ESMO

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.

Medigene AG Reports Full-Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Research, EUR, Ovarian cancer, Q&A, Partnership, BioNTech, Webcast, Patient, Co-stimulation, G&A, Synovial sarcoma, HLA, AACR, Clinical trial, Therapy, ESMO, Depreciation, Safety, TCR, Patent, Stomach, USD

Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial results for the fiscal year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial results for the fiscal year ended December 31, 2023, and provided a corporate update.
  • General and administrative (G&A) expenses were EUR 9.3 million in 2023 compared to EUR 7.7 million in the year prior.
  • First pre-clinical data on MDG2011 was presented at the ESMO Congress 2023 and the SITC Annual Meeting 2023.
  • As of Dec 31, 2023, Medigene’s IP portfolio consisted of 112 issued and 131 pending patents across 28 patent families.

BioAtla Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Progress

Retrieved on: 
Tuesday, March 26, 2024
Research, AXL, Head, Congress, NSCLC, SAN, Patient, Webcast, Observation, G&A, Peripheral neuropathy, CAB, Melanoma, D&O, Sarcoma, CD3, AACR, DLT, Conditional, ESMO, SITC, Therapy, ADC, Annual general meeting, SCCHN, Pharmaceutical industry

General and administrative (G&A) expenses were $5.9 million for the quarter ended December 31, 2023 compared to $6.7 million for the same quarter in 2022.

Key Points: 
  • General and administrative (G&A) expenses were $5.9 million for the quarter ended December 31, 2023 compared to $6.7 million for the same quarter in 2022.
  • Net loss for the quarter ended December 31, 2023 was $26.9 million compared to a net loss of $27.6 million for the same quarter in 2022.
  • Cash used for the quarter ended December 31, 2023 was $29.8 million.
  • Cash and cash equivalents as of December 31, 2023 were $111.5 million, compared to $215.5 million as of December 31, 2022.

AACR 2024: PDC*line Pharma Presents Interim Clinical Results From Last Cohort of Patients in Phase I/II Trial with PDC*lung01 Cancer Vaccine

Retrieved on: 
Monday, April 8, 2024
Stem Cells, Biotechnology, Health, Pharmaceutical, Biometrics, Oncology, Other Science, Research, Genetics, Science, Clinical Trials, KU Leuven, Mutation, Database, Survival, Best, DCR, Patient, Data, Aes, Șaeș, Progression-free survival, AACR, Kaplan–Meier estimator, Clinical trial, Cancer, Injection, ESMO, Safety, Symantec Endpoint Protection, DSMB, Poster, PFS, Vaccine, PDC

PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).

Key Points: 
  • PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).
  • The phase I/II trial (PDC-LUNG-101) aimed to assess the safety, tolerability, immunogenicity and preliminary clinical activity of PDC*lung01 in NSCLC patients, alone or in combination with anti-PD-1 treatment.
  • PDC*Line is reporting preliminary efficacy results for 19 evaluable patients in the B2 cohort that reached the 9-month PFS mark.
  • The final analysis of the clinical trial including the 45 patients from the B2 cohort will be conducted in Q3, 2024.

FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Retrieved on: 
Sunday, April 7, 2024
PART, EGFR, Mutation, BTD, NSCLC, Disease, Progression-free survival, Patient, Heel, Corr, NDA, Breakthrough, Non-Euclidean geometry, Doctor of Philosophy, CDE, Society, ESMO, Safety, ASCO, FDA, Annual general meeting, Food, Pharmaceutical industry

SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.

Key Points: 
  • SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.
  • This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1).
  • This new BTD will enable us work more closely with the FDA and accelerate its clinical development and regulatory submission."
  • Affecting roughly 2%-4% of NSCLC patients, EGFR Exon20ins mutations have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity.

Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 21, 2024
Research, Administration, Trastuzumab, Congress, Patient, Roche, Cancer, Trial of the century, PRS, ESMO, Operation, Research and development, ISAC, PD-1, Pharmaceutical industry

REDWOOD CITY, Calif., March 21, 2024 (GLOBE NEWSWIRE) --  Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • –   Cash balance of $128.6 million as of December 31, 2023, anticipated to fund key milestones through late 2025
    REDWOOD CITY, Calif., March 21, 2024 (GLOBE NEWSWIRE) --  Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • “We made substantial progress advancing our two proprietary clinical-stage development programs in 2023,” said Randall Schatzman, Ph.D., Chief Executive Officer.
  • “We have now administered BDC-1001, which we have renamed trastuzumab imbotolimod, to patients in all five of the Phase 2 cohorts.
  • BDC-3042 also continues to advance, and has now entered the fourth dose escalation cohort without a dose-limiting toxicity.

