Clinical Trials at Major University; New Application Targeting Tumors with an IP Portfolio of 9 Patents Issued, 9 Pending for Cancer Treatments Partnered with Imugene: RenovoRx (NASDAQ: RNXT)

– Clinical-Stage Biopharma Company Developing Proprietary Targeted Combination Therapies for High Unmet Medical Needs in Oncology.  

– Trans-Arterial Micro-Perfusion (TAMPTM) Therapy Designed to Directly Target Tumors While Potentially Minimizing Toxicities. 

– Engaged Oklahoma University Health as the First Clinical Site in Preparation for Phase III Clinical Trial for Bile Duct Cancer. 

– Clinical Data Abstract to be Presented at the 2024 Society of Interventional Radiology Annual Scientific Meeting.

– Research Supports Lead Oncology Product Candidate and its Novel Therapy Platform for the Treatment of Locally Advanced Pancreatic Cancer.

– Strong Intellectual Property Portfolio with 9 Issued Patents for Proprietary Trans-Arterial Micro-Perfusion Therapy Platform and Delivery System.

– New Patent Application to Expand IP Coverage for Therapeutic Classes Across DNA/RNA Altering Modalities, Cell Therapy, and Antibody-Based Therapies.

– Welcomed Ducreux, M.D., Ph.D., Head of the Gastrointestinal Oncology Unit and Gastrointestinal Oncology Tumor Board at Gustave Roussy, Professor of Oncology at Paris-Saclay University in France, and Vice-Chair of ESMO GI.

– Collaboration with Imugene validates Trans-Arterial Micro-Perfusion and Will Expand the Use of the Delivery Platform Beyond Chemotherapy to Immunotherapy.

– Therapy Platform in Phase III Clinical Trial for Pancreatic Cancer, Interim Analysis completed in March 2023 and Recommended a Continuation of the Study.

– Treatment Prespecified to Provide Primary Endpoint of a 6-Month Overall Survival Benefit. 

RenovoRx, Inc. (NASDAQ: RNXT) is a clinical-stage biopharmaceutical company developing proprietary targeted combination therapies for high unmet medical needs with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. The RNXT proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (IV) therapy). 

The RNXT unique approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. RNXT Phase III lead product candidate, RenovoGemTM, a novel oncology drug-device combination product, is being investigated under a US IND that is regulated by FDA 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA.) RNXT is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale. 

RNXT Engages Oklahoma University Health as First Clinical Site in Preparation for the Pivotal Phase III CouGar Clinical Trial in Bile Duct Cancer

On December 21st RNXT announced the expansion of their clinical development pipeline in preparation for the commencement of a second Phase III trial. The CouGar Trial will evaluate RNXT RenovoGem in bile duct cancer, specifically unresectable locally advanced extrahepatic cholangiocarcinoma (eCCA).

The RNXT pivotal Phase III CouGar study is a randomized study designed to evaluate the safety and efficacy of unresectable, locally advanced eCCA using intravenous cisplatin, gemcitabine, and durvalumab (all forms of chemotherapy) versus Trans-Arterial Micro-Perfusion via RenovoGem (delivery system and gemcitabine) with intravenous durvalumab. Oklahoma University (OU) Health is the first clinical site for the CouGar study.

RNXT RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon NDA approval.

Clinical Data Abstract at the 2024 Society of Interventional Radiology Annual Scientific Meeting

Research Supports RenovoRx’s Lead Oncology Product Candidate, RenovoGem™, and its Novel Therapy Platform, TAMP™, for the Treatment of Locally Advanced Pancreatic Cancer

On December 19th RNXT announced the acceptance of a clinical data abstract for the 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, held March 23-28 in Salt Lake City, Utah. The abstract will highlight the RNXT lead product candidate, RenovoGem, and the proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC), a difficult-to-access, solid tumor cancer.

“We are pleased to present research supporting our TAMP therapy platform at the upcoming SIR 2024 conference, the largest professional gathering of interventional radiologists in North America,” said Shaun Bagai, CEO of RNXT. “This research adds to the continued progress of our pivotal Phase III TIGeR-PaC study in LAPC. We remain steadfast in our commitment to deliver transformative therapies to potentially extend and improve the quality of life of cancer patients.”

For more information about the conference, visit https://www.sirmeeting.org.

International Patent Application for Novel Targeted Combination Drug-Delivery Oncology Therapy Platform

On December 13th RNXT announced the Company has filed an international patent application under the Patent Cooperation Treaty (PCT) for its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform. RNXT already holds a strong intellectual property portfolio with 9 issued patents and 9 pending patents for its proprietary TAMP platform and delivery system in the US, EU, and Asia. The patent portfolio covers two main areas, mechanical and biological.

