• 10 Jun 2024
• Admin
• News Article

Sermonix Pharma Receives Chinese Approval of IND Application for Isofoxifene

Overview

Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), 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).

IND Approval

• 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.

Henlius Expansion

• 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.

Words from CEO: Sermonix

• “With active ELAINE-3 enrollment already underway in the US, 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.”

Words from CEO: Henlius

• “The collaboration between Henlius and Sermonix started in January 2024,” said 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

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.

ELAINE-1 and ELAINE-2

• 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

• 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. 
• ER+ breast cancer comprises 60-70% of all breast cancers. 
• Endocrine therapy remains the mainstay treatment for ER+ breast cancer and the most widely used class of aromatase inhibitor 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. 
• However, almost all patients treated with AIs in the advanced setting develop resistance, 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. 
• Currently, there are limited treatment options for ER+/HER2- breast cancer with ESR1 mutations, and thus a large clinical need exists.