- |||||||||| M1069 / EMD Serono, Domain Therap
Preclinical, Journal: Dual A2A/ A2B adenosine receptor antagonist M1069 counteracts immuno-suppressive mechanisms of adenosine and reduces tumor growth in vivo. (Pubmed Central) - Nov 4, 2024 In vivo, M1069 decreased tumor growth as a monotherapy and enhanced anti-tumor activity of bintrafusp alfa (BA) or cisplatin in syngeneic adenosinehi/CD73hi 4T1 breast tumor model, but not in the CD73 knockout (KO) 4T1 tumor model or in adenosinelow/CD73low MC38 murine colon carcinoma model. In summary, our dual A2A/A2B AR antagonist M1069 may counteract immune-suppressive mechanisms of high concentrations of adenosine in vitro and in vivo and enhance the anti-tumor activity of other agents, including BA and cisplatin.
- |||||||||| DT-7012 / Domain Therap
Characterization of DT-7012, a highly differentiated anti-CCR8 mAb clinical candidate (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1308; The binding and killing activity of DT-7012 was specific to CCR8 and CCR8+ cells, without affecting the other immune cell populations, suggesting a good safety profile of the Domain's candidate. Conclusions These data demonstrate major competitive advantages over the competitive anti-CCR8 mAbs currently in clinical development making DT-7012 a potential novel best-in-class anti-CCR8 mAb candidate.
- |||||||||| ADX88178 / National Institute on Drug Abuse, Addex, foliglurax (PXT2331) / Lundbeck
Preclinical, Journal: Metabotropic Glutamate Receptor 4 (mGlu4) Positive Allosteric Modulators Lack Efficacy in Rat and Marmoset Models of L-DOPA-Induced Dyskinesia. (Pubmed Central) - Mar 11, 2024 Given the weak efficacy and side-effect profile of amantadine, alternative strategies to reduce glutamate transmission are being investigated...We hypothesized that two mGlu4 positive allosteric modulators, Lu AF21934 ((1?S,2?R)-N1-(3,4-dichlorophenyl)cyclohexane-1,2-dicarboxamide) and ADX88178 (5-Methyl-N-(4-methylpyrimidin-2-yl)-4-(1H-pyrazol-4-yl)thiazol-2-amine), would provide relief in rat and primate models of L-DOPA-induced dyskinesia...This study found no benefit of mGlu4 positive allosteric modulators in tackling L-DOPA-induced dyskinesia. These findings are concordant with the recent failure of foliglurax in phase II clinical trials supporting the predictive validity of these pre-clinical dyskinesia models, while raising further doubt on the anti-dyskinetic potential of mGlu4 positive allosteric modulators.
- |||||||||| M1069 / EMD Serono, Domain Therap
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases: MS201929_0032: First in Human Study of M1069 in Advanced Solid Tumors (clinicaltrials.gov) - Oct 19, 2023 P1, N=15, Terminated, N=30 --> 15 | Trial completion date: Dec 2023 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2023 --> May 2023; Overarching portfolio-level review of the company's oncology pipeline resulted in early termination of the study. The study was not terminated due to safety.
- |||||||||| M1069 / EMD Serono, Domain Therap
Enrollment closed, Metastases: MS201929_0032: First in Human Study of M1069 in Advanced Solid Tumors (clinicaltrials.gov) - Mar 22, 2023 P1, N=30, Active, not recruiting, Our results show that positive allosteric modulation of mGlu4 receptors with foliglurax provided neuroprotective effects in the MPTP mouse model of PD. Recruiting --> Active, not recruiting
- |||||||||| Anti-CCR8 antibody / Domain Therap
Beyond CCR8: key epitopes targeting dynamic CCR8 conformational states and a diversity of monoclonal antibodies to modulate the tumor microenvironment for the treatment of cancers (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1696; In parallel, treatment of tumor-bearing mice with cell-depleting anti-CCR8 antibody indeed eradicated established tumors with induction of potent tumor-specific effector/memory T cells...Up to date, targeting selective CCR8 epitopes mimicking dynamic conformational CCR8 stage according to CCR8 positive cell subset or activation cellular state will be a key issue and differentiate therapeutic approach for the TME modulation in the treatment of cancer. Moreover, the use of depleting anti-CCR8 mAb with enhanced cytotoxic activity (i.e., ADCC, CDC, ADCP) can also reduce the number of CCR8 immune suppressive cells in a tumor.
- |||||||||| foliglurax (PXT2331) / Lundbeck
Preclinical, Journal: A positive allosteric modulator of mGlu4 receptors restores striatal plasticity in an animal model of l-Dopa-induced dyskinesia. (Pubmed Central) - Sep 14, 2022 This study aimed to clarify the effects of foliglurax, a selective mGlu4-PAM, on the loss of bidirectional synaptic plasticity associated with l-DOPA-induced dyskinesia (LID)...Moreover, this co-treatment rescued striatal bidirectional plasticity and attenuated the intensity of l-DOPA-induced dyskinesia. This is the first demonstration in an animal model of PD and dyskinesia that a mGlu4 PAM can restore striatal synaptic plasticity.
