CD46

FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Tuesday, April 2, 2024
Neutropenia, Prostate cancer, Survival, RECIST, Prostate-specific antigen, Patient, SAN, Neoplasm, MMAE, Weight loss, Publishing, Peripheral neuropathy, University, CD46, Spacecraft, Society, Safety, ASCO, Adenocarcinoma, Fatigue, ADC, PSA, FDA, Fortis, Lead, Food, Pharmaceutical industry

“We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.

Key Points: 
  • “We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
  • In the dose-expansion arm of the trial, patients were treated at the 2.7 mg/kg adjusted body weight dosing (AjBW) until disease progression.
  • The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts.
  • These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with CD46 positive prostate cancer.

FibroGen Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 6, 2023
Sale, JDE, AstraZeneca, LAPC, Pancreatic Cancer Action Network, American Society of Nephrology, CD46, Poster, Society, Bank statement, Chronic kidney disease, Immunotherapy, Growth, ADC, Interest, ASN, Webcast, Abstract, Pamrevlumab, Pancreatic cancer, Oncology, Anemia, CKD, European Society of Gynaecological Oncology, Investment, Patient, CIA, SAN, Shanda, Pharmaceutical industry, Video game, Vaccine, Roxadustat

Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.

Key Points: 
  • Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.
  • Restructuring charge for the third quarter of 2023 was $12.6 million, or $0.13 impact to net loss per basic and diluted share, resulting from the reduction in U.S. workforce announced in July 2023.
  • The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.
  • FibroGen will host a conference call and webcast today, Monday, November 6, 2023, at 5:00 PM Eastern Time to discuss financial results and provide a business update.

FibroGen Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 7, 2023
Pancreatic cancer, Interim, Chronic kidney disease, Pancreatic Cancer Action Network, LAPC, Bank statement, Research, Second, AstraZeneca, Sale, Interest, JDE, Shanda, DMD, Patient, Investment, CD46, Anemia, SAN, Webcast, ADC, Growth, Pamrevlumab, MSTV, IPF, Therapy, Idiopathic pulmonary fibrosis, Pharmaceutical industry, Management, Video game, Vaccine, Life insurance, Roxadustat

Achieved second quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $23.9 million compared to $23.3 million in the second quarter of 2022.

Key Points: 
  • Achieved second quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $23.9 million compared to $23.3 million in the second quarter of 2022.
  • Achieved second quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca of $76.4 million, compared to $53.1 million in the second quarter of 2022, an increase of 44%, driven by over 40% growth in volume.
  • Total revenue for the second quarter of 2023 was $44.3 million, as compared to $29.8 million for the second quarter of 2022, an increase of 49%.
  • FibroGen will host a conference call and webcast today, Monday, August 7, 2023, at 5:00 PM Eastern Time to discuss financial results and provide a business update.

FibroGen Announces Topline Results from Phase 3 ZEPHYRUS-1 Study of Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis

Retrieved on: 
Monday, June 26, 2023
Pancreatic cancer, Pancreatic Cancer Action, LAPC, FVC, Vital capacity, HIV disease progression rates, DMD, Patient, CD46, SAN, ADC, Pamrevlumab, MPH, IPF, Death, Idiopathic pulmonary fibrosis, Safety, Medical device, Pharmaceutical industry, Medical imaging, Vaccine, MD

SAN FRANCISCO, June 26, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced topline results from its Phase 3 ZEPHYRUS-1 trial evaluating the safety and efficacy of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF). The study compared treatment with pamrevlumab to placebo and did not meet the primary endpoint of change from baseline in forced vital capacity (FVC) at week 48 (p=0.29). The mean decline in FVC from baseline to week 48 was 260 ml in the pamrevlumab arm compared to 330 ml in the placebo arm (placebo-corrected difference of 70 ml; 95% CI -60 to 190 ml). The secondary endpoint of time to disease progression (FVC percent predicted decline of ≥10% or death) was also not met (HR= 0.78; 95% CI 0.52 to 1.15).

Key Points: 
  • SAN FRANCISCO, June 26, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced topline results from its Phase 3 ZEPHYRUS-1 trial evaluating the safety and efficacy of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
  • Topline data from the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory DMD patients expected 3Q 2023.
  • Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected 1H 2024.
  • Topline data from the Pancreatic Cancer Action Network (PanCAN) Precision PromiseSM Phase 3 study of pamrevlumab in metastatic pancreatic cancer.

