HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [6]

Active Indication

HER2 Positive Solid TumorsHR-positive/HER2-low Breast CarcinomaHormone receptor positive HER2 positive breast cancer+ [61]

Inactive Indication

Advanced Gastroesophageal Junction Adenocarcinoma

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo Europe GmbH

+ [8]

Inactive Organization

Daiichi Sankyo Taiwan Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (20 Dec 2019),

HER2 Positive Breast Cancer

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Australia), Priority Review (Australia), SAKIGAKE (Japan), Priority Review (United States), Breakthrough Therapy (United States), Orphan Drug (Japan)

Structure/Sequence

Boost your research with our ADC technology data.

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Sequence Code 18481L

Source: *****

Sequence Code 44772H

Source: *****

156

Clinical Trials associated with Fam-trastuzumab deruxtecan-NXKI

NCT06899126

/ Not yet recruitingPhase 3

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS <50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Start Date07 Sep 2025

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

[+1]

NCT06585969

/ Not yet recruitingPhase 3IIT

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer

Start Date01 May 2025

Sponsor / Collaborator

Danish Breast Cancer Cooperative Group

ChiCTR2500099141

/ SuspendedNot ApplicableIIT

A Prospective Clinical Study Evaluating the Predictive Value of MRI Radiomics with Machine Learning Algorithms for Treatment Response to Trastuzumab Deruxtecan in Breast Cancer Patients with Brain Metastases

Start Date01 May 2025

Sponsor / Collaborator

Affiliated Hospital of Guangdong Medical University

100 Clinical Results associated with Fam-trastuzumab deruxtecan-NXKI

100 Translational Medicine associated with Fam-trastuzumab deruxtecan-NXKI

100 Patents (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

772

Literatures (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

31 Dec 2025·Human Vaccines & Immunotherapeutics

Cost-effectiveness of trastuzumab deruxtecan as a second-line treatment for HER2-mutant advanced non-small cell lung cancer

Article

Author: You, Shuhui ; Gong, Caifeng ; Cai, Qi ; Huang, Jinglong ; Zhang, Wen ; Zhou, Aiping

The study of DESTINY-Lung01 and DESTINY-Lung02 demonstrated the favorable efficacy and optimal dosage of trastuzumab deruxtecan (T-DXd) in managing the human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC) patients who had received previous treatment. The study sought to assess the cost-effectiveness of T-DXd in both the United States (US) and Chinese healthcare systems. Markov models were developed to evaluate the overall cost, incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs), and life years (LYs) of treatment with T-DXd compared with docetaxel, nivolumab, and pyrotinib for patients in the US and China. The level of willingness-to-pay (WTP) in the US and China is 150,000/QALYs and 32,517/QALYs, respectively. Sensitivity analyses were carried out to ensure the precision of the model. T-DXd yielded additional QALYs of 0.63 and 0.06 with an ICER of $338997.84 and $1437258.33 per QALY, respectively, in the US compared to the docetaxel and nivolumab regimens. And T-DXd yielded additional QALYs of 0.63, 0.06, and 0.13 with an ICER of $137959.45, $623805.93, and $515447.12 per QALY, respectively, in China compared to the docetaxel, nivolumab, and pyrotinib regimens. Sensitivity analysis showed that the cost of drugs is the most influential factor. T-DXd provides substantial therapeutic benefit for NSCLC patients with HER2 mutations who have had previous treatment but is not deemed cost-effective in either the US or China when compared to docetaxel, nivolumab, and pyrotinib. Price reduction is perhaps the main way to make T-DXd cost-effective.

01 Jun 2025·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Emerging Paradigms in Genitourinary Cancers: Integrating Molecular Imaging, Hypoxia-Inducible Factor–Targeted Therapies, and Antibody-Drug Conjugates in Renal Cell and Urothelial Carcinomas

Review

Author: Hofman, Michael S. ; Wulff-Burchfield, Elizabeth M. ; Eapen, Renu ; McKay, Rana R.

