Evofem Biosciences, Inc. and Orion Biotechnology Canada Ltd. have entered into a collaboration agreement to evaluate the compatibility and stability of Orion’s novel CCR5 antagonist, OB-002, in Evofem’s Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel with the goal of developing a Multipurpose Prevention Technology (MPT) product candidate for indications including the prevention of HIV in women.
 
The collaboration will focus on determining compatibility and stability of OB-002 in Phexxi with results expected in 3Q22. Assuming positive results, the companies will seek government and philanthropic funding for subsequent clinical trials of the MPT vaginal gel product candidate.
 
“For too long, women have had to assemble a grab-bag of products to protect against pregnancy, various STIs, and HIV,” said Saundra Pelletier, Chief Executive Officer of Evofem Biosciences. “This partnership with Orion aims to develop a first-of-its-kind product with potential to revolutionize the way women protect their sexual and reproductive health: no unintended pregnancies, no STIs, and no HIV — all in one applicator.”
 
Ian McGowan, Chief Medical Officer of Orion Biotechnology, added, “It is unacceptable that we are still seeing high rates of new HIV infections among women each year and there is clearly a compelling need to expand the HIV prevention portfolio. Orion is very excited to be collaborating with Evofem to address this important issue and develop an MPT product for women across the world.”
 
In trials to date of Orion’s novel CCR5 antagonist, OB-002 has demonstrated best-in-class in vitro potency. OB-002 was 100% effective in blocking transmission of HIV infection in a non-human primate model. A 15-subject Phase 1 study of vaginally administered OB-002 gel demonstrated that the OB-002 gel was safe and well tolerated, with no evidence of systemic absorption.
 
Phexxi is a hormone-free, on-demand prescription contraceptive vaginal gel that was launched in the U.S. in September 2020. Top-line data is expected from Evofem’s pivotal Phase 3 trial for the prevention of chlamydia and gonorrhea in women in the second half of 2022.