On September 25, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted and transformative cancer therapies using its proprietary AI and machine learning (ML) platform, RADR, with multiple clinical stage drug programs, reported the dosing of the first patient in the Phase 1 clinical trial evaluating Lantern’s investigational new drug LP-184 in patients with advanced solid tumors (Press release, Lantern Pharma, SEP 25, 2023, View Source [SID1234635391]).

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"The first patient dosing in our Phase 1 trial of LP-184 is a critical milestone and underscores the commitment of our team to advancing our pipeline of therapies to patients," stated Panna Sharma, Lantern’s President and CEO. "This milestone is about more than advancing a novel drug candidate. It also validates our unique approach of leveraging AI and machine learning to expedite drug development. Insights from our proprietary AI and ML platform, RADR, were instrumental in our development of LP-184 and aided in understanding its mechanism of action, identifying and prioritizing its cancer indications, and generating machine learning biomarker signatures to assist with patient selection in future clinical trials. The rapid advancement of LP-184 into a first-in-human Phase 1 trial underscores the immense potential that we see in this drug candidate, as well as for our approach to AI-enabled drug development. We believe LP-184 has blockbuster potential for patients with multiple types of advanced solid tumors and CNS cancers, many of which have no or limited effective therapeutic options, and we are excited to envision the impact this could have in transforming the lives of patients."

The single arm multicenter Phase 1 trial (NCT05933265) is assessing the safety and tolerability of escalating doses of LP-184 to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors and recurrent high-grade gliomas, including glioblastoma (GBM). The study has been designed as a 35 patient trial with patients receiving LP-184 infusion on Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, pharmacokinetics, and clinical activity, and dose escalation is planned with minimum of three patient cohorts. Lantern has already activated two clinical trial sites and plans to activate multiple additional sites in the US over the next 100 days. Lantern anticipates the Phase 1A portion of the trial to be completed in the first half of 2024.

After the Phase 1 trial is completed, Lantern plans to advance LP-184 into additional clinical trials for multiple solid tumor indications, and Lantern’s subsidiary, Starlight Therapeutics, will advance the clinical development of LP-184 for all brain and CNS indications under the name STAR-001. Globally, the aggregate annual market potential of LP-184/STAR-001’s programs is estimated to be approximately $11-13 billion, consisting of $6-7 billion for solid tumors and $5-6 billion for CNS cancers.

About LP-184:

LP-184 is a unique small molecule that utilizes its powerful mechanism of action, known as synthetic lethality, to exploit common vulnerabilities in solid tumor and CNS cancers with DNA damage repair (DDR) deficiencies. The anti-tumor potential of LP-184 has been demonstrated across an extensive number of in-vitro and in-vivo cancer models, including pancreatic, bladder, triple-negative breast cancer (TNBC), glioblastoma (GBM), brain metastases, and ATRT. In addition to LP-184’s promise as a single agent, its antitumor potency has the potential to be enhanced when used in combination with existing FDA-approved agents and other treatment modalities including spironolactone, PARP inhibitors, and radiation therapy. Results validating LP-184’s anti-tumor potential have been published at leading conferences and journals including, the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, the Society for Neuro-Oncology annual meeting, the San Antonio Breast Cancer Symposium, and the Frontiers in Drug Discovery Journal.