Tides Weekly | Global Peptide and Oligonucleotide Therapeutics News Roundup
Sirius Therapeutics
Oligonucleotide Drug Developer
QL Biopharm
Recombinant Protein Drug Developer
On July 10, 2024, Novo Nordisk announced that it had received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for once-weekly basal insulin icodec (insulin icodec) for the treatment of diabetes.
About Icodec
The molecular design of Icodec removes insulin's B30 while introducing four amino acid mutations: A14E, B16H, B25H, and B29K. A C20 fatty acid chain is attached at B29K. Compared to insulin detemir and insulin degludec (which are conjugated with C14 and C16, respectively), Icodec exhibits a stronger ability to bind to albumin, thereby achieving...The purpose of a longer half-life. The A14E, B16H, and B25H mutations aim to reduce enzymatic degradation while decreasing affinity for the insulin receptor (IR), reducing IR-mediated clearance, and further prolonging the half-life.
About Novo Nordisk
Novo Nordisk was founded in 1923 and is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes, obesity, rare blood diseases, endocrine disorders, and other serious chronic conditions.
July 11, 2024Sirius Therapeutics (SHANGHAI) Co., Ltd. ("Sirius Therapeutics") announced that the Phase I clinical trial of its self-developed small nucleic acid drug (SRSD107 injection) has recently completed dosing for all subjects. This Phase I clinical study was conducted simultaneously in Australia and mainland China, with preliminary research data showing that SRSD107 has good safety and tolerability, as well as expected pharmacokinetic characteristics.
About SRSD107 Injection
SRSD107 Injection is a double-stranded small interfering RNA (siRNA) drug independently developed by Sirius Therapeutics. By specifically targeting the liver-directed coagulation factor XI (FXI) mRNA, it inhibits the protein expression of FXI and blocks the activation of the intrinsic coagulation pathway.Active, thereby achieving anticoagulant/antithrombotic effects.
About Sirius Therapeutics
Sirius Therapeutics is an innovative biotechnology company dedicated to advancing human health and well-being. Focused on the development of next-generation nucleic acid therapies for cardiovascular diseases, the company aims to become a leader in transforming the prevention and treatment of chronic conditions. Its current pipeline includes SRSD107, which is in clinical development for thromboembolic disorders, and SRDS101, aimed at treating dyslipidemia.
On July 12, 2024, the Drug Clinical Trial Registration and Information Disclosure Platform showed that QL Biopharm initiated a Phase II clinical study (Registration No.: CTR20242527) for its novel ultra-long-acting glucagon-like peptide-1 receptor (GLP-1R) agonist ZT002 injection in patients who are overweight or obese.
This randomized, double-blind, placebo-controlled Phase II study plans to recruit 300 patients in China, aiming to evaluate the efficacy, safety, and pharmacokinetic characteristics of ZT002 injection in overweight or obese subjects. The primary endpoint is overweight/obese subjects.The percentage change in body weight from baseline after 24 weeks of treatment. Secondary endpoints include the proportion of subjects with ≥5%, ≥10%, and ≥15% weight reduction from baseline after 24 weeks of treatment; absolute change in body weight from baseline, etc.
About QL Biopharm
QL Biopharm is a clinical-stage biotechnology company focused on developing innovative biologics for the treatment of metabolic diseases. Patient-centered and driven by original research, QL Biopharm’s proprietary technology platform covers all aspects of recombinant protein production.
On July 15, 2024, AusperBio (Hangzhou Haobo Pharmaceuticals Co., Ltd. and AusperBio Therapeutics, Inc.) announced the completion of a $37 million Series A financing round. The round was led by InnoPinnacle Fund with additional investments from Vivo Capital, Hanking Capital, Qiming Venture Partners, and YuanSheng Capital. The proceeds will primarily be used to rapidly advance the Phase II clinical trial of AusperBio's potential cornerstone hepatitis B cure, AHB-137, as well as combination therapy exploration and CMC production among other development activities. Additionally, the funds will support the expansion of the proprietary Med-Oligo™ technology platform and its product pipeline.
