access-principles-1access-principles-2access-principles-3backcarrierdevelopmentease_of_administrationexportimplantableinjectablenon-implantablenon_carriernon_injectableother_featuresprintroute_of_administrationtherapeutic_areatype_of_tech

Type of technology

Intra-vaginal ring

Administration route

Topical (Vaginal)

Development state and regulatory approval

Active Pharmaceutical Ingredient (API)

Estrogens

Development Stage

Phase I

Regulatory Approval

Under clinical investigation

Description

The EEG intravaginal ring (IVR) is a multipurpose prevention technology providing 90-day contraception and HIV PrEP. It contains etonogestrel (ETG), ethinyl estradiol (EE), and the anti-HIV lectin griffithsin (QGRFT) within a silicone matrix. QGRFT is a potent natural antiviral agent. Further, Sustained release is enabled by silk fibroin, supporting controlled delivery. This system offers effective contraception and may reduce HIV transmission and resistance development.

Developer(s)

Population Council
Originator
United States of America

Population Council

Founded in 1952 by John D. Rockefeller III, the Population Council is a nonprofit research group focused on population, health, and development. It helped shape global family planning policy and advanced reproductive drug development, including contraceptive implants, intrauterine systems, and vaginal rings.

Oak Crest Institute of Science
Originator
United States of America

Oak Crest Institute of Science

Founded in 1952 by John D. Rockefeller III, the Population Council is a nonprofit research group focused on population, health, and development. It helped shape global family planning policy and advanced reproductive drug development, including contraceptive implants, intrauterine systems, and vaginal rings.

Technology highlight

1) 90 day sustained release silicone based intravaginal ring 2) Anti-HIV and Contraceptive MPT 3) Self adminstered

Illustration(s)

Technology main components

1) Etonogestrel 2) Ethinyl Estradiol 3) QGriffithsin (QGRFT) 4) Silk fibroin

Information on the raw materials sourcing, availability and anticipated price

Not provided

Delivery device(s)

Intravaginal pod shaped silicone based ring

APIs compatibility profile

API desired features
Water-insoluble molecules

Small molecules

Cervical anesthetics such as lidocaine, contraceptives such as 17O-ethinyl-levonogestrel 17b-hydroxy-estra-4,9,11-trien-3-one, estradiol. Etonogestrel, levonogestrel, medroxyprogesterone acetate, NESTORONE, norethindrone, progesterone, estrogen receptor modulators such as RU-486, anti-endometriosis drugs such as Terbutaline, antivirals such as acyclovir and gancy clovir; blood flow increasing drugs like Sildenafil: labor inducing drugs like misoprostol; preterm labor drugs like indomethacin; overactive bladder drugs like oxybutynin, morning sickness drugs such as Bromocriptine.

Proteins

Prefered molecular weight - 2,000 to 5,000.000 Da. High molecular weight water soluble polymers such as Sulfated polysaccharides such as carrageenan, particularly lambda carrageenan. Naturally occuring potent HIV agent - Griffithsin (GRFT), is a 12.8 kDa lectin protein derived from red algae is the choice of protein. Glycoproteins, peptides/polypeptides, peptide hormones, such as insulin, nucleic acid derivatives, including oligonucleotides and aptamers, glucoaminoglycans (GAGs),

Additional solubility data

Not provided

Additional stability data

Not provided

API loading: Maximum drug quantity to be loaded

50-75 wt%

API co-administration

3 different APIs : Not provided

LogP

Not provided

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Precision weighing balances, sieves / powder feeders, stainless steel storage bins, jacketed mixing vessel, injection molding machine, pellet press / compactor, ultrasonic or mechanical compression tools, drilling / micro-machining system, Thermal sealing unit, drying oven / vacuum dryer, peristaltic filling systems

Manufacturing

Cleanroom (ISO 7/8 depending on product class) Manufacturing includes: 1. Carrageenan formulation (gel / core preparation) + zinc complex formation 2. Formulating IVR using embedded groove technique or aperture-filled ring or central core ring method.

Specific analytical instrument required for characterization of formulation

1. GPC/SEC (molecular weight distribution of carrageenan) 2. FTIR spectroscopy (functional group identification) 3. DSC/TGA (thermal properties) 4. XRD (crystallinity for drug/polymer systems) 5. HPLC / UPLC for NNRTIs (e.g., MIV-150), hormones, etc. 6. ICP-MS / AAS for zinc quantification

Excipients

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

Silk fibroin

Residual solvents used

Not provided

Additional features

Other features of the technology
  • Removable
  • Single-use
  • Molded
Release properties

Release kinetics are not published yet.

Injectability

Not applicable

Safety

Reported Adverse events (AEs) where 9 Grade 1 AEs (mild). In which, 7 were unrelated to ring use; 2 possibly/unlikely related; Bacterial vaginosis (during 56 mm and 66 mm ring use). Further there were no serious adverse events (SAEs) reported and discontinuations due to adverse events).

Stability

No formal stability studies (ICH, shelf-life, degradation, etc.) reported

Storage conditions and cold-chain related features

No storage conditions (temperature, humidity, shelf-life, packaging) are specified

Therapeutic area(s)

  • HIV
Use case(s)
  • Prevention

Potential associated API(s)

  • Estrogens
  • Antivirals for treatment of HIV infections, combinations

Use of technology

Ease of administration
  • Self-administered
Frequency of administration

Every 3 months

User acceptance

Not provided

Targeted user groups

Age Cohort
  • Adults
Genders
  • Female
  • Cisgender female
  • Transgender female
Pregnant individuals

Unspecified

Lactating individuals

Unspecified

Healthy individuals

Yes

Comment

Not provided

Estrogens

Class(es)

Hormonal contraceptive

Development stage

Phase I

Clinical trial number(s)

NCT05128136

Foreseen/approved indication(s)

Contraception

Foreseen user group

< 18 years old sexually active women

Foreseen duration between application(s)

3 monthly

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Under clinical investigation

Antivirals for treatment of HIV infections, combinations

Class(es)

Red algal lectin (Nicotiana benthamiana)

Development stage

Phase I

Clinical trial number(s)

NCT05128136

Foreseen/approved indication(s)

Anti-HIV agent

Foreseen user group

< 18 years ol sexually active women

Foreseen duration between application(s)

3 monthly

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Under clinical investigation

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

There are no publication

Collaborate for development

Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology

Share technical information for match-making assessment

Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit

Work with MPP to expand access in LMICs

In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing

Partnerships

No partner indicated

All sponsors

No sponsor indicated

Comment & Information