HDAC6

Tenaya Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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Monday, March 18, 2024
PKP2, Biopsy, ARV, Administration, Fast track (FDA), Gene editing, Patient, SAN, CGMP, BlackRock, HDAC6, Column, G&A, IND, Research and development, Clinical trial, HCM, Investment, Therapy, Antibody, MYBPC3, Safety, FDA, ARVC, Heart failure, LP, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • “Tenaya had a successful year of sustained execution in 2023 that meaningfully advanced our portfolio of genetic medicines for heart disease.
  • Research & Development (R&D) Expenses: R&D expenses were $22.9 million for the fourth quarter and $98.0 million for the full year ended December 31, 2023.
  • General & Administrative (G&A) Expenses: G&A expenses were $8.6 million for the fourth quarter and $33.2 million for the full year ended December 31, 2023.
  • Net Loss: Net loss was $29.9 million, or $0.40 per share for the fourth quarter ended December 31, 2023.

ORYZON Reports Financial Results and Corporate Update for Quarter Ended December 31, 2023

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Monday, February 26, 2024
Borderline personality disorder, HOPE, HDAC6, National Cancer Institute, EVOLUTION, CMT, Agitation, Data analysis, Convertible bond, ICIS, ALS, SCLC, Azacitidine, Duration, ICI, IIS, Sciatic nerve, Deficit spending, Paclitaxel, DSM-IV codes, Development, Genomics, ALS Association, FMS, LSD1, AML, Clinical Global Impression, MSKCC, Conference, Aggression, Safety, Biomarker, CNS, Venetoclax, CRADA, OHSU, MRD, Clinical trial, BPD, Measure (mathematics), IND, FCCC, Dor, Human, Innovation, EMA, Kabuki syndrome, NET, NCI, Aes, Glomus tumor, FDA, GST, Food, Platinum, Schizophrenia, Phase II, Charcot–Marie–Tooth disease, Medicine, Patient, BEST, Disease, Pharmaceutical industry

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.
  • Research and development (R&D) expenses were $3.9 and $16.6 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $5.0 and $18.1 million for the quarter and twelve months ended December 31, 2022.
  • General and administrative expenses were $1.2 and $4.2 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.2 and $4.8 million for the quarter and twelve months ended December 31, 2022.
  • Net losses were $1.4 and $5.0 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.6 and $5.9 million for the quarter and twelve months ended December 31, 2022.

Tenaya Therapeutics Announces Publication of Preclinical HDAC6 Inhibitor Data for Heart Failure with Preserved Ejection Fraction in Nature Communications

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Monday, February 26, 2024
SAN, Metabolism, Inflammation, Food, HDAC6, HDAC, Exercise, Tubulin, Heart failure, Safety, Therapy, Acetylation, Patient, Hypertrophy, Fibrosis, SGLT2, MTAC, Oxidative stress, Nature Communications, Heart, HFD, Plasma, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced the publication of preclinical research related to Tenaya’s small molecule inhibitors of histone deacetylase 6 (HDAC6), including TN-301, in the February 26, 2024, issue of Nature Communications. The article, titled “Targeting HDAC6 to Treat Heart Failure with Preserved Ejection Fraction in Mice,” details the potential of inhibiting HDAC6 for the treatment of Heart failure with preserved ejection fraction (HFpEF), a form of heart failure that effects more than three million people in the U.S. alone1.

Key Points: 
  • The article, titled “Targeting HDAC6 to Treat Heart Failure with Preserved Ejection Fraction in Mice,” details the potential of inhibiting HDAC6 for the treatment of Heart failure with preserved ejection fraction (HFpEF), a form of heart failure that effects more than three million people in the U.S. alone1.
  • Tenaya’s highly selective small molecule inhibitors of the enzyme HDAC6 were discovered using the company’s modality-agnostic target discovery and validation capabilities.
  • For preclinical studies, Tenaya researchers used TYA-018, an HDAC6 inhibitor structurally and functionally similar to the company’s clinical candidate, TN-301.
  • The selective effects of HDAC6 inhibition were reaffirmed through genetic deletion studies, in which treatment of Hdac6 knockout mice did not display any of the beneficial effects that wild-type HFpEF mice did following treatment.

ORYZON Awarded with a Grant for ORY-4001 From the ALS Association in the U.S.

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Monday, December 4, 2023
ALS, Peripheral neuropathy, Toxicology, HDAC6, Research, Polyneuropathy, Disease, IPSC, CMT, ALS Association, Life expectancy, Respiratory failure, USD, Genomics, Death, Systemic disease, Proteostasis, Neurodegenerative disease, Axonal transport, Diagnosis, Safety, Pharmaceutical industry

The Association has awarded Oryzon a 498,690 USD grant through its Lawrence and Isabel Barnett Drug Development Program to support the regulatory preclinical development of ORY-4001, a highly selective HDAC6 inhibitor, for amyotrophic lateral sclerosis (ALS).

