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

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesDigestive System Disorders+ [4]

Active Indication

Breast CancerEarly Stage Breast CarcinomaMetastatic breast cancer+ [12]

Inactive Indication

Advanced breast cancerAdvanced HER2-Positive Breast CarcinomaAdvanced Pancreatic Adenocarcinoma+ [15]

Originator Organization

Genentech, Inc.

Active Organization

F. Hoffmann-La Roche Ltd.

Shanghai Roche Pharmaceuticals Ltd.Roche Registration Ltd.

+ [9]

Inactive Organization

Roche Pharma AG

Drug Highest PhaseApproved

First Approval Date

United States (22 Feb 2013),

HER2 Positive Breast Cancer

RegulationFast Track (United States), Priority Review (China), Priority Review (Australia), Breakthrough Therapy (United States)

Structure/Sequence

Boost your research with our ADC technology data.

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Sequence Code 18481L

Source: *****

Sequence Code 44772H

Source: *****

159

Clinical Trials associated with ADO-Trastuzumab Emtansine

NCT06348134

/ Not yet recruitingPhase 2IIT

Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of Chicago

NCT04419181

/ SuspendedPhase 2IIT

A Feasibility Study of De-escalation of Chemotherapy in Patients with Early-Stage HER2 Positive Breast Cancer

The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

Start Date11 Aug 2025

Sponsor / Collaborator

University of Rochester

NCT06439693

/ Not yet recruitingPhase 2IIT

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study:

The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.
The names of the study drugs involved in this study are:
Paclitaxel (a type of anti-microtubule agent)
Docetaxel (a type of anti-microtubule agent)
Nab-Paclitaxel (a type of anti-microtubule agent)
Trastuzumab (a type of IgG1 kappa monoclonal antibody)
Pertuzumab (a type of monoclonal antibody)
Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)
Tucatinib (Tyrosine Kinase HER2 Inhibitor)
Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)

Start Date01 Nov 2024

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

100 Clinical Results associated with ADO-Trastuzumab Emtansine

100 Translational Medicine associated with ADO-Trastuzumab Emtansine

100 Patents (Medical) associated with ADO-Trastuzumab Emtansine

1,563

Literatures (Medical) associated with ADO-Trastuzumab Emtansine

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

HER-2 SMASH

Article

Author: Şahin İnan, Zeynep Deniz ; Özkaraca, Mustafa ; Altun, Ahmet ; Yulak, Fatih ; Öztürk, Ayşegül ; Lacın, Burak Batuhan ; Alandağ, Celal

PURPOSE:

Human epidermal growth factor-2 (HER-2) targeted drugs are used in only HER-2 overexpressed cancers. However, only a small portion of these cancer types are HER-2 overexpressed. In this study, we aimed to upregulate HER-2 receptors in MCF-7 breast cancer and HT-29 colon cancer cell cultures, which these cells are not HER-2 upregulated in natural status.

METHODS:

We used a 10-day non-cytotoxic lapatinib dose to upregulate HER-2 receptors. HER-2 levels of these cell lines were tested with ELISA and immunofluorescence tests before and after 10 days of lapatinib administration. After upregulation of HER-2, we administered trastuzumab, and T-DM1 to these cell lines to observe whether there is an increase in anticancer activity. We used a cell viability test to show the cytotoxicity of trastuzumab and T-DM1. Also, we used ELISA and immunofluorescence for HER-2 pathway proteins to understand the mechanism of increased anti-cancer activity.

RESULTS:

We showed that administration of lapatinib for 10 days leads to overexpression of HER-2 receptors on both MCF-7 and HT-29 cells. A significant increase in the cytotoxicity of trastuzumab or T-DM1 was observed after 10 days of lapatinib administration.

CONCLUSION:

We named this method the smash method, which is the volleyball term. In volleyball, the ball is raised while low and quickly hits the ground again, just like we do with the HER-2 receptor. The smash method can switch HER-2 negative or HER-2 low tumors into HER-2 overexpressed, iatrogenically. Thus, we can use her2-targeted therapies in all cancer patients instead of a small portion.

