KING OF PRUSSIA, PA — SEED Therapeutics Inc. has announced that its molecular glue therapy, ST-01156, has been granted Rare Pediatric Disease and Orphan Drug designations by the U.S. Food and Drug Administration (FDA). This novel therapy targets RBM39, an RNA splicing factor linked to multiple solid tumor indications, and represents a significant step in addressing cancers with high unmet needs.
The FDA’s Rare Pediatric Disease designation positions SEED to potentially receive a priority review voucher upon approval of ST-01156. The company is preparing to file an Investigational New Drug (IND) application in the first half of 2025 as it advances toward becoming a clinical-stage organization.
“SEED is rapidly transitioning into a clinical-stage company, with the planned IND filing in the next few months for ST-01156, our novel and potentially best-in-class RBM39 degrader. This marks a significant milestone in our four-year journey to bring innovative therapies to patients,” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of SEED and BeyondSpring Inc. “RBM39 is a validated target to address cancers with high unmet medical needs, as highlighted in a recent Nature Reviews Drug Discovery article. At SEED, we are committed to improving patient outcomes through pioneering science and rational drug development.”
The Rare Pediatric Disease and Orphan Drug designations underscore ST-01156’s potential to address significant unmet needs in rare oncology cases. “The FDA’s Rare Pediatric Disease and Orphan Drug designations for ST-01156 represent an important milestone, recognizing its potential to address significant unmet needs in rare oncology indications,” said Jackson Tai, Board Member of SEED. “These designations may help expedite and reduce the cost of developing, approving, and commercializing this therapeutic agent.”
Additionally, SEED’s largest shareholder, BeyondSpring Inc. (NASDAQ: BYSI), has signed definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED. Following the transactions, BeyondSpring is expected to retain approximately 14.4% ownership in SEED.
“The transactions announced today will diversify SEED’s shareholder base. We believe this is a key step in ensuring that our capital structure and ownership distribution align with institutional investor expectations,” Tai added. “SEED is now better positioned to pursue key initiatives, including advancing its clinical pipeline, extending its capital markets options, and maintaining its leadership in the field of targeted protein degradation.”
With FDA recognition and a strategic focus on innovative therapies, SEED Therapeutics is poised to make significant strides in combating complex cancers.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.