Trial of the century

Allogene Therapeutics Awarded Grant from the California Institute for Regenerative Medicine to Advance Development of an Allogeneic CAR T in Renal Cell Carcinoma

Retrieved on: 
Friday, April 26, 2024
Cancer, Safety, Regenerative medicine, TS, Metastasis, Trial of the century, Doctor of Philosophy, Development, Disease, CIRM, Autoimmune disease, Kite Pharma, Research and development, Patient, RCC, CD70, AACR, Clinical trial, Kidney cancer, Therapy, SAN, Pharmaceutical industry

It is a disease in need of innovation as current therapies are based on a few mechanistic targets and complete response rates are low.

Key Points: 
  • It is a disease in need of innovation as current therapies are based on a few mechanistic targets and complete response rates are low.
  • The grant will support the ongoing Phase 1 TRAVERSE trial which assesses safety, tolerability and preliminary efficacy of ALLO-316 in advanced RCC that has progressed despite standard therapy.
  • Additionally, the grant will support translational and clinical analyses to inform a recommended Phase 2 regimen.
  • A more comprehensive data update from the ongoing trial is planned for later in 2024.

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

Retrieved on: 
Thursday, 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.

Junshi Biosciences Announces NDA Acceptance in Hong Kong for Toripalimab

Retrieved on: 
Thursday, 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.

FibroBiologics Plans to Collaborate with Charles River to Manufacture Fibroblast-based Spheroids

Retrieved on: 
Thursday, April 25, 2024
Conditional sentence, Cancer, Fibroblast, Communication, Trial of the century, Research, Degenerative disc disease, CDMO, Form, DNA, Therapy, Risk, Patient, Psoriasis, Charles River Laboratories, Multiple sclerosis, Wound healing, Drug discovery, Letter, Pharmaceutical industry

HOUSTON, April 25, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics") and Charles River Laboratories (“Charles River”), a highly respected, global provider of drug discovery, development, and manufacturing solutions, today announced the signing of a letter of intent allowing for the transfer, testing and validation of FibroBiologics’ technology.

Key Points: 
  • HOUSTON, April 25, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics") and Charles River Laboratories (“Charles River”), a highly respected, global provider of drug discovery, development, and manufacturing solutions, today announced the signing of a letter of intent allowing for the transfer, testing and validation of FibroBiologics’ technology.
  • To help advance FibroBiologics’ fibroblast-based therapies into the clinic, Charles River will conduct feasibility studies on FibroBiologics' cell manufacturing processes within its facility.
  • Additionally, contingent upon entering into a master services agreement, Charles River would serve as the contract development and manufacturing organization (CDMO) responsible for producing drug products for certain FibroBiologics’ clinical trials.
  • Combined with its legacy testing capabilities, Charles River offers a premier “concept-to-cure” advanced therapies solution.

Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next Generation Colorectal Cancer Diagnostic

Retrieved on: 
Thursday, April 25, 2024
FDA, Cancer, CDC, Colorectal cancer, CRC, Trial of the century, Polyp, Patient, Colonoscopy, FIT, Gene expression, Messenger, Biomarker, PMA, Medical imaging

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.

Key Points: 
  • “We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.
  • Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer.
  • Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.
  • The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

Acrivon Therapeutics Reports Initial Positive Clinical Data for ACR-368 and Pipeline Program Progress Today at Corporate R&D Event

Retrieved on: 
Wednesday, April 24, 2024
Cancer, Ovarian cancer, RECIST, AP3, Trial of the century, IND, PKMYT1, Dor, Patient, Endometrial cancer, Medicine, WEE1, Event, Neoplasm, ACRV, Clinical trial, Therapy, File, Pharmaceutical industry

WATERTOWN, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics (AP3), to host a corporate R&D event. The company plans to present initial positive clinical data from the ongoing registrational-intent Phase 2 ACR-368 clinical trials, which showed prospective validation of the proprietary ACR-368 OncoSignature patient selection biomarker test with a 50% confirmed objective response rate (ORR) in patients with ovarian and endometrial cancers. Acrivon is also sharing new preclinical data for ACR-2316, now with accelerated IND filing timelines, as well as actionable findings with the machine learning-enabled AP3 platform.