The new RNXT international patent application is filed under the Patent Cooperation Treaty on methods and apparatuses that may be used to deliver one or more therapeutic agents through the vasa vasorum (small blood vessels that supply the walls of larger arteries or veins) to a target tissue. RNXT 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. RNXT anticipates that the patent application will be published in May of 2024.

RNXT Expands Scientific Advisory Board with Michel Ducreux, M.D., Ph.D.

On November 16th RNXT announced the appointment of Michel Ducreux, M.D., Ph.D. to the Company’s Scientific Advisory Board (SAB). Dr. Ducreux is the Head of the Gastrointestinal Oncology Unit and Gastrointestinal Oncology Tumor Board at Gustave Roussy, Professor of Oncology at Paris-Saclay University in France, and Vice-Chair of ESMO GI.

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 Ph.D. in health sciences. He has held previous positions as assistant physician and professor of oncology at the Gastrointestinal Oncology Unit of Gustave Roussy and Paul Brousse Hospital in Villejuif, France. He was a Medical Affairs Director at Gustave Roussy from January 2011 to December 2019. He is the former Chair of the European Organisation for Research and Treatment of Cancer (EORTC) Gastrointestinal Tract Cancer Group and the former Chair of the Gastrointestinal Group of the French Federation of Anticancer Centers (FNCLCC). He is a co-editor for Gastrointestinal Oncology of the European Journal of Cancer.

Third Quarter 2023 Financial Results and Operational Highlights

On November 11th RNXT announced financial results for the third quarter ended September 30, 2023.

Key Business Highlights:

Continued to advance RNXT Phase III TIGeR-PaC clinical trial for the treatment of LAPC. The first of two interim analyses was completed in March 2023, and the Data Monitoring Committee recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month OS benefit and secondary endpoints including reduced adverse events versus standard of care. Additionally, Dr. Michael J. Pishvaian, Johns Hopkins Medicine and Principal Investigator of TIGeR-PaC, presented at the Global Summit on Gastrointestinal Malignancies in Bermuda. The presentation, “Increasing Local Gemcitabine Delivery Using TAMP in the Chemotherapy Advances in Pancreatic Cancer,” highlighted the proprietary TAMP therapy platform and its design to ensure precise delivery for targeted treatment of cancer, and its potential for increased safety, tolerance, and improved efficacy.

Ripal Gandhi, FSIR, FSVM, investigator in the TIGeR-PaC study, presented, “Advances in Pancreatic Cancer: Trans-arterial Therapy on the Horizon,” at the Symposium on Clinical Interventional Oncology (CIO) on September 22-24, 2023, in Orlando, Florida. Dr. Gandhi highlighted the TAMP therapy platform as a potential targeted treatment option for patients diagnosed with locally advanced pancreatic cancer versus the standard of care. Dr. Gandhi is a member of the Miami Cancer Institute and Miami Cardiac and Vascular Institute physician team, a Clinical Professor at Florida International University Herbert Wertheim College of Medicine, and an Associate Professor at USF School of Medicine.

Collaboration with Imugene Ltd (ASX: IMU) further validates the TAMP platform and will expand the use of RenovoRx’s delivery platform beyond chemotherapy to immunotherapy.

 

Financial Highlights for Third Quarter ended September 30, 2023:

RNXT 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. The increase was primarily due to our ongoing Phase III clinical trial cost of $0.4 million, an increase in employee and related benefits costs of $0.3 million, and general and administrative allocated costs of $0.2 million. This increase was partially offset by a decrease in costs associated with a secondary manufacturer of $0.1 million.

G&A Expenses: General and administrative expenses were $1.3 million for the third quarter ended September 30, 2023, flat compared to the same period last year. Employee and related benefits costs increased $0.3 million compared to the same quarter last year. This increase was offset by a decrease in directors’ and officers’ insurance expenses of $0.1 million, including allocation of general and administrative expenses to research and development of $0.2 million.

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. The decrease is primarily due to an increase in operating expenses of $0.8 million, offset by $1.5 million reported gain on the fair value of common warrants issued under our Registered Direct Offering in April 2023.

RNXT Share Structure: Shares of common stock outstanding, as of September 30, 2023, were 10,693,080.

 

For more information on $RNXT visit www.renovorx.com

$RXNT Presentation: https://marketnewsreporting.com/innovative-therapy-for-targeted-treatment/

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Media Contact
Company Name: RenovoRx, Inc.
Contact Person: Shaun Bagai, CEO
Email: Send Email
Phone: (650) 284-4433
Address:4546 El Camino Real Suite B1
City: Los Altos
State: California 94022
Country: United States
Website: https://renovorx.com/


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