An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
Regeneron Expands Clinical-Stage Obesity Portfolio with Strategic In-Licensing of Novel Dual GLP-1/GIP Receptor Agonist
On June 2, Regeneron Pharmaceuticals, Inc., announced a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited (“Hansoh”) to acquire exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong, and Macau for a dual GLP-1/GIP receptor agonist currently in Phase 3 testing.
This novel therapeutic candidate (HS-20094) – studied in over 1,000 patients and administered as a weekly subcutaneous injection – has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist. A Phase 3 trial in obesity in China and Phase 2b study in diabetes are ongoing.
Under the terms of the agreement, Regeneron will make an upfront payment to Hansoh of $80 million, with potential additional payments of up to $1.93 billion for achievement of development, regulatory and sales milestones. Future potential royalties for global net sales outside of the designated territories would be in the low double digits.
“Regeneron is committed to advancing better obesity treatments by enhancing quality of weight loss,” says George Yancopoulos, MD, PhD, co-chair, president and chief scientific officer of Regeneron. “Despite the transformative impact of recent weight loss therapies, significant unmet needs remain, including the ability to sustain weight loss and maintain muscle mass over time. Securing access to a GLP-1/GIP receptor agonist will increase the versatility of our clinical programs for obesity and accelerate our mission to support quality, sustained weight loss and the associated long-term health benefits.”
“In-licensing a late-stage GLP1/GIP agonist will allow us to study combinations with Regeneron’s proprietary drugs and drug candidates in order to holistically address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes and liver conditions,” says Boaz Hirshberg, MD, senior vice president, Clinical Development, Internal Medicine at Regeneron. “This is an exciting development in our obesity work at Regeneron, which also includes the muscle-sparing Phase 2 COURAGE study investigating the addition of trevogrumab, our GDF8 antibody to semaglutide, with and without garetosmab, our anti-activin antibody. Interim data from this study was announced earlier.”
This agreement is subject to customary closing conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States.
Sandoz Launches First and Only Interchangeable Denosumab Biosimilars in U.S.
On June 2, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to patients in the U.S. starting immediately.
WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines XGEVA®* (denosumab) and Prolia®* (denosumab), respectively.
This launch builds on Sandoz’s established leadership in biosimilars and oncology, dating back to the introduction of the first biosimilar in the U.S. in 2015. WYOST® and Jubbonti® are key biosimilar value drivers that are integral to the Sandoz growth strategy, representing a significant step forward in advancing the company’s ambition to be the biosimilar leader in the U.S.
Keren Haruvi, president, Sandoz North America, said: “Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for U.S. patients.”
WYOST® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines. WYOST® and Jubbonti® are approved as interchangeable with the reference medicines for all indications. WYOST® and Jubbonti® will be launching with an established Q code.
Sandoz is providing comprehensive support resources for patients who are prescribed WYOST® and Jubbonti®, including reimbursement and financial support.
Claire Gill, chief executive officer, Bone Health and Osteoporosis Foundation, said: “Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve.”
Avenzo Therapeutics Initiates Phase 1/2 Clinical Study of AVZO-023, a Potential Best-in-Class, Novel CDK4 Selective Inhibitor
Avenzo Therapeutics, Inc. on June 6 announced initiation of a Phase 1/2 clinical study of its potential best-in-class cyclin-dependent kinase 4 (CDK4) selective inhibitor, AVZO-023, in patients with advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and select other advanced solid tumors.
“CDK4 is a key driver in HR+/HER2- breast cancer, and selective inhibition has emerged as a promising strategy to improve efficacy and minimize toxicity,” says Antonio Giordano, MD, PhD, clinical director, Center for Cancer Therapeutic Innovation, Dana-Farber Cancer Institute. “Preclinically, AVZO-023 demonstrates best-in-class selectivity and potency, potentially enabling rational combinations with not only endocrine therapy but also CDK2 inhibitors to address emerging resistance.”
The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-023 as a single agent and in combination with endocrine therapy and with AVZO-021, Avenzo’s potential best-in-class CDK2 inhibitor. AVZO-021 is currently being studied in HR+/HER2- metastatic breast cancer and other advanced solid tumors.
“We are excited to have initiated our third clinical trial – and our second study in a week – ahead of our anticipated timeline,” says Mohammad Hirmand, MD, co-founder and chief medical officer of Avenzo Therapeutics. “We look forward to investigating the potential of AVZO-023, including in combination with AVZO-021, as we believe AVZO-023 and AVZO-021 both have the potential to make a difference in the lives of patients with HR+/HER2- breast cancer.”
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