Key Points: 
  • The Association has awarded Oryzon a 498,690 USD grant through its Lawrence and Isabel Barnett Drug Development Program to support the regulatory preclinical development of ORY-4001, a highly selective HDAC6 inhibitor, for amyotrophic lateral sclerosis (ALS).
  • Dr. Jordi Xaus, Oryzon’s CSO, said: “It is an honor to have the support of the ALS Association.
  • Established in 1985, the ALS Association is the largest philanthropic funder of ALS research in the world.
  • The Association is working to make ALS a livable disease while urgently searching for new treatments and a cure.

Avstera Therapeutics Announces FDA Clearance of IND Application for AVS100, a Novel Highly Selective HDAC6 Inhibitor Targeting Solid Tumors

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Monday, December 18, 2023
Georgetown University, Tumor-associated macrophage, AMES, Research, GLP, Safety, Therapy, Incidence, RECIST, Toxicology, IND, Risk, Macrophage, Patient, FIH, PFS, MD Anderson Cancer Center, U.S. FDA, FDA, Pembrolizumab, Animal, ICB, SAB, Pharmacokinetics, Marketing, Investigational New Drug, FAAAS, Progression-free survival, ORR, MD, Cancer, MTD, Phase, Doctor of Philosophy, HDAC6, Biomarker, Infrared spectroscopy correlation table, Immunotherapy, Coronavirus Scientific Advisory Board, Neoplasm, Rat, Dog, Government, Pharmaceutical industry, Medicine

AVS100 is a novel, orally bioavailable selective HDAC6i targeting locally advanced or metastatic solid tumors, including in combination with pembrolizumab.

Key Points: 
  • AVS100 is a novel, orally bioavailable selective HDAC6i targeting locally advanced or metastatic solid tumors, including in combination with pembrolizumab.
  • "The FDA clearance of our IND for AVS100 marks an amazing step for our company towards the fulfillment of our mission.
  • "FDA clearance of our IND for AVS100 represents a significant milestone for Avstera's mission in providing state of the art oncological agents to tackle solid tumors.
  • Undoubtedly, the IND approval of AVS100 selective HDAC6 inhibitor will open new opportunities to potentially enhance response rates for patients."

PurMinds Appoints Leading Drug Designer, Dr. Alan Kozikowski, to Chief Scientific Officer and Appoints Pharma Veteran Dr. Max Arella to Scientific Advisory Board

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Thursday, November 9, 2023
ALS, AD, CSO, Therapy, GSK-3, Invention, Publication, Research, Drug development, NCE, Myenteric plexus, Risk, Alzheimer's disease, Neuroscience, HDAC6, HDAC, DSM-IV codes, Chemistry, SAB, United States Air Force Scientific Advisory Board, Pharmaceutical industry, Medical device

Dr. Kozikowski is a Global leader in medicinal chemistry designing Novel Chemical Entities (NCEs) for oncology and neuroscience.

Key Points: 
  • Dr. Kozikowski is a Global leader in medicinal chemistry designing Novel Chemical Entities (NCEs) for oncology and neuroscience.
  • Dr. Arella is a seasoned drug development and technology transfer expert and former drug scout for big pharmaceutical companies.
  • Dr. Arella served as Chief Scientist and member of Scientific Advisory Boards of small, medium and large pharmaceuticals companies since 1996.
  • Previously PurMinds' acting CSO, Dr. Arella was instrumental in guiding PurMinds' business strategy in drug development.

Tenaya Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

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Wednesday, November 8, 2023
FDA, CGMP, MYBPC3, Heart failure, IND, ARV, AAV, Food, PD, Heart, Fast track (FDA), PKP2, ARVC, G&A, Ischemia, European Medicines Agency, Research and development, SGLT2, HCMS, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAD, R, Orphan, Hypertrophic cardiomyopathy, American Heart, Plasma, Clinical trial, HDAC6, EMA, Cardiomyopathy, Gene, General Administration of Sport of China, Heart failure with preserved ejection fraction, Safety, HCM, Therapy, Patient, Investment, AHA, Administration, SAN, Investigational New Drug, Pharmaceutical industry, Vaccine, Medical device, Rare-earth element, Tenaya

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results and provided a corporate update for the third quarter ended September 30, 2023.

Key Points: 
  • In October 2023, Tenaya shared positive Phase 1 data for TN-301 at the 2023 Heart Failure Society of America (HFSA) Annual Scientific Meeting.
  • General & Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2023, were $7.8 million.
  • Non-cash stock-based compensation included in G&A expense was $2.2 million for the quarter ended September 30, 2023.
  • Net Loss: Net loss for the quarter ended September 30, 2023, was $29.1 million, or $0.39 per share.