01 Apr 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Stability of intravenous antibody dilutions in clinical use: Differences across patient populations with varying body weights

Article

Author: Guo, Xiang ; Yu, Chuanfei ; Xu, Dongze ; Wang, Cui ; Li, Hanhan ; Hu, Xueyan ; Zhou, Zhenhao ; Wu, Hao ; He, Pengfei ; Guo, Sha ; Qi, Zhiyun

Antibody-drug conjugate (ADC) plays a crucial role in the treatment of various diseases and intravenous injection is the primary administration route for ADCs due to its high bioavailability. However, this method requires drug preparation and dilution, which can compromise the stability of the solution and increase the risk of aggregation as excipient concentrations are reduced during dilution. Antibody drug dosing is often based on patient body weight and typically diluted in either 0.9% (w/v) sodium chloride or 5% (w/v) dextrose injections. Variations in patient body weight lead to differences in the final concentrations of both the drug and excipients, affecting stability. In this study, we examined the stability of intravenous dilutions for patients with varying body weights using trastuzumab and ado-trastuzumab emtansine ADCs. Analytical techniques including size-exclusion chromatography (SEC), fluid imaging microscopy (FIM), bicinchoninic acid (BCA) assay, and turbidity testing were employed to assess monomer, oligomer, and aggregate levels before and after dilution. Machine learning was applied to distinguish the morphology of sub-visible particles. Our findings reveal that weight-based dosing leads to significant stability differences in intravenous preparations. This study offers important insights into the formulation stability of biopharmaceuticals and their clinical use.

01 Apr 2025·BREAST

Antibody-drug conjugates in elderly patients with breast cancer

Review

Author: Lay, Ludovica ; Puglisi, Fabio ; Esposto, Rocco ; Minisini, Alessandro Marco ; Aprile, Giuseppe ; Bonotto, Marta ; De Pieri, Giulia

Breast cancer remains a leading cause of cancer-related mortality worldwide, with elderly patients (aged >65 years) comprising a substantial portion of those affected. The treatment of breast cancer in this population is often complicated by frailty, comorbidities and polypharmacy. This review explores the application of antibody-drug conjugates (ADCs), such as trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), in treating breast cancer among elderly populations. The underrepresentation of older patients in clinical trials complicates efficacy and safety assessments in this group. Current evidence indicates that ADCs are both effective and tolerable in elderly patients, demonstrating improved progression-free survival (PFS) and overall survival (OS) alongside a manageable safety profile. Data from several trials like the EMILIA, TH3RESA and DestinyBreast studies demonstrate that T-DM1 and T-DXd maintained benefit in PFS and OS for HER2-positive breast cancer in older patients, despite a slight increase in adverse events. The ASCENT and TROPiCS-02 trials further confirm that SG provides significant improvements in PFS and OS in elderly patients at the cost of an increase in some toxicity. Emerging ADCs, including datopotamab deruxtecan and ARX-788, show promise but lack extensive geriatric-specific data. While the ADCs offer encouraging results in terms of efficacy and safety, with appropriate dose adjustments, further research is needed to optimize their use in elderly patients with breast cancer.

