RenovoRx Continues to Grow Intellectual Property Portfolio for its Novel Drug-Delivery Therapy Platform
RenovoRx continues to grow its intellectual property (IP) portfolio, boasting 18 issued patents and 13 pending patents, as it advances commercialization and clinical trials in 2025.
The company recently published a new international patent application for its Trans-Arterial Micro-Perfusion (TAMP) therapy platform, which targets and delivers treatments directly to specific tissues using micro-vessels.
RenovoRx holds 8 issued and 6 pending U.S. patents and 10 issued and 7 pending patents outside the U.S., including its 2024 international application.
The TAMP technique aims to deliver therapies precisely to tumor sites, potentially reducing toxicities compared to systemic intravenous treatments.
RenovoRx's Phase III TIGeR-PaC clinical trial, evaluating its first product candidate using the FDA-cleared RenovoCath device, is expected to complete patient enrollment and the second interim analysis by mid-2025. The company also received its first purchase orders for the RenovoCath device.
RenovoRx continua a espandere il suo portafoglio di proprietà intellettuale (IP), vantando 18 brevetti rilasciati e 13 brevetti in attesa, mentre avanza nella commercializzazione e nelle sperimentazioni cliniche nel 2025.
Recentemente, l'azienda ha pubblicato una nuova domanda di brevetto internazionale per la sua piattaforma terapeutica Trans-Arterial Micro-Perfusion (TAMP), che mira a somministrare trattamenti direttamente a tessuti specifici utilizzando micro-vasi.
RenovoRx detiene 8 brevetti rilasciati e 6 brevetti in attesa negli Stati Uniti e 10 brevetti rilasciati e 7 brevetti in attesa al di fuori degli Stati Uniti, compresa la sua domanda internazionale del 2024.
La tecnica TAMP punta a somministrare terapie direttamente ai siti tumorali, riducendo potenzialmente le tossicità rispetto ai trattamenti per via endovenosa sistemica.
Il trial clinico di Fase III TIGeR-PaC di RenovoRx, che valuta il suo primo candidato prodotto utilizzando il dispositivo RenovoCath approvato dalla FDA, dovrebbe completare l'arruolamento dei pazienti e la seconda analisi intermedia entro metà del 2025. Inoltre, l'azienda ha ricevuto i suoi primi ordini d'acquisto per il dispositivo RenovoCath.
RenovoRx sigue expandiendo su cartera de propiedad intelectual (IP), con 18 patentes emitidas y 13 patentes pendientes, mientras avanza en la comercialización y ensayos clínicos en 2025.
Recientemente, la compañía publicó una nueva solicitud de patente internacional para su plataforma terapéutica Trans-Arterial Micro-Perfusion (TAMP), que dirige y entrega tratamientos directamente a tejidos específicos usando microvasos.
RenovoRx posee 8 patentes emitidas y 6 patentes pendientes en EE. UU. y 10 patentes emitidas y 7 patentes pendientes fuera de EE. UU., incluyendo su solicitud internacional de 2024.
La técnica TAMP tiene como objetivo entregar terapias precisamente en los sitios tumorales, potencialmente reduciendo las toxicidades en comparación con tratamientos intravenosos sistémicos.
El ensayo clínico de Fase III TIGeR-PaC de RenovoRx, que evalúa su primer candidato a producto utilizando el dispositivo RenovoCath aprobado por la FDA, se espera que complete el reclutamiento de pacientes y el segundo análisis intermedio para mediados de 2025. La compañía también recibió sus primeras órdenes de compra para el dispositivo RenovoCath.
RenovoRx는 지적 재산권(IP) 포트폴리오를 계속 확장하고 있으며, 18개의 특허와 13개의 특허 출원 중인 상황에서 2025년 상용화 및 임상 시험을 진행하고 있습니다.
최근 이 회사는 특정 조직에 직접 치료를 전달하는 Trans-Arterial Micro-Perfusion (TAMP) 치료 플랫폼에 대한 새로운 국제 특허 출원을 발표했습니다.
RenovoRx는 8개의 발행된 미국 특허와 6개의 대기 특허를 보유하고 있으며, 미국 외에는 10개의 발행된 특허와 7개의 대기 특허가 있습니다. 여기에는 2024년의 국제 출원이 포함되어 있습니다.
