Uterine serous carcinoma

Zentalis Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Progress

Retrieved on: 
Tuesday, May 7, 2024
Cancer, Safety, Uterine serous carcinoma, Research, Depreciation, Medication, Osteosarcoma, AML, Development, Administration, ASCO, Therapy, BRAF, ADC, Patient, Society, PROC, WEE1, USC, AACR, Annual general meeting, Ovarian cancer, SAN, Platinum, Pharmaceutical industry

NEW YORK and SAN DIEGO, May 07, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the quarter ended March 31, 2024, and highlighted recent corporate accomplishments. "Zentalis continues to advance towards a catalyst-rich period during the second half of 2024 and into 2025, with a clear path to demonstrating the clinical profile of azenosertib, our potentially first-in-class and best-in-class WEE1 inhibitor, across various tumor types," said Kimberly Blackwell, M.D., Chief Executive Officer. "We believe that the data emerging this year and next have the potential to establish azenosertib’s monotherapy activity, differentiated safety and efficacy profile, and its ability to address significant unmet need for patients with serious gynecological cancers. Our clinical development plan remains on track as we work to bring azenosertib to patients living with gynecological cancers and other solid tumors.”

Key Points: 
  • NEW YORK and SAN DIEGO, May 07, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the quarter ended March 31, 2024, and highlighted recent corporate accomplishments.
  • On April 9, 2024, Zentalis presented preclinical data demonstrating that azenosertib exerts synergistic anti-tumor activity with KRASG12C inhibitors at the American Association of Cancer Research (AACR) Annual Meeting.
  • On April 5, 2024, Cam Gallagher was appointed interim Chief Financial Officer while the Company conducts a search for a new Chief Financial Officer.
  • This decrease of $0.7 million was primarily attributable to $0.8 million and $0.7 million decreases in depreciation and other expenses, respectively.

Zentalis Pharmaceuticals Reports Full Year 2023 Financial Results and Operational Updates

Retrieved on: 
Tuesday, February 27, 2024
BRAF, Therapy, SAN, Eventide, Research, AML, GSK, PARP, Cancer, Platinum, Portfolio manager, Drug development, Uterine serous carcinoma, Medication, Webcast, Ovarian cancer, Administration, PROC, USC, Patient, Pharming, MPH, Link, Development, NDA, WEE1, Acute myeloid leukemia, Partnership, Pharmaceutical industry

NEW YORK and SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the year ended December 31, 2023, and highlighted recent corporate accomplishments.

Key Points: 
  • "Zentalis is making remarkable progress in advancing our clinical development program for azenosertib, our potentially groundbreaking WEE1 inhibitor, across various tumor types," stated Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis.
  • "In November 2023, we disclosed promising clinical data demonstrating the potential of azenosertib as an effective monotherapy in ovarian cancer and uterine serous carcinoma.
  • On November 10, 2023, Zentalis participated in a webcast with Joyce F. Liu, M.D., MPH, to discuss azenosertib ovarian cancer clinical data.
  • General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2023 were $64.4 million, compared to $54.6 million during the year ended December 31, 2022.

 Debiopharm Launches Expansion of WEE1 Inhibitor Monotherapy Research in Gynecological Cancers and Other Biomarker-driven Solid Tumors

Retrieved on: 
Thursday, March 7, 2024
Research, Women, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, Science, Oncology, Cancer, Woman, Omics, Uterine serous carcinoma, Female, EOC, Risk, Safety, Biomarker, Prognosis, Endometrial cancer, DDR, USC, Patient, Fibroadenoma, Infection, Diagnosis, WEE1, Lymph, Fallopian tube cancer

The expansion of this Phase 1 study, NCT05109975 , is to characterize the safety, tolerability, and initial signs of antitumor activity of Debio 0123 when administered as monotherapy.

Key Points: 
  • The expansion of this Phase 1 study, NCT05109975 , is to characterize the safety, tolerability, and initial signs of antitumor activity of Debio 0123 when administered as monotherapy.
  • Two out of the three expansion arms of the study will be using biomarkers to pre-select patients with different solid tumors while the third arm will be treating patients with recurrent serous endometrial carcinoma.
  • Maximizing efficacy, while preserving safety are key elements that Debiopharm is eager to assess throughout the clinical development of Debio 0123.
  • With the successful realization of these requirements, Debio 0123 could become the first choice WEE1 inhibitor.

