Yumanity Therapeutics Announces Study Demonstrating In Vivo Efficacy of YTX-7739 in a Glioblastoma Multiforme (GBM) Mouse Model

Boston, Massachusetts, UNITED STATES

YTX-7739 demonstrates efficacy, including increased median overall survival, both as a single agent and in combination with temozolomide, the standard-of-care for GBM

Shared therapeutic target with Parkinson’s disease expands potential utility of 
YTX-7739 to non-neurodegenerative diseases

Study presented at SNO/NCI Joint Symposium: Targeting CNS Tumor Metabolism

BOSTON, April 06, 2021 (GLOBE NEWSWIRE) -- 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-7739
YTX-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 SCD
SCD 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 Therapeutics
Yumanity 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 Statements
This 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.

Burns McClellan, Inc.
John Grimaldi
(212) 213-0006

Burns McClellan, Inc.
Ryo Imai / Robert Flamm, Ph.D.
rimai@burnsmc.com / rflamm@burnsmc.com
(212) 213-0006