An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.
The main question the study aims to answer is:
• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

Start Date31 Oct 2023

Sponsor / Collaborator

Sermonix Pharmaceuticals LLCStartup

EUCTR2020-005936-31-LT / Not yet recruitingPhase 2

An Open-label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation

Start Date24 May 2021

Sponsor / Collaborator

Sermonix Pharmaceuticals LLCStartup

NCT04432454 / Active, not recruitingPhase 2

An Open-label, Multicenter Study Evaluating the Safety of Lasofoxifene in Combination With Abemaciclib for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and Have an ESR1 Mutation ( ELAINEII )

This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.

Start Date29 Sep 2020

Sponsor / Collaborator

Sermonix Pharmaceuticals LLCStartup

100 Clinical Results associated with Lasofoxifene Tartrate

100 Translational Medicine associated with Lasofoxifene Tartrate

100 Patents (Medical) associated with Lasofoxifene Tartrate

159

Literatures (Medical) associated with Lasofoxifene Tartrate

01 Dec 2023·Annals of oncology : official journal of the European Society for Medical Oncology

Lasofoxifene versus fulvestrant for ER+/HER2− metastatic breast cancer with an ESR1 mutation: results from the randomized, phase II ELAINE 1 trial

Article

Author: Lavasani, S ; Fleming, G F ; Hamilton, E ; Moreno-Aspitia, A ; Plourde, P V ; Sammons, S L ; Damodaran, S ; Portman, D J ; O'Connor, T ; Graff, S L ; Daniel, B R ; Gradishar, W J ; Bagegni, N A ; Pluard, T J ; Vidal, G A ; Goetz, M P ; Brufsky, A ; Schwartzberg, L S ; Wang, G ; Rugo, H S ; Yerushalmi, R ; Gal-Yam, E N ; Grosse Perdekamp, M T ; Cristofanilli, M A ; Batist, G ; Stover, D G ; Warner, E

BACKGROUND:

Acquired estrogen receptor alpha (ER/ESR1) mutations commonly cause endocrine resistance in ER+ metastatic breast cancer (mBC). Lasofoxifene, a novel selective ER modulator, stabilizes an antagonist conformation of wild-type and ESR1-mutated ER-ligand binding domains, and has antitumor activity in ESR1-mutated xenografts.

PATIENTS AND METHODS:

In this open-label, randomized, phase II, multicenter, ELAINE 1 study (NCT03781063), we randomized women with ESR1-mutated, ER+/human epidermal growth factor receptor 2 negative (HER2-) mBC that had progressed on an aromatase inhibitor (AI) plus a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) to oral lasofoxifene 5 mg daily or IM fulvestrant 500 mg (days 1, 15, and 29, and then every 4 weeks) until disease progression/toxicity. The primary endpoint was progression-free survival (PFS); secondary endpoints were safety/tolerability.

RESULTS:

A total of 103 patients received lasofoxifene (n = 52) or fulvestrant (n = 51). The most current efficacy analysis showed that lasofoxifene did not significantly prolong median PFS compared with fulvestrant: 24.2 weeks (∼5.6 months) versus 16.2 weeks (∼3.7 months; P = 0.138); hazard ratio 0.699 (95% confidence interval 0.434-1.125). However, PFS and other clinical endpoints numerically favored lasofoxifene: clinical benefit rate (36.5% versus 21.6%; P = 0.117), objective response rate [13.2% (including a complete response in one lasofoxifene-treated patient) versus 2.9%; P = 0.124], and 6-month (53.4% versus 37.9%) and 12-month (30.7% versus 14.1%) PFS rates. Most common treatment-emergent adverse events with lasofoxifene were nausea, fatigue, arthralgia, and hot flushes. One death occurred in the fulvestrant arm. Circulating tumor DNA ESR1 mutant allele fraction (MAF) decreased from baseline to week 8 in 82.9% of evaluable lasofoxifene-treated versus 61.5% of fulvestrant-treated patients.

CONCLUSIONS:

Lasofoxifene demonstrated encouraging antitumor activity versus fulvestrant and was well tolerated in patients with ESR1-mutated, endocrine-resistant mBC following progression on AI plus CDK4/6i. Consistent with target engagement, lasofoxifene reduced ESR1 MAF, and to a greater extent than fulvestrant. Lasofoxifene may be a promising targeted treatment for patients with ESR1-mutated mBC and warrants further investigation.