143

News (Medical) associated with ADO-Trastuzumab Emtansine

13 Mar 2025

·www.prnewswire.com

Enliven Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update

Updated Phase 1 data for ELVN-001 expected mid-2025 as positive enrollment momentum continues Expected monotherapy and combination data from the ELVN-002 Phase 1 trials in second half of 2025 Strong balance sheet with $313 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into mid-2027 BOULDER, Colo., Mar. 13, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update, including highlights of pipeline progress. "We are very pleased with the ongoing progress we are making as a Company. We continue to hear significant enthusiasm and excitement from investigators on both of our programs. The momentum of ELVN-001 has accelerated since the data presentation at the ESH-iCMLf conference," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "2025 is a big year for Enliven and we are excited for the upcoming program updates. We are focused on continued clinical execution and preparing for the potential start of a pivotal trial for ELVN-001 in 2026." Recent Research and Development Highlights and Upcoming Milestones ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion In 2024, the Company announced positive initial data from the ongoing Phase 1 clinical trial that compared favorably to the precedent Phase 1 trials for the approved BCR::ABL1 tyrosine kinase inhibitors (TKIs). The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML). The first patient was dosed in the Phase 1 trial evaluating ELVN-001 in Japanese patients with CML (NCT06787144). The Company plans to report additional data from the ongoing Phase 1a/b trial in the middle of 2025. ELVN-002 is a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations Enliven continued to enroll patients in its Phase 1 trial evaluating ELVN-002 as a monotherapy agent in patients with HER2+ and HER2 mutant tumors and its exploratory cohort in combination with Kadcyla® (an approved HER2 antibody drug conjugate) in patients with HER2+ metastatic breast cancer (MBC) (NCT05650879). Additionally, the Company continued to enroll patients in its Phase 1 trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in patients with HER2+ MBC and colorectal cancer (CRC) and began dosing patients in the Phase 1b trial specifically evaluating patients with CRC (NCT06328738). Enliven plans to report data from the ongoing Phase 1 trials in the second half of 2025. Fourth Quarter and Full Year 2024 Financial Results Cash Position: As of December 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $313.4 million, which is expected to provide cash runway into mid-2027. Research and development (R&D) expenses: R&D expenses were $20.7 million for the fourth quarter of 2024, compared to $17.9 million for the fourth quarter of 2023. R&D expenses were $80.8 million for the full year 2024, compared to $64.6 million for the full year 2023. General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2024 were $6.2 million, compared to $4.8 million for the fourth quarter of 2023. G&A expenses were $23.8 million for the full year 2024, compared to $19.0 million for the full year 2023. Net Loss: Enliven reported a net loss of $23.2 million for the fourth quarter of 2024, compared to a net loss of $19.4 million for the fourth quarter of 2023. Total net loss for the full year 2024 was $89.0 million, compared to $71.6 million for the full year 2023. About Enliven Therapeutics Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial position, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding Enliven's programs, including ELVN-001 and ELVN-002; expected milestones for ELVN-001 and ELVN-002, including the potential timing for a start of a potential pivotal trial and the expected timing of data from the clinical trials of ELVN-001 and ELVN-002, including updated data from the Phase 1 trial evaluating ELVN-001 in patients with CML and the Phase 1 trials in ELVN-002; statements relating to Enliven's expected cash runway; and statements by Enliven's Co-founder and Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the limited operating history of Enliven; the ability to advance product candidates through clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; Enliven's limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven's preclinical studies and clinical trials to materially change from the final data; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; the decision to develop or seek strategic collaborations to develop Enliven's current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties, including those more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), which may be found in the section titled "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven's future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. SOURCE Enliven Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Financial StatementClinical ResultOrphan Drug

