most common adverse events (AEs).

Conclusion:

As a retrospective descriptive study, our analysis describes the use and outcomes of the IPyC regimen across multiple lines of therapy in HER2-positive MBC, highlighting the need for and supporting the design of prospective studies to evaluate this regimen.

195

News (Medical) associated with Inetetamab

10 Apr 2026

·allsci.com

DualityBio files HER2 ADC trastuzumab pamirtecan for 1st approval in China

DualityBio submitted a Biologics License Application (BLA) to China’s National Medical Products Administration (NMPA) for trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an antibody-drug conjugate (ADC) co-developed with BioNTech, seeking approval as a second-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The NMPA has accepted the application for review, marking the first regulatory filing for this asset in any jurisdiction for a breast cancer indication. The filing seeks approval for trastuzumab pamirtecan in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane chemotherapy, the company said. DualityBio has entered a separate commercialization collaboration with 3SBio covering Chinese mainland, Hong Kong, and Macao for multiple indications of the asset. The BLA is supported by interim data from Study DB-1303-O-3001, a randomized, controlled, open-label, multicenter Phase III trial conducted in China. The study compared trastuzumab pamirtecan against trastuzumab emtansine (T-DM1) in patients previously treated with trastuzumab and taxane chemotherapy. The Independent Data Monitoring Committee determined that the trial met its primary endpoint of statistically significant improvement in progression-free survival, assessed by blinded independent central review, at a pre-specified interim analysis. Full PFS data and overall survival results were not disclosed in the announcement. The choice of T-DM1 as the comparator reflects the treatment landscape in China, where access and reimbursement dynamics differ from those in Western markets. Globally, trastuzumab deruxtecan (T-DXd) has displaced T-DM1 as the preferred second-line standard following the DESTINY-Breast03 trial, which demonstrated a median PFS of approximately 28.8 months with T-DXd versus 6.8 months with T-DM1. T-DXd received US FDA approval for this setting in 2022 and, in December 2025, received further FDA approval in combination with pertuzumab for first-line HER2-positive metastatic breast cancer. The DB-1303-O-3001 trial’s design therefore positions trastuzumab pamirtecan against a comparator that, while still used in China, has been substantially superseded elsewhere. The molecule has been awarded US FDA Fast Track and Breakthrough Therapy designations, though those were granted for endometrial cancer rather than breast cancer. Trastuzumab pamirtecan is built on DualityBio’s DITAC (Duality Immune Toxin Antibody Conjugates) platform and uses a topoisomerase-I inhibitor payload, placing it in the same mechanistic class as T-DXd. The HER2-positive metastatic breast cancer space is now populated by multiple topoisomerase-I inhibitor-based ADCs, and any differentiation for trastuzumab pamirtecan will depend on comparative efficacy, safety profile, and access dynamics in China. BioNTech licensed global rights outside Greater China to two DualityBio ADCs including trastuzumab pamirtecan in a 2023 deal worth over USD 1.5 billion. BioNTech is currently sponsoring global Phase I/II and III trials, respectively, for the molecule in breast cancer and uterine cancer. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Drug ApprovalFast TrackBreakthrough TherapyCSCO

