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

Start Date10 Jun 2021

Sponsor / Collaborator

Universitair Medisch Centrum Groningen

NCT04739527

/ Active, not recruitingPhase 1

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.

Start Date10 Jun 2021

Sponsor / Collaborator

University Medical Center Groningen

[+1]

NCT03697707

/ Active, not recruitingPhase 2

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

Start Date15 Oct 2018

Sponsor / Collaborator

Mendus AB

[+1]

100 Clinical Results associated with Vididencel

100 Translational Medicine associated with Vididencel

100 Patents (Medical) associated with Vididencel

Literatures (Medical) associated with Vididencel

01 Dec 2023·International Journal of Biological Macromolecules

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

Article

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

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.

01 Oct 2018·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

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

Q2 · MEDICINE

Article

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

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.

01 Nov 2017·Journal of ImmunotherapyQ4 · MEDICINE

DCOne as an Allogeneic Cell-based Vaccine for Multiple Myeloma

Q4 · MEDICINE

Article

Author: Apel, Arik ; Arnason, Jon ; Morin, Adam ; Pyzer, Athalia R. ; Stroopinsky, Dina ; Avigan, David ; van Wetering, Sandra ; Leaf, Rebecca Karp ; Jain, Salvia ; Hamdan, Ayad ; Nahas, Myrna R. ; Kruisbeek, Ada M. ; Cole, Leandra ; Washington, Abigail ; Ephraim, Adam ; Rosenblatt, Jacalyn

Multiple myeloma (MM) is characterized by progressive immune dysregulation, loss of myeloma-specific immunity, and an immunosuppressive milieu that fosters disease growth and immune escape. Accordingly, cancer vaccines that reverse tumor-associated immune suppression represent a promising therapeutic avenue of investigation. We examined the potential of an allogeneic cellular vaccine to generate immune responses against MM tumor cells. The DCOne vaccine is comprised of a human myeloid leukemia cell line differentiated into a fully functional dendritic cell, expressing a range of tumor-associated antigens that are also known targets in MM. We found that the myeloma-specific antigens expressed by the DCOne vaccine can traffic via extracellular vesicles to surrounding antigen-presenting cells, thus stimulating autologous T-cell responses. Indeed, coculture of peripheral blood mononuclear cells from patients with MM with the DCOne vaccine resulted in the expansion of activated CD8+ T cells expressing interferon-γ and perforin, with no significant change in the percentage of CD4+ T cells producing interleukin-10. Further, coculture of patient’s tumor cells with peripheral blood mononuclear cells and DCOne induced cytotoxic T-lymphocyte-mediated killing of autologous MM cells. These findings demonstrate that the allogeneic DCOne vaccine can induce T-cell activation and myeloma-specific immunity via cross presentation of antigens by native antigen-presenting cells.

News (Medical) associated with Vididencel

03 Apr 2025

·mendus.com

Data supporting the use of Mendus’ DCOne platform to improve production of ovarian cancer TIL therapies presented at ITOC conference

Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, today announced that the company has presented data supporting the use of its DCOne platform to expand ovarian cancer tumor-infiltrating lymphocytes (TILs) at the Immunotherapy of Cancer Conference (ITOC). The data support the use of Mendus’ DCOne platform to overcome key hurdles in the production of TIL-based therapies for solid tumor indications. Adoptive cell therapies based on tumor-infiltrating lymphocytes derived from patients’ tumor tissues have proven successful in melanoma and are also being developed as a promising new treatment for other solid tumors. The production of therapeutic quantities of TILs is dependent on reliable methods to massively expand these cells extracted from available tumor material collected via surgery, while maintaining their functional characteristics needed to fight cancer cells upon reinjection. In collaboration with academic collaborators at the University Medical Center Groningen (UMCG), Mendus has explored the use of its proprietary DCOne platform to expand functional TILs from ovarian cancer tissue samples. The data presented during the ITOC conference on April 3 demonstrate that TIL production can be significantly improved with dendritic cells derived from Mendus’ DCOne cell line. Addition of DCOne mDCs resulted in at least five times higher TIL expansion, with the majority being effector-memory T cells. The DCOne platform can therefore be used to improve the quantity and quality of TILs for treatment of patients with ovarian cancer and other solid tumors. Mendus’ DCOne platform provides for GMP-grade, off-the-shelf leukemic-derived dendritic cells. Based on the company’s know-how of dendritic cell biology, Mendus has been working on the ex vivo expansion of immune cells as a basis for novel adoptive cell therapies, including memory NK cells associated with improved survival in blood-borne tumors. The data presented at ITOC indicate that the platform is versatile and can also be used for the production of TILs, an upcoming therapy for solid tumors. Mendus has secured a number of grants to support its research programs and collaborations, including the Oncode Accelerator program and a public-private partnership grant with UMCG from Health~Holland. Mendus has an ongoing clinical collaboration with UMCG for the ALISON study, a Phase I trial evaluating safety and efficacy of Mendus’ lead product vididencel in high-grade serous ovarian cancer patients. 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/ AttachmentsData supporting the use of Mendus’ DCOne platform to improve production of ovarian cancer TIL therapies presented at ITOC conference

