On August 14, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning (ML) platform with multiple clinical-stage drug programs, reported to have received a notice of allowance from the United States Patent and Trademark Office (USPTO) covering a method of treatment for Atypical Teratoid Rhabdoid Tumor (ATRT) using LP-184, an aggressive and rapidly growing form of cancer of the central nervous system (CNS) (Press release, Lantern Pharma, AUG 14, 2023, View Source [SID1234634401]).
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"This patent allowance further fortifies Lantern Pharma’s intellectual property portfolio, providing us with an additional layer of protection for our potential blockbuster LP-184 program, which is being developed for multiple targeted oncology indications, including ATRT in pediatric patients," said Panna Sharma, CEO of Lantern Pharma. "Historically, pediatric ATRT has been treated with a combination of surgery, radiation, and chemotherapy, but unfortunately, these approaches have often resulted in unfavorable long-term outcomes for the children affected."
Drs. Kosj and Jaymi Yamoah, Co-founders of Hope4ATRT, a research entity dedicated to directing resources and research to families in the fight against ATRT, commented, "As parents of a child who did not survive ATRT, we are compelled to advocate for more effective and less toxic treatment options for children still in this battle, and we are always thrilled to see progress in ATRT research. The work by Lantern scientists to rapidly develop new therapies with potential to treat ATRT brings us hope for the future."
Sharma continued, "The urgent need for new treatment options for pediatric brain cancers cannot be overstated. Our in-silico and in-vivo observations indicate that LP-184 has the potential to become an essential part of the treatment options for these patients, and this patent allowance provides a further assurance of protection for our advances in the treatment of this devastating disease."
LP-184 is the first of Lantern’s drug candidates developed by leveraging Lantern’s AI and ML platform, RADR, to advance to a first-in-human Phase 1 basket trial. Lantern has rapidly advanced the clinical development of LP-184, activated the initial clinical trial sites, and has begun screening patients. Indications for the LP-184 trial are anticipated to include relapsed/refractory advanced pancreatic cancer, glioblastoma (GBM), brain metastases (brain mets), and multiple other recurring, advanced solid tumors with DNA damage response deficiencies.
The dosage and safety data obtained in the Phase 1 trial will be used to advance the CNS indications, including ATRT, for a future Phase 2 trial to be sponsored by Lantern’s wholly-owned subsidiary, Starlight Therapeutics Inc. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $10+ billion, consisting of $5+ billion for CNS cancers and $6+ billion for other solid tumors.
The U.S. Food and Drug Administration (FDA) has previously granted LP-184 Rare Pediatric Disease Designation and Orphan Drug Designation (ODD) for the treatment of pediatric patients with ATRT. The FDA has also previously granted LP-184 ODD for the treatment of pancreatic cancer and for the treatment of malignant glioma, including GBM.
A notice of allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed and grants the patent upon payment of the patent issuance fee. Additional corresponding patent applications are pending in Europe, Japan, Canada, and Australia.
About ATRT
ATRT is an aggressive and rare form of cancer of the central nervous system that predominantly affects children under the age of three. The National Cancer Institute (NCI) classifies ATRT as Grade IV tumors, meaning they are malignant (cancerous), aggressive, and fast-growing. The root genetic cause of ATRTs is attributed to bi-allelic mutations that inactivate either SMARCB1 (also known as INI1) or SMARCA4. Approximately 90 percent of pediatric ATRTs can be attributed to alterations in the SMARCB1 gene. SMARCB1 was included among several genes whose expression negatively correlated with LP-184 sensitivity in tumors. This in silico correlation was confirmed by in vitro and in vivo assessments of LP-184 in ATRT, with the highest potency of LP-184 in vivo having been seen in ATRT xenografts.