Delving into the Latest Updates on Agatolimod with Synapse

Overview

Basic Info

Drug Type

CpG ODN

Synonyms

Agatolimod (USAN), Agatolimod Sodium, CPG B ODN

+ [10]

Target

TLR9

Action

agonists, stimulants

Mechanism

TLR9 agonists(Toll like receptor 9 agonists), Immunostimulants

Therapeutic Areas

NeoplasmsRespiratory DiseasesImmune System Diseases+ [5]

Active Indication-

Inactive Indication

Advanced breast cancerAdvanced cancerAdvanced Lung Non-Small Cell Carcinoma+ [14]

Originator Organization

Pfizer Inc.

Noviga Research AB

Active Organization

Noviga Research AB

Inactive Organization

Pfizer Inc.

Novartis AG

Ludwig Institute for Cancer Research Ltd.

+ [1]

License Organization-

Drug Highest PhasePreclinical

First Approval Date-

Regulation-

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Structure/Sequence

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Sequence Code 29253626

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A phase I study of combination immunotherapy with five peptides cocktail, CpG, and immune modulators for patients with advanced or metastatic colorectal cancer - A phase I study of combination immunotherapy with five peptides cocktail, CpG, and immune modulators for patients with advanced or metastatic colorectal cancer

Start Date17 May 2016

Sponsor / Collaborator-

NCT01164514

/ TerminatedPhase 1IIT

A Randomized, Partial-Blinded, Placebo-Controlled, Phase I Safety and Immunogenicity Study in Healthy Subjects of Detoxified J5 Core Glycolipid/ Group B Meningococcal Outer Membrane Protein Vaccine for Gram Negative Bacterial Sepsis Administered With and Without Synthetic CPG Oligodeoxynucleotide 7909 Adjuvant

The purpose of this study is to test the safety of an experimental vaccine against sepsis (infection of the blood) alone and with an experimental adjuvant (a substance that may improve vaccine effectiveness). This study will also find out how well antibodies are made after receiving vaccine alone or vaccine combined with adjuvant. Participants will include up to 34 healthy volunteers between the ages 18-50 years. Participants will be randomly assigned to 1 of 4 groups to receive vaccine alone, vaccine with adjuvant (2 different dosages) or placebo (inactive substance). Participants will receive 3 vaccinations at different times during the study (Day 0, Day 29 and Day 59). Study procedures will include blood samples, urine samples, electrocardiogram (measures heart activity) and a completion of a memory aid to document side effects. Participation will involve 16 clinic visits and 3 follow-up telephone calls over 12 months.

Start Date01 Nov 2011

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Agatolimod

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100 Translational Medicine associated with Agatolimod

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100 Patents (Medical) associated with Agatolimod

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1,291

Literatures (Medical) associated with Agatolimod

31 Dec 2025·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of SARS-CoV-2 protein subunit recombinant vaccine (Indovac®) in healthy populations aged 18 years and above in Indonesia: A phase I, observer-blind, randomized, controlled study

Article

Author: Hapsari, Rebriarina ; Farhanah, Nur ; Pramudo, Setyo Gundi ; Sekartini, Rini ; Wirahmadi, Angga ; Sari, Rini Mulia ; Maria, Suzy ; Mahati, Endang ; Yeremia, Glenn Fernandez ; Mulyono, Mulyono ; Anantyo, Dimas Tri ; Puspita, Mita ; Maharani, Nani ; Nency, Yetty Movieta ; Setyaningsih, Lilis

Indonesian vaccine producer (PT BIOFARMA), conducted a study to assess the safety and immunogenicity of a new COVID-19 vaccine candidate. This vaccine is based on a recombinant subunit protein platform, with the SARS-CoV-2 receptor-binding domain (RBD) as its target antigen. The study compared the candidate's safety and immunogenicity to the control group vaccine, the Sinovac vaccine, 28 days after administration. This was an observer-blinded and randomized Phase 1 trial which recruited 175 subjects. The subject received 0.5 ml of vaccine in two doses. The subjects were split into five treatment groups, consisting of different combinations of doses between RBD and CpG. The safety of this vaccine was evaluated within 7 days after the first dose and for 6 months after the second dose, while the immunogenicity was evaluated on days 14 and 28 after the second dose. The overall incidence of AEs was 54.86% from the beginning of the vaccination to 28 days after each injection. Most AEs were local pain and had no serious AEs. The study revealed a significant rise in the Geometric Mean Titer (GMT) of IgG antibodies in every group, indicating a strong immune response. The phase I data demonstrated that the new vaccine candidate showed promising results in safety and immunogenicity.

