Nasopharyngeal carcinoma

WestGene's mRNA Therapeutic Cancer Vaccine Receives FDA Approval

Retrieved on: 
Freitag, Mai 10, 2024
Ionization, Patient, Esophageal cancer, IIT, Toxicity, Patent, Nasopharyngeal carcinoma, NPC, Messenger, FDA, Cervical cancer, Malignancy, Breast cancer, Vaccine, Bone marrow, EB, Lipid, Multiple sclerosis, Research, Stomach, Lupus, Cancer, Lung cancer, Liver cancer

CHENGDU, China, May 10, 2024 /PRNewswire/ -- WestGene, a biotech company dedicated to mRNA technology, announces a historic milestone with the FDA IND approval of its mRNA therapeutic cancer vaccine, WGc-043.

Key Points: 
  • CHENGDU, China, May 10, 2024 /PRNewswire/ -- WestGene, a biotech company dedicated to mRNA technology, announces a historic milestone with the FDA IND approval of its mRNA therapeutic cancer vaccine, WGc-043.
  • This landmark achievement marks the world's first approval of an EB virus-related mRNA therapeutic cancer vaccine.
  • The FDA approval of WGc-043 represents a significant advance in cancer treatment, offering new hope to patients with advanced EB virus-related cancers.
  • EB virus is highly correlated with more than ten malignancies, including nasopharyngeal carcinoma (NPC), natural killer T-cell lymphoma (NKTL), gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer, cervical cancer, and autoimmune diseases such as multiple sclerosis and systemic lupus erythematosus.

WestGene's mRNA Therapeutic Cancer Vaccine Receives FDA Approval

Retrieved on: 
Freitag, Mai 10, 2024
Ionization, Patient, Esophageal cancer, IIT, Toxicity, Patent, Nasopharyngeal carcinoma, NPC, Messenger, FDA, Cervical cancer, Malignancy, Breast cancer, Vaccine, Bone marrow, EB, Lipid, Multiple sclerosis, Research, Stomach, Lupus, Cancer, Lung cancer, Multimedia, Liver cancer

CHENGDU, China, May 10, 2024 /PRNewswire/ -- WestGene, a biotech company dedicated to mRNA technology, announces a historic milestone with the FDA IND approval of its mRNA therapeutic cancer vaccine, WGc-043.

Key Points: 
  • CHENGDU, China, May 10, 2024 /PRNewswire/ -- WestGene, a biotech company dedicated to mRNA technology, announces a historic milestone with the FDA IND approval of its mRNA therapeutic cancer vaccine, WGc-043.
  • This landmark achievement marks the world's first approval of an EB virus-related mRNA therapeutic cancer vaccine.
  • The FDA approval of WGc-043 represents a significant advance in cancer treatment, offering new hope to patients with advanced EB virus-related cancers.
  • EB virus is highly correlated with more than ten malignancies, including nasopharyngeal carcinoma (NPC), natural killer T-cell lymphoma (NKTL), gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer, cervical cancer, and autoimmune diseases such as multiple sclerosis and systemic lupus erythematosus.

Junshi Biosciences Announces NDA Acceptance in Hong Kong for Toripalimab

Retrieved on: 
Donnerstag, April 25, 2024
PFS, Shirin David, JAMA, Risk, NDA, Government, Progression-free survival, New Drug Application, American Medical Association, Cisplatin, Death, Immunotherapy, Trial of the century, ASCO, European, Health department, Dor, Patient, Nasopharyngeal carcinoma, Society, NPC, Marketing, Clutch (eggs), Journal, Pharmaceutical industry

Toripalimab plus chemotherapy also reduced the risk of disease progression or death by 48% and the risk of death by 37%, all while demonstrating a manageable safety profile.

Key Points: 
  • Toripalimab plus chemotherapy also reduced the risk of disease progression or death by 48% and the risk of death by 37%, all while demonstrating a manageable safety profile.
  • So far, toripalimab has been approved for marketing in the Chinese mainland and the US.
  • Several NDAs are currently under regulatory review in the European Union, UK, Australia, Singapore, Malaysia and Hong Kong Special Administrative Region (“SAR”).
  • Furthermore, NDAs for toripalimab have also been submitted in India, South Africa, Chile and Jordan.

