On January 8, 2025 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 platform, reported three abstracts were accepted to be presented at several upcoming industry conferences including ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) 2025, Society of Interventional Oncology (SIO) 2025 and Society of Surgical Oncology (SSO) 2025 (Press release, Renovorx, JAN 8, 2025, View Source [SID1234649528]).

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The abstracts support RenovoRx’s novel and patented TAMP therapy platform via additional human PK data and pre-clinical data. 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.

RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial is evaluating the Company’s first product candidate, a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device via TAMP for the intra-arterial administration of 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.

Abstract Details:

ASCO GI 2025

Title: Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial
Authors: Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Emmanuel Zervos MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
Location: Moscone West, San Francisco CA
Date/Time: January 24, 2025 at 11:30 a.m. PT
SIO 2025

Title: Micro-CT imaging following intra-arterial delivery of a radiopaque silicone polymer using a double-balloon occlusion catheter in pigs: a model to analyze tissue penetration via the trans-arterial micro perfusion (TAMP) technique
Authors: Paula Novelli MD, Christopher Laing MD, Aloke Finn MD, Frank Kolodgie PhD, Robert Strasser BSc, Ramtin Agah MD
Location: Horseshoe Las Vegas, Las Vegas NV
Date/Time: February 2, 2025 at 12:30 p.m. PT
SSO 2025

Title: Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial
Authors: Emmanuel Zervos MD, Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
Location: Tampa Convention Center, Tampa FL
Dates: March 27 – 29, 2025
The abstracts accepted at ASCO (Free ASCO Whitepaper) GI 2025 and SSO 2025 are sub-studies of the ongoing Phase III TIGeR-PaC clinical trial.

"These abstracts support the potential for our TAMP therapy platform to provide a meaningful advancement in the standard of care for cancer treatment," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "TAMP focuses on drug concentration optimization in tumors by delivering therapies with our RenovoCath delivery system. This targeted approach to cancer treatment is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy’s toxicities versus the standard of care. Specifically, our approach enables physicians to utilize RenovoCath to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor."

Dr. Agah added, "We also look forward to the completion of patient enrollment and our second interim analysis in our pivotal Phase III TIGeR-PaC clinical trial in LAPC by the end of the first half of 2025."

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.

On January 8, 2025 Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") reported that China’s National Medical Products Administration (NMPA) has approved PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC) (Press release, Astellas, JAN 8, 2025, View Source [SID1234649497]). The treatment combination will provide a new therapeutic option to patients with la/mUC in China and offer an alternative to platinum-containing chemotherapy, the standard of care for nearly 40 years.1

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Bladder cancer leads to significant morbidity and mortality across China. Over 92,000 people were diagnosed with bladder cancer in 2022, and approximately 41,000 deaths were reported as a result of the disease.2 Urothelial cancer, which accounts for 90% of all bladder cancers, is a debilitating and frforequently aggressive cancer.3 When the disease is diagnosed at a late stage, survival rates are often extremely poor, driving the urgent need for new treatment strategies that can extend patients’ lives.

Professor Guo Jun, Lead Primary Investigator of the EV-302 trial in China, Director of the Department of Urologic Oncology and Melanoma/Sarcoma, Beijing Cancer Hospital, China, Vice Chairman and Chief-Secretary of the Chinese Society of Clinical Oncology (CSCO):
"The NMPA approval of enfortumab vedotin in combination with pembrolizumab is the first non-platinum treatment for Chinese patients with advanced urothelial cancer that can be used in the first-line setting. The results of the EV-302 study demonstrate that this combination nearly doubled median overall survival (OS), and increased median progression-free survival (PFS), overall response rate and complete response rate compared to platinum-based chemotherapy. These results were seen in a broad population of patients with locally advanced or metastatic urothelial cancer, regardless of patients’ biomarker status, cisplatin eligibility or liver metastasis. I believe that this new treatment regimen will change the clinical treatment landscape of urothelial carcinoma in China and bring hope of longer survival to more Chinese patients with advanced urothelial carcinoma."

Professor Huang Jian, Lead Primary Investigator of the EV-302 Study in China, Chairman of the Urology Subcommittee of the Chinese Medical Association, Department of Urology at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China:
"The current first-line treatment strategy for advanced urothelial carcinoma in China is platinum-based chemotherapy, with very limited clinical options available. The approval of enfortumab vedotin in combination with pembrolizumab represents the first treatment regimen in the past 20-30 years that has shown superiority over platinum-based chemotherapy in the entire population. We hope that this combination could become the future standard of care treatment."

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas:
"We are delighted that the NMPA has recognized the benefits that enfortumab vedotin has offered to patients with previously treated locally advanced or metastatic urothelial cancer in China following its approval in August 2024. This latest approval in combination with pembrolizumab marks another step forward in our mission to bring new, innovative treatment strategies to patients in China. We look forward to making a significant impact on patients’ lives, helping to slow disease progression and give them precious more time."