Novel approaches in molecular imaging and targeted therapeutics are transforming the management of renal cell carcinoma (RCC) and urothelial carcinoma (UC). This review focuses on three key areas of innovation: molecular imaging, hypoxia-inducible factor-2α (HIF-2α) inhibition, and antibody-drug conjugates (ADCs). In molecular imaging, prostate-specific membrane antigen positron emission tomography/computed tomography has shown promise in RCC, while novel tracers targeting carbonic anhydrase IX and nectin-4 are emerging for RCC and UC, respectively. These approaches may enable better characterization of disease and treatment response monitoring. HIF-2α inhibition represents a breakthrough in targeting the fundamental pathobiology of clear cell RCC, with belzutifan demonstrating significant clinical benefit in both von Hippel-Lindau disease and sporadic RCC. Next-generation HIF-2α inhibitors, including casdatifan, show promising early clinical results with distinct pharmacologic properties. ADCs have become a cornerstone of UC treatment, with enfortumab vedotin plus pembrolizumab now approved as first-line therapy. Multiple human epidermal growth factor receptor 2 (HER2)-directed ADCs have shown efficacy in HER2-expressing UC, including trastuzumab deruxtecan, which recently received tumor-agnostic approval. While ADC development in RCC faces unique challenges, novel approaches including immunostimulatory payloads and bispecific antibodies are being explored. The integration of these advances in molecular imaging and therapeutics offers opportunities for more personalized treatment approaches in RCC and UC.

01 May 2025·EUROPEAN UROLOGY

European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2025 Guidelines

Review

Author: Bruins, Harman Max ; Smith, Emma J ; Sæbjørnsen, Sæbjørn ; Martini, Alberto ; Mariappan, Param ; Cathomas, Richard ; van der Heijden, Antoine G ; Dimitropoulos, Konstantinos ; Neuzillet, Yann ; Panebianco, Valeria ; Efstathiou, Jason A ; Thalmann, George N ; Fietkau, Rainer ; Lorch, Anja ; Mertens, Laura S ; Kailavasan, Mithun ; Compérat, Eva ; Meijer, Richard P ; Carrion, Albert ; Milowsky, Matthew I ; Rink, Michael

BACKGROUND AND OBJECTIVE:

This publication represents a summary of the updated 2025 European Association of Urology (EAU) guidelines for muscle-invasive and metastatic bladder cancer (MMIBC). The aim is to provide practical recommendations on the clinical management of MMIBC with a focus on diagnosis, treatment, and follow-up.

METHODS:

For the 2025 guidelines, new and relevant evidence was identified, collated, and appraised via a structured assessment of the literature. Databases searched included Medline, EMBASE, and the Cochrane Libraries. Recommendations within the guidelines were developed by the panel to prioritise clinically important care decisions. The strength of each recommendation was determined according to a balance between desirable and undesirable consequences of alternative management strategies, the quality of the evidence (including the certainty of estimates), and the nature and variability of patient values and preferences.

KEY FINDINGS AND LIMITATIONS:

The key recommendations emphasise the importance of thorough diagnosis, treatment, and follow-up for patients with MMIBC. The guidelines stress the importance of a multidisciplinary approach to the treatment of MMIBC patients and the importance of shared decision-making with patients. The key changes in the 2025 muscle-invasive bladder cancer (MIBC) guidelines include the following: a new recommendation for the use of susceptible FGFR3 alterations to select patients with unresectable or metastatic urothelial carcinoma for treatment with erdafitinib; significant adaption and update of the recommendations for pre- and postoperative radiotherapy and sexual organ-preserving techniques in women; new recommendation related to radical cystectomy and extent of lymph node dissection based on the results of the SWOG trial; recommendation related to hospital volume; new recommendations for salvage cystectomy after trimodality therapy and for the management of all patients who are candidates for trimodality bladder-preserving treatment in a multidisciplinary team setting using a shared decision-making process; significant adaption and update to the recommendation for adjuvant nivolumab in selected patients with pT3/4 and/or pN+ disease not eligible for, or who declined, adjuvant cisplatin-based chemotherapy; and addition of a new recommendation for metastatic disease regarding the antibody-drug conjugate trastuzumab deruxtecan in case of HER2 overexpression; in addition, removal of the recommendations on sacituzumab govitecan as the manufacturer has withdrawn the US Food and Drug Administration approval for this product; update of the follow-up of MIBC; and full update of the management algorithms of MIBC.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

This overview of the 2025 EAU guidelines offers valuable insights into risk factors, diagnosis, classification, treatment, and follow-up of MIBC patients and is designed for effective integration into clinical practice.

