Open label first-in-human study of TH1902 in solid cancer, with 4 sequential parts:
Part 1 (dose escalation): patients with recurrent advanced solid tumors (all comers) that have relapsed or are refractory to standard chemotherapy, surgery, radiation therapy, and for which no known effective therapies exist.
Part 2 (expansion): selected patient populations with recurrent advanced TNBC, HR+ breast cancer, epithelial ovarian cancer, endometrial cancer, cutaneous melanoma, thyroid cancer, SCLC, prostate cancer and other cancers known to express SORT1 that are refractory to standard therapy.
Part 3 (optimization): patients diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer, including high grade peritoneal or fallopian tube cancer, or high grade endometrioid cancer, that is refractory or resistant to standard therapies, should not be considered platinum sensitive, and where current therapy is not considered to be providing benefit.
Part 4 (basket expansion): selected cancer type diagnosed with histologically or cytologically confirmed cancers, where TH1902 has been studied and/or showed activity (in Parts 1 to 3), that is refractory or resistant to standard therapies, and where current therapy is not considered to be providing benefit.

开始日期2021-03-04

申办/合作机构

Theratechnologies, Inc.

[+6]

100 项与 Sudocetaxel Zendusortide 相关的临床结果

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100 项与 Sudocetaxel Zendusortide 相关的转化医学

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100 项与 Sudocetaxel Zendusortide 相关的专利（医药）

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项与 Sudocetaxel Zendusortide 相关的文献（医药）

2021-10-01·Cancer Science2区 · 医学

TH1902, a new docetaxel‐peptide conjugate for the treatment of sortilin‐positive triple‐negative breast cancer

2区 · 医学

ArticleOA

作者: Charfi, Cyndia ; Marsolais, Christian ; Demeule, Michel ; Larocque, Alain ; Zgheib, Alain ; Kozelko, Sophie ; Béliveau, Richard ; Currie, Jean‐Christophe ; Annabi, Borhane

AbstractTriple‐negative breast cancer (TNBC) is a heterogeneous subgroup of cancers which lacks the expression and/or amplification of targetable biomarkers (ie, estrogen receptor, progestrogen receptor, and human epidermal growth factor receptor 2), and is often associated with the worse disease‐specific outcomes than other breast cancer subtypes. Here, we report that high expression of the sortilin (SORT1) receptor correlates with the decreased survival in TNBC patients, and more importantly in those bearing lymph node metastases. By exploiting SORT1 function in ligand internalization, a new anticancer treatment strategy was designed to target SORT1‐positive TNBC‐derived cells both in vitro and in two in vivo tumor xenografts models. A peptide (TH19P01), which requires SORT1 for internalization and to which many anticancer drugs could be conjugated, was developed. In vitro, while the TH19P01 peptide itself did not exert any antiproliferative or apoptotic effects, the docetaxel‐TH19P01 conjugate (TH1902) exerted potent antiproliferative and antimigratory activities when tested on TNBC‐derived MDA‐MB‐231 cells. TH1902 triggered faster and more potent apoptotic cell death than did unconjugated docetaxel. The apoptotic and antimigratory effects of TH1902 were both reversed by two SORT1 ligands, neurotensin and progranulin, and on siRNA‐mediated silencing of SORT1. TH1902 also altered microtubule polymerization and triggered the downregulation of the anti‐apoptotic Bcl‐xL biomarker. In vivo, both i.p. and i.v. administrations of TH1902 led to greater tumor regression in two MDA‐MB‐231 and HCC‐70 murine xenograft models than did docetaxel, without inducing neutropenia. Altogether, the data demonstrates the high in vivo efficacy and safety of TH1902 against TNBC through a SORT1 receptor‐mediated mechanism. This property allows for selective treatment of SORT1‐positive TNBC and makes TH1902 a promising avenue for personalized therapy with the potential of improving the therapeutic window of cytotoxic anticancer drugs such as docetaxel.

