Lantern Pharma & Starlight Therapeutics Present LP 184 (STAR 001) Phase 1b Trial Design and Preclinical Data in Glioblastoma at Society for Neuro Oncology (SNO) 2024[...]

Lantern Pharma & Starlight Therapeutics Present LP-184 (STAR-001) Phase 1b Trial Design and Preclinical Data in Glioblastoma at Society for Neuro-Oncology (SNO) 2024 Highlighting Novel Synthetic Lethality

• The Phase 1b clinical trial design presented at SNO2024 combines LP-184 (STAR-001) with spironolactone to potentially enhance therapeutic response in recurrent glioblastoma (GBM) patients.
• Preclinical data, including in previously published research by Lantern Pharma, demonstrates up to 6-fold increase in GBM cell sensitivity when LP-184 is combined with spironolactone.
• LP-184 continues to advance through the existing Phase 1a clinical trial to assess safety and establish a maximum tolerated dose (MTD); no dose-limiting toxicities have been observed to date across nine patient cohorts enrolled.
• The clinical development for LP-184 in CNS cancers is planned to be advanced as STAR-001 by Starlight Therapeutics in later stage human clinical trials.

DALLAS--(BUSINESS WIRE)-- Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence company transforming oncology drug development, and its wholly-owned subsidiary Starlight Therapeutics, focused exclusively on CNS and brain cancers, today announced the presentation of new preclinical data and Phase 1b trial design for LP-184 (to be developed as STAR-001 for CNS indications) in glioblastoma at the Society for Neuro-Oncology (SNO) 2024 Annual Meeting in Houston, Texas.

The poster presentation highlighted LP-184's unique mechanism of action, brain penetrance properties, and potential enhanced therapeutic effect when combined with spironolactone in glioblastoma multiforme (GBM). LP-184 is currently under investigation in a Phase 1a dose-escalation safety study (NCT05933265) in adult patients with advanced solid tumors including GBM.

"The data and trial design presented at SNO2024 further validate and progress LP-184's potential as a promising new treatment option for glioblastoma patients," said Panna Sharma, President and CEO of Lantern Pharma. "Through our subsidiary Starlight Therapeutics, we are positioned to advance LP-184 as STAR-001 specifically for brain cancers and CNS indications, where treatment options are limited and often ineffective. The combination with spironolactone represents an innovative approach, which has been developed with the aid of our AI platform RADR®, to potentially enhance therapeutic response in this devastating disease."

The key highlights from the poster presented by Dr. Schreck from Johns Hopkins Medicine and Dr. Kulkarni from Lantern Pharma at SNO2024 include:

• LP-184 shows favorable brain penetrance with a brain tumor/plasma concentration ratio of 0.2 compared to 0.1 for the existing standard of care, temzolomide.
• Preclinical studies show spironolactone increases GBM cell sensitivity to LP-184 up to 6-fold through ERCC3 degradation - which induces NERD (nucleotide excision repair deficiency) making the cancer cells both more sensitive to LP-184/STAR-001 and largely unable to repair themselves after exposure to the drug-candidate.
• Multiple time point and dose level experiments show that GBM cells treated with spironolactone showed significant depletion of ERCC3 - including at 25μM of spironolactone which showed up-to 95% depletion of ERCC3 by 24h.
• LP-184 is effective in temozolomide-resistant GBM models and is agnostic to MGMT methylation status.
• PTGR1 expression analysis from GTEX normal brain and TCGA GBM highlights that PTGR1 levels are higher in brain tumor tissue (median 5.15) as compared to normal brain tissue (median 3.95).
• ERCC3-dependent TC-NER activity was identified as a determinant of LP-184 synthetic lethality predicting that LP-184's therapeutic potential will be enhanced in patients with intrinsic or spironolactone-induced NER deficient tumors.
• Phase 1b trial being considered will evaluate LP-184 as both monotherapy and in combination with spironolactone using Simon's 2-stage optimal design in patients with IDH wild type GBM at first progression.

Following determination of the Maximum Tolerated Dose and/or Recommended Phase 2 Dose from the ongoing Phase 1a study, Starlight Therapeutics plans to initiate a Phase 1b trial evaluating LP-184/STAR-001 in two cohorts of recurrent GBM patients: one arm which anticipates administration of STAR-001 as monotherapy and the other arm which anticipates administration of STAR-001 in combination with spironolactone (200 mg daily).

The trial, as currently anticipated and designed, will assess safety, pharmacokinetics, and objective response using RANO 2.0 criteria. Additionally, the study will evaluate biomarkers including PTGR1 expression, ERCC3 levels, and DNA damage markers to help identify patients most likely to respond to treatment. Lantern has previously reported on achieving significant development milestones in the creation of a molecular diagnostic using quantitative PCR to assess PTGR1 levels from clinical patient samples.

LP-184 (to be developed as STAR-001 for CNS indications) is a fully synthetic small molecule that belongs to the acylfulvene class of alkylating agents. It induces DNA double-strand breaks and has shown promise across a range of solid tumors, including in preclinical GBM models. LP-184 is activated by PTGR1, which is over-expressed in approximately 80% of recurrent GBM tumors. The FDA has granted LP-184 both Orphan Drug and Fast Track designations for the treatment of malignant gliomas / glioblastoma.

ABOUT STARLIGHT THERAPEUTICS

Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma, is focused exclusively on the clinical development and commercialization of promising oncology therapies for CNS and brain cancers. Starlight leverages Lantern's RADR® AI platform to advance precision medicine approaches for adult and pediatric patients with CNS cancers, many of which have limited or no treatment options. For more information, please visit - www.starlightthera.com .

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 platform, RADR®, leverages billions of oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. For more information, please visit http://www.lanternpharma.com .

Please find more information at:

• Website: www.lanternpharma.com
• LinkedIn: https://www.linkedin.com/company/lanternpharma/
• X: @lanternpharma

FORWARD LOOKING STATEMENT:

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR^® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR^® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that our research and the research of our collaborators may not be successful, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR^® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 18, 2024. You may access our Annual Report on Form 10-K for the year ended December 31, 2023 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.

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Source: Lantern Pharma Inc.

Released November 26, 2024

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