24 Mar 2026

·www.prnewswire.com

DualityBio (9606.HK) Announces 2025 Annual Results

HONG KONG, March 24, 2026 /PRNewswire/ -- Duality Biotherapeutics, Inc. (Hong Kong Stock Exchange Code: 09606.HK, hereinafter referred to as "DualityBio" or the "Company"), a leading global clinical-stage innovative biopharmaceutical company, today announced its first annual results since listing on April 15, 2025 (for the year ended December 31, 2025), providing a comprehensive update on its global clinical pipeline and corporate operations. Dr. John Zhu, Founder, founder and Chief Executive Officer of DualityBio, stated: "Over the past decade, the innovative pharmaceutical industry has evolved from partial exploration to systematic development. Today, we stand at a brand-new starting point – an era that is more open, more uncertain yet more imaginative. Technological advancement is reshaping industry boundaries, global clinical and regulatory systems are gradually integrating, and innovation is no longer confined to a single region but occurs collaboratively worldwide, marking the 'Great Voyage Era of Innovative Drugs'. In 2025, DualityBio anchored on innovation and forged ahead steadily in the ADC track. Leveraging the profound accumulation of our four core technology platforms, we drove the full-speed advancement of core assets: the enrollment of over 3,200 patients globally has verified our R&D strength and original aspiration for global layout; in-depth collaborations with partners such as BioNTech and Avenzo have continuously amplified innovation value, injecting strong momentum for long-term development. In 2026, we will build on this momentum to accelerate the commercialization of core products, deepen pipeline iteration and technological breakthroughs, and steadily advance the A-share listing plan, responding to every expectation with a clearer growth path and more solid performance. The road to innovation is long and challenging. DualityBio will always be guided by unmet clinical needs, keep forging ahead in the journey of overcoming intractable diseases, and embark on a journey of value growth with all partners." Financial Highlights During the reporting period, the Company achieved total revenue of RMB1.852 billion , providing a solid financial foundation for the continuous advancement of business. R&D investment remained at a high level, with annual R&D expenses reaching RMB838 million; the adjusted loss for the year was RMB389 million (calculated by deducting the fair value change of preferred shares issued prior to the Global Offering from the loss for the year. Such fair value changes arose from the preferred shares issued in connection with previous equity financings prior to the Global Offering on April 15, 2025. From this date onward, these preferred shares ceased to exist, and there will be no further profit or loss impact of this nature in subsequent financial periods). The Company maintained a healthy cash flow position, with cash and bank balances of RMB3.325 billion as of the end of the period (comprising cash and cash equivalents, restricted cash and term deposits with initial term over three months), and achieved a net cash inflow from operating activities of RMB195 million, which has been positive for three consecutive years, providing sufficient capital support for the Company's long-term growth, subsequent pipeline advancement, clinical research and commercialization layout. Milestone of First-Wave Assets: Pivotal Clinical and Regulatory Progress In 2025, DualityBio drove the accelerated global clinical progress of its ADC pipeline relying on four core technology platforms. The Company currently has 10 clinical stages self-developed ADC candidates. Global clinical trials have enrolled over 3,200 patients cumulatively, with more than 1,200 new patients enrolled in 2025 alone, of which approximately 50% are located in the U.S., EU, Australia and other regions outside China, covering 17 countries and over 300 clinical centers, fully verifying the Company's global clinical development capabilities. The clinical development of Trastuzumab pamirtecan (DB-1303/BNT323 or "T- Pam") achieved a milestone breakthrough in 2025. In September 2025, the Independent Data Monitoring Committee ("IDMC") reviewed the interim data of a Phase 3 registrational trial (DYNASTY-Breast01; NCT06265428) and confirmed that the trial had achieved the primary endpoint of Progression-Free Survival ("PFS"), as evaluated by Blinded Independent Central