TAMP 기술은 치료법을 종양 부위에 정확하게 전달하는 것을 목표로 하여, 전신 정맥 치료에 비해 독성을 줄일 수 있습니다.
RenovoRx의 3상 TIGeR-PaC 임상 시험은 FDA에서 승인된 RenovoCath 장치를 사용하여 첫 번째 제품 후보를 평가하며, 2025년 중반까지 환자 등록 및 두 번째 중간 분석을 완료할 것으로 예상됩니다. 또한, 회사는 RenovoCath 장치에 대한 첫 번째 구매 주문을 받았습니다.
RenovoRx continue d'élargir son portefeuille de propriété intellectuelle (PI), avec 18 brevets délivrés et 13 brevets en attente, tout en avançant dans la commercialisation et les essais cliniques en 2025.
Récemment, l'entreprise a publié une nouvelle demande de brevet international pour sa plateforme thérapeutique Trans-Arterial Micro-Perfusion (TAMP), qui cible et délivre des traitements directement à des tissus spécifiques à l'aide de micro-vaisseaux.
RenovoRx détient 8 brevets délivrés et 6 brevets en attente aux États-Unis et 10 brevets délivrés et 7 brevets en attente en dehors des États-Unis, y compris sa demande internationale de 2024.
La technique TAMP vise à administrer des thérapies précisément sur les sites tumoraux, ce qui pourrait réduire les toxicités par rapport aux traitements intraveineux systémiques.
L'essai clinique de Phase III TIGeR-PaC de RenovoRx, évaluant son premier candidat de produit utilisant le dispositif RenovoCath approuvé par la FDA, devrait compléter le recrutement des patients et la deuxième analyse intermédiaire d'ici la moitié de 2025. L'entreprise a également reçu ses premières commandes pour le dispositif RenovoCath.
RenovoRx erweitert weiterhin sein Portfolio an geistigem Eigentum (IP) und kann 18 erteilte Patente und 13 anhängige Patente vorweisen, während es die Kommerzialisierung und klinische Studien im Jahr 2025 vorantreibt.
Das Unternehmen hat kürzlich einen neuen internationalen Patentantrag für seine Trans-Arterial Micro-Perfusion (TAMP) Therapieplattform veröffentlicht, die darauf abzielt, Behandlungen direkt an bestimmte Gewebe über Mikrovesseln zu liefern.
RenovoRx hält 8 erteilte und 6 anhängige US-Patente sowie 10 erteilte und 7 anhängige Patente außerhalb der USA, einschließlich seines internationalen Antrags von 2024.
Die TAMP-Technik zielt darauf ab, Therapien präzise an Tumororte zu liefern, was potenziell die Toxizität im Vergleich zu systemischen intravenösen Behandlungen reduzieren könnte.
Die Phase III TIGeR-PaC klinische Studie von RenovoRx, die den ersten Produktkandidaten mit dem von der FDA genehmigten RenovoCath-Gerät bewertet, wird voraussichtlich bis Mitte 2025 die Patientenrekrutierung und die zweite Zwischenanalyse abschließen. Das Unternehmen erhielt außerdem seine ersten Bestellungen für das RenovoCath-Gerät.
- RenovoRx holds 18 issued and 13 pending patents, indicating strong IP protection.
- Published a new international patent application expanding IP coverage for the TAMP platform.
- Phase III TIGeR-PaC clinical trial expected to complete patient enrollment and second interim analysis by mid-2025.
- Received first purchase orders for RenovoCath devices.
- None.
Insights
The intellectual property expansion for RenovoRx's TAMP platform represents a critical strategic move. The new patent application WO2024102497 specifically targets the vasa vasorum delivery mechanism - a sophisticated approach that could revolutionize localized drug delivery in oncology. The technology leverages micro-vessels surrounding larger blood vessels, potentially offering superior drug penetration compared to traditional IV administration.
The 18 issued patents and 13 pending patents create a robust protective moat around their technology. Most notably, the ability to deliver various therapeutic agents (antibodies, nanoparticles, charged molecules) through micro-vessels indicates versatility beyond just chemotherapy administration. This could significantly expand the platform's commercial applications and partnership opportunities.
The advancement of the Phase III TIGeR-PaC trial with anticipated completion of enrollment and second interim analysis by H1 2025 represents a near-term catalyst. Initial RenovoCath purchase orders suggest early market validation, though revenue impact remains to be seen.
