Yumanity Therapeutics (NASDAQ: YMTX), a biopharmaceutical company
focused on the development of innovative, disease-modifying
therapies for neurodegenerative diseases, today announced results
of a study that demonstrate in vivo efficacy, including increased
median overall survival, of YTX-7739 in a mouse model for
glioblastoma multiforme (GBM). The study was conducted by
researchers at the Massachusetts General Hospital and is being
presented virtually today at the Society for NeuroOncology/National
Cancer Institute (SNO/NCI) Joint Symposium: Targeting CNS Tumor
Metabolism. YTX-7739 is currently in clinical development by
Yumanity Therapeutics as a potential treatment for Parkinson’s
disease.
The research entitled, Targeting Fatty Acid Biosynthesis in
Glioblastoma, was conducted in the laboratory of Christian E. Badr,
Ph.D., of Massachusetts General Hospital and presented by Katharina
M. Eyme. They had recently shown that GBM cancer stem cells are
highly susceptible to pharmacological permutation of stearoyl-CoA
desaturase (SCD). SCD inhibition in these cells leads to the toxic
accumulation of saturated fatty acids and impairs DNA damage
repair, hence sensitizing cells to DNA-damaging agents such as
temozolomide (TMZ). In this study, YTX-7739, an orally available
SCD inhibitor that is in clinical development for the treatment of
Parkinson’s disease, was administered either alone or with TMZ to
mice following intracranial implantation of GBM cells. The
investigators found that YTX-7739, and a second SCD inhibitor in
development by Yumanity, YTX-9184, each increased median survival
as monotherapy and was synergistic with TMZ in both aggressive and
slow growing tumors. The authors concluded that SCD inhibition
could possibly be a viable approach to improving treatment of GBM
in humans, as either single or adjunctive therapy.
“These data point to modulation of SCD activity as a potential
shared therapeutic target between Parkinson’s disease and
glioblastoma, expanding the potential promise of our lead asset,
YTX-7739, to non-neurodegenerative brain diseases,” said Richard
Peters, M.D., Ph.D., President, Chief Executive Officer and
Director of Yumanity Therapeutics. “As a science-driven
organization that is dedicated to developing disease-modifying
drugs for patients with high unmet medical needs, we are working
with our collaborators at the Massachusetts General Hospital to
explore its compelling preclinical results and how they might be
leveraged to benefit patients suffering from glioblastoma.”
About YTX-7739YTX-7739 is Yumanity
Therapeutics’ proprietary lead small molecule investigational
therapy designed to penetrate the blood-brain barrier and inhibit
the activity of a novel target, stearoyl-CoA desaturase (SCD). SCD
appears to play an important and previously unrecognized role in
mitigating neurotoxicity arising from the effects of pathogenic
alpha-synuclein protein aggregation and accumulation, which
ultimately results in the death of neurons and the subsequent
dysregulation of movement and cognition that afflicts patients
living with these diseases. Through inhibition of SCD, YTX-7739
modulates an upstream process in the alpha-synuclein pathological
cascade and has been shown to rescue or prevent toxicity in
cellular and preclinical models. The company is assessing the
potential utility of YTX-7739 as a disease modifying therapy for
Parkinson’s disease.
About SCDSCD is an enzyme that catalyzes fatty
acid desaturation, the products of which are incorporated into
phospholipids, triglycerides, or cholesterol esters. These
lipid-related molecules regulate multiple diverse cellular
properties and processes, including membrane structure and
function, vesicle trafficking, intracellular signaling and
inflammation. SCD expression is regulated by a transcription factor
known as SREBF1, which has been identified in human genome-wide
association studies as a risk factor for Parkinson’s disease. In
preclinical models, SCD inhibition appears to normalize the dynamic
interaction of pathological alpha-synuclein with membranes, which
improves neuronal function and reduces toxicity, leading to
enhanced neuronal survival. Alpha-synuclein-dependent disruption of
membrane-related biological pathways, such as vesicle trafficking,
is closely linked to the formation of Lewy body protein/membrane
aggregations, a hallmark pathological feature of Parkinson’s
disease.