21 Feb 2025

·www.echemi.com

Exciting Advances in Breast Cancer Treatment with New Drugs and Technologies

Recent developments in the field of breast cancer treatment are generating significant excitement, with several promising updates emerging. On February 19, Hansai Aitai announced that its second phase clinical trial for HX009, in combination with the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan, has been approved by China's National Medical Products Administration (NMPA). This trial targets patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have previously received first or second-line systemic therapy and exhibit low or very low HER2 expression. In January, Daiichi Sankyo and AstraZeneca received U.S. approval for trastuzumab deruxtecan to treat patients with hormone receptor-positive, HER2 low-expressing or ultra-low expressing breast cancer that is not amenable to surgery. AstraZeneca also gained approval for olaparib for a new indication in early high-risk breast cancer patients with harmful or suspected harmful germline BRCA mutations, following neoadjuvant or adjuvant chemotherapy. These innovative drugs are breaking barriers in breast cancer treatment, especially for TNBC, which is particularly aggressive and often affects younger women. The absence of the three common receptor markers—estrogen receptor (ER), progesterone receptor (PR), and HER2—has made treatment options limited, traditionally relying on surgery, radiotherapy, and chemotherapy. Currently, the treatment landscape for TNBC is constrained, with chemotherapy being the primary option in China. However, overseas, PD-(L)1 inhibitors and PARP inhibitors have been approved for first-line therapy. Gilead's sacituzumab govitecan, the world’s first Trop-2 targeted ADC, was approved in China in 2022 for previously treated advanced TNBC. The breast cancer drug market is entering a harvest phase with multiple targets being explored. HER2 ADC drugs like Roche’s T-DM1 and AstraZeneca/Daiichi Sankyo’s DS-8201 are showing significant therapeutic potential, with over ten HER2 ADC drugs currently in clinical development. Additionally, TROP2 has emerged as a crucial target for TNBC treatment, with several ADC drugs targeting this antigen, indicating considerable potential in clinical studies. The advent of PROTAC technology also offers new hope for ER-positive breast cancer, aiming to overcome treatment resistance by degrading specific pathogenic proteins. As breast cancer treatments evolve, these innovations provide more options and hope for patients. The breakthroughs in TROP2 and HER2 ADCs not only enhance treatment precision but also significantly improve patient outcomes and survival rates. With the maturation of PROTAC technology, the future of breast cancer therapy promises to be more personalized, precise, and diverse.

Drug ApprovalADC

19 Feb 2025

·www.sonnetbio.com

Sonnet BioTherapeutics Announces That Its Proprietary Antibody Drug Conjugate (ADC) Platform is Available for Drug Discovery Partnerships with Potential for Producing Multiple Pipeline Drug Candidates

