Lantern Pharma Launches Starlight Therapeutics to Revolutionize Treatments for CNS and Brain Cancers

Lantern Pharma, Inc. (NASDAQ: LTRN) has taken a bold step forward in oncology drug development by forming a wholly-owned subsidiary, Starlight Therapeutics Inc., to explore the potential of its drug candidate LP-184 in central nervous system and brain cancer indications. If successful, STAR-001 – as LP-184 is referred to in its CNS indications – could revolutionize the treatment of glioblastoma, brain metastases, and several rare pediatric CNS cancers, with an estimated global market potential of $6.0 billion (USD) and over 500,000 cases annually.

Starlight is forging ahead in the oncology arena with its revolutionary CNS oncology franchise, STAR-001. This cutting-edge drug candidate is poised to make a lasting impact on some of the most malignant and unaddressed primary and secondary CNS cancers. By leveraging the power of RADR® AI platform and analyzing billions of oncology-focused data points, Starlight has developed a drug candidate with an effective anti-tumor mechanism of action and synthetic lethality. To further its development, Starlight is collaborating with renowned institutions such as the Kennedy Krieger Institute at Johns Hopkins and the Greehey Children’s Cancer Research Institute at UT Health – San Antonio. With clinical trials set to start in late 2023, STAR-001 is set to revolutionize the oncology field.

Lantern’s CEO and President, Panna Sharma, is excited to announce the formation of Starlight Therapeutics, a wholly-owned subsidiary dedicated to advancing the development of STAR-001, one of the most promising drug candidates for CNS cancer patients in decades. With the formation of Starlight, Lantern is able to focus its efforts and resources on making significant progress in this devastating set of diseases, with the potential to partner with other biopharma companies dedicated to the same goal. In addition, Lantern has discovered and validated several pediatric and adult brain cancers that have shown early promise to LP-184, now STAR-001, in CNS cancers. By focusing their efforts via Starlight Therapeutics, Lantern is committed to providing hope to the CNS cancer patient community and creating meaningful additional upside for their investors.

STAR-001 is a revolutionary small molecule that is capable of crossing the blood-brain barrier and utilizing its groundbreaking synthetic lethality mechanism to target vulnerabilities in CNS cancers with DNA damage repair (DDR) deficiencies. The anti-tumor potential of STAR-001 has already been demonstrated in a number of in-vitro and in-vivo models, including GBM, brain mets, and ATRT, and has been featured in prestigious conferences and publications such as the Society for Neuro-Oncology annual meeting, the American Association for Cancer Research annual meeting, and the Frontiers in Drug Discovery Journal. Impressive preclinical results have been presented from these events and publications, showcasing the promise of STAR-001 in tackling these life-threatening cancers.

STAR-001 has been found to be twice as bioavailable in brain tumors compared to both normal brain tissue and temozolomide (TMZ), the current standard-of-care (SOC) agent for glioblastoma. Through pharmacokinetic studies, STAR-001 has demonstrated promising potential for treating this devastating form of cancer.

STAR-001 treatment proved to be an incredible success in mice implanted with subcutaneous GBM cell-derived xenograft (CDX) tumors from models of the two major GBM subtypes, MGMT methylated and MGMT unmethylated, as it resulted in 107% tumor growth inhibition in both. Even more remarkable, 75% of mice with tumors from the MGMT unmethylated GBM model and 30% of mice with tumors from the MGMT methylated GBM model were entirely tumor-free after STAR-001 treatment!

The potential for STAR-001 to be combined with the FDA-approved agent spironolactone to boost anti-tumor potency was recently revealed in in-vitro GBM models with different MGMT methylation states. The results of the study were impressive, with STAR-001’s IC50 decreasing by a whopping 3-6X, culminating in IC50 values as low as 34-94nM.

STAR-001 has been shown to be highly effective against brain mets, exhibiting nanomolar potency against cell lines derived from non-small cell lung cancer, melanoma, and breast cancer, including HER2- and Triple Negative varieties. This impressive result highlights the potential of this drug in treating a wide range of cancers.

Mice implanted with ATRT CDX tumors were treated with STAR-001 in two different doses of 2 mg/kg and 4 mg/kg (I.V.). The results were remarkable, with near complete tumor growth inhibition of 82-91% respectively. These results demonstrate the potential of STAR-001 as an effective treatment for ATRT CDX tumors.

The FDA has granted STAR-001 Orphan Drug Designations (ODD) for malignant gliomas (including GBM) and ATRT due to its remarkable ability to combat CNS cancers. In addition, STAR-001 was also awarded the Rare Pediatric Disease Designation for ATRT, which affects 60-70 children in the United States annually. Its potential in this area is encouraging and brings hope to these vulnerable families.

Starlight is launching an ambitious clinical development strategy, with its leading candidate, STAR-001, at the helm. This innovative agent is set to tackle recurrent high-grade gliomas (HGGs), including glioblastoma multiforme (GBM), which has had no effective single-agent treatment options in nearly two decades. Notably, STAR-001 has potential to benefit the over 65% of GBM patients with unmethylated MGMT, who are currently underserved by the current standard-of-care, temozolomide (TMZ). In addition, Starlight is exploring other opportunities for STAR-001, including adult and pediatric CNS cancers and combination regimens.

In 2023, Lantern will embark on a Phase 1A basket trial for LP-184 (STAR-001), a potential game-changer in the fight against a range of solid tumors. This includes recurrent brain cancers, metastatic CNS cancers, pancreatic cancer, and solid tumors with DDR deficiencies. After the launch of Starlight, Lantern will continue to drive forward LP-184’s preclinical and clinical development for non-CNS indications and provide AI-driven bioinformatic and computational biology support to Starlight. This could be a revolutionary breakthrough in the field of oncology.

About Lantern Pharma:

Lantern Pharma (NASDAQ: LTRN) is revolutionizing the way oncology therapeutics are discovered and delivered with its proprietary RADR® AI and machine learning platform. By using its advanced platform to identify biomarker signatures that indicate a patient’s likelihood of responding to a genomically-targeted therapeutic, Lantern’s approach is leading the way in delivering best-in-class outcomes with precision.

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