Key Points: 
  • Acrivon is also sharing new preclinical data for ACR-2316, now with accelerated IND filing timelines, as well as actionable findings with the machine learning-enabled AP3 platform.
  • “Today we present initial clinical data from our ongoing Phase 2 clinical trial which we believe highlights the power of our next generation proteomics-based AP3 precision medicine platform,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics.
  • Consistent with past trials, the ACR-368 treatment-related adverse event profile was predominantly reversible and transient with only mechanism-based, hematological adverse events.
  • The webcast will be available for at least 30 days following the event.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Anavex Life Sciences Corp. (AVXL)

Retrieved on: 
Wednesday, April 24, 2024
News, Suite, GPM, Avatar, Court, Trial of the century, Excellence

You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

Key Points: 
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • On January 2, 2024, Anavex announced results from a Phase 2/3 EXCELLENCE Clinical Study in Pediatric Rett Syndrome, reporting that the “co-primary endpoint .
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • Glancy Prongay & Murray LLP, Los Angeles

Revive Therapeutics Announces Type C Meeting Request Granted by FDA for Clinical Study of Bucillamine to Treat Long COVID

Retrieved on: 
Tuesday, April 23, 2024
RVV, FDA, COVID, Safety, Economics, CDC, Infection, Death, Trial of the century, Doctor of Philosophy, Research, Cough, Heart rate, Therapy, Patient, Hospital, Fever, COVID-19, Harvard University, Pharmaceutical industry

The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1.

Key Points: 
  • The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1.
  • Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID.
  • The Company is advancing the clinical development of Bucillamine by leveraging the published research and data from its previous Phase 3 clinical trial (the “Study”) and is finalizing the regulatory and clinical package that includes a proposed clinical study for long COVID to present to the FDA.
  • Additional analyses of the Study data may suggest Bucillamine’s potential for long COVID.

Back Discomfort Hits Just Above the Belt, According to Life Extension Survey

Retrieved on: 
Tuesday, April 23, 2024
Inflammation, Life extension, MD, Trial of the century, Motion, Exercise, Life, Buttocks, Posture, Quality of life, Ginger, Dietary supplement

A recent survey* of 4,752 Life Extension customers found that 80% of those who experience back discomfort feel it in their lower back specifically, and 44% of this group deal with discomfort or stiffness daily.

Key Points: 
  • A recent survey* of 4,752 Life Extension customers found that 80% of those who experience back discomfort feel it in their lower back specifically, and 44% of this group deal with discomfort or stiffness daily.
  • *March 2024 survey of Life Extension customers.
  • “In a clinical study, the combination of chaste tree extract and ginger extract reduced lower back discomfort, as evidenced by reduced stiffness and increased flexibility and comfort,” said Life Extension Chief Scientific Officer Andrew Swick .
  • Dr. Smith added that office workers may be particularly prone to discomfort in this area between the ribcage and buttocks.

Benitec Biopharma Reports Positive Interim Clinical Trial Data for First OPMD Subject Treated with BB-301 in Phase 1b/2a Study

Retrieved on: 
Thursday, April 18, 2024
FDA, Dysphagia, Mutation, EDT, Nature, COMP, Oculopharyngeal muscular dystrophy, Hope, Food, News, Death, Yogurt, Pharmacotherapy, Observation, PABPN1, Disease, OPMD, Subject, Ptosis, Patient, EMA, Caregiver, Committee, Clinical trial, Trial of the century, Orphan drug, European Medicines Agency, Pharmaceutical industry

HAYWARD, Calif., April 18, 2024 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announces positive interim clinical data from the 90-day timepoint following the administration of BB-301 to the study’s first subject (Subject 1) treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD). BB-301 has been granted Orphan Drug designation by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

Key Points: 
  • “To date, no clinical studies have systematically demonstrated a clinical improvement in OPMD patients across both objective and subjective measures of swallowing.
  • We are, therefore, pleased to report positive interim clinical data from multiple radiographic measures as well as subject-reported outcome measures from the first subject treated with BB-301,” said Jerel A.
  • Videofluoroscopic swallowing studies represent the gold standard analytical method for the quantitative assessment of dysphagia (swallowing difficulty) in the clinical setting.
  • The event replay will be placed on the News & Events tab on the Investor page of the Benitec website.