Delving into the Latest Updates on Zamerovimab/Mazorelvimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Mazorelvimab/Zamerovimab, 重组抗狂犬病毒人源化单克隆抗体(深圳龙瑞药业有限公司)

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Target

RABV-G

Mechanism

RABV-G inhibitors(RABV-G inhibitors)

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication

Rabies

Inactive Indication-

Originator Organization

Synermore Biologics(Beijing) Co., Ltd.

Active Organization

Synermore Biologics (Suzhou) Co., Ltd.

Inactive Organization

Synermore Biologics Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (04 Jun 2024),

Rabies

RegulationOrphan Drug (US)

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Gene Sequence

Sequence Code 616722296L

The sequence is quoted from: *****

Sequence Code 616723707H

The sequence is quoted from: *****

Sequence Code 616722295H

The sequence is quoted from: *****

Sequence Code 616723708L

The sequence is quoted from: *****

This is a Phase 3, blinded, randomized study of SYN023 compared to a China licensed Human Rabies Immunoglobulin (a Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll the World Health Organization (WHO) Category III rabies exposure subjects. The subject's death and rabies data will be reviewed by Data and safety monitoring board (DSMB) to confirm the safety. Besides, rabies vaccine would be administered after Study Drug in each group.
This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in China.

Start Date23 Sep 2020

Sponsor / Collaborator

Synermore Biologics (Suzhou) Co., Ltd.

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TCTR20190507001 / Not yet recruitingPhase 2/3

A Phase 2b Randomized Blinded Study to Evaluate SYN023 Compared to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in Adults with Different Rabies Exposure Risks

Start Date01 Nov 2019

Sponsor / Collaborator

Synermore Biologics Co., Ltd.

[+1]

100 Clinical Results associated with Zamerovimab/Mazorelvimab

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100 Translational Medicine associated with Zamerovimab/Mazorelvimab

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100 Patents (Medical) associated with Zamerovimab/Mazorelvimab

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6

Literatures (Medical) associated with Zamerovimab/Mazorelvimab

01 Sep 2024·Vaccine

A phase 2b, Randomized, double blinded comparison of the safety and efficacy of the monoclonal antibody mixture SYN023 and human rabies immune globulin in patients exposed to rabies

Article

Author: Borja-Tabora, Charissa Fay ; Quiambao, Beatriz P ; Solimen, Domingo P ; Reyes, Mari Rose De Los ; Roa, Camilo ; Barez, Marie Yvette ; Capeding, Maria Rosario ; Payumo, Ronald Allan ; McClain, J Bruce ; Reid, Caroline ; Zoleta-De Jesus, Loreta ; Chuang, Ariel ; Tsao, Eric ; Emmeline Montellano, May

BACKGROUNDSYN023 is an anti-rabies monoclonal antibody mixture administered as part of post-exposure prophylaxis regimens. The rabies virus neutralizing antibody (RVNA) concentration generally accepted as an adequate immune response to vaccination is ≥ 0.5 IU/mL.METHODSWithin 54 h of potential rabies exposure, 448 patients in two risk substrata of WHO Category III exposure were randomized to receive either 0.3 mg/kg SYN023 or 0.133 mL/kg human rabies immunoglobulin (HRIG) injected in and around the wound site(s) plus a course of rabies vaccination. Patients were followed for safety and absence of rabies for ≥ 365 days.RESULTSGMT RVNA was higher with SYN023 throughout the 2-week post-treatment period. In the primary analysis group (n = 368), 99.4 % of SYN023 recipients versus 4.5 % of HRIG recipients had protective RVNA levels on Day 4. On Day 8, 98.1 % SYN023 versus 12.2 % HRIG recipients were protected. The SYN023:HRIG ratio of geometric mean titer of RVNA (RVNA GMTs) on Day 8 (19.42) exceeded the 10 % superiority margin (P < 0.0001) indicating higher Day 8 RVNA with SYN023. On Day 99, the SYN023:HRIG RVNA GMT ratio (0.66) was below the non-inferiority margin of 20 % (P = 0.9485) suggesting some moderation of vaccine immune response by SYN023 relative to HRIG. The ratio of percent SYN023:HRIG recipients achieving RVNA ≥ 0.5 IU/mL on Day 99 (0.98) met the non-inferiority margin of 20 % (P = 0.013) indicating anti-rabies immune response with SYN023 was non-inferior to HRIG despite this effect. There were no probable/confirmed rabies cases in any patient. Study regimens were well tolerated.CONCLUSIONSSYN023 provided higher RVNA than HRIG soon after rabies exposure. By Day 99 post-treatment, GM RVNA with SYN023 was lower than HRIG, however, the percent of SYN023 recipients with a protective response was not inferior at this time point. No rabies cases were reported in the study. The SYN023 safety profile was acceptable.CLINICALTRIALSgov ID: NCT03961555.

01 Sep 2021·VaccineQ3 · MEDICINE

Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial

Q3 · MEDICINE

Article

Author: Chuang, Ariel ; Tsao, Eric ; Moore, Susan M ; McClain, J Bruce ; Reid, Caroline

