Lasofoxifene

Henlius and Sermonix Announce Strategic Collaboration and Exclusive License Agreements for Novel Endocrine Therapy Lasofoxifene

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Thursday, January 11, 2024
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Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights.

Key Points: 
  • Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights.
  • Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China.
  • “In Phase 2 clinical trials, investigational lasofoxifene demonstrated its potential for the treatment of ER+/HER2- breast cancer harboring ESR1 mutation,” said Ping Cao, senior vice president and chief business development officer of Henlius.
  • “Lasofoxifene will play a critical role in complementing Henlius' pipeline of its breast cancer product.

Sermonix Pharmaceuticals Shares Encore ELAINE-2 Poster Presentation at 2023 Metastatic Breast Cancer Research Conference

Retrieved on: 
Tuesday, September 5, 2023
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COLUMBUS, Ohio, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, today announced it shared an encore poster presentation at the 10th annual Metastatic Breast Cancer Research Conference (MBCRC) highlighting the results of its Phase 2 ELAINE-2 clinical study.

Key Points: 
  • COLUMBUS, Ohio, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, today announced it shared an encore poster presentation at the 10th annual Metastatic Breast Cancer Research Conference (MBCRC) highlighting the results of its Phase 2 ELAINE-2 clinical study.
  • The poster, “ Lasofoxifene plus abemaciclib for treating ER+/HER2-, ESR1-mutated, metastatic breast cancer after progression on prior therapies: ELAINE-2 update ,” was presented Wednesday, Aug. 30.
  • Results were initially shared at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and updated in June at ASCO 2023.
  • With patient follow-up through Jan. 31, 2023, the combination of lasofoxifene and abemaciclib continued to be well-tolerated, with clinically meaningful efficacy in women with ER+/HER2- metastatic breast cancer and an ESR1 mutation.

Sermonix Pharmaceuticals to Present Two Posters at The Menopause Society 2023 Annual Meeting

Retrieved on: 
Thursday, June 29, 2023
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We look forward to engaging with our peers at The Menopause Society 2023 Annual Meeting and sharing our most recent findings.”

Key Points: 
  • We look forward to engaging with our peers at The Menopause Society 2023 Annual Meeting and sharing our most recent findings.”
    Sermonix will share its two posters Thursday, Sept. 28, from 6:15-7:15 p.m.
  • “The theme of this year’s meeting is ‘Midlife Women’s Health in the Era of Precision Medicine,’” said Dr. Lisa Larkin, president-elect of The Menopause Society board of trustees.
  • We look forward to Sermonix’s participation in The Menopause Society Annual Meeting and as a member of our 2023 Corporate Liaison Council.”
    Sermonix in March initiated ELAINE-3, a registrational Phase 3 study of 400 patients assessing the efficacy of lasofoxifene and abemaciclib.
  • To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit https://sermonixpharma.com .

Sermonix Pharmaceuticals Shares ASCO Poster Presentation on Longer Patient Follow-up Results for ELAINE-2 Study in ESR1-mutated Metastatic Breast Cancer

Retrieved on: 
Monday, June 5, 2023
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CHICAGO, June 05, 2023 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, today broadly shared a poster presentation detailing the results of its ELAINE-2 clinical study with longer patient follow-up.

Key Points: 
  • CHICAGO, June 05, 2023 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, today broadly shared a poster presentation detailing the results of its ELAINE-2 clinical study with longer patient follow-up.
  • The poster was initially presented yesterday at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • “No new safety signals were noted when looking at lasofoxifene and abemaciclib with longer patient follow-up,” said Paul Plourde, M.D., vice president of oncology clinical development at Sermonix.
  • Sermonix in March initiated ELAINE-3, a registrational Phase 3 study of 400 patients assessing the efficacy of lasofoxifene and abemaciclib.

Sermonix Pharmaceuticals to Share Longer Patient Follow-up Results for ELAINE-2 in Poster Presentation at ASCO 2023

Retrieved on: 
Thursday, May 25, 2023
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ASCO 2023 will be held June 2-6 at McCormick Place in Chicago.

Key Points: 
  • ASCO 2023 will be held June 2-6 at McCormick Place in Chicago.
  • The previously reported PFS, a median of 13 months, and ORR of 50% were promising, with longer term follow-up to be provided at ASCO 2023.
  • Encouraging Phase 2 monotherapy and combination results in ELAINE-1 and ELAINE-2 respectively led Sermonix in March to initiate ELAINE-3, a confirmatory Phase 3 randomized study.
  • Sermonix will also convene meetings of its ELAINE-3 Steering Committee and ELAINE-3 Translational Committee while at ASCO.