Building on proven targeting of the FHAB domain, Sonnet’s ADC platform offers flexible payload capacity and controllable drug-antibody ratios (DAR) An epidermal growth factor receptor 2 (HER2) ADC construct designated – SON-5010 showed similar activities as compared with Kadcyla® and also trastuzumab-MMAE, in a preclinical study Company’s ADC Platform offers the potential for novel ADCs with homogeneous structural integrity, tumor targeting domain, interchangeability of toxin payloads and flexible conjugation site usage Management releases “What This Means” segment discussing its ADC platform; Access here PRINCETON, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced its plans to advance the development of its proprietary Antibody Drug Conjugate (ADC) platform which was designed to circumvent many of the technical challenges associated with ADCs. Additionally, the Company announced the release of a Virtual Investor “What This Means” segment to discuss plans for its ADC platform, which is now available here. “In order to increase our value proposition to cancer patients, in addition to our existing FHAB platform we have developed a bolt-on ADC platform that takes advantage of our FHAB targeting domain and flexible docking peptides, which offer controllable DAR capacity,” commented Pankaj Mohan, Ph.D., Founder and Chief Executive Officer of Sonnet. “Further, we believe our ADC platform is differentiated from other ADCs by stable structural integrity, extended conjugation site flexibility, potential for enhanced tumor penetration and retention with the FHAB domain, and potential to select and conjugate one of several possible payloads having different mechanisms of action (MOA) for killing cancer cells. With a plug-and-play ADC platform, we could generate a number of ADC candidates, and thus, we are seeking value-driven discovery partnerships.” The initial proof-of-concept (POC) construct was designated as SON-5010, which is produced through a two-step process whereby the targeting scaffold and payload domains are either expressed and purified from mammalian cells or chemically synthesized, respectively, and then joined to create the final ADC conjugate using a chemical linkage process. The SON-5010 ADC construct is comprised of an anti-HER2-FHAB-anti-HER2 targeting scaffold linked to a docking peptide that has 3 equally spaced lysine residues which serve as conjugation sites for monomethyl auristatin E (MMAE), a synthetic antineoplastic agent that disrupts the microtubule network and suppresses cell proliferation and mitosis, including G2/M arrest. This initial SON-5010 ADC was used in a head-to-head comparison with an approved product, Kadcyla®, which has a very similar anti-HER2 targeting domain and linker chemistry but is conjugated with a different toxin payload known as mertansine (DM1) and a trastuzumab-MMAE complex, consisting of a humanized anti-HER2 receptor monoclonal antibody with the same linker chemistry and 3x MMAE DAR payload as SON-5010. John Cini, Ph.D., Co-Founder and Chief Scientific Officer commented, “Sonnet is excited about the early POC data shown by this novel plug-and-play, non-IgG ADC format that incorporates Sonnet’s albumin binding scFv into the targeting scaffold. The binding of albumin in this particular ADC format provides the differentiated potential for accumulation of the FHAB-ADC complex into the tumor. The SON-5010 ADC was produced with the same linker chemistry and MMAEx3 as in trastuzumab (Herceptin®) and has shown in vitro human serum stability at 37oC and similar cellular cytotoxicity results. In a direct in vivo comparison with Kadcyla and Herceptin® at 10mg/kg in the BT-474 HER2+ carcinoma breast tumor mouse model, SON-5010 demonstrated similar tumor reduction activity and no detectable toxicity. The potential diverse application of Sonnet’s ADC platform could be applied with a wide variety of linkers and toxins, resulting in complete controllable DAR. Further, Sonnet’s ADC platform has the ability to show bispecific or tri-specific tumor targeting capability when associated with the FHAB scFv, which could potentially improve its ADC clinical efficiency.” Dr. Stephen McAndrew, Ph.D., Chief Business Officer commented, “We believe this ADC platform differentiates itself by offering the potential for flexibility around multiple targeting scaffolds, controllable DARs and choice of payload. We plan to continue global prosecution of our intellectual property around this ADC platform while we seek discovery partnership opportunities aimed at developing proprietary ADC drug candidates.” About Sonnet BioTherapeutics Holdings, Inc. Sonnet is an oncology-focused biotechnology company with a proprietary platform for developing targeted biologic drugs with single or bifunctional action. Known as FHAB (Fully Human Albumin-Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB platform is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines. Sonnet’s lead program, SON-1010, or IL-12-FHAB, is in development for the treatment of advanced solid tumors, certain types of sarcoma, and platinum-resistant ovarian cancer (PROC). SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement with Roche in combination with atezolizumab (Tecentriq®) for the treatment of PROC. The Company is also evaluating its second product candidate, SON-1210, an IL12-FHAB-IL15 for solid tumors, in collaboration with the Innovative Immuno-Oncology Consortium (IIOC), and plans to commence an investigator-initiated and funded Phase 1/2a study for the treatment of locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The Company’s SON-080 program is a low dose of rhIL-6 in development for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN). SON-080 demonstrated encouraging results in a Phase 1b/2a clinical trial, being well tolerated with no evidence of a pro-inflammatory cytokine response. In October 2024, Sonnet announced a license agreement with Alkem Laboratories, Inc. who will assume responsibility for advancing development of the SON-080 program into a Phase 2 study in DPN in India. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to, the Company's product development, the Company's cash runway clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations Contact: JTC Team, LLC Jenene Thomas 908-824-0775 SONN@jtcir.com Released February 19, 2025