BACKGROUNDSYN023-002 is a randomized, blinded, controlled study comparing rabies virus neutralizing activity (RVNA) and safety of SYN023, a monoclonal anti-rabies antibody mixture, to human-serum derived anti-rabies immunoglobulin (RIG) when administered with commercially available vaccines to healthy adult volunteers.METHODSParticipants were randomized among 4 treatment groups (SYN023 + Imovax, SYN023 + RabAvert, HyperRab + Imovax, HyperRab + RabAvert). On Day 0, subjects received 1 dose of RIG (0.3 mg/kg SYN023 or 20 IU/mL HyperRab) and their first of 5 vaccine doses. The primary objective was to compare cumulative RVNA between SYN023 and HyperRab recipients. Secondary objectives were to compare safety and to assess SYN023 pharmacokinetics and immunogenicity.RESULTSAll 164 randomized subjects initiated treatment and were included in safety analyses. At least 34 subjects/treatment group received all treatment and had complete RVNA results, thus were included in the primary endpoint analysis. Mean RVNAs were approximately ten-fold higher in SYN023 recipients compared to HyperRab recipients until Day 14. From Day 14 onwards, mean RVNA was lower in SYN023 recipients, but remained above the RVNA level widely considered adequate (≥0.5 IU/mL) through Day 112 (study end). The point estimate of the cumulative RVNA (83.22% SYN023/HyperRab), but not the lower CI bound (90% CI: 66.06%, 104.83%), fell within the protocol-defined similarity margin. Each RIG + vaccine regimen appeared safe with mostly mild AEs and no serious or severe related events observed. Except injection site pain (22% HyperRab recipients vs. 6% SYN023 recipients), treatment-related AEs incidences were similar between RIGs. Anti-SYN023 antibodies were observed but had no apparent effects on PK or safety.CONCLUSIONSSYN023 administered with commercially available vaccines provides adequate antibody coverage beginning earlier than other commercially available RIGs with an acceptable safety profile. Some suppression of vaccine response occurred, but RVNA levels ≥ 0.5 IU/mL were maintained throughout the relevant period.REGISTRATIONClinicalTrials.gov #NCT02956746.FUNDINGSynermore biologics.

01 Jul 2021·Clinical Pharmacology in Drug Development

Safety, Pharmacokinetics, and Neutralizing Activity of SYN023, a Mixture of Two Novel Antirabies Monoclonal Antibodies Intended for Use in Postrabies Exposure Prophylaxis

Article

Author: Moore, Susan M. ; Tsao, Eric ; McClain, J. Bruce ; Chuang, Ariel

AbstractSYN023 is a mixture of 2 humanized monoclonal antirabies antibodies (CTB011, CTB012). Two first‐in‐human studies evaluated ascending intramuscular (IM) injected doses (Study SYN023‐001; N = 15) and IM vs subcutaneous (SC) administration (Study SYN023‐003; N = 35) in healthy adults. In both studies, end points were safety, pharmacokinetics (PK), pharmacodynamics/rabies virus neutralizing activity (RVNA), and immunogenicity (anti‐SYN023 antibodies). Adverse events were mild and infrequent at all doses tested by IM injection (0.3 mg/kg, 1.0 mg/kg, 2.0 mg/kg), or by SC injection (0.3 mg/kg). There were no apparent trends in adverse event frequency or nature with increased dose or with administration route. Serum PK of SYN023 component antibodies appeared comparable to each other at each dose tested and when administered IM versus SC with serum exposure doubling over the second week after administration. At the lowest dose tested (0.3 mg/kg) by either IM or SC injection, RVNA levels exceeded the concentration generally accepted as protective against rabies (≥0.5 IU/mL) by day 1 after administration. Supra‐inhibitory levels persisted >42 days. RVNA increased with higher doses. Anti‐CTB011 and anti‐CTB012 antibodies occurred with no apparent effect on PK or safety. These data support the potential use of SYN023 in antirabies postexposure prophylaxis.

100 Deals associated with Zamerovimab/Mazorelvimab

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Rabies	CN	Synermore Biologics (Suzhou) Co., Ltd.	04 Jun 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Rabies	1,448	克瑞毕±人狂犬病免疫球蛋白（HRIG）	wmihsdjlfp(orqpgbnuta) = 基于6项临床试验的研究结果，克瑞毕®在狂犬病病毒暴露者及健康受试者中无论是单独使用还是与狂犬病疫苗联用，皆具有良好的安全性。结果显示，克瑞毕®组受试者的不良反应发生率要低于HRIG组，且克瑞毕®组内没有因不良反应导致退出的受试者，常见的不良反应多为注射部位肿胀及疼痛，不良反应发生率显著低于HRIG对照组。 kkqhdbxlfi (nlpauwlvzv )	Positive	20 Oct 2023
NCT04644484 (CTgov)	Phase 3	Rabies	1,000	Rabies Vaccine+SYN023	kivlhyqxzx(gtpzinhkzt) = wsqhdkgqyq cfjbcfbwcs (wymtxzfnyq, qkgcsrvccd - nztkfannbf) View more	-	21 Apr 2023
NCT02956746 (SYN023-002, Pubmed \| Vaccine) Manual	Phase 2	Rabies	164	rabies vaccination+SYN023	xgttpkdqsp(vczhrmujvv) = dprutbnggu ticzxniqld (revrejcnwv ) View more	Positive	24 Sep 2021
NCT02956746 (SYN023-002, Pubmed \| Vaccine) Manual	Phase 2	Rabies	164	rabies vaccination+HyperRab	(wxtftbrkmm) = vyfywjlcgn lcskhdplsw (wselmyatdk )	Positive	24 Sep 2021
NCT02956746 (RabiesMab \| SYN023-002, CTgov)	Phase 1/2	Rabies	164	Imovax+SYN023 (Imovax, SYN023)	qqudwykgdq(ufswdiqgud) = wscymtahbq kqfdgntnlo (brsqsegxub, iwpzaxtfoe - ijbhmhjgdn) View more	-	27 Feb 2019
NCT02956746 (RabiesMab \| SYN023-002, CTgov)	Phase 1/2	Rabies	164	Imovax+HyperRAB ST (human rabies immune globulin) (Imovax, Human Rabies Immune Globulin)	qqudwykgdq(ufswdiqgud) = txwhuvbaeo kqfdgntnlo (brsqsegxub, lnplcqcxrk - phdznetmbm) View more	-	27 Feb 2019