LSD1

Salarius Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, March 22, 2024
Research, Topotecan, TC, LSD1, Survival, Bone marrow, Progression-free survival, DCR, Patient, Acquisition, Deuterium, NHL, IND, Myelodysplastic syndrome, Non-Hodgkin lymphoma, Clinical trial, Azacitidine, Chronic myelomonocytic leukemia, Probability, Cyclophosphamide, FDA, MD Anderson Cancer Center, Ewing sarcoma, Consultant, Food, Pharmaceutical industry

HOUSTON, March 22, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the three and 12 months ended December 31, 2023 and provided a business update.

Key Points: 
  • Cash and cash equivalents were $5.9 million as of December 31, 2023, compared with $12.1 million as of December 31, 2022.
  • In August 2023 Salarius announced a comprehensive review of strategic alternatives focused on maximizing shareholder value.
  • Research and development expenses were $0.06 million for the fourth quarter of 2023, compared with $4.7 million for the fourth quarter of 2022, reflecting the above-mentioned cost-savings plan.
  • Net cash used for operating activities during the fourth quarter of 2023 was $1.5 million, compared with $4.7 million during the same quarter in 2022, reflecting the above-mentioned cost-savings plan.

Exscientia Business and Financial Update for the Full Year 2023

Retrieved on: 
Thursday, March 21, 2024
Biotechnology, Pharmaceutical, Oncology, Health, Artificial Intelligence, Health Technology, Technology, Clinical Trials, Research, Federal Reserve Bank, Automation, Ovarian cancer, DSM-IV codes, CDK7, Learning, LSD1, Bill, Half-life, UGT1A1, International, Inflammation, Patient, EDT, G&A, Cancer, AI, Bristol Myers Squibb, IND, Medicine, Merck Group, Sumitomo Pharma, PKC, ID, GMT, MALT1, Acute leukemia, Pharmaceutical industry

Recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the fourth quarter and full year 2023, are summarised below.

Key Points: 
  • Recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the fourth quarter and full year 2023, are summarised below.
  • Exscientia will host a conference call Thursday, March 21 at 12:30 p.m. GMT / 8:30 a.m. EDT.
  • This study has the potential to support the ongoing development of ‘539, Exscientia’s LSD1 inhibitor
    In July 2023, Exscientia launched EXCYTE-1, a first-of-its-kind prospective observational study in ovarian cancer.
  • A replay will be available for 90 days under “Events and Presentations” in the “Investors and Media” section of the Exscientia website .

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

Retrieved on: 
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.

ORYZON to Provide Corporate Progress Updates at Several Events in February-March

Retrieved on: 
Monday, February 5, 2024
Rose garden, Genomics, Oncology, LSD1, CNS, Eldorado Hotel

Oryzon will attend the 2024 Epigenetic Mechanisms and Cancer Treatment conference, organized by Keystone Symposia, which will be held on February 4-7 at the Eldorado Hotel & Spa in Santa Fe, NM (USA).

Key Points: 
  • Oryzon will attend the 2024 Epigenetic Mechanisms and Cancer Treatment conference, organized by Keystone Symposia, which will be held on February 4-7 at the Eldorado Hotel & Spa in Santa Fe, NM (USA).
  • Dr. Tamara Maes, Chairman of Oryzon’s Scientific Advisory Board, will give a presentation entitled “Identifying an Effective Team: Optimizing Combo Treatments With the LSD1 Inhibitor Iadademstat for Oncological Indications” on February 7.
  • Oryzon will provide a corporate update and will participate in a panel entitled “Neuro Advances Panel: Highlighting the Main Opportunities” on February 28.
  • The company will hold one-on-one meetings with pharmaceutical companies and global investors.