About Yumanity TherapeuticsYumanity
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to accelerating the revolution in the treatment of
neurodegenerative diseases through its scientific foundation and
drug discovery platform. The Company’s most advanced product
candidate, YTX-7739, is currently in Phase 1 clinical development
for Parkinson’s disease. Yumanity’s drug discovery platform is
designed to enable the Company to rapidly screen for potential
disease-modifying therapies by overcoming toxicity of misfolded
proteins in neurogenerative diseases. Yumanity’s pipeline consists
of additional programs focused on Lewy body dementia, multi-system
atrophy, amyotrophic lateral sclerosis (ALS or Lou Gehrig’s
disease), frontotemporal lobar dementia (FTLD), and Alzheimer’s
disease. For more information, please visit www.yumanity.com.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by words and phrases such as “aims,” “anticipates,” “believes,”
“could,” “designed to,” “estimates,” “expects,” “forecasts,”
“goal,” “intends,” “may,” “plans,” “possible,” “potential,”
“seeks,” “will,” and variations of these words and phrases or
similar expressions that are intended to identify forward-looking
statements. These forward-looking statements include, without
limitation, statements regarding the potential therapeutic benefits
of our prospective product candidates and results of preclinical
studies, including YTX-7739, and the design, commencement,
enrollment, and timing of ongoing or planned clinical trials,
clinical trial results, product approvals and regulatory pathways,
and the anticipated benefits of our drug discovery platform. Any
such statements in this press release that are not statements of
historical fact may be deemed to be forward-looking statements.
Results in preclinical or early-stage clinical trials may not be
indicative of results from later stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements, or the scientific data
presented.
Any forward-looking statements in this press release are based
on Yumanity Therapeutics’ current expectations, estimates and
projections about our industry as well as management’s current
beliefs and expectations of future events only as of today and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to, the risk that
any one or more of our product candidates will not be successfully
developed or commercialized, the risk of cessation or delay of any
ongoing or planned clinical trials of Yumanity Therapeutics or our
collaborators, the risk that Yumanity Therapeutics may not
successfully recruit or enroll a sufficient number of patients for
our clinical trials, the risk that Yumanity Therapeutics may not
realize the intended benefits of its drug discovery platform, the
risk that our product candidates will not have the safety or
efficacy profile that we anticipate, the risk that prior results,
such as signals of safety, activity or durability of effect,
observed from preclinical or clinical trials, will not be
replicated or will not continue in ongoing or future studies or
trials involving Yumanity Therapeutics’ product candidates, the
risk that we will be unable to obtain and maintain regulatory
approval for our product candidates, the risk that the size and
growth potential of the market for our product candidates will not
materialize as expected, risks associated with our dependence on
third-party suppliers and manufacturers, risks regarding the
accuracy of our estimates of expenses and future revenue, risks
relating to our capital requirements and needs for additional
financing, risks relating to clinical trial and business
interruptions resulting from the COVID-19 outbreak or similar
public health crises, including that such interruptions may
materially delay our enrollment and development timelines and/or
increase our development costs or that data collection efforts may
be impaired or otherwise impacted by such crises, and risks
relating to our ability to obtain and maintain intellectual
property protection for our product candidates. For a discussion of
these and other risks and uncertainties, and other important
factors, any of which could cause Yumanity Therapeutics’ actual
results to differ materially and adversely from those contained in
the forward-looking statements, see the section entitled “Risk
Factors” in the definitive proxy statement/prospectus/information
statement filed with the Securities and Exchange
Commission on November 12, 2020, as well as discussions
of potential risks, uncertainties, and other important factors in
Yumanity Therapeutics’ subsequent filings with the Securities
and Exchange Commission. Yumanity Therapeutics explicitly disclaims
any obligation to update any forward-looking statements except to
the extent required by law.
Investors:Burns McClellan, Inc.John
Grimaldijgrimaldi@burnsmc.com (212) 213-0006
Media:Burns McClellan, Inc.Ryo Imai / Robert
Flamm, Ph.D.rimai@burnsmc.com / rflamm@burnsmc.com (212)
213-0006
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