Innovent and SanegeneBio Announce First Participant Dosed in a Phase 1 Clinical Trial of IBI3016 (AGT siRNA)

SAN FRANSCISO and SUZHOU, China, Aug. 2, 2024 /PRNewswire/ — Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) today announced the first participant has been successfully dosed in a Phase 1 First-in-Human (FIH) clinical trial of IBI3016.

IBI3016 (SanegeneBio’s R&D code: SGB-3908) is an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that IBI3016 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. IBI3016 is developed using SanegeneBio’s next-generation proprietary siRNA technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, Innovent and Sanegene Bio entered into a strategic collaboration to co-develop IBI3016. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of IBI3016.

This FIH study (NCT06501586) is a Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) of IBI3016 in healthy volunteers and patients with mild hypertension, aiming to support the further clinical development of IBI3016.

Dr. Lei Qian, Vice President of Clinical Development at Innovent Biologics, stated: "siRNA therapies, due to their long-acting effects and stable efficacy, hold tremendous potential in the management of chronic diseases, particularly in the cardiovascular and metabolic (CVM) therapeutic areas, where long-term disease control and management are critical. Leveraging SanegeneBio’s strengths in siRNA drug development and Innovent’s clinical development expertise in CVM diseases, we have efficiently advanced IBI3016 into the clinic. We are committed to a rigorous, science-driven clinical development strategy and will work closely with SanegeneBio to advance the clinical development of IBI3016 with high quality and efficiency, and the hope to bring this innovative treatment to a wide range of hypertension patients as well as other potential disease areas."

Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated: "Hypertension represents a significant unmet clinical need globally. IBI3016, as a transformative RNAi therapy, has demonstrated superior drug activity, sustained efficacy, and favorable safety and tolerability profiles in preclinical studies. The rapid initiation and progress of the Phase 1 study of IBI3016 would not have been possible without the strong support from the research center at Peking University Third Hospital, as well as the collaborative efforts of the clinical teams at Innovent and Sanegene. We look forward to continued close collaboration with Innovent as we diligently execute the clinical development plan for IBI3016 and achieve positive outcomes. Our ultimate goal is to fully realize the therapeutic potential of IBI3016, offering a more effective, safer, and patient-friendly treatment option for individuals with hypertension."

About Hypertension

Hypertension is a common chronic disease that currently affects over 1 billion people worldwide. It not only increases the risk of cardiovascular and cerebrovascular diseases while also potentially leading to complications such as kidney damage and impaired vision. With the aging population and the prevalence of risk factors such as obesity, lack of physical exercise, and unhealthy diet, the prevalence of hypertension is increasing globally. Effective anti-hypertension treatments exist, but they have some drawbacks. For example, patients must take anti-hypertension drugs daily, and because hypertension often has mild or no noticeable symptoms, it can lead to poor medication adherence. Poor compliance has become a major challenge in the treatment of hypertension, with less than 20% of hypertension patients achieving long-term effective control[i]. To address this challenge in hypertension treatment, siRNA drugs offer an alternative solution by directly reducing AGT expression. These drugs provide long-lasting effects, good safety, and high compliance, making them a promising option for better treatment and long-term benefits for patients.

About IBI3016 (AGT siRNA)

IBI3016 (SanegeneBio’s R&D code: SGB-3908) is an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that IBI3016 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. IBI3016 is developed using SanegeneBio’s next-generation proprietary siRNA technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, Innovent and SanegeneBio entered into a strategic collaboration to co-develop IBI3016. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of IBI3016.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, ‘Start with Integrity, Succeed through Action,’ Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer: Innovent does not recommend any off-label usage.

About SanegeneBio

SanegeneBio is an emerging RNAi-based company developing innovative RNA interference (RNAi) therapeutics driven by the cutting-edge delivery technology. Founded in 2021, SanegeneBio was led by a team of industry-leading experts and has operations in both the US and China. Since its incorporation, SanegeneBio has successfully established proprietary chemical modification platform, hepatic and extrahepatic delivery platforms, enabling tissue-specific delivery of a wide range of RNA therapeutics to efficiently knock down disease-causing genes. Our fast-growing RNAi portfolio covers a broad range of therapeutic areas including cardiovascular and metabolic diseases, immunology-related diseases, and nervous system diseases. Among them, our first RNAi drug has entered into the clinical stage, and several pipelines are in progress simultaneously. SanegeneBio is committed to developing transformational RNAi medicines through striving for scientific innovation to address unmet medical needs worldwide and change the lives of patients and families.

Innovent’s Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent’s competitive environment and political, economic, legal and social conditions.

Reference

[i] Global report on hypertension: the race against a silent killer, WHO 2023, https://www.who.int/publications/i/item/9789240081062

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