Sirnaomics Announces Completion of IND-Enabling Studies of Safety and Efficacy for STP125G with NHP Models, Targeting ApoC3 for Treatment of Cardiovascular Diseases

Jul 24, 2024 | Business

HONG KONG, GERMANTOWN, MD & SUZHOU BIOBAY, CHINA, July 23, 2024 – (ACN Newswire) – Sirnaomics Ltd. (HKG: 2257), ‘Sirnaomics’ or the “Company”, together with subsidiaries the “Group”, a leading biopharmaceutical company engaging in the discovery and development of advanced RNAi therapeutics, announced today that it has completed IND-enabling studies for STP125G, an siRNA therapeutics targeting Apolipoprotein C3 (ApoC3), based on its proprietary GalAhead(TM) mxRNA technology. The safety and efficacy results from the non-human primate (NHP) studies strongly support an IND filing with the U.S. FDA for initiating a Phase I clinical study of STP125G for cardiovascular disease indications.

ApoC3 is a widely known player in triglyceride metabolism, and it has been recently recognized as a polyhedric factor which may regulate several pathways beyond lipid metabolism by influencing cardiovascular, metabolic, and neurological disease risk. High levels of triglycerides (TG) are associated with inicreased risk of cardiovascular diseases. For severe hypertriglyceridemia (sHTG) patients whose TG level is more than 1000 mg/dL, the risk of developing acute pancreatitis is 5 to 10 times that in the general population. Down-regulation of ApoC3 using siRNA or antisense oligonucleotides is effective in lowering TG in sHTG patients.

During an efficacy evaluation of STP125G with non-human primate model (N = 4), we observed a dose-dependent silencing activity among 1 mg/kg, 3 mg/kg and 10 mg/kg doses with a strong safety profile. The maximum target silencing efficacy was achieved at 10 mg/ kg dosage around week 4 and was maintained for an additional 9 weeks (the total length of this 13-week study). The safety evaluation of STP125G using non-human primate model (N = 4) demonstrated an excellent safety readout with a single subcutaneous administration at 50 mg/kg, 100 mg/kg or 250 mg/kg. The maximum target silencing efficacies were like the level of 10 mg/kg for all three high dosages.

“STP125G is the second drug candidate based on our GalAheadTM mxRNA technology that has shown excellent safety and potent efficacy results with the NHP models. Its long-lasting silencing activity against ApoC3 may provide better therapeutic benefit to patients suffering cardiovascular conditions, than those of antisense and other siRNA drugs,” Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics, indicated. “Those data readouts further validated STP125G as a novel siRNA therapeutic candidate for treatment of hypertriglyceridemia and other cardiovascular diseases, using our proprietary GalAhead(TM)-based delivery technology”.

About ApoC3 and STP125G

ApoC3 is an important emerging target linking hypertriglyceridemia with cardiovascular disease (CVD). ApoC3 is a potent modulator of many established CVD risk factors, and is found on chylomicrons, VLDL, LDL, and HDL particles. Many studies show that in humans, apoC3 levels are an independent risk factor for CVD, and its presence on lipoproteins may promote their atherogenicity. Recent findings of the role of ApoC3 has been implicated in HDL metabolism and in the development of atherosclerosis, inflammation, and ER stress in endothelial cells. ApoC3 has been recently considered an important player in insulin resistance mechanisms, lipodystrophy, diabetic dyslipidemia, and postprandial hypertriglyceridemia (PPT). The emerging evidence of the involvement of ApoC3 in the pathogenesis of Alzheimer’s disease open the way to further study if modification of ApoC3 level slows disease progression. Furthermore, ApoC3 is clearly linked to cardiovascular disease (CVD) risk, and progression of coronary artery disease (CAD) as well as the calcification of aortic valve and recent clinical trials has pointed out the inhibition of ApoC3 as a promising approach to manage hypertriglyceridemia and prevent CVD. Several evidences highlight the role of ApoC3 not only in triglyceride metabolism but also in several cardio-metabolic pathways. STP125G is a single-stranded siRNA therapeutics targeting ApoC3 mRNA, based on Sirnaomics proprietary GalAheadTM mxRNA technology.

About Sirnaomics

Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAheadTM, Sirnaomics has established an enriched drug candidate pipeline. STP122G, the first drug candidate utilizing the Group’s GalAheadTM mxRNA technology, is currently in Phase I development. STP125G is the second siRNA therapeutics based on Sirnaomics proprietary GalAheadTM mxRNA technology, targeting ApoC3 mRNA for cardiovascular disease treatment. STP237G is the first dual-targeted drug based on a GalAheadTM muRNA technology and is in the late stage of preclinical evaluation. The Group has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the expansion of the Group’s clinical pipeline and establishment of the Group’s manufacturing facility, Sirnaomics focuses on a transition from a biotech company to a biopharma corporation. Learn more at: www.sirnaomics.com.

