RNA polymerase II

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update

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金曜日, 3月 29, 2024
Patient, PTCL, G&A, IND, Prednisone, Neoplasm, Therapy, SMDC, Medicinal chemistry, Lymphoma, Research, Frontiers Media, RNA polymerase II, Body modification, Primate, RNA, NIH, CPT, Potential, Safety, CDK9, ADC, MCL1, Solubility, Oncogene, RNA polymerase, Venetoclax, Journal, Manuscript, Cancer, Peripheral T-cell lymphoma, AACR, Antibody, MYC, Downregulation and upregulation, DLBCL, Annual general meeting, HER2, European Hematology Association, EHA, Spacecraft, PDX, Bangladesh Technical Education Board, Journal of Medicinal Chemistry, Blood, Pharmaceutical industry

PALO ALTO, Calif., March 29, 2024 (GLOBE NEWSWIRE) --  Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Vincerx presented preclinical data at the 2023 AACR Annual Meeting demonstrating significant activity in patient-derived xenograft (PDX) lymphoma mouse models.
  • Vincerx shared preclinical data at the 2023 ASH Annual Meeting showing superior activity and safety compared with commercially available B-cell targeted ADCs.
  • For the fourth quarter and full year 2023, Vincerx reported a net loss of $4.9 million, or $0.23 per share, and a net loss of $40.2 million, or $1.89 per share, respectively.
  • For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.8 million, or $0.65 per share, and a net loss of $63.0 million, or $3.00 per share, respectively.

Pioneering Technique Reveals New Layer of Human Gene Regulation

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金曜日, 2月 9, 2024
Human, NYU Langone Health, RNA, Chromatin, Tick, Cell division, Cancer, Howard Hughes Medical Institute, IIS, DNA repair, Genetic code, Bangladesh Technical Education Board, Protein, NYU, RNA polymerase II, Multimedia, DNA, Genome, Biochemistry, Gene expression, Pharmacology, Gene, Bacteria, National Institutes of Health, Ageing, Doctor of Philosophy, Disease, Vaccine

Now a new study led by Nudler's team at NYU Langone Health reveals that their new technique, Long Range Cleavage sequencing (LORAX-seq), can directly detect where backtracking events begin and end.

Key Points: 
  • Now a new study led by Nudler's team at NYU Langone Health reveals that their new technique, Long Range Cleavage sequencing (LORAX-seq), can directly detect where backtracking events begin and end.
  • The results also suggest that persistent backtracking occurs frequently throughout genomes, happens more often near certain gene types, and has functions well beyond DNA repair.
  • "If further work expands our findings to different developmental programs and pathological conditions, backtracking may be akin to epigenetics, the discovery of which revealed a surprising new layer of gene regulation without changing the DNA code."
  • Locked, backtracked complexes are less likely to be rescued by TFIIS-driven cleavage, and more likely to delay transcription of the gene involved.

Vincerx Pharma Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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火曜日, 11月 14, 2023
ASH, ADC, EMA, Patient, Camptothecin, Research, Therapy, Cancer, Oncogene, Poster, Multiple myeloma, Hematology, PALO, Safety, Therapeutic index, IND, DLBCL, Prednisone, Mantle cell lymphoma, Tumor microenvironment, SMDC, Society, RNA, Venetoclax, Corporation, Spacecraft, SME, Salivary gland tumour, MCL1, Cohort, European Medicines Agency, PDX, B-cell lymphoma, University, HER2, Acute lymphoblastic leukemia, Myelodysplastic syndrome, PTCL, MYC, MCL, Neoplasm, CPT, Peripheral T-cell lymphoma, Small and medium-sized enterprises, CDK9, FDA, RNA polymerase II, NIH, Toxicity, Vaccine, Pharmaceutical industry, Fine chemical, Medical imaging, Rare-earth element, Cryptocurrency

PALO ALTO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC)(“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • “We continue to take a very disciplined approach to our portfolio, focusing our resources on our two lead programs, VIP943 and VIP236.
  • We will present new data on robust preclinical activity at the 65th American Society for Hematology Meeting (ASH 2023) in December.
  • Collaborators from the University of Calgary will present a poster at ASH 2023 showing preclinical activity in pediatric leukemia.
  • For the quarter ended September 30, 2023, Vincerx reported a net loss of approximately $9.7 million, or $0.46 per share, compared to a net loss of approximately $16.9 million, or $0.80 per share, for the quarter ended September 30, 2022.