Coherus Completes Divestiture of Ophthalmology Franchise

Retrieved on: 
Montag, März 4, 2024
Nasopharyngeal carcinoma, Ophthalmology, CHRS, FDA, Sale, PD-1, Tumor microenvironment, Latham & Watkins, Ranibizumab

REDWOOD CITY, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS) today announced the completion of the previously announced divestiture of its CIMERLI® (ranibizumab-eqrn) ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology LLC, to Sandoz, Inc. for upfront all-cash consideration of $170 million. This divestiture included Coherus’ CIMERLI biologics license application, ophthalmology sales and select field reimbursement teams, and access to proprietary commercial software.

Key Points: 
  • REDWOOD CITY, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS) today announced the completion of the previously announced divestiture of its CIMERLI® (ranibizumab-eqrn) ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology LLC, to Sandoz, Inc. for upfront all-cash consideration of $170 million.
  • This divestiture included Coherus’ CIMERLI biologics license application, ophthalmology sales and select field reimbursement teams, and access to proprietary commercial software.
  • Coherus received upfront, all-cash consideration of $170 million plus certain purchase price adjustments, which will be finalized following the closing pursuant to the agreement between Coherus and Sandoz.
  • J.P. Morgan Securities LLC acted as the Company’s financial advisor, and Latham & Watkins LLP acted as legal counsel to Coherus in connection with the transaction.

Coherus Amends Term Loan Agreement with Pharmakon Advisors, LP

Retrieved on: 
Montag, Februar 5, 2024
Growth, Consent, CHRS, Nasopharyngeal carcinoma, Sales management, Ophthalmology, Creditor, LP, Security (finance)

REDWOOD CITY, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced it has entered into an agreement with Pharmakon Advisors, LP to revise the terms of its loan agreement entered in January 2022. Following the closing of the previously announced divestiture of the ophthalmology franchise to Sandoz, Coherus plans to prepay $175 million of $250 million principal balance in Q2 2024, leaving a residual balance of $75 million and reducing projected annual interest payments by about 70%.

Key Points: 
  • REDWOOD CITY, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced it has entered into an agreement with Pharmakon Advisors, LP to revise the terms of its loan agreement entered in January 2022.
  • “The divestiture of the ophthalmology franchise, when completed, is projected to provide us with the opportunity to improve our capital structure and reduce interest payment obligations by paying down a significant portion of the principal on term loan debt while renegotiating certain terms,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus.
  • “With three UDENYCA formats in the pegfilgrastim market, the launch of LOQTORZI into nasopharyngeal carcinoma, plus a promising immuno-oncology pipeline, they have positioned themselves for success as an oncology company.
  • Other terms of the Existing Loan Agreement, as amended by the Consent and Amendment, remain generally identical to those under the Existing Loan Agreement.

Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

Retrieved on: 
Freitag, Februar 2, 2024
Orbis, HC, JAMA, TGA, HSA, European, Shirin David, Immunotherapy, Trial of the century, Nasopharyngeal carcinoma, NPC, PFS, Clutch (eggs), Cisplatin, Patient, Safety, ASCO, New Drug Application, American Medical Association, Shanda, Progression-free survival, FDA, Marketing, OCE, Dor, Food, Society, Health Canada, Risk, Journal, Death, Health care, NDA, HKEX, Pharmaceutical industry

This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE).

Key Points: 
  • This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE).
  • At present, eight regulatory agencies have joined Project Orbis, including the FDA, the Australia Therapeutic Goods Administration (“TGA”), HSA, Health Canada (HC), the U.K.
  • Previously, two NDAs for toripalimab for the treatment of NPC had been submitted to the TGA through Project Orbis and were successfully accepted.
  • Junshi Biosciences will explore accelerated marketing opportunities in countries and regions where it is applicable.

WestGene Spearheads Oncology Breakthroughs at the 3rd mRNA-Based Therapeutics Summit

Retrieved on: 
Mittwoch, Januar 24, 2024
Speech, Therapy, Research, Nasopharyngeal carcinoma, Summit, IIT, NKT, AI, Government, EMA, BioNTech, CureVac, Cancer, Acquisition, WHO, Drug development, Safety, Intellectual property, Toxicity, Patent, Merck, Messenger, HBV, LNP, Vaccine, Colorectal cancer, CEPI

CHENGDU, China, Jan. 24, 2024 /PRNewswire/ -- Kicking off the New Year with remarkable achievements, Chengdu-based WestGene made a significant impact at the 3rd mRNA-Based Therapeutics Summit in Berlin, Germany.

