Source: Phanes Therapeutics, Inc.
Beijing, Shanghai, Songshan Lake in Guangdong, China; San Diego, USA
On March 25, 2024, Phanes Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of innovative drugs in the field of oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its PT886 for the treatment of patients with metastatic claudin 18.2 positive pancreatic cancer. Previously, PT886 was granted Orphan Drug designation by the FDA for the treatment of pancreatic cancer in 2022, and its clinical trial application in China was approved by the CDE this February.
PT886 is a globally pioneering bispecific antibody (dual antibody) with a natural IgG structure, targeting Claudin 18.2 and CD47, for the treatment of gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. PT886 is developed through Phanes' proprietary bispecific antibody technology platform, PACbody.®And SPECpair®Build.Pancreatic cancer is an aggressive cancer characterized by high incidence and mortality rates. The 5-year survival rate for patients diagnosed with metastasis is only 3%. It is predicted that approximately 51,000 Americans will die from pancreatic cancer in 2024. By 2030, pancreatic cancer is expected to surpass breast cancer, prostate cancer, and colorectal malignancies as the leading cause of cancer-related deaths in the United States.Dr. Minghan Wang, founder and CEO of Phanes, stated"PT886 has the potential to become a transformative treatment option for patients with metastatic claudin 18.2-positive pancreatic cancer, a disease with limited benefits from current standard therapies. PT886 is the result of Phanes' ingenious innovation in the design of novel therapeutic approaches and practical technologies."PT886 in the U.S. multicenter Phase I clinical trial (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and pancreatic cancer. These patients have experienced disease progression after receiving available standard therapies, or the standard therapies have been proven ineffective, intolerable, or deemed inappropriate.About Phanes Therapeutics
PhanesWorldPharmaceuticals (Phanes Therapeutics, Inc.) is a clinical-stage biotechnology company dedicated to the research and development of innovative drugs in the field of oncology. The company currently has three projects in clinical stages, including the best-in-class monoclonal antibody (mAb) project PT199, and two first-in-class bispecific antibody (bsAbs) projects, PT886 and PT217. Both PT886 and PT217 have received FDA Orphan Drug Designation.
Phanes Therapeutics has leveraged its proprietary technology platform, PACbody.®、SPECpair®and ATACCbody®Built a strong R&D pipeline to develop novel biologics, addressing highly unmet medical needs in the field of cancer. PACbody®SPECpair is a proprietary method for constructing bispecific antibodies without the need for protein engineering, allowing the antibody molecules to maintain their natural structure with superior CMC properties.®Technical platform capable of using traditional monoclonal antibody preparation processes to produce bispecific antibodies with a natural IgG structure. ATACCbody®Technical Platform: A proprietary technology that uses immune-oncology molecules with adjustable activity to target solid tumors, aiming to minimize the risk of cytokine storms.The content of the article is for reference only and does not constitute investment advice. Investors who take action based on this information bear their own risks. The article maintains a neutral stance regarding the statements and viewpoints expressed, and does not provide any explicit or implicit guarantees concerning the accuracy, reliability, or completeness of the content. Readers are advised to use the information solely as a reference and assume full responsibility for their actions. The various articles published by this official account focus on sharing; if there is any infringement, please contact us, and we will delete the content.Booths for the Class of 2024 are now available for booking!
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