Lantern Pharma Announces First Patient Enrolled in Taiwan for Phase 2 HARMONIC™ Clinical Trial of LP-300 in Never-Smoker NSCLC Patients

• Multiple clinical trial sites across Taiwan are actively screening patients, following successful site initiation visits.
• Expansion into Taiwan is particularly significant as over 50% of lung cancer cases in Taiwan occur in never-smokers.

DALLAS--(BUSINESS WIRE)-- Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR® AI platform, today announced that the first patient has been enrolled and dosed in Taiwan for its Phase 2 HARMONIC™ clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs).

The enrollment of the first patient in Taiwan extends the recent expansion of the HARMONIC™ trial into Asia, where there is a notably higher prevalence of never-smoker NSCLC patients compared to Western populations. Taiwan represents a particularly important region for the trial, as more than half of all new lung cancer diagnoses in Taiwan occur in people who are classified as never-smokers. Never-smokers in the context of lung cancer have been commonly defined, by the CDC and other health agencies, as people who have smoked less than 100 cigarettes in their lifetime.

"The enrollment of our first patient in Taiwan marks another important milestone in the expansion of our HARMONIC™ trial," said Panna Sharma, President and CEO of Lantern Pharma. "The extremely high proportion of never-smoker lung cancer patients in Taiwan makes this region important for accelerating our enrollment with the objective of addressing a critical unmet need in a population where this disease has an outsized impact."

The scientific and clinical community is increasingly recognizing that lung cancers in nonsmokers and never-smokers represent a distinct disease entity with unique clinical, genomic, pathological, and biological characteristics. Lantern believes that this has particular importance for the Harmonic™ trial, as it underscores the need of targeted, precision therapy approaches for this unique patient population. Lung cancer in never-smokers constitutes one of the top 10 causes of cancer-related deaths globally, making it a crucial focus for therapeutic innovation.

The expansion into Asia follows encouraging preliminary results from the trial's initial safety lead-in cohort, which demonstrated an 86% clinical benefit rate and 43% objective response rate among the first seven patients. The HARMONIC™ trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker NSCLC patients that have relapsed following treatment with TKIs.

Dr. Reggie Ewesuedo, VP of Clinical Development at Lantern Pharma commented, "The initiation of patient dosing in Taiwan demonstrates the continued momentum of our Asia expansion strategy. With active screening now occurring at multiple sites across both Japan and Taiwan, we expect to see accelerated enrollment in the trial. The enthusiasm we've seen from clinical collaborators in Taiwan reflects the significant need for new therapeutic options for never-smoker NSCLC patients in this region."

The Phase 2 HARMONIC™ trial is actively screening in multiple cancer centers in the US, Japan and Taiwan and is expected to enroll up to 90 patients across two treatment arms. The two treatment arms are randomized, at a ratio of 2 to 1, and will compare the co-primary endpoints of PFS (progression free survival) and OS (median overall survival) of:

- the LP-300 arm which is expected to enroll 60 patients (LP-300 which will be given in combination with the standard of care chemotherapy doublet)
- the SOC arm which is expected to enroll 30 patients (the standard of care arm will only dose patients with the chemotherapy doublet alone).

Initial results from the Phase 2 clinical trial from the lead-in patient cohort can be reviewed in an earlier press release issued by Lantern Pharma. Lantern plans to review, and share the interim data from, the Phase 2 trial for PFS and OS (co-primary endpoints) after 30 clinical events have been observed.

About LP-300

LP-300 is a disulfide small molecule and an investigational new drug candidate. It has been well characterized to have a multimodal mechanism of action directed towards tyrosine kinase receptors and cell redox enzymes. It is believed to modulate cellular redox in key signaling pathways in NSCLC and directly engage with TKI receptors via cysteine modification.

It is known that lung carcinomas in never smoker patients have a much higher percentage of mutations in certain tyrosine kinase (TK) oncogenes such as EGFR, ALK, ROS, and MET-1, contributing to tumor formation and growth, while lung carcinomas in smokers are much more likely to have growth-driver mutations in oncogenes such as RAS, and much lower percentages of mutations in TK oncogenes. Both published (Parker 2015) and unpublished studies have shown that LP-300 covalently binds to and/or inhibits the kinase activity of each of these TK oncogenes (EGFR, ALK, ROS, and MET-1), suggesting that a greater number of lung adenocarcinomas in never smokers, compared to smokers, could be susceptible to the inhibitory effects of LP-300.

LP-300 has been evaluated in 5 Phase 1 and 5 Phase 2 or 3 clinical trials in over 1,000 subjects. In a retrospective subgroup analysis from a prior Phase 3 trial, never smoker lung adenocarcinoma patients receiving the combination of LP-300 with cisplatin and paclitaxel chemotherapy were observed to have significant survival benefit compared to the never smoker patients receiving cisplatin and paclitaxel without LP-300.

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) platform, RADR^®, leverages over 100 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 that span multiple cancer indications, including both solid tumors and blood cancers 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 - 2.5 million per program.

Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. We have also established a wholly-owned subsidiary, Starlight Therapeutics, 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.

Please find more information at:

• Website: www.lanternpharma.com
• Harmonic Clinical Trial: www.harmonictrial.com
• LinkedIn: https://www.linkedin.com/company/lanternpharma/
• X: @lanternpharma

FORWARD LOOKING STATEMENT:

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Source: Lantern Pharma Inc.