INTERNATIONAL PARTNERSHIP FOR MICROBICIDES INC
8405 COLESVILLE ROAD STE 600, SILVER SPRING, MD 20910 www.ipmglobal.org

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Organizations Filed Purposes: TO DEVELOP HIV PREVENTION PRODUCTS AND OTHER SEXUAL AND REPRODUCTIVE HEALTH TECHNOLOGIES FOR WOMEN, AND TO MAKE THEM AVAILABLE AND ACCESSIBLE WHERE THEY ARE URGENTLY NEEDED.

IPM's clinical affairs department is responsible for quality control and compliance, medical safety, clinical operations, biometrics, public affairs, community public affairs and socio-behavioral sciences for IPM's clinical trials. Key clinical trials initiated or ongoing in 2019 included: - Clinical Trials of the monthly dapivirine vaginal ring The dapivirine ring extended access and monitoring study (DREAM study/ IPM 032) initiated in July 2016, DREAM was a Phase IIIb open-label study providing the dapivirine ring to women who participated in the former Phase III dapivirine ring trial in Africa (The Ring Study/ IPM 027) who tested HIV-negative and were not pregnant. The study collected additional safety data and information on how women use the ring. As of January 2019, all DREAM participants were exited from the trial. The results from the study were announced in 2019 and showed increases in participant use of the monthly dapivirine ring and modelling data suggest greater HIV-1 risk reduction by over 50% compared to the Phase III clinical trials. Although these modelling results are limited due to the lack of a placebo comparison group, they indicate an encouraging trend IPM hopes to see continue if the ring receives regulatory approval and rolled out. In 2019, IPMs clinical trial partner, the United States (US) National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), initiated the "Reversing the Epidemic in Africa with Choices in HIV prevention" study (REACH/MTN-034). The trial is designed to collect data on the safety and acceptability of the monthly dapivirine ring versus daily oral PrEP (Truvada) in HIV-uninfected adolescent females between the ages of 16-21 years old. This trial will remain ongoing through 2021. - Clinical trial of IPM's three-month dapivirine ring Building on the promise of IPM's monthly dapivirine ring, IPM developed the three-month dapivirine ring, which is designed to increase convenience and reduce annual costs as compared to the monthly dapivirine ring. The phase I trial, which was conducted by the MTN in collaboration with IPM, will inform the design of future clinical studies and a possible regulatory strategy for this product. The trial initiated in December 2017 and the last participant visit occurred in January 2019. Data analysis and results are expected to be complete in 2020. - Clinical trials of the dapivirine-contraceptive vaginal ring, a multipurpose prevention technology (MPT) The three-month dapivirine-contraceptive ring is designed to provide slow and simultaneous release of both the antiretroviral (ARV) drug dapivirine to prevent HIV and the contraceptive hormone levonorgestrel to prevent unintended pregnancy. The first safety study of IPM's dapivirine-contraceptive ring began in April 2017 at two sites in the United States, and is being led by IPM's partner, the US National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN). Data analysis/study report development was ongoing in 2019 for this study; a final clinical study report is expected in 2020. A second phase I clinical trial of the MPT ring was conducted by the Contraceptive Clinical Trials Network (CCTN) from Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in collaboration with the MTN. The trial began in July 2018 and participant visits completed in August 2019. Data analysis and results are expected to be complete in 2020.

Product Development: The product development (PD) division leads non-clinical, formulation, manufacturing, chemistry manufacturing and controls (CMC), analytical, and material planning and supply activities for IPM's products. This division is responsible for product supply and associated activities to support clinical trials (including manufacturing, packaging, labeling, distribution, stability) as well as the post-use testing of dapivirine rings to support adherence assessments during trials. In 2019, PD's efforts included conducting CMC gap-filling activities to address feedback received from regulatory agencies, including the questions received from the EMA as part of the review process of the monthly dapivirine ring regulatory dossier. Further to this, the PD team continued development of the three-month dapivirine ring and the dapivirine-contraceptive ring.

Regulatory Affairs & Quality Assurance: IPM's regulatory affairs team oversees the monthly dapivirine ring regulatory process, providing leadership in dossier preparation and filings in Europe, the United States, South Africa and other target African countries, where IPM is planning market introduction of the ring. This division also supports all regulatory efforts for other IPM products on the product development pathway; this support includes submission and maintenance of investigational new drug (IND) documentation and conducting regulatory agency interactions related to new protocols for upcoming clinical trials. In partnership with the regulatory affairs team, the quality assurance (QA) team ensures IPM's product development and clinical studies are conducted in compliance with all applicable drug and safety laws. Audits are conducted during the conduct of clinical trials to provide assurance of protocol compliance, and compliance with international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ICH) guidelines, good clinical practices (GCP), and all applicable regulations. Vendor audits are also conducted where IPM's clinical, preclinical, or CMC work is being conducted.

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