Annals of Oncology

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

Retrieved on: 
Sunday, April 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

OSE Immunotherapeutics Highlights Clinical Portfolio Advancements and Provides 2024 Outlook

Retrieved on: 
Friday, January 19, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Journal of Immunology, HCC, ICI, CD47, Cancer, EMA, Journal, Pembrolizumab, IL-7, Kidney transplantation, Acute lymphoblastic leukemia, Annals of Oncology, Nivolumab, Fortification, ESMO, Hepatocellular carcinoma, Safety, Inflammation, Ulcerative colitis, Patent, Ovarian cancer, Failure, Survival, Immunotherapy, Boehringer Ingelheim, Committee, Myelocyte, Oncology, Patient, European Medicines Agency, ALL, Partnership, Lung cancer, Head, Pancreatic cancer, Phase II, FDA, Clinical trial, FOLFIRI, Pharmaceutical industry

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.
  • Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “The Company has a broad portfolio of 5 products in clinical development with significant advances reached in 2023 and key milestones expected in 2024.
  • Our shared ambition at OSE is to create value by leading our two advanced assets in phase 2 and phase 3 to a clinical inflection point allowing a structuring agreement.
  • Thus, from Q1 2024, the Company could have validated doses and therapeutic regimens to consider the implementation of possible other clinical trials.

Sermonix Pharmaceuticals Announces Publication of ELAINE-1 and ELAINE-2 Trial Results in Annals of Oncology

Retrieved on: 
Monday, December 11, 2023
Editorial, Quality of life, ESR1, Hospital, ESMO, Medicine, ASCO, Woman, Breast cancer, Fulvestrant, Annals of Oncology, Eli Lilly, Breast, Business model, Progression-free survival, Massachusetts General Hospital, Congress, Society, Trial of the century, International Society, Mutation, Annual general meeting, Neoplasm, Oncology, Patient, PFS, Therapy, Pharmaceutical industry

Also, 30.7% of patients on lasofoxifene achieved a PFS of 12 months compared to 14.1% on fulvestrant.

Key Points: 
  • Also, 30.7% of patients on lasofoxifene achieved a PFS of 12 months compared to 14.1% on fulvestrant.
  • Results were initially shared at a poster discussion session during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and updated in June at ASCO 2023.
  • Annals of Oncology provides rapid and efficient peer-review publications on innovative cancer treatments or translational work related to oncology and precision medicine.
  • To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit SermonixPharma.com .

Inspirna Announces Clinical Data from Phase 1b/2 Study of Ompenaclid (RGX-202) in Advanced Colorectal Cancer at ESMO Congress 2023

Retrieved on: 
Monday, October 23, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Bevacizumab, Neoplasm, PRS, MTD, RAS, Annals of Oncology, ESMO, Principal investigator, Therapy, Assistant, Infrared spectroscopy correlation table, FOLFIRI, MOS, Congress, European Society for Medical Oncology, SLC6A8, BID, Rasm, HIV disease progression rates, Poster, BEV, CRC, Index, KOL, Cedars-Sinai Medical Center, ORR, RECIST, Annals, Apoptosis, Patient, Randomized controlled trial, Mutation, PR, Pharmaceutical industry, Medicine

The Phase 1b/2 study of ompenaclid in combination with FOLFIRI/BEV in second-line (2L) advanced or metastatic CRC patients has completed enrollment, with an ongoing follow up period.

Key Points: 
  • The Phase 1b/2 study of ompenaclid in combination with FOLFIRI/BEV in second-line (2L) advanced or metastatic CRC patients has completed enrollment, with an ongoing follow up period.
  • The primary endpoint of the study is to determine maximum tolerated dose (MTD), objective response rate (ORR), and treatment-emergent adverse events (TEAEs).
  • The abstract is published in the ESMO Congress 2023 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.
  • Title: Phase 1b/2 study of ompenaclid (RGX-202-01), a first-in-class oral inhibitor of the creatine transporter SLC6A8, in combination with FOLFIRI and bevacizumab (BEV) in RAS mutated (RASm) second-line (2L) advanced/metastatic colorectal cancer (mCRC)

Research Conducted by Florida Cancer Specialists & Research Institute Featured at European Society of Medical Oncology 2023 Congress