The NMPA’s approval of enfortumab vedotin in combination with pembrolizumab is supported by the results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial demonstrated that the treatment combination improved median overall survival (OS) and median progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. A median OS of 31.5 months (95% CI: 25.4-NR) was achieved with the treatment combination compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). A median PFS of 12.5 months (95% CI: 10.4-16.6) was reported with the treatment combination compared to 6.3 months (95% CI: 6.2-6.5) with platinum-containing chemotherapy, representing a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). The safety results were consistent with those previously reported with this treatment combination, and no new safety issues were identified.1

Astellas has already reflected the impact from this latest approval from the NMPA in China in its financial forecast for the current fiscal year ending March 31, 2025.

For more information, please see the press release "China’s National Medical Products Administration Accepts Astellas and Pfizer’s Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer" issued on March 28, 2024: View Source

About Bladder and Urothelial Cancer
Urothelial cancer, or bladder cancer, begins in the urothelial cells, which line the urethra, bladder, ureters, renal pelvis, and some other organs.4 Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.3,5,6 If bladder cancer has spread to surrounding organs or muscles, it is called locally advanced disease.7 If the cancer has spread to other parts of the body, it is called metastatic disease.8 Approximately 12% of cases are locally advanced or metastatic urothelial cancer at diagnosis.9

In China, the incidence rate of bladder cancer in 2022 ranked 11th among all cancers, with over 92,000 new cases diagnosed that year.2 The five year prevalence of bladder cancer in China is estimated to be 2.5/100,000 cases, or 276,102 cases.2 Continuous treatment and surveillance makes bladder cancer one of the most expensive cancer types over the lifetime of a patient, and the costliest cancer when compared to other malignancies.10

About EV-302
EV-302 is an ongoing, open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated la/mUC. The trial enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab or platinum-containing chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include ORR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by BICR, and safety.1

The most common (≥3%) Grade 3 or higher adverse events related to treatment with enfortumab vedotin and pembrolizumab were maculo-papular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. The safety results in EV-302 are generally consistent with the known safety events previously reported with each agent alone, and with the safety profile of this combination in EV-103 in cisplatin-ineligible patients with la/mUC. No new safety issues were identified.1

The EV-302 trial is part of an extensive clinical program evaluating this combination in multiple stages of urothelial cancer and other solid tumors. Findings from EV-302 were presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and were published in the New England Journal of Medicine.1

For more information on the EV-302 trial (NCT04223856) go to View Source

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.11 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).12

PADCEV is indicated in China as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors, and in combination with KEYTRUDA (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer.

Ongoing Investigational Trials
EV-302 (NCT04223856) is an open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC) who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.

EV-103 (NCT03288545) is an ongoing, multi-cohort, open-label, multicenter Phase 1b/2 trial investigating enfortumab vedotin alone or in combination with pembrolizumab and/or chemotherapy in first- or second-line settings in patients with la/mUC and in patients with muscle-invasive bladder cancer (MIBC).

EV-203 (NCT04995419) is a Phase 2, multicenter, single-arm bridging trial in China designed to evaluate the efficacy, safety, and pharmacokinetic performance of enfortumab vedotin as treatment for patients in China. A total of 40 patients were enrolled in the trial.

Enfortumab vedotin in combination with pembrolizumab is being investigated in an extensive program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in MIBC in EV-304 (NCT04700124, also known as KEYNOTE-B15) and EV-303 (NCT03924895, also known as KEYNOTE-905). The use of enfortumab vedotin in combination with pembrolizumab in second-line urothelial cancer and MIBC has not been proven safe or effective.

EV-104 (NCT05014139) is a Phase 1 trial exploring enfortumab vedotin in patients with non-muscle invasive bladder cancer (NMIBC). The trial is being conducted in two-parts, assessing dose escalation and dose expansion with enfortumab vedotin when administered intravesically as a monotherapy.

EV-202 (NCT04225117) is an ongoing, multi-cohort, open-label, multicenter Phase 2 trial investigating enfortumab vedotin alone in patients with previously treated advanced solid tumors. This trial also has a cohort that is investigating enfortumab vedotin in combination with pembrolizumab in patients with previously untreated recurrent / metastatic head and neck squamous cell carcinoma.

Important Safety Information
For Important Safety Information for enfortumab vedotin please see the full Summary of Product Characteristics at: View Source

On January 8, 2025 Vividion Therapeutics, Inc., a clinical-stage biopharmaceutical company utilizing novel discovery technologies to unlock high-value, traditionally undruggable targets and develop small molecule precision therapeutics for devastating cancers and immune disorders, reported the acquisition of Tavros Therapeutics, Inc., a precision oncology platform company (Press release, Vividion Therapeutics, JAN 8, 2025, View Source [SID1234649513]). Vividion is a wholly owned and independently operating subsidiary of Bayer AG.

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The addition of Tavros greatly expands Vividion’s functional genomics expertise and capabilities, bringing proprietary methods for genomic screening that can identify new target opportunities, as well as support discovery and translational efforts towards known targets. Combining the Tavros platform with Vividion’s chemoproteomics expertise and capabilities will greatly enhance Vividion’s efforts to generate potential best- and first-in-class drug targets across oncology and immunology.

Vividion and Tavros have been working together for the past two years under a strategic collaboration to discover and develop novel precision therapeutics capable of addