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23 Diseases |  |
5 Trials |
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5 Trials |  |
54 News |  |
- |||||| VRDN-001 / Viridian Therap
Enrollment open: STRIVE: A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - Jun 3, 2024
P3, N=212, Recruiting, Sponsor: Viridian Therapeutics, Inc.
Not yet recruiting --> Recruiting
- |||||||||| VRDN-001 / Viridian Therap
New P3 trial: STRIVE: A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - Apr 25, 2024
P3, N=212, Not yet recruiting, Sponsor: Viridian Therapeutics, Inc.
- |||| VRDN-001 / Viridian Therap
Enrollment open, Trial initiation date: An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies (clinicaltrials.gov) - Mar 7, 2024
P3, N=143, Recruiting, Sponsor: Viridian Therapeutics, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Dec 2023 --> Feb 2023
- || VRDN-001 / Viridian Therap
Enrollment closed: Study of ZB001 in Chinese Patients With Thyroid Eye Disease (clinicaltrials.gov) - Jan 12, 2024
P1, N=16, Active, not recruiting, Sponsor: Zenas BioPharma (USA), LLC
Not yet recruiting --> Recruiting | Initiation date: Dec 2023 --> Feb 2023 Recruiting --> Active, not recruiting
- |||||||| VRDN-001 / Viridian Therap
New P3 trial: An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies (clinicaltrials.gov) - Dec 21, 2023
P3, N=143, Not yet recruiting, Sponsor: Viridian Therapeutics, Inc.
- || VRDN-001 / Viridian Therap
Enrollment change: Study of ZB001 in Chinese Patients With Thyroid Eye Disease (clinicaltrials.gov) - Dec 15, 2023
P1, N=16, Recruiting, Sponsor: Zenas BioPharma (USA), LLC
Recruiting --> Active, not recruiting N=24 --> 16
- VRDN-003 / Viridian Therap
VRDN-003, a Novel Half-Life Extended IGF-1 Receptor Antibody for TED: Preclinical PK and Human PK Modeling (DEMAND) - Oct 28, 2023 - Abstract #AAO2023AAO_2178;
In human PK modeling, SC dosing of VRDN-003 either once or twice a month produced drug concentrations in the range of those achieved with VRDN-001 IV administration at 3 mg/kg or 10 mg/kg every 3 weeks. Conclusion These results suggest VRDN-003 may provide a low-volume, SC injection option for patients with TED, with similar clinical effect to that observed with IV infusion of VRDN-001.
- VRDN-003 / Viridian Therap
Antagonist Properties of VRDN-003, a Next-Generation, Half-Life Extended Antibody to IGF-1 Receptor for TED (POSTER THEATER) - Oct 28, 2023 - Abstract #AAO2023AAO_1819;
Conclusion These results suggest VRDN-003 may provide a low-volume, SC injection option for patients with TED, with similar clinical effect to that observed with IV infusion of VRDN-001. In addition, both antibodies provided similar and near-complete inhibition of IGF-1
- VRDN-001 / Viridian Therap
VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease (TED): In Vitro Pharmacology and Clinical Phase 1/2 Results (WEST 2006) - Oct 28, 2023 - Abstract #AAO2023AAO_1572;
P3
VRDN-001's near-complete inhibition of IGF-1 binding and signaling may explain the rapid, marked improvements in TED symptoms in this Phase 1/2 RCT. The potential efficacy and safety of VRDN-001 in TED are being further assessed in the THRIVE Phase 3 RCT.
- |||| VRDN-001 / Viridian Therap
Enrollment open: A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED) (clinicaltrials.gov) - Oct 16, 2023
P3, N=159, Recruiting, Sponsor: Viridian Therapeutics, Inc.
The potential efficacy and safety of VRDN-001 in TED are being further assessed in the THRIVE Phase 3 RCT. Not yet recruiting --> Recruiting
- || VRDN-001 / Viridian Therap
Trial completion: A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects (clinicaltrials.gov) - Sep 28, 2023
P1, N=24, Completed, Sponsor: Zenas BioPharma (USA), LLC
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || VRDN-001 / Viridian Therap
Enrollment open: Study of ZB001 in Chinese Patients With Thyroid Eye Disease (clinicaltrials.gov) - Sep 28, 2023
P1, N=24, Recruiting, Sponsor: Zenas BioPharma (USA), LLC
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||| VRDN-001 / Viridian Therap
Trial completion date, Trial primary completion date: A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED) (clinicaltrials.gov) - Sep 24, 2023
P3, N=159, Not yet recruiting, Sponsor: Viridian Therapeutics, Inc.
Not yet recruiting --> Recruiting Trial completion date: Dec 2025 --> Sep 2025 | Trial primary completion date: Sep 2025 --> Dec 2024
- VRDN-001 / Viridian Therap
In Vitro Pharmacology and Phase 1/2 Results of VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor in Thyroid Eye Disease (TED) () - Sep 20, 2023 - Abstract #ATA2023ATA_271;
P3
We assessed VRDN?001 in vitro pharmacology compared with teprotumumab and clinical proof of concept in a phase 1/2 randomized controlled trial (NCT05176639). Inhibition of biotinylated IGF?1 binding to IGF?1R expressing FreeStyle
- ||| VRDN-001 / Viridian Therap
Trial primary completion date: A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED) (clinicaltrials.gov) - Sep 11, 2023
P3, N=154, Recruiting, Sponsor: Viridian Therapeutics, Inc.
Inhibition of biotinylated IGF?1 binding to IGF?1R expressing FreeStyle Trial primary completion date: Mar 2025 --> Jul 2024
- |||||||| VRDN-001 / Viridian Therap
New P3 trial: A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED) (clinicaltrials.gov) - Sep 1, 2023
P3, N=159, Not yet recruiting, Sponsor: Viridian Therapeutics, Inc.
- | VRDN-001 / Viridian Therap
Journal: Poly-l-glutamic acid modification modulates the bio-nano interface of a therapeutic anti-IGF-1R antibody in prostate cancer. (Pubmed Central) - Aug 20, 2023
PGA conjugation also enhances AVE1642's anti-tumor activity in an orthotopic prostate cancer mouse model, while PGA-AVE1642 induces more significant suppression of cancer cell proliferation/angiogenesis than AVE1642. These findings demonstrate that PGA conjugation modulates an antibody's bio-nano interface, mechanism of action, and therapeutic activity.
- ||| VRDN-001 / Viridian Therap
Phase classification, Trial completion date, Trial primary completion date: A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED) (clinicaltrials.gov) - Jul 27, 2023
P3, N=154, Recruiting, Sponsor: Viridian Therapeutics, Inc.
These findings demonstrate that PGA conjugation modulates an antibody's bio-nano interface, mechanism of action, and therapeutic activity. Phase classification: P2/3 --> P3 | Trial completion date: Mar 2024 --> May 2025 | Trial primary completion date: Feb 2024 --> Mar 2025
- ||| VRDN-001 / Viridian Therap
Trial completion date, Trial primary completion date: A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED) (clinicaltrials.gov) - Jul 14, 2023
P2/3, N=184, Recruiting, Sponsor: Viridian Therapeutics, Inc.
Phase classification: P2/3 --> P3 | Trial completion date: Mar 2024 --> May 2025 | Trial primary completion date: Feb 2024 --> Mar 2025 Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Jun 2023 --> Feb 2024
- Tepezza (teprotumumab) / Horizon Therapeutics, Roche, VRDN-001 / Viridian Therap
VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor in Development for Thyroid Eye Disease (TED), Binds to a Distinct Epitope from Teprotumumab (W-184A) - May 11, 2023 - Abstract #ENDO2023ENDO_2675;
Despite having overlapping epitopes, VRDN-001 is distinct from teprotumumab in both its mutational signature and its more complete antagonism of IGF-1 mediated signaling. VRDN-001's unique binding and functional antagonism characteristics may contribute to the robust pharmacodynamic responses observed in healthy volunteers and favorable efficacy signals observed in early clinical trials of TED patients.
- VRDN-001 / Viridian Therap
VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor in Development for Thyroid Eye Disease (TED): Pharmacodynamic Responses in Healthy Volunteers and Patients with Active TED (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_2142;
VRDN-001's unique binding and functional antagonism characteristics may contribute to the robust pharmacodynamic responses observed in healthy volunteers and favorable efficacy signals observed in early clinical trials of TED patients. Abstract is embargoed at this time.
- VRDN-001 / Viridian Therap
Durability of Treatment Response With VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor, in Patients with Thyroid Eye Disease (TED): Phase 1/2 Clinical Study (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_2141;
P2/3
Further, these results were achieved with a lower dose and fewer treatments than in prior RCTs of other anti-IGF-1R antibodies. Results from the additional 3 mg/kg and 20 mg/kg cohorts may extend these findings and define potential VRDN-001 treatment regimens.