Retrieved on: 
Friday, October 20, 2023
Research, Annals of Oncology, ESMO, SERD, Physician, MAPK, Congress, European Society for Medical Oncology, Estate (law), Drug development, B7-H4, Adenoid cystic carcinoma, FIH, Abstract, Oncology, Safety, Cancer, FCS, ATR, Patient, Diagnosis, Conjugation, Pharmaceutical industry, MD

FORT MYERS, Fla., Oct. 20, 2023 /PRNewswire/ -- Research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) is featured this week among the latest advancements and findings in cancer care at the European Society of Medical Oncology (ESMO) Congress in Madrid, Spain. Five FCS physicians are the first authors and/or co-authors of 12 cancer research studies that will be shared at the global gathering of oncologists, researchers, patient advocates, pharmaceutical representatives and journalists. With more than 30,000 members from 168 countries worldwide, ESMO is the leading professional organization for medical oncology.

Key Points: 
  • FORT MYERS, Fla., Oct. 20, 2023 /PRNewswire/ -- Research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) is featured this week among the latest advancements and findings in cancer care at the European Society of Medical Oncology (ESMO) Congress in Madrid, Spain.
  • With more than 30,000 members from 168 countries worldwide, ESMO is the leading professional organization for medical oncology.
  • The ESMO Congress 2023 is a global stage for the exchange of potentially practice-changing data and multidisciplinary conversations that will spur transformative therapies against cancer.
  • All of the study abstracts will be published online in the ESMO Congress 2023 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.

Burning Rock Received Breakthrough Device Designation from China’s NMPA for its Multi-Cancer Early Detection Test

Retrieved on: 
Monday, October 16, 2023
Food, Annals of Oncology, NGS, Risk, National Medical Products Administration, Ageing, Cancer, Rock, US Foods, FDA, LSE, Nucleic acid thermodynamics, NMPA, US FDA, Medical imaging, Water Drops on Burning Rocks

GUANGZHOU, China, Oct. 15, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.

Key Points: 
  • GUANGZHOU, China, Oct. 15, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.
  • OverC™ MCDBT is intended for early detection of multiple cancer types in adults of either sex, aged 50-75 years old, at average risk for cancer.
  • Mr. Yusheng Han, founder and CEO of Burning Rock, said, “We are very inspired that our multi-cancer early detection product has received recognition from both US and China regulatory authorities.
  • We obtained our first Breakthrough Device Designation from China NMPA in 2016 for NGS-based therapy selection test, and the China NMPA Breakthrough Device Designation granted for OverC™ MCDBT would pave the way for a clearer registration path through confirmative performance validation and utility establishment.

Allarity Therapeutics and FivepHusion Announce Collaboration to Support Clinical Development of Deflexifol™ with DRP® Companion Diagnostics

Retrieved on: 
Monday, July 31, 2023
Bevacizumab, Investigational New Drug, LV, Therapy, Clinical collaboration, ESMO, Oxaliplatin, Cancer, Pharmacokinetics, Lead, Oncology, Annals of Oncology, Police, Patient, Colorectal cancer, Drug combination, Medicine, Knowledge, Investigational device exemption, Ides, CDX, European Society for Medical Oncology, Safety, Pharmaceutical industry, Medical device, Vaccine

BOSTON and SYDNEY (July 31, 2023) — Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, and Detsamma Investments Pty.

Key Points: 
  • BOSTON and SYDNEY (July 31, 2023) — Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, and Detsamma Investments Pty.
  • Deflexifol™ is a novel anti-cancer drug reformulation designed to address the safety and efficacy limitations of standard-of-care 5FU chemotherapy.
  • It combines, in a single infusion, 5FU and LV, a drug that potentiates 5FU anti-tumor activity, to improve the therapeutic activity of 5FU.
  • Financial terms of the clinical collaboration, option and potential license are not disclosed.

