YTX-7739 / J&J - LARVOL DELTA

COMPARATIVE PHARMACOLOGY AND EFFICACY ESTABLISHES A PLASMA BIOMARKER FOR YTX-7739, A CLINICAL STAGE STEAROYL-COA DESATURASE INHIBITOR FOR PARKINSON’S DISEASE (ADPD 2022) - "The robust pharmacology and efficacy associated with SCD inhibition by YTX-7739 support and inform on-going clinical evaluation of YTX-7739 as a disease-modifying drug for synucleinopathies. Importantly, the strong correlation between plasma and brain pharmacology establishes plasma as a suitable matrix to assess target engagement in human clinical studies."

Biomarker • Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • SCD

Targeting de novo lipid synthesis induces lipotoxicity and impairs DNA damage repair in glioblastoma mouse models. (PubMed, Sci Transl Med) - "When administered as a single agent, or in combination with temozolomide (TMZ), YTX-7739 showed therapeutic efficacy in orthotopic GSC mouse models owing to its lipotoxicity and ability to impair DNA damage repair. Conversely, AMPK activation mitigates lipotoxicity and renders GSCs resistant to the loss of DNLS, both in culture and in vivo, by decreasing the saturation state of phospholipids and diverting toxic lipids into lipid droplets. Together, our findings reveal mechanisms of metabolic plasticity in GSCs and provide a framework for the rational integration of DNLS-targeted GBM therapies."

Journal • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • SCD

Yumanity Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Developments (GlobeNewswire) - "As of September 30, 2022, cash, cash equivalents and investments were $8.4 million, compared to $36.5 million as of December 31, 2021. The decrease was primarily due to a $12.8 million payment to extinguish the Company’s remaining debt during the first quarter of 2022, spending on the clinical development of YTX-7739 primarily in the first quarter of 2022, and costs related to being a public company....Research and development expense was $0.7 million compared to $6.6 million for the third quarter of 2021. The decrease in R&D expense was primarily due to the elimination of a significant portion of the Company’s R&D personnel in connection with the restructuring announced in February 2022 as well as pausing of clinical development efforts for YTX-7739 while the U.S. Food and Drug Administration partial clinical hold is in effect."

Commercial • CNS Disorders • Parkinson's Disease

Yumanity Therapeutics Announces Effectiveness of Registration Statement on Form S-4 In Connection With Proposed Asset Sale to Janssen and Merger with Kineta, Inc. (Yahoo News) - "Yumanity Therapeutics, Inc...announced that the registration statement on Form S-4 (the 'Registration Statement'), relating to the previously announced asset sale to Janssen Pharmaceutica NV ('Janssen') and merger with Kineta, Inc. ('Kineta'), has been declared effective by the U.S. Securities and Exchange Commission....The first definitive agreement is an asset purchase agreement for the sale of Yumanity’s lead clinical-stage product candidate, YTX-7739, as well as Yumanity’s unpartnered discovery-stage neuroscience product candidates and targets to Janssen, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, for $26 million in cash."

M&A • CNS Disorders • Parkinson's Disease

Yumanity Therapeutics Reports Second Quarter 2022 Financial Results and Recent Corporate Developments (GlobeNewswire) - “Research and development (R&D) expense: Research and development expense was $1.1 million compared to $7.3 million for the second quarter of 2021. The decrease in R&D expense was primarily due to the elimination of a significant portion of the Company’s R&D personnel in connection with the restructuring announced in February 2022 as well as pausing of clinical development efforts for YTX-7739 while the FDA partial clinical hold is in effect.”