- || VRDN-001 / Viridian Therap
Enrollment closed: A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects (clinicaltrials.gov) - Mar 21, 2023
P1, N=24, Active, not recruiting, Sponsor: Zenas BioPharma (USA), LLC
Results from the additional 3 mg/kg and 20 mg/kg cohorts may extend these findings and define potential VRDN-001 treatment regimens. Recruiting --> Active, not recruiting
- || VRDN-001 / Viridian Therap
New P1 trial: Study of ZB001 in Chinese Patients With Thyroid Eye Disease (clinicaltrials.gov) - Mar 20, 2023
P1, N=24, Not yet recruiting, Sponsor: Zenas BioPharma (USA), LLC
- VRDN-001 / Viridian Therap
Phase 1 Safety and Pharmacodynamic Results of VRDN-001, a Full Antagonist Antibody to the Insulin-Like Growth Factor-1 Receptor (IGF-1R) in Development for Thyroid Eye Disease (TED) (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_1814;
P2/3
Recruiting --> Active, not recruiting Conclusions VRDN-001 administered to healthy volunteers at 3
- VRDN-001 / Viridian Therap
Phase 1/2 Clinical Study of VRDN-001, A Full Antagonist Antibody to the Insulin-Like Growth Factor-1 Receptor (IGF-1R), in Patients with Thyroid Eye Disease (TED) (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_1808;
P2/3
Conclusions Two infusions of 10 mg/kg VRDN-001 led to rapid, substantial improvement across all efficacy measures at 6 weeks in TED patients, surpassing 6-week results from prior RCTs of other anti-IGF-1R antibodies. Results from the additional 3 mg/kg and 20 mg/kg cohorts may extend these findings and define potential VRDN-001 treatment regimens.
- ||||| VRDN-001 / Viridian Therap
Phase classification, Enrollment change: A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED) (clinicaltrials.gov) - Dec 27, 2022
P2/3, N=184, Recruiting, Sponsor: Viridian Therapeutics, Inc.
Results from the additional 3 mg/kg and 20 mg/kg cohorts may extend these findings and define potential VRDN-001 treatment regimens. Phase classification: P1/2 --> P2/3 | N=76 --> 184
- || VRDN-001 / Viridian Therap
Enrollment open: A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects (clinicaltrials.gov) - Oct 20, 2022
P1, N=24, Recruiting, Sponsor: Zenas BioPharma (USA), LLC
Phase classification: P1/2 --> P2/3 | N=76 --> 184 Not yet recruiting --> Recruiting
- | VRDN-001 / Viridian Therap
New P1 trial: A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects (clinicaltrials.gov) - Sep 15, 2022
P1, N=24, Not yet recruiting, Sponsor: Zenas BioPharma (USA), LLC
- VRDN-001 / Viridian Therap
Characterization of VRDN-001, a High Affinity and Potent anti-Insulin-like Growth Factor-1 Receptor (IGF-1R) Inhibitory Antibody for the Treatment of Thyroid Eye Disease (TED) (A0336) - Apr 29, 2022 - Abstract #ARVO2022ARVO_2285;
VRDN-001 shut down IGF-1R signaling at concentrations that can be achieved with moderate clinical doses. The in vitro profile of VRDN-001 suggests favorable efficacy and exposure requirements for treatment of TED patients.
- VRDN-001 / Viridian Therap
VRDN-001: a Novel IGF-1R Monoclonal Antibody for Treatment of Thyroid Eye Disease: Adaptive Design Strategy for Clinical Development (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3871;
The distinguishing property of adaptive design strategy allows the trial to adjust to information not available when the trial began. Specific advantages realized include statistical efficiency, ethical considerations, choice of dosages to be brought forward, and reduced sample size requirements. Our planned exploration of VRDN-001 seeks to incorporate principles of adaptive design as we explore its safety and efficacy.
- | VRDN-001 / Viridian Therap
New P1/2 trial: A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED) (clinicaltrials.gov) - Jan 3, 2022
P1/2, N=76, Recruiting, Sponsor: Viridian Therapeutics, Inc.
- | Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
Journal: Emerging immune targets for the treatment of multiple myeloma. (Pubmed Central) - May 15, 2019
No OR was observed with monotherapy using BI-505, siltuximab, bevacizumab, AVE-1642, figitumumab, atacicept, milatuzumab, dacetuzumab, lucatumumab, IPH2101, lorvotuzumab, BT062 and nivolumab...A recent experience of CAR T-cell (B-cell maturation antigen) therapy in advanced MM has shown global response of 100%. The future of monoclonal antibodies and adoptive T cells for MM treatment seems promising.