MCL1

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

Retrieved on: 
Friday, March 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.

Edgewood Oncology Announces Positive Efficacy Data From Investigator-Sponsored Study of BTX-A51 in Preclinical Models of Liposarcoma

Retrieved on: 
Sunday, April 7, 2024
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Bone marrow, CDK7, MDM2, Apoptosis, BH3, CDK, AML, Dana–Farber Cancer Institute, Patient, LPS, Neoplasm, DNA, Cancer, Liposarcoma, Clinical trial, Azacitidine, CDK9, MCL1, Vaccine

The presentation (Abstract 604), “Targeting casein kinase 1 alpha (CK1alpha) and transcriptional CDKs (CDK7/9) in human liposarcomas,” highlighted findings for BTX-A51 in preclinical human models of LPS.

Key Points: 
  • The presentation (Abstract 604), “Targeting casein kinase 1 alpha (CK1alpha) and transcriptional CDKs (CDK7/9) in human liposarcomas,” highlighted findings for BTX-A51 in preclinical human models of LPS.
  • The data demonstrate that BTX-A51 has preclinical efficacy in treating patient-derived LPS in cell lines and human xenograft models and provides insight into the synergy gained by inhibiting both CK1α and CDK9.
  • “Dedifferentiated liposarcomas (DDLPS) are rare tumors derived from precursors of fat cells which can occur anywhere in the body.
  • Importantly, preliminary in vivo data in an LPS patient-derived xenograft model reveal that BTX-A51 is well-tolerated under conditions that inhibit tumor growth.

GenFleet and BeiGene Enter into Trial Collaboration for a Potentially First-in-class Combination Therapy to Initiate Phase Ib/II Study of GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib) Treating Diffuse Large B Cell Lymphoma

Retrieved on: 
Thursday, March 28, 2024
B-cell lymphoma, Plasma, Shanghai Cancer Center, Rituximab, Apoptosis, Leukemia, International Journal of Hematology, Patient, Hospital, Doxorubicin, Vincristine, Fudan University, CC3, Standard of care, Acute myeloid leukemia, Epidemiology, Biomedical Chromatography, Prednisone, Peripheral T-cell lymphoma, PARP, National Cancer Center, Therapy, MYC, BTK, Safety, BeiGene, CDK9, Cyclophosphamide, DLBCL, Canadian International Council, MCL1, Follicular lymphoma, Pharmaceutical industry

The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.

Key Points: 
  • The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.
  • This study will be the first combination trial conducted by a Chinese biotech to combine CDK9 inhibitor and BTK inhibitor targeting DLBCL.
  • The trials of GFH009 treating peripheral T-cell lymphoma and acute myeloid leukemia have entered into phase II stage in China and the U.S. respectively.
  • Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020–2025, Leukemia & Lymphoma, 2021
    3.

GenFleet Therapeutics Announces GFH009 Granted with FDA Fast Track, Orphan Drug Designations for Treating R/R Peripheral T-cell Lymphomas and Acute Myeloid Leukemia

Retrieved on: 
Thursday, January 11, 2024
Oncogene, FTD, MYC, Patient, Therapy, Accelerated approval (FDA), Acute myeloid leukemia, Venetoclax, Food and Drug Administration, ODD, Azacitidine, Food, MCL1, NDA, Safety, Priority review, FDA, BLA, Marketing, AML, Bone marrow, PTCL, CDK9, Pharmaceutical industry

GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the FDA for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML).

Key Points: 
  • GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the FDA for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML).
  • Numerous subjects in GFH009 studies achieved complete or partial responses, and superior safety profile & efficacy of GFH009 was observed in previous studies.
  • GenFleet is conducting a multi-center, open-label, single-arm study of GFH009 for the treatment of r/r PTCL in close to 40 sites in China.
  • GFH925 was granted with NDA acceptance, priority review and two breakthrough therapy designations in China; GFH009 received FDA fast track and orphan drug designations for two indications.

HiberCell Announces Presentation at ASH, Highlighting Preclinical Data for HC-7366 with Standard of Care Agents in Acute Myeloid Leukemia (AML)

Retrieved on: 
Friday, December 15, 2023
Metastasis, Conference, Exposition, AACR, ISR, CRISPR, MCL1, ASH, Azacitidine, BCL2, Venetoclax, Patient, Therapy, AML, GCN2, SOC, Explosive

“Our data also demonstrated that HC-7366 has monotherapy activity in TP53-mutant preclinical models as well as tumor regressions in models of AML as part of a triplet combination with venetoclax and azacitidine.

Key Points: 
  • “Our data also demonstrated that HC-7366 has monotherapy activity in TP53-mutant preclinical models as well as tumor regressions in models of AML as part of a triplet combination with venetoclax and azacitidine.
  • Both the TP53-mutant and relapsed/refractory, to venetoclax and azacitidine, are settings with poor prognoses for patients and represent major unmet clinical needs.
  • The triplet combination of low-dose HC-7366, venetoclax, and azacitidine is significantly more efficacious than the venetoclax/azacitidine doublet.
  • Together, these data support the treatment of AML patients with HC-7366 in combination with venetoclax and azacitidine.

