Cyclin-dependent kinase 4

Arvinas and Pfizer Announce Interim Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) and Plans to Expand Vepdegestrant Development Program

Retrieved on: 
Tuesday, December 5, 2023
CBR, Patient, Febrile neutropenia, ESR1, Breast Cancer Research, HER2, Neoplasm, Infection, Breast cancer, Fulvestrant, PFE, Colorectal cancer, Cyclin-dependent kinase 4, Chimera, Neutropenia, Melanoma, Sarah Cannon Research Institute, DNA, Incidence, Research, CDK4, ARVN, Abstract, FIH, Proteolysis, Face, Webcast, CDK, Safety, PFS, Circulating tumor DNA, Pharmaceutical industry

NEW HAVEN, Conn. and NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced clinical data for vepdegestrant (ARV-471), a novel oral PROteolysis TArgeting Chimera (PROTAC®) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE®). Interim results from the Phase 1b combination cohort demonstrate encouraging clinical activity in heavily pre-treated patients with a median of four lines of therapy across disease settings with locally advanced or metastatic ER positive/human epidermal growth factor 2 (HER2) negative (ER+/HER2-) breast cancer. These data will be presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • These data will be presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • The results from this trial evaluating vepdegestrant in combination with palbociclib help advance our goals of benefitting patients with ER+/HER2- breast cancer.
  • “Collectively, the data presented this year at SABCS for vepdegestrant, especially in combination with palbociclib, show the potential of this investigational innovative therapeutic option.
  • A conference call and webcast will be held with executives from Arvinas and Pfizer to discuss the data presented at SABCS.

Sermonix Pharmaceuticals Announces JCO Precision Oncology Publication of Case Report on a Complete Remission in a Metastatic Breast Cancer Patient Participating in ELAINE-1 Trial

Retrieved on: 
Monday, November 6, 2023
Science, Breast, Report, ESMO, Progression-free survival, Therapy, Metastatic breast cancer, RL, Congress, European Society for Medical Oncology, Cyclin-dependent kinase 4, Conference, Breast cancer, Research, Cancer, Estrogen receptor alpha, Poster, JCO, Sheba Medical Center, ESR1, Fuchs, Prognosis, RM, Oncology, Estrogen, Clinical Cancer Research, Mortality, Patient, Fulvestrant, Mutation, Pharmaceutical industry, Medical imaging, Liquor, Woman, Incidence

The open-access case report, “ Lasofoxifene Monotherapy Induces Durable Complete Remission in a Patient with ER+, HER2- Metastatic Breast Cancer with an ESR1 Mutation ,” details a patient result that was reported during Sermonix’s Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-1, NCT03781063) study.

Key Points: 
  • The open-access case report, “ Lasofoxifene Monotherapy Induces Durable Complete Remission in a Patient with ER+, HER2- Metastatic Breast Cancer with an ESR1 Mutation ,” details a patient result that was reported during Sermonix’s Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-1, NCT03781063) study.
  • The case was previously presented as a poster and brief talk at the annual Metastatic Breast Cancer Research Conference in September 2022.
  • Topline results from the ELAINE-1 trial, including this patient, were reported at the European Society for Medical Oncology (ESMO) Congress 2022.
  • 5Jeselsohn R, De Angelis C, Brown M, et al: The Evolving Role of the Estrogen Receptor Mutations in Endocrine Therapy-Resistant Breast Cancer.

Sermonix’s Lasofoxifene Improves Vaginal/Vulvar Symptoms Relative to Fulvestrant in ELAINE 1 Study of Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation

Retrieved on: 
Monday, March 6, 2023
Therapy, Mutation, Breast, AIS, Woman, Lasofoxifene, ESR1, Memorial Sloan Kettering Cancer Center, Dry, International Society, Menopause, Patient, ESMO, Progression-free survival, European Society for Medical Oncology, Breast cancer, Congress, VAS, Pain, Oncology, Cyclin-dependent kinase 4, VVA, Vua tiếng Việt, Fulvestrant, Vaginal discharge, Irritation, Birth control, Dietary supplement

Top-line data for ELAINE 1, which began enrollment in September 2019, were shared in September at the European Society for Medical Oncology (ESMO) Congress 2022.

