Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM)
(“Aptorum Group”), a biopharmaceutical company focused on the
development of novel therapeutics including orphan diseases and
oncology indications, announced further positive data from its
latest in vivo studies showing significant activity against
neuroblastoma tumor reduction when treated with its lead compound
SACT-1 in combination with standard of care (SOC) chemotherapy.
Separately, SACT-1 was also screened for its in vitro activity
against over 300 cancer cell lines and showed positive results in a
number of cancer types including in particular colorectal cancer,
leukemia and lymphoma, etc.
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**Unpaired student’s t-test, p<0.01,
n=8 (based on initial 22 days period) (Graphic: Business Wire)
Our repurposed drug candidate, SACT-1 is undergoing preparation
for IND submission and is on track for regulatory application to
target to commence phase 1b/2a clinical trials under the US FDA’s
505(b)(2) pathway.
“Neuroblastoma is one of the most prevailing solid tumor cancers
in children, representing 8% - 10% of all childhood tumors,
accounting for c. 15% of all cancer related deaths in the pediatric
population1. For the high-risk patient group, the 5-year survival
rate of this condition is around 40-50% as observed by the American
Cancer Society2 based on existing treatment. We are delighted to
see the progress of our SACT-1, one of our first assets from our
SMART-ACT® platform. We are extremely excited to observe SACT-1’s
significant effect on tumor shrinkage when used in combination with
standard of care chemotherapy in our latest in vivo studies.
Moreover, we believe that SACT-1 may have potential applications in
a number of other cancer types, including non-orphan cancers, which
we will be continuing to investigate further for its wider
application,” said Dr. Clark Cheng, the Chief Medical Officer and
Executive Director of the company.
Summary of our in vivo assessment against neuroblastoma and in
vitro assessment against other cancers are discussed below.
Neuroblastoma In Vivo Assessment
Based on the initial 22 day data of a recent study we conducted
in a xenograft mouse model of neuroblastoma, SACT-1 was orally
administered daily at 60mg/kg in combination of SOC chemotherapy
brought a statistically significant tumor shrinkage (unpaired
student’s t-test, p<0.01) from Day 15 to Day 22, compared to the
control group which received SOC only. Indeed, the combination
reduced the tumor size by up to 54.2% in the first 22 days compared
with the control (SOC only). SACT-1 appears to be effective in
accelerating the effect of the SOC in early time points (from Day 1
- 7 vs control). This further supports our earlier in vitro
observation that SACT-1 promotes tumor DNA damage and tumor cell
death.
Other Cancer Types In Vitro Assessment
In addition, SACT-1 was also screened for in vitro activity in a
panel of over 300 cancer cell lines. Similar to our previous
findings against neuroblastoma cell lines, SACT-1 exhibits similar
anti-tumor efficacy across one or more other major cancer types,
including but not limited to colorectal cancer, leukemia and
lymphoma cell lines. As a result, in addition to treating
neuroblastoma, SACT-1 may have potential applications in the
treatment of other cancers. Based on this discovery, the company
plans to carry out further in vivo studies to study the efficacy of
SACT-1 over other types of cancers to maximize the potential of
SACT-1.
About SACT-1
As part of Aptorum Group’s SMART-ACT® platform, SACT-1 was
discovered from our SMART-ACT® platform focused on orphan and unmet
diseases. SACT-1 is a repurposed drug targeted for the treatment of
neuroblastoma (and potentially other cancer types) especially in
combination with SOC chemotherapy. SACT-1’s mechanism has been
demonstrated in vitro to enhance DNA damage and tumor cell
death.
About Aptorum Group Limited
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a
pharmaceutical company dedicated to developing and commercializing
novel therapeutics to tackle unmet medical needs. Aptorum Group is
pursuing therapeutic projects in orphan diseases, infectious
diseases, metabolic diseases, woman’s health and other disease
areas.
For more information about Aptorum Group, please visit
www.aptorumgroup.com.
For further general presentation, please visit:
https://ir.aptorumgroup.com/static-files/ca36cc65-6f23-4105-895e-f5f234ecca1e
Disclaimer and Forward-Looking Statements
This press release does not constitute an offer to sell or a
solicitation of offers to buy any securities of Aptorum Group.
This press release includes statements concerning Aptorum Group
Limited and its future expectations, plans and prospects that
constitute “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. For this purpose,
any statements contained herein that are not statements of
historical fact may be deemed to be forward-looking statements. In
some cases, you can identify forward-looking statements by terms
such as “may,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,”
“believes,” “estimates,” “predicts,” “potential,” or “continue,” or
the negative of these terms or other similar expressions. Aptorum
Group has based these forward-looking statements, which include
statements regarding projected timelines for application
submissions and trials, largely on its current expectations and
projections about future events and trends that it believes may
affect its business, financial condition and results of operations.
These forward-looking statements speak only as of the date of this
press release and are subject to a number of risks, uncertainties
and assumptions including, without limitation, risks related to its
announced management and organizational changes, the continued
service and availability of key personnel, its ability to expand
its product assortments by offering additional products for
additional consumer segments, development results, the company’s
anticipated growth strategies, anticipated trends and challenges in
its business, and its expectations regarding, and the stability of,
its supply chain, and the risks more fully described in Aptorum
Group’s Form 20-F and other filings that Aptorum Group may make
with the SEC in the future, as well as the prospectus that received
the French Autorité des Marchés Financiers visa n°20-352 on 16 July
2020.
As a result, the projections included in such forward-looking
statements are subject to change and actual results may differ
materially from those described herein. Aptorum Group assumes no
obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or
otherwise.
This announcement is not a prospectus within the meaning of the
Regulation (EU) n°2017/1129 of 14 June 2017 as amended by
Regulations Delegated (EU) n°2019/980 of 14 March 2019 and
n°2019/979 of 14 March 2019.
This press release is provided “as is” without any
representation or warranty of any kind.
1
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668791/#:~:text=Neuroblastoma%20is%20the%20most%20common,deaths%20in%20the%20pediatric%20population.
2
https://www.cancer.org/cancer/neuroblastoma/detection-diagnosis-staging/survival-rates.html
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Investor relations
Aptorum Group limited Investor Relations Department: Tel: +44
020 80929299 Email: investor.relations@aptorumgroup.com
Redchip – Financial Communications United States Investor
relations RedChip Companies, Inc. dave@redchip.com +1 407 491
4498
Actifin – Financial Communications Europe Investor relations
Ghislaine Gasparetto ggasparetto@actifin.fr +33 1 56 88 11 22
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