01 Dec 2023·Annals of oncology : official journal of the European Society for Medical Oncology

Open-label, phase II, multicenter study of lasofoxifene plus abemaciclib for treating women with metastatic ER+/HER2− breast cancer and an ESR1 mutation after disease progression on prior therapies: ELAINE 2

Article

Author: Peguero, J A ; Cherian, M A ; Goetz, M P ; Barve, M ; Anderson, I C ; Damodaran, S ; Portman, D J ; Blau, S ; Elkhanany, A ; O'Sullivan, C C ; Plourde, P V ; Moore, H C F

BACKGROUND:

Acquired ESR1 mutations in estrogen receptor-positive (ER+) metastatic breast cancer (mBC) drive treatment resistance and tumor progression; new treatment strategies are needed. Lasofoxifene, a next-generation, oral, endocrine therapy and tissue-specific ER antagonist, provided preclinical antitumor activity, alone or combined with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in ESR1-mutated mBC.

PATIENTS AND METHODS:

In the open-label, phase II, ELAINE 2 trial (NCT04432454), women with ESR1-mutated, ER+/human epidermal growth factor receptor 2-negative (HER2-) mBC who progressed on prior therapies (including CDK4/6i) received lasofoxifene 5 mg/day and abemaciclib 150 mg b.i.d until disease progression/toxicity. The primary endpoint was safety/tolerability. Secondary endpoints included progression-free survival (PFS), clinical benefit rate (CBR), and objective response rate (ORR).

RESULTS:

Twenty-nine women (median age 60 years) participated; all but one were previously treated with a CDK4/6i (median duration 2 years). The lasofoxifene-abemaciclib combination was well tolerated with primarily grade 1/2 treatment-emergent adverse events (TEAEs), most commonly diarrhea, nausea, fatigue, and vomiting. One patient (with no prior CDK4/6i) discontinued treatment due to grade 2 diarrhea. No deaths occurred during the study. Median PFS was 56.0 weeks [95% confidence interval (CI) 31.9 weeks-not estimable; ∼13 months]; PFS rates at 6, 12, and 18 months were 76.1%, 56.1%, and 38.8%, respectively. CBR at 24 weeks was 65.5% (95% CI 47.3% to 80.1%). In 18 patients with measurable lesions, ORR was 55.6% (95% CI 33.7% to 75.4%). ESR1-mutant circulating tumor DNA (ctDNA) allele fraction decreased from baseline to week 4 in 21/26 (80.8%) patients.

CONCLUSIONS:

Lasofoxifene plus abemaciclib had an acceptable safety profile, was well tolerated, and exhibited meaningful antitumor activity in women with ESR1-mutated, ER+/HER2- mBC after disease progression on prior CDK4/6i. Observed decreases in ESR1-mutant ctDNA with lasofoxifene concordant with clinical response suggest target engagement. If the ELAINE 2 findings are confirmed in the initiated, phase III, ELAINE 3 trial, these data could be practice-changing and help address a critical unmet need.

19 Nov 2023·Cureus

Novel Advances in the Role of Selective Estrogen Receptor Modulators in Hormonal Replacement Therapy: A Paradigm Shift

Review

Author: Acharya, Neema ; Motlani, Gunjan ; Motlani, Vidhi ; Somyani, Drishti ; Agrawal, Shruti ; Dave, Apoorva ; Pamnani, Soumya

Estrogen is a key regulatory hormone in the functioning of a female reproductive system. Estrogen hormone regulates many complex physiological processes, which has its role in reproduction and skeletal and cardiovascular systems by acting on estrogen receptors alpha (ERα) and beta (ERβ), which are nuclear transcription factors. Selective estrogen receptor modulators (SERMs) are now being used to treat bone loss, breast carcinoma, and menopausal symptoms, metabolic neurodegenerative because of their characteristics that allow them to function as both estrogen agonists and antagonists, depending on the target tissue. First-generation SERMs, such as Tamoxifen, are used in the management protocol for breast cancer, which is estrogen receptor (ER-positive). Raloxifene is a second-generation SERM that is a valuable adjunct used to treat and prevent osteoporosis in postmenopausal women and prevent compression fractures of the vertebral column. Novel SERM molecules are on the horizon, proven more potent and efficacious in preventing and treating osteoporosis. These include Ospemifene, lasofoxifene, bazedoxifene and arzoxifene. The benefits of Raloxifene versus that of Bazedoxifene are under trial. Despite their therapeutic benefits and actions, these medications are not without adverse effects, such as thromboembolic disorders. Increased risk of uterine cancer has been linked to Tamoxifen. This article delves into the world of SERMs, including their development and discovery. The newer SERMs in late development, ospemifene, lasofoxifene, bazedoxifene, and arzoxifene, are described in detail.