Commercial • CNS Disorders • Parkinson's Disease

Yumanity Therapeutics Announces Definitive Agreements for Two Strategic Transactions (GlobeNewswire) - "Yumanity Therapeutics, Inc...announced it has entered into definitive agreements for two strategic transactions....The first definitive agreement is an asset purchase agreement for the sale of Yumanity’s lead clinical-stage product candidate, YTX-7739, as well as Yumanity’s unpartnered discovery-stage neuroscience product candidates and targets to Janssen Pharmaceutica NV ('Janssen'), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, for $26 million in cash....Under the second definitive agreement, Kineta will become a wholly-owned subsidiary of Yumanity in an all-stock transaction, resulting in a combined publicly traded company re-named Kineta, Inc., that will focus on immuno-oncology and continue Yumanity’s ongoing research collaboration with Merck & Co. in amyotrophic lateral sclerosis and frontotemporal lobar dementia."

M&A • CNS Disorders • Parkinson's Disease

"$YMTX to sell clinical-stage product candidate YTX-7739 as well as its unpartnered discovery-stage neuroscience product candidates and targets to Janssen in $26M cash transaction. $JNJ" (@BioStocks)

Clinical

Yumanity Therapeutics Reports First Quarter 2022 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Yumanity Therapeutics...today announced financial results for the first quarter ended March 31, 2022, and provided an overview of the Company’s recent corporate developments....As of March 31, 2022, cash, cash equivalents and investments were $17.5 million, compared to $36.5 million as of December 31, 2021. The decrease was primarily due to a $12.7 million payment to extinguish the Company’s remaining debt, as well as spending on the clinical development of YTX-7739 and costs related to being a public company."

Commercial • CNS Disorders • Parkinson's Disease

A Brain-Penetrant Stearoyl-CoA Desaturase Inhibitor Reverses α-Synuclein Toxicity. (PubMed, Neurotherapeutics) - "YTX-7739 efficiently reduced pS129 + and PK-resistant αSyn in both human wild-type αSyn and 3K mutant mice similar to the level of 3K-SKO. Together, these data provide further validation of SCD as a PD therapeutic target and YTX-7739 as a clinical candidate for treating human α-synucleinopathies."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • SCD

Yumanity Therapeutics Reports Full-Year 2021 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Yumanity Therapeutics...today announced financial results for full-year ended December 31, 2021 and provided an overview of the Company’s recent corporate developments....Research and development expense was $26.4 million compared to $22.3 million for the prior year. The increase in R&D expense was due to the costs associated with the YTX-7739 clinical program, the YTX-9184 preclinical program, and increased spending on early-stage discovery efforts."

Commercial • CNS Disorders • Parkinson's Disease

A BRAIN-PENETRANT STEAROYL-COA DESATURASE INHIBITOR REVERSES Α-SYNUCLEIN TOXICITY IN CELLULAR SYNUCLEINOPATHY MODELS (ADPD 2022) - "Together, these data provide validation of SCD as a therapeutic target, and YTX-7739 as a clinical candidate, for treating human α-synucleinopathies."

SCD

Non-clinical Pharmacology of YTX-7739: a Clinical Stage Stearoyl-CoA Desaturase Inhibitor Being Developed for Parkinson's Disease. (PubMed, Mol Neurobiol) - "YTX-7739 thus achieved sufficient concentrations in the brain to inhibit SCD and produce pharmacodynamic responses that were well-tolerated in rats and monkeys. These results provide a framework for evaluating YTX-7739 pharmacology clinically as a disease-modifying therapy to treat synucleinopathies."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • SCD

Yumanity Reports Partial Clinical Hold by U.S. FDA on Multidose Clinical Trials for YTX-7739 (GlobeNewswire) - "Yumanity Therapeutics...was notified via email by the U.S. Food and Drug Administration (FDA) that the FDA has placed a partial clinical hold on multidose clinical trials of YTX-7739, currently being developed for the treatment of Parkinson’s disease. The FDA has not halted all clinical programming and is permitting the Company’s planned single dose clinical trial to proceed. The partial clinical hold suspends initiation of multiple dose clinical trials in the U.S. until the FDA’s questions have been addressed. The Company expects to receive additional detail from the FDA within the next 30 days. Yumanity anticipates working closely with the FDA to adequately address their concerns."