Dr. Guofeng Cheng, co-founder and CEO of Haobo Medicine, stated: "We are extremely honored to have completed this significant financing amidst the current market environment. This round of financing not only signifies recognition of our R&D achievements but also provides crucial momentum for the next chapter of Haobo Medicine. The successful completion of this financing, along with the recent approval of AHB-137 by the CDE...""Inclusion in the breakthrough therapy category enables us to further accelerate the clinical development of AHB-137."
About Haobo Pharmaceuticals
AusperBio, a clinical-stage innovative drug R&D company operating simultaneously in China and the United States, is committed to developing First-in-class and Best-in-class self-innovative targeted delivery small nucleic acid drugs. AusperBio owns the proprietary intellectual property Med-Oligo™ ASO patent technology platform, focusing on functional cures for chronic hepatitis B (HBV) and highly efficient targeted treatments for liver diseases, while expanding into targeted small nucleic acid therapies for new targets beyond the liver.
On July 15, 2024, Roche announced the Phase Ib clinical data of its investigational GLP-1/GIP small molecule agonist CT-388. The results showed that the higher dose had not yet reached the peak weight loss at six months. An abstract to be presented in September at the annual meeting of the European Association for the Study of Diabetes in Madrid revealed that CT-388's weight loss effect at 24 weeks had not plateaued, suggesting the potential for achieving better weight loss outcomes than the previously reported average weight loss rate of 18.8%.
About CT-388
CT-388 is a once-weekly subcutaneous injectable GLP-1/GIP receptor dual agonist preparing to enter Phase 2 trials, currently under development for the treatment of obesity and type 2 diabetes. CT-388 is designed to exhibit potent activity on both GLP-1 and GIP receptors while minimizing β-arrestin recruitment to either receptor. This biased signaling is expected to significantly reduce receptor internalization and subsequent desensitization, potentially prolonging the pharmacological activity of the drug. The therapy is anticipated to be used as monotherapy or in combination with other treatments to enhance weight loss effects and may expand to other indications.
About Roche
Founded in 1896 and headquartered in Basel, Switzerland, Roche has over 125 years of history. It is a global leader in biotechnology and in vitro diagnostics, as well as one of the leading companies in the industrial production of original research drugs. Roche's rapid international expansion is attributed to the entrepreneurial spirit of its founder, Fritz Hoffmann.
July 17, 2024Fulink Technology Co., Ltd. (hereinafter referred to as "Fulink Technology"), a fully integrated international radiopharmaceuticals company, announced that it has signed an out-licensing agreement with global biotechnology company SK Biopharmaceuticals. Under the agreement, Fulink Technology grants SK Biopharmaceuticals the rights to conduct clinical trials of the radiopharmaceutical FL-091 globally.Exclusive rights for bed research, development, production, and commercialization targeting Neurotensin Receptor 1 (NTSR1)-positive cancers.
The total amount of this transaction is $571.5 million, including upfront payment, R&D and commercial milestone payments, with royalties not included. According to the terms of the agreement, SK Biopharmaceuticals will license in a radiopharmaceutical targeting NTSR1.The RDC project FL-091 and its alternative compounds will be developed into an innovative anti-tumor drug.
About FL-091
FL-091 is an innovative small-molecule radioligand carrier targeting NTSR1-positive solid tumors. The overexpression of NTSR1 is associated with disease progression in various cancers, including colorectal cancer, breast cancer, pancreatic cancer, and head and neck cancer. FL-091 radioligand has demonstrated favorable biodistribution characteristics, significantly enhanced NTSR1 binding affinity, and excellent anti-tumor activity. Currently, targeting NTSR1-positive cancerThe α-therapy candidate drug 225Ac-FL-091 is currently in the development stage.
About FL Technology
Full Link Pharmaceuticals Co., Ltd. ("Full Link Pharmaceuticals") is a fully integrated international radiopharmaceutical therapy company with offices in Belgium, Germany, and China. Centered on patients worldwide, Full Link Pharmaceuticals is committed to building a full industrial chain nuclear medicine company that integrates the research and development, production, and commercialization of radiopharmaceuticals. By leading innovative research, the company addresses fundamental challenges faced by current radiopharmaceuticals and advances the development of future therapies.
July 17, 2024Roche announced positive results from two treatment groups in the Phase I clinical trial of CT-996. The data showed that obese subjects without type 2 diabetes who received CT-996 treatment experienced an average placebo-adjusted weight loss of -6.1% (p <0.001) after 4 weeks.