Frontiers in Oncology3区 · 医学

New Peptide-Drug Conjugates for Precise Targeting of SORT1-Mediated Vasculogenic Mimicry in the Tumor Microenvironment of TNBC-Derived MDA-MB-231 Breast and Ovarian ES-2 Clear Cell Carcinoma Cells

3区 · 医学

ArticleOA

作者: Béliveau, Richard ; Charfi, Cyndia ; Ouanouki, Amira ; Demeule, Michel ; Larocque, Alain ; Marsolais, Christian ; Zgheib, Alain ; Annabi, Borhane ; Danalache, Bogdan Alexandru ; Currie, Jean-Christophe

Vasculogenic mimicry (VM) is defined as the formation of microvascular channels by genetically deregulated cancer cells and is often associated with high tumor grade and cancer therapy resistance. This microcirculation system, independent of endothelial cells, provides oxygen and nutrients to tumors, and contributes also in part to metastasis. VM has been observed in ovarian cancer and in triple negative breast cancer (TNBC) and shown to correlate with decreased overall cancer patient survival. Thus, strategies designed to inhibit VM may improve cancer patient treatments. In this study, sortilin (SORT1) receptor was detected inin vitro3D capillary-like structures formed by ES-2 ovarian cancer and MDA-MB-231 TNBC-derived cells when grown on Matrigel.SORT1gene silencing or antibodies directed against its extracellular domain inhibited capillary-like structure formation.In vitro, VM also correlated with increased gene expression of matrix metalloproteinase-9 (MMP-9) and of the cancer stem cell marker CD133.In vivoES-2 xenograft model showed PAS+/CD31-VM structures (staining positive for both SORT1 and CD133). TH1904, a Doxorubicin-peptide conjugate that is internalized by SORT1, significantly decreasedin vitroVM at low nM concentrations. In contrast, VM was unaffected by unconjugated Doxorubicin or Doxil (liposomal Doxorubicin) up to μM concentrations. TH1902, a Docetaxel-peptide conjugate, altered even more efficientlyin vitroVM at pM concentrations. Overall, current data evidence for the first time that 1) SORT1 itself exerts a crucial role in both ES-2 and MDA-MB-231 VM, and that 2) VM in these cancer cell models can be efficiently inhibited by the peptide-drug conjugates TH1902/TH1904. These new findings also indicate that both peptide-drug conjugates, in addition to their reported cytotoxicity, could possibly inhibit VM in SORT1-positive TNBC and ovarian cancer patients.

Cancers2区 · 医学

The Peptide-Drug Conjugate TH1902: A New Sortilin Receptor-Mediated Cancer Therapeutic against Ovarian and Endometrial Cancers

2区 · 医学

ArticleOA

作者: Zgheib, Alain ; Charfi, Cyndia ; Béliveau, Richard ; Ouanouki, Amira ; Demeule, Michel ; Marsolais, Christian ; Currie, Jean-Christophe ; Larocque, Alain ; Annabi, Borhane ; Danalache, Bogdan Alexandru

Sortilin (SORT1) receptor-mediated endocytosis functions were exploited for this new approach for effective and safe treatments of gynecological cancers. Here, high expression of SORT1 was found in >75% of the clinically annotated ovarian and endometrial tumors analyzed by immunohistochemistry. Therefore, the anticancer properties of the peptide-drug conjugate TH1902, a peptide that targets SORT1 and which is linked to docetaxel molecules, were investigated both in vitro using ovarian and endometrial cancer cell cultures and in vivo using xenograft models. In vitro, TH1902 inhibited cell proliferation and triggered higher SORT1-dependent cell apoptosis than unconjugated docetaxel did in ES-2 and SKOV3 ovarian cancer cell lines. The uptake of the Alexa488-TH19P01 peptide from TH1902 was reduced upon siRNA-mediated silencing of SORT1. In vivo, weekly administration of TH1902 showed better tolerability compared to equivalent docetaxel doses and inhibited tumor growth in ovarian and endometrial xenograft mice models. TH1902 as a single agent inhibited ovarian tumor growth more than either of the unconjugated taxanes or carboplatin. Furthermore, TH1902 combination with carboplatin also demonstrated better efficacy when compared to both taxanes-carboplatin combinations. Overall, TH1902 shows better in vivo efficacy, compared to that of docetaxel and even paclitaxel, against SORT1-positive ovarian and endometrial cancers and could be safely combined with carboplatin.

项与 Sudocetaxel Zendusortide 相关的新闻（医药）

2025-02-04

·PRNewswire

Global Peptide-Drug Conjugate Market to Show Enormous Growth at a CAGR of ~29% by 2032 | DelveInsight

