Zotiraciclib

Imago BioSciences Receives Orphan Designation From European Medicines Agency for Bomedemstat for the Treatment of Essential Thrombocythemia

Retrieved on:

Friday, July 30, 2021

Science, Cardiology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical trials, Life sciences, Health sciences, Health, Biotechnology law, Drug discovery, Orphan drug, Pharmaceuticals policy, Myeloproliferative neoplasm, European Medicines Agency, Zotiraciclib

Imago BioSciences, Inc. (Imago) (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), today announced that the European Medicines Agency (EMA) has granted orphan designation for bomedemstat, a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of essential thrombocythemia (ET).

Key Points:

Imago BioSciences, Inc. (Imago) (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), today announced that the European Medicines Agency (EMA) has granted orphan designation for bomedemstat, a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of essential thrombocythemia (ET).
The Phase 2 clinical trial of bomedemstat for the treatment of ET continues to actively enroll globally ( NCT04254978 ).
Gaining this designation is an important regulatory milestone that gives us added momentum in advancing the development of bomedemstat.
Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of ET and MF, European Medicines Agency (EMA) Orphan Designation for the treatment of ET and MF, and PRIority MEdicines (PRIME) Designation by the EMA for the treatment of MF.

Day One Receives FDA Rare Pediatric Disease Designation for DAY101 for the Treatment of Pediatric Low-Grade Glioma

Retrieved on:

Tuesday, July 27, 2021

Health sciences, Health, Life sciences, Biotechnology law, Drug discovery, Pharmaceuticals policy, Orphan drugs, Glioma, Breakthrough therapy, Food and Drug Administration, Zotiraciclib, Pritumumab

In addition to FDA Rare Pediatric Disease Designation, DAY101 has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options.

Key Points:

In addition to FDA Rare Pediatric Disease Designation, DAY101 has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options.
In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.
The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children.
In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.

WPD Pharmaceuticals’ Licensor Receives FDA Fast Track Designation for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme; WPD Poland Arranges Loans

Retrieved on:

Monday, July 12, 2021

Cancer, Clinical medicine, Medicine, Oncology, Brain tumor, Glioblastoma, Blastoma, Zotiraciclib, Paclitaxel trevatide

As previously reported, CNS had also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

Key Points:

As previously reported, CNS had also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.
Receiving Fast Track Designation from the U.S. FDA is a significant achievement in the advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain.
Many patients have almost no meaningful options and thousands lose the fight against this cancer every year.
CNS recently announced the start of patient enrollment in its study of Berubicin for the treatment of recurrent glioblastoma multiforme.

TriAct Therapeutics Announces Iniparib Granted Orphan Drug Designation by the FDA for Treatment of Malignant Glioma

Retrieved on:

Wednesday, July 7, 2021

Health, Cancer, Orphan drugs, Brain tumor, Glioblastoma, Oncology, Iniparib, Zotiraciclib, Depatuxizumab mafodotin

SAN FRANCISCO, July 7, 2021 /PRNewswire/ -- TriAct Therapeutics, a private, late clinical stage oncology therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead drug, iniparib, for the treatment of patients with malignant gliomas.

Key Points:

SAN FRANCISCO, July 7, 2021 /PRNewswire/ -- TriAct Therapeutics, a private, late clinical stage oncology therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead drug, iniparib, for the treatment of patients with malignant gliomas.
The FDA noted that the designation granted is broader than the glioblastoma indication proposed in the Company's request and that treatment of glioblastoma is within the scope of this orphan drug designation.
"Receiving orphan drug designation is an important milestone in our effort to bring this promising new therapy to both adult and pediatric patients suffering from malignant gliomas, including newly diagnosed glioblastoma," said Tom White, co-founder and Chief Executive Officer of TriAct.
Iniparib is a well characterized, clinical stage drug candidate that kills cancer cells by targeting their redox metabolism, spiking oxidative stress levels and triggering programmed cell death.

Global Glioblastoma Multiforme (GBM) Treatment Market Could Reach Nearly $1.8 Billion By 2027

Retrieved on:

Tuesday, June 29, 2021

Cancer, Brain tumor, Health, Clinical medicine, Glioblastoma, Blastoma, Glioma, GBM, Glioblast, Zotiraciclib

The report said that: " The global Glioblastoma multiforme(GBM) drugs market is projected to reach nearly $1.8 billion by 2027, expanding at a CAGR of 12.8% during the forecast period, driven by rising geriatric population, growing incidence cases and rich clinical pipeline of new products.