Tenaya Therapeutics Presents Encouraging New Clinical and Preclinical Data from HDAC6 Inhibitor Program TN-301 for the Potential Treatment of Heart Failure with Preserved Ejection Fraction at the 2023 HFSA Annual Scientific Meeting

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Monday, October 9, 2023
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SOUTH SAN FRANCISCO, Calif. and CLEVELAND, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today released new data for TN-301 at the 2023 Heart Failure Society of America (HFSA) Annual Scientific Meeting. TN-301 is Tenaya’s highly selective small molecule inhibitor of histone deacetylase 6 (HDAC6) being developed for the potential treatment of heart failure with preserved ejection fraction (HFpEF).

Key Points: 
  • TN-301 is Tenaya’s highly selective small molecule inhibitor of histone deacetylase 6 (HDAC6) being developed for the potential treatment of heart failure with preserved ejection fraction (HFpEF).
  • "TN-301 continues to generate promising early data as a differentiated candidate for the treatment of HFpEF, a form of heart failure with few treatment options and unacceptably low survival rates.
  • In Stage 1, participants received single ascending doses (SAD) of either TN-301 at doses ranging from 1mg – 700mg or placebo.
  • Plasma exposure and target engagement observed in this healthy participant study met or exceeded those required for maximal efficacy in preclinical studies.

PurMinds Acquires Novel Chemical Entity HDAC6 Inhibitor for Neurological Disorders

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Thursday, September 28, 2023
NCE, Axonal transport, Neuron, Therapy, Disease, HDAC, GSK-3, DSM-IV codes, Nutrient, Research, CMT, Multiple sclerosis, HDAC6, Neuroscience, Acquisition, Parkinson's disease, Alzheimer's disease, Charcot–Marie–Tooth disease, Pharmaceutical industry, ALS

Toronto, Ontario--(Newsfile Corp. - September 28, 2023) - PurMinds NeuroPharma ("PurMinds" or the "Company"), a neuroscience company with a robust clinical pipeline combining small molecules, psychedelic compounds and other modalities, pursuing breakthrough therapeutic solutions for neurological disorders hallmarked by neurodegeneration, today announced completion of acquisition of a small molecule novel chemical entity (NCE) known as SW-200, a non-hydroxamic acid that shows superior histone deacetylase 6 (HDAC6) selectivity.

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - September 28, 2023) - PurMinds NeuroPharma ("PurMinds" or the "Company"), a neuroscience company with a robust clinical pipeline combining small molecules, psychedelic compounds and other modalities, pursuing breakthrough therapeutic solutions for neurological disorders hallmarked by neurodegeneration, today announced completion of acquisition of a small molecule novel chemical entity (NCE) known as SW-200, a non-hydroxamic acid that shows superior histone deacetylase 6 (HDAC6) selectivity.
  • Drugs that inhibit the molecular target HDAC6 are a novel class of therapeutics that are able to functionally enhance the axonal transport of nutrients, growth factors and neurotransmitters in neurons.
  • Encouraged by scientific studies that have shown efficacy in rodent models of neurodegenerative disorders, PurMinds NeuroPharma anticipates the successful development of an HDAC6 inhibitor for Charcot-Marie Tooth Disease (CMT) - a progressive neurodegenerative disorder, which causes disabling deficits in nerve function affecting 1 in 2500 people with no current cure.
  • "HDAC6 inhibition represents an innovative therapeutic target to address a range of neurological conditions currently without a cure.

Tenaya Therapeutics to Present Data for TN-301 and TN-201 at Upcoming Medical Conferences

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Thursday, September 21, 2023
Cleveland Clinic, Gene, Heart failure, Safety, Efficacy, Hypertrophic cardiomyopathy, HCMS, Heart Failure Society of America, HDAC6, Clinical trial, Patient, SAN, Poster, Therapy, MYBPC3, HCM, Disease, Pharmaceutical industry, Vaccine, Online shopping, Heart failure with preserved ejection fraction

SOUTH SAN FRANCISCO, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced today that poster presentations related to its TN-201 and TN-301 programs will be presented at the 2023 Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions taking place October 6, 2023, and at the Heart Failure Society of America (HFSA) Annual Scientific Meeting occurring October 6-9, 2023. Both meetings are being held this year in Cleveland, Ohio.

Key Points: 
  • TN-301 is Tenaya’s proprietary, highly selective small molecule inhibitor of histone deacetylase 6 (HDAC6) being developed for the potential treatment of heart failure with preserved ejection fraction (HFpEF).
  • Data to be presented at HFSA will include results from the company’s Phase 1 clinical trial of TN-301 in healthy adult participants.
  • Tenaya has previously reported that TN-301 was generally well tolerated and that target engagement was achieved.
  • The company will also present new data from preclinical studies examining the effects of its HDAC6 inhibitor in combination with an approved HFpEF treatment in a model of disease.