License out/inImmunotherapyADCPhase 2

100 Deals associated with ADO-Trastuzumab Emtansine

External Link

KEGG	Wiki	ATC	Drug Bank
-	ADO-Trastuzumab Emtansine	L01XC14	DB05773

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Breast Cancer	China	Roche Pharma (Schweiz) AG	21 Jan 2020
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	15 Nov 2013
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	15 Nov 2013
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	15 Nov 2013
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	15 Nov 2013
Metastatic breast cancer	European Union	Roche Registration GmbH	15 Nov 2013
Metastatic breast cancer	Iceland	Roche Registration GmbH	15 Nov 2013
Metastatic breast cancer	Liechtenstein	Roche Registration GmbH	15 Nov 2013
Metastatic breast cancer	Norway	Roche Registration GmbH	15 Nov 2013
HER2 Positive Breast Cancer	United States	Genentech, Inc.	22 Feb 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	Phase 3	United States	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	China	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Japan	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Argentina	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Belgium	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Brazil	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Canada	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Czechia	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Finland	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	France	Hoffmann-La Roche, Inc.	03 Sep 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01772472 (KATHERINE, Pubmed) Manual	Phase 3	HER2 Positive Breast Cancer Adjuvant HER2 Positive	-	T-DM1	cksbhrqdqn(wtlothoqqo): HR = 0.54 (95% CI, 0.44 - 0.66) View more	Positive	16 Jan 2025
NCT01772472 (KATHERINE, Pubmed) Manual	Phase 3	HER2 Positive Breast Cancer Adjuvant HER2 Positive	-	trastuzumab		Positive	16 Jan 2025
ESMO_ASIA2024	Not Applicable	Early Stage Breast Carcinoma Adjuvant Her-2 positive	180	Adjuvant Trastuzumab Emtansine (T-DM1)	mwixbewnqd(ehrwyftkhh) = aevyjfjzxs ickvhrbiud (nfkghpjayt )	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	Early Stage Breast Carcinoma Adjuvant Her-2 positive	180	trastuzumab emtansine (Residual Cancer Burden (RCB) Class 2)	vceoiqzwko(ksmkafapte) = mhwovbsdqc nmwzuxltzq (heirtkneep )	Positive	07 Dec 2024
NCT04197687 (ASCO2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant	20	H2NVAC + T-DM1	pkzbiriyqu(wqgprktdfa) = xtmnebbodg mhocgwwqms (boqmrzrmmz ) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Adjuvant	116	Biosimilar TDM1	dwiztymuzv(lzoaipcbhs) = Common adverse effects were fatigue mboijpuimh (dyxklcjctj ) View more	Positive	24 May 2024
JPRN-UMIN000030783 (JCOG1607 HERB TEA, ASCO2024)	Phase 3	Advanced HER2-Positive Breast Carcinoma First line	148	Trastuzumab emtansine (T-DM1)	tznqmnyfys(yzoaasvdoe) = hjffmhxzas mopvxemncu (nqstaroahk, 0.310 - 1.808)	Negative	24 May 2024
ASCO2024	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 2+	172	T-DM1	ionatmhtdo(nhslbrawqo) = tangktrtkv qerjmlxgwz (afgibudies, 3.9 - 6.3) View more	Negative	24 May 2024
NCT02568839 (PREDIX HER2, ESMO_BC2024)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant Ki67 \| age \| CCL3 ... View more	90	Trastuzumab emtansine (T-DM1)	yldjnnkidy(oynomybqis) = nwfzbcpupy mlvtrrpqix (evjhljcdpb ) View more	Positive	14 May 2024
NCT02568839 (PREDIX HER2, ESMO_BC2024)	Phase 2		90	Placebo	yldjnnkidy(oynomybqis) = xxqemzjhsp mlvtrrpqix (evjhljcdpb ) View more	Positive	14 May 2024
NCT02236000 (NSABP FB-10, Pubmed) Manual	Phase 1/2	HER2 Positive Breast Cancer Second line HER2 Positive	49	T-DM1 + neratinib	dmwtgmmbif(phghjhzxod) = ehuyvubpeu grfzvgibmd (nipmkzggoj ) View more	Positive	22 Apr 2024
NCT04589845 (TAPISTRY, AACR2024) Manual	Phase 2	HER2 Positive Solid Tumors HER2	35	Trastuzumab emtansine	ussmvubwrw(lrxuqgyddw) = crddjlqgks gsaflpcxir (wjzofnffni, 4.8 - 30.3) View more	Negative	05 Apr 2024
ESMO_ASIA2023	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	30	T-DM1 biosimilar	vdztlewecj(pshzicsccj) = qewtphksmk ixmkubfnkr (jsedfuexss, 13.46 - 17.17) View more	Positive	02 Dec 2023

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