CONTACT:

Investor Relations:
USA:
George Ji, MBA
Head of Finance and Administration
Email: usa@sirnaomics.com

Asia:
Johnson Shen, M.A.
Senior Business Manager for Investor Relations
Email: johnsonshen@sirnaomicschina.com

Asia

Sirnaomics Ltd., the RNA Therapeutics Biopharmaceutical Company with Strong Presence in Both China and the U.S. Successfully Listed on Main Board of SEHK

Dec 30, 2021 | Business

Sirnaomics Ltd. (“Sirnaomics” or “Company”, together with its subsidiaries, the “Group”, stock code: 2257.HK), the RNA therapeutics biopharmaceutical company with strong presence in both China and the U.S., and the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutics, is officially listed and commenced trading on the Main Board of The Stock Exchange of Hong Kong Limited (“SEHK”) today.

Sirnaomics’s listing ceremony in Suzhou: Ms. Yun Monica Zhang, China Chief Operating Officer, Board Secretary and Joint Company Secretary (Left); Dr. Yang Lu, Founder, Chairman, Executive Director, President and Chief Executive Officer (Second left); Mr. George Ji, Chief Operation Officer (Second right); Dr. Edward Yongxiang Wang, Chief Production Officer (Right)

The total number of offer shares under the Global Offering amounts to 7,540,000 shares, with the final offer price determined at HK$65.90 per offer share. The net proceeds from the Global Offering to be received by the Company, after deduction of the underwriting fees and expenses paid and payable by the Company in connection with the Global Offering, are estimated to be approximately HK$395.7 million. The Hong Kong offer shares initially offered under the Hong Kong Public Offering have been slightly over-subscribed, where the total number of valid applications amounted to approximately 5.68 times of the total number of Hong Kong offer shares initially available for subscription under the Hong Kong Public Offering. The offer shares initially offered under the International Offering have also been slightly over-subscribed by approximately 1.22 times.

The product pipeline of Sirnaomics has over a dozen of candidates for a wide range of therapeutic indications across rare diseases and diseases with large patient populations covering oncology, fibrosis, medical aesthetics, antiviral, cardiometabolic diseases and other fields. Its product candidates currently span all stages from preclinical research and IND-enabling studies to Phase I and Phase II clinical trials, creating an enriched portfolio and an extended timeline of product candidates. The proprietary delivery platforms for administration of RNA-based therapeutics are the foundation Sirnaomics’ pipeline, and the related proprietary PNP and novel GalNAc delivery platforms confer advantages over conventional delivery platforms. The Company believes its highly innovative RNAi delivery platforms set Sirnaomics in a class by itself. The PNP delivery platform allows delivery of both siRNA and mRNA to diseased cells via local or systemic administration, providing distinct advantages in low toxicity, easy manufacturing and the capability to reach many targeted organs and cell types. The results of Phase IIa clinical trial in oncology validate both the effectiveness of its PNP delivery platform and the therapeutic targets for isSCC, positioning the Company for accelerated development of other pipeline products using the same PNP delivery platform. The Company’s core product candidate STP705, another clinical stage product candidate STP707, and at least eight other preclinical candidates all utilize the PNP delivery platform. RNAimmune, a controlled subsidiary of Sirnaomics, also applies PNP and a related proprietary delivery platform based on polypeptide-lipid nanoparticles (PLNP), to develop mRNA-based therapeutics and vaccines.

Dr. Patrick Y. Lu, Founder, Chairman of Board, President and CEO of Sirnaomics said, “Today marked a significant milestone in Sirnaomics’ history. Our successful debut in the Hong Kong stock market shows global investors’ profound recognition for our strategic model, growth potential, proprietary and novel drug delivery platforms, rich product pipeline and experienced management team. We are so proud and would like to express our sincere gratitude to investors for their trust and support to Sirnaomics. We are committed to becoming a fully-integrated international biopharmaceutical company. Leveraging its deep experience in RNA therapeutics and novel delivery platform technologies, the Company will continuously advance the development of innovative therapeutic modalities for the treatment of a broad range of diseases and strengthen our intellectual properties to maximize the clinical potential to rapidly discover, develop and commercialize more transformative therapeutics and vaccines for patients around the world.”

About Sirnaomics Ltd.
Sirnaomics Ltd. (“Sirnaomics” or “Company”, stock code: 2257.HK) is an RNA therapeutics biopharmaceutical company with product candidates in pre-clinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. The Company is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the U.S, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutics for its core product, STP705.