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

Retrieved on: 
Tuesday, November 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.

Prelude Announces Strategic Pipeline Progress and Updates, including its Partnership with AbCellera, and Reports Third Quarter Financial Results

Retrieved on: 
Wednesday, November 1, 2023
Survival, Research, Standard of care, Research and development, Plasma, AACR, IV, Antigen, MCL1, SMARCA4, MD, G&A, SMARCA2, Conference, Hematological Cancer Research Investment and Education Act, Chromatin, CDK9, MYC, Protein, AbCellera, R, Growth, Cell death, Antibody, Partnership, Spacecraft, Cancer, Hepatotoxicity, Security (finance), Brain, Bone marrow, Toxicity, Safety, Lymphoid leukemia, Patient, EU, Administration, Neutropenia, AML, Mutation, Prelude, Pharmaceutical industry, Vaccine, Fine chemical, IND, PRB

WILMINGTON, Del., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today provides strategic pipeline updates and reports third quarter financial results.

Key Points: 
  • Given the overlap with the CDK9 program, Prelude does not plan to advance PRT1419 further at this time.
  • Given the focus of the Company on SMARCA2 and CDK9, Prelude will not advance the program further and is actively pursuing further clinical development with external partners.
  • “We made significant progress in the third quarter with our four clinical stage molecules and, as planned, conducted a rigorous assessment of each program.
  • We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Acute Myeloid Leukemia

Retrieved on: 
Tuesday, October 10, 2023
Diagnosis, ODD, Food, Azacitidine, MD, Venetoclax, CDK9, Safety, AML, FDA, Acute myeloid leukemia, Bone marrow, Rare, Marketing, Hematological Cancer Research Investment and Education Act, Doctor of Science, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MRD, SLS, MCL1, Patient, MYC, Toxic encephalopathy, Pharmaceutical industry

This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

Key Points: 
  • This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • “SLS009 is a novel and highly selective CDK9 inhibitor that has already shown a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity.
  • ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs.
  • These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.

SELLAS Announces Positive Topline Data in Lymphoma Cohort from SLS009 Phase 1 Dose-Escalation Trial, Supporting Advancement to Phase 2 Clinical Study; Primary and Secondary Endpoints Met

Retrieved on: 
Thursday, September 21, 2023
Pharmacodynamics, Lymphoma, PTCL, MYC, Index, Peripheral T-cell lymphoma, PD, Relapse, Trae tha Truth, Pharmacokinetics, Cmax, Biomarker, Acute myeloid leukemia, Plasma, QW, AML, Doctor of Science, SLS, MD, Patient, Hypokalemia, Bilirubin, AUC, MCL1, MTD, Bone marrow, Toxic leukoencephalopathy, CDK9, BIW, Safety, Vaccine, Pharmaceutical industry, Generic drug

All primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD), were successfully achieved.

Key Points: 
  • All primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD), were successfully achieved.
  • A dose-limiting toxicity occurred in one out of five patients treated at the 100 mg dose level.
  • No dose-limiting toxicities were observed at any other dose level, and there were no unexpected toxicities across the study.
  • For more information on the Phase 1 study of SLS009 in r/r AML and r/r lymphomas, please visit ClinicalTrials.gov and reference Identifier NCT04588922 .

Prelude Therapeutics Announces Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 3, 2023
Neutropenia, KRAS, Hepatotoxicity, Glioblastoma, SMARCA2, EU, Cell death, Sarcoma, HER2, Chromatin, Survival, Cancer, Mutation, Head, G&A, Brain, Deletion, MEK, SMARCA4, Lung cancer, Richter's transformation, HR, Net, Azacitidine, Patient, Security (finance), Administration, Mantle cell lymphoma, MCL1, MCL, Toxicity, Research and development, T-cell lymphoma, Bone marrow, Growth, Research, R, IND, Cardiotoxicity, CDK9, Safety, Breast cancer, Rare-earth element, Pharmaceutical industry, Vaccine, Dietary supplement, Life insurance

WILMINGTON, Del., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.

Key Points: 
  • Recent equity financing extends cash runway into 2026, enabling advancement of Prelude’s pipeline through critical milestones
    WILMINGTON, Del., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
  • The Company intends to provide a program update by year end and present initial results at a future scientific meeting.
  • Research and Development (R&D) Expenses: For the second quarter of 2023, R&D expense increased to $25.0 million from $21.3 million for the prior year period.
  • General and Administrative (G&A) Expenses: For the second quarter of 2023, G&A expenses decreased to $7.4 million from $8.2 million for the prior year period.