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- || SYN004 / Synermore
PK/PD data, Preclinical, Journal: Preclinical Pharmacokinetics and Biodistribution of LR004, a Novel Antiepidermal Growth Factor Receptor Monoclonal Antibody. (Pubmed Central) - Jan 30, 2024
Autoradiography and NanoSPECT/CT confirmed the sustained retention of I-LR004 at the tumor site in xenograft mice. These findings demonstrated the adequate tumor targeting capabilities of I-LR004 in EGFR-positive tumors, which may improve dosing strategies and future drug development.
- | ribaxamase (SYN-004) / Theriva Bio
Trial completion date, Trial primary completion date: SYN-004 Safety and Tolerability in Allo-HCT Subjects (clinicaltrials.gov) - Oct 13, 2023
P1b/2a, N=36, Recruiting, Sponsor: Theriva Biologics, Inc.
These findings demonstrated the adequate tumor targeting capabilities of I-LR004 in EGFR-positive tumors, which may improve dosing strategies and future drug development. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- || SYN004 / Synermore, SYN125 / Synermore
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions (clinicaltrials.gov) - Apr 12, 2023
P1, N=22, Active, not recruiting, Sponsor: Synermore Biologics Co., Ltd.
Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 Recruiting --> Active, not recruiting | N=36 --> 22 | Trial completion date: May 2022 --> Sep 2023 | Trial primary completion date: Feb 2022 --> Jul 2023
- ribaxamase (SYN-004) / Theriva Bio, SYN004 / Synermore
Interim analysis of SYN-004 phase 1b/2a trial in haematopoietic cell transplant (HCT) recipients (A / 10) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_4188;
- ribaxamase (SYN-004) / Synthetic Biologics, SYN004 / Synermore
Interim Analysis of Syn-004 Phase 1b/2a Trial in Hematopoietic Cell Transplant (HCT) Recipients () - Jan 22, 2023 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_1424;
Recruiting --> Active, not recruiting | N=36 --> 22 | Trial completion date: May 2022 --> Sep 2023 | Trial primary completion date: Feb 2022 --> Jul 2023 There are no recording files available for this presentation
- | SYN004 / Synermore
Journal: Rational Design and Systemic Appraisal of an EGFR-Targeting Antibody-Drug Conjugate LR-DM1 for Pancreatic Cancer. (Pubmed Central) - May 29, 2022
By harnessing the payload DM1 and a monoclonal antibody LR004 through a noncleavable linker succinimidyl-4-(N-maleimidomethyl)-cyclohexane-1-carboxylate, we designed and evaluated an antibody-drug conjugate LR-DM1 with an appropriate drug-antibody ratio of 3.6...Moreover, LR-DM1 possessed a relatively broad therapeutic index with a half-lethal dose above 300 mg/kg, which was over 15-fold higher than the highest administration dosage of 20 mg/kg. This initial study on LR-DM1 holds promise for further development of a new antibody drug conjugate that is transformative for treatment of patients concerned.
- | ribaxamase (SYN-004) / Theriva Bio
Trial completion date, Trial primary completion date: SYN-004 Safety and Tolerability in Allo-HCT Subjects (clinicaltrials.gov) - Apr 21, 2022
P1b/2a, N=36, Recruiting, Sponsor: Synthetic Biologics Inc.
This initial study on LR-DM1 holds promise for further development of a new antibody drug conjugate that is transformative for treatment of patients concerned. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- | SYN004 / Synermore, LR004-VC-MMAE / Shandong Xinhua Pharma, Chinese Academy of Medical Sciences
Journal: Excellent effects and possible mechanisms of action of a new antibody-drug conjugate against EGFR-positive triple-negative breast cancer. (Pubmed Central) - Mar 24, 2022
LR004-VC-MMAE showed effective antitumor activity by inhibiting the activation of EGFR signaling and the expression of cancer stemness marker genes. It might be a promising therapeutic candidate and provides a potential therapeutic avenue for the treatment of EGFR-positive TNBC.
