An open label, phase 1 study to evaluate the safety, feasibility and immunogenicity of an allogeneic, cell-based vaccine (DCP-001) in high grade serous ovarian cancer patients after primary treatment - ALISON

开始日期2021-06-10

申办/合作机构

Universitair Medisch Centrum Groningen

NCT04739527

/ Active, not recruiting临床1期

An Open Label, Phase 1 Study to Evaluate the Safety, Feasibility and Immunogenicity of an Allogeneic, Cell-based Vaccine (DCP-001) in High Grade Serous Ovarian Cancer Patients After Primary Treatment

Phase I study to evaluate safety and systemic immunogenicity of the DCP-001 vaccine in patients with high grade serous ovarian cancer after primary treatment.

开始日期2021-06-10

申办/合作机构

University Medical Center Groningen

[+1]

NCT03697707

/ Active, not recruiting临床2期

An International, Multicentre, Open-label Study To Evaluate The Efficacy and Safety of Two Different Vaccination Regimens of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia That Are In Remission With Persistent MRD

Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD

开始日期2018-10-15

申办/合作机构

Mendus AB

[+1]

100 项与 Vididencel 相关的临床结果

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100 项与 Vididencel 相关的转化医学

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100 项与 Vididencel 相关的专利（医药）

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项与 Vididencel 相关的文献（医药）

2023-12-01·International journal of biological macromolecules

Isolation and characterization of a nephroprotective polysaccharide from Dendrobium chrysotoxum Lindl against LPS-induced acute kidney injury mice

Article

作者: Liu, Hailin ; Lao, Shenghui ; Hao, Yuting ; Liao, Wenzhen ; Chen, Xiao ; Ye, Guangying ; Wang, Zaihua

The structure and bioactivity of a novel polysaccharide from Dendrobium Chrysotoxum Lindl (DCP-1) were investigated. The crude polysaccharides of Dendrobium Chrysotoxum Lindl (DCP) were extracted by hot water extraction, and the protein was removed by enzymatic hydrolysis and Sevage. After purification, the chemical structure of polysaccharides was identified by infrared spectroscopy, methylation analysis and nuclear magnetic resonance spectroscopy. Then, a mouse model of acute kidney injury (AKI) was constructed using lipopolysaccharide (LPS), and pretreated with DCP. Structure characterization demonstrated that the number-average molecular weight and mass average molar mass of DCP-1 were 28.43 kDa and 15.00 kDa, respectively. DCP-1 mainly consisted of mannose (37.8 %) and glucose (55.6 %). The main linkage types of DCP-1 were contained 1,4-Linked Manp and 1,4-Linked Glcp. And DCP-1 was demonstrated to be an O-acetylglucomannan with β-ᴅ-configuration in pyranoid form. Besides, the bioactivity of DCP was further investigated. The results showed that DCP exhibited notable anti-inflammatory activity in LPS-induced AKI mice. After treated with DCP, the creatinine (CREA) and urea nitrogen (BUN) in serum were successfully down-regulated in AKI mice. DCP treatment prevented the characteristic morphological changes of LPS-induced renal tubular injury. The results showed that DCP treatment significantly reduced the concentration of oxidative damage indicators (MDA, SOD) and the expression of inflammatory indices (TNF-α, IL-6, MCP-1, COX-2). In general, the newly extracted polysaccharide DCP showed excellent nephroprotective effect, which enabled it to be an ideal natural medicine for kidney diseases therapy.

2018-10-01·Cancer immunology, immunotherapy : CII2区 · 医学

A novel allogeneic off-the-shelf dendritic cell vaccine for post-remission treatment of elderly patients with acute myeloid leukemia

2区 · 医学

Article

作者: de Gruijl, Tanja D ; Singh, Satwinder Kaur ; Kruisbeek, Ada M ; Eeltink, Corien M ; van de Loosdrecht, Arjan A ; den Hartog, Yvonne ; Santegoets, Saskia J A M ; Kaspers, Jorn ; Koppes, Malika ; van Wetering, Sandra ; Ossenkoppele, Gert J

