Lantern Pharma Announces First Patient Dosed in the Phase 1 Study for LP-184 in Advanced Solid Tumors
- LP-184 is being studied in a first-in-human Phase 1 clinical trial, having been developed with guidance from Lantern’s AI Platform, RADR®, as a potential therapy for a wide range of advanced solid tumors.
- LP-184 is one of two molecules in Lantern’s synthetic-lethal franchise that has been shown to have anti-cancer activity in tumors with DNA damage repair deficiency.
- Lantern estimates that LP-184 has a global aggregate market potential of approximately $11-13 billion, consisting of $6-7 billion for solid tumors and $5-6 billion for CNS cancers.
DALLAS--(BUSINESS WIRE)-- 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, today announced 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.
"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.
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 annual meeting, the Society for Neuro-Oncology annual meeting, the San Antonio Breast Cancer Symposium, and the Frontiers in Drug Discovery Journal.
About Lantern Pharma:
Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) RADR® platform leverages over 34 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Our lead development programs include two Phase 2 clinical programs and recently initiated Phase 1 clinical programs for two additional product candidates with potential in multiple important cancer indications. We have also established a wholly-owned subsidiary, Starlight Therapeutics Inc., to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers, many of which have no effective treatment options. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world.
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Investor Relations Associate
Source: Lantern Pharma Inc.
Released September 25, 2023