The strategic timing of RenovoRx's international patent application is noteworthy from an IP protection standpoint. By publishing WO2024102497 ahead of potential commercialization, they're establishing clear priority dates and expanding territorial coverage. The combination of 8 U.S. patents and 10 international patents, plus pending applications, creates a comprehensive IP shield that could deter potential competitors and increase licensing value.
The specificity of claims around vasa vasorum-based delivery methods suggests careful patent drafting to maximize protection while potentially creating additional barriers to entry. This layered IP strategy, combining device patents (RenovoCath) with method patents (TAMP), strengthens their market position and could enhance partnership negotiations or potential M&A discussions.
RenovoRx Holds a Strong IP Portfolio with 18 Issued Patents and 13 Pending Patents as it Moves Forward with Commercialization and Clinical Trial Plans in 2025
New Patent Filing Anticipated to Expand IP Coverage for RenovoRx’s Innovative TAMP™ Approach to Targeted Drug Delivery
RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared delivery system, today highlighted its strong intellectual property (IP) position as it moves forward with commercial plans and clinical trial advancement in 2025, utilizing its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform.
Earlier this year, RenovoRx published a new international patent application for its TAMP therapy platform to expand its IP portfolio. RenovoRx already holds strong IP including coverage of its proprietary TAMP therapy platform and RenovoCath delivery system, with 8 issued and 6 pending
The new published international patent application WO2024102497 describes methods and tools for delivering treatments (including antibodies, nanoparticles, or charged molecules) directly to specific tissues. This is accomplished using micro-vessels (called the vasa vasorum) that supply the outer walls of larger blood vessels near the specific target tissue to be treated. This invention opens innovative and effective ways to target and deliver cancer treatments in local tissue beyond the current standard-of-care, systemic (intravenous “IV”) treatment.
"Delivering therapeutics through micro-vessels around the artery via our novel Trans-Arterial Micro-Perfusion technique is central to our treatment paradigm and value proposition,” said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. “We already hold strong IP protection for our technology, and our 2024 pending patent further describes and seeks protection for the novelty of our approach."
TAMP is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.
"As we move forward in 2025 with our commercial plans for RenovoCath and the advancement of our pivotal Phase III TIGeR-PaC clinical trial, both of which are driven by TAMP, it is important to highlight the strong IP foundation we have and continue to expand. The new patent application filed earlier this year would further the value that TAMP can offer the oncology community as an innovative and effective approach to drug delivery," said Shaun Bagai, CEO, RenovoRx. "Once approved, it will incrementally extend our IP coverage and increase the commercial value proposition for both TAMP and RenovoCath."
RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial is evaluating its first product candidate, a novel investigational oncology drug-device combination utilizing the FDA-cleared RenovoCath device via TAMP for the intra-arterial administration of the chemotherapy gemcitabine. RenovoRx currently anticipates completion of both patient enrollment and the second interim analysis for TIGeR-PaC by the end of the first half of 2025.
Moreover, RenovoRx recently announced the receipt of its first purchase orders for RenovoCath devices. This milestone marks a positive continuation of RenovoRx’s previously announced efforts to commercialize RenovoCath as a standalone device to be used by doctors in accordance with its FDA-cleared instructions for use. RenovoCath is powered by TAMP.
About RenovoCath
Based on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.
About the TIGeR-PaC Clinical Trial
TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of chemotherapy, gemcitabine.
The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The study's primary endpoint is an Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event (i.e., patient death), which is estimated to occur in late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.
About RenovoRx, Inc.
RenovoRx is a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel,
The Company’s Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a
The intra-arterial infusion of gemcitabine by the RenovoCath catheter is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon NDA approval by the FDA.
RenovoRx is also actively exploring other commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith and at the investor conference described herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies, including the overall timing and timing for additional interim data readouts for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath® or TAMP™ as standalone commercial products and our commercialization plans in general, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, (iii) our efforts to explore commercialization strategies utilizing our TAMP technology and (iv) the anticipated benefits of the patent application and our intellectual property portfolio generally as described herein. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of TIGeR-PaC and any other preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.
Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
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KCSA Strategic Communications
Valter Pinto or Jack Perkins
T:212-896-1254
RenovoRX@KCSA.com
Source: RenovoRx, Inc.
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