Trial suspension • CNS Disorders • Parkinson's Disease

Yumanity’s Approach to Neurodegenerative Diseases Validated by Two External Collaborations (GlobeNewswire) - "Yumanity Therapeutics...today provided an update on recent corporate developments. This includes the achievement of a research milestone for our joint amyotrophic lateral sclerosis (ALS) / frontotemporal lobar dementia (FTLD) program, which triggered a $5 million milestone payment to Yumanity from Merck and the awarding of a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to accelerate early proof-of-concept testing of a promising Parkinson’s disease therapy....Yumanity was awarded a $500,000 grant to further investigate preclinical efficacy and biomarker development for YTX-7739, which is in clinical development for the treatment of Parkinson’s disease....Yumanity...is expecting to start its randomized Phase 2 clinical trial in 2022."

Commercial • Financing • New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia • Parkinson's Disease

Non-clinical pharmacology of YTX-7739, a clinical stage stearoyl-CoA desaturase inhibitor being developed for Parkinson's disease (Neuroscience 2021) - "YTX-7739 thus achieved sufficient concentrations in brain to inhibit SCD and produce pharmacodynamic responses that were well-tolerated in rats and nonhuman primates. These results provide a framework for evaluating YTX-7739 pharmacology clinically as a disease-modifying therapy to treat synucleinopathies."

Clinical • CNS Disorders • Parkinson's Disease • SCD

A brain-penetrant stearoyl-CoA desaturase inhibitor reverses α-synuclein toxicity in synucleinopathy models in vitro and in Parkinson’s disease-like mice (Neuroscience 2021) - "YTX-7739 efficiently reduced pS129+ and PK-resistant in both human wild-type αSyn and mutant 3K mice. Together, these data provide further validation of SCD as a therapeutic target, and YTX-7739 as a clinical candidate, for treating human α-synucleinopathies.; Grant Support: NIH NINDS R01 NS109510; R01 NS083845"

Preclinical • CNS Disorders • Parkinson's Disease • SCD

PHASE IB RESULTS FOR YTX-7739, AN ORALLY ADMINISTERED STEAROYL-COA DESATURASE INHIBITOR IN DEVELOPMENT FOR PARKINSON’S DISEASE (ADPD 2022) - "Conclusions Positive data from the phase Ib study of YTX-7739 patients with Parkinson’s disease will support ongoing clinical development. Study conclusions will be updated at the time or presentation."

P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease • SCD

Yumanity Therapeutics Reports Third Quarter 2021 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Yumanity Therapeutics...today announced financial results for the third quarter ended September 30, 2021 and provided an overview of the Company’s recent corporate developments and upcoming milestones....The Company expects to initiate a Phase 2 clinical trial of YTX-7739 in patients with Parkinson’s disease in 2022....Research and development expense was $6.6 million for the third quarter of 2021 compared to $5.5 million for the comparable period of the prior year. The increase in R&D expense was due to the costs associated with the YTX-7739 clinical program, the YTX-9184 preclinical program, and increased spending on early-stage discovery efforts."

Commercial • New P2 trial • CNS Disorders • Parkinson's Disease

Phase I single (SAD) and Multiple Ascending Dose (MAD) studies evaluating the safety, tolerability Pharmacokinetics (PK) and Pharmacodynamics (PD) of YTX-7739, a novel brain penetrant small molecule SCD inhibitor, in healthy subjects (CTAD 2021) - "YTX-7739 was well tolerated and demonstrated a favorable safety profile in healthy subjects receiving single oral doses up to 400 mg or multiple doses of 15 mg or 25 mg for up to 28 days. YTX-7739 demonstrated a dose proportional PK profile in the fed state in plasma and CSF. Proof of biology and target engagement was achieved, with dose dependent decreases observed on the target engagement biomarker (FA-DI) that were consistent with a drug effect."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Fatigue • Gaucher Disease • Genetic Disorders • Immunology • Inflammation • Lewy Body Disease • Metabolic Disorders • Movement Disorders • Pain • Parkinson's Disease • SCD