Review ("BICR"), relative to the control arm. This trial is conducted in China to evaluate the efficacy of DB-1303/BNT323 versus T-DM1 in patients with HER2+ unresectable and/or metastatic Breast Cancer ("BC") previously treated with trastuzumab and taxane. Another Phase 3 trial of the product in China (NCT06265428) targets patients with HER2+ unresectable/metastatic breast cancer previously treated with trastuzumab and taxane, and the Biologics License Application ("BLA") has been submitted to the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA"), which is currently in the formal acceptance and review stage. A potential registrational cohort in a global Phase 1/2 trial for HER2-expressing advanced/recurrent Endometrial Cancer ("EC") has completed enrollment, and partner BioNTech plans to submit a BLA to the U.S. Food and Drug Administration ("FDA") in 2026. In addition, the global Phase 3 trial of the product (DYNASTY-Breast02; NCT06018337) completed enrollment in February 2026, targeting advanced or metastatic HR+, HER2-low breast cancer, with interim data expected to be available in 2026. As the Company's core ADC product targeting the B7-H3 antigen, DB-1311/BNT324 has continuously released positive clinical data in multiple solid tumor indications. In June 2025, the Company presented data from 73 heavily pretreated patients with metastatic Castration-Resistant Prostate Cancer ("mCRPC") at the American Society of Clinical Oncology ("ASCO") Annual Meeting; the 6-month Radiographic Progression-Free Survival ("rPFS") rate was 67.7% (as of March 4, 2025). In February 2026, at the ASCO Genitourinary ("GU") Cancers Symposium, the Company further presented updated data from 146 heavily pretreated mCRPC patients, with a median rPFS of 11.3 months and a median Overall Survival ("mOS") of 22.5 months; in patients with no prior exposure to Lutetium-177 ("Lu-177"), the median rPFS reached 13.6 months; in patients who had previously received Lu-177 (with a median of 5 prior lines of therapy), the median rPFS remained 11.3 months, and the median OS was not yet reached. Safety findings were consistent with prior reports; nausea and hematologic events were the most common adverse events and were mainly Grade 1-2; in the 6 mg/kg dose group (n=110), the incidence of Grade ≥3 Treatment-Related Adverse Events ("TRAE") was 20.0%, the discontinuation rate due to TRAE was 5.5%, and no treatment-related deaths were reported. Meanwhile, the product also demonstrated considerable potential in gynecological tumors. Data presented at the European Society for Medical Oncology ("ESMO") Asia Congress in December 2025 showed that in previously treated cervical cancer patients (n=30), DB-1311/BNT324 achieved an Unconfirmed Objective Response Rate ("uORR") of 43.3%, a Confirmed Objective Response Rate ("cORR") of 33.3%, a Disease Control Rate ("DCR") of 86.7%, and a median Progression-Free Survival ("mPFS") of 7.0 months; in Platinum-Resistant Ovarian Cancer ("PROC") patients (n=12), the cORR was 58.3%, DCR was 75.0%, and mPFS was 8.2 months. The above data fully confirm the broad application potential of the product in various solid tumors. Based on the excellent preliminary data, the first global Phase 3 trial (NCT07365995) evaluating DB-1311/BNT324 compared to docetaxel in taxane-naïve mCRPC patients is planned to start in 2026, with primary endpoints of PFS and OS. As an innovative ADC developed by the Company targeting the HER3 antigen, DB-1310 has achieved important clinical breakthroughs in both Non-Small Cell Lung Cancer ("NSCLC") and breast cancer("BC " ), and obtained two Fast Track Designations from the U.S. FDA. In June 2025, the Company presented clinical data from patients with Epidermal Growth Factor Receptor mutation ("EGFRm") NSCLC at the ASCO Annual Meeting. As of April 11, 2025, across the 1.5 mg/kg to 6.5 mg/kg dose range in 172 subjects, DB-1310 demonstrated a manageable safety profile, with Grade ≥3 TRAE occurring in 36% of patients and a low treatment-related discontinuation rate of 3.5%; among 46 efficacy-evaluable patients, the uORR was 43.5%, cORR was 28.3%, DCR was 91.3%, mPFS was 7.03 months, and mOS was 18.89 months; in the 5 mg/kg dose group (n=16), the cORR was 37.5%, DCR was 87.5%, mPFS was 8.28 months, and mOS was not reached. In December 2025, at the San Antonio Breast Cancer Symposium ("SABCS"), the Company presented data from pretreated HR+/HER2- breast cancer patients. In patients receiving DB-1310 at doses of 5.0-5.5 mg/kg (n=18), DB-1310 achieved a uORR of 55.6%, a cORR of 50.0%, and a confirmed DCR of 94.4%, with a manageable safety profile primarily involving Grade 1-2 hematologic and gastrointestinal events, a TRAE-related discontinuation rate of 4.5%, and no new safety signals. At the regulatory level, the R&D process of DB-1310 has been accelerated: in July 2025, it received Fast Track Designation from the FDA for the treatment of adult patients with advanced, unresectable or metastatic non-squamous NSCLC with an EGFR exon 19 deletion or L858R mutation who have progressed on or after treatment with a third-generation EGFR Tyrosine Kinase Inhibitor ("TKI") and platinum-based chemotherapy; in December 2025, it received an additional Fast Track Designation from the FDA for the treatment of adult patients with advanced/unresectable or metastatic HR-positive/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy, CDK4/6 inhibitor, with or without chemotherapy for unresectable or metastatic disease, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Deepen Global Cooperation and Unleash Strategic Synergies DualityBio continues to advance the "Duality Flywheel Model", deepen global cooperation, and maximize the value of self-developed assets. The Company has established a robust global cooperation network, entering into multiple out-licensing and collaboration agreements with leading industry players worldwide, including core partners such as BioNTech, BeOne, Adcendo, GlaxoSmithKline ("GSK") and Avenzo, with a total transaction value exceeding US$6 billion, fully demonstrating the industry's high recognition of the Company's independent R&D technology platforms. Exploration of IO2.0+ADC Combination Therapies Next-generation IO+ADC combination therapy is a core development trend in the global biopharmaceutical industry. The "bispecific antibody + ADC" combination can not only improve the efficacy of indications already covered by bispecific antibody combined with chemotherapy but also expand the scope of indications that cannot be covered by existing therapies, making it an important development direction in the field of tumor treatment. The Company is collaborating with BioNTech to explore the combination potential of DB-1303/BNT323, DB-1311/BNT324 and DB-1305/BNT325 with pumitamig (PD-L1xVEGF bispecific antibody) to expand their frontline application in various solid tumors. DB-1303/BNT323 in Combination with Pumitamig: In May 2025, the first patient was dosed in a global Phase 1/2 clinical trial evaluating the combination therapy in patients with HR+ or HR-, HER2-low, ultralow, or null advanced metastatic breast cancer or Triple-Negative Breast Cancer ("TNBC"), with trial data expected to be available in 2026. DB-1311/BNT324 in Combination with Pumitamig: In May 2025, the first patient was dosed in a global Phase 1/2 clinical trial evaluating the combination therapy in patients with advanced lung cancers; in July 2025, the first patient was dosed in a global Phase 2 clinical trial evaluating DB-1311/BNT324 in combination with pumitamig or with DB-1305/BNT325 in patients with advanced solid tumors, with data from both trials expected to be available in 2026. For DB-1311, DualityBio holds an exclusive option to share the development and commercialization costs and profits and losses from the exploitation of the first DB-1311 product in the United States, in accordance with the terms set out in the agreement. As of the date of this announcement, the Company has not exercised this cost & profit/loss sharing option and retains the right to do so in the future. DB-1305/BNT325 in Combination with Pumitamig Clinical Readout: In April 2025, the first clinical data evaluating the combination of pumitamig and DB-1305/BNT325 were presented at the 2025 American Association for Cancer Research ("AACR") Annual Meeting. Interim data from 67 patients showed that the combination therapy had a manageable safety profile with a low incidence of overlapping toxicities and early signs of anti-tumor activity in patients with PROC, NSCLC or TNBC; among evaluable PROC patients (n=13), seven achieved partial response and three had stable disease. In addition, DualityBio has established cooperative partnerships with companies such as BeOne, Adcendo, GSK and Avenzo, leveraging complementary advantages in R&D and global commercialization to jointly drive value growth. Next-Generation Innovation Progress: Continuously Expand Moat with Diversified Platforms and Product Pipelines In addition to first-wave core assets, the Company has advanced the rapid development of a series of high-potential ADCs and Bispecific ADCs ("BsADCs"): DB-2304 (BDCA2 ADC): A potential First-in-class ADC for the treatment of Systemic Lupus Erythematosus ("SLE") and Cutaneous Lupus Erythematosus ("CLE"), with the first patient dosed in the Phase 2a study. Data from a Phase 1 randomized controlled study (Clinical Trial Code: NCT06625671, Phase 1/2a study) was presented orally at the 53rd Autumn Immunology Conference ("AIC 2025"). The results showed that DB-2304 was generally safe and well-tolerated in healthy subjects, with linear Pharmacokinetics ("PK") characteristics, and could effectively bind to the target, verifying its pharmacologic mechanism. DB-1418/AVZO-1418 (EGFR×HER3 BsADC): Partner Avenzo has announced the first patient dosed in the Phase 1 portion of a global Phase 1/2 trial in patients with advanced solid tumors. In November 2025, Avenzo announced that DB-1418/AVZO-1418 received Fast Track Designation from the FDA for the treatment of patients with unresectable, locally advanced, or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R mutation whose disease has progressed on or after therapy with an EGFR TKI. DB-1419 (B7-H3×PD-L1 BsADC): Currently the only B7-H3×PD-L1 BsADC under clinical development globally, a global Phase 1/2a trial is being conducted in patients with advanced/metastatic solid tumors and is currently enrolling patients. DB-1317 (ADAM9 ADC): A next-generation ADC targeting ADAM9, a highly expressed antigen in gastrointestinal cancers, a global Phase 1a/1b trial is being conducted in patients with selected advanced/metastatic solid tumors and is currently enrolling patients. DB-1324 (CDH17 ADC): Licensed to GSK for development outside Greater China, received IND clearance from the FDA in December 2025, and a global Phase 1/2 clinical trial is being conducted in patients with advanced/metastatic gastrointestinal tumors and is currently enrolling patients. 2026: Build on Momentum and Forge Ahead To fully prepare for commercialization in the Chinese market, DualityBio has established a core commercial team, with senior leaders appointed in key functional areas including strategic planning, market access and commercial partner management. In January 2025, DualityBio entered into a collaboration agreement with 3SBIO Inc. (HKEX: 1530, "3SBIO"), leveraging its professional Contract Sales Organization ("CSO") capabilities to accelerate launch preparations for Trastuzumab pamirtecan, ensuring rapid and targeted access to key markets and customer segments. In the Territory (Mainland China, Hong Kong and Macau), 3SBIO will also provide related commercialization services – including market access, medical affairs, and channel management – to support the product's commercial activities. The Company has submitted a BLA to the CDE for Trastuzumab pamirtecan (DB-1303) for the treatment of breast cancer. Globally, partner BioNTech is also actively advancing the process of submitting a BLA to the U.S. FDA for HER2-expressing endometrial cancer. In addition to clinical execution, in line with the Company's global development and domestic commercialization layout, on October 17, 2025, the Board of Directors of the Company resolved to propose the issuance of RMB-denominated ordinary shares to be listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange. Looking ahead, DualityBio will always implement the strategic original aspiration of "Global Team, Global Clinical Trials, Global Market", aiming to evolve into a global leading pharmaceutical enterprise and provide therapeutic options for patients worldwide. About DualityBio DualityBio (HKEX:09606) is a clinical-stage biotechnology company dedicated to the discovery and development of next-generation antibody-drug conjugates to treat cancer and autoimmune diseases.DualityBio has built several advanced ADC technology platforms with global intellectual property protection. Leveraging a robust pipeline, the company is conducting multiple global clinical trials across 17 countries and has enrolled more than 3,200 patients across its clinical-stage ADC candidates. The company has established strategic collaborations with global pharmaceutical companies and biotechnology innovators to accelerate the development and commercialisation of its therapies. For more information, please visit: SOURCE Duality Biotherapeutics, Inc. 21% more press release views with Request a Demo