01 Jun 2025·Journal of Esthetic and Restorative Dentistry

Comparative Analysis Between Strip and Gels Indicated for at Home Bleaching: Analysis of Color Alteration, Roughness and Microhardness of Dental Enamel

Article

Author: Ferreira, M. C. B. ; Briso, A. L. F. ; Esteves, L. M. B. ; Fagundes, T. C. ; Catelan, A. ; Cintra, L. T. A. ; Aidar, K. M. S. ; Goto, J.

ABSTRACT:

Purpose:

To compare the color alteration, surface roughness and microhardness and cross‐sectional microhardness of bovine enamel treated with at‐home whitening strips and gels.

Materials and Methods:

Sixty‐six pigmented specimens (n = 11) were allocated to six groups: C—cotton wool moistened with distilled water for 1 h; SDS—sodium dithionite strip, for 1 h; HPS—6.5% hydrogen peroxide strip, for 1 h; CPS—20% carbamide peroxide strip, for 1 h; HPG—7.5% hydrogen peroxide gel, for 1 h; CPG—10% carbamide peroxide gel, for 4 h. The treatments lasted 10 days, calculating the ∆E, ∆E00, and ∆WID at baseline, 5 and 10 days, and 14 days after completion. Additional 66 polished discs (n = 11) were used to analyze the surface roughness and microhardness of enamel before and after bleaching, cross‐sectional microhardness and integrated mineral loss (ΔZ; %Vol × μm). Data were subjected to statistical analysis by two‐way Anova RM and Tukey post‐test (α = 0.05).

Results:

In ∆E and ∆WID analysis, greater values were obtained in CPG (p < 0.001), followed by HPG and HPS (p = 0.271). SDS and CPS (p < 0.001) exceeded only C (p < 0.001). In ∆E00, at completion of treatments, the results were similar; however, HPG = HPS = CPS (p = 0.237). There was an increase in roughness and decrease in surface microhardness in all bleaching groups (p < 0.005). Concerning the cross‐sectional microhardness, the treatments were equal to C at 150 μm, the last depth analyzed. For ΔZ, the values of SDS, CPS, HPG, and CPG groups showed similar mineral loss (p > 0.001), and the lowest value was exhibited in the Control group, followed by HPS group (p < 0.001).

Conclusion:

Although the strips were aesthetically effective, the CPG and HPG groups presented highest values in the ∆E00 and ∆WID analysis. However, all treatments influenced the enamel surface, increasing roughness and decreasing surface and transverse microhardness.

Clinical Relevance:

The whitening gels promoted greater chromatic changes, but all treatments affected the enamel surface, increasing roughness and decreasing surface and transverse microhardness.

21 May 2025·INTERNATIONAL IMMUNOLOGY

CD20 and CD19 promote proliferation driven by the IgM-TLR9-L265P MyD88 complex

Article

Author: Shibata, Takuma ; Shimizu, Yuri ; Sato, Ryota ; Miyake, Kensuke ; Fukui, Ryutaro ; Tsubata, Takeshi ; Kobayashi, Yohei ; Tsukamoto, Hiroki

Abstract:

The cancer driver mutation L265P MyD88 is found in approximately 30% of cases in the activated B cell-like subgroup of diffuse large B cell-like lymphoma (ABC DLBCL). L265P MyD88 forms a complex with TLR9 and IgM, referred to as the My-T-BCR complex, to drive proliferation. We here show that the B cell surface molecules CD19 and CD20 enhance proliferation mediated by the My-T-BCR complex. Using the interleukin 3 (IL-3)-dependent Ba/F3 line transduced to express the IgM complex (IgM, CD79a, and CD79b) and TLR9, we observed proliferation in the presence of anti-IgM antibody and the TLR9 ligand CpG-B. TLR9 was constitutively associated with IgM and L252P MyD88. CD19 promoted proliferation with anti-IgM and CpG-B specifically in L252P MyD88-expressing Ba/F3 cells, while CD20 enhanced the proliferation in both wild-type- and L252P MyD88-expressing Ba/F3 cells. Additionally, CD20 uniquely enabled IgM-mediated proliferation in L252P MyD88-expressing Ba/F3 cells. Although CpG-B was not required for this proliferation, TLR9 expression remained indispensable. In the ABC DLBCL line TMD8, anti-IgM antibody-mediated growth was impaired by the lack of CD20 and CD19 or of TLR9. Mechanistically, CD19 promoted IgM-dependent AKT phosphorylation, whereas CD20 increased expression of cell surface IgM, thereby enhancing the formation of the IgM-TLR9 complex. These findings suggest that CD19 and CD20 differentially contribute to the proliferation driven by the My-T-BCR complex.