In elderly acute myeloid leukemia (AML) patients post-remission treatment options are associated with high comorbidity rates and poor survival. Dendritic cell (DC)-based immunotherapy is a promising alternative treatment strategy. A novel allogeneic DC vaccine, DCP-001, was developed from an AML-derived cell line that uniquely combines the positive features of allogeneic DC vaccines and expression of multi-leukemia-associated antigens. Here, we present data from a phase I study conducted with DCP-001 in 12 advanced-stage elderly AML patients. Patients enrolled were in complete remission (CR1/CR2) (n = 5) or had smoldering disease (n = 7). All patients were at high risk of relapse and ineligible for post-remission intensification therapies. A standard 3 + 3 dose escalation design with extension to six patients in the highest dose was performed. Patients received four biweekly intradermal DCP-001 injections at different dose levels (10, 25, and 50 million cells DCP-001) and were monitored for clinical and immunological responses. Primary objectives of the study (feasibility and safety) were achieved with 10/12 patients completing the vaccination program. Treatment was well tolerated. A clear-cut distinction between patients with and without detectable circulating leukemic blasts during the vaccination period was noted. Patients with no circulating blasts showed an unusually prolonged survival [median overall survival 36 months (range 7-63) from the start of vaccination] whereas patients with circulating blasts, died within 6 months. Long-term survival was correlated with maintained T cell levels and induction of multi-functional immune responses. It is concluded that DCP-001 in elderly AML patients is safe, feasible and generates both cellular and humoral immune responses.

2017-08-01·International journal of biological macromolecules1区 · 化学

Isolation, characterization and bioactivities of the polysaccharides from Dicliptera chinensis (L.) Juss.

1区 · 化学

Article

作者: Zhang, Kefeng ; Li, Jun ; Huang, Simao ; Wei, Riming ; Gao, Ya ; Xu, Yourui ; Zhong, Mingli ; Cao, Houkang

The polysaccharides of Dicliptera chinensis (L.) Juss. (DCP-1 and DCP-2) were extracted and isolated using the methods of water extract-ethanol precipitate and sephadex column chromatography and characterized by gel permeation chromatography (GPC), Fourier transform infrared spectrometry (FT-IR) and gas chromatography (GC), respectively. The antioxidant activity of DCPs was evaluated by scavenging activity of DPPH, hydroxyl, superoxide anion and ABTS radical. Moreover, the anti-aging activity of DCP-2 was investigated using an aging model-induced by D-galactose (D-gal) in mice. The results show that the weight average molecular weight (Mw) of DCP-2 was 2 273Da with a narrow polydispersity index of 1.01, and it was a heteropolysaccharide and consisted of glucose, galactose, arabinose, rhamnose and mannose with a molar ratio of 3.20:2.54:1.69:1.58:1.00. DCP-2 had stronger antioxidant activity against DPPH, hydroxyl, superoxide anion and ABTS radical, while DCP-1 had hardly any antioxidant activity and DCP had weaker antioxidant activity. Furthermore, DCP-2 can enhance antioxidant capacity and had anti-aging activity against D-gal induced aging mice. These results proposed that DCP-2 might be developed as a potential functional food with the activity of anti-aging.