Clinical ResultPhase 1Phase 2Fast TrackASCO

08 Mar 2025

·www.prnewswire.com

Why the Global Cancer Market Could Surpass $900 Billion--And the Stocks Leading the Charge

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, March 8, 2025 /PRNewswire/ -- As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights. Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to the World Health Organization (WHO), breast cancer cases are projected to rise by nearly 40% by 2050. Despite the concerning trends in cancer incidence, 2025 has seen key advancements from biotech companies at the forefront of oncology research, with Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Exelixis, Inc. (NASDAQ: EXEL), Cardiff Oncology, Inc. (NASDAQ: CRDF), ALX Oncology Holdings Inc. (NASDAQ: ALXO), and Verastem, Inc. (NASDAQ: VSTM) continuing to push the boundaries of cancer treatment. Continue Reading Pelareorep Facts (PRNewsfoto/USA News Group) The article continued: Within a new research report on the Global Oncology Market from Vision Research Reports, cancer therapies are projected to surpass US$903.81 billion by 2034, growing at a 10.9% CAGR along the way. The World Economic Forum is optimistic, recently touting 12 new breakthroughs in the fight against cancer. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, has just released its Q4 and full-year 2024 financial results, providing investors with a clearer picture of its progress as it moves toward potential future FDA approvals for its lead drug, pelareorep, a promising immunotherapy designed to help the immune system recognize and destroy cancer cells more effectively. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." The data mentioned by Pisano from BRACELET-1 showed that patients receiving pelareorep and paclitaxel lived longer and responded better to treatment compared to those receiving paclitaxel alone. Given the consistency of these results, Oncolytics believes that its upcoming registration-enabling trial could pave the way for an accelerated approval submission with the FDA. This is an important development, as HR+/HER2- breast cancer is one of the most commonly diagnosed and treated breast cancers worldwide, representing a massive market opportunity for the company. Beyond breast cancer, Oncolytics is making significant progress in two other hard-to-treat cancers: pancreatic cancer and anal carcinoma. "When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients," added Pisano. Oncolytics recently presented new data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, showcasing pelareorep's potential to improve patient outcomes in these aggressive diseases. In anal cancer, results from the ongoing GOBLET study showed that 33% of patients responded to treatment when pelareorep was combined with atezolizumab, a checkpoint inhibitor. Notably, one patient experienced a complete response, with their cancer disappearing and staying undetectable for over 15 months. This level of response in such a difficult-to-treat cancer is highly encouraging, leading Oncolytics to expand the trial to enroll additional patients. Meanwhile, in pancreatic cancer, the company successfully cleared a critical safety review for its combination study using pelareorep with modified FOLFIRINOX with and without atezolizumab, allowing the trial to progress to the next phase. Pancreatic cancer has one of the lowest survival rates of any major cancer, and with few effective treatments available, pelareorep's continued success in this area could position Oncolytics as a key player in gastrointestinal oncology. From a financial standpoint, Oncolytics reported a cash position of $15.9 million at the end of 2024, giving it enough runway to continue executing on its clinical development strategy through the third quarter of 2025. While the company operates at a loss—as is typical for clinical-stage biotechs—it has been strategically managing its spending to ensure that key trials remain funded. Research and development expenses remained stable compared to the previous year, reflecting a disciplined financial approach that prioritizes high-impact studies. With several potentially transformative catalysts on the horizon, including the initiation of a registration-enabling study in breast cancer and new pancreatic cancer data expected later in the year, investors will be watching closely to see how Oncolytics navigates its next steps. The coming months will be crucial for Oncolytics as it pushes forward in its mission to bring pelareorep to market. With strong clinical results, growing regulatory support, and a well-managed cash position, the company is well-positioned to capitalize on its momentum. If its upcoming breast cancer study confirms the benefits seen in BRACELET-1, Oncolytics could find itself on a fast track to regulatory approval, potentially opening the door to a major commercial opportunity. