Glioma

NH TherAguix receives FDA Fast Track designation

Retrieved on: 
Donnerstag, Mai 30, 2024
GBM, Patient, Central Europe, Phase, Biology, Gadolinium, Glioblastoma, Food, Glioma, Ipsen, FDA, MRI, Drug development, Neoplasm, Research, CMO, Brain, Death, Fast Track, Head, Radiation, Nanomedicine, Glomus tumor, NHT, Pharmaceutical industry

This new designation marks an important regulatory milestone for NH TherAguix, paving the way for accelerated development of its lead drug candidate, and is in line with the deployment of the company's new development strategy, following the recent appointment of Vincent Carrère as CEO.

Key Points: 
  • This new designation marks an important regulatory milestone for NH TherAguix, paving the way for accelerated development of its lead drug candidate, and is in line with the deployment of the company's new development strategy, following the recent appointment of Vincent Carrère as CEO.
  • Last September, Vincent joined NH TherAguix to lead the final steps of AGuIX® clinical developments through registration trials, until expected market approval.
  • “We are delighted to have received this FDA Fast Track designation for AGuIX® in the treatment of malignant glioma.
  • This Fast Track designation will facilitate NH TherAguix more frequent interactions with the FDA as well as accelerated approval and priority review in glioblastoma indications.

Royalty Pharma and Agios Pharmaceuticals Enter Into Vorasidenib Royalty Agreement for $905 Million

Retrieved on: 
Dienstag, Mai 28, 2024
Breakthrough therapy, Patient, Progression-free survival, Glioma, Food, Prevalence, FDA, EDT, Trial of the century, PDUFA, IDH, Incidence, Webcast, Pivotal, Food and Drug Administration, INDIGO, Enzyme, Pharmaceutical industry

“We are excited to acquire royalties on vorasidenib, which if approved, would be the first targeted therapy for patients with IDH-mutant glioma,” said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma.

Key Points: 
  • “We are excited to acquire royalties on vorasidenib, which if approved, would be the first targeted therapy for patients with IDH-mutant glioma,” said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma.
  • Under the terms of the agreement, Royalty Pharma will pay Agios $905 million in upfront cash on FDA approval of vorasidenib in exchange for a 15% royalty on annual U.S. net sales of vorasidenib up to $1 billion and a 12% royalty on annual U.S. net sales greater than $1 billion.
  • Royalty Pharma projects greater than $1 billion in peak annual sales potential for vorasidenib, which is expected to generate royalties of greater than $150 million annually to Royalty Pharma.
  • Royalty Pharma will host a conference call and simultaneous webcast to discuss the transaction today, Tuesday, May 28th at 8:30 a.m. Eastern Time.

Agios Announces $905 Million Purchase Agreement for Vorasidenib Royalty

Retrieved on: 
Dienstag, Mai 28, 2024
Agios Pharmaceuticals, Food, Goldman Sachs, Sickle cell disease, FDA, Sale, PDUFA, IDH, AGIO, Thalassemia, Glioma, Enzyme, Pharmaceutical industry

CAMBRIDGE, Mass., May 28, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, announced that the company has agreed to sell its rights to its 15% royalty on potential U.S. net sales of Servier’s vorasidenib to Royalty Pharma. Under the terms of the agreement, Agios will receive an upfront payment of $905 million upon approval of vorasidenib by the U.S. Food and Drug Administration (FDA) and Royalty Pharma will receive the entirety of the 15% royalty on annual U.S. net sales of vorasidenib up to $1 billion, and a 12% royalty on annual U.S. net sales greater than $1 billion. Agios will retain a 3% royalty on annual U.S. net sales greater than $1 billion.

