Top-line findings were initially shared in a late-breaking oral presentation at ESMO Congress 2022

COLUMBUS, Ohio, Sept. 13, 2022 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, today announced results of its signal-seeking Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1) Phase 2 study. The results were initially shared Sept. 10 during a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.

The open-label ELAINE 1 (NCT03781063) study began U.S. enrollment in September 2019, assessing the efficacy and safety of oral lasofoxifene versus intramuscular fulvestrant, a selective estrogen receptor degrader (SERD), in 103 patients. All participants were post-CDK4/6 inhibitor/aromatase inhibitor therapy and had an ESR1 mutation. Progression-free survival was the primary endpoint.

Median progression-free survival (PFS) was 6.04 mos. (95% CI, 2.82–8.04) for lasofoxifene vs. 4.04 mos. (95% CI, 2.93–6.04) for fulvestrant, P=0.138 (HR, 0.699 [95% CI, 0.445–1.125])

Clinical benefit rate (CBR) was 36.5% for lasofoxifene vs. 21.6% for fulvestrant, P=0.12. CBR is defined as the percentage of all subjects with a complete or partial response; or stable disease for >/= 24 weeks

Objective response rate was 13.2% for lasofoxifene vs. 2.9% for fulvestrant, P=0.12, with 1 confirmed complete response (CR) (72-week duration) and 4 confirmed partial responses (PR) in the lasofoxifene arm vs. 1 PR in the fulvestrant arm

PFS was numerically and consistently greater with lasofoxifene vs. fulvestrant when visceral metastasis and/or Y537S ESR1 mutation subgroups were analyzed

While not reaching statistical significance in this 103-patient study, all endpoints numerically favored lasofoxifene

PFS at 6 mos. for lasofoxifene was 53.4% vs. 37.9% for fulvestrant; PFS at 12 mos. was 30.7% for lasofoxifene vs. 14.1% for fulvestrant

Clearance of ctDNA also favored lasofoxifene over fulvestrant

Most common adverse events were fatigue, nausea, arthralgias and hot flashes; most were Grade 1/2. No thrombotic events occurred

ELAINE 1 is the first clinical trial comparing lasofoxifene with fulvestrant in ESR1-mutated metastatic breast cancer patients with progression on an aromatase inhibitor (Al) in combination with a CDK4/6 inhibitor, and the first to demonstrate anti-tumor activity and target engagement of a novel selective estrogen receptor modulator (SERM) in this setting. ELAINE 2, a Phase 2 single-arm trial of lasofoxifene in combination with the CDK4/6 inhibitor abemaciclib, showed efficacy in heavily pretreated patients with ESR1-mutated mBC post-CDK4/6i (ASCO 2022).

“Sermonix is pleased with the outcomes reported in our ELAINE 1 trial comparing lasofoxifene with fulvestrant, suggesting lasofoxifene’s anti-tumor activity and potential to play a critical role in the targeted precision medicine treatment of ESR1-mutated advanced ER+ breast cancer,” said Dr. David Portman, Sermonix founder and chief executive officer. “Lasofoxifene following endocrine/CDK4/6 inhibitor therapies continues to be studied and we anticipate efficacy will be confirmed in a larger clinical study. Sermonix is planning a Phase 3 registrational combination study based on these results as well as encouraging efficacy and safety demonstrated in the ELAINE 2 study of lasofoxifene and abemaciclib reported at this year’s ASCO annual meeting.”

“ELAINE 1 suggested lasofoxifene's activity in patients with metastatic breast cancer post-CDK4/6i and an ESR1 mutation,” said Dr. Paul Plourde, Sermonix vice president for clinical oncology development. “While not reaching statistical significance in our modestly powered study, all efficacy parameters numerically favored lasofoxifene over fulvestrant. Moreover, the safety profile indicates lasofoxifene was well tolerated with few Grades 3 and 4 adverse events and a differentiated profile from injectable and oral SERDs. Lasofoxifene trials may offer new hope for patients with mutated ESR1 metastatic breast cancer.” About Lasofoxifene 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.

About Sermonix 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 SermonixPharma.com.

Contact information: Glenn Garmont LifeSci Advisors Managing Director, Investor Relations Corporate Communications ggarmont@lifesciadvisors.com 646-876-5521

A labor shortage at a pharmaceutical company along with increased demand left Adderall on back-order at many pharmacies across the country.

