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RenovoRx, Inc. reports news on targeted oncology drug delivery, the commercialization of RenovoCath®, and clinical development of its TAMP™ therapy platform. The company is a life-sciences issuer developing localized cancer therapies and commercializing RenovoCath, a patented FDA-cleared drug-delivery device used for temporary vessel occlusion and chemotherapeutic drug infusion.
Recurring updates cover RenovoCath adoption at U.S. cancer centers, intellectual-property protection for the device, financing activity, financial results, and presentations of clinical or pharmacologic data. News also tracks IAG, the investigational intra-arterial gemcitabine product candidate delivered via RenovoCath, including disclosures tied to the TIGeR-PaC trial in locally advanced pancreatic cancer and orphan drug designations for pancreatic and bile duct cancer.
RenovoRx reported Q3 2024 financial results with $9.6 million in cash as of September 30, sufficient to fund operations through next interim analysis of its Phase III TIGeR-PaC clinical trial and RenovoCath commercialization efforts. The company reported a net loss of $2.5 million, with R&D expenses at $1.7 million and G&A expenses at $1.2 million. RenovoCath, their FDA-cleared delivery system, is advancing towards commercialization with increased production and potential revenue generation in 2025. The Phase III trial for locally advanced pancreatic cancer is progressing towards completion of patient enrollment, expected in first half of 2025.
RenovoRx (Nasdaq: RNXT) announces increased production of its FDA-cleared RenovoCath® delivery system due to high demand from oncologists and interventional radiologists. The company has expanded its relationship with manufacturing partner Medical Murray, issuing a warrant for up to 709,500 shares of RenovoRx common stock as performance incentives. RenovoRx remains committed to its Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC), using the TAMP™ therapy platform.
The company is exploring commercial opportunities for RenovoCath as a standalone device, with plans to launch during 2025. RenovoRx has promoted Robert Strasser to Vice President of R&D and Operations to support these efforts. The company maintains sufficient cash to fund both the next interim read-out on TIGeR-PaC and RenovoCath go-to-market activities.
RenovoRx (RNXT) announced that Dr. Ripal Gandhi will present at the Symposium on Clinical Interventional Oncology, highlighting the company's TAMP (Trans-Arterial Micro-Perfusion) therapy platform for treating locally advanced pancreatic cancer (LAPC). The presentation will focus on:
1. Clinical challenges of standard LAPC treatments
2. TAMP as a potential targeted oncology option
3. Status of the ongoing Phase III TIGeR-PaC study
4. Recent publication in The Oncologist® on early-stage clinical data
The presentation will take place on September 21, 2024, at 9:30am ET in Miami Beach, Florida. Dr. Gandhi, a principal investigator for RenovoRx's TIGeR-PaC trial since 2018, will discuss how TAMP may offer LAPC patients an alternative to systemic chemotherapy, which often has effectiveness and severe side effects.
RenovoRx (Nasdaq: RNXT), a clinical-stage biopharmaceutical company, announced that CEO Shaun Bagai will present at H.C. Wainwright's 26th Annual Global Investment Conference on September 9, 2024 at 7:00 a.m. ET in New York City. Bagai will discuss:
- Progress on the pivotal Phase III TIGeR-PaC clinical trial for Locally Advanced Pancreatic Cancer (LAPC) using their proprietary TAMP™ therapy platform
- New commercial business development opportunities for their FDA-cleared RenovoCath® delivery system
The company recently appointed Ryan Witt as Senior Vice President of Corporate Strategy and Partnerships in June 2024. A webcast of the presentation will be available, and one-on-one investor meetings can be scheduled through H.C. Wainwright or KCSA Strategic Communications.
RenovoRx (Nasdaq: RNXT) has announced the enrollment of the first patient at the University of Nebraska Medical Center (UNMC) for its ongoing Phase III TIGeR-PaC clinical trial. The study is evaluating RenovoGem™, a novel therapy for Locally Advanced Pancreatic Cancer (LAPC) using the TAMP™ (Trans-Arterial Micro-Perfusion) platform. This approach aims to deliver gemcitabine chemotherapy directly to the tumor site, potentially overcoming the challenge of drug penetration through the tumor's protective scar tissue.
The trial compares TAMP therapy to standard intravenous chemotherapy. UNMC, which joined the study in June 2024, is expected to help drive enrollment to completion by next year. The TIGeR-PaC study is currently enrolling unresectable LAPC patients across multiple US sites, reflecting RenovoRx's commitment to improving outcomes for patients with difficult-to-treat pancreatic cancer.
RenovoRx (Nasdaq: RNXT) announced the publication of positive early-stage clinical data for its Trans-Arterial Micro-Perfusion (TAMP) therapy platform in The Oncologist. The study focused on treating Locally Advanced Pancreatic Cancer (LAPC) using TAMP to deliver gemcitabine. Key findings include:
1. Overall Survival (OS) of 27.1 months for LAPC patients with prior radiation treated with TAMP-delivered chemotherapy.
2. Median OS of 12.6 months for all 35 evaluable LAPC patients.
3. TAMP is currently being evaluated in a Phase III clinical trial for LAPC treatment.
The study suggests TAMP could potentially offer a safer, more effective treatment option for LAPC compared to standard systemic chemotherapy, with fewer side effects.
RenovoRx announces the acceptance of their manuscript, titled “Treatment of Locally Advanced Pancreatic Cancer (LAPC) Using Localized Trans-Arterial Micro Perfusion (TAMP™) of Gemcitabine: Combined Analysis of RR1 and RR2,” for publication in The Oncologist, a prestigious peer-reviewed journal. The manuscript, authored by Dr. Hassan Hatoum, will be in the Summer 2024 issue and presents clinical data on the survival of LAPC patients treated with RenovoRx's TAMP therapy platform. This data stems from early Phase I/II dose escalation safety study (RR1) and a post-marketing observational registry study (RR2). TAMP is also under evaluation in the ongoing pivotal Phase III TIGeR-PaC study, comparing its efficacy to the standard intravenous chemotherapy in LAPC treatment.
RenovoRx has announced that the University of Nebraska Medical Center (UNMC) has commenced patient enrollment for its pivotal Phase III TIGeR-PaC clinical trial. This study is investigating RenovoGem, a drug-device combination utilizing the company's Trans-Arterial Micro-Perfusion (TAMP) therapy platform, to treat Locally Advanced Pancreatic Cancer (LAPC). The trial aims to compare the effectiveness of TAMP's targeted chemotherapy delivery to the current standard-of-care, systemic intravenous chemotherapy. The trial hopes to improve patient outcomes by enabling higher drug concentrations to reach the tumor, potentially leading to better survival rates and fewer side effects.
RenovoRx, a clinical-stage biopharmaceutical company, has appointed Ryan Witt as Senior Vice President, Head of Corporate Strategy and Partnerships. This new role underscores the company's commitment to exploring and executing clinical and commercial opportunities for its RenovoGem™ product, currently in Phase III trials, and its FDA-cleared drug-delivery device. Witt, who has over 15 years of experience, has previously served in various strategic leadership roles, including Chief Business Officer at Spinogenix and Chief Operating Officer at Immix Biopharma. His appointment aims to leverage his expertise to advance RenovoRx's pivotal Phase III clinical trial, expand into additional cancer treatments, and explore new business opportunities.
RenovoRx has raised $17.2 million in gross proceeds since early 2024, enabling the advancement of its pivotal Phase III TIGeR-PaC clinical trial for Locally Advanced Pancreatic Cancer (LAPC) and the expansion of its drug-delivery platform into additional cancer indications. The company, led by CEO Shaun Bagai, aims to improve patient outcomes with its precision oncology therapies. Recent promotions within the management team and publications supporting the Trans-Arterial Micro-Perfusion (TAMP) platform demonstrate progress. A second interim analysis for the TIGeR-PaC trial is expected by late 2024, following the completion of the first interim analysis in March 2023.