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Sirnaomics Ltd. Announces Proposed Listing on the Main Board of SEHK

Dec 20, 2021 | Business

Sirnaomics Ltd. (“Sirnaomics” or “Company”, stock code: 2257.HK), the RNA therapeutics biopharmaceutical company withs strong presence in both China and the U.S., today announces the proposed listing of its shares on the Main Board of The Stock Exchange of Hong Kong Limited (“SEHK”).

Sirnaomics plans to offer an aggregate of 7,540,000 Offer Shares under the Global Offering (subject to the Over-allotment Option), consisting of 6,786,000 International Offer Shares (subject to reallocation and the Over-allotment Option) and 754,000 Hong Kong Offer Shares (subject to reallocation), at a price range between HK$65.90 and HK$72.70 per share.

The Company will start its public offering in Hong Kong at 9 a.m. on December 20, 2021 (Monday) and end at 12 noon on December 23, 2021 (Thursday). Dealings in shares on SEHK are expected to commence on December 30, 2021 (Thursday), with the stock code of 2257.HK in board lots of 50 shares each.

China International Capital Corporation Hong Kong Securities Limited is the Sole Sponsor, Joint Global Coordinator and Joint Bookrunner. The Hongkong and Shanghai Banking Corporation Limited, Nomura International (Hong Kong) Limited, China Merchants Securities (HK) Co., Limited, and China PA Securities (Hong Kong) Company Limited are the Joint Global Coordinators and Joint Bookrunners.

The Global Offering introduced Kunming Jiashiqing and Innoforce Pharmaceuticals as the cornerstone investors.

Strong presence in both China and the U.S., with product candidates in a broad range of therapeutic areas

Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the U.S which is also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutics. The Company’s product pipeline has over a dozen product candidates for a range of therapeutic indications across rare and large market diseases covering oncology, fibrosis, medical aesthetics, antiviral, cardiometabolic disease and other fields. Its product candidates currently span all stages between preclinical research and IND-enabling studies to Phase I and Phase II clinical trials, creating an enriched portfolio and an extended timeline of product candidates. The Company utilizes the complementary regulatory systems in China and the U.S. to accelerate development and attain regulatory approvals, including by pursuing candidates and indications where orphan drug designation can be achieved in the U.S., which can shorten the review period from 1-2 years to 6-12 months.

Significant advantages in proprietary and novel drug delivery technology platform to improve the continuous development of RNA therapeutics and mRNA vaccines

The proprietary delivery platforms for administration of RNA-based therapeutics are the foundation of the product pipeline of Sirnaomics, and the related proprietary PNP and novel GalNAc delivery platforms confer advantages over conventional delivery platforms. The Company believes its highly innovative RNAi delivery platforms set Sirnaomics in a class by itself. The PNP delivery platform allows delivery of both siRNA and mRNA to diseased cells via local or systemic administration, providing distinct advantages in low toxicity, easy manufacturing and the capability to reach many targeted organs and certain cell types. The results of Phase IIa clinical trial in oncology validates both the effectiveness of its PNP delivery platform and the therapeutic targets for isSCC, positioning the Company for accelerated development of other pipeline products using the same PNP delivery platform. The Company’s core product candidate STP705, as well as other clinical stage product candidate STP707, and at least eight other preclinical product candidates utilize the PNP delivery platform. RNAimmune, a controlled subsidiary of Sirnaomics, also applies PNP delivery platform, and a related proprietary delivery platform based on polypeptide-lipid nanoparticles (PLNP), to formulate mRNA-based therapeutics and vaccines.

Besides, the proprietary GalNAc RNAi delivery platforms, GalAhead(TM) and PDoV-GalNAc of Sirnaomics, enable specific delivery to liver hepatocytes with enhanced endosome escape properties and dual siRNA target design, resulting in high potency. The GalNAc-conjugate delivery platforms rely on peptide conjugates and/or unique RNA structures that allow knockdown of single or multiple distinct mRNA targets. The GalAhead(TM) delivery platform conjugates GalNAc moieties to unique RNAi trigger structures that can target one or more genes simultaneously. In PDoV-GalNAc RNAi platform, GalNAc is conjugated to a peptide linker and up to two siRNAs are also conjugated to the same peptide. The Company has three pipeline products utilizing its GalAhead(TM) delivery platform quickly approaching IND-enabling studies.

The Company is currently developing several delivery platforms, including different approaches of siRNA/chemo-drug conjugates, peptide ligand tumor targeting and respiratory virus treatment via airway delivery. The Company is committed to investing in research and development in its advanced delivery platforms to enable the expansion and refinement of the range of organs and tissues that can be targeted by its pipeline products and to drive future growth opportunities.

