Accelerates Clinical Trials for Core Products STP705, STP707 and STP122G
HONG KONG, Germantown, Md. and SUZHOU, China, March 28, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company"; together with its subsidiaries, "Sirnaomics" or the "Group"; stock code: 2257), a leading biopharmaceutical company engaged in the discovery and development of advanced RNAi therapeutics, has announced its audited annual results for the year ended 31 December 2023 (the "Year").
In order to ensure sufficient cash runway in the face of global macroeconomic uncertainty, the Group has undergone three rounds of restructuring. It has also prioritized the allocation of resources to programs that have the significant potential to advance the development of its core products. The Group's loss for the Year narrowed by 12.7% to US$84.99 million, demonstrating the effectiveness of these initiatives.
Clinical trials progress smoothly with orderly development of multiple product pipelines During the Year, Sirnaomics continued to advance a prioritized product pipeline, conducting five siRNA clinical trials in the U.S. for its lead clinical drug candidates STP705 and STP707, and STP122G, in addition to RV-1730 and RV-1770, the mRNA vaccine programs that received Investigational New Drug Application (IND) approval from the Food and Drug Administration (FDA) sponsored by RNAimmune, its non-wholly owned subsidiary.
STP705 STP705 for the treatment of squamous cell carcinoma in situ (isSCC) has advanced into late-stage clinical development. The Group is in active communication with the U.S. FDA to seek further guidance on late-stage clinical development. After discussing the Phase IIa and Phase IIb results with the U.S. FDA in an End-of-Phase II meeting, the Group was well positioned to advance STP705 into clinical studies for the treatment of isSCC. The Group have now proposed a well-designed Phase II/III study to serve as a pivotal trial to achieve alignment with the U.S. FDA and expects to provide an update to the FDA in the second quarter of 2024.
The Phase II clinical study of STP705 for the treatment of basal cell carcinoma (BCC) was fully completed in 2023. The final data readout showed very favorable efficacy with no systemic drug-related adverse events (AEs) and serious adverse events (SAEs), further validating the broad potential of this drug candidate for the treatment of non-melanoma skin cancers and beyond. The Group will hold the End-of-Phase II meeting with the U.S. FDA to obtain guidance on the future path forward for the late-stage development of STP705 for the treatment of BCC. Based on the previous experience with isSCC, the Group expects communication with the FDA to be smooth and efficient.
The Group completed the Phase I study of STP705 for focal fat reduction in the fourth quarter 2023. The positive results and the histological observations provide preliminary evidence that STP705 may become a best-in-class drug candidate for focal fat reduction and is worthy of further investigation. This will better inform later stage development of this asset in the medical aesthetics category.
STP707 The dose escalation for the Phase I clinical study of STP707 for the treatment of multiple solid tumors was completed in August 2023. Based on preliminary efficacy observations, 74% of evaluable patients demonstrated a best response of stable disease according to Response Evaluation Criteria in Solid Tumors. The results of this Phase I basket clinical study are encouraging for a potential combination study with immune checkpoint inhibitor drugs. The Group looks forward to further clinical trials with STP707, which has the potential to address the unmet needs of patients with refractory solid tumors such as pancreatic and other cancers.
STP122G STP122G, a treatment for coagulation disorders, is currently undergoing a Phase I clinical study in volunteers, with the first cohort completed and active dosing monitoring in the second cohort. This study marks the first time Sirnaomics has applied its proprietary GalNAc RNAi platform technology, GalAhead™, to one of its siRNA-based candidates and conducted a trial in a patient population with a high unmet need for anticoagulation but low bleeding incidence. By targeting Factor XI (FXI), the Group has the potential to address multiple conditions requiring anticoagulation, including atrial fibrillation, pulmonary embolism, deep vein thrombosis, and deep venous thrombosis prophylaxis for surgical procedures.
Other product pipelines
Two products of RNAimmune, Sirnaomics's non-wholly owned subsidiary specializing in the discovery and development of mRNA-based therapeutics and vaccines, received regulatory clearance on its IND from the U.S. FDA in December 2023 and April 2023, respectively. RNAimmune has initiated two Phase I clinical trials for RV-1770, an mRNA vaccine targeting the human respiratory syncytial virus, and RV-1730, a SARS-CoV-2 vaccine booster candidate.
The Group expects to file a U.S. IND for STP125G and STP144G from the GalAhead™ delivery platform in 2025.
Commencement of production at Guangzhou facility to meet clinical needs With the production of the full GMP batch of STP707 for human injection in the first quarter of 2023, the Guangzhou facility is expected to begin full GMP-compliant manufacturing of the Group's pipeline products, including formulation, filling and finishing for both liquid and solid dose production, testing and release. During the Year, the Guangzhou facility also completed the expansion of the filling line capacity to include liquid dose filling in 2R vials in order to support the Group's GalAhead™ platform.
Following the second full year of successful operation of the Guangzhou Fill and Finish (F&F) Facility, which was established in December 2021, the facility continues to support the optimization of the Group's clinical supply strategy in Asia by adapting production to its current needs. The expected annual capacity of around 50,000 vials of lyophilized solid dose and 150,000 to 200,000 vials of liquid dose for human injectables dose capacity is sufficient to support all of the Group's currently planned clinical trials and future clinical developments.
Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officerof Sirnaomics, said, "During the Year, we undertook a restructuring of our Group's operations and expanded cash flow through various measures, enabling us to proactively respond to the challenges of the macroeconomic environment while further enhancing operational efficiency, better aligning resources with our strategic objectives and further developing our core products. With the top priority of commercializing STP705 for the treatment of isSCC, we are moving full speed ahead with late-stage clinical studies and have begun to explore potential partnerships. We have also started to explore the application of STP705 in the medical aesthetic industry. As with the first GalAhead™ mxRNA candidate, STP122G, which was successfully advanced to the clinical stage, based on the Company's unique and innovative delivery platform technology, we will advance more promising first-in-class preclinical assets into clinical stage, such as STP125G for the treatment of familial hypertriglyceridemia. Our other core product, STP707, and our exclusive targeted PNP delivery have demonstrated their potential to treat a variety of solid tumors, especially for pancreatic cancer, and will set us apart from other RNA players globally. Going forward, we will continue to focus on creating healthier and better lives for patients while also creating value for our shareholders, customers and stakeholders."
About Sirnaomics Ltd. (Stock Code: 2257) Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase II clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more at www.sirnaomics.com.