Key Points:

The report said that: " The global Glioblastoma multiforme(GBM) drugs market is projected to reach nearly $1.8 billion by 2027, expanding at a CAGR of 12.8% during the forecast period, driven by rising geriatric population, growing incidence cases and rich clinical pipeline of new products.
Glioblastoma is the most common primary malignant form of brain cancer.Despite technological advances in surgery and radio-chemotherapy, glioblastoma remains largely resistant to treatment."
The iHealthcareAnaylist report continued: "A few agents have been approved by the US FDA for the treatment of high-grade gliomas following orphan drug designation, but most have failed to reach the market.
CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme.

Global Glioblastoma Multiforme (GBM) Treatment Market Could Reach Nearly $1.8 Billion By 2027

Retrieved on:

Tuesday, June 29, 2021

Cancer, Brain tumor, Health, Clinical medicine, Glioblastoma, Blastoma, Glioma, GBM, Glioblast, Zotiraciclib

The report said that: " The global Glioblastoma multiforme(GBM) drugs market is projected to reach nearly $1.8 billion by 2027, expanding at a CAGR of 12.8% during the forecast period, driven by rising geriatric population, growing incidence cases and rich clinical pipeline of new products.

Key Points:

The report said that: " The global Glioblastoma multiforme(GBM) drugs market is projected to reach nearly $1.8 billion by 2027, expanding at a CAGR of 12.8% during the forecast period, driven by rising geriatric population, growing incidence cases and rich clinical pipeline of new products.
Glioblastoma is the most common primary malignant form of brain cancer.Despite technological advances in surgery and radio-chemotherapy, glioblastoma remains largely resistant to treatment."
The iHealthcareAnaylist report continued: "A few agents have been approved by the US FDA for the treatment of high-grade gliomas following orphan drug designation, but most have failed to reach the market.
CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme.

FDA Grants Fast Track Designation to CNS Pharmaceuticals for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme

Retrieved on:

Tuesday, June 29, 2021

Cancer, Clinical medicine, Health, Oncology, Brain tumor, Glioblastoma, Blastoma, Zotiraciclib, Medivir

As previously reported, the Company has also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

Key Points:

As previously reported, the Company has also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.
"Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain.
CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme.
CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

Day One Receives Orphan Designation from the European Commission for DAY101 for the Treatment of Glioma

Retrieved on:

Monday, June 21, 2021

Health sciences, Life sciences, Health, Pharmaceuticals policy, Biotechnology law, Drug discovery, Orphan drug, European Medicines Agency, Breakthrough therapy, Orphan Drug Act, Zotiraciclib

The designation was based on a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products.

Key Points:

The designation was based on a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products.
Orphan designation for DAY101 from the European Commission exemplifies the urgent medical need for additional treatment options for glioma and builds upon the previous Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration for DAY101, said Davy Chiodin, PharmD, chief development officer of Day One.
Orphan designation by the European Commission provides companies with certain benefits and incentives, including protocol assistance, reduced regulatory fees and up to 10 years of market exclusivity following regulatory approval.
In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.

Kronos Bio to Present Pre-Clinical Data at the AACR Virtual Annual Meeting 2021 for KB-0742, an Oral CDK9 Inhibitor Targeting MYC-amplified Cancers

Retrieved on:

Wednesday, March 10, 2021

Branches of biology, Biology, Cell Cycle, Proteins, Transcription factors, Myc, Oncogenes, Cyclin-dependent kinase 9, Zotiraciclib

ET

Key Points:

ET
Kronos Bio initiated a Phase 1/2 clinical trial of KB-0742 in patients with advanced solid tumors or non-Hodgkin lymphoma earlier this year.
KB-0742 is a highly selective, orally bioavailable inhibitor of cyclin dependent kinase 9 (CDK9) in development for the treatment of MYC-amplified solid tumors.
Kronos Bio leverages its SMM screening platform to conduct high-throughput screens against traditionally undruggable target proteins, in particular transcription factors.
The company is also developing KB-0742, an oral inhibitor of cyclin dependent kinase 9 (CDK9), for the treatment of MYC-amplified solid tumors.

Oblato Announces Fast Track Designation of OKN-007 for Diffuse Intrinsic Pontine Glioma from the FDA

Retrieved on:

Wednesday, March 3, 2021

Diffuse intrinsic pontine glioma, Fast track, Glioma, Food and Drug Administration, Fast track, Health, Life sciences, Medicine, Zotiraciclib, Clinica 0-19

PRINCETON, N.J., March 3, 2021 /PRNewswire/ --Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG).

Key Points:

PRINCETON, N.J., March 3, 2021 /PRNewswire/ --Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG).
The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
In addition to the Fast Track Designation, Oblato has already received Rare Pediatric Disease designation for DIPG.
"We anticipate that the Fast Track Designation for DIPG will shorten the NDA review process.