Key Points: 
  • Top-line data for ELAINE 1, which began enrollment in September 2019, were shared in September at the European Society for Medical Oncology (ESMO) Congress 2022.
  • This secondary analysis aimed to investigate changes in vaginal/vulvar symptoms with lasofoxifene versus fulvestrant, as lasofoxifene improved symptoms of vulvovaginal atrophy (VVA) in two previous Phase 3 studies among postmenopausal women with moderate to severe VVA.
  • Vaginal/vulvar symptoms were evaluated in an exploratory analysis using the vaginal (VAS) and vulvar (VuAS) assessment scales, instruments validated in breast cancer patients to assess dryness, soreness, irritation, and pain.
  • “We look forward to further investigating lasofoxifene’s efficacy, as a treatment for metastatic breast cancer with fewer negative side effects that greatly impact patients’ quality of life.”

Grant for High-Risk, High-Impact Brain Cancer Research Awarded to Ivy Center Investigator

Retrieved on: 
Thursday, November 10, 2022
GLOBE, Meninges, III, Meningioma, Engineering, Protein, Doctor of Philosophy, American Brain Tumor Association, Faculty, Research, Biology, Glioblastoma, Hedera, Brain, II, Assistant, Ribociclib, Time, Drug development, Neoplasm, Barrow Neurological Institute, Cell, Patient, Growth, Breast cancer, Associate, Cyclin-dependent kinase 4, Arizona State University, MD, FDA, Medical imaging, Pharmaceutical industry

Dr. Tien is a rising star in translational brain cancer research and PK/PD-triggered early-phase clinical trials.

Key Points: 
  • Dr. Tien is a rising star in translational brain cancer research and PK/PD-triggered early-phase clinical trials.
  • This funding will allow us to advance the translational work were doing at the Ivy Brain Tumor Center and directly impact patients, said Dr. Tien.
  • Ivy Brain Tumor Center at the Barrow Neurological Institute in Phoenix, AZ is a non-profit translational research program that employs a bold, early-phase clinical trials strategy to identify new treatments for aggressive brain tumors, including glioblastoma.
  • Follow the Ivy Brain Tumor Center on Facebook , Instagram , Twitter and LinkedIn .

Cyclin-Dependent Kinase 9 (CDK9) Inhibitor Drug Pipeline Market Research Report 2022 - ResearchAndMarkets.com

Retrieved on: 
Monday, February 14, 2022
Health, Pharmaceutical, CDK9, Cyclin-dependent kinase 9, Therapy, Pharmaceutical industry, Fine chemical, Cyclin-dependent kinase 4

The "Cyclin-Dependent Kinase 9 (CDK9) Inhibitor - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cyclin-Dependent Kinase 9 (CDK9) Inhibitor - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Cyclin-Dependent Kinase 9 (CDK9) Inhibitor - Pipeline Insight, 2022" report offers comprehensive insights of the pipeline (under development) therapeutics scenario and growth prospects across Cyclin-Dependent Kinase 9 (CDK9) Inhibitor development.
  • The report provides detailed coverage of the pipeline landscape for this mechanism of action, equipped with data from multiple sources with complete pipeline analysis by developmental stage, associated indications, route of administration and molecule type.
  • The report assesses the active Cyclin-Dependent Kinase 9 (CDK9) Inhibitor pipeline products by developmental stage, product type, molecule type, and administration route.

Carrick Therapeutics Announces Collaboration with Roche to Evaluate Novel Samuraciclib Combination to Treat HR+ Breast Cancer

Retrieved on: 
Monday, August 2, 2021
Drugs, Clinical medicine, Cancer, Antiestrogens, Cancer treatments, Breast cancer, Triple-negative breast cancer, Selective estrogen receptor degrader, Fulvestrant, Cyclin-dependent kinase 4, HER2/neu, Palbociclib

The collaboration will utilize Roches MORPHEUS Phase 1b/2 platform for rapid and efficient combination development, with upfront randomization versus a control group.

Key Points: 
  • The collaboration will utilize Roches MORPHEUS Phase 1b/2 platform for rapid and efficient combination development, with upfront randomization versus a control group.
  • This new study expands Carricks portfolio of clinical trials with samuraciclib, which is also being evaluated in a Phase 2a study in combination with fulvestrant for CDK4/6i resistant HR+, HER2- metastatic breast cancer.
  • We are excited to initiate this collaboration with Roche to explore the broad potential of samuraciclib in combination with giredestrant, a next-generation oral SERD, said Tim Pearson, Chief Executive Officer of Carrick Therapeutics.
  • Samuraciclib is also being evaluated in triple negative breast cancer (TNBC) and prostate cancer with further potential in pancreatic, ovarian and colorectal cancers.

