- 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.
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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20221215005355/en/
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 profile identifies 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:
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 impact of the COVID-19
pandemic, (ii) the risk that our research and the research of our
collaborators may not be successful, (iii) 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, (iv) the risk that no drug product based on our
proprietary RADR® A.I. platform has received FDA marketing approval
or otherwise been incorporated into a commercial product, and (v)
those other factors set forth in the Risk Factors section in our
Annual Report on Form 10-K for the year ended December 31, 2021,
filed with the Securities and Exchange Commission on March 10,
2022. You may access our Annual Report on Form 10-K for the year
ended December 31, 2021 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221215005355/en/
Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Please find more information at: Website: www.lanternpharma.com
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