Sermonix’s Lasofoxifene Improves Vaginal/Vulvar Symptoms Relative to Fulvestrant in ELAINE 1 Study of Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation

Retrieved on: 
Monday, March 6, 2023
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Top-line data for ELAINE 1, which began enrollment in September 2019, were shared in September at the European Society for Medical Oncology (ESMO) Congress 2022.

Key Points: 
  • Top-line data for ELAINE 1, which began enrollment in September 2019, were shared in September at the European Society for Medical Oncology (ESMO) Congress 2022.
  • This secondary analysis aimed to investigate changes in vaginal/vulvar symptoms with lasofoxifene versus fulvestrant, as lasofoxifene improved symptoms of vulvovaginal atrophy (VVA) in two previous Phase 3 studies among postmenopausal women with moderate to severe VVA.
  • Vaginal/vulvar symptoms were evaluated in an exploratory analysis using the vaginal (VAS) and vulvar (VuAS) assessment scales, instruments validated in breast cancer patients to assess dryness, soreness, irritation, and pain.
  • “We look forward to further investigating lasofoxifene’s efficacy, as a treatment for metastatic breast cancer with fewer negative side effects that greatly impact patients’ quality of life.”

Sermonix Pharmaceuticals and Quantum Leap Healthcare Announce New Study Arm to Evaluate Lasofoxifene in Ongoing I-SPY 2 Clinical Trial

Retrieved on: 
Monday, February 13, 2023
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COLUMBUS, Ohio, and SAN FRANCISCO, Feb. 13, 2023 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc. and Quantum Leap Healthcare Collaborative™ today announced that Sermonix’s investigational next-generation targeted endocrine therapy, lasofoxifene, will be evaluated in a new study arm of the ongoing I-SPY endocrine program sponsored by Quantum Leap.

Key Points: 
  • COLUMBUS, Ohio, and SAN FRANCISCO, Feb. 13, 2023 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc. and Quantum Leap Healthcare Collaborative™ today announced that Sermonix’s investigational next-generation targeted endocrine therapy, lasofoxifene, will be evaluated in a new study arm of the ongoing I-SPY endocrine program sponsored by Quantum Leap.
  • “To date, we have successfully identified activity from lasofoxifene, and will soon be initiating a Phase 3 registrational trial.
  • Lasofoxifene will be evaluated along with other investigational agents in separate study arms as part of the platform trial.
  • Sermonix will supply lasofoxifene and provide financial support to Quantum Leap for this study.

Sermonix Pharmaceuticals Announces Poster Presentation on Phase 1 Ethnobridging Study of Lasofoxifene at the 12th AACR-JCA Joint Conference: Breakthroughs in Cancer Research — Translating Knowledge Into Practice

Retrieved on: 
Thursday, December 8, 2022
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The American Association for Cancer Research (AACR) and Japanese Cancer Association (JCA) are proud to offer this 12th AACR-JCA Joint Conference.

Key Points: 
  • The American Association for Cancer Research (AACR) and Japanese Cancer Association (JCA) are proud to offer this 12th AACR-JCA Joint Conference.
  • Formal and informal interactions as well as international collaborations are fostered through this unique forum.
  • Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.
  • 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.

Sermonix Pharmaceuticals Shares Additional Findings From Its ELAINE 1 Clinical Study at the 4th Annual Congress of the International Society of Liquid Biopsy

Retrieved on: 
Friday, October 21, 2022
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Investigators evaluated mutant allele fraction (MAF) ctDNA dynamics following treatment with lasofoxifene or fulvestrant.

Key Points: 
  • Investigators evaluated mutant allele fraction (MAF) ctDNA dynamics following treatment with lasofoxifene or fulvestrant.
  • PFS and CBR were 6.04 months and 37% for lasofoxifene versus 4.04 months and 22% for fulvestrant, respectively.
  • Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience in the oncology drug development arena.
  • Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lamberts Pharmaceutical Division.

Sermonix Pharmaceuticals Announces Results of Phase 2 Study of Lasofoxifene vs. Fulvestrant in Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation

Retrieved on: 
Tuesday, September 13, 2022
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(95% CI, 2.936.04) for fulvestrant, P=0.138 (HR, 0.699 [95% CI, 0.4451.125])

Key Points: 
  • (95% CI, 2.936.04) for fulvestrant, P=0.138 (HR, 0.699 [95% CI, 0.4451.125])
    Clinical benefit rate (CBR) was 36.5% for lasofoxifene vs. 21.6% for fulvestrant, P=0.12.
  • 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.
  • Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.
  • Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lamberts Pharmaceutical Division.