Junshi Biosciences Announces Approval for Marketing of VV116 in China

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月曜日, 1月 30, 2023
Treatment, RNA, Marketing, Zhejiang University, Chemistry, Ministry, Safety, Chinese Academy of Sciences, Drug discovery, RNA-dependent RNA polymerase, COVID-19, Ministry of Science and Technology (Vietnam), National Medical Products Administration, Omicron, III, SSE, Shanghai Institute of Technology, Patient, HIV disease progression rates, Physics, Viral load, RNA polymerase II, Severe acute respiratory syndrome coronavirus 2, HKEX, Development, Infection, Death, Approval, Toxicity, State Key Laboratories, Wuhan Institute of Virology, Diagnosis, Pharmaceutical industry, Science, Virology, Materia medica

SHANGHAI, China, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the National Medical Products Administration (the “NMPA”) has conducted urgent review and approval under Special Examination and Approval of Drugs, and conditionally approved for marketing Deuremidevir Hydrobromide Tablets (project code: JT001/VV116, “VV116”), an oral nucleoside analog anti-SARS-CoV-2 drug, for the treatment of adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”).

Key Points: 
  • SHANGHAI, China, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the National Medical Products Administration (the “NMPA”) has conducted urgent review and approval under Special Examination and Approval of Drugs, and conditionally approved for marketing Deuremidevir Hydrobromide Tablets (project code: JT001/VV116, “VV116”), an oral nucleoside analog anti-SARS-CoV-2 drug, for the treatment of adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”).
  • VV116 is a new oral nucleoside analog antiviral drug, which can be non-covalently bound to the active center of RNA-dependent RNA polymerase (“RdRp”) of SARS-CoV-2 in the form of nucleoside triphosphate, directly inhibiting the activity of RdRp of the virus and blocking the replication of virus, thus realizing the antiviral effect.
  • Preclinical studies have shown that VV116 exhibited significant antiviral effects against both the original COVID-19 strain and mutant strains, including Omicron, and exhibited no genetic toxicity.
  • The study was led by academician Lanjuan LI, Director of the State Key Laboratory for Diagnosis & Treatment of Infectious Diseases (Zhejiang University) as primary investigator.

Junshi Biosciences Announces NEJM Publication of Results of Phase 3 Study of VV116 Versus PAXLOVID for Adults at High Risk for Progression to Severe COVID-19

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木曜日, 12月 29, 2022
Fudan University, Clinical trial, HKEX, The New England Journal of Medicine, AE, Article, Renji Hospital, RNA polymerase II, Ruijin Hospital, Smoking, SSE, Overweight, III, NEJM, COVID-19, Transport, Death, Female, FAS, Trial of the century, Shanghai Jiao Tong University School of Medicine, AES, BMI, Patient, Cardiovascular disease, Severe acute respiratory syndrome coronavirus 2, Development, Omicron, Safety, Hypertension, Hospital, Obesity, Șaeș, Diabetes, Incidence, HR, Pharmaceutical industry, Medicine

It is the first time that NEJM published the clinical trial results of China-developed anti-SARS-CoV-2 drug.

Key Points: 
  • It is the first time that NEJM published the clinical trial results of China-developed anti-SARS-CoV-2 drug.
  • The results indicated that the primary endpoint of the study realized the designed noninferiority endpoint, and VV116 group had a shorter time to sustained clinical recovery with less safety concerns as compared with PAXLOVID.
  • Finally, a total of 771 patients (Full Analysis Set, FAS) were treated with VV116 (n = 384) or PAXLOVID (n = 387).
  • The incidence of AEs in VV116 group was lower than that in the PAXLOVID group (all-grade AEs: 67.4% vs. 77.3%, Grade 3 or 4 AE: 2.6% vs. 5.7%).