17

News (Medical) associated with Agatolimod

28 May 2025

·liddspharma.com

LIDDS AB (publ) Interim Report January – March 2025

Net sales amounted to 0 (0) TSEK The operating result for the period was -1 254 (-1) TSEK The net result was -1 311 (-5) TSEK corresponding to earnings per share of -0,01 (-0.00) SEK Cash flow from operating activities amounted to -738 (-64) TSEK Cash and cash equivalents amounted to 4 768 (10 947) TSEK On April 2, the board of directors decided to cease further development of the project areas Nanodotax, Nanoimod and NOV 202. Taking into account the principle of prudence, the board of directors, decided on April 10 to write down the book values of all intangible assets in LIDDS and Noviga as of 2024-12-31. This decision resulted in a deviation for the annual report compared to the published year-end report for 2024. Due to the reasons to believe that the company’s equity was less than on-half of the registered share capital, the board of directors decided to prepare a balance sheet for liquidation purpose on April 22. The balance sheet for liquidation purpose prepared and reviewed by the company’s auditor showed that the equity was less than half of the registered share capital and therefore the board of directors decided on April 24 to call a first control meeting. During the first quarter, the focus has continued to be on trying to commercialize the three projects Nanoimod, Nanodotax and NOV 202. Furthermore, the work to reduce the company’s costs has continued. In beginning of April, we finally concluded, after extensive attempts, that Lidds will not succeed with the investments on which we have concentrated the company’s resources on and therefore we did not see any opportunity to capitalize the company for further clinical studies. As a result, the board of directors decided to terminate further development of these project areas. The work will now be fully focused on utilizing the values that the company owns in the form of the NanoZolid technology platform and its patents, the subsidiary Noviga with the drug candidate NOV 202 and its patents. In addition, we will investigate the interest for the company’s listing on First North and any values for the accumulated loss carry forwards that have arisen. Mats Wiking CEO and CFO The interim report is available on the company’s website https://liddspharma.com/en/investors/financial-reports/. For additional information, please contact Mats Wiking, CEO and CFO Phone: +46 (0)70 620 04 00 E-mail: mats.wiking@liddspharma.com LIDDS’ Certified Adviser is Redeye AB LIDDS in brief: LIDDS is a Swedish pharmaceutical company focused on the development of oncology drugs. LIDDS has a proprietary drug delivery technology, NanoZolid®, on which several projects are based. With NanoZolid, LIDDS can formulate drugs for local/intratumoral administration, with a maintained and controlled release and with minimal negative side-effects. In addition to these projects, LIDDS develops proprietary drug candidate NOV202 that have shown very good results in pre-clinical studies. The company is listed on Nasdaq First North Growth market.