The increasing global prevalence of cancer is fueling the demand for peptide-drug conjugates as targeted therapies, providing improved effectiveness and lower systemic toxicity than conventional treatments. Additionally, the expanding use of peptide-based therapeutics, driven by their enhanced treatment outcomes, biocompatibility, and precise tumor-targeting capabilities, is further propelling market growth. LAS VEGAS , Feb. 4, 2025 /PRNewswire/ -- DelveInsight's Peptide-drug Conjugate Market Insights report provides the current and forecast market analysis, individual leading peptide-drug conjugate companies' market shares, challenges, peptide-drug conjugate market drivers, barriers, trends, and key market peptide-drug conjugate companies in the market. Key Takeaways from the Peptide-drug Conjugate Market Report As per DelveInsight estimates, North America is anticipated to dominate the global peptide-drug conjugate market during the forecast period. The LUTATHERA (lutetium Lu 177 dotatate) category in the peptide drug conjugates market dominated with a market share of 37% in 2024. Notable peptide-drug conjugate companies such as Novartis AG, Oncopeptides AB, Cybrexa Therapeutics, Avacta Therapeutics, ProteinQure, Theratechnologies Inc., CBP, Soricimed Biopharma, NMS Group S.p.A., Mainline Scientific LLC., Bicycle Therapeutics, and several others, are currently operating in the peptide-drug conjugate market. In April 2024, PeptiDream Inc. announced the expansion of its peptide discovery collaboration with Novartis Pharma AG. Using its proprietary Peptide Discovery Platform System (PDPS®), PeptiDream identified and optimized macrocyclic peptides for conjugation with radionuclides for therapeutic and diagnostic applications. In March 2023, Ono Pharmaceutical Co., Ltd. announced that it entered into a drug discovery collaboration agreement with PeptiDream Inc., to discover and develop novel macrocyclic constrained peptide drugs against multiple targets of Ono's interest. To read more about the latest highlights related to the PDC market, get a snapshot of the key highlights entailed in the Global Peptide-drug Conjugate Market Report Peptide-drug Conjugate Overview Peptide-drug conjugates (PDCs) are an emerging class of targeted therapeutics that combine the specificity of peptides with the potent efficacy of cytotoxic drugs. These conjugates leverage peptides as targeting ligands to deliver drugs selectively to diseased cells, such as cancerous or infected tissues, thereby minimizing off-target toxicity. The design of PDCs involves three key components: a targeting peptide, a linker, and a payload (therapeutic drug). The peptide is typically selected based on its ability to recognize and bind to overexpressed receptors on diseased cells, ensuring precise drug delivery. The linker plays a crucial role in controlling drug release, which can be triggered by specific conditions like enzymatic cleavage or pH changes in the tumor microenvironment. Compared to antibody-drug conjugates (ADCs), PDCs offer advantages such as smaller size, better tissue penetration, and lower immunogenicity. They are particularly promising for targeting intracellular pathways, where antibodies may struggle to enter. Advances in peptide engineering, including modifications to enhance stability and binding affinity, have further improved the efficacy of PDCs in preclinical and clinical settings. PDCs are being explored in various therapeutic areas, including oncology, infectious diseases, and metabolic disorders. As research progresses, optimizing peptide selection, linker chemistry, and payload potency will be critical in developing next-generation PDCs with superior safety and efficacy profiles. Peptide-drug Conjugate Market Insights North America dominated the global peptide drug conjugates market in 2024, accounting for the largest share of 56.70%. The market is expected to grow at a CAGR of 28.47% from 2025 to 2032, primarily driven by the increasing incidence of cancer in the U.S. Additionally, the region's market growth is fueled by rising collaborations among key industry players for PDC development and increasing investments in this sector. Furthermore, major companies in North America are emphasizing research and development to create innovative peptide-drug conjugates. For instance, in February 2021, Theratechnologies Inc. announced that the U.S. FDA granted fast-track designation to TH1902, a docetaxel-based peptide-drug conjugate, for treating patients with sortilin-positive recurrent advanced solid tumors that are resistant to standard therapies. In addition, in April 2024, Novartis, which already has two FDA-approved PDC drugs, expanded its collaboration with PeptiDream to further develop peptide-drug conjugates in a deal exceeding USD 2.8 billion. These factors collectively contribute to the anticipated growth of the peptide drug conjugates market in the region. To know more about why North America is leading the market growth in the PDC market, get a snapshot of the Peptide-drug Conjugate Market Outlook Peptide-drug Conjugate Market Dynamics The peptide-drug conjugate market is witnessing significant growth, driven by advancements in targeted therapies and the increasing prevalence of cancer and other chronic diseases. PDCs combine the specificity of peptides with the potency of cytotoxic drugs, offering an improved therapeutic index compared to traditional chemotherapy. With growing interest in precision