ImmunotherapyPhase 1Cell Therapy

20 Feb 2025

·mendus.com

First patient enrolled in the AMLM22-CADENCE trial with Mendus’ product vididencel

Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, today announced that the first patient has been enrolled in the AMLM22-CADENCE trial, which studies Mendus’ lead product vididencel as a novel maintenance therapy in acute myeloid leukemia (AML). In this multi-center, randomized controlled Phase 2 trial, the Australasian Leukaemia and Lymphoma Group (ALLG) is studying vididencel as a novel AML maintenance treatment in combination with oral azacitidine (AZA), currently the only approved AML maintenance drug. In the trial, patients in first complete remission following intensive induction chemotherapy receive standard treatment with AZA or the combination of AZA + vididencel. Vididencel is administered as 4 biweekly intradermal injections, followed by 3 booster injections up to 6 months after start of treatment. The first stage of the AMLM22-CADENCE trial will randomize 40 patients and in the second stage, efficacy of the combination will be assessed in an additional 100 patients. This trial will provide initial safety data on vididencel as add-on to current standard of care and contributes to the further expansion of the regulatory dossier. 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/ AttachmentsFirst patient enrolled in the AMLM22-CADENCE trial with Mendus’ product vididencel

Phase 2ImmunotherapyDrug Approval

12 Feb 2025

·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

Clinical ResultPhase 1ImmunotherapyPhase 2Executive Change

100 Deals associated with Vididencel

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	Norway	Mendus AB	15 Oct 2018
Acute Myeloid Leukemia	Phase 2	Sweden	Mendus AB	15 Oct 2018
Acute Myeloid Leukemia	Phase 2	Netherlands	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	Sweden	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	Germany	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	Finland	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	Norway	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	Netherlands	Mendus AB	15 Oct 2018
Interdigitating Dendritic Cell Sarcoma	Discovery	Netherlands	Mendus AB	01 Apr 2011
Leukemic Infiltration	Discovery	Netherlands	Mendus AB	01 Apr 2011

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03697707 (ADVANCE-II, ASH2023) Manual	Phase 2	Acute Myeloid Leukemia	20	Vididencel	(vtcuqzwhqd) = none augwmjlufv (cubdgphvtw ) View more	Positive	11 Dec 2023
NCT01373515 (Literature) Manual	Phase 1	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome Maintenance	12	DCP-001 (Responder)	(wdsejfrapm) = ihukmlcfvb mroelejhnc (mesudzifgs, 90–1849) View more	Positive	02 Nov 2023
NCT01373515 (Literature) Manual	Phase 1		12	DCP-001 (Non-responder)	(wdsejfrapm) = jmzhkrlass mroelejhnc (mesudzifgs ) View more	Positive	02 Nov 2023
NCT03697707 (ADVANCE-II, GlobeNewswire) Manual	Phase 2	Acute Myeloid Leukemia Maintenance	20	DCP-001	(uvegzjaczx) = fvogkkioun zwqbgqbsvg (octoayyejg ) View more	Positive	16 May 2022
NCT01373515 (ASH 12019 \| ASH 22019) Manual	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	12	Vididencel	(rtcytcaytl) = fewpvwstdd kpuytsnbqj (sacbmjykgk ) View more	Positive	13 Nov 2019

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