News (Medical) associated with Lasofoxifene Tartrate

06 Jun 2024

·www.biospace.com

Sermonix Pharmaceuticals Announces Chinese Approval of Investigational New Drug Application for Lasofoxifene

IND approval in China allows Shanghai Henlius Biotech, Sermonix’s Chinese development partner for oral lasofoxifene, to enroll ELAINE-3 trial patients in China Under strategic collaboration agreement signed in January, Henlius received exclusive rights from Sermonix to develop, manufacture and commercialize oral lasofoxifene in China Sermonix and Henlius will engage with PMDA and collaborate on expedited co-development of oral lasofoxifene in Japan COLUMBUS, Ohio, June 06, 2024 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), today announced that China’s National Medical Products Administration (NMPA) approved the investigational new drug application (IND) for oral lasofoxifene (HLX78 in China) submitted with the assistance of Chinese development partner Shanghai Henlius Biotech, Inc. (2696.HK). The IND approval allows Henlius to join the ongoing global registrational ELAINE-3 trial with responsibility in China. ELAINE-3 (NCT05696626), the third Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) trial, is assessing the efficacy of oral lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio®) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. This month, Henlius expanded its license from Sermonix to add additional Asia territories for upfront, milestone and royalty payments. The agreement also allows Henlius to share with Sermonix expedited co-development of oral lasofoxifene in Japan. Sermonix has completed a Phase 1 Japanese PK study and, together with Henlius, will begin engagement with the Pharmaceuticals and Medical Devices Agency (PMDA) to address a regulatory path to study lasofoxifene in Japan, which is an important region for expanded global access to lasofoxifene investigation. “With active ELAINE-3 enrollment already underway in the U.S., Canada, EU and Israel, we are pleased to announce that Henlius, our Chinese development partner for oral lasofoxifene, received approval for its investigational new drug application,” said Dr. David Portman, Sermonix founder and chief executive officer. “This milestone clears Henlius to enroll patients in ELAINE-3 in China, therefore further diversifying our patient population and potentially helping more people to better confront this terrible disease.” “The collaboration between Henlius and Sermonix started in January 2024,” said Ms. Ping Cao, Henlius chief business development officer and SVP of business development. “In mere months from agreement to amendment, our unified dedication shines, turning swift collaboration and full-hearted implementation into tangible success – as underscored by our product's IND approval in China." Oral lasofoxifene is an investigational novel targeted endocrine therapy in clinical development that has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. In two completed Phase 2 clinical studies (ELAINE-1 and ELAINE-2), lasofoxifene demonstrated anti-tumor activity against tumors with ESR1 mutations as a monotherapy and in combination with abemaciclib, a CDK4/6 inhibitor. Lasofoxifene’s bioavailability and potent activity in mutations of the estrogen receptor, in addition to its potential to improve sexual and urogenital health with a well-tolerated profile, could hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, and, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer. Breast cancer is the second most diagnosed cancer in the world, according to GLOBOCAN 2022. There were around 2.3 million new cases of breast cancer in 2022 globally, including more than 357,000 in China.1 ER+ breast cancer comprises 60-70% of all breast cancers.2 Endocrine therapy remains the mainstay treatment for ER+ breast cancer and the most widely used class of aromatase inhibitor (AI) has been recommended by the National Comprehensive Cancer Network (NCCN) and Chinese Society of Clinical Oncology (CSCO) guidelines to be the adjuvant and first-line standard of care for patients with ER+/HER2- breast cancer.3,4 However, almost all patients treated with AIs in the advanced setting develop resistance,5 with ESR1 mutations being one of the most prevalent alterations, present in up to 40% of patients and a significant mechanism of resistance to endocrine therapy.6 Currently, there are limited treatment options for ER+/HER2- breast cancer with ESR1 mutations, and thus a large clinical need exists. [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and MortalityWorldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. [2] Ignatiadis M, Sotiriou C. Luminal breast cancer: from biology to treatment[J]. Nat Rev Clin Oncol, 2013, 10(9): 494-506. doi: 10.1038/nrclinonc.2013.124. [3] Chinese Society of Clinical Oncology (CSCO) Breast Cancer Guidelines 2023 [4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2023 [5] Rozeboom B, Dey N, De P. ER+ metastatic breast cancer: past, present, and a prescription for an apoptosis-targeted future. Am J Cancer Res. 2019;9(12):2821-2831. Published 2019 Dec 1. [6] Spoerke JM, Gendreau S, Walter K, et al. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nat Commun. 2016;7:11579. Published 2016 May 13. doi:10.1038/ncomms11579 About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. 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. To learn more about Sermonix, visit SermonixPharma.com. To learn more about the ELAINE studies, visit DiscoverElaine.com. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 3 have been approved for marketing in overseas markets, 23 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832