EQS-News: Heidelberg Pharma Signs Research and Exclusive Option Agreement with Binghamton University on Immunostimulatory Technology Platform

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日曜日, 12月 18, 2022
HPHA, RNA, Associate, Colorectal cancer, Antibody-drug conjugate, Research Foundation – Flanders (FWO), Antibody, School, SUNY, Carnegie, Cancer, GCC, State University of New York, ADC, Multiple myeloma, Control, Binghamton University, ISIN, FSE, ATACS, Frankfurt Stock Exchange, University at Buffalo School of Pharmacy and Pharmaceutical Sciences, Patient, B-cell lymphoma, Survival, Eukaryote, CD37, State, Immune system, Research, ATAC, Southern Tier, State university system, PSMA, RNA polymerase II, II, BCMA, Therapy, Fine chemical, Vaccine, EU, Pharmacy

Ladenburg, Germany, 16 December 2022 – Heidelberg Pharma AG (FSE: HPHA) today announced that it has entered into a research and exclusive option agreement with Binghamton University, State University of New York, Binghamton, NY, USA, related to a novel and proprietary immunostimulatory technology platform.

Key Points: 
  • Ladenburg, Germany, 16 December 2022 – Heidelberg Pharma AG (FSE: HPHA) today announced that it has entered into a research and exclusive option agreement with Binghamton University, State University of New York, Binghamton, NY, USA, related to a novel and proprietary immunostimulatory technology platform.
  • These immunostimulatory agents are synergistic with cytotoxic agents, including ADCs generated by Heidelberg Pharma’s ATAC technology.
  • The agreement was signed by the subsidiary Heidelberg Pharma Research GmbH and by The Research Foundation for The State University of New York on behalf of Binghamton University.
  • Binghamton University, also known as the State University of New York at Binghamton, is one of four doctoral granting research universities in the SUNY system.

EQS-News: Heidelberg Pharma AG: Encouraging Clinical Data from Two Antibody Drug Conjugates Based on Heidelberg Pharma’s ATAC Technology Presented at the ASH Annual Meeting 2022

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日曜日, 12月 18, 2022
HPHA, RNA, Phase, Colorectal cancer, Amanitin, Patient, Clinical trial, Partnership, Lymphatic system, Antibody, MDS, Safety, Cancer, Bone marrow, ADC, Multiple myeloma, Control, GCC, ISIN, FSE, ATACS, Human, Frankfurt Stock Exchange, AML, CD117, Acute myeloid leukemia, B-cell lymphoma, Magenta, Survival, Eukaryote, CD37, Myelodysplastic syndrome, ATAC, Therapy, Blood, BCMA, PSMA, RNA polymerase II, II, Pharmaceutical industry, Fine chemical, EU

Ladenburg, Germany, 14 December 2022 – Heidelberg Pharma AG (FSE: HPHA) today announced that initial clinical data from two Antibody Drug Conjugates (ADCs) based on the Company’s proprietary ATAC technology was presented at the ASH Annual Meeting 2022.

Key Points: 
  • Ladenburg, Germany, 14 December 2022 – Heidelberg Pharma AG (FSE: HPHA) today announced that initial clinical data from two Antibody Drug Conjugates (ADCs) based on the Company’s proprietary ATAC technology was presented at the ASH Annual Meeting 2022.
  • Antibody drug conjugates (ADCs) combine the high affinity and specificity of antibodies with the potency of cytotoxic small molecules for the treatment of cancer.
  • Heidelberg Pharma AG is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA.
  • ATAC® is a registered trademark of Heidelberg Pharma Research GmbH in the EU and USA.

Kronos Bio Announces Selection of Recommended Phase 2 Dose for its Oral CDK9 Inhibitor, KB-0742, After Reaching Target Engagement Goal with Acceptable Safety Profile in Ongoing Phase 1/2 Clinical Trial

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水曜日, 12月 7, 2022
SYK, Squamous cell carcinoma, Cohort study, CDK9, Enzyme, Bio, Chordoma, Sarcoma, SAN, Security (finance), Ovarian cancer, RNA polymerase II, RNA polymerase, Cancer, Cmax, Large-cell lung carcinoma, MYC, KRON, Research, Plasma, PK, Kronos, Drug, COVID-19, CDK, Patient, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that data from the ongoing dose-escalation stage of its Phase 1/2 clinical trial of KB-0742, the company’s cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified and transcriptionally addicted solid tumors, support a recommended Phase 2 dose (RP2D) of 60 mg.

