On December 8, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that it will share a poster presentation at the 12th AACR (Free AACR Whitepaper)-JCA Joint Conference: Breakthroughs in Cancer Research — Translating Knowledge into Practice, which is being held December 10-14 in Maui, Hawaii (Press release, Sermonix Pharmaceuticals, DEC 8, 2022, https://sermonixpharma.com/sermonix-pharmaceuticals-announces-poster-presentation-on-phase-1-ethnobridging-study-of-lasofoxifene-at-the-12th-aacr-jca-joint-conference-breakthroughs-in-cancer-research-translating-know/ [SID1234624960]).
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The poster describes a Phase 1 single-dose ethnobridging study evaluating the safety, tolerability and pharmacokinetics (PK) of oral lasofoxifene (5 mg) in healthy Japanese and Caucasian women. A total of 16 women (eight Caucasian and eight Japanese) were enrolled, and patient/baseline characteristics were similar between both groups. Lasofoxifene was well tolerated, with two grade one adverse events considered not related to treatment (calf soreness in a Caucasian woman and upper right arm bruise in a Japanese woman).
The PK data are currently being analyzed and will be presented at the conference. Results of this analysis are expected to show similar lasofoxifene PK profiles between Caucasian and Japanese women.
"We believe targeted lasofoxifene holds great promise for ESR1-mutated metastatic breast cancer patients not only in the U.S. and Europe, but globally," stated David Portman, M.D., chief executive officer of Sermonix. "To that end, this analysis from this important ethnobridging study will potentially support the development of lasofoxifene for the treatment of ESR1-mutated metastatic breast cancer in Japan."
Poster presentation details:
Title: Phase 1, Open-Label, Single Dose, Ethnobridging Study Evaluating the Safety, Tolerability and Pharmacokinetics of Lasofoxifene in Healthy Japanese and Caucasian Women
Poster #: A83
Session: Poster session A
Date: Sunday, December 11, 2022
Time: 5:30 p.m. – 7:30 p.m. local time (10:30 p.m. Sunday – 12:30 a.m. Monday, EST)
About the AACR (Free AACR Whitepaper)-JCA Joint Conference
The American Association for Cancer Research (AACR) (Free AACR Whitepaper) and Japanese Cancer Association (JCA) are proud to offer this 12th AACR (Free AACR Whitepaper)-JCA Joint Conference. This meeting series has a long tradition of bringing together outstanding researchers from the United States, Japan and around the world to share their findings and present the latest advances in basic, translational and clinical cancer research. Formal and informal interactions as well as international collaborations are fostered through this unique forum. Just as its predecessors have done, this AACR (Free AACR Whitepaper)-JCA Joint Conference will take a broad view of contemporary cancer research and will be of interest to basic, translational and clinical investigators at all career levels.
About Lasofoxifene
Lasofoxifene is an investigational, targeted endocrine treatment, and next-generation nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.