Cyclin E

NiKang Therapeutics Doses First Patient in a Phase 1/1b Study of NKT3447, an Oral, Selective Inhibitor of CDK2 Which Reduces Cyclin E Expression

Retrieved on: 
Monday, April 15, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, CDK1, Phosphorylation, Safety, Cyclin-dependent kinase 2, Pharmacokinetics, Cell cycle, Patient, Endometrial cancer, Cyclin E, Standard of care, CDK2, Therapy, Cancer, Ovarian cancer, Pharmaceutical industry

NiKang Therapeutics Inc. (“NiKang”) is a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs.

Key Points: 
  • NiKang Therapeutics Inc. (“NiKang”) is a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs.
  • The Company announced today that the first patient has been dosed in a phase 1/1b, open-label, first-in-human dose escalation and expansion study of single agent NKT3447, a small molecule that inhibits cyclin-dependent kinase 2 (CDK2).
  • NKT3447 is designed to treat patients with cancers driven by cyclin E amplification or overexpression, which is present in many different tumor types.
  • The Phase 1/1b trial (NCT06264921) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of NKT3447 in adult patients with advanced or metastatic solid tumors driven by cyclin E or CDK2.

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

Retrieved on: 
Tuesday, March 26, 2024
Ovarian cancer, Cyclin, IND, Therapy, Anemia, Research, University, Cell cycle, MD Anderson Cancer Center, PLK1, DDR, Investigational New Drug, Safety, Pharmacokinetics, Synthetic lethality, WEE1, U.S. FDA, Mutation, Acceleration, Part, HERG, ATR, KOL, Acquisition, Cancer, AACR, Research and development, Poster, FDA, Cyclin E, Toxicity, Aplastic anemia, Administration, Conference, APRE, PLK3, PLK2, Division, Data, Cardiotoxicity, Pharmaceutical industry

DOYLESTOWN, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • “Aprea had a very productive 2023 with significant progress across our diversified pipeline of synthetic lethality-based cancer therapeutics.
  • An update from Part 1 of the trial was featured in a poster presentation at the AACR-NCI-EORTC International Conference in October 2023.
  • Select Financial Results for the Fourth Quarter ended December 31, 2023
    As of December 31, 2023, Aprea reported cash and cash equivalents of $21.6 million.
  • Research and Development (R&D) expenses were $2.0 million for the quarter ended December 31, 2023, compared to $0.5 million for the fourth quarter of 2022.

NiKang Therapeutics Presents the Discovery and Unique Mechanism of Action of a Selective CDK2 Inhibitor NKT3447 at AACR Annual Meeting 2024

Retrieved on: 
Friday, April 5, 2024
Oncology, Health, Other Science, Clinical Trials, Research, Science, Biotechnology, CDK1, Phosphorylation, CDK2, CDK, Patient, Cell cycle, AACR, Therapy, Cancer, Safety, Pharmacokinetics, Cyclin E, Pharmaceutical industry

NKT3447 is an orally bioavailable small molecule CDK2 inhibitor that exhibits high selectivity against CDK1 and other CDKs, prolonged pharmacodynamic effects, and a distinct mechanism of action.

Key Points: 
  • NKT3447 is an orally bioavailable small molecule CDK2 inhibitor that exhibits high selectivity against CDK1 and other CDKs, prolonged pharmacodynamic effects, and a distinct mechanism of action.
  • It downregulates cyclin E and suppresses activating phosphorylation of CDK2 on Thr160.
  • “We are pleased to share the discovery of NKT3447, a highly selective CDK2 inhibitor with unique properties, at the AACR Annual Meeting”, said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang.
  • Discovery of a selective slow-off CDK2 inhibitor NKT3447 with distinct features of suppressing CDK2, downregulating cyclin E, and achieving prolonged pathway inhibition

Aprea Therapeutics Announces Private Placement Financing of up to $34.0 Million

Retrieved on: 
Monday, March 11, 2024
Cyclin, Exchange, Prospectus, APRE, DNA, Cyclin E, Sale, Breast, WEE1, DDR, Therapy, Patient, United, Security (finance), IND, Synthetic lethality, ATR, VWAP

DOYLESTOWN, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that it has entered into a securities purchase agreement with new and existing healthcare focused institutional investors and certain Company insiders to raise up to $34.0 million in gross proceeds, including initial upfront funding of $16.0 million and up to an additional $18.0 million upon cash exercise of accompanying warrants at the election of the investors.

Key Points: 
  • “This meaningful financing led by high quality healthcare institutions will support Aprea in our goal to be a leader in the field of Synthetic Lethality (SL) and DNA Damage and Response (DDR),” said Dr. Oren Gilad, President and CEO of Aprea.
  • The private placement is expected to close on or about March 13, 2024 subject to satisfaction of customary closing conditions.
  • Aprea intends to use the upfront net proceeds from the private placement for general corporate purposes and to fund clinical development of APR-1051, the Company’s WEE1 inhibitor product candidate which recently received IND clearance.
  • Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers

Retrieved on: 
Monday, March 11, 2024
APRE, Toxicity, Cyclin E, FDA, Cancer, Food, PLK, Breast, Safety, Therapy, Clinical trial, IND, WEE1, Pharmaceutical industry

DOYLESTOWN, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (IND 169359) for APR-1051.