- || ribaxamase (SYN-004) / Theriva Bio
Enrollment open: SYN-004 Safety and Tolerability in Allo-HCT Subjects (clinicaltrials.gov) - Mar 1, 2021
P1b/2a, N=36, Recruiting, Sponsor: Synthetic Biologics Inc.
It might be a promising therapeutic candidate and provides a potential therapeutic avenue for the treatment of EGFR-positive TNBC. Not yet recruiting --> Recruiting
- | SYN004 / Synermore, SYN125 / Synermore
Trial completion date, Trial primary completion date, Combination therapy: A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions (clinicaltrials.gov) - Jan 25, 2021
P1, N=36, Recruiting, Sponsor: Synermore Biologics Co., Ltd.
Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Sep 2021 --> Feb 2022
- || ribaxamase (SYN-004) / Synthetic Biologics, ceftriaxone / Generic mfg., SYN004 / Synermore
Clinical, P2b data, Journal: Use of ribaxamase (SYN-004), a β-lactamase, to prevent Clostridium difficile infection in β-lactam-treated patients: a double-blind, phase 2b, randomised placebo-controlled trial. (Pubmed Central) - Jun 15, 2020
P2
The imbalance in deaths between the groups appeared to be related to the underlying health of the patients. Ribaxamase has the potential to prevent C difficile infection in patients treated with intravenous β-lactam antibiotics, and our findings support continued clinical development of ribaxamase to prevent C difficile infection.
- | Journal: The current novel therapeutic regimens for Clostridium difficile infection (CDI) and the potentials of Traditional Chinese Medicine in treatment of CDI. (Pubmed Central) - May 9, 2020
However, more rigorously designed basic researches and randomised controlled trials need to conduct to appraise the function mechanisms and effects of TCM. Finally, it is concluded that the combined therapeutic potentials of TCM and western medicine could be harness to resolve the recurrence and improve the outcome of CDI.
- || SYN004 / Synermore, SYN125 / Synermore
New P1 trial, Combination therapy: A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions (clinicaltrials.gov) - Apr 26, 2020
P1, N=36, Recruiting, Sponsor: Synermore Biologics Co., Ltd.
- | ceftriaxone / Generic mfg.
Journal: SYN-007, an Orally Administered Beta-Lactamase Enzyme, Protects the Gut Microbiome from Oral Amoxicillin/Clavulanate without Adversely Affecting Antibiotic Systemic Absorption in Dogs. (Pubmed Central) - Jan 26, 2020
Ribaxamase degraded ceftriaxone in the gastrointestinal tract, protected the gut microbiome, significantly reduced the incidence of Clostridioidesdifficile disease and attenuated emergence of antibiotic resistant organisms...Importantly, SYN-007 functioned in the presence of clavulanate to protect the gut microbiome indicating that SYN-007 activity was not inhibited by clavulanate in the dog gastrointestinal tract. SYN-007 has the potential to expand microbiome protection to beta-lactam/beta-lactamase inhibitor combinations delivered orally or systemically.
- | ceftriaxone / Generic mfg., amoxicillin / Generic mfg.
Journal: Low dose oral beta-lactamase protects the gut microbiome from oral beta-lactam-mediated damage in dogs. (Pubmed Central) - Jan 10, 2020
Ribaxamase inactivated intestinal ceftriaxone, protected the gut microbiome, and significantly reduced the incidence of Clostridioides difficile disease...In dogs that received oral amoxicillin, SYN-007 reduced microbiome disruption without interfering with amoxicillin systemic absorption...These data demonstrate that effective SYN-007 doses can be reduced at least 10-fold while maintaining gut microbiome preservation. The potential to employ low SYN-007 doses to protect the gut microbiota has important implications for enhancing therapeutic outcomes for patients receiving oral beta-lactam antibiotics while simultaneously reducing cost per dose and ultimately, healthcare expenses.
