| |OCTOBER 20248CULLINAN THERAPEUTICS RECEIVES US FDA NOD FOR PHASE 1 TRIAL OF CLN-978ANNOVIS BIO RECEIVES US FDA NOD TO BEGIN PHASE 3 STUDIES OF BUNTANETAPCullinan Therapeutics, Inc., a biopharmaceutical company specializing in developing targeted therapies, confirmed FDA approval for their Investigational New Drug Application for CLN-978. This enables the global phase 1 clinical trial in the US for assessing CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE).The study will include participants with a SLEDAI score of eight or higher who have not responded well to at least two therapies, including one standard immunosuppressive or biologic agent. Phase A involves increasing the dosage gradually to establish the optimal dosage for future studies, commencing with an initial dosage of 10 micrograms. Phase B will involve expanding the dose by exploring various schedules based on the data collected in Phase A.The main goal of the research is to assess the safety of CLN-978 in treating active moderate to severe SLE. Additional goals consist of pharmacokinetics, kinetics of B cells, immunogenicity, and clinical activity."We are pleased to continue progressing our global phase 1 clinical trial in the US with FDA clearance of our IND Application," said Jeffrey Jones, MD, MBA, chief medical officer, Cullinan Therapeutics. "There remains a significant unmet medical need among patients with systemic lupus erythematosus, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978, our novel bispecific T cell engager, targets CD19, offering a highly differentiated approach to deliver the potency of T cell redirecting therapy with off-the-shelf access and convenient dosing through subcutaneous administration". POAnnovis Bio Inc, based in Malvern, a company in the advanced stages of clinical drug development, revealed on October 10, 2024, the positive results of their meeting with the US Food and Drug Administration regarding transformative treatments for neurodegenerative diseases like Alzheimer's and Parkinson's.The phase 3 program will examine buntanetap in early Alzheimer's disease patients through two clinical trials: a 6-month study to confirm symptomatic effects and an 18-month study to show potential disease-modifying effects. Although the Company intends to conduct both studies, a successfully run 6 month clinical trial may be enough to support filing for a new drug application, possibly within one year of starting the study.Furthermore, the US FDA did not express any issues regarding the company's data on the safety of buntanetap, such as liver enzymes, drug interactions, dose selection, pharmacokinetics, and population pharmacokinetics. They verified that the development can continue using the new crystal form of buntanetap."We are now ready to move into the highly anticipated phase 3 stage," said Maria Maccecchini, founder, president, and CEO of Annovis Bio. "Our priority is to bring the treatment to patients as early as possible, and we are committed to ensuring the next clinical trial is executed at the highest standards to attain an expedited NDA submission. Our team is already preparing for trial initiation early next year and will continue to keep you updated as we advance towards our goal". POTOP STORIES
< Page 7 | Page 9 >