Yumanity Therapeutics Announces Positive Top-Line Results of Phase 1b Clinical Trial for YTX-7739 in Patients with Parkinson’s Disease; Company Plans to Advance Program to Phase 2 (Yahoo Finance) - P1, N=N/A; “Yumanity Therapeutics…today reported that its lead product candidate, YTX-7739, in development for the treatment of Parkinson’s disease, achieved its primary endpoints in a randomized, placebo-controlled Phase 1b clinical trial in patients with mild-to-moderate Parkinson’s disease….YTX-7739 was generally well tolerated and demonstrated favorable pharmacokinetic/pharmacodynamic (PK/PD) profiles and a safety profile with no serious adverse events. YTX-7739 achieved the expected target engagement in the patients studied and results were consistent with earlier studies in healthy volunteers and preclinical models.”

P1 data • CNS Disorders • Parkinson's Disease

Yumanity Therapeutics Reports Second Quarter 2021 Financial Results and Recent Corporate Developments (GlobeNewswire) - "The Company expects to announce topline results from the Phase 1b part of the MAD study of YTX-7739 in patients with Parkinson’s disease in the fall of 2021....The Company expects to initiate a Phase 2 trial of YTX-7739 in patients with Parkinson’s disease next year."

New P2 trial • P1 data • CNS Disorders • Parkinson's Disease

Yumanity Therapeutics’ YTX-7739 Achieved Target Engagement at Doses That Were Generally Well Tolerated in a Phase 1a Multiple Ascending Dose Study in Healthy Volunteers (GlobeNewswire) - "Yumanity Therapeutics...today reported that its lead product candidate, YTX-7739, in development for the treatment of Parkinson’s disease (PD), demonstrated dose-dependent decreases in target fatty acids, which can be interpreted as evidence of in vivo target engagement, in a Phase 1a multiple ascending dose (MAD) clinical trial in healthy volunteers...'We look forward to the results of our ongoing Phase 1b safety and biomarker study to assess the effect of chronic dosing in patients with Parkinson’s disease...'Topline results from the Phase 1b part of the study are expected in mid-2021.'...Study data will be presented at Yumanity’s upcoming R&D Day on May 17, 2021 and at a future medical conference."

P1 data • CNS Disorders • Parkinson's Disease

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

Preclinical • Glioblastoma • Oncology

Yumanity Therapeutics Reports Full Year 2020 Financial Results and Recent Corporate Developments (GlobeNewswire) - P1, N=NA; "Announced the results from the Phase 1, single-ascending dose (SAD) study in healthy volunteers of YTX-7739, a novel SCD inhibitor being developed for the treatment of Parkinson’s disease...Initiated dosing of the Phase 1b part of our MAD study of YTX-7739 in patients with Parkinson’s disease...Presented results of a study of YTX-7739 that demonstrate pharmacological, physiological and behavioral pre-clinical proof of concept in a Parkinson’s disease (PD) mouse model....The Company remains on track to announce preliminary results from the Phase 1b part of the MAD study of YTX-7739 in patients with Parkinson’s disease by mid-year 2021."

P1 data • Preclinical • Trial status • CNS Disorders • Parkinson's Disease

Yumanity Therapeutics’ YTX-7739 Demonstrates Prevention of Motor Function Deficits in a Parkinson’s Disease Mouse Model (GlobeNewswire) - "Yumanity Therapeutics...today announced results of a study of its lead program, YTX-7739, that demonstrate pharmacological, physiological and behavioral pre-clinical proof of concept in a Parkinson’s disease (PD) mouse model. This oral presentation and two posters will be presented at the 15th Annual International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2021) Virtual Conference, March 9 to 14, 2021...The research entitled, YTX-7739, A Clinical Stage Stearoyl-CoA Desaturase Inhibitor for Parkinson’s Disease Improves Behavioral and Pathological Features in an a-Synuclein Mouse Model..."

PK/PD data • Preclinical • CNS Disorders • Parkinson's Disease