Stéphane Bancel discusses the company’s latest Covid shot and prospects for using mRNA in seasonal flu vaccines and personalized treatments for cancer

Intellia said Friday it knocked out the gene responsible for a rare and deadly swelling disorder. But CRISPR stocks sank.

Pfizer Inc. and BioNTech SE said Friday that the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMA) has recommended the companies' COVID-19 vaccine Comirnaty be converted to standard, or "full," Marketing Authorization (MA) from conditional MA for all indications and formulations. The companies said the European Commission (EC) will review the CHMP recommendation and is expected to make a decision "soon." The vaccine has been granted MA by the EC to pre

How do you fix a forgetful memory? Neurologist shares brain exercises to keep memory sharp, including reading fiction, cooking from recipes and playing games.

J&J (JNJ) announces a new $5 billion stock buyback plan. CHMP recommends authorizing Pfizer's (PFE) Omicron BA.4 and BA.5 boosters in Europe.

Based on positive top-line data from phase III on its pentavalent meningococcal vaccine, Pfizer (PFE) intends to submit a regulatory application to the FDA seeking approval by year-end.

Intellia Therapeutics said two of its experimental Crispr treatments produced positive results in early-stage trials.

A San Francisco-based immunology company that wants to help eradicate infectious disease globally has expanded its footprint in St. Louis, opening a new $41 million office within the Cortex innovation district. It says the new facility will be critical to advancing research to treat several infectious diseases, including Covid-19.

In June, a Dallas area doctor who was feeling unwell wanted to use a saline IV bag she had gotten from her work to try to rehydrate. She tapped it into her veins while at home. Minutes later, she suffered a major medical event and died, court records say. Now, Raynaldo Rivera Ortiz Jr., an anesthesiologist at her surgical facility, faces federal charges for allegedly tampering with IV bags in a way that resulted in the death of his colleague as well as several other cardiac emergencies, accordin

Regeneron (REGN) and its partner Alnylam announce promising data from its ongoing phase I study evaluating ALN-HSD in healthy adults and NASH patients.

Two COVID-19 antibody therapies are no longer recommended by the World Health Organization (WHO), on the basis that Omicron and the variant's latest offshoots have likely rendered them obsolete. On Thursday, WHO experts said they strongly advised against the use of the two therapies in patients with COVID-19, reversing previous conditional recommendations endorsing them, as part of a suite of recommendations published https://www.bmj.com/content/370/bmj.m3379 in the British Medical Journal. GSK and partner Vir Biotechnology's sotrovimab - which has generated billions in sales and became one of the British drugmaker's top sellers last year - was pulled off the U.S. market by the U.S. Food and Drug Administration (FDA) in April.

Lumakras had mixed results in a closely watched clinical trial comparing the drug to docetaxel. Analysts wonder if Mirati Therapeutics' drug will do better.

Pharmaceutical giant Merck (NYSE: MRK) delivered outstanding second-quarter results in July, largely driven by its mainstay cancer blockbuster, Keytruda. The company reported 28% year-over-year total revenue growth and continues to develop Keytruda for new cancer indications. Under the radar, however, Keytruda returned some bad news in three separate late-stage clinical trials this summer.

It should come as no surprise that Sen. Lindsey Graham is the one to expose one of the Republican Party’s biggest lies of late. | Opinion

Xylazine, an animal tranquilizer, and nitazine, a powerful opioid, are increasingly found in the illicit drug supply.

COVID in seniors may be linked to a higher risk for Alzheimer's, according to a new study published in the Journal of Alzheimer's Disease.

The latest clinical news from Bristol Myers Squibb (NYSE: BMY) was quite encouraging, sufficient to drive the pharmaceutical giant's stock higher on an otherwise uninspired day for the broader stock market. Bristol Myers Squibb's share price experienced a nearly 2% bump, a notably better showing than the S&P 500 index's more than 1% decline. Bristol Myers Squibb's good news from the lab was that its enduringly popular cancer drug Opdivo did quite well in its latest round of testing.

"If we are forcing millions of people into this world, we as a society — whether you are right, whether you are left, whether you are 'pro-life' or not — it doesn't matter. You will all suffer the consequences of a crowded, broken political, healthcare, and education system."View Entire Post ›

Here's what experts say about getting the two vaccines at once.