- Funds will be used to further advance lasofoxifene through late-stage clinical development as a next-generation oral SERM to treat women with increasingly prevalent ESR1 breast cancer mutations
- Initial data from both Phase 2 clinical trials is expected in H1 2022
COLUMBUS, Ohio, Nov. 15, 2021 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, today announced that it successfully closed a $40 million Series A3 financing round led by Perceptive Xontogeny Ventures Fund II (PXV Fund). Existing investors also participated in the financing.
As part of the agreement, Fred Callori and Ben Askew, Ph.D., partners in the PXV Fund, were appointed to the Sermonix Board of Directors.
“We are excited to welcome investors who share our passion as we work to leverage a precision medicine approach to address a significant unmet need in the metastatic breast cancer setting,” said David Portman, M.D., Sermonix founder and chief executive officer. “This is a pivotal moment for Sermonix. With a strengthened balance sheet and both our ELAINE Phase 2 studies fully enrolled and progressing, we have set the stage for a catalyst-rich 2022, with initial data from each trial expected in the first half.”
The PXV Fund team brings significant scientific, business, operational and investment expertise to the Sermonix team, with a singular goal of shepherding lasofoxifene through compelling and rigorously designed clinical proof-of-concept studies.
“We are pleased to announce our support for Sermonix Pharmaceuticals in their endeavors to develop an effective treatment for the approximately 40% of breast cancer patients who develop ESR1 mutations and progress following endocrine therapy,” said Mr. Callori. “We believe lasofoxifene, if approved, may become a treatment of choice for oncologists and many of their patients with this challenging disease. The accomplished team at Sermonix recognizes the acute medical need and will be executing effectively on these strategies.”
Sermonix recently announced significant progress in the advancement of its ELAINE (Evaluation of Lasofoxifene in ESR1 Mutations) Phase 2 clinical program for lasofoxifene:
- In August, Sermonix announced completion of enrollment in its Phase 2 ELAINE 1 trial (NCT03781063), which is evaluating lasofoxifene versus the current standard of care, fulvestrant, for the treatment of ER+/HER2- breast cancer in patients with an ESR1 mutation. Sermonix expects topline data from the trial, which enrolled a total of 100 patients, in the first half of 2022.
- In June, Sermonix announced completion of enrollment in its Phase 2 Elaine 2 trial (NCT04432454), which is evaluating lasofoxifene in combination with Eli Lilly and Company’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib. Initial data from the trial is expected in the first half of 2022.
LifeSci Capital acted as placement agent for Sermonix on this transaction.
Lasofoxifene is an investigational, 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.
Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. Sermonix Pharmaceuticals was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women’s health, menopause and selective estrogen receptor modulator (SERM) therapy. The Sermonix management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience in the oncology drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in SERM biology. Miriam Portman, M.D., is chief operating officer. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D. vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at https://sermonixpharma.com/.
About Perceptive Xontogeny Venture Funds
The Perceptive Xontogeny Venture Funds are Perceptive Advisors’ investment vehicles focused purely on early-stage, private venture investments in life sciences companies. Primary investments for the venture funds include companies that are seeking a lead investor for Series A financings, which include both companies that are seeded and operationally supported by Xontogeny LLC, an affiliated biotech accelerator, as well as unaffiliated companies that are seeking direct Series A investments. For more information, visit https://perceptivelife.com/.