Key Points: 
  • – Royalty Pharma to Acquire Rights to Agios’ 15% Royalty on Potential Vorasidenib U.S. Net Sales for $905 Million Upfront upon FDA Approval of Vorasidenib; Agios to Share in Economics Above Certain Revenue Thresholds –
    – In Total, Agios to Receive $1.1 Billion in Payments upon FDA Approval of Vorasidenib; PDUFA Action Date of August 20, 2024 –
    CAMBRIDGE, Mass., May 28, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, announced that the company has agreed to sell its rights to its 15% royalty on potential U.S. net sales of Servier’s vorasidenib to Royalty Pharma.
  • Under the terms of the agreement, Agios will receive an upfront payment of $905 million upon approval of vorasidenib by the U.S. Food and Drug Administration (FDA) and Royalty Pharma will receive the entirety of the 15% royalty on annual U.S. net sales of vorasidenib up to $1 billion, and a 12% royalty on annual U.S. net sales greater than $1 billion.
  • Agios will retain a 3% royalty on annual U.S. net sales greater than $1 billion.
  • As part of that divestiture, Agios is owed a milestone payment of $200 million upon vorasidenib’s approval by the FDA, as well as a 15% royalty on U.S. net sales of vorasidenib.

Global Oncolytic Virus Immunotherapy Market Opportunity & Clinical Trials Insight to 2030 - Regulatory Approvals and Pharmaceutical Investments Driving Market Growth - ResearchAndMarkets.com

Retrieved on: 
Montag, Mai 27, 2024
FDA, Pharmaceutical, Health, Oncology, Pembrolizumab, Patient, Nanoparticle, Oncolytic virus, Immunotherapy, Astellas Pharma, NRG, Laboratory, Glioma, Investment, Candel, H101, Immune system, Bristol Myers Squibb, Therapy, Government, Head, Snow, Breast cancer, Optimism, Genelux Corporation, Growth, PD-1, Cancer, Potyvirus, Irinotecan, Pancreatic cancer, EMA, Melanoma, Research, Fast Track, Attention, Merck, Oncos, Gastrointestinal cancer, OH2, Roche, Indication, Virus, PD-L1, Antibody, Quality of life, Vaccine

The "Global Oncolytic Virus Immunotherapy Market Opportunity & Clinical Trials Insight 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Oncolytic Virus Immunotherapy Market Opportunity & Clinical Trials Insight 2030" report has been added to ResearchAndMarkets.com's offering.
  • As the global medical community continues to advance targeted cancer therapies, oncolytic virus immunotherapy has emerged as a seminal player in this dynamic field.
  • Global Oncolytic Virus Immunotherapy Therapy Market Opportunity: > USD 1.50 Billion by 2030
    Oncolytic Viruses Immunotherapies Clinical Trials by Company, Indication & Phase
    Comprehensive Insight on Oncolytic Virus Immunotherapies in Clinical Trials: > 180 Therapies
    Cancer endures to be a relentless adversary, challenging both patients and the medical community across the world.
  • Continuous research, innovation, and collaboration are essential to sustaining this growth and realizing the full potential of oncolytic virus immunotherapy.

ONCOTELIC TO PARTICIPATE AT THE ASCO 2024 MEETING

Retrieved on: 
Montag, Mai 20, 2024
Meta-analysis, Patient, Neoplasm, Progression-free survival, Messenger, Therapy, IRF5, Glioma, Incidence, TGFB2, Cancer, OTCQB, ASCO, FOLFIRINOX

AGOURA HILLS, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) announced today its Chief Clinical Officer- Dr. Anthony Maida will be participating at the ASCO 2024 meeting.

Key Points: 
  • AGOURA HILLS, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) announced today its Chief Clinical Officer- Dr. Anthony Maida will be participating at the ASCO 2024 meeting.
  • Abstract: e16318.
  • Meta-analysis comparing the incidence of serious adverse events, overall survival, and progression-free survival in patients with pancreatic adenocarcinoma harboring unresectable tumors treated with modified FOLFIRINOX or FOLFIRINOX regimen.
  • The prognostic impact of transforming growth factor beta 2 (TGFB2) mRNA levels, in conjunction with interferon-gamma receptor activation of interferon regulatory factor 5 (IRF5) and expression of CD276/B7-H3 in low-grade gliomas.

Brain Cancer Canada Awards Grant for Innovative Medical Avatar Technology to Improve Treatments in High Grade Gliomas like Glioblastoma

Retrieved on: 
Donnerstag, Mai 16, 2024
Patient, Doctor of Philosophy, Survival, Faculty, Glioma, Neoplasm, Brain tumor, Research, Chorioallantoic membrane, Brain, FMSS, Chicken, CAM, Medical imaging

High grade gliomas can spread rapidly through brain tissue which typically leads to very poor prognosis for patients.

Key Points: 
  • High grade gliomas can spread rapidly through brain tissue which typically leads to very poor prognosis for patients.
  • The grant supports the innovative Sherbrooke Brain Cancer Avatar Initiative, employing novel CAMavatar technology.
  • This funding is part of Brain Cancer Canada's broader initiative during May's Brain Cancer Awareness Month, known as "Go Grey in May."
  • This is the second of four major grants issued by Brain Cancer Canada this month, highlighting its commitment to advancing research and support for brain cancer patients.

Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene

Retrieved on: 
Donnerstag, April 25, 2024
Glioma, Shanda, MET, WHO, Temozolomide, Safety, Risk, NMPA, National Medical Products Administration, Glioblastoma, Isocitrate dehydrogenase, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Partnership, Trial of the century, Etoposide, OS, History, CNS, IDH, Patient, Neoplasm, Met, APLM, NSCLC, Lung cancer, Pharmaceutical industry

FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points: 
  • "The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
  • Surgery, radiation treatment, and chemotherapy are current standard treatment strategies for gliomas with poor prognoses.
  • These preliminary data support cross-region similarity of patient response to treatment with vebreltinib.
  • This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.

XOMA Earns $9 Million Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDATM (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG)

Retrieved on: 
Donnerstag, April 25, 2024
FDA, Glioma, NDA, Food, Economics, New Drug Application, BRAF, Patient, Therapy, LGG, BRAF V600, Pharmaceutical industry

EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. 

Key Points: 
  • First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
    EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
  • “This is an important milestone for XOMA and our royalty portfolio, but more importantly, it is a watershed event for children living with low-grade gliomas with BRAF alterations that have relapsed or progressed,” stated Owen Hughes, Chief Executive Officer of XOMA.
  • In March 2021, XOMA paid $13.5 million upfront to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, plus a share of potential event-based economics, in addition to the economics associated with vosaroxin, from Viracta Therapeutics.

TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation

Retrieved on: 
Montag, April 15, 2024
FDA, University, Fast Track, Pharmacy, Food and Drug Administration, TLX, NDA, Food, Radiology, MD, ASX, PET, Partnership, Research, Glioma, UCSF, Patient, FET, Radiopharmaceutical, 18F-FET, Diagnosis

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).

Key Points: 
  • MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).
  • The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET).
  • Concurrently, Telix is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients.
  • This designation enables expedited review and closer consultation with the FDA during the review process.

Avistone Announces the Approval of Vebreltinib as the First MET-TKI Treatment for a Rare Brain Glioma Subtype in China

Retrieved on: 
Donnerstag, April 25, 2024
Oncology, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Glioma, Shanda, MET, Temozolomide, Safety, Radiation, NMPA, Glioblastoma, Isocitrate dehydrogenase, Prognosis, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Lung cancer, Etoposide, OS, History, Risk, CNS, Therapy, IDH, Patient, Neoplasm, NSCLC, Pharmaceutical industry

This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.

Key Points: 
  • This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.
  • In November 2023, vebreltinib received conditional approval for the treatment of metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC) from the NMPA.
  • Glioma is a refractory primary malignant intracranial tumor, accounting for approximately 46% of intracranial tumors [1].
  • The approval of vebreltinib for the ZM fusion-positive glioma indications is based on the positive results of the FUGEN study (NCT06105619).