Financial Statement

28 May 2025

·liddspharma.com

Correction: LIDDS AB (publ) Interim Report January – March 2025

The year in the headings has been corrected to 2025. First quarter 2025 (the Group) ·Net sales amounted to 0 (0) TSEK ·The operating result for the period was -1 254 (-1) TSEK ·The net result was -1 311 (-5) TSEK corresponding to earnings per share of -0,01 (-0.00) SEK ·Cash flow from operating activities amounted to -738 (-64) TSEK ·Cash and cash equivalents amounted to 4 768 (10 947) TSEK Significant events after the reporting period (during April) ·On April 2, the board of directors decided to cease further development of the project areas Nanodotax, Nanoimod and NOV 202. ·Taking into account the principle of prudence, the board of directors, decided on April 10 to write down the book values of all intangible assets in LIDDS and Noviga as of 2024-12-31. This decision resulted in a deviation for the annual report compared to the published year-end report for 2024. ·Due to the reasons to believe that the company’s equity was less than on-half of the registered share capital, the board of directors decided to prepare a balance sheet for liquidation purpose on April 22. ·The balance sheet for liquidation purpose prepared and reviewed by the company’s auditor showed that the equity was less than half of the registered share capital and therefore the board of directors decided on April 24 to call a first control meeting. CEO statement During the first quarter, the focus has continued to be on trying to commercialize the three projects Nanoimod, Nanodotax and NOV 202. Furthermore, the work to reduce the company's costs has continued. In beginning of April, we finally concluded, after extensive attempts, that Lidds will not succeed with the investments on which we have concentrated the company's resources on and therefore we did not see any opportunity to capitalize the company for further clinical studies. As a result, the board of directors decided to terminate further development of these project areas. The work will now be fully focused on utilizing the values that the company owns in the form of the NanoZolid technology platform and its patents, the subsidiary Noviga with the drug candidate NOV 202 and its patents. In addition, we will investigate the interest for the company's listing on First North and any values for the accumulated loss carry forwards that have arisen. Mats Wiking CEO and CFO The interim report is available on the company’s website https://liddspharma.com/sv/investerare/finansiella-rapporter/ For additional information, please contact Mats Wiking, CEO and CFO Phone: +46 (0)70 620 04 00 E-mail: mats.wiking@liddspharma.com LIDDS’ Certified Adviser is Redeye AB LIDDS in brief: LIDDS is a Swedish pharmaceutical company focused on the development of oncology drugs. LIDDS has a proprietary drug delivery technology, NanoZolid®, on which several projects are based. With NanoZolid, LIDDS can formulate drugs for local/intratumoral administration, with a maintained and controlled release and with minimal negative side-effects. In addition to these projects, LIDDS develops proprietary drug candidate NOV202 that have shown very good results in pre-clinical studies. The company is listed on Nasdaq First North Growth market. Attachments LIDDS Interim Report Q1 2025

Financial Statement

20 Feb 2025

·liddspharma.com

LIDDS AB (publ) Year-end Report 2024

Net sales amounted to 0 MSEK The operating result for the period was -1.1 MSEK The net result was -1.0 MSEK corresponding to earnings per share of SEK -0.01 Cash flow from operating activities amounted to -1.0 MSEK Cash and cash equivalents amounted to 5.5 MSEK Net sales amounted to 0 MSEK The operating result for the period was -4.5 MSEK The net result was -4.3 MSEK corresponding to earnings per share of SEK -0.04 Cash flow from operating activities amounted to -5.4 MSEK On the Extraordinary General Meeting of shareholders on the 9 January 2024 Daniel Lifveredson, Torbjörn Browall and Lars-Inge Sjöqvist were elected new members of the Board. In January it was announced that an agreement to acquire Noviga Research AB had been signed. In May, Mats Wiking was appointed new CEO from 1 September 2024. In accordance with previous decisions, LIDDS has continued to realize the cost savings which has been possible to implement without affecting the underlying assets that the company has. The goal for the fourth quarter was to try to get some form of financing or other solution for one or more of the three clinical projects that we are focusing on. LIDDS has not yet been able to achieve any success in these discussions with external parties. In order for LIDDS to be able to carry out clinical projects under its own management (where Nanodotax and Nanoimod are almost ready), significant capital contributions are required. For Noviga, capital is also required to be able to carry out a tox study, which would probably take LIDDS to a higher valuation. Even though the financial markets have started to show improvement, LIDDS continues to assess that it is not in the best interest for the shareholders to try to raise capital thru the market, considering the company’s current valuation. The current focus is to find external party/parties that can realize and execute the above-mentioned projects, and we are actively working to find such a solution for one or more of the projects. With LIDDS current cash and cost structure, the company believes that we have the endurance to find the best possible arrangement for its shareholders. Mats Wiking CEO and CFO The interim report is available on the company’s website https://liddspharma.com/sv/investerare/finansiella-rapporter/

