New data from in vitro, in vivo, and IND enabling studies supports LP-284’s development for MCL, an aggressive form of B-cell non-Hodgkin's lymphoma (NHL) with immediate patient needs.
Lantern is anticipating filing the IND with the FDA in early 2023 and initiating a first-in-human Phase 1 trial for LP-284 in NHLs, including MCL and double hit lymphoma (DHL), by mid 2023.
In the US and Europe, MCL and DHL are diagnosed in approximately 9,000 patients each year and have an estimated annual market potential of $1.2 billion USD.
DALLAS--(BUSINESS WIRE)-- Lantern Pharma, Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.") and machine learning (“M.L.”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced it presented new positive preclinical data for its drug candidate LP-284 for Mantle Cell Lymphoma (MCL) at the American Society of Hematology Annual meeting.
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Figure 1. In mice implanted with MCL CDX tumors that had been treated and then grown resistant to Bortezomib or Ibrutinib, subsequent LP-284 treatment of 4 mg/kg (i.v.) resulted in near complete tumor regression in the SOC resistant MCL CDX tumors (** p < 0.01). (Photo: Business Wire)
The ASH poster highlights new results for LP-284 from preclinical studies for MCL and initial results from investigational new drug (IND) enabling studies. LP-284 treatment was demonstrated to have significantly greater tumor growth inhibition (TGI) in mice implanted with MCL cell derived xenograft (CDX) tumors, when compared to treatment with the standard-of-care (SOC) agents Ibrutinib or Bortezomib (see Table 1).
Table 1.
Agent (Dose; Administration)
LP-284
(4 mg/kg; i.v.)
LP-284
(2 mg/kg; i.v.)
Bortezomib
(1 mg/kg; i.p.)
Ibrutinib
(50 mg/kg; p.o.)
TGI (%)
113%
63%
22%
8%
Table Legend: Tumor growth inhibition (TGI); Intravenous (i.v.); Intraperitoneal (i.p.); Oral (p.o.)
Additionally, in mouse MCL CDX tumors that had been treated and then grown resistant to either Ibrutinib or Bortezomib, subsequent LP-284 treatment of 4 mg/kg (i.v.) resulted in near complete tumor regression in the SOC resistant MCL CDX tumors (see Figure 1). These new promising results are critically important from a clinical perspective as nearly all MCL patients eventually relapse from Ibrutinib and Bortezomib treatment.
New in vitro data was also presented that identified a potential mechanism of LP-284’s anti-tumor activity in MCL. LP-284 treatment of MCL cell lines significantly down-regulated key cancer promoting genes and pathways, including the onco-fusion gene CCND1 and genes in the MYC pathway. Combined, these new in vitro and in vivo preclinical data for LP-284 strongly support its anti-tumor activity in MCL over current SOC agents and its continued advancement towards a Phase 1 clinical trial.
“This compelling pre-clinical efficacy and tumor response data, in both new lymphomas and those that had become resistant to standard of care agents, is an exciting advancement for LP-284 in hematological cancers and positions Lantern to advance our discussions with biopharma companies for partnering and collaborative development opportunities,” stated Panna Sharma, Lantern’s CEO and President. “Even with the vanguard of new CAR T-cell therapy approaches in B-cell cancers, there is a critical need for improved options for B-cell cancer patients that don’t qualify for, have access to, or can’t afford CAR T-cell therapy,” continued Sharma.
The ASH poster also shows initial results from the large animal non-GLP toxicology portion of the IND enabling studies for LP-284, where the no observed adverse effect level (NOAEL) of LP-284 was determined to be 0.3 mg/kg/dose. Establishment of the NOAEL will facilitate the completion of IND enabling studies, which Lantern is anticipating in Q1 of 2023, followed by an anticipated launch of a first in human Phase 1 clinical trial later in 2023.
A full version of the poster presentation can be found on Lantern’s website.
About LP-284:
LP-284 is a novel small molecule and DNA damaging agent being developed by Lantern for the treatment of several non-Hodgkin’s lymphomas (NHL) including MCL and double hit lymphoma (DHL). Lantern’s LP-284 program has been accelerated and de-risked using A.I. insights and biological modeling powered by RADR®. Lantern has been able to advance LP-284 from initial RADR® insights regarding anti-cancer activity and potential mechanisms of action in hematological cancers, to selection of specific subtypes of lymphomas with superior response, to late stage IND enabling studies and initial design of first in human clinical trials in less than 2 years.
About Lantern Pharma:
Lantern Pharma (NASDAQ: LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR® A.I. and machine learning platform to discover biomarker signatures that identify patients most likely to respond to its pipeline of genomically-targeted therapeutics. Lantern is currently developing four drug candidates and an ADC program across twelve disclosed tumor targets, including two phase 2 programs. By targeting drugs to patients whose genomic pro them as having the highest probability of benefiting from the drug, Lantern's approach represents the potential to deliver best-in-class outcomes.
Forward-looking Statements:
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