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Exelixis, Inc. (NASDAQ: EXEL), reported promising results earlier this year from a subgroup analysis of its Phase 3 CABINET trial, which evaluated cabozantinib in patients with advanced gastrointestinal (GI) neuroendocrine tumors (NETs). The data presented at ASCO GI 2025 showed that cabozantinib significantly improved progression-free survival (PFS) compared to placebo, with a median PFS of 8.5 months versus 5.6 months. The findings highlight cabozantinib's potential to become a new standard of care for GI NETs, an area with limited treatment options. The FDA is currently reviewing Exelixis' supplemental New Drug Application (sNDA), with a decision expected by April 3, 2025. "These new data add to the robust results from the CABINET trial that demonstrate the benefits of cabozantinib across a wide range of patients with neuroendocrine tumors and further underscore the potential of cabozantinib to become a much-needed new option for those with GI NET, which accounts for the majority of real-world patients with this tumor type," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to continuing to work with the U.S. FDA as they review our regulatory application for cabozantinib for the treatment of patients with previously treated advanced neuroendocrine tumors." Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently shared its Q4 2024 and FY 2024 results and business update as it continues to advance its lead program, onvansertib, a promising PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer (mCRC). "2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., CEO of Cardiff Oncology. In its latest Phase 2 trial (CRDF-004), patients receiving the 30mg dose of onvansertib showed a 64% objective response rate, nearly doubling the 33% response rate in the control group. Cardiff also secured a new U.S. patent covering the use of onvansertib in combination with bevacizumab (bev) for previously untreated KRAS-mutant mCRC patients, adding long-term value to its intellectual property. ALX Oncology Holdings Inc. (NASDAQ: ALXO) is pushing forward with key advancements in its clinical pipeline, including the continued development of evorpacept, a CD47-blocking immunotherapy designed to enhance the effects of existing cancer treatments. The company announced plans to expand clinical trials into breast and colorectal cancer, aiming to evaluate evorpacept in combination with trastuzumab for HER2-positive breast cancer and with cetuximab for colorectal cancer. "Our conviction in evorpacept's potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data," said Jason Lettmann, CEO at ALX Oncology. "We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data." In addition to its immunotherapy efforts, ALX Oncology is preparing to advance ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), into the clinic, with an Investigational New Drug (IND) application planned for Q1 2025. Verastem, Inc. (NASDAQ: VSTM) is making strides in RAS/MAPK pathway-driven cancers, with new Phase 2 trial data on its lead combination therapy, avutometinib plus defactinib, set to be presented at the 2025 Society of Gynecologic Oncology (SGO) Annual Meeting. The investigational treatment has already earned Priority Review from the FDA, with a PDUFA decision expected by June 30, 2025, for patients with KRAS-mutant low-grade serous ovarian cancer (LGSOC). "The presentation of the RAMP 201 primary analysis, which served as the basis of the acceptance of our NDA that is under Priority Review with the FDA, includes additional subgroup analysis by KRAS mutational status," said Dan Paterson, President, and CEO of Verastem Oncology. "We also recognize the importance of these findings to the broader cancer community as part of our growing pool of data reinforcing the potential to change expectations in managing RAS/MAPK pathway-driven cancers." As Verastem moves forward with its RAMP clinical trials, the company continues to expand its pipeline, including a Phase 3 confirmatory trial (RAMP 301) in LGSOC and a collaboration with Amgen to evaluate its therapy in combination with LUMAKRAS™ for KRAS G12C mutant lung cancer. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo: SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultASCOImmunotherapyPhase 3

100 Deals associated with Inetetamab

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KEGG	Wiki	ATC	Drug Bank
D03257	Inetetamab	L01FD01	DB00072

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Breast Cancer	China	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	17 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2026	Not Applicable	Advanced HER2-Positive Breast Carcinoma HER2-positive	67	Inetetamab combined with Pyrotinib	dbdzgdmggq(jzceyjkiwu) = lhrjubzdba uizunaqvdn (ftuxoymhfn, 16.05 - 29.53) View more	Positive	23 Oct 2026
				Inetetamab combined with Pyrotinib (first- or second-line therapy)	dbdzgdmggq(jzceyjkiwu) = dapddtfxpb uizunaqvdn (ftuxoymhfn, 21.5 - 34.5)
ESMO2025	Not Applicable	HER2-positive	237	TKI plus anti-HER2 antibody	uusatlbdjj(acdbaeqbsl) = yiaullwcgv yqtzdfrmxi (qvqgzlcdqr ) View more	Negative	17 Oct 2025
				TKI	uusatlbdjj(acdbaeqbsl) = ruizhdatab yqtzdfrmxi (qvqgzlcdqr ) View more
ESMO2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2+	301	Inetetamab + Pyrotinib + Chemotherapy	mmmalaffrf(ssaxbwenac) = zdaknryljb ikbsbcchdx (niwoscmqxr, 9.8 - 14.2) View more	Positive	17 Oct 2025
				Inetetamab + Pyrotinib + Chemotherapy (1st line)	mmmalaffrf(ssaxbwenac) = skwjziovvm ikbsbcchdx (niwoscmqxr )
NCT05749016 (Phase II clinical trial, ASCO2025)	Phase 2	Locally advanced breast cancer Neoadjuvant HER2-positive	44	Inetetamab	zequsisfsv(yssuikrnzz) = bfdjimbwxo ipqwgnjplo (ososigniqd )	Positive	30 May 2025
				Trastuzumab	zequsisfsv(yssuikrnzz) = ggcgazfxtu ipqwgnjplo (ososigniqd )
CTR20222482 (Pubmed) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	62	Inetetamab + Pertuzumab + Nab-paclitaxel	hjdwkxrmvv(qygdytkzrr) = gtxwzghewr recvchowki (ulcfoljvxk, 43.3 - 69.0) View more	Positive	01 May 2025
SABCS2024 \| NEWS Manual	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	90	Inetetamab-containing regimens	xmzjmumxlq(okdaaktobz) = bhpdsurhvi wnrhlmufsg (ksuforzeoq, 7.3 - 17) View more	Positive	26 Nov 2024
				Inetetamab-containing regimens (brain metastases)	xmzjmumxlq(okdaaktobz) = dzfqyozale wnrhlmufsg (ksuforzeoq, 4.7 - 19.3) View more
NCT05749016 (ESMO2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	39	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	hvkqrtqkww(zxwwxqcuve) = ylthdtzukx ofdyqillwg (povvgprqzc ) View more	Positive	16 Sep 2024
				Neoadjuvant treatment with TCbIP	hvkqrtqkww(zxwwxqcuve) = yqamspgfyz ofdyqillwg (povvgprqzc )
NCT06305702 (ESMO2024)	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	500	Inetetamab	wfgjuiitps(rhuweujpyt) = leukopenia was generally well-tolerated gurjgdbmfm (uauzlxnlsl ) View more	Positive	16 Sep 2024
				Inetetamab + Tyrosine Kinase Inhibitors + Chemotherapy
NCT05749016 (Pubmed) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma Neoadjuvant HER2 Positive	-	Inetetamab + Pertuzumab + Taxanes + Carboplatin (TCbIP)	bgszhymygi(jiwpeigcfd) = tsgryxtfsn rxjllzrprs (wxzzmunuoq ) View more	Positive	22 Jul 2024
				Trastuzumab + Pertuzumab + Taxanes + Carboplatin (TCbHP)	bgszhymygi(jiwpeigcfd) = dizkduhdyb rxjllzrprs (wxzzmunuoq ) View more
NCT05749016 (ASCO2024) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma Neoadjuvant HER2 Positive	28	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	gwseyrvcxf(xoyiujsyzf) = ekexzcsita jlfiimvser (xxamxbemyo ) View more	Positive	24 May 2024
				Trastuzumab + Pertuzumab + Paclitaxel + Carboplatin (TCbHP)	gwseyrvcxf(xoyiujsyzf) = ppphdpvcaq jlfiimvser (xxamxbemyo ) View more

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