FibroGen Enters into Exclusive License for FOR46 with Fortis Therapeutics

Retrieved on: 
Monday, May 8, 2023
Avalon, Fortis, Partner (business rank), Research, Patient, CD46, SAN, Cancer, LA, ADC, Therapy, Prostate cancer, Pharmaceutical industry

SAN FRANCISCO and LA JOLLA, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) and Fortis Therapeutics announced that FibroGen has entered into an exclusive license with Fortis Therapeutics for FOR46, a potential first-in-class Phase 1 antibody-drug conjugate (ADC) targeting a novel epitope on CD46.

Key Points: 
  • SAN FRANCISCO and LA JOLLA, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) and Fortis Therapeutics announced that FibroGen has entered into an exclusive license with Fortis Therapeutics for FOR46, a potential first-in-class Phase 1 antibody-drug conjugate (ADC) targeting a novel epitope on CD46.
  • As part of the clinical development strategy, FibroGen will continue Fortis Therapeutics’ work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody (PET46) for patient selection.
  • “The agreement with Fortis Therapeutics bolsters FibroGen’s clinical pipeline in a capital-efficient manner, providing a product candidate with the potential to address a significant unmet medical need in oncology,” said Enrique Conterno, Chief Executive Officer, FibroGen.
  • During the four-year evaluation period, FibroGen has the option to acquire Fortis Therapeutics for $80 million.

IconOVir Announces New Preclinical Data Showcasing Best-in-Class Potential of ICVB-1042, its Lead Oncolytic Virus, at SITC 2022

Retrieved on: 
Thursday, November 10, 2022
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, 2021 Essex County Council election, Plasma, Salk Institute for Biological Studies, Mutation, Tropism, Safety, Immunotherapy, Neoplasm, Technology, Glioma, Glioblastoma, Cytotoxicity, CAR, OVS, Lung, Breast, CD46, Cancer, Cell, Engineering, Patient, Prostate, Infection, Society, OV, SITC, Pharmaceutical industry, Medical imaging, Mobile phone, Vaccine

The data will be presented in three posters at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2022), which is being held in Boston, MA and virtually from November 8-12, 2022.

Key Points: 
  • The data will be presented in three posters at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2022), which is being held in Boston, MA and virtually from November 8-12, 2022.
  • Preclinical Data Demonstrate ICVB-1042s Selective Replication, Broad Tumor Tropism, Safety and Anti-Tumor Activity
    IconOVir presented two abstracts describing the results of in vitro and in vivo studies.
  • These data demonstrate that ICVB-1042 selectively replicates in tumor cells compared to normal cells, while also benefiting from enhanced tropism, anti-tumor activity and tolerability.
  • IconOVir is a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus therapy to improve the treatment of patients with cancer.

Fortis Therapeutics Closes $40 Million Series A Financing to Advance Novel Anti-CD46 Therapeutic to Treat Late-Stage Prostate Cancer and Multiple Myeloma

Retrieved on: 
Monday, March 29, 2021
Research, FDA, Genetics, Clinical trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Clinical medicine, Medical specialties, Medicine, Immunology, Antineoplastic drugs, Biotechnology, MCRPC, Antibody-drug conjugate, CD46, Multiple myeloma, Prostate cancer, Cancer immunotherapy, Research, FDA, Genetics, Clinical trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Clinical medicine, Medical specialties, Medicine, Immunology, Antineoplastic drugs, Biotechnology, MCRPC, Antibody-drug conjugate, CD46, Multiple myeloma, Prostate cancer, Cancer immunotherapy, FOR46, Fortis Therapeutics

Fortis Therapeutics, Inc. , an immuno-oncology biotech developing FOR46, a novel antibody drug conjugate (ADC) against CD46, today announced the close of a $40 million Series A financing.

Key Points: 
  • Fortis Therapeutics, Inc. , an immuno-oncology biotech developing FOR46, a novel antibody drug conjugate (ADC) against CD46, today announced the close of a $40 million Series A financing.
  • The proceeds of the financing will be used to advance FOR46 in clinical trials for the treatment of relapsed or refractory multiple myeloma and metastatic castration-resistant prostate cancer (mCRPC).
  • Our preliminary clinical data is very exciting, and we are actively advancing our clinical studies in prostate cancer and multiple myeloma and pursuing additional indications.
  • Fortis Therapeutics is an immuno-oncology biotech developing a novel antibody-drug conjugate for late-stage multiple myeloma and metastatic castration-resistant prostate cancer.