Phase 2License out/inPhase 1Phase 3Drug Approval

30 May 2024

·www.biospace.com

Sermonix Pharmaceuticals to Present Poster on ELAINE-3 Trial in Progress at ASCO 2024

COLUMBUS, Ohio, May 30, 2024 (GLOBE NEWSWIRE) --Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), today announced it will present a poster updating the progress of its Phase 3 ELAINE-3 clinical trial at the annual meeting of the American Society of Clinical Oncology (ASCO). ASCO 2024 will be held May 31-June 4, 2024, at McCormick Place in Chicago. Poster Details: Title: Open-label, randomized, multicenter, phase 3, ELAINE-3 study of the efficacy and safety of lasofoxifene plus abemaciclib for treating ER+/HER2-, locally advanced or metastatic breast cancer with an ESR1 mutation. Abstract Number: TPS1127 Poster Board Number: 101b Session Date/Time: June 2, 2024, 9 a.m.-noon CDT A global registrational study, the third Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) trial is assessing the efficacy of oral lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio®) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. “Sermonix looks forward to updating our peers at ASCO 2024 about the progress of ELAINE-3, which is actively enrolling in the U.S., Canada, Europe and Israel,” said Dr. David Portman, Sermonix founder and chief executive officer. “In previous trials, lasofoxifene demonstrated compelling anti-tumor activity against tumors with increasingly prevalent ESR1 mutations and potential benefit on quality of life with respect to vaginal and sexual health. We are excited to gain a greater understand of lasofoxifene’s potential as ELAINE-3 progresses, and hopefully bring it one important step closer to patients.” About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. 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. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832

Phase 3ASCO

19 Apr 2024

·www.biospace.com

Sermonix to Host KOL Fireside Chat on Advancements in the Metastatic Breast Cancer Treatment Landscape on April 22, 2024

COLUMBUS, Ohio, April 19, 2024 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC) harboring ESR1 mutations, today announced it will host a virtual KOL fireside chat on Monday, April 22, 2024 from noon to 1 p.m. ET, featuring Senthil Damodaran, M.D., Ph.D. (MD Anderson Cancer Center) and Seth Wander, M.D., Ph.D. (Harvard Medical School, Massachusetts General Hospital) to discuss the unmet need and current treatment landscape for metastatic breast cancer. To register, click here. The event will focus on the company's ELAINE (Evaluating Lasofoxifene in ESR1 Mutations) studies investigating lasofoxifene in patients with locally advanced or metastatic estrogen receptor-positive/human epidermal growth factor 2-negative (ER+/HER2-) breast cancer expressing an estrogen receptor 1 (ESR1) mutation. With Phase 2 ELAINE-1 and ELAINE-2 studies both completed and having demonstrated compelling anti-tumor activity against tumors with increasingly prevalent ESR1 mutations, enrollment is currently open for ELAINE-3, a large, randomized, Phase 3 study with clinical trial sites across the United States, Europe, Asia-Pacific, Israel, and Canada. A live question and answer session will follow the formal presentations. About Senthil Damodaran, M.D., Ph.D. Senthil Damodaran, M.D., Ph.D. is an associate professor in breast medical oncology with a joint appointment in Investigational Cancer Therapeutics at the MD Anderson Cancer Center. His research focuses on 1) biomarker-driven clinical trials, 2) application of omics for target discovery in breast cancers, and 3) characterization of secondary drug resistance mechanisms. At MD Anderson, he leads the department’s biomarker-directed clinical and translational efforts and serves as the lead for multiple biomarker-enriched clinical studies including CTEP and ETCTN trials. Dr. Damodaran also serves on the American Society of Clinical Oncology and American Board of Internal Medicine expert panels. About Seth Wander, M.D., Ph.D. Seth Wander, M.D., Ph.D. is a medical oncologist at the Massachusetts General Hospital with a clinical and translational research interest in breast cancer and cancer genomics. Dr. Wander completed his undergraduate degree at Cornell University, where he studied Molecular and Cell Biology and graduated magna cum laude with distinction in research. He pursued his M.D. and Ph.D. in Cancer Biology at the University of Miami. Dr. Wander completed his internship and residency in internal medicine at the Massachusetts General Hospital and his fellowship training in medical oncology at the Dana-Farber Cancer Institute and the Massachusetts General Hospital Cancer Center. Dr. Wander is active in both the clinic and laboratory, where his research interests involve genomic mechanisms of resistance to targeted therapies in metastatic breast cancer. Dr. Wander has published more than forty peer-reviewed manuscripts focused on the emerging field of precision medicine and related topics in oncology. His research is focused on leveraging genetic and molecular sequencing results to understand how cancers become resistant to standard therapies in order to develop novel, personalized treatment strategies. He is an assistant professor of medicine at Harvard Medical School and remains engaged in teaching medical students, residents, and fellows. He was a recipient of the 2017 Dana-Farber Cancer Institute Wong Family Translational Research Award and a 2018 recipient of the Conquer Cancer Foundation/American Society of Clinical Oncology Young Investigator Award. Dr. Wander, as part of a multidisciplinary team, leads a variety of clinical trials focused on developing novel clinical strategies for patients with metastatic breast cancer and resistance to standard hormonal and targeted agents. He has presented educational sessions and original research both nationally and internationally related to drug resistance and the development of personalized treatment strategies for 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. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. 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. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832