Zentalis Pharmaceuticals Reports Third Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Monday, November 6, 2023
Ovarian cancer, Research, PARP, AACR, Acute myeloid leukemia, Therapy, USC, G&A, Conference, WEE1, Maintenance, R, Clinical Ovarian Cancer & Other Gynecologic Malignancies, National Center for Advancing Translational Sciences, Senior, Development, Uterine serous carcinoma, Biology, Partnership, Cancer, GSK, Medication, ORR, Platinum, Culture, NDA, Genentech, Safety, Amyloidosis, American Association for Cancer Research, Patient, Administration, SAN, State Administrative Expenses, Pharmaceutical industry

“Azenosertib continues to show very encouraging monotherapy anti-tumor activity, safety and tolerability in both ovarian cancer and uterine serous carcinoma.

Key Points: 
  • “Azenosertib continues to show very encouraging monotherapy anti-tumor activity, safety and tolerability in both ovarian cancer and uterine serous carcinoma.
  • Zentalis is the only company known to have both a WEE1 inhibitor, azenosertib, and a BCL-2 inhibitor, ZN-d5, in clinical development.
  • Research and Development Expenses: Research and development (R&D) expenses for the quarter ended September 30, 2023 were $46.8 million, compared to $42.2 million for the quarter ended September 30, 2022.
  • General and Administrative Expenses: General and administrative (G&A) expenses for the quarter ended September 30, 2023 were $16.0 million, compared to $12.0 million during the quarter ended September 30, 2022.

Zentalis Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Wednesday, August 9, 2023
Amgen, DNA, ZymoGenetics, AACR, Drug development, Therapy, DDR, Neoplasm, Uterine serous carcinoma, Paclitaxel, American Association for Cancer Research, Coronavirus Scientific Advisory Board, Woman, Outer ring road, Medication, Cyclin E1, Biomarker, Bayer, USC, Carboplatin, Carcinoma, MD Anderson Cancer Center, ASCO, Development, State Administrative Expenses, American Society of Clinical Oncology, Patient, Homologous recombination, SAN, University, Administration, Annual general meeting, Cancer, Clinical Ovarian Cancer & Other Gynecologic Malignancies, R, Research, Ovarian cancer, Society, ORR, Safety, Pharmaceutical industry, Cryptocurrency, Cyclin

NEW YORK and SAN DIEGO, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the quarter ended June 30, 2023, and highlighted recent corporate accomplishments.

Key Points: 
  • Azenosertib plus chemotherapy combinations also demonstrated positive results in women facing heavily pretreated ovarian cancer.
  • Presented positive azenosertib + chemotherapy combination data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • Zentalis is preparing for a Phase 3 trial of azenosertib using intermittent dosing in combination with chemotherapy in Cyclin E1+ platinum-sensitive ovarian cancer.
  • Cash and Marketable Securities Position: As of June 30, 2023, Zentalis had cash, cash equivalents and marketable securities of $553.0 million.

Zentalis Announces Intermittent Azenosertib Monotherapy Dosing Nearly Doubles Efficacy Over Continuous Dosing

Retrieved on: 
Tuesday, June 6, 2023
Therapy, Trae tha Truth, Medication, USC, MD Anderson Cancer Center, ASCO, WEE1, Patient, SAN, University, AUC, Cancer, Webcast, Ovarian cancer, ORR, Uterine serous carcinoma, Safety, Fatigue, Pharmaceutical industry, Vaccine

NEW YORK and SAN DIEGO, June 06, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced the monotherapy recommended Phase 2 dose (RP2D) for azenosertib, the Company's potentially first-in-class WEE1 inhibitor. Based on encouraging Phase 1 dose optimization clinical data, the RP2D for azenosertib as a monotherapy is 400 mg daily (QD) on a 5 days on, 2 days off (5:2) weekly administration schedule. This intermittent dosing schedule more than doubled steady state drug exposure in comparison to continuous dosing, and achieved promising efficacy signals, while maintaining safety and improving tolerability.

Key Points: 
  • This intermittent dosing schedule more than doubled steady state drug exposure in comparison to continuous dosing, and achieved promising efficacy signals, while maintaining safety and improving tolerability.
  • Across all tumor types, 74 patients were treated with continuous dosing schedules and 53 patients were treated with intermittent dosing schedules.
  • Intermittent dosing maintained azenosertib safety and improved tolerability as compared to continuous dosing.
  • Gastrointestinal, fatigue, and hematologic Grade 3 and 4 treatment-related adverse events (TRAEs) were comparable or favorable versus continuous dosing.

