LTRN: Multiple Collaborations Illuminating Way Forward

By John Vandermosten, CFA

NASDAQ:LTRN

READ THE FULL LTRN RESEARCH REPORT

Since Our Last Update

Lantern Pharma, Inc. (NASDAQ:LTRN) has promulgated several updates since our report on the company’s third quarter 2021 results. In its latest corporate presentation, Lantern also updated the number of datapoints that have been accumulated on its Response Algorithm for Drug Positioning & Rescue (RADR) platform to over 13 billion in January 2022, a tenfold increase over levels a year ago.

Highlights since our last update include:

➢ LP-184 presentation at SNO1 2021 Annual Meeting – November 2021

➢ Presentation of KOL event – November 2021

➢ Share repurchase program announced – November 2021

➢ Positive data presented on LP-284 at the 63rd ASH2 Annual Meeting – December 2021

➢ Precision oncology collaboration with NCI expanded – January 2022

➢ Collaboration and research agreement executed with DCRC – January 2022

Share Repurchase Program

On November 22, 2021, Lantern announced that its board had authorized a share repurchase program to acquire up to $7 million of Lantern’s common stock. Lantern may purchase its common stock on the open market, through private transactions or otherwise. The timing, share repurchase amount and price will vary on market conditions as well as corporate and regulatory limitations.

Lantern Expands NCI Precision Oncology Collaboration

On January 12, 2022, Lantern announced the expansion of its precision oncology collaboration with the National Cancer Institute (NCI). Lantern first entered into the partnership with the NCI’s Developmental Therapeutics Branch (DTB) in October 2019 to identify gene signatures that help predict a potential response of a patient’s tumor to a drug therapy. After identifying biomarker correlations for Lantern’s LP-184 and LP-284, the second phase of the collaboration will leverage CellMiner and CellMinerCDB data in search of additional -omic response predictors. Data from Project Achilles at the Broad Institute will also be included for insight into efficacy under specific genetic and molecular conditions.

Danish Cancer Society Research Center Collaboration

On January 18, 2022, Lantern announced a collaboration and research agreement with The Danish Cancer Society Research Center (DCRC) to support clinical development of LP-100 and LP-184, as well as the development of improved diagnostic methods to identify nucleotide excision repair (NER) deficient tumors, a predictor of LP-100 and LP-184 efficacy. The collaboration will explore the use of expanded mutational signature-based analyses to identify said tumors, and will include a comprehensive analysis of breast, ovarian, prostate, lung, kidney, bladder, stomach, pancreatic and esophageal cancer. Through the collaboration, patients that can benefit from NER deficiency targeting will be identified, which will assist in determining overall market size for the candidates. Dr. Zoltan Szallasi, MD, principal investigator at DCRC, will lead the collaboration research. Dr. Szallasi serves joint appointments as Group Leader of the Translational Cancer Genomics department at DCRC and as Faculty, Computational Health Informatics Program (CHIP) and Assistant Professor of Pediatrics at Boston Children’s Hospital affiliated with Harvard Medical School. The collaboration is also expected to add millions of datapoints to Lantern’s RADR platform.

Presentations

Lantern presented at both SNO3 Annual Meeting 2021 in mid-November and the 63rd ASH4 Annual Meeting in mid-December 2021.

At the SNO meeting, in vivo and in vitro results were presented for LP-184 in glioblastoma multiforme (GBM) expressing elevated PTGR1. Results showed nanomolar potency in multiple cell lines, including those predicted to be sensitive to LP-184 (PTEN mutant), and one GBM cell line with unmethylated MGMT promoter, known to be resistant to standard of care temozolomide (TMZ) chemotherapy. LP-184 was found to be 300-1000 times more potent than TMZ. LP-184 also showed near complete tumor regression and survival benefit in subcutaneous and intracranial GBM xenograft models, respectively. LP-184 was found to have comparable blood-brain barrier permeability to TMZ. The poster presentation can be found here.

The ASH meeting featured positive in vitro data for LP-284 in hematologic cancers. The research sought to evaluate the efficacy of LP-284 in the NCI’s 60 human tumor cell lines (NCI-60), which have the most extensive cancer pharmacology database in the world.5  The research also aimed to identify the metabolic activation enzyme of LP-284 in silico and the hematologic cancer subtypes that may be amenable to LP-284 treatment. Results showed a distinct anti-tumor profile of LP-284 versus other compounds in Lantern’s portfolio and had the broadest anti-hematologic cancer activity. Unlike LP-184 and Irofulven, LP-284 did not show activity correlated with PTGR1 expression. But with activity in low PTGR1 expressing hematologic cancer cell lines, an alternative LP-284 activator was evident. LP-284 exhibited nanomolar potency in mantle cell lymphoma, Burkitt’s lymphoma, multiple myeloma, chronic myeloid leukemia, and acute lymphoblastic leukemia. Finally, spironolactone was found to sensitize SUDHL6 (double-hit lymphoma) and RPMI8226 (multiple myeloma) cell lines, reducing LP-284’s IC50 by 2.4-fold. The poster presentation can be found here.