medicine, pharmaceutical companies are heavily investing in PDC research and development, leading to an expanding pipeline of clinical candidates. One of the key market drivers is the rising demand for novel drug delivery systems that enhance efficacy while minimizing off-target effects. Peptides, due to their high specificity and low immunogenicity, serve as excellent carriers for cytotoxic payloads. Additionally, advancements in peptide synthesis and linker technologies have improved the stability and half-life of PDCs, making them more viable for clinical applications. Companies such as Bicycle Therapeutics and PeptiDream are leading the innovation in this space. Despite the promising outlook, the PDC market faces challenges such as manufacturing complexities, high development costs, and regulatory hurdles. Peptide synthesis and conjugation processes require stringent quality control, and scalability remains a concern. Furthermore, competition from other targeted therapies, such as ADCs and small-molecule inhibitors, poses a challenge for widespread adoption. Looking ahead, growth opportunities exist in expanding indications beyond oncology, such as antimicrobial, autoimmune, and neurodegenerative diseases. Strategic collaborations between biotech firms and large pharmaceutical companies are accelerating clinical development, while advancements in artificial intelligence and computational modeling are further refining peptide design and optimization. With ongoing innovations and increasing investments, the PDC market is poised for substantial expansion in the coming years. Get a sneak peek at the PDC market dynamics @ Peptide-drug Conjugate Market Dynamics Analysis Peptide-drug Conjugate Market Assessment Peptide-drug Conjugate Market Segmentation Peptide-drug Conjugate Market Segmentation By Product: LUTATHERA (lutetium Lu 177 dotatate), PEPAXTI (Melphalan flufenamide), and PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) Peptide-drug Conjugate Market Segmentation By Cancer Type: Prostate Cancer, Gastrointestinal Cancer, Multiple Myeloma Peptide-drug Conjugate Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the PDC market are set to emerge as the trendsetter explore @ Peptide-drug Conjugate Companies Table of Contents Interested in knowing the PDC market by 2032? Click to get a snapshot of the Peptide-drug Conjugate Market Trends Related Reports Antibody-drug Conjugates in Oncology Competitive Landscape Antibody-drug Conjugates in Oncology Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ADC in oncology companies, including Jiangsu Hengrui Medicine Co., Bio-Thera Solutions, MediLink Therapeutics, Byondis, AbbVie, Oxford BioTherapeutics, Iksuda Therapeutics, Novelty Nobility, LegoChem Biosciences, DualityBio, Lepu Biopharma, Ambrx, CSPC ZhongQi Pharmaceutical Technology, MacroGenics, ADC Therapeutics, Genor Biopharma, CStone Pharmaceuticals, AstraZeneca, Alteogen, Biocity Biopharmaceutics, among others. Antibody-drug Conjugates Competitive Landscape Antibody-drug Conjugates Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ADC companies, including Sorrento Therapeutics, Ambrx, MacroGenics, SOTIO Biotech, Klus Pharma, BioAtla, BiOneCure Therapeutics, Shanghai Miracogen, ProfoundBio, ImmunoGen, Arcus Biosciences, CytomX Therapeutics, RemeGen, Bliss Biopharmaceutical, Aivita Biomedical, CoImmune, Zenith Epigenetics, Sutro Biopharma, Ambrx, Mythic Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Byondis, MediLink Therapeutics (Suzhou), Oncomatryx Biopharma, MacroGenics, Shanghai Miracogen, Mirati Therapeutics, Ambrx, Orum Therapeutics, Silverback Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Aivita Biomedical, Northwest Biotherapeutics, Daiichi Sankyo, Merck, Pfizer, GSK, AstraZeneca, Eisai, FOSUN PHARMA, LaNova, Mabwell Therapeutics, MBRACE THERAPEUTICS, MINGHUSI PHARMACEUTICALS, BioNTech , Bio-Thera, Corbus Pharmaceuticals, AbbVie, Multitude Therapeutics, Innovent, OnCusp Therapeutics, Simcere, Ymmunobio, Jiangsu Hengrui Medicine, among others. Antibody-drug Conjugates Market Antibody Drug Conjugates Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ADC companies, including Sorrento Therapeutics, Ambrx, MacroGenics, SOTIO Biotech, Klus Pharma, BioAtla, BiOneCure Therapeutics, Shanghai Miracogen, ProfoundBio, ImmunoGen, Arcus Biosciences, CytomX Therapeutics, RemeGen, Bliss Biopharmaceutical, Aivita Biomedical, CoImmune, Zenith Epigenetics, Sutro Biopharma, Ambrx, Mythic Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Byondis, MediLink Therapeutics (Suzhou), Oncomatryx Biopharma, MacroGenics, Shanghai Miracogen, Mirati Therapeutics, Ambrx, Orum Therapeutics, Silverback Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Aivita Biomedical, Northwest Biotherapeutics, Daiichi Sankyo, Merck, Pfizer, GSK, AstraZeneca, Eisai, FOSUN PHARMA, LaNova, Mabwell Therapeutics, MBRACE THERAPEUTICS, MINGHUSI PHARMACEUTICALS, BioNTech , Bio-Thera, Corbus Pharmaceuticals, AbbVie, Multitude Therapeutics, Innovent, OnCusp Therapeutics, Simcere, Ymmunobio, Jiangsu Hengrui Medicine, among others. Bispecific Antibody Competitive Landscape Bispecific Antibody Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key bispecific antibodies companies, including Janssen, Amgen, Akeso, Zymeworks, Roche, IGM Biosciences, MacroGenics, Provention Bio, Jiangsu Alphamab Biopharmaceuticals, Sichuan Baili Pharmaceutical, Regeneron Pharmaceuticals, Boehringer Ingelheim, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

快速通道多肽偶联药物

2024-12-09

·GlobeNewswire-Health Care

Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian Cancer

No dose-limiting toxicities reported in two different weekly doses in heavily pre-treated patients Preliminary evidence of dose response includes significant tumor shrinkage and one patient with complete resolution of a liver lesion MONTREAL, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Thera technologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced data from Part 3 (dose optimization, weekly dosing schedule) of its ongoing Phase 1b trial of sudocetaxel zendusortide (TH1902) – the company’s lead investigational peptide drug conjugate (PDC) – in patients with advanced ovarian cancer. Based on results demonstrating favorable tolerability and signals of efficacy, the Medical Review Committee, which includes study investigators and external experts, has unanimously recommended continued evaluation and exploration of higher doses. “We are encouraged by the tolerability and preliminary efficacy data for sudocetaxel zendusortide seen thus far in this part of the Phase 1 study, which was designed to explore dose optimization utilizing a weekly dosing schedule in a population of heavily pre-treated ovarian cancer patients,” commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “These latest results add to the growing body of evidence that our novel PDC technology can deliver a toxic payload into cancer cells with little impact on non-cancerous tissues and we believe there could be further clinical implications at a higher dose.” A total of 13 patients with advanced ovarian cancer who progressed despite prior platinum-based and taxane chemotherapy were enrolled in two Arms in Part 3 of the Phase 1b trial. Seven patients were enrolled in Arm A and received a 1.75-mg/kg/week dose of sudocetaxel zendusortide on a weekly infusion, three-weeks-on/one-week-off schedule every 28 days. The six patients enrolled in Arm B received a 2.5-mg/kg/week dose on the same schedule. Investigators observed no dose-limiting toxicities in either arm. Although there were no responses observed in the five Arm A participants that comprised the per-protocol (PP) set, there was encouraging evidence of activity observed in three of the six patients enrolled in the Arm B PP set, including one patient with a complete resolution of a liver lesion. Those three Arm B patients also experienced significant reductions in the CA-125 ovarian tumor marker as well as significant tumor shrinkage, including two patients with more than a 25% reduction in tumor size. Additionally, Arm B participants in the PP set received a mean of 10.25 weeks of treatment compared to a mean of 7.6 weeks of treatment in patients treated on Arm A. All patients in Arm B received at least two cycles of treatment, with some completing up to four cycles (on-treatment range: 4-18 weeks). The Company received permission from the U.S. Food and Drug Administration (FDA) in 2023 to amend the initial Phase 1b clinical trial protocol based on results from Parts 1 and 2, which utilized every-3-week dosing. For Part 3, the protocol was amended to explore dosing weekly for three weeks, followed by a one-week break and shifted the focus to patients with ovarian cancer. At the 2024 American Society of Clinical Oncology (ASCO) annual meeting earlier this year, Theratechnologies presented an updated analysis from Parts 1 and 2 of the study, in which sudocetaxel zendusortide induced durable disease stabilization (up to 45 weeks) lasting beyond treatment completion in several patients with a variety of solid tumors. The ASCO presentation also highlighted early signals of efficacy observed in female cancers (ovarian cancer, endometrial cancer, triple-negative breast cancer [TNBC]), as well as a manageable safety profile when sudocetaxel zendusortide was dosed at 300mg/m2 given once every 3 weeks with few Grade 3 adverse events (AEs). “The latest data from Part 3 of the Phase 1 trial build on a compelling body of preclinical and translational evidence of antitumor activity with sudocetaxel zendusortide,” said Ira Winer, M.D., Ph.D., FACOG, a member of the Gynecologic Oncology and Phase 1 Clinical Trials Multidisciplinary Teams at Karmanos Cancer Center and Professor of Oncology at Wayne State University School of Medicine in Detroit, MI. “While this is a small sample of patients, it is not often that we see promising signs of efficacy, combined with favorable safety and tolerability data, in this patient population with advanced disease. We therefore recommend and encourage continued investigation with further dose escalation for this agent.” In addition to the Phase 1b clinical trial results, there is also an extensive body of preclinical data demonstrating the flexibility of the Company’s SORT1+ Technology™ platform when conjugated with different toxic payloads. With a significant portion of the clinical trial data to date now available, Theratechnologies will accelerate its search for a partner to advance its oncology program. About Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology™ Sudocetaxel zendusortide is a first-of-its-kind sortilin receptor (SORT1)-targeting PDC, and the first compound to emerge from the Company’s broader licensed oncology platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Theratechnologies has established the SORT1+ Technology™ platform as an engine for the development of PDCs that target SORT1, which is expressed in multiple tumor types. SORT1 is a “scavenger” receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival. It is estimated that SORT1 is expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast (TNBC), and pancreatic cancers, making this receptor an attractive target for anticancer drug development. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on LinkedIn and X (formerly Twitter). Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: (i) the conjugation of different toxic payloads to be directed into cancer cells; (ii) signs of efficacy, combined with safety and tolerability data of sudocetaxel zendusortide; (iii) the further development of the Company’s lead PDC, sudocetaxel zendusortide; and (iv) the search for a partner to advance the oncology program. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. These assumptions include, without limitation, that: (i) the technology stemming from the oncology platform will allow for the development and conjugation of various PDC and payloads to treat cancer; and (ii) the Company will be able to find a partner to pursue the development of the oncology platform. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, (i) the lack of observation of signs of efficacy and safety results as sudocetaxel zendusortide may be further studied; (ii) difficulties in developing and conjugating payloads to peptides derived from the oncology platform; and (iii) the inability of the Company to find a partner to pursue the development of the oncology platform. We refer current and potential investors to the “Risk Factors” section of our annual information form filed under a Form 20-F dated February 21, 2024, available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800 Investor Inquiries:Joanne Choi Senior Director, Investor Relationsjchoi@theratech.com551-261-0401

