DALLAS, July 27, 2021 /PRNewswire/ -- Lantern Pharma
(NASDAQ: LTRN), a clinical stage biopharmaceutical company using
its proprietary RADR® artificial intelligence ("A.I.")
platform to transform the cost, pace, and timeline of oncology drug
discovery and development, today announced it has entered into an
Asset Purchase Agreement to reacquire global development and
commercialization rights for Irofulven (LP-100) from Allarity,
formerly known as Oncology Venture. This transaction includes
global rights to the clinical stage drug candidate Irofulven
(LP-100), as well as the developed clinical protocol for an
intended study in bladder and prostate cancer patients who have a
mutation in the ERCC2/3 genes. Lantern also received an exclusive
license to use Allarity's companion diagnostic in future
development and commercialization of LP-100. Lantern will assume
full authority to manage and guide future clinical development and
commercialization of the drug candidate.
![Lantern Pharma (LTRN) Logo (PRNewsfoto/Lantern Pharma) Lantern Pharma (LTRN) Logo (PRNewsfoto/Lantern Pharma)](https://mma.prnewswire.com/media/1216507/Lantern_Pharma_Logo.jpg)
"Based on the promising initial survival data, and the new
observations on LP-100's efficacy in cancers with DNA repair
deficiency, regaining the rights and future control of the program
will increase Lantern's strategic flexibility regarding
drug-development, and greatly increase the potential upside to
Lantern from future successful development of LP-100," said
Panna Sharma, President and CEO of
Lantern Pharma. "This program is very synergistic with our other
drug candidates that are also focused on DNA damage repair and the
NER pathway. Most importantly, LP-100 has the potential to be an
important compound — either as monotherapy or in combination — for
several challenging cancers that are impacting patients globally.
We are looking forward to advancing the LP-100 program using our
data-driven and precision medicine approach."
In the current Phase 2 trial, being conducted in Denmark, 9 patients, out of a targeted
enrollment of 27, have been treated based on meeting criteria
established by Allarity's DRP® (Drug Response
Predictor) companion diagnostic technology. The current Irofulven
clinical trial seeks to evaluate the anti-tumor effect after
treatment of Irofulven in combination with prednisolone in patients
who progressed on androgen receptor (AR)-targeted therapy and
docetaxel-pretreated metastatic castration-resistant prostate
cancer patients. Results from the initial 9 patients have shown a
median overall survival (mOS) of 12.5 months, which is
substantially greater than other 4th line (and later) regimens of
metastatic castration-resistant treatment that have generated mOS
ranging from 7.1 to 9.9 months. Based on this improvement in
overall survival, and other observations from discussions with
study investigators, Lantern will be working with clinical trial
investigators and sites to evaluate further enrollment. Lantern
will also be considering other improvements, guided by data and
publications, suggesting enhanced efficacy of LP-100 in tumors with
mutations in certain DNA repair genes. Lantern believes that
using DNA repair gene mutations or deficiency as an additional
selection criteria has the potential to enhance the selection of
patients that can respond to and benefit from LP-100 therapy and
further improve mOS.
Analysts at GlobalData estimate that there were over 42,900
cases of metastatic castration-resistant prostate cancer in the US
during 2020, and over 170,000 cases globally. Approximately 25-30%
of these patients in the US and globally, need treatment options in
the third-line setting, or later and have the potential for
treatment with LP-100 once approved as a therapeutic in this
setting. In addition, approximately 25-30% of all metastatic
prostate cancers have been observed to have mutations in DNA repair
genes in multiple meta-analysis of the disease.
According to Sharma, "Our goal is to build upon the existing
trial in metastatic castration-resistant prostate cancer patients
and evaluate additional launches in other cancers with mutations in
ERCC2/3, BRCA, PTEN, ATM, and other DNA-repair pathway genes.
Several studies have shown efficacy of LP-100 and LP-184 in these
pathways, especially in prostate and bladder cancers. Having both
of these drug candidates in our portfolio is synergistic and allows
us to develop several options towards a potentially approved
therapeutic in cancers with significant unmet need for tens of
thousands of patients annually."
LP-100 was initially revitalized by Lantern and its founders
using a genomic and data-driven approach to uncover those cancers
that were most sensitive to LP-100, and then focusing on the
genomic features of the prostate cancers that showed the most
sensitivity to the compound. According to Sharma, "Bringing LP-100
back to Lantern is the best path for the future development of this
drug candidate allowing for a hybrid approach that combines
real-world patient genomics and data-driven drug development."
Under the terms of the Asset Purchase Agreement, Lantern will
pay an initial upfront amount of US $1.0
million, and future escrow payments that have the potential
to deliver an additional US $1.0
million to Allarity based on drug manufacturing and trial
enrollment milestones within the next 24 months. Allarity is also
eligible to receive up to US $16
million in additional milestone payments over the life of
the program based on IP license milestones and regulatory filings
and approvals in the US and EU, and low- to mid-single-digit
royalties on future commercial net sales.
"We are looking forward to further developing and extending the
potential of LP-100 for cancer patients, and this agreement allows
us to provide additional focus and resources on defining this drug
candidate's role in both prostate and other DNA repair deficient
cancers. We are encouraged by the initial observations from the
first 9 patients, and we believe these observations support further
study of LP-100 in terms of the role it might play in the battle to
extend survival in late stage prostate cancer patients," stated
Panna Sharma, CEO of Lantern
Pharma.
Contacts
Investor Relations
Panna Sharma, CEO
IR@lanternpharma.com
628-777-3339
Public Relations
Nicholas Koulermos, Vice
President
lantern@5wpr.com
646-843-1812
About Lantern Pharma
Lantern Pharma (LTRN) is a
clinical-stage oncology-focused biopharmaceutical company
leveraging its proprietary RADR® A.I. platform and
machine learning 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 seven 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. More
information is available at: www.lanternpharma.com and Twitter
@lanternpharma.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the United States Securities Act of
1933, as amended, and Section 21E of the United States Securities
Exchange Act of 1934, as amended. These forward-looking statements
involve risks, uncertainties and other factors, many of which are
outside of Lantern's control and which could cause actual results
to differ materially from the results discussed in the
forward-looking statements. These forward-looking statements
include statements concerning Lantern's plans, objectives, goals,
future events, performance and/or other information that is not
historical information, including among other things, statements
relating to: future events; strategic plans to develop and advance
Irofulven (LP-100); potential future clinical testing and treatment
indications for Irofulven (LP-100); and estimates regarding
potential markets and potential market sizes. There are a number of
important factors that could cause 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
clinical testing and development of Irofulven (LP-100) may not be
successful and may not yield meaningful results, (iii) the risk
that Irofulven (LP-100) may not receive future regulatory marketing
approval or otherwise become a commercial product, and (iv) those
other factors set forth in the Risk Factors section in Lantern's
Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and
Exchange Commission on March 10,
2021. You may access Lantern's Annual Report on Form 10-K
for the year ended December 31, 2020
under the investor SEC filings tab of Lantern's website
at www.lanternpharma.com or on the SEC's website
at www.sec.gov. Given these risks and uncertainties, Lantern
can give no assurances that such forward-looking statements will
prove to be accurate, or that any other results or events projected
or contemplated by such forward-looking statements will in fact
occur, and investors are cautioned not to place undue reliance on
these statements. All forward-looking statements in this press
release represent the judgment of Lantern as of the date hereof,
and, except as otherwise required by law, Lantern disclaims any
obligation to update any forward-looking statements to conform the
statement to actual results or changes in its expectations.
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SOURCE Lantern Pharma