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KING OF PRUSSIA, Pa., Jan. 28, 2025 (GLOBE NEWSWIRE) -- SEED Therapeutics Inc. (“SEED”), a biotechnology company pioneering the discovery of molecular glues for targeted protein degradation (TPD) using its proprietary RITE3™ platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease and Orphan Drug designations to SEED’s ST-01156 molecular glue. This novel agent degrades RBM39, an RNA splicing factor implicated in multiple mechanism-targeted solid tumor indications.
SEED is advancing ST-01156 toward an Investigational New Drug (IND) application, with an expected IND filing in the first half of 2025. The Rare Pediatric Disease designation positions SEED to potentially receive an FDA priority review voucher upon approval of ST-01156.
SEED also announced that its largest shareholder, BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring”), has entered into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED. Upon completion of the transactions, BeyondSpring is expected to retain approximately 14.4% of SEED’s outstanding shares.
Pioneering Progress in Targeted Protein Degradation
“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. “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.”
FDA Recognition and Strategic Growth
“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.”
Tai added: “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. 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.”