- |||||||||| Journal: Clinical investigations of compounds targeting metabotropic glutamate receptors. (Pubmed Central) - Sep 14, 2022
Antagonists of mGlu2/3Rs (decoglurant and TS-161) have been studied in depression where TS-161 has advanced into a planned Phase 2 study in treatment-resistant depression...The mGlu4R potentiator, foliglurax, did not meet its primary endpoint in patients with Parkinson's disease. Ongoing efforts to develop mGluR-targeted compounds continue to promise these glutamate modulators as medicines for psychiatric and neurological disorders.
- |||||||||| foliglurax (PXT2331) / Lundbeck
Clinical, P2 data, Journal: A Randomized, Double-Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease. (Pubmed Central) - May 25, 2022 Ongoing efforts to develop mGluR-targeted compounds continue to promise these glutamate modulators as medicines for psychiatric and neurological disorders. There was no evidence in this study that foliglurax has efficacy in improving levodopa-induced motor complications in PD.
- |||||||||| M1069 / EMD Serono, Domain Therap
Enrollment open, Metastases: MS201929_0032: First in Human Study of M1069 in Advanced Solid Tumors (clinicaltrials.gov) - Apr 1, 2022 P1, N=24, Recruiting, There was no evidence in this study that foliglurax has efficacy in improving levodopa-induced motor complications in PD. Not yet recruiting --> Recruiting
- |||||||||| M1069 / EMD Serono, Domain Therap
M1069 as dual A2A/ A2B adenosine receptor antagonist counteracts immune-suppressive mechanisms of adenosine and reduces tumor growth in vivo (Section 37) - Mar 9, 2022 - Abstract #AACR2022AACR_5472; These findings were further corroborated with the results from in vivo studies in a murine CD73hi/adenosine-rich 4T1 syngeneic breast tumor model, in which M1069, but not an A2A-selective antagonist, reduced tumor growth as a monotherapy and enhanced anti-tumor activity with chemotherapeutic agents. In summary, M1069 is a potent, dual A2A/A2B adenosine receptor antagonist, which is expected to counteract immune-suppressive mechanisms in the presence of high concentrations of adenosine and enhance the anti-tumor activity of chemotherapies.
- |||||||||| foliglurax (PXT2331) / Lundbeck
Journal: Improved Synthesis of the Thiophenol Precursor N-(4-Chloro-3-mercaptophenyl)picolinamide for Making the mGluR4 PET Ligand. (Pubmed Central) - Aug 26, 2020 Recently [C]mG4P012 (previously [C]KALB012 and presently named as [C]PXT012253 by Prexton Therapeutics) had been used as a biomarker during the preclinical development of a potential therapeutic drug, PXT0002331 (an mGluR4 PAM), for PD and L-dopa-induced dyskinesia...To support the translational research of [C]mG4P012 and the other potential applications, we have developed a new route for synthesis of the thiophenol precursor and optimized the reaction conditions. The synthesis of N-(4-chloro-3-mercaptophenyl)picolinamide from 1-chloro-4-nitrobenzene has been greatly improved from 8% to 52% total yield with easy handling and in gram scales.
- |||||||||| foliglurax (PXT2331) / Lundbeck
Enrollment closed, Trial completion date, Trial primary completion date: AMBLED: Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients (clinicaltrials.gov) - Feb 10, 2020 P2a, N=157, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Oct 2019 --> Mar 2020 | Trial primary completion date: Sep 2019 --> Feb 2020
- |||||||||| foliglurax (PXT2331) / Lundbeck
Journal: An mGlu4-Positive Allosteric Modulator Alleviates Parkinsonism in Primates. (Pubmed Central) - Oct 18, 2019 This work provides a demonstration that a positive allosteric modulator of metabotropic glutamate receptor 4 can alleviate the motor symptoms of PD and the motor complications induced by l-dopa in primates. PXT002331 is the first compound of its class to enter phase IIa clinical trials.
- |||||||||| foliglurax (PXT2331) / Lundbeck
Trial completion: What the Body Does to Foliglurax in Healthy Volunteers (clinicaltrials.gov) - Sep 5, 2019 P1, N=6, Completed, PXT002331 is the first compound of its class to enter phase IIa clinical trials. Not yet recruiting --> Completed
- |||||||||| foliglurax (PXT2331) / Lundbeck
Trial completion: A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects (clinicaltrials.gov) - Sep 28, 2016 P1, N=64, Completed, Not yet recruiting --> Recruiting Recruiting --> Completed
- |||||||||| foliglurax (PXT2331) / Lundbeck
Enrollment open: A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects (clinicaltrials.gov) - Jan 29, 2016 P1, N=72, Recruiting, Recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||||| foliglurax (PXT2331) / Lundbeck
New P1 trial: A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects (clinicaltrials.gov) - Dec 24, 2015 P1, N=72, Not yet recruiting,
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