732

News (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

17 Apr 2025

·www.prnewswire.com

Greater Precision of HER2-Expressing Breast Cancer Treatment with 3D Pathology: New JelloX Research Collaboration

In the preliminary findings of a study conducted with the National Taiwan University Hospital, over 50% of sample cases were reclassified as HER2-expressing when 3D pathology was applied. HSINCHU, April 16, 2025 /PRNewswire/ -- JelloX Biotech Inc., a Taiwan-based startup at the forefront of cancer pathology, announced the preliminary results of a research collaboration with the National Taiwan University Hospital (NTUH) on breast cancer patients. The study found that JelloX's 3D pathology technology identified a significantly increased proportion of tumors with HER2-low and HER2-ultralow expression compared to conventional methods, demonstrating this technology's increased sensitivity and potential as a superior diagnostic tool for HER2 detection in breast cancers. Continue Reading This is a 3D fluorescent-stained image of mammary ducts from a breast cancer patient. Green areas indicate drug-targeted receptors. Unlike traditional 2D pathology, this reveals the spatial distribution of receptors, reducing the risk of misjudging treatment decisions. Contact JelloX at [email protected] to explore partnerships and learn more about the company's cutting-edge 3D pathology technology. According to the US National Cancer Institute, breast cancer is the most prevalent form of cancer. However, the difficulty of precisely determining treatment has made the identification of HER2 expression essential. In HER2-low and HER2-ultralow metastatic breast cancer, the novel antibody-drug conjugate (ADC) Trastuzumab deruxtecan (T-DXd) has demonstrated robust efficacy over conventional chemotherapy. Yet considering HER2 spatial heterogeneity, traditional diagnostic methods have shown to be less precise than 3D pathology in detecting the presence of the HER2 protein. "For the specific challenges posed by metastatic breast cancer and the need to identify predictive biomarkers accurately, the high sampling capacity of 3D pathology holds particular potential," commented Dr. Yen-Yin Lin, CEO of JelloX. "JelloX Biotech's Comprehensive HER2 Diagnostic Solution is poised to revolutionize HER2 diagnostics. With a more comprehensive data set on tumor samples, healthcare providers can be empowered to make more precise diagnoses, ensuring that the right patients receive the right treatment at the right time." New findings with NTUH on HER2 breast cancer In JelloX's research collaboration with NTUH, preliminary findings indicate that more than half of the analyzed cases exhibited diagnostic discrepancies when re-evaluated using the company's advanced 3D pathology methods. Notably, among patients initially classified as HER2-null by traditional methods, more than 66.7% were reclassified as HER2-expressing (HER2-low or HER2-ultralow) using 3D technology, thereby becoming potentially eligible for T-DXd treatment. These findings echo the company's recent results using samples from colorectal and esophageal cancers, demonstrating that 3D pathology may have broader potential across various cancer types. The full findings will be shared at the Global Breast Cancer Conference in South Korea on April 17. Implications for breast cancer treatment and drug guidelines T-DXd has demonstrated significant efficacy in tumors with HER2 expression. However, tumors classified as HER2-null under conventional pathological testing are ineligible for T-DXd treatment. By detecting HER2 more precisely using 3D pathology methods, we can identify more patients eligible for T-DXd therapy. In addition to cancer patients, JelloX's 3D pathology technology has the potential to expand possibilities across healthcare stakeholders: For physicians: This advanced diagnostic tool offers a more comprehensive patient data set and, when integrated with AI, helps reduce physician workloads. For pharmaceutical companies and research institutions: The technology enhances companion diagnostics (CDx) for drug usage and is a valuable tool for new drug development. For healthcare systems: 3D pathology optimizes medical resource allocation and minimizes unnecessary financial and healthcare burdens. About JelloX Biotech Inc. Based in Hsinchu, Taiwan, JelloX Biotech Inc. is a startup that focuses on advancing cancer pathology through 3D digital imaging and AI technology. For more information, please visit: SOURCE JelloX Biotech Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDiagnostic Reagents

08 Apr 2025

·pipelinereview.com

DATROWAY® Approved in the EU for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

