SEED Receives FDA Rare Pediatric Disease and Orphan Drug Designations for Lead Oncology Asset RBM39 Degrader and Enters Strategic Transactions with New Investors
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."
About SEED Therapeutics
SEED Therapeutics is an innovative biotech company focused on discovering and developing targeted protein degradation (TPD) therapeutics, with the mission to transform the treatment of diseases that currently have limited or no treatment options. Leveraging its cutting-edge RITE3™ platform, SEED is at the forefront of molecular glue-based TPD, addressing diseases in oncology and neurodegeneration. Through active collaborations with Eli Lilly and Company and Eisai Co., Ltd., and backed by a comprehensive intellectual property portfolio, SEED has built a robust pipeline of novel drug candidates now approaching clinical development. Visit www.seedtherapeutics.com to learn more.
About BeyondSpring
BeyondSpring is a global clinical-stage biopharmaceutical company advancing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring is advancing its first-in-class lead asset, Plinabulin, into late-stage clinical development as a direct anti-cancer agent in non-small cell lung cancer (NSCLC) and other cancer indications. Plinabulin binds to a differentiated pocket in tubulin, distinct from other tubulin binders, and is a potent inducer of dendritic cell maturation, which activates both adaptive and innate immunity. In combination with docetaxel, Plinabulin has demonstrated significant overall survival benefits compared to docetaxel alone in second- and third-line NSCLC with EGFR wild type (Lancet Respir Med 2024). Additionally, Plinabulin has shown a significant reduction in severe neutropenia across multiple clinical studies. BeyondSpring's pipeline also includes three preclinical immuno-oncology assets. Visit www.beyondspringpharma.com for more information.
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