临床1期临床结果ASCO会议快速通道

2024-05-23

·GlobeNewswire-Health Care

Theratechnologies’ Sudocetaxel Zendusortide ASCO 2024 Presentation Demonstrates Signs of Long-Term Efficacy and Manageable Safety Profile in Patients with Solid Tumors

Poster highlights durable disease stabilization lasting beyond treatment completionResults suggest a unique, multimodal mechanism of action that differs from other cancer therapeuticsFavorable tolerability sets stage for Part 3 (dose optimization) of Phase 1 trial, already underway MONTREAL, May 23, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced Phase 1 data demonstrating signs of long-term efficacy and a manageable safety profile of its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), in patients with solid tumors. The data will be presented in a poster session on June 1, 9:00 AM-12:00 PM CDT (abstract #3081, poster board #226) at the 2024 American Society of Clinical Oncology (ASCO) annual meeting, which is taking place May 31-June 4, 2024, in Chicago, IL. In an updated analysis from Parts 1 and 2 of an ongoing Phase 1 clinical trial, sudocetaxel zendusortide induced durable disease stabilization (up to 45 weeks) lasting beyond treatment completion. The results suggest a unique, multimodal mechanism of action distinct from other cancer therapeutics, including induction of immune cell infiltration even in “cold” tumor models, inhibition of vasculogenic mimicry, targeting of chemotherapy-resistant cancer stem cells, and activation of the cGAS/STING immune pathway, among other actions. Additionally, investigators observed an early efficacy signal primarily in female cancers (ovarian cancer, endometrial cancer, triple-negative breast cancer [TNBC]), with seven of 16 participants (44%) achieving a clinical benefit rate (complete response + partial response + stable disease), as confirmed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The poster presentation, which constitutes the first report of long-term efficacy, safety, and pharmacokinetic (PK) data from the Phase 1 study, also suggests that sudocetaxel zendusortide has a manageable safety profile when dosed at 300mg/m2, with few Grade 3 adverse events (AEs). “The initial long-term Phase 1 data further validate and expand upon the preliminary evidence of antitumor activity with sudocetaxel zendusortide in individuals with solid tumors,” said Ira Winer, M.D., Ph.D., FACOG, a member of the Gynecologic Oncology and Phase 1 Clinical Trials Multidisciplinary Teams at Karmanos Cancer Center and Associate Professor of Oncology at Wayne State University. “It is highly unusual to see such long-lasting disease stabilization even after treatment cessation in patients with advanced disease. These updated data provide an informative baseline as we seek to optimize the dose of this novel peptide-drug conjugate in patients with platinum-resistant ovarian cancer in the next stage of the Phase 1 trial.” Study details Dr. Winer and colleagues conducted an analysis of the long-term efficacy, safety, and PK of sudocetaxel zendusortide from Parts 1 and 2 of the Phase 1 trial, which seeks primarily to characterize the agent’s safety and tolerability. Part 1 (modified intrapatient dose escalation, n=18) included patients with recurrent/refractory advanced tumors (all comers) with no limit on the number of previous therapies, including taxanes. Part 2 (dose expansion, n=18) included patients with cancers with known high expression of the sortilin (SORT1) receptor, including ovarian cancer, endometrial cancer, TNBC, and melanoma. Part 3 (dose optimization) of the Phase 1 trial, in patients with advanced ovarian cancer that is no longer platinum-sensitive, is ongoing. In a sub-analysis of efficacy in 16 patients with TNBC, ovarian, and endometrial cancers, seven patients exhibited RECIST 1.1-confirmed clinical benefit, with six patients achieving long-term stabilization of disease (up to a maximum of 45 weeks in duration) even after drug discontinuation in some patients. One patient with ovarian cancer had an overall partial response (PR), with a RECIST 1.1-confirmed complete response (CR) in target lesions, and stabilization of disease (SD) in non- target lesions, lasting up to 24 weeks from initiation of treatment. In addition, one patient with endometrial cancer, whose dose was escalated from 60 mg/m2 to 360 mg/m2 in