Key Points: 
  • CHENGDU, China, Jan. 24, 2024 /PRNewswire/ -- Kicking off the New Year with remarkable achievements, Chengdu-based WestGene made a significant impact at the 3rd mRNA-Based Therapeutics Summit in Berlin, Germany.
  • The Summit, held January 23-25, is a key event in the field of mRNA drug development, attracting over 200 specialists from various parts of the world.
  • Founded by two visionary scientists, Dr. Wei Yuquan and Dr. Xiangrong Song, WestGene Biotech is dedicated to pioneering the field of mRNA therapeutics.
  • This project, along with its extensive pipeline, positions WestGene at the forefront of biopharmaceutical innovation and research.

WestGene Spearheads Oncology Breakthroughs at the 3rd mRNA-Based Therapeutics Summit

Retrieved on: 
Mittwoch, Januar 24, 2024
Speech, Therapy, Research, Nasopharyngeal carcinoma, Multimedia, Summit, IIT, NKT, AI, Government, EMA, BioNTech, CureVac, Cancer, Acquisition, WHO, Drug development, Safety, Intellectual property, Toxicity, Patent, Merck, Messenger, HBV, LNP, Vaccine, Colorectal cancer, CEPI

CHENGDU, China, Jan. 24, 2024 /PRNewswire/ -- Kicking off the New Year with remarkable achievements, Chengdu-based WestGene made a significant impact at the 3rd mRNA-Based Therapeutics Summit in Berlin, Germany.

Key Points: 
  • CHENGDU, China, Jan. 24, 2024 /PRNewswire/ -- Kicking off the New Year with remarkable achievements, Chengdu-based WestGene made a significant impact at the 3rd mRNA-Based Therapeutics Summit in Berlin, Germany.
  • Renowned for her pivotal role in mRNA research, Dr. Xiangrong Song, co-founder and CEO of WestGene, presented the latest advances in the company's oncology sector, with a special focus on mRNA-based cancer vaccines.
  • The Summit, held January 23-25, is a key event in the field of mRNA drug development, attracting over 200 specialists from various parts of the world.
  • Founded by two visionary scientists, Dr. Wei Yuquan and Dr. Xiangrong Song, WestGene Biotech is dedicated to pioneering the field of mRNA therapeutics.

Viracta Therapeutics Provides Clinical Update and Outlook for 2024

Retrieved on: 
Donnerstag, Januar 4, 2024
SDD, NPC, Food, Stage 2, Nasopharyngeal carcinoma, Lymphoma, DLBCL, FDA, PTLD, ODD, SAN, Therapy, Peripheral T-cell lymphoma, Patient, PTCL, Pharmaceutical industry

SAN DIEGO, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today provided a clinical update, including its roadmap for advancing Nana-val’s clinical development in 2024. Nana-val (nanatinostat in combination with valganciclovir), is the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers.

Key Points: 
  • Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma (PTCL) cohort of patients treated with Nana-val (n=11) in the first quarter of 2024.
  • Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024.
  • Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024.
  • Best responses through the fifth dose cohort included two confirmed partial responses and five stable diseases out of 17 patients.

Coherus Announces U.S. Launch of LOQTORZI™

Retrieved on: 
Dienstag, Januar 2, 2024
DCR, Platinum, NPC, Partnership, Neoplasm, Nasopharyngeal carcinoma, Survival, ABC, Immune system, Risk, CHRS, Prognosis, McKesson Corporation, FDA, PD-1, Hope, Progression-free survival, NCCN, Research, Education, Cisplatin, HCPCS, Cancer, Sarcoma, Death, Cardinal, Patient, OS, PFS, NDC, PD-L1, Pharmaceutical industry

REDWOOD CITY, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced that LOQTORZI™ (toripalimab-tpzi) is now available through select specialty distributors in the United States. LOQTORZI is indicated in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.

Key Points: 
  • In December, the NCCN committee classified LOQTORZI as a preferred category 1 treatment option in combination with gemcitabine and cisplatin.
  • LOQTORZI has demonstrated impressive clinical benefits, including PFS and OS, offering R/M NPC patients new hope for extended survival,” said Paul Reider, Chief Commercial Officer of Coherus.
  • Contact Coherus BioSciences Customer Services at 1-844-562-6004 for more information.
  • Coherus expects a product-specific, permanent J-code to be assigned to LOQTORZI in mid-2024.