ORYZON Announces Topline Results from Phase IIb PORTICO Study of Vafidemstat in Borderline Personality Disorder (BPD)

Retrieved on: 
Friday, January 5, 2024
Phase, LSD1, Identity disturbance, NMDR, Agitation, Depression, FDA, CMO, Conference call, Journal, Conference, Disease, Aggression, Emptiness, Knowledge, Schizophrenia, Overalls, Safety, Deficit spending, Steven Spielberg filmography, Aes, GST, Genomics, Anxiety, CNS, Gene, Biomarker, Webcast, Suicidal ideation, Patient, Memory, BEST, Borderline personality disorder, BPD, Observation, Paranoia, Medical imaging

MADRID, Spain and BOSTON, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with a strong unmet medical need, today announced topline results from the Phase IIb PORTICO trial, evaluating the efficacy and safety of vafidemstat in Borderline Personality Disorder (BPD).

Key Points: 
  • ORYZON will host a conference call and webcast on January 7, 2024 at 5:30 pm Pacific Time to discuss PORTICO Phase IIb results.
  • However, statistically significant overall disease improvement was achieved on the secondary endpoint Borderline Evaluation of Severity (BEST) across weeks 8-12 (p = 0.042).
  • It was also encouraging to note that all results favored vafidemstat treatment over placebo across the multiple independent primary and secondary efficacy endpoints.
  • An important aim of PORTICO was to learn what potential endpoints would be important to leverage in a future Phase III registrational trial.

Merck Announces Phase 3 Trial Initiations for Four Investigational Candidates From its Promising Hematology and Oncology Pipeline

Retrieved on: 
Friday, January 5, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, LSD1, Lung cancer, Science, Lymphocytosis, Bone marrow, Research, Malignancy, Orion, Chronic lymphocytic leukemia, CLL, Merck & Co., BTK, Cancer, Patient, SLL, MRK, ADC, Therapy, NSCLC, CYP11A1, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors.
  • Global Phase 3 studies have been initiated and are actively enrolling for the following investigational candidates:
    Bomedemstat, an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, being evaluated for the treatment of certain patients with essential thrombocythemia (ET);
    Nemtabrutinib, an investigational oral, reversible, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, being evaluated for the treatment of certain patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL);
    MK-2870, an investigational trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, which is being evaluated for certain patients with non-small cell lung cancer (NSCLC) and certain patients with previously treated endometrial carcinoma;
    and MK-5684, an investigational CYP11A1 inhibitor being developed in collaboration with Orion, which is being evaluated for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).
  • “These Phase 3 trial initiations for four of our investigational candidates represent a critical step forward in our efforts to advance potential treatment options for people with solid tumors and hematologic neoplasms and malignancies,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
  • “We have a proud legacy of turning breakthrough science into medicines that save and improve lives around the world, and we are dedicated to continuing research to expand our broad portfolio of oncology therapeutics to continue to address unmet needs in cancer care.”

Investigator-initiated Phase 1/2 Clinical Trial Using Salarius Pharmaceuticals’ Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Resumes Patient Enrollment

Retrieved on: 
Wednesday, January 3, 2024
DCR, LSD1, SUSAR, Database, Canaccord Genuity, Food, Survival, Learning, Cyclophosphamide, Chronic myelomonocytic leukemia, Probability, Bone marrow, FDA, TC, Progression-free survival, Myelodysplastic syndrome, CMML, MD, MDS, Clinical trial, Monroe Dunaway Anderson, University, Azacitidine, Effectiveness, MD Anderson Cancer Center, Sarcoma, Patient, Ewing sarcoma, Pharmaceutical industry

While these efforts are ongoing, the Company continues to support the continuation of its clinical programs, as appropriate.

Key Points: 
  • While these efforts are ongoing, the Company continues to support the continuation of its clinical programs, as appropriate.
  • In October 2022, the FDA placed the MDACC investigator-initiated trial under a partial clinical hold following a suspected unexpected serious adverse reaction (SUSAR) in the FET-rearranged arm of Salarius’ Phase 1/2 trial with seclidemstat in sarcomas.
  • In addition to the MDACC investigator-initiated clinical trial, seclidemstat has been studied in a company-sponsored Phase 1/2 clinical trial evaluating its use in combination with TC for the treatment of relapsed/refractory Ewing sarcoma.
  • The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with TC as a treatment for relapsed and refractory Ewing sarcoma.