Phase II Clinical Trial For LP-300

Lantern expects to launch a Phase II trial for LP-300 in never-smoker non-small cell lung cancer (NSCLC) patients in the next several months. Problems related to equipment, materials and staffing at the drug manufacturer led to a delay in delivering product to clinical sites for LP-300. Partner Deep Lens was added to enable faster recruitment of suitable patients in the never-smoker NSCLC study. The partner’s technology will search through thousands of medical records to match the most appropriate patients with the objectives of the trial. 20 sites are expected to enroll from 4 to 5 patients each, helping achieve the 90-patient target.

The company is interfacing with the FDA and other regulatory bodies to refine the design of the trial and is seeking approval from investigators and institutional review boards. Lantern expects to use a combination treatment that includes doublet chemotherapy. The trial is expected to be a two-year, multi-center study enrolling 90 patients equally split between two arms of standard of care chemotherapy and standard of care chemotherapy + LP-300. Subjects enrolled in the study will have been diagnosed with adenocarcinoma NSCLC with little to no history of smoking and no prior chemotherapy. Beyond assessing the response to treatment in the target population, the trial will also serve to assess the efficacy of LP-300 in combination with chemotherapy on non-smokers, compare efficacy of LP-300 in non-smoking males and non-smoking females, further investigate safety, toxicity and tolerability and investigate biomarkers. Endpoints are expected to be overall survival, progression-free survival, objective response rate, identification of gene signatures correlated with potential LP-300 efficacy from matched tumor tissue analysis and protection against chemotherapy-induced nephrotoxicity.

Milestones

➢ LP-100 (mCRPC)

◦ Responsibility for trial transferred to Lantern – July 2021

◦ Refine and simplify trial design – 2022

◦ Reenter the clinic – 2022

➢ LP-300 (non-smoker NSCLC)

◦ Collaboration with Deep Lens to accelerate recruitment – 3Q:21

◦ Launch of 90 patient Phase II – 1H:22

➢ LP-184 (pancreatic cancer)

◦ Granted orphan designation – August 2021

◦ Host KOL event – November 18, 2021

◦ Develop and submit IND – 2022

◦ Phase I trial – mid-2022

➢ LP-184 (GBM)

◦ Preclinical results from collaborative research program – November 2021

◦ Launch Phase I/II study – 2022

➢ LP-184 (ADCs)

◦ Preclinical studies launched – 2022

◦ Preclinical data available – 2022

◦ IND development – 2022

➢ LP-284

◦ Data presentation at American Society of Hematology (ASH) conference – December 2021

Summary

Lantern has provided several updates since our report on the company’s third quarter 2021 results. In its latest corporate presentation, Lantern updated its datapoint count for the RADR platform which surpassed 13 billion datapoints in January 2022. Highlights since our last update include LP-184 presentation at SNO 2021 Annual Meeting, a virtual KOL webinar, the announcement of a $7 million share repurchase program, presentation on LP-284 at 63rd ASH Annual Meeting, expansion of collaboration with NCI, and establishment of a collaboration and research agreement with DCRC.

Management anticipates 2022 to be a year of continued growth and progress with six programs in the pipeline and a large war chest of cash to fund preclinical and clinical work for years to come. We anticipate the start of the Phase II LP-300 study in NSCLC among non-smokers in 2022, and look forward to IND-enabling studies of LP-184 in multiple solid tumors, continued advancement of the ADC program and further investment in RADR’s growing dataset. Management also expects to disclose additional PTGR1 over-expressing tumors as indications for LP-184. LP-284 has emerged as a contender in hematologic cancers based on an evaluation by RADR and in-vitro studies.

For added detail on Lantern’s proprietary AI development platform, RADR, and for background on indications and Lantern’s clinical candidates, please refer to further discussion in our initiation.

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1. Society for Neuro-Oncology

2. American Society of Hematology

3. Society for Neuro-Oncology

4. American Society of Hematology

5. Abaan OD, Polley EC, Davis SR, et al. (2013) The exomes of the NCI-60 panel: a genomic resource for cancer biology and systems pharmacology. Cancer Research.

6. Source: Lantern Pharma January 2022 Corporate Presentation.

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