TOKYO, Japan & MUNICH, Germany I April 08, 2025 I DATROWAY ® (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). The approval by the European Commission follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast01 phase 3 trial. In TROPION-Breast01, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 months (95% CI: 4.9-6.8) in the chemotherapy arm. The final overall survival (OS) results of the trial did not achieve statistical significance (median OS of 18.6 months in the DATROWAY arm versus 18.3 months in the chemotherapy arm [HR 1.01; 95% CI: 0.83-1.22]) and may have been affected by subsequent ADC treatment. “With the majority of breast cancer cases historically considered HR positive, HER2 negative, additional treatment options are needed to improve outcomes for patients with metastatic disease that continues to progress following endocrine-based therapy and initial chemotherapy,” said Barbara Pistilli, MD, Head of the Breast Cancer Unit in the Medical Oncology Department of Gustave Roussy Cancer Center, Villejuif, France. “The approval of DATROWAY in the EU will provide these patients with a new treatment option that can help slow the progression of this disease.” “Treating metastatic HR positive, HER2 negative breast cancer presents challenges, particularly treatment resistance and disease progression that occur following endocrine-based therapy and initial chemotherapy,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “DATROWAY represents the second antibody drug conjugate approved for breast cancer based on Daiichi Sankyo’s DXd technology and the third medicine to be approved in the EU from our oncology pipeline, underscoring our commitment to creating new medicines for patients with cancer.” “Though the HR positive breast cancer treatment landscape has evolved in the last several years, disease progression on front-line therapies remains a common and complex challenge for patients with metastatic disease,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “With today’s approval of DATROWAY, patients in the EU with HR positive, HER2 negative breast cancer now have a new and needed alternative to conventional chemotherapy.” Grade 3 or higher adverse events from a pooled safety analysis of two clinical studies, including 443 patients who received DATROWAY (6 mg/kg) for a median duration of 6.2 months (range: 0.7-28.5), were stomatitis (7.9%), fatigue (4.3%), anemia (3.2%), AST increased (2.7%), vomiting (1.6%), ALT increased (1.6%), nausea (1.4%), urinary tract infection (1.4%), COVID-19 (1.1%), decreased appetite (1.1%), neutropenia (1.1%) and pneumonia (1.1%). Grade 5 adverse events occurred in 0.7% of patients due to interstitial lung disease/pneumonitis, dyspnea and sepsis. About TROPION-Breast01 TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025. TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov . About Hormone Receptor Positive, HER2 Negative Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 1 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally. 1 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually. 2 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 3 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-). 3 Endocrine therapy is widely given consecutively in the early lines of treatment for metastatic HR positive breast cancer. 4 However, after initial treatment, further efficacy from endocrine therapy is often limited. 4 About DATROWAY DATROWAY (datopotamab deruxtecan) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results of the TROPION-Breast01 trial. About the DATROWAY Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU ® in March 2019 and DATROWAY in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . SOURCE: Daiichi Sankyo