Part 1, completed a total of 11 treatment cycles; this patient’s disease remained stable throughout eight months of treatment, up to the time of consent withdrawal. All 16 patients had prior exposure to taxane-containing regimens (range: 1-6). The investigators characterized the prolonged stabilization of disease as clinically significant in this heavily pretreated patient population, which typically experiences recurrence during or shortly after treatment discontinuation. Sudocetaxel zendusortide has a manageable safety profile, with most treatment-related AEs rated as mild to moderate in severity and managed with standard supportive care or dose reductions. Investigators noted that the low number of Grade 3 AEs compares favorably to the published literature for unconjugated docetaxel. PK measures showed that exposure to free docetaxel was much lower than that for sudocetaxel zendusortide, a finding that may explain the lower incidence and severity of AEs seen with sudocetaxel zendusortide versus docetaxel alone. The maximum concentration (Cmax) of sudocetaxel zendusortide was 30.4 micromolar (μM), compared to 0.58 μM for free docetaxel. The 24-hour area under the curve (AUC24) for sudocetaxel zendusortide was 74.8 nanomoles per hour per liter (h.nmol/mL), versus 3.1 h.nmol/mL for free docetaxel. The free docetaxel/sudocetaxel zendusortide AUC ratio was less than 1% up to 300 mg/m2, suggesting that most docetaxel remains associated with the peptide over the period of analysis. “One year after our presentation of preliminary evidence of antitumor activity at the 2023 ASCO annual meeting, the Phase 1 sudocetaxel zendusortide trial continues to yield important information about long-term efficacy, safety, and pharmacokinetics of this promising peptide-drug conjugate,” commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “These latest data leave us well positioned for Part 3 of the study, in which we aim to optimize the dose to see further signs of efficacy while limiting toxicity. We look forward to sharing more data from this ongoing trial in the future.” About Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology™ Sudocetaxel zendusortide is a first-of-its-kind sortilin receptor (SORT1)-targeting PDC, and the first compound to emerge from the Company’s broader licensed oncology platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a Phase 1 clinical trial. Theratechnologies has established the SORT1+ Technology™ platform as an engine for the development of PDCs that target SORT1, which is expressed in multiple tumor types. SORT1 is a “scavenger” receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival. It is estimated that SORT1 is expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast (TNBC), and pancreatic cancers, making this receptor an attractive target for anticancer drug development. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the conduct of Part 3 of the Phase 1 clinical trial using sudocetaxel zendusortide, the data on signs of long-term efficacy of sudocetaxel zendusortide and safety of sudocetaxel zendusortide, and the further development of the Company’s lead PDC, sudocetaxel zendusortide. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. These assumptions include, without limitation, that the Company will successfully complete Part 3 of the Phase 1 clinical trial, that signs of long-term efficacy and safety will be observed in such Part 3 of the Phase 1 clinical trial and no untoward side effects will be reported, and the further development of the Company’s lead PDC, sudocetaxel zendusortide, will continue generating reportable data and will be successful. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, the lack of observation of signs of efficacy and safety results during Part 3 of the Phase 1 clinical trial, the reporting of adverse side effects from the use of sudocetaxel zendusortide leading to a halt of the clinical trial and, eventually, the Company’s further development of its lead PDC, sudocetaxel zendusortide, and additional PDCs. We refer current and potential investors to the “Risk Factors” section (Item 3.D) of our Form 20-F dated February 21, 2024, available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800 Investor Inquiries:Philippe DubucSenior Vice President and Chief Financial Officerpdubuc@theratech.com438-315-6608