Key Points: 
  • “APR-1051 is a next-generation inhibitor of WEE1 kinase and, based on its unique characteristics, we believe it will be best in class,” said Dr. Oren Gilad, President and CEO of Aprea.
  • “The FDA's clearance of our IND is a critical step in the APR-1051 development program.
  • Aprea has conducted extensive pre-clinical studies with APR-1051, which have demonstrated that the molecule has potent anti-tumor activity, along with a favorable pharmacokinetic (PK) profile.
  • *
    Clearance of the IND application will allow Aprea to initiate the Phase 1 ACESOT-1051 dose escalation trial to evaluate the safety, tolerability, and preliminary efficacy of APR-1051.

Bayer to acquire exclusive license from Cedilla Therapeutics on selective inhibitors in pre-clinical precision oncology

Retrieved on: 
Thursday, June 1, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Cyclin E, CDK2, Third Rock Ventures, Standard of care, Cedilla, Cancer, Therapy, Safety, Pharmaceutical industry, Bayer

Bayer and Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, today announced an exclusive license agreement to develop and commercialize Cedilla Therapeutics’ CyclinE1/CDK2 complex inhibitors which selectively address oncogenic drivers.

Key Points: 
  • Bayer and Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, today announced an exclusive license agreement to develop and commercialize Cedilla Therapeutics’ CyclinE1/CDK2 complex inhibitors which selectively address oncogenic drivers.
  • Overexpression or genetic activation of Cyclin Dependent Kinase 2 (CDK2) binding partner cyclin E is a key oncogenic process in several cancers.
  • Cedilla’s small molecules conditionally modulate the protein complex in its functional state resulting in highly selective inhibition.
  • Cedilla will also be eligible to receive royalties on medicines based on their technology commercialized by Bayer.

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

Retrieved on: 
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.

Cyclacel Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, August 10, 2022
FDA, Apoptosis, PLK1, CLL, Lymphoma, Histology, Biomarker, Risk, Hematology, CDK2, GLOBE, R, Breast, PTCL, Microdeletion syndrome, Clinical trial, Conference call, Cell cycle, Biliary tract, Research, Neoplasm, Annual report, ET, MCL1, CTCL, Income, Cyclin E, CDK9, Patient, COVID-19, CYCC, Company, Pancreatic cancer, PET, BCL2, Safety, Lymphatic system, MYC, NASDAQ, PK, KRAS, Â, All rights reserved, Treatment of lung cancer, News, Webcast, Simon, Ovarian cancer, CR, Conference, Toxic leukoencephalopathy, Food, Endometrial cancer, Vaccine, Fine chemical, Pharmaceutical industry, Medical imaging, Online gambling, Broadcasting, Cyclacel, Leukemia

- Oral fadraciclib demonstrated good tolerability with continuous dosing;

Key Points: 
  • - Oral fadraciclib demonstrated good tolerability with continuous dosing;
    - Conference call scheduled for August 10, 2022 at 4:30 pm ET -
    BERKELEY HEIGHTS, N.J., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced second quarter 2022 financial results and provided a business update.
  • In the second half of 2022 we are optimizing the dosing schedule to maximize target coverage and determine recommended Phase 2 dose (RP2D).
  • Tax credit receipts of $3.3 million in respect of the financial year ended December 31, 2021, were received in April 2022.
  • The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.

Circle Pharma Appoints Paul Park, MBA, as its Chief Business Officer

Retrieved on: 
Tuesday, July 26, 2022
Research, Venture Capital, Professional Services, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, JD, Cyclin E, Trastuzumab, Wharton School of the University of Pennsylvania, Doctor of Philosophy, CEO, AB, Cyclin A, Drug discovery, Cell cycle, Health, Therapy, Cancer, Cell, Brown University, MBA, Pharma, Aetion, Ionis Pharmaceuticals, Patient, AstraZeneca, Cyclin, Rb, Squamous cell carcinoma, Pharmaceutical industry, Amgen, Circle

Circle Pharma, a company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, has appointed Paul Park, MBA, as its Chief Business Officer.

Key Points: 
  • Circle Pharma, a company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, has appointed Paul Park, MBA, as its Chief Business Officer.
  • Paul has a strong record of leading deals including large pharma partnerships, major M&A transactions, licensing and financings, as well as strategic corporate development experience, noted David J. Earp, JD, PhD, Circles president and CEO.
  • Earlier in his career at Amgen he played key roles in the acquisitions of Tularik and Immunex.
  • He obtained an AB in health and society from Brown University and an MBA in healthcare management from The Wharton School.