Coherus BioSciences Reports Fourth Quarter, Full Year 2023 Financial Results and Provides Current Business Update

Retrieved on: 
Wednesday, March 13, 2024
HCC, Research, PIN, Conference call, Congress, Relative value unit, Conference, Head, Exercise, NSCLC, Risk, Patient, CHRS, Otorhinolaryngology, Biomarker, Sale, Acquisition, NCCN, NPC, Ophthalmology, IL-27, IND, Bevacizumab, OPSCC, Investigational New Drug, Investment, ESMO, GAAP, Workforce, Medicare, FDA, COGS, Total, Development, Pharmaceutical industry

UDENYCA net product sales increased 10% in the fourth quarter 2023 to $36.2 million compared to $33.0 million in the third quarter.

Key Points: 
  • UDENYCA net product sales increased 10% in the fourth quarter 2023 to $36.2 million compared to $33.0 million in the third quarter.
  • Since commercial launch in May 2023, more than 727 accounts have ordered the Autoinjector presentation.
  • “Throughout 2023, Coherus demonstrated significant progress in transforming the Company’s business model and product portfolio for long-term sustainable growth,” said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer.
  • Coherus is introducing a guidance range of combined 2024 R&D and SG&A expenses from $250 to $265 million.

Merck Initiates Phase 3 Clinical Trial of MK-1084, an Investigational Oral KRAS G12C Inhibitor, in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Certain Patients With Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, April 4, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Congress, Mutation, NSCLC, Progression-free survival, Patient, Neoplasm, Merck & Co., Cancer, Lung cancer, TPS, MRK, ESMO, Safety, Pharmacokinetics, PD-L1, Astex Pharmaceuticals, Pharmaceutical industry

“KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.

Key Points: 
  • “KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
  • The primary endpoints of the study are progression-free survival and overall survival, and key secondary endpoints include objective response rate and duration of response.
  • Preliminary safety and efficacy data from this trial were previously presented at the European Society for Medical Oncology (ESMO) Congress in 2023.
  • MK-1084 is being developed through a collaboration with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd.

OSE Immunotherapeutics Reports Full Year 2023 Financial Results and Provides Business Strategy Update

Retrieved on: 
Wednesday, March 27, 2024
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, HCC, AbbVie, GPCR, Ulcerative colitis, Head, Alpha globulin, Survival, Data science, Data analysis, Drug discovery, Partnership, Hook effect, HNSCC, Boehringer Ingelheim, Inflammation, Patient, Research, RNA, Veloxis Pharmaceuticals, Cancer, Lung cancer, Bank statement, AACR, Investment, First, Therapy, ESMO, Collaboration, Hepatocellular carcinoma, RNA therapeutics, FDA, Artificial intelligence, Audit committee, Food, Pharmaceutical industry

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today reported its consolidated annual financial results for 2023 and provided an update on key proprietary clinical and preclinical achievements, on ongoing collaboration and licensing agreements, as well as on the 2024 Company’s outlook.

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today reported its consolidated annual financial results for 2023 and provided an update on key proprietary clinical and preclinical achievements, on ongoing collaboration and licensing agreements, as well as on the 2024 Company’s outlook.
  • Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, adds: “Our business-model is mostly based on recurrent and strategic partnerships with pharmaceutical companies.
  • A meeting of the Board of Directors of OSE Immunotherapeutics was held on March 27, 2024.
  • Following the Audit Committee opinion, the Board approved the annual and consolidated financial statements prepared under IFRS on 31 December 2023.

Personalis Announces Publication Validating NeXT Personal® Test for Ultra-sensitive MRD Detection and Cancer Treatment Response Monitoring

Retrieved on: 
Tuesday, March 26, 2024
Biotechnology, Genetics, Health, Oncology, WGS, Genomics, Plasma, Congress, PPM, PSNL, NSCLC, Adenocarcinoma, Patient, Publishing, DNA, Cancer, LUAD, Lung cancer, NeXT, Neoplasm, ESMO, MRD, Medicare, Recurrence, Medical imaging

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced a new publication validating the company’s NeXT Personal test, an ultra-sensitive, tumor-informed circulating tumor DNA (ctDNA) assay.

Key Points: 
  • Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced a new publication validating the company’s NeXT Personal test, an ultra-sensitive, tumor-informed circulating tumor DNA (ctDNA) assay.
  • “The robust validation results in this publication provide a foundational building block towards achieving Medicare coverage for NeXT Personal,” said Richard Chen, MD, MS, Chief Medical Officer and Executive Vice President, R&D of Personalis.
  • “Taken together, the results show NeXT Personal’s capability for ultra-sensitive detection of ctDNA in patient plasma samples and the test’s potential to reliably inform clinicians and patients on residual cancer, cancer treatment response, and cancer recurrence through ctDNA detection, earlier than conventional detection approaches,” Chen noted.
  • This data from the TRACERx Study demonstrated the assay was able to find cancer nearly a year ahead of imaging and was predictive of clinical outcomes in early-stage lung cancer patients.