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]

NL-OMON55212 / CompletedNot Applicable

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

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 Aug 2017·International Journal of Biological MacromoleculesQ1 · CHEMISTRY

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

Q1 · CHEMISTRY

Article

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

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.

News (Medical) associated with Vididencel

15 Mar 2024

·www.globenewswire.com

Mendus’ major shareholders and members of the Board of Directors and Management declare their intention to exercise warrants of series TO3

Press Release Stockholm, Sweden, March 15, 2024 Mendus AB (“Mendus” or the “Company”) has received written declarations of intent whereby the Company’s major shareholders, holding approximately 65.8 percent of shares in the Company, declare their intention to exercise warrants of series TO3 (the “Warrants”) to subscribe for newly issued shares corresponding to their holdings of Warrants during the subscription period 15-29 March 2024 at the subscription price of 0.48 SEK per share. The major shareholders have confirmed that their holdings of Warrants at least equal the number that was allotted to them in connection to their participation in the rights issue in July 2023. All shareholding members of the Company’s Board of Directors and Management team have also declared their intention to exercise all their Warrant holdings. In total, these declarations of intent are expected to result in the exercise of approximately 71.6 percent of the outstanding Warrants. Mendus’ CEO Erik Manting comments: “The commitments by our largest shareholders, together with all the shareholding members of the board and all in the management team, to exercise their warrants which were issued during our latest financing round in July 2023 underscores the progress made by Mendus since. After the positive Phase 2 data presented at the ASH2023 conference in December, we were happy to present the major steps we are taking to expand the clinical development and to scale-up the manufacturing of vididencel together with our partners ALLG and NorthX Biologics at our Business Update event earlier this week. We are also very grateful for the continued support by our shareholders.” The outstanding Warrants were allotted as part of the units that were subscribed for in connection to the preferential rights issue and the directed issue that Mendus carried out in July 2023. If all outstanding Warrants are exercised, the Company will receive approximately SEK 90.6 million in gross proceeds. The declarations of intent are expected to lead to the exercise of approximately 71.6 percent of the outstanding Warrants. The declarations of intent have been made by Van Herk Investments BV, Flerie Invest AB (publ) and Fjärde AP-fonden as well as all shareholding members of the Board of Directors and Management team. The declaration of intent from Van Herk Investments BV is contingent upon them receiving an exemption from the Securities Council (Sv. “Aktiemarknadsnämnden”) to be able to increase their shareholding. In the event that such exemption is not received, Van Herk Investments BV will exercise warrants such that, following the outcome of the exercise period, their percentage ownership will remain unchanged. The declaration of intent from Fjärde AP-fonden to exercise their Warrant holdings is conditional upon their shareholding in the Company not exceeding 9.9 percent. Accordingly, the actual number of Warrants exercised by Van Herk Investments BV and Fjärde AP-fonden will depend on the aforementioned conditions. 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 survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based 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/ Attachment 240315 Mendus - Warrants Commitment ENG

ImmunotherapyPhase 2

15 Mar 2024

·www.globenewswire.com

The exercise period for warrants of series TO3 commences today

Press Release Stockholm, Sweden, March 15, 2024 On June 8, 2023, Mendus AB (publ) (“Mendus” or the “Company”), (NASDAQ Stockholm: IMMU), announced that the Board of Directors had resolved on a capital raise of approximately SEK 317 million (the “Transaction”), comprised of a directed issue of shares and warrants to Flerie Invest AB of approximately SEK 90 million (the “Directed Issue”), in combination with a fully secured rights issue of units of approximately SEK 227 million (the “Rights Issue”). The Transaction was completed in July 2023. The exercise period for the warrants of series T03 that were allotted as part of the Transaction (the “Warrants”) commences today on Friday 15 March 2024. Upon full exercise of the Warrants the Company will receive proceeds of up to approximately SEK 90.6 million. Summary of the Warrants Each warrant issued in the Directed Issue and the Rights Issue entitles subscription of one new share during the period commencing on Friday 15 March up to and including Friday 29 March 2024. The exercise price of the Warrants is SEK 0.48. Upon full exercise of the Warrants the Company will receive proceeds of up to approximately SEK 90.6 million. Mendus intends to use proceeds from the Warrants to finance the continuation of its operations and extension of cash runway to Q3 2025, including futility analysis of the oral azacitidine (5’aza) combination trial with vididencel as a first step towards pivotal-stage trial design and primary analysis of the ilixadencel proof-of-concept trial. The Warrants are admitted to trading on Nasdaq Stockholm under the ticker IMMU TO3. Last day of trading of the Warrants is on Tuesday 26 March 2024. Warrants that are not exercised by Friday 29 March 2024 expire without value. Provided that the Warrants are fully exercised, the number of shares in Mendus will increase by 188,701,103 from 863,148,371 to 1,051,849,474 and the share capital will increase by approximately SEK 9,435,055.2 from approximately SEK 43,157,418.6 to approximately SEK 52,592,473.8. This will entail a dilution of approximately 17.9 percent based on the total maximum outstanding shares after the exercise of all Warrants. Warrant holders have the opportunity to compensate themselves financially for the dilution effect by selling their Warrants. Complete terms and conditions for the Warrants are available at the Company’s website. Exercise of the Warrants Nominee-registered Warrants If the warrant holder holds Warrants in a deposit account, in an investment savings account or capital insurance, exercise and payment shall take place with the nominee, who will provide further instructions on how to exercise the Warrants. The warrant holder should contact its nominee well in advance for further instructions regarding exercising of the Warrants. Directly registered Warrants (VP account) Exercise of Warrants is carried out through an application form available on AktieInvest Fondkommission’s website www.aktieinvest.se. Payment is made in accordance with the instructions on the application form. Both the application form and payment must be submitted to AktieInvest Fondkommission by Friday, 29 March 2024, at the latest. No issue statement will be sent out. 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 survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based 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/ Important informationThe information in this press release does not contain or constitute an offer to acquire, subscribe for or otherwise trade in shares, warrants or other securities in Mendus. The invitation to the persons concerned to subscribe for units consisting of shares and warrants in the Company has only been made through the prospectus published by the Company on July 11, 2023. Attachment 240315 Mendus - Warrants Exercise period PR (ENG)

Immunotherapy

23 Feb 2024

·www.globenewswire.com

Mendus to hold Business Update event on March 12

Press Release Stockholm, Sweden, February 23, 2024 Mendus AB (“Mendus” publ; IMMU.ST), will hold an in-person and live-streamed business update event in Stockholm on March 12, 15:00-17:00 CET to discuss the company’s latest pipeline advancements. Mendus has recently presented positive Phase 2 data with vididencel in acute myeloid leukemia (AML), an aggressive blood-borne tumor associated with high relapse rates, at the ASH 2023 conference. Vididencel addresses the need for safe and effective AML maintenance treatments, which prolong disease-free and overall survival following initial chemotherapy. Based on the positive data in AML, Mendus will expand the clinical development of vididencel in combination with standard of care in a randomized controlled trial together with the Australasian Leukaemia and Lymphoma Group (ALLG). To facilitate late-stage development and prepare for commercial launch, Mendus is scaling up the vididencel manufacturing capacity together with NorthX Biologics, a leading Nordic contract development and manufacturing organization for cell and gene therapies. At the business update event, Mendus will present together with its strategic partners ALLG and NorthX Biologics the next steps in the development of vididencel as a promising new maintenance treatment option for AML patients. The live presentation will be in English and followed by a question-and-answer session. Guests are welcome to stay and mingle with management afterwards. Venue: Inderes Event Studio (Västra Trädgårdsgatan 19, Stockholm) Date and time: March 12 at 15:00–17:00 CET, registration is open from 14:30 Please register to attend via email to ir@mendus.com Those unable to attend in person can listen to the presentation webcast: https://ir.financialhearings.com/mendus-business-update-march-2024 Questions can be sent ahead of the presentation to ir@mendus.com For more information, please contact:Erik Manting, CEOE-mail: ir@mendus.com About Mendus AB (publ)Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based 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. http://www.mendus.com/ Attachment 240223 Mendus business update ENG

Clinical ResultImmunotherapyPhase 2

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	NL	Mendus AB	15 Oct 2018
Acute Myeloid Leukemia	Phase 2	SE	Mendus AB	15 Oct 2018
Acute Myeloid Leukemia	Phase 2	NO	Mendus AB	15 Oct 2018
Acute Myeloid Leukemia	Phase 2	FI	Mendus AB	15 Oct 2018
Acute Myeloid Leukemia	Phase 2	DE	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	DE	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	NL	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	FI	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	SE	Mendus AB	15 Oct 2018
Residual Neoplasm	Phase 2	NO	Mendus AB	15 Oct 2018

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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	(vmmgmqboze) = none cenrgpqpwx (zbhyfxlpnr ) View more	Positive	11 Dec 2023
NCT01373515 (Literature) Manual	Phase 1	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome Maintenance	12	DCP-001 (Responder)	(pjpnjbqibw) = wzimkehiyx nxgzvkzcaq (rotqbujppx, 90–1849) View more	Positive	02 Nov 2023
NCT01373515 (Literature) Manual	Phase 1		12	DCP-001 (Non-responder)	(pjpnjbqibw) = pzeazzvwne nxgzvkzcaq (rotqbujppx ) View more	Positive	02 Nov 2023
NCT03697707 (ADVANCE-II, GlobeNewswire) Manual	Phase 2	Acute Myeloid Leukemia Maintenance	20	DCP-001	(yyzsiuvnxb) = novrbhscks sfvuvcbulb (bbiegsqwcw ) View more	Positive	16 May 2022
NCT01373515 (ASH2019) Manual	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	12	Vididencel	(owwnvdwwdr) = ylbocrvuof jonadersmn (bgrgvbafdd ) View more	Positive	13 Nov 2019

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