临床1期快速通道ASCO会议临床结果多肽偶联药物

100 项与 Sudocetaxel Zendusortide 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床1期	美国	Theratechnologies, Inc.	2021-03-04
晚期恶性实体瘤	临床1期	加拿大	Theratechnologies, Inc.	2021-03-04
皮肤黑色素瘤	临床1期	加拿大	Theratechnologies, Inc.	2021-03-04
皮肤黑色素瘤	临床1期	美国	Theratechnologies, Inc.	2021-03-04
前列腺癌	临床1期	加拿大	Theratechnologies, Inc.	2021-03-04
前列腺癌	临床1期	美国	Theratechnologies, Inc.	2021-03-04
小细胞肺癌	临床1期	美国	Theratechnologies, Inc.	2021-03-04
小细胞肺癌	临床1期	加拿大	Theratechnologies, Inc.	2021-03-04
甲状腺癌	临床1期	美国	Theratechnologies, Inc.	2021-03-04
甲状腺癌	临床1期	加拿大	Theratechnologies, Inc.	2021-03-04

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04706962 (GlobeNewswire) 人工标引	临床1期	卵巢癌	13	Sudocetaxel Zendusortide 1.75 mg/kg/week	(醖範選構蓋築顧壓願觸) = 製選觸壓鑰構鬱遞鏇壓繭鹹鹽鑰淵顧鑰窪鬱獵 (簾顧衊積醖壓鹹襯醖廠 ) 更多	积极	2024-12-09
NCT04706962 (GlobeNewswire) 人工标引	临床1期	卵巢癌	13	Sudocetaxel Zendusortide 2.5 mg/kg/weekSudocetaxel Zendusortide 2.5 mg/kg/week	(醖範選構蓋築顧壓願觸) = 廠憲蓋蓋齋衊窪鹹顧範繭鹹鹽鑰淵顧鑰窪鬱獵 (簾顧衊積醖壓鹹襯醖廠 ) 更多	积极	2024-12-09
NCT04706962 (ASCO2024) 人工标引	临床1期	实体瘤 SORT1 expression	25	TH1902 300 mg/m2	(齋顧蓋壓夢遞窪淵構觸) = 獵積蓋淵襯膚膚夢鑰範廠願製膚遞鹽範鑰廠鹹 (繭膚衊壓鑰廠餘廠齋齋 ) 更多	积极	2024-05-24
NCT04706962 (ASCO2024) 人工标引	临床1期	实体瘤 SORT1 expression	25	Docetaxel	(齋顧蓋壓夢遞窪淵構觸) = 鬱鬱醖願窪壓選構網憲廠願製膚遞鹽範鑰廠鹹 (繭膚衊壓鑰廠餘廠齋齋 ) 更多	积极	2024-05-24
NCT04706962 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	18	Sudocetaxel zendusortide	(鏇齋構鏇簾衊積積廠壓) = At the at 300 mg/m2 cohort, seven pts received a mean of 2.9 cycles. AEs (regardless of relatedness) occurred in all 7 (100%) pts, mostly Gr 1-2. 繭淵壓鬱鑰鑰選繭鏇淵 (觸衊淵夢鏇觸艱繭積獵 )	积极	2023-05-31
NCT04706962 (Corporate Publications) 人工标引	临床1期	肿瘤	18	TH1902	(壓積鑰鹽繭願夢鬱鬱鑰) = 420 mg/m^2 including grade 3 neuropathy, grade 4 neutropenia, grade 3 ocular changes (visual acuity, keratitis and ocular surface dryness) 選積網築鑰觸簾壓鹹鹹 (糧齋繭鏇鹽構齋顧衊艱 ) 更多	积极	2022-07-14