LAPC

RenovoRx Files New International Patent for Novel Targeted Combination Drug-Delivery Oncology Therapy Platform

Retrieved on: 
Mittwoch, Dezember 13, 2023
Oncology, Health, Medical Devices, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Patent Cooperation Treaty, Artery, SBRT, Potyvirus, Data monitoring committee, DMC, PCT, FDA, LAPC, Standard of care, Patent, Vein, TAMP, Pharmaceutical industry

RenovoRx, Inc. (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, announced today that the Company has filed an international patent application under the Patent Cooperation Treaty (PCT) for its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform.

Key Points: 
  • RenovoRx, Inc. (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, announced today that the Company has filed an international patent application under the Patent Cooperation Treaty (PCT) for its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform.
  • The patent portfolio covers two main areas, mechanical and biological.
  • RenovoRx believes that these methods and apparatuses via the TAMP therapy platform may provide a novel and important pathway for the targeted delivery of therapeutic classes across DNA/RNA-altering modalities, cell therapy, oncolytic viruses, bi-specific antibodies, and monoclonal antibodies for the treatment of a variety of clinical indications.
  • "This patent application further expands the value of TAMP into the delivery of larger therapeutic assets, as a unique platform in oncology, beyond our current Phase III clinical asset," said Shaun Bagai, CEO, RenovoRx.

RenovoRx Expands Scientific Advisory Board with Appointment of Michel Ducreux, M.D., Ph.D.

Retrieved on: 
Donnerstag, November 16, 2023
Oncology, Health, Medical Devices, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Medicine, European Journal of Cancer, Gustave Roussy, European Journal, EORTC, Hepatocellular carcinoma, Treatment, Ducreux, ESMO, Gastrointestinal cancer, Research, Medical Affairs Bureau, SAB, LAPC, Gastroenterology, University, Paris-Saclay University, Doctor of Philosophy, Neoplasm, Glomus tumor, Medical imaging, Medical device, Cancer

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced the appointment of Michel Ducreux, M.D., Ph.D. to the Company’s Scientific Advisory Board (SAB).

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced the appointment of Michel Ducreux, M.D., Ph.D. to the Company’s Scientific Advisory Board (SAB).
  • Dr. Ducreux was trained in medicine, gastroenterology, and gastrointestinal tract oncology at the University of Paris Sud.
  • Dr. Ducreux earned his master’s degree in biological sciences and PhD in health sciences.
  • “I am excited to be working with my distinguished colleagues on RenovoRx’s Scientific Advisory Board,” stated Dr. Ducreux.

RenovoRx Reports Third Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Dienstag, November 14, 2023
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Principal, Pancreatic cancer, Associate, Research, Safety, Tomorrow's India Global Summit, D, Data monitoring committee, FSVM, Insurance, Patient, CIO, ASX, LAPC, IMU, Standard of care, Cancer, Florida International University, Symposium, Partnership, Imugene, Immunotherapy, Horizon, TAMP, Clinical, Medical imaging, Payment card, Medicine

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced financial results for the third quarter ended September 30, 2023.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced financial results for the third quarter ended September 30, 2023.
  • Financial Highlights for Third Quarter ended September 30, 2023:
    Cash Position: Cash and cash equivalents as of September 30, 2023, were $3.2 million.
  • R&D Expenses: Research and development expenses were $1.6 million for the quarter ended September 30, 2023, compared to $0.8 million for the quarter ended September 30, 2022.
  • Net Loss: Net loss was $1.4 million for the quarter ended September 30, 2023, compared to net loss of $2.1 million for the quarter ended September 30, 2022.

FibroGen Reports Third Quarter 2023 Financial Results

Retrieved on: 
Montag, 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.

Galera Announces Receipt of Type A Meeting Minutes and Strategic Update

Retrieved on: 
Dienstag, Oktober 31, 2023
Type, FDA, Sale, SOM, LAPC, Therapy, Manganese, Death, GRECO, Galera, Lung cancer, NDA, Cancer, Investment, Patient, SBRT, Pharmaceutical industry, Stifel

MALVERN, Pa., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has received official meeting minutes from the Type A meeting with the United States Food and Drug Administration (FDA) held September 28, 2023 in which the FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese (avasopasem) for radiotherapy-induced SOM. The Company also decided to halt the Phase 2b GRECO-2 trial of rucosopasem manganese (rucosopasem) in patients with locally advanced pancreatic cancer (LAPC) and the Phase 1/2 GRECO-1 trial of rucosopasem in patients with non-small cell lung cancer (NCSLC), following a futility analysis of the GRECO-2 trial. The Company believes this decision will enable the Company to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value.

Key Points: 
  • The Company believes this decision will enable the Company to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value.
  • In the Type A Meeting minutes, the FDA reiterated that results from an additional Phase 3 trial will be required to support resubmission of the Company’s New Drug Application (NDA) for avasopasem in radiotherapy-induced SOM.
  • If the Company is unable to undertake any strategic alternative, it may be required to cease operations altogether.
  • Galera estimates that its balance of cash, cash equivalents and short-term investments as of September 30, 2023 was $28.4 million.

