Focus on integrating resources to leading development projects
Focus on promoting core productsSTP705,STP707andSTP122Gclinical research
Hong Kong, Germany Town, Maryland, and Suzhou, China, March 28, 2024 /PRNewswire/ -- Sirnaomics Ltd. (“Company”, together with its subsidiaries, collectively referred to as “the Company”Sirnaomics“or”conglomerate“; Stock Code: 2257), an industry-leading biopharmaceutical company focused on the development and creation of RNAi drugs, announced audited annual results for the year ended December 31, 2023 (“this year”).
In view of global macroeconomic uncertainty and ensuring sufficient cash reserves, the Group has so far carried out three rounds of optimization and prioritized the allocation of resources to projects with great potential to advance the development of core products. The relevant measures worked, and the Group's loss for the year narrowed by 12.7% to US$84.99 million.
Clinical trials are progressing smoothly, and multiple product pipelines are developing in an orderly manner
This year, siRNAomics continued to conduct five siRNA clinical trials on the main clinical candidates STP705 and STP707 along with STP122g. In addition, the mRNA vaccine projects RV-1730 and RV-1770, led by its non-wholly-owned subsidiary RNAIMMUNE, have also been approved by the US Food and Drug Administration (FDA) for New Research Drugs (IND).
STP705
STP705, which is used to treat squamous cell carcinoma in situ (isSCC), has entered the late-stage clinical development stage, and the Group is currently actively communicating with the US FDA to obtain further guidance for late-stage clinical development. After discussing phase IIa and phase IIb results with the US FDA through a Phase II summary meeting, the Group is ready to advance STP705 into clinical research to treat ISSCC. The Group has now carefully designed a phase II/III clinical trial based on guidance from the US FDA, and is expected to provide the US FDA with the latest progress of the plan in the second quarter of 2024.
The STP705 phase II clinical study for the treatment of basal cell carcinoma (BCC) was fully completed in 2023. The final data showed ideal efficacy. There were no systemic drug-related adverse events (AEs) or serious adverse events (SAE), further verifying STP705's great potential for treating non-melanoma skin cancer and other fields. The Group plans to hold a Phase II summary meeting with the US FDA to obtain guidance on future development of STP705 to treat BCC. Based on the Group's existing experience gained from ISSCC development, the Group expects that communication with the US FDA will be efficient and successful.
The Group completed a phase I clinical study of STP705 for partial fat loss in the fourth quarter of 2023. Positive results and preliminary histological observations prove that STP705 may be the best candidate for partial fat loss and is worth further research. This will better guide the later development of this product in the medical and aesthetic field.
STP707
The dose escalation for the STP707 phase I clinical study for the treatment of various solid tumors was completed in August 2023. According to initial efficacy observations and solid tumor response evaluation criteria, 74% of evaluable patients showed the best response in stable condition. The results of this phase I basket clinical trial promoted joint drug use research between the Group and immune checkpoint inhibitor drugs. STP707 is expected to address the unmet medical needs of patients with intractable solid tumors such as pancreatic cancer and other cancers, and the Group looks forward to expanding its clinical trial footprint.
STP122G
In a phase I clinical study of STP122G for anticoagulation treatment in healthy volunteers, the first sequence has been completed and data collected, while the second sequence has also been administered and is being actively monitored. The study marks the first time siRNAomics is using its proprietary innovative GalNAC-RNAi platform technology GALAhead in its siRNA drug candidate to test on a patient population with unmet treatment needs for anticoagulant diseases but with a low incidence of bleeding. By targeting 11 factors, the Group may target a variety of diseases requiring anticoagulants, such as atrial fibrillation, pulmonary embolism, deep vein thrombosis, and deep vein thrombosis prevention during surgery.
Other pipeline products
The IND application for two products from RNAIMMUNE, a non-wholly-owned subsidiary of sirnaOmics focused on the development of mRNA therapeutics and vaccines, obtained regulatory approval from the US FDA in December 2023 and April 2023, respectively. Two phase I clinical trials of the mRNA vaccine RV-1770 against human respiratory syncytial virus and RV-1730 as a SARS-CoV-2 booster vaccine can be initiated.
The Group also expects to file IND records in the US for STP125g and STP144G products based on the Galahead delivery platform in 2025.
Guangzhou factory put into use to improve clinical needs
With the production of a complete GMP batch of STP707 for human injection in the first quarter of 2023, the Guangzhou factory is expected to be able to fully produce pipeline products in accordance with GMP specifications, including formulation, filling and encapsulation, testing and release of liquid and solid agents. This year, the Guangzhou plant also completed the expansion of the filling line capacity to fill liquid doses into 2R vials to support the GalaHead platform.
The Guangzhou filling and finished products plant was established in December 2021 and has been successfully operating for more than two years. The plant continues to support the optimization of clinical supply strategies in Asia by adjusting production to meet current needs. The Guangzhou filling and finished product plant is expected to have an annual production capacity of about 50,000 bottles of freeze-dried solids for human injection and 150,000 to 200,000 bottles of liquid preparations, which is enough to support all currently planned clinical trials and future clinical development.
SirnaomicsDr. Lu Yang, Founder, Chairman of the Board, Executive Director, President and CEOHe said, “In this year, the Group's business has been structurally optimized and cash flow will be expanded through various measures to enable us to actively address the challenges of the macroeconomic environment, further improve operational efficiency, align resources more effectively with our strategic goals, and continue to advance the development of our core products. With regard to the top priority of commercializing STP705 for the treatment of ISSCC, we are advancing late-stage clinical research at full speed and are beginning to explore potential partners. At the same time, we are also beginning to explore the application of STP705 in the medical aesthetic industry. Just as STP122g, the first GALAhead MxRNA product successfully advanced to the clinical stage, based on the company's unique and innovative delivery platform technology, we will also advance more promising pioneering pre-clinical products such as STP125G for the treatment of hypercholesterolemia to the clinical stage. Another core product, STP707, and our exclusive patented PNP delivery have shown their potential to treat a variety of solid tumors. Their excellent performance in pancreatic cancer treatment will also set us apart from other RNA participants around the world. In the future, we will continue to strive to create a healthy and beautiful life for patients and wholeheartedly create value for our shareholders, customers and stakeholders.”
regardingSirnaomics Ltd.
siRNAomics is an RNA therapy biopharmaceutical company. The company's candidate products are in the clinical and preclinical stages, focusing on exploring and developing innovative drugs to treat indications with medical needs and huge market opportunities. siRNAomics is the first clinical-stage RNA therapy biopharmaceutical company with significant market positions in both Asia and the US. With its proprietary delivery technology: a peptide nanoparticle delivery platform and a second-generation GalNAc conjugate delivery platform, the Group has established a very rich pipeline of drug candidates. With many successes in the company's STP705 and STP707 clinical projects, siRNAomics is currently in an international leading position in promoting RNAi drugs for tumor treatment. STP122g is the first drug candidate for GALAhead technology to enter clinical development. With the establishment of the Sirnomics clinical production facility, the Group is currently making the leap from a biotech company to a biopharmaceutical company. For more information about the company, please visit: