Technology name
Last update: Dec 2024Non-ARV/Non-Hormonal Dual-Purpose Monthly Vaginal Ring (Onering) (MATRIX-003)
Developer(s)
Type of technology
Intra-vaginal ring
Administration route
Topical (Vaginal)
Development state and regulatory approval
Soluble adenyl cyclase (sAC) inhibitors
Pre-clinical
Not provided
Description
The dual-purpose vaginal ring is a silicone-based, doughnut-shaped vaginal ring designed for monthly contraception and prevention of diseases. It has an outer diameter of 55 mm and incorporates two drug delivery cassettes. One cassette contains a novel antiviral peptide, which is a protein fragment, while the other cassette delivers a hormone-free contraceptive agent—a soluble adenyl cyclase (sAC) inhibitor. Both active agents are released simultaneously at a controlled rate over a 28-day period.
Developer(s)
Oak Crest Institute
The Oak Crest Institute of Science was founded in 2001 in Monrovia, California, by Dr. Marc Baum. It began as an independent, non-profit research organization with a mission to conduct impactful scientific research while training the next generation of scientists. Over the years, it has grown into a hub for interdisciplinary research, focusing on drug delivery and infectious diseases.
Technology highlight
1. Sustained Release: Enables controlled and simultaneous release of two distinct drugs within the vaginal flora, ensuring localized and prolonged therapeutic efficacy. 2. Self-Administration: Designed for ease of use, allowing users to independently insert and remove the device. 3. Cost-Effectiveness: Low manufacturing costs make it an accessible option for widespread use. 4. Extended Shelf Life: Exhibits a longer shelf life compared to other long-acting contraceptive formulations, enhancing storage stability and usability.
Illustration(s)
Technology main components
The Onering is a silicone-based, doughnut-shaped vaginal ring featuring two distinct lobes. Each lobe consists of a reservoir support structure enclosed by a rate-controlling membrane and sealed with a reservoir end cap. (i) Lobe One contains a novel antiviral peptide, which is a protein fragment. (ii) Lobe Two contains a soluble adenyl cyclase (sAC) inhibitor.
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Safety, Efficacy and Evidence Summary
The safety outcomes of the Early Phase 1 trial (MATRIX-003) have not yet been disclosed, as the study only commenced in the first quarter of 2024.
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APIs compatibility profile
Soluble adenyl cyclase (sAC) inhibitors, including TDI-10229, LRE1, KH7, ADCY10, and TDI-11861, can be utilized in the dual-purpose design of the Onering/MATRIX-003. These inhibitors are selected for their slower dissociation rates and efficient local absorption within the vaginal environment. Currently, sAC inhibitors, whether as first- or second-line agents, have not yet received approval from any regulatory authority.
Antiviral peptides, effective against human immunodeficiency virus (HIV), human papillomavirus (HPV), and herpes simplex virus (HSV), are targeted as a component of combination therapy in the Onering. These antivirals include (i) HIV: Enfuvirtide (T20), C34, TAT-derived peptides, VIRIP, Griffithsin; (ii) HPV: P18, L2-based peptides, HPV-16E7 peptides, RG1 epitope-derived peptides, Mimotopes; (iii) HSV: LL-37, TAT-CaM fusion peptides, BVD-21, G2 peptide, EP-100. Out of these peptides, Enfuvirtide (T20) is currently approved by USFDA (United States Food and Drug Adminstration).
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50-75 wt%
2 different APIs : one API should be an antiviral peptide and other API should be a sAC inhibitor (an hormonal free contraceptive)
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Scale-up and manufacturing prospects
Not provided
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Excipients & delivery device(s)
No proprietary excipient used
No novel excipient or existing excipient used
No residual solvent used
No delivery device
Additional features
- Drug-eluting
- Monolithic
- Removable
- Single-use
- Molded
- Reservoir-type
- At least 1 year shelf life
Not provided
Not applicable
The shelf life of the formulation is longer than most of the long acting formulation i.e., 2 years.
Store at a temperature range of 15°C to 30°C (59°F to 86°F).
Therapeutic area(s)
- Other(s) : "HPV, HSV"
- HIV
- Contraception
- Pre-Exposure Prophylaxis (PrEP)
- Treatment
Potential associated API(s)
- Other antivirals
- Soluble adenyl cyclase (sAC) inhibitors
Use of technology
- Self-administered
Monthly
Targeted user groups
- Adults
- Older Adults
- Female
- Cisgender female
- Transgender female
Unspecified
Unspecified
Unspecified
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Other antivirals
Antiviral Peptides
Pre-clinical
Not provided
HIV, HSV and HPV
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Once monthly
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Soluble adenyl cyclase (sAC) inhibitors
Hormone Free Contraceptive
Pre-clinical
Not provided
Contraception
Not provided
Once monthly
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There are either no relevant patents or these were not yet submitted to LAPaL