Cyclacel Reports Preliminary Data From Its Phase 1/2 Clinical Trial of Oral Fadraciclib in Patients With Solid Tumors and Lymphoma at ENA 2022

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Wednesday, October 26, 2022
Company, National University Hospital, MYC, Endometrial cancer, City of Hope National Medical Center, Safety, Cyclin E, CTD, Lymphatic system, Hematology, RNAP, HER2, CDK, CR, Cyclin, Risk, BCL2, CLL, Trastuzumab, Breast cancer, Uterine serous carcinoma, Cyclin-dependent kinase, CDK9, RNA, Annual report, Phosphorylation, Patient, Multiple myeloma, NCT, MCL1, CCNE, ALL, News, Adult, Research, COVID-19, Lymphoma, PLK1, FDA, B-cell lymphoma, RNA polymerase II, CDK2, AML, Ovarian cancer, All rights reserved, Cell cycle, Gene, Neuroblastoma, MD Anderson Cancer Center, Cyclacel, Pharmaceutical industry

Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9.

Key Points: 
  • Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9.
  • By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death of cancer cells at sub-micromolar concentrations.
  • Fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; NCT#04983810 ) and a Phase 1/2 trial for the treatment of hematological malignancies (065-102; NCT#05168904 ).
  • In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously administered, single-agent fadraciclib.

Cyclacel Pharmaceuticals To Present Preliminary Data From The Phase 1/2 Clinical Trial Of Oral Fadraciclib At The 34th EORTC-NCI-AACR Symposium

Retrieved on: 
Thursday, October 13, 2022
Cyclin E, News, RNAP, PLK1, Risk, CLL, All rights reserved, AML, Lymphoma, Multiple myeloma, Annual report, Patient, Neuroblastoma, Cyclacel, Research, RNA, CDK2, CR, B-cell lymphoma, HER2, Endometrial cancer, RNA polymerase II, Cyclin-dependent kinase, Company, Trastuzumab, Phosphorylation, CCNE, Breast cancer, Uterine serous carcinoma, Adult, Safety, MYC, BCL2, CDK9, Lymphatic system, Hematology, Cell cycle, ALL, FDA, COVID-19, CDK, NCT, MCL1, Gene, Ovarian cancer, CTD, Pharmaceutical industry

Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9.

Key Points: 
  • Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9.
  • Fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; NCT#04983810 ) and a Phase 1/2 trial for the treatment of hematological malignancies (065-102; NCT#05168904 ).
  • In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously administered, single-agent fadraciclib.
  • The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.

Zentalis Pharmaceuticals Announces Overview of Clinical and Preclinical Data Presented at AACR

Retrieved on: 
Monday, April 11, 2022
Company, Private Securities Litigation Reform Act, Cancer, Uterine serous carcinoma, Population, Therapy, NEW, AML, ORR, AACR, SEC, American Association, Failure, EGFR, NSCLC, Ovarian cancer, Association, Safety, Biology, U.S. Securities and Exchange Commission, COVID-19, GLOBE, SERD, Large-cell lung carcinoma, SAN, Annual report, DCR, American Association for Cancer Research, Patient, Toxicity, Pharmaceutical industry, USC, Wee1

NEW YORK and SAN DIEGO, April 11, 2022 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced a summary of clinical and preclinical data reviewed during the American Association of Cancer Research (AACR) Annual Meeting, being held in New Orleans, Louisiana from April 8-13, 2022.

Key Points: 
  • Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis, commented, The data presented at AACR demonstrate the encouraging anti-tumor activity and tolerability of our potentially best-in-class candidates across our pipeline.
  • CAMPRO CAspase Mediated PROteolysis (CAMPRO) describes novel biology elucidated by Zentalis that demonstrates the synergy between BCL-2 and Wee1 inhibition.
  • Zentalis is the only company to have both a Wee1 inhibitor (ZN-c3) and a BCL-2 inhibitor (ZN-d5) in clinical development.
  • Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers.

Zentalis Pharmaceuticals to Present New Clinical and Preclinical Data at the AACR Annual Meeting 2022

Retrieved on: 
Tuesday, March 8, 2022
Safety, AACR, SAN, Private Securities Litigation Reform Act, Large-cell lung carcinoma, Company, Date-time group, USC, Therapy, Failure, Annual report, U.S. Securities and Exchange Commission, SERD, Cancer, CT, GLOBE, Uterine serous carcinoma, EGFR, American Association, 2021 Essex County Council election, WEE1, COVID-19, SEC, Association, NSCLC, American Association for Cancer Research, Pharmaceutical industry, Communications satellite

The meeting will be held in New Orleans, Louisiana on April 8-13, 2022.

Key Points: 
  • The meeting will be held in New Orleans, Louisiana on April 8-13, 2022.
  • We are thrilled that five presentations will be highlighted at the upcoming AACR Annual Meeting, all of which continue to showcase our Wee1 inhibitors versatility as a monotherapy and in combination across tumor types, commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis Pharmaceuticals.
  • The Company has licensed ZN-c3, ZN-c5 and ZN-d5 to its joint venture, Zentera Therapeutics, to develop and commercialize these candidates in China.
  • This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.