Olema Oncology Reports First Quarter 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, May 11, 2021
Cell Cycle, Communication, Forward-looking statement, Cyclin-dependent kinase 4

\xe2\x80\x9cLooking ahead, we remain on track to share initial clinical data at a medical meeting later this year and advance OP-1250 into Phase 2 monotherapy expansion.

Key Points: 
  • \xe2\x80\x9cLooking ahead, we remain on track to share initial clinical data at a medical meeting later this year and advance OP-1250 into Phase 2 monotherapy expansion.
  • We also plan to initiate a Phase 1b study to evaluate OP-1250 in combination with a CDK4/6 inhibitor in the second half of 2021.
  • These statements include those related to the development of OP-1250, including timelines related to data presentation, trial initiation and advancement, and enrollment, as well as the sufficiency of our financial resources.
  • Except as required by law, Olema assumes no obligation to update these forward-looking statements or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.\n'

Veru Announces the Presentation of Positive Phase 2 Clinical Data of Enobosarm in AR+ER+HER2- Metastatic Breast Cancer Patients that Have Progressed on Estrogen Blocking Agents and CDK 4/6 Inhibitor at the ESMO Breast Cancer Congress 2021

Retrieved on: 
Wednesday, May 5, 2021
Chemical compounds, Branches of biology, Drugs, Protein kinase inhibitors, Piperazines, Aromatase inhibitors, Progonadotropins, Cyclin-dependent kinase 4, Oncogenes, Letrozole, Breast cancer, Nonsteroidal

Patients who have metastatic breast cancers that progress on estrogen receptor blocking agent and CDK4/6 inhibitor therapies are a group in which we need to define the most optimal drug treatment.

Key Points: 
  • Patients who have metastatic breast cancers that progress on estrogen receptor blocking agent and CDK4/6 inhibitor therapies are a group in which we need to define the most optimal drug treatment.
  • Enobosarm is in clinical development for the treatment of metastatic ER+HER2- breast cancer patients whose disease has progressed after treatment with a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor.
  • In the U.S., FC2 is available by prescription through multiple third-party telemedicine and internet pharmacy providers and retail pharmacies.
  • An NDA was filed by FDA in April 2021 with a PDUFA date in December 2021.

Onconova Therapeutics Announces FDA Permission for Study to Proceed Under its Investigational New Drug Application for Multi-kinase CDK4/6 Inhibitor ON 123300

Retrieved on: 
Monday, December 21, 2020
Branches of biology, Cell Cycle, Biology, Kinase, Cyclin-dependent kinase 4, Protein kinase inhibitor, Enzymes

We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with ON 123300, said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova.

Key Points: 
  • We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with ON 123300, said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova.
  • Additional patient cohorts are under consideration, including but not limited to patients diagnosed with advanced colorectal cancer, and non-Hodgkins lymphoma, in particular mantle cell lymphoma.
  • Onconovas lead pipeline compound is the novel small molecule ON 123300, a proprietary, first-in-class multi-kinase inhibitor targeting tumor-driving kinases including CDK4/6 and ARK5.
  • Onconova Therapeutics is a biopharmaceutical company focused on discovering and developing novel products to treat cancer.

Onconova Therapeutics to Present Update During the 2020 BIO Investor Forum Digital Event

Retrieved on: 
Tuesday, October 13, 2020
Branches of biology, Cell Cycle, Cyclin-dependent kinase 4, Oncogenes, Proteins, Cancer, Biology

Dr. Fruchtman and Avi Oler, Senior VP, Corporate Development, will be available for 1x1 meetings scheduled through the Bio Partnering system.

Key Points: 
  • Dr. Fruchtman and Avi Oler, Senior VP, Corporate Development, will be available for 1x1 meetings scheduled through the Bio Partnering system.
  • Onconova Therapeutics is a biopharmaceutical company focused on discovering and developing novel products to treat cancer.
  • The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
  • Onconova is in preclinical development with its novel, proprietary, CDK4/6 + ARK5 inhibitor, ON 123300.