- | ceftriaxone / generics, amoxicillin / generics
Journal: Oral Beta-Lactamase Protects the Canine Gut Microbiome from Oral Amoxicillin-Mediated Damage. (Pubmed Central) - May 30, 2019
...SYN-004 (ribaxamase) is a beta-lactamase formulated for oral delivery intended to degrade intravenously administered beta-lactam antibiotics in the gastrointestinal (GI) tract...Clinical benefit was established in animal and human studies in which ribaxamase was shown to degrade ceftriaxone in the GI tract, thereby preserving the gut microbiome, significantly reducing Clostridioides difficile disease, and attenuating antibiotic resistance...These data demonstrate that SYN-007 diminishes amoxicillin-mediated microbiome disruption and mitigates emergence and propagation of antibiotic resistance genes without interfering with antibiotic systemic absorption. Thus, SYN-007 has the potential to protect the gut microbiome by inactivation of beta-lactam antibiotics when administered by both oral and parenteral routes and to reduce emergence of antibiotic-resistant pathogens.
- | ribaxamase (SYN-004) / Synthetic Biologics, SYN004 / Synermore
Clinical, P2b data, Journal: Characterization of Clostridium difficile Isolates Collected during a Phase 2b Clinical Study with SYN-004 (ribaxamase) for the Prevention of C. difficile Infection. (Pubmed Central) - May 7, 2019
During a Phase 2b study with SYN-004 (ribaxamase) for prevention of Clostridium difficile infection (CDI) conducted in North America and Eastern Europe, 45 C. difficile isolates from subjects with laboratory-confirmed CDI and or colonized with C. difficile were collected and characterized. Several C. difficile PCR ribotypes, including 027 and 198, were identified.
- SYN-007 / Synthetic Biologics, ceftriaxone / Generic mfg.
The oral beta-lactamase SYN-007 protects the gut microbiome from damage caused by oral amoxicillin /clavulanate without interfering with amoxicillin systemic absorption in dogs (Arena 2) - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_3637;
Notably, clavulanate did not interfere with SYN-007-mediated protection of the gut microbiome indicating that clavulanate did not inhibit beta-lactamase activity within the dog GI tract. These data demonstrate that the dual enteric coating formulation of SYN-007 prevented premature release of the beta-lactamase in the upper small intestine while allowing enzyme release soon enough to protect the colonic microbiota.
- | SYN004 / Synermore
Trial completion: SYN004_Ph_1: Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors (clinicaltrials.gov) - Nov 16, 2018
P1, N=10, Completed, Sponsor: Synermore Biologics Co., Ltd.
These data demonstrate that the dual enteric coating formulation of SYN-007 prevented premature release of the beta-lactamase in the upper small intestine while allowing enzyme release soon enough to protect the colonic microbiota. Recruiting --> Completed
- | SYN004 / Synermore
Enrollment change: SYN004_Ph_1: Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors (clinicaltrials.gov) - Aug 14, 2018
P1, N=10, Recruiting, Sponsor: Synermore Biologics Co., Ltd.
Recruiting --> Completed N=18 --> 10
- SYN004 / Synermore
Trial primary completion date: SYN004_Ph_1: Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors (clinicaltrials.gov) - Jan 10, 2018
P1, N=18, Recruiting, Sponsor: Synermore Biologics Co., Ltd.
N=18 --> 10 Trial primary completion date: Jan 2018 --> Sep 2018
- SYN004 / Synermore
Trial primary completion date: SYN004_Ph_1: Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors (clinicaltrials.gov) - Aug 22, 2017
P1, N=18, Recruiting, Sponsor: Synermore Biologics Co., Ltd.
Trial primary completion date: Jan 2018 --> Sep 2018 Trial primary completion date: Dec 2016 --> Dec 2017
- ribaxamase (SYN-004) / Theriva Bio
Phase classification: A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy (clinicaltrials.gov) - Jun 20, 2017
P1b/2a, N=11, Completed, Sponsor: Synthetic Biologics Inc.