Exscientia Business Update for Third Quarter 2023

Retrieved on: 
Thursday, November 9, 2023
Biotechnology, Pharmaceutical, Oncology, Health, Artificial Intelligence, Health Technology, Technology, Clinical Trials, Research, Drug design, GBP, NSCLC, IND, MALT1, ESMO, Ovarian cancer, International, GMT, EST, Congress, Head, European Society for Medical Oncology, G&A, PKC, Colorectal cancer, Acute leukemia, Acquisition, Federal Reserve Bank, BMS, Growth, CDK7, ID, Risk, Bristol Myers Squibb, Jaundice, Merck Group, Pancreatic cancer, AlphaFold, Sumitomo Pharma, Lung cancer, LSD1, USD, AI, Berlin, Patient, Toxicity, AML, Automation, Pharmaceutical industry, Medical imaging, Rare-earth element, Fine chemical, Cryptocurrency, Bank, Sanofi

Recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the third quarter of 2023, are summarised below.

Key Points: 
  • Recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the third quarter of 2023, are summarised below.
  • Exscientia will host a conference call Thursday, November 9 at 1:30 p.m. GMT / 8:30 a.m. EST.
  • A replay will be available for 90 days under “Events and Presentations” in the “Investors and Media” section of the Exscientia website .
  • The increase in revenue quarter over quarter was primarily due to $8.38 million in revenue recognised from the projects that Exscientia and BMS mutually determined not to proceed with further development of under the BMS collaboration.

Salarius Completes FDA Type B Meeting for Seclidemstat Ewing Sarcoma Development Program

Retrieved on: 
Tuesday, November 7, 2023
Survival, FDA, Trial of the century, TC, Salinicola salarius, Cyclophosphamide, Hematological Cancer Research Investment and Education Act, Food, Progression-free survival, DCR, Canaccord Genuity, Disclosure, Acquisition, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ewing sarcoma, Clinical trial, Cancer, ORR, LSD1, MD Anderson Cancer Center, Patient, Pharmaceutical industry, Topotecan

HOUSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma. The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting.

Key Points: 
  • FDA briefing included new Ewing sarcoma clinical data from ongoing investigation where 60% of first-relapse patients achieved disease control and have not progressed after at least 14.5, 19.7 and 22.8 months
    Future development activities were identified; Salarius intends to submit an amended Ewing sarcoma clinical trial protocol
    HOUSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma.
  • The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting.
  • Salarius is currently evaluating strategic options to advance the clinical development of seclidemstat with a third party.
  • The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with topotecan and cyclophosphamide (TC) chemotherapy as a treatment for relapsed and refractory Ewing sarcoma.

ORYZON Reports Financial Results and Corporate Updates for Quarter Ended September 30, 2023

Retrieved on: 
Friday, October 27, 2023
Research, ORY, Fruit, DMC, Food, Deficit spending, Risk, Medicine, ECNP, Schizophrenia, Platinum, ICMJE recommendations, SCLC, Charcot–Marie–Tooth disease, Sciatic nerve, Psychotherapy, Paclitaxel, NET, FCCC, MRD, Safety, EVOLUTION, BPD, Kabuki syndrome, Patient, Borderline personality disorder, ALS, Fox Chase Cancer Center, Genomics, Human, Duration, Glomus tumor, Measure (mathematics), Clinical trial, Dor, DSM-IV codes, Animal, European College of Neuropsychopharmacology, LSD1, FMS, CMT, FDA, IND, Innovation, ISIN, CNS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, HOPE, AML, Failure, Medical device, Pharmaceutical industry, Nursing, Cryptocurrency, EU, Science

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

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the third quarter.
  • The company has started a structured dialogue with corporate pharma to identify a suitable partner to move forward the asset to Phase III, pending positive results.
  • General and administrative expenses were $0.7 and $2.9 million for the quarter and nine months ended September 30, 2023, respectively, compared to $0.7 and $3.3 million for the quarter and nine months ended September 30, 2022.
  • Net losses were $0.8 and $3.4 million for the quarter and nine months ended September 30, 2023, respectively, compared to $0.7 and $3.9 million for the quarter and nine months ended September 30, 2022.