NANOBIOTIX Announces Updated Preliminary Results From Phase 1 Pancreatic Cancer Trial and New Exploratory Analysis From Completed Phase 1 Head and Neck Cancer Trial at ESMO 2023

Retrieved on: 
Montag, Oktober 23, 2023
Survival, Patient, RT, ESMO, NBTXR3, MOS, Lymph, Head, PFS, MD, Monroe Dunaway Anderson, Doctor of Philosophy, Duration, CA19-9, Quality of life, NANO, Rated R, Chemoradiotherapy, Clinical trial, Pancreatic cancer, Oncology, University, Nanobiotix, Safety, European Society for Medical Oncology, Cancer, Progression-free survival, MD Anderson Cancer Center, OS, Diagnosis, Medical imaging, Residential care, Pharmaceutical industry, Euronext, LAPC

PARIS and CAMBRIDGE, Mass., Oct. 23, 2023 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the “Company”), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced updated data from two presentations at the 2023 Annual Congress of the European Society for Medical Oncology (ESMO).

Key Points: 
  • The 5-year overall survival rate for patients with unresectable locally advanced pancreatic cancer (LAPC) remains less than 5%.
  • Normally, these patients receive the combination of cytotoxic chemotherapy followed by concurrent chemoradiation if no metastatic progression has occurred.
  • Innovative new treatments that might extend survival and avoid additional harmful side effects are an urgent unmet need for this patient population.
  • “With the Phase 1 study now complete, our focus is to ensure that we learn everything we can to anticipate the potential results of NANORAY-312.

Interim Results from a NanOlogy Phase 2 Clinical Trial of its Intratumoral Investigational Drug in the Treatment of Locally Advanced Pancreatic Cancer

Retrieved on: 
Dienstag, Oktober 10, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Immunosuppression, TME, Pancreatitis, SOC, Cedars-Sinai Medical Center, AACR, Standard of care, LAPC, University, Survival, Disease, Abdominal pain, Nausea, University of Illinois College of Medicine, Immunotherapy, Pancreatic cancer, LSAM, Immunomodulation, Paclitaxel, Plasma, Parkview Health, Illinois College, Tumor necrosis factor, Tissue, NK, Phenotype, Blood, Conference, Research, Pharmaceutical industry, Dietary supplement, Vaccine, Medical device, Medical imaging, Pancreas, MD, Safety

The research article entitled Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome provides safety and response data from dose escalation and 2-injection cohorts.

Key Points: 
  • The research article entitled Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome provides safety and response data from dose escalation and 2-injection cohorts.
  • “Pancreatic cancer is among the most lethal cancers with 5-year survival of only 12%,” said lead investigator and author, Neil Sharma, MD.
  • The research article reports data from evaluable subjects in the first two cohorts while the third is pending final readout.
  • Additionally, two posters presented downstaging and immune data from the Phase 2 trial following IT LSAM-PTX at the recent AACR Special Conference on Pancreatic Cancer.

Galera Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Montag, August 14, 2023
Workforce, Pancreatic cancer, SBRT, HNC, Therapy, Symantec Endpoint Protection, LAPC, Head, Glomerular filtration rate, Clinical trial, Survival, NDA, Cancer, New Drug Application, NSCLC, Cisplatin, ASCO, SOM, Radiation, GRECO, Patient, Investment, Annual general meeting, CRL, Research, FDA, Galera, CKD, Society, Food, Safety, Pharmaceutical industry

MALVERN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the second quarter ended June 30, 2023, and provided recent corporate updates.

Key Points: 
  • MALVERN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the second quarter ended June 30, 2023, and provided recent corporate updates.
  • Research and development expenses were $7.6 million in the second quarter of 2023, compared to $6.6 million for the same period in 2022.
  • General and administrative expenses were $9.2 million in the second quarter of 2023, compared to $5.3 million for the same period in 2022.
  • As of June 30, 2023, Galera had cash, cash equivalents and short-term investments of $38.8 million.

FibroGen Reports Second Quarter 2023 Financial Results

Retrieved on: 
Montag, 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.

RenovoRx to Present at the 43rd Annual Canaccord Genuity Growth Conference

Retrieved on: 
Montag, Juli 31, 2023
Biotechnology, Pharmaceutical, Health, Other Health, Interim, Gastrointestinal cancer, LAPC, ESMO, ASX, IMU, Conference, DMC, Pharmaceutical industry, Imugene

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced that its CEO Shaun Bagai will provide a corporate overview and update at the 43rd Annual Canaccord Genuity Growth Conference on Thursday, August 10, 2023 at 10:30 AM ET in Boston, MA.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced that its CEO Shaun Bagai will provide a corporate overview and update at the 43rd Annual Canaccord Genuity Growth Conference on Thursday, August 10, 2023 at 10:30 AM ET in Boston, MA.
  • The TIGeR-PaC study is evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC).
  • Interim data demonstrates a 6-month overall survival benefit, 8-month delay in cancer progression, and 65% reduction in adverse effects over systemic (intravenous) chemotherapy.
  • To schedule a one-on-one investor meeting with RenovoRx’s management team, please contact a conference representative or KCSA Strategic Communications at [email protected] .