Trial primary completion date: Dec 2016 --> Dec 2017 Phase classification: P1/2 --> P1b/2a
- ribaxamase (SYN-004) / Theriva Bio
Phase classification: A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy (clinicaltrials.gov) - Jan 23, 2017
P1b/2a, N=15, Completed, Sponsor: Synthetic Biologics Inc.
Phase classification: P1/2 --> P1b/2a Phase classification: P1/2 --> P1b/2a
- |||| ribaxamase (SYN-004) / Synthetic Biologics
Trial completion: A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI (clinicaltrials.gov) - Nov 14, 2016
P2, N=413, Completed, Sponsor: Synthetic Biologics Inc.
Phase classification: P1/2 --> P1b/2a Active, not recruiting --> Completed
- SYN004 / Synermore
Enrollment open, Trial initiation date, Trial primary completion date: SYN004_Ph_1: Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors (clinicaltrials.gov) - Oct 18, 2016
P1, N=18, Recruiting, Sponsor: Synermore Biologics Co., Ltd.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Initiation date: Jun 2015 --> Mar 2015 | Trial primary completion date: Jul 2016 --> Dec 2016
- ||| ribaxamase (SYN-004) / Synthetic Biologics
Enrollment closed: A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI (clinicaltrials.gov) - Oct 7, 2016
P2, N=372, Active, not recruiting, Sponsor: Synthetic Biologics Inc.
Not yet recruiting --> Recruiting | Initiation date: Jun 2015 --> Mar 2015 | Trial primary completion date: Jul 2016 --> Dec 2016 Recruiting --> Active, not recruiting
- | ribaxamase (SYN-004) / Theriva Bio
Trial completion, Enrollment change: A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy (clinicaltrials.gov) - Apr 21, 2016
P1/2, N=15, Completed, Sponsor: Synthetic Biologics Inc.
Recruiting --> Active, not recruiting Recruiting --> Completed | N=20 --> 15
- |||| ribaxamase (SYN-004) / Synthetic Biologics
Enrollment open: A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI (clinicaltrials.gov) - Nov 17, 2015
P2, N=372, Recruiting, Sponsor: Synthetic Biologics Inc.
Recruiting --> Completed | N=20 --> 15 Not yet recruiting --> Recruiting
- | ribaxamase (SYN-004) / Theriva Bio
Trial completion, Enrollment change: A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy (clinicaltrials.gov) - Nov 17, 2015
P1/2, N=11, Completed, Sponsor: Synthetic Biologics Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | N=20 --> 11
- | ribaxamase (SYN-004) / Theriva Bio
Enrollment closed: A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy (clinicaltrials.gov) - Oct 2, 2015
P1/2, N=20, Active, not recruiting, Sponsor: Synthetic Biologics Inc.
Active, not recruiting --> Completed | N=20 --> 11 Recruiting --> Active, not recruiting
- ||||| ribaxamase (SYN-004) / Synthetic Biologics
New P2 trial: A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI (clinicaltrials.gov) - Sep 29, 2015
P2, N=372, Not yet recruiting, Sponsor: Synthetic Biologics Inc.
- ribaxamase (SYN-004) / Theriva Bio
New P1/2 trial: A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy (clinicaltrials.gov) - Jun 16, 2015
P1/2, N=20, Recruiting, Sponsor: Synthetic Biologics Inc.
- ribaxamase (SYN-004) / Theriva Bio
New P1/2 trial: A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy (clinicaltrials.gov) - Apr 17, 2015
P1/2, N=20, Recruiting, Sponsor: Synthetic Biologics Inc.
- SYN004 / Synermore
New P1 trial: SYN004_Ph_1: Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors (clinicaltrials.gov) - Mar 18, 2015
P1, N=18, Not yet recruiting, Sponsor: Synermore Biologics Co., Ltd.