项与 Vididencel 相关的新闻（医药）

2025-02-12

·mendus.com

Mendus AB Year-end Report 2024

Preparations for pivotal-stage readiness of vididencel in AML on trackThe hard work of the Mendus team to advance the company’s lead product vididencel in acute myeloid leukemia (AML) continued to pay off during the fourth quarter of 2024. In December, we presented positive updated survival data of the ongoing ADVANCE II Phase 2 trial at ASH, demonstrating that the majority of patients treated remained alive at 41.8 months median follow-up. Also in Q4, we received positive EMA and FDA feedback endorsing our registration trial preparations. We successfully advanced our manufacturing alliance for the large-scale production of vididencel. The progress realized during the quarter keeps us on track to achieve pivotal-stage readiness of vididencel in AML as our lead program in the second half of 2025. Erik Manting, Ph.D.Chief Executive Officer Significant events of Q4 2024 Net sales for the period amounted to KSEK – (-) Result for the period amounted to KSEK -31,515 (-41,165) Earnings and diluted earnings per share totalled SEK -0.63 (-0.95*) Cash runway extended until beginning of 2026 versus earlier guidance until Q4 2025 Mendus presented preclinical data supporting the combination of its intratumoral primer ilixadencel with the immune checkpoint inhibitor avelumab at the 39th annual meeting of the Society for Immunotherapy of Cancer (SITC). Mendus announced that the members of the Nomination Committee for the 2025 Annual General Meeting were appointed. The Nomination Committee consists of Erik Esveld, appointed by Van Herk Investments B.V, Karl Elmqvist, appointed by Flerie Invest AB, and Mats Andersson, appointed by Holger Blomstrands Byggnads AB. Mendus presented positive survival data from the ongoing ADVANCE II Phase 2 trial at the ASH 2024 conference. The data showed that the majority of AML patients treated with vididencel remain alive and disease-free in long-term follow-up, with a median follow-up of 41.8 months. Mendus also presented two preclinical abstracts during the ASH 2024 conference. The first abstract demonstrated synergies between vididencel and the combination of venetoclax and azacitidine, two backbone drugs in the treatment of AML, with venetoclax having a direct synergistic effect on vididencel’s mode of action. The second abstract supports the potential use of vididencel in the treatment of chronic myeloid leukemia (CML). Mendus reported positive topline data from the ALISON Phase 1 clinical trial with vididencel in ovarian cancer. The data confirmed that vididencel stimulates immune responses against ovarian cancer antigens, as a potential basis for an effective anti-tumor response, and the strong safety profile for vididencel. Mendus announced that Institut Bergonié was no longer in a position to study Mendus’ intratumoral immune primer ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial, because third party funding for the trial had been terminated. Significant events after end of reporting period Mendus announced a summary of the feedback received from FDA and EMA in the fourth quarter of 2024. The feedback is supportive of the preparations for a registration trial with vididencel in AML. Financial summary * The comparative numbers recalculated taking into account the reverse split, 20:1 The full report is attached as PDF and is available on the company’s website: https://mendus.com/investors/financial-reports/ Webcast investor call, February 13, 08.30 CETThe company will host a live presentation and business update today at 08.30 CET. The presentation will be held in English and includes a Q&A session. If you wish to participate via webcast please use the link below.https://mendus.events.inderes.com/q4-report-2024/register If you wish to participate and ask questions via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference.https://conference.inderes.com/teleconference/?id=5004794 For more information, please contact:Erik MantingChief Executive OfficerE-mail: ir@mendus.com About Mendus AB (publ) Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving long-term survival for cancer patients, while preserving health and quality of life. We leverage our understanding of dendritic cell biology to develop an advanced clinical pipeline of immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. https://www.mendus.com/ AttachmentsMendus Q4 2024 ENG 02 13 FinalMendus AB Year-end Report 2024

临床结果临床1期免疫疗法临床2期高管变更

2024-12-18

·mendus.com

Mendus and UMCG announce positive topline data from the ALISON trial with vididencel in ovarian cancer

Press Release Stockholm, Sweden, December 18, 2024 Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, announces positive topline data from the ALISON Phase 1 clinical trial with its lead product vididencel in ovarian cancer. The data collected from all 17 patients treated confirm that vididencel stimulates immune responses against ovarian cancer antigens, as a potential basis for an effective anti-tumor response. The strong safety profile for vididencel was confirmed. The ALISON trial is a single-center Phase 1 trial carried out by the University Medical Center Groningen, The Netherlands (UMCG). The trial explores the potential of vididencel to induce clinically relevant immune responses in high-grade serous ovarian carcinoma (HGSC). Mendus and UMCG had earlier reported at the ESMO Gynaecological Cancers conference in June 2024 that 10 patients treated with vididencel in the ALISON trial had stable disease and 7 patients had imaging-confirmed recurrence at week 22. Based on the updated analysis of samples collected from all patients treated with vididencel, a vaccine-induced immune response (VIR) against one or more tumor antigens that are regularly upregulated in HGSC was observed in 12 out of 17 patients (71%). The observed immune responses to different tumor antigens provides a potential basis for an effective anti-tumor response. Stable disease at week 22 was observed in 2 out of 5 patients (40%) without VIR, whereas the majority of patients with VIR had stable disease (8 out of 12 patients, or 67%). “Ovarian cancer is the deadliest gynaecological cancer, particularly due to its high recurrence rate, with recurring tumors being generally unresponsive to earlier lines of treatment.” said Dr Hans Nijman, Professor Obstetrics and Gyneacology and Head of Immuno-oncology at UMCG. “Active immunotherapies like vididencel, which aim to improve immune responses against residual disease, therefore hold promise as a novel treatment option to improve disease-free and overall survival of ovarian cancer patients after primary treatment. We look forward to further evaluate the potential clinical benefit of vididencel based on long-term follow-up of patients treated in the ALISON trial.” The ALISON trial confirmed the strong safety profile of vididencel, indicating only mild adverse reactions, predominantly at the site of injection. Long-term follow-up of patients treated with vididencel as part of the ALISON trial is ongoing, with a next read-out based on 2-year follow-up expected in 2025Q4. For more information, please contact: Erik MantingChief Executive OfficerE-mail: ir@mendus.com About Mendus AB (publ) Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving long-term survival for cancer patients, while preserving health and quality of life. We leverage our understanding of dendritic cell biology to develop an advanced clinical pipeline of immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. https://www.mendus.com/ Attachments241218 ALISON Topline ENG