HUTCHMED Announces Appointment of Independent Non-executive Director and Member of Board Committees 

Retrieved on: 
Wednesday, May 10, 2023
Molecular biology, The Elements of Style, Journal of Thoracic Oncology, Internet Technical Committee, Law, Lung cancer, Oncology, Article, Doctor of Philosophy, European Society for Medical Oncology, Audit committee, Teaching hospital, Professor, Retirement, Journal, University Hospital (Newark, New Jersey), Ageing, Health, Ludwig Cancer Research, Annals of Oncology, Swiss, SIX Swiss Exchange, Teaching, International Association, Research, Attention, Annals, Security (finance), Editor-in-chief, Woman, Swiss Federal Institute of Technology, ESMO, Medicine, NSCLC, US, HKEX, Letter, Swiss Federal Institute of Aquatic Science and Technology, Part, University of Lausanne, Galenica, Strategic Advisory Board for Intellectual Property Policy, HK, Management, Nursing

The Board of HUTCHMED is of the view that Professor Peters will make significant contributions to the Company.

Key Points: 
  • The Board of HUTCHMED is of the view that Professor Peters will make significant contributions to the Company.
  • Mr Simon To, Chairman of HUTCHMED said “On behalf of the Board, I would like to extend a warm welcome to Professor Peters to the Company.
  • Professor Peters is also an independent director of Galenica AG, which is listed on the SIX Swiss Exchange.
  • The director’s fees of Professor Peters as an Independent Non-executive Director, member of the Technical Committee and member of the Audit Committee of the Company under her appointment letter are US$76,000, US$8,000 and US$13,500 per annum respectively.

Burning Rock Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Tuesday, March 28, 2023
Pancreatic cancer, LSE, Advertising, DNA, CRC, Nucleic acid thermodynamics, London Stock Exchange, Marketing, NGS, COVID-19, Silicon Valley Bank, Cancer, Main–Market Historic District, Research, Annals of Oncology, ID, ASCO, MRD, Silicon, US, Gastrointestinal cancer, Hospital, Patient, Investment, Webcast, Depreciation, Neoplasm, FDA, Recurrence, Regulation of tobacco by the U.S. Food and Drug Administration, NMPA, Food, Cryptocurrency, Medical imaging, Pharmaceutical industry, Video game

Total value of new contracts entered into during 2022 amounted to RMB250 million, representing a 36% increase from 2021.

Key Points: 
  • Total value of new contracts entered into during 2022 amounted to RMB250 million, representing a 36% increase from 2021.
  • Revenues were RMB142.2 million (US$20.6 million) for the three months ended December 31, 2022, representing a 3.5% decrease from RMB147.3 million for the same period in 2021.
  • Gross profit was RMB380.0 million (US$55.1 million) for 2022, representing a 4.4% increase from RMB364.1 million for 2021.
  • Burning Rock will host a conference call to discuss the fourth quarter and full year 2022 financial results at 8:00 a.m. U.S. Eastern Time (8:00 p.m. Hong Kong time) on March 28, 2023.

Aldeyra Therapeutics Announces Positive Primary Vitreoretinal Lymphoma Pre-NDA Meeting with the FDA

Retrieved on: 
Thursday, December 1, 2022
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Marketing, Retina, Risk, Therapy, Photophobia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Priority review, Survey of Ophthalmology, Security (finance), Retinoblastoma, Incidence, AAO, Patient, NDA, Viscosity, Duane syndrome, Allergic conjunctivitis, New Drug Application, FDA, COVID-19, Growth, Result, Financial condition report, Diagnosis, Methotrexate, Food, Analysis, Toxicity, Annual report, Retinitis pigmentosa, Floater, Failure, Data analysis, Type, Clinical trial, Safety, Drug discovery, PH, Conversation, Annals of Oncology, Survival, USP, Pharmaceutical industry, Ophthalmology

ADX-2191, which has received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma, is a novel, vitreous-compatible formulation of methotrexate.

Key Points: 
  • ADX-2191, which has received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma, is a novel, vitreous-compatible formulation of methotrexate.
  • ADX-2191 has received FDA Orphan Drug Designation for the prevention of proliferative vitreoretinopathy, and the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.
  • Primary vitreoretinal lymphoma is a rare, aggressive, and potentially fatal retinal cancer that is diagnosed in approximately 300 to 600 patients in the United States per year.
  • Data on file; Primary Vitreoretinal Lymphoma by D. J. Wilson on AAO EyeWiki; M. Sagoo, Survey of Ophthalmology (2014); Grimm et.