Potential first-in-class dual-targeted RNAi therapeutics for the effective treatment of cancer and fibrotic diseases

STP705 and STP707 are the Company’s lead product candidates, which are dual-targeting RNAi therapeutics based on more than a decade of experience researching TGF-beta1 and its synergistic effects when combined with COX-2 for tumor suppression and fibroblast. Currently, the mechanism of action for both TGF-beta1 and COX-2 in tumor biology and fibrotic disease is widely recognized. Both act as gatekeeper genes, where their inhibition blocks a downstream cascade of events that would otherwise lead to tumor cell proliferation, survival, invasion, angiogenesis and immune evasion. Moreover, by silencing TGF-beta1 and COX-2 simultaneously, Sirnaomics’ product candidates achieve a higher potency than inhibiting either alone. The therapeutic effectiveness for STP705 has been confirmed by the successful Phase IIa results of Sirnaomics. No currently marketed drug product utilizes this molecular targeting approach.

Comprehensive intellectual property portfolio driven by independent research and development capability

Since inception, Sirnaomics has set strategic focus in developing innovative technologies and seeking protection using a comprehensive strategy for filing for patent protection across markets and technology areas. All of the pipeline products have been developed primarily in-house in its research centers in the U.S. and China such that the development of its product candidates is initiated and directed by in-house team and the Company does not rely on third party in-licenses for its product pipeline. As of 10 December, 2021, Sirnaomics owned 20 issued patents (9 in China, 9 in the U.S. and 2 in Europe) and have filed 119 patent applications that are currently pending (19 in China, 43 in the U.S., 6 in Europe, 8 under the Patent Cooperation Treaty and 43 in other jurisdictions). Sirnaomics’ patent claims cover the siRNA and mRNA drug composition in its pipeline products, delivery platforms, modes of delivery for pipeline products, manufacturing technology, and methods of use in various therapeutic areas. Senior management and experienced outside intellectual property counsels collaboratively craft the globally-integrated intellectual property strategy with an eye to broad protection in China, the U.S., Europe and other key jurisdictions.

In addition, based on the Company’s independent research and development capabilities and the development potential of its core candidate product, STP705, Sirnaomics has been cooperating with other well-known Chinese pharmaceutical companies in recent years, including Innovent, Shanghai Junshi, Walvax and Guangzhou Xiangxue, etc., covering the therapeutic areas of multiple cancer, influenza virus, and hypertrophic scar.

Seasoned management team and world-class industry expertise

Sirnaomics is led by the management team with deep experience and capabilities in discovering, developing, manufacturing and commercializing RNA therapeutics. Dr. Patrick Y. Lu, Founder, Chairman of Board, President and CEO, has over 28 years biopharma research and development experience in China and the U.S. Dr. Lu has led the teams building up a robust technology platform and an enriched RNA therapeutic product pipeline. Dr. Lu is an inventor on 53 patents with over 55 authored scientific publications, and has been recognized with multiple awards and grants in China and the U.S. for his innovative research and entrepreneurship. In addition, the management team and scientific advisory board have on average more than 20 years of pharma research and development experience at the world’s leading pharmaceutical companies and research institutions in China and the U.S.

Looking forward, Sirnaomics is committed to becoming a fully-integrated international biopharmaceutical company. Leveraging its deep experience in RNA therapeutics and novel delivery platform technologies, the Company will advance the development of innovative therapeutic modalities for the treatment of a broad range of disease states and strengthen its intellectual property position, accelerate the commercialization of its core product candidate STP705, develop and commercialize a diverse portfolio of transformative RNA products in a broad range of therapeutic areas, including both rare diseases and diseases with large patient populations. In additions, the Company also plans to expand its internal GMP manufacturing capabilities, develop commercialization abilities, and selectively pursue synergistic collaboration opportunities to maximize the potential of its clinical product candidates to rapidly discover, develop and commercialize a portfolio of transformative therapeutics and vaccines for patients suffering from a wide range of both rare and large market diseases.

About Sirnaomics Ltd.
Sirnaomics Ltd.(“Sirnaomics” or “Company”, stock code: 2257.HK) is an RNA therapeutics company with product candidates in pre-clinical and clinical stages that focused on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. The Company is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the U.S, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutics for its core product, STP 705.

This press release is issued by Porda Havas International Finance Communications Group for and on behalf of Sirnaomics Ltd. For further information, please contact:

Porda Havas International Finance Communications Group
Email: sirnaomics.hk@pordahavas.com






Topic: Press release summary