Phase 3Clinical ResultDrug ApprovalADCLicense out/in

08 Apr 2025

·www.pharmaceutical-technology.com

Epsilogen acquires TigaTx to expand pan-isotope cancer antibody pipeline

Epsilogen and TigaTx have not disclosed the financial terms of the deal. Credit: RealPeopleGroup via Getty Images. UK biotech Epsilogen has acquired US-based antibody developer TigaTx in a deal that collates work from the two companies’ alternative antibody isotopes for cancer. The move combines Epsilogen’s clinical focus on immunoglobulin E (IgE) antibodies with TigaTx’s work on immunoglobulin A (IgA), creating what the companies describe as a “pan-isotope” platform for oncology. The financial terms of the deal were not disclosed, but TigaTx will become a wholly owned subsidiary of Epsilogen as part of the transaction. While most approved antibody therapies – like Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) – are based on the immunoglobulin G (IgG) isotope, Epsiologen and TigaTx are developing candidates that harness alternative immune pathways. IgE antibodies used by Epsilogen are designed to activate immune responses through macrophages and T cells while TigaTX’s IgA platform targets neutrophils. “Combining the capabilities of Epsilogen with those of TigaTx gives us the ability to choose the most relevant isotype for a given cancer, whether a cold tumour environment we want to drive multiple immune effector cells into or leverage neutrophils,” said Epsilogen’s CEO Tim Wilson in the 7 April announcement. “The transaction also facilitates the combination of different isotype functions into a single antibody molecule,” Wilson added. Epsilogen’s lead asset, MOv18 IgE, is currently being investigated in a Phase Ib study (NCT06547840) in patients with platinum-resistant ovarian cancer. Earlier Phase I data showed MOv18 IgE to be safe and well tolerated with signs of clinical activity. MOv18 IgE is positioned as a potential rival to AbbVie’s Elahere (mirvetuximab soravtansine) because both candidates target the folate receptor alpha (FRa). Elahere secured full approval by the US Food and Drug Administration (FDA) in 2024 for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. According to GlobalData’s Pharma Intelligence Center, Elahere is projected to make $2bn in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology. The acquisition adds a second clinical candidate to the pipeline in the form of TigaTX’s TIGA-001, an anti-EGFR IgA antibody that will now be developed under Epsilogen as EPS-401. The therapy is expected to enter the clinic next year. The broader pipeline includes additional IgE candidates targeting various tumour-associated antigens, all in preclinical stages. Both companies completed funding rounds in 2024. In September, Epsilogen raised £43.25m in a Series B funding round led by existing backers British Patient Capital, the Novartis Venture Fund, Epidarex Capital, the 3B Future Health Fund and ALSA Ventures. Meanwhile, TigaTx announced up to $35.5m in funding in December. The funds came from the Advanced Research Projects Agency for Health (ARPA-H) and a two-year small business innovation research (SBIR) grant from the National Cancer Institute (NCI) of the US National Institutes of Health (NIH).