免疫疗法临床结果临床1期ASCO会议

2024-12-17

·mendus.com

Mendus to participate in upcoming industry conferences in September

Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, announces that it will participate in the following upcoming industry and investor conferences in September: International Society for Cell & Gene Therapy Europe 2024 Regional MeetingGothenburg, Sweden, September 4-6, 2024Mendus will present the regulatory milestones of its clinical-stage programs vididencel and ilixadencel during a poster session held on September 4, 18.30–20.00 CEST. In addition, Mendus Head of Regulatory Affairs, Dr Anna Koptina Gültekin, will participate in a panel discussion held on September 5 about the importance of interactions with regulatory authorities during drug development.ISCT EU 2024 H.C. Wainwright 26th Annual Global Investment ConferenceNew York City, USA, September 9-11Mendus CEO Erik Manting will participate for investor meetings and a company presentation.HCW Events Nordic Life Science Days 2024Malmö, Sweden, September 18-19, 2024Mendus CEO Erik Manting will take part in a presentation hosted by the Dutch Government about the collaboration potential between Sweden and The Netherlands in the Life Sciences sector.NLSDays Pareto Securities' 15th Annual Healthcare ConferenceStockholm, Sweden, September 19, 2024Mendus CEO Erik Manting will participate for investor meetings and a company presentation.Pareto Securities' 15th Annual Healthcare Conference

免疫疗法

100 项与 Vididencel 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性髓性白血病	临床2期	芬兰	Mendus AB	2018-10-15
急性髓性白血病	临床2期	德国	Mendus AB	2018-10-15
急性髓性白血病	临床2期	荷兰	Mendus AB	2018-10-15
急性髓性白血病	临床2期	挪威	Mendus AB	2018-10-15
急性髓性白血病	临床2期	瑞典	Mendus AB	2018-10-15
残留肿瘤	临床2期	芬兰	Mendus AB	2018-10-15
残留肿瘤	临床2期	德国	Mendus AB	2018-10-15
残留肿瘤	临床2期	荷兰	Mendus AB	2018-10-15
残留肿瘤	临床2期	挪威	Mendus AB	2018-10-15
残留肿瘤	临床2期	瑞典	Mendus AB	2018-10-15

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临床结果

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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


NCT03697707 (ADVANCE-II, ASH2023) 人工标引	临床2期	急性髓性白血病	20	Vididencel	獵膚選壓築積鑰觸衊齋(遞齋衊窪構憲鏇鹽襯壓) = none 夢顧鑰衊糧選網遞夢網 (壓範窪選構繭顧簾構築 ) 更多	积极	2023-12-11
NCT01373515 (Literature) 人工标引	临床1期	急性髓性白血病 \| 高危骨髓增生异常综合征维持	12	DCP-001 (Responder)	鹹選鬱遞顧廠夢鏇糧夢(網鏇鹹網窪獵膚網鬱構) = 齋顧憲窪觸壓積簾壓範齋鹽簾積壓蓋餘廠範鬱 (餘顧觸網築夢窪糧網築, 90–1849) 更多	积极	2023-11-02
NCT01373515 (Literature) 人工标引	临床1期	急性髓性白血病 \| 高危骨髓增生异常综合征维持	12	DCP-001 (Non-responder)	鹹選鬱遞顧廠夢鏇糧夢(網鏇鹹網窪獵膚網鬱構) = 積顧繭襯鬱顧衊膚願鑰齋鹽簾積壓蓋餘廠範鬱 (餘顧觸網築夢窪糧網築 ) 更多	积极	2023-11-02
NCT03697707 (ADVANCE-II, GlobeNewswire) 人工标引	临床2期	急性髓性白血病维持	20	DCP-001	衊夢鏇憲鹽製廠餘憲鑰(選遞遞餘獵艱製築鑰醖) = 繭築鏇願簾憲鏇壓蓋築鏇襯範鹽觸選構鏇憲蓋 (窪壓糧憲憲餘網壓淵糧 ) 更多	积极	2022-05-16
NCT01373515 (ASH 12019 \| ASH 22019) 人工标引	临床1期	急性髓性白血病 \| 骨髓增生异常综合征	12	Vididencel	艱鹹醖願齋鹽淵糧憲觸(築觸夢艱構衊糧艱遞構) = 廠窪夢觸憲淵範餘糧鹽襯願製憲範繭簾繭觸鬱 (醖憲願艱艱鹽範鑰衊鑰 ) 更多	积极	2019-11-13