VHL

Kymera Therapeutics Announces Scientific Presentations at the American Association for Cancer Research 2024 Annual Meeting

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Monday, April 8, 2024

WATERTOWN, Mass., April 08, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that new preclinical data showing the structural and molecular mechanisms underlying anti-tumor activity of its novel STAT3 degrader, KT-333, were presented in a late-breaking research poster session at the AACR Annual Meeting taking place April 5-10, 2024, in San Diego, California. Additionally, Nello Mainolfi, PhD, Founder, President and CEO, will present in the Major Symposium at the conference highlighting the Company’s unique target selection strategy and strong preclinical to clinical translation observed across the Company’s first-in-class oncology programs, KT-333 and KT-253, a potent and selective degrader of MDM2.

Key Points: 
  • For these reasons, STAT3 degraders may provide a solution to the development of targeted and selective drugs to address multiple STAT3 dependent pathologies.
  • Additionally, this unique mechanism of action led to induction of proinflammatory anti-tumorigenic transcriptional signatures in the tumor microenvironment.
  • This has resulted in robust antitumor activity in patients, as reported in the Company’s latest clinical update at the American Society of Hematology (ASH) Annual Meeting in December 2023.
  • The Company expects to complete both studies and share additional clinical data to inform the programs’ next development steps in 2024 at upcoming medical meetings.

Orphan designation: 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile Treatment of von Hippel-Lindau disease, 21/08/2020 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024

Orphan designation: 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile Treatment of von Hippel-Lindau disease, 21/08/2020 Withdrawn

Key Points: 


Orphan designation: 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile Treatment of von Hippel-Lindau disease, 21/08/2020 Withdrawn

FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI

Retrieved on: 
Friday, December 15, 2023

Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.

Key Points: 
  • Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.
  • Patients could have received up to three prior treatment regimens and were required to have measurable disease per RECIST v1.1.
  • Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients.
  • Adverse reactions that required dose reduction in ≥1% of patients were hypoxia (5%) and anemia (3.2%).

FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

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Tuesday, September 19, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies.
  • The sNDA is based on data from the LITESPARK-005 trial, in which WELIREG demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee.
  • A statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR) was also demonstrated.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 17, 2024.

Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, August 18, 2023

LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies.

Key Points: 
  • LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies.
  • A statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR) was also demonstrated.
  • A trend toward improvement in overall survival (OS), a dual primary endpoint, was observed; however, this result did not reach statistical significance.
  • The safety profile of WELIREG in this trial was consistent with that observed in previously reported studies.

Canadians with rare diseases do not get timely diagnosis and care - with funding and the plan in place, it's time for political leadership

Retrieved on: 
Tuesday, February 28, 2023

Canada is the only major developed nation without a comprehensive rare diseases strategy to help patients and families.

Key Points: 
  • Canada is the only major developed nation without a comprehensive rare diseases strategy to help patients and families.
  • One is the development of a new national list of drugs for rare diseases and the other is the creation of rare disease centres to specialize in rare disease treatment.
  • Canadians with rare diseases and their families have waited far too long and with severe consequences that in many cases could be prevented.
  • Rare disease centres would address a wide variety of gaps that exist in the diagnosis and treatment of rare diseases."

Vial Introduces New Member, Dr. Eric Jonasch of the MD Anderson Cancer Center, to their Oncology CRO Advisory Board

Retrieved on: 
Wednesday, August 31, 2022

Eric Jonasch, MD, is a Genitourinary Medical Oncology Professor and Physician at The University of Texas MD Anderson Cancer Center, Houston, TX.

Key Points: 
  • Eric Jonasch, MD, is a Genitourinary Medical Oncology Professor and Physician at The University of Texas MD Anderson Cancer Center, Houston, TX.
  • Dr. Jonasch brings over thirty years of experience in Genitourinary Medical Oncology and cancer research to the board.
  • In addition to Vial's Oncology CRO Advisory Board, Dr. Jonasch is a Medical Advisory Board Member for Von Hippel Lindau (VHL) Family Alliance.
  • Vial operates across multiple Therapeutic Areas ( Dermatology CRO , Ophthalmology CRO , Oncology CRO , and Gastroenterology CRO ).

NiKang Therapeutics Presents Preclinical Data Highlighting NKT2152’s Therapeutic Potential in Clear Cell Renal Cell Carcinoma (ccRCC) and Solid Tumors Beyond ccRCC at AACR Annual Meeting 2022

Retrieved on: 
Friday, April 8, 2022

The anti-tumor effect observed in several xenograft models suggests NKT2152 may have broader activity in other solid tumors beyond ccRCC that lack a VHL gene deficiency.

Key Points: 
  • The anti-tumor effect observed in several xenograft models suggests NKT2152 may have broader activity in other solid tumors beyond ccRCC that lack a VHL gene deficiency.
  • We will explore such opportunities with the goal of helping more patients in need.
  • This trial is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in patients with advanced ccRCC.
  • NiKang Therapeutics is a clinical stage biotech company focused on discovering and developing innovative small molecule oncology medicines to help patients with unmet medical needs.

Global Quantum Cascade Lasers Market to Reach $462.2 Million by 2026

Retrieved on: 
Thursday, March 24, 2022

SAN FRANCISCO, March 24, 2022 /PRNewswire/ -- A new market study published by Global Industry Analysts Inc., (GIA) the premier market research company, today released its report titled "Quantum Cascade Lasers - Global Market Trajectory & Analytics" .

Key Points: 
  • SAN FRANCISCO, March 24, 2022 /PRNewswire/ -- A new market study published by Global Industry Analysts Inc., (GIA) the premier market research company, today released its report titled "Quantum Cascade Lasers - Global Market Trajectory & Analytics" .
  • Amid the COVID-19 crisis, the global market for Quantum Cascade Lasers estimated at US$391.1 Million in the year 2022, is projected to reach a revised size of US$462.2 Million by 2026, growing at a CAGR of 4% over the analysis period.
  • This segment currently accounts for a 29.9% share of the global Quantum Cascade Lasers market.
  • The U.S. Market is Estimated at $220.2 Million in 2022, While China is Forecast to Reach $18.7 Million by 2026
    The Quantum Cascade Lasers market in the U.S. is estimated at US$220.2 Million in the year 2022.

Endothelial PAS Domain-Containing Protein 1 Inhibitors - 2021 Pipeline Landscape Report with Insights on 7+ Companies and Drugs - ResearchAndMarkets.com

Retrieved on: 
Friday, December 17, 2021

This report provides comprehensive insights about 7+ companies and 7+ pipeline drugs in Endothelial PAS domain-containing protein 1 inhibitors pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 7+ companies and 7+ pipeline drugs in Endothelial PAS domain-containing protein 1 inhibitors pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Endothelial PAS domain-containing protein 1 inhibitors R&D.
  • The therapies under development are focused on novel approaches to treat/improve Endothelial PAS domain-containing protein 1 inhibitors.
  • It also analyses Endothelial PAS domain-containing protein 1 inhibitors therapeutic drugs key players involved in developing key drugs.