Financial StatementExecutive ChangeAcquisitionIPO

100 Deals associated with Agatolimod

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External Link

KEGG	Wiki	ATC	Drug Bank
D08841	Agatolimod	-	DB15018

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Austria	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Belgium	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Brazil	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Cyprus	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Czechia	Pfizer Inc.	01 Nov 2005
Advanced Lung Non-Small Cell Carcinoma	Phase 3	France	Pfizer Inc.	01 Nov 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00145158 (CTgov)	Phase 1/2	Melanoma, Cutaneous Malignant	23	CpG 7909 (Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909)	czysvrhwhy = fneuosxqts jqzoxuppac (uvcubrajss, lniupdqpda - ynetfrtlzg) View more	-	07 Apr 2022
NCT00145158 (CTgov)	Phase 1/2	Melanoma, Cutaneous Malignant	23	8 HLA-A2-restricted peptides and Montanide ISA51 (Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51)	czysvrhwhy = xgywsxtyma jqzoxuppac (uvcubrajss, dkuayjsfvu - gqyompvdtl) View more	-	07 Apr 2022
CSCO2021	Not Applicable	Uterine Cervical Cancer	-	CpG/OX40/cGAMP	lcqzivkzae(qdxfraovrz) = lalmlrygcg tiwziguzlt (growykmbmq )	-	25 Sep 2021
NCT00199836 (CTgov)	Phase 1	Neoplasms	14	NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51	ebcjfldhuj = qixrubzicm vpwheamqbx (ethhshscyy, icswphqyld - orusqgwnwc) View more	-	15 Jul 2021
AACR2017	Phase 2	Melanoma Adjuvant	-	Saline	iskxynkmow(fpdqismgmh) = qaxfvvsbls hhwvocksoc (vakbiteode, 21 - 71)	Positive	01 Jul 2017
NCT00880581 (CTgov)	Phase 2	Indolent B-Cell Non-Hodgkin Lymphoma	30	Local radiotherapy+PF-3512676	yalenuomco = qgtxhichbl haxczcrnqm (mjyldpmail, oxudhgbkre - cmfomtdhvd) View more	-	14 Mar 2017
NCT00824733 (CTgov)	Phase 2	Locally advanced breast cancer \| Metastatic breast cancer	6	Correlative Studies+PF03512676+Trastuzumab	cnmoocmkap(sttfwwcsrv) = hoqbwkmffw srjfljfury (qwllphggpw, iipwnurika - svdzzeziqb) View more	-	14 Jan 2016
SITC2015	Phase 2	Melanoma Adjuvant	62	GM-CSF (3 μg/kg)	nlpzsujdqv(oxtyzimgni) = at a median follow-up of 79 months, this translated into a significantly longer recurrence-free survival (RFS) in the CpG-treated group (p=0.010) ymbhbcnnln (vxpyzymxmd )	Positive	04 Nov 2015
SITC2015	Phase 2	Melanoma Adjuvant	62	CpG-B (PF-3512676/CpG7909, 8 mg)		Positive	04 Nov 2015
NCT00185965 (CTgov)	Phase 1/2	Mycosis Fungoides	30	CPG 7909 (Lymphoma, B-cell Low-grade (BCL))	jrtezqoucv = vlwwrxumbv gkgpbimxba (vziaedpmfx, xtcecljvfc - eaviiqszcd) View more	-	01 Aug 2014
NCT00185965 (CTgov)	Phase 1/2	Mycosis Fungoides	30	CPG 7909 (Mycosis Fungoides (MF))	jrtezqoucv = mbeexwqxhc gkgpbimxba (vziaedpmfx, tfgqsoxdjz - hebzxusaoy) View more	-	01 Aug 2014
NCT00471471 (Pubmed \| J Immunother)	Phase 1	Metastatic melanoma Adjuvant	22	Vaccination with MART-1, gp100, and Tyrosinase peptides + PF-3512676 + GM-CSF	gkmghsdsdg(ifdhozudzt) = xnldukewmu phmiwpyvhq (ejqwnxhzxd, 11.3 - ∞)	-	01 May 2012
AACR2011	Not Applicable	Melanoma	12	Vaccination with MART-1 (27-35), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides given in-oil-adjuvant with TLR-9 agonist PF-3512676 and GMCSF	ujenqnwwvi(czkwilrtkc) = gpvmplhwaf bajjcrtvzu (sklrmzifmi ) View more	-	15 Apr 2011