Phase 2Phase 3Executive ChangeASCO

100 Deals associated with Lasofoxifene Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lasofoxifene Tartrate	G03	DB06202

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	EU	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	IS	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	LI	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	NO	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Atrophic Vaginitis	NDA/BLA	US	Sermonix Pharmaceuticals LLCStartup	-
ER-positive/HER2-negative Breast Cancer	Phase 3	US	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	AU	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	BE	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	CA	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	CZ	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	FR	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	DE	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	HU	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	IL	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04432454 (ELAINE 2, ASCO2023) Manual	Phase 2	ER-positive/HER2-negative/ ESR1-mutated breast cancer ESR1 \| ER Positive \| HER2 Negative	29	Lasofoxifene 5 mg/day + Abemaciclib 150 mg	fauxuudhju(otfndpjesv) = LAS/Abema was well tolerated with primarily grade 1/2 treatment-emergent adverse events (most commonly diarrhea, nausea, fatigue, and vomiting) isiuftihze (pggzvvgyof )	Positive	31 May 2023
NCT03781063 (ELAINE 1, ESMO2022) Manual	Phase 2	ER-positive/HER2-negative Breast Cancer Second line ER+/HER2-/ESR1-mutated	103	lasofoxifene	pygkzyvddq(xjoxehmsoh) = zxtqzbelom riqphufslz (wnfnrcljrb, 2.82 - 8.04) View more	Superior	10 Sep 2022
				fulvestrant	pygkzyvddq(xjoxehmsoh) = nuguywcsmt riqphufslz (wnfnrcljrb, 2.93 - 6.04) View more
NCT04432454 (ELAINE 2, ASCO2022)	Phase 2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	29	Lasofoxifene 5 mg/day + Abemaciclib 150 mg BID	khcgvxxezw(vzdlgxowvk) = bdzaixslfk dsflehlbht (mtcvsftysf, 44.0–77.3) View more	-	02 Jun 2022
NCT00141323 (PEARL, Pubmed \| Circulation)	Phase 3	Osteoporosis, Postmenopausal	8,556	Lasofoxifene 0.5 mg/d	mdcxjrpciv(dqayqijqon): hazard ratio = 0.56 (95% CI, 0.32 - 0.98) View more	-	26 Oct 2010
				Placebo
NCT00141323 (Pubmed \| Br Dent J)	Phase 3	Osteoporosis, Postmenopausal	8,556	Lasofoxifene 0.25 mg	ebhlaboohe(gmjwjivysc) = znchhtgldo hzrduagxci (jvtrdmbecv ) View more	-	25 Feb 2010
				Lasofoxifene 0.5 mg	ebhlaboohe(gmjwjivysc) = ygqgjcvuzw hzrduagxci (jvtrdmbecv ) View more

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Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis