Lantern Pharma Announces Formation of Starlight Therapeutics to Advance Transformative Therapies for CNS (Central Nervous System) and Brain Cancers

Lantern Pharma, a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that it has formed a wholly-owned subsidiary, Starlight Therapeutics Inc. (“Starlight”), to develop drug candidate LP-184’s central nervous system (CNS) and brain cancer indications – including glioblastoma (GBM), brain metastases (brain mets.), and several rare pediatric CNS cancers. Starlight will refer to the molecule LP-184, as it is developed in CNS indications, as “STAR-001”. Combined, STAR-001’s targeted treatment indications are estimated to represent an annual global market potential of approximately $6.0 billion (USD) and over 500,000 global cases each year.

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Starlight plans on establishing a leading CNS oncology franchise to develop the unique drug candidate STAR-001 for some of the most malignant and unaddressed primary and secondary CNS cancers. The programs being developed by Starlight were born from the analysis of billions of oncology-focused data points and by using Lantern’s AI platform, RADR^®. STAR-001’s powerful anti-tumor mechanism of action, synthetic lethality, and collaborations with internationally recognized institutions, including the Kennedy Krieger Institute at Johns Hopkins and the Greehey Children’s Cancer Research Institute at UT Health – San Antonio, make it well positioned to advance in targeted and efficient clinical development programs. Starlight intends to pursue human clinical trials for multiple CNS indications starting in late 2023, building on prior IND-enabling studies and the Phase 1 clinical testing that will be conducted by Lantern.

“The formation of Starlight allows Lantern to put extreme focus on advancing STAR-001 through targeted clinical trials and dedicate increased time, resources, and personnel to progress one of the most promising drug candidates for CNS cancer patients in decades,” stated Panna Sharma, Lantern’s CEO and President. “Additionally, establishing Starlight as a wholly-owned subsidiary will increase the potential to partner with other biopharma companies who are looking to develop a franchise in CNS cancers and to further accelerate the progression of STAR-001 towards changing patient outcomes in this devastating set of diseases,” continued Sharma. “Since our initial discovery, in which we used large-scale, multi-omic network analysis from our RADR AI platform, to validate that GBM was sensitive to LP-184 and that LP-184 had excellent blood-brain barrier permeability, our team has found, validated, and published on several additional pediatric and adult brain cancers that have shown early promise to LP-184, now STAR-001, in CNS cancers,” stated Sharma. “Our portfolio of opportunities and pipeline in CNS cancers has grown five-fold and includes multiple indications lacking any accepted standard-of-care. We believe that by focusing our efforts via Starlight Therapeutics we can accelerate and deepen our commitment to the CNS cancer patient community, while also creating the potential for meaningful additional upside for our investors,” concluded Sharma.

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STAR-001 is a unique blood-brain barrier permeable small molecule that utilizes its powerful mechanism of action, synthetic lethality, to exploit common vulnerabilities in CNS cancers with DNA damage repair (DDR) deficiencies. The anti-tumor potential of STAR-001 has been demonstrated across an extensive number of in-vitro and in-vivo CNS cancer models, including GBM, brain mets., and atypical teratoid rhabdoid tumors (ATRT), and has been presented at leading conferences and publications including, the Society for Neuro-Oncology annual meeting, the American Association for Cancer Research annual meeting, and the Frontiers in Drug Discovery Journal. Highlights of STAR-001’s promising preclinical results from these presentations and publications are included below:

• Pharmacokinetic studies have shown STAR-001 to have 2X the bioavailability in brain tumors, compared to normal brain tissue, and to have 2X the bioavailability in brain tumors compared to the bioavailability of temozolomide (TMZ), the GBM standard-of-care (SOC) agent.
• In mice implanted with subcutaneous GBM cell-derived xenograft (CDX) tumors from models of the two major GBM subtypes, known as MGMT methylated and MGMT unmethylated, STAR-001 treatment resulted in 107% tumor growth inhibition in both tumor types. In these experiments, 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.
• STAR-001 has the potential for combination with the FDA-approved agent spironolactone to enhance STAR-001’s anti-tumor potency. In in-vitro GBM models with different MGMT methylation states, STAR-001 treatment with spironolactone significantly decreased STAR-001’s IC50 by 3-6X, resulting in IC50s in the low nanomolar range of 34-94nM.
• STAR-001 has been demonstrated to have nanomolar potency in brain mets. cell lines that originated from non-small cell lung cancer, melanoma, and breast cancer (HER2- and Triple Negative).
• STAR-001 treatment of mice implanted with ATRT CDX tumors, at either 2 mg/kg or 4 mg/kg doses (I.V.), showed near complete tumor growth inhibition between 82-91%, respectively.

Based on STAR-001’s demonstrated anti-tumor potential in CNS cancers, the FDA has granted STAR-001 Orphan Drug Designations (ODD) for malignant gliomas (including GBM) and ATRT. Additionally, STAR-001 was granted a Rare Pediatric Disease Designation for ATRT, which occurs in 60-70 pediatric patients a year in the US.

Starlight’s clinical development strategy will initially focus on progressing STAR-001 through early-stage clinical trials for adult recurrent high-grade gliomas (HGGs), including GBM. There have been no effective single-agent treatment options approved for GBM in nearly two decades. The current GBM standard-of-care agent, TMZ, is ineffective in MGMT unmethylated patients, who represent over 65% of all GBM patients. Starlight is planning several additional clinical programs for STAR-001 including adult and pediatric CNS cancers and combination regimens.

Commencing in mid-2023, Lantern is anticipating a Phase 1A basket trial for LP-184 (STAR-001), in a range of solid tumors including: recurrent brain cancers (including GBM and HGGs), metastatic CNS cancers (brain mets.), pancreatic cancer, and solid tumors with DDR deficiencies. The clinical development of STAR-001 in CNS cancers beyond the Phase 1A trial will be conducted exclusively by Starlight. Following the launch of Starlight, Lantern will continue to advance LP-184’s preclinical and clinical development for non-CNS indications (including pancreatic cancer and other solid tumors) and will also provide AI-driven bioinformatic and computational biology support to Starlight.

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