Drug ApprovalPhase 1ImmunotherapyAcquisitionADC

100 Deals associated with Fam-trastuzumab deruxtecan-NXKI

External Link

KEGG	Wiki	ATC	Drug Bank
-	Fam-trastuzumab deruxtecan-NXKI	L01XC	DB14962

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HER2 Positive Solid Tumors	United Kingdom	Daiichi Sankyo UK Ltd.	09 Apr 2025
HR-positive/HER2-low Breast Carcinoma	United States	Daiichi Sankyo Co., Ltd.	28 Jan 2025
Hormone receptor positive HER2 positive breast cancer	South Korea	Daiichi Sankyo Co., Ltd.	19 Sep 2022
HER2 mutant non-small cell lung cancer	United States	Daiichi Sankyo, Inc.	11 Aug 2022
HER2 Positive Stomach Adenocarcinoma	Australia	AstraZeneca Pty Ltd.	08 Oct 2021
HER2-Low Breast Carcinoma	Australia	AstraZeneca Pty Ltd.	08 Oct 2021
Metastatic breast cancer	Canada	AstraZeneca Canada, Inc.	15 Apr 2021
HER2 positive Gastroesophageal Junction Adenocarcinoma	United States	Daiichi Sankyo, Inc.	15 Jan 2021
HER2-positive gastric cancer	Japan	Daiichi Sankyo Co., Ltd.	25 Sep 2020
HER2 Positive Breast Cancer	United States	Daiichi Sankyo, Inc.	20 Dec 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	Phase 3	-	Daiichi Sankyo Co., Ltd.	07 Sep 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	United States	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	China	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Japan	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Argentina	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Australia	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Austria	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Belgium	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Brazil	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Canada	Daiichi Sankyo, Inc.	21 Mar 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04494425 (DB-06 \| DESTINY-Breast06, CTgov)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast \| Hormone receptor positive HER2 positive breast cancer \| Advanced breast cancer	866	T-DXd (T-DXd)	ajvrzepscy(zrwdcpoakf) = sntypiqitt lrrurmkzbf (vppatdjcgn, ltuvvnugbl - wlfonogzqu) View more	-	02 Apr 2025
				nab-paclitaxel+paclitaxel+capecitabine (Chemotherapy)	ajvrzepscy(zrwdcpoakf) = hgkpqlyrjz lrrurmkzbf (vppatdjcgn, qepdhdeiia - auzmvtzozd) View more
NCT04686305 (DL-03, ESMO_ELCC2025)	Phase 1	metastatic non-small cell lung cancer \| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma \| Locally Advanced Lung Non-Small Cell Carcinoma First line HER2 overexpression	34	Trastuzumab deruxtecan (T-DXd)	eluzibpqxm(jvkfxfhuea) = juqnofeaql ylhpndhkug (sfzfhylzlw ) View more	Positive	26 Mar 2025
DESTINY-Gastric04 (NEWS) Manual	Phase 3	HER2-positive gastric cancer Second line HER2 Positive	-	ENHERTU	hfmuicctfh(lohjatjurg) = wzkxopkskm amlkjzvrfi (xrdxcdzbpp, 9.6 - 14.3) View more	Positive	03 Mar 2025
				irinotecan or paclitaxel	hfmuicctfh(lohjatjurg) = gyyhuoqmby amlkjzvrfi (xrdxcdzbpp, 6.9 - 10.7) View more
ESMO_TAT2025	Not Applicable	-	48	trastuzumab deruxtecan (High SAT density (HU))	odvwbhsywp(ulfaatgkry) = mgolrjdoyo fjffuyusbg (tuqeavayvt )	Positive	03 Mar 2025
				trastuzumab deruxtecan (High VAT density (HU))	qwrjjcpqul(tsqvvyhgul) = rlyjijuvup qohpghoyod (rahitxqlkx )
NCT04379596 (DESTINY-Gastric03, ASCO_GI2025) Manual	Phase 1/2	HER2-positive gastric cancer \| HER2 positive Esophageal Carcinoma \| HER2 positive Gastroesophageal Junction Adenocarcinoma First line HER2 Positive	75	T-DXd 6.4 mg/kg + FP + Pembrolizumab	sqicvxqnxw(kwqduwtysf) = jpauwrnrug ayphawweje (hlzuldwgfk ) View more	Positive	23 Jan 2025
				T-DXd 5.4 mg/kg + FP + Pembrolizumab	sqicvxqnxw(kwqduwtysf) = zrzkdwevxe ayphawweje (hlzuldwgfk ) View more
NCT04042701 (DS8201-A-U106, ESMO_IO2024) Manual	Phase 1	Non-Small Cell Lung Cancer HER2 Expression \| ERBB2 Mutation (Activating)	55	Trastuzumab deruxtecan (T-DXd) + Pembrolizumab (cohort 3 (HER2E; immunohistochemistry 1+, 2+, or 3+))	ukutchylyw(axpyjivnid) = lehbbtkblz hawdlmiwmx (jsmsclxztj, 32.2 - 75.6) View more	Positive	12 Dec 2024
				Trastuzumab deruxtecan (T-DXd) + Pembrolizumab (cohort 4 (HER2m))	ukutchylyw(axpyjivnid) = rxirqfnhbf hawdlmiwmx (jsmsclxztj, 48.2 - 82.0) View more
NCT04989816 (DESTINY-Gastric06, ESMO_ASIA2024) Manual	Phase 2	HER2-positive gastric cancer \| HER2 positive Gastroesophageal Junction Adenocarcinoma HER2 Positive	95	Trastuzumab deruxtecan 6.4 mg/kg	yhwyacftay(xqwkschkpb) = ixpleptojh dxdvegdzgs (bjkzuzaxho ) View more	Positive	07 Dec 2024
NCT04482309 (DP-02, ESMO_ASIA2024)	Phase 2	HER2 Positive Cancer HER2 IHC 3+ \| HER2 IHC 2+ \| in situ hybridization-positive ... View more	-	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg	pflowdzoom(bnzcwfjjdj) = sigwmjnhpa bmzoxzqpan (csbfeexnpy, 5.6 - 8.0) View more	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	HER2-Low Breast Carcinoma HER2-low \| IHC 1+ \| IHC 2+	70	≥ 3 lines of chemotherapy	rfxcbggbpn(wyisiexgvn) = grade 3-4 AEs were neutropenia, anemia, and leukopenia (each 7.1%) chdwxjisyd (lhvfogjyhh ) View more	Positive	07 Dec 2024
				≤ 2 lines of chemotherapy
NCT05246514 (DL-05 \| DESTINY-Lung05 \| DESTINY-Lung05 (DL-05), CTgov)	Phase 2	HER2 mutant non-small cell lung cancer	72	Trastuzumab deruxtecan	obvkwdjxfd = aangcpenvw pdlvajdyye (selptkhscs, lziqxyazlb - ztdvoxzkmq) View more	-	04 Dec 2024

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