Key Points: 
  • This level of target engagement is consistent with demonstrating anti-tumor activity based on preclinical models.
  • A total of 26 patients have been enrolled and treated in the dose escalation phase of the study.
  • The long plasma half-life enables KB-0742 to achieve sustained pharmacologically active concentrations while avoiding potentially toxic peak (Cmax) concentrations.
  • Kronos Bio is a biopharmaceutical company that is advancing two investigational compounds in clinical trials for patients with cancer.

Atea Pharmaceuticals Announces First Patient Dosed in SUNRISE-3 Phase 3 Registrational Trial of Bemnifosbuvir, an Investigational Oral Antiviral for the Treatment of COVID-19

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火曜日, 11月 29, 2022
Hospital, Virology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Respiratory syncytial virus, BID, Rest, COVID-19, Severe acute respiratory syndrome coronavirus 2, Infection, High Risk, Doctor of Philosophy, Patient, SOC, Degenerative disease, Omicron, Arm, Standard of care, Biochemistry, HIV disease progression rates, Atea, Combination therapy, Food, Mortality, Regardless, Annual report, Niran, HCV, Study, Biology, Safety, Global Health, Dengue virus, Fever Dream, RNA, RSV, Disease, MD, Immunodeficiency, Virus, Death, Feinberg School of Medicine, RNA polymerase II, Vaccine, Pharmaceutical industry

BOSTON, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced the enrollment of the first patient in the SUNRISE-3 Phase 3 trial, a global multicenter trial evaluating bemnifosbuvir (AT-527) for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression to hospitalization and death. The patient was enrolled and dosed at a U.S. clinical trial site. The study is designed to enroll at least 1,500 patients with mild or moderate COVID-19, and the primary endpoint is all-cause hospitalization or death through Day 29 in at least 1,300 patients in the monotherapy arm. Bemnifosbuvir is an investigational orally administered, direct-acting antiviral derived from Atea’s purine nucleotide prodrug platform.

Key Points: 
  • The patient was enrolled and dosed at a U.S. clinical trial site.
  • Bemnifosbuvir is an investigational orally administered, direct-acting antiviral derived from Ateas purine nucleotide prodrug platform.
  • New variants not susceptible to currently available preventive tools are driving COVID-19 infection waves, which should enable timely patient enrollment in SUNRISE-3.
  • Bemnifosbuvirs profile supports the potential for bemnifosbuvir to become a cornerstone monotherapy and combination oral therapy for the treatment of COVID-19.

Ascletis Announces IND Approval of Oral 3CLpro Inhibitor ASC11 for COVID-19 by U.S. FDA

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水曜日, 11月 23, 2022
Patient, HBV, Food, Ritonavir, COVID-19, PBC, Viral disease, Fatty liver disease, Omicron, Severe acute respiratory syndrome coronavirus 2, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HKEX, Degenerative disease, U.S. FDA, Hong Kong Stock Exchange, IND, FDA, Acne, Investigational New Drug, NASH, Pharmacokinetics, Primary biliary cholangitis, RNA polymerase II, Safety, Pharmaceutical industry, Vaccine

HANGZHOU and SHAOXING, China, Nov. 23, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19.

Key Points: 
  • U.S. FDA has approved to study safety, tolerability and pharmacokinetics of ASC11 at various doses in healthy subjects co-dosed with 100 mg ritonavir tablets.
  • Both ASC11 and ritonavir tablets are manufactured by Ascletis.
  • In antiviral cellular assays with infectious SARS-CoV-2, ASC11 demonstrated much higher potency against SARS-CoV-2 than other 3CLpro inhibitors including Nirmatrelvir, S-217622, PBI-0451 and EDP-235.
  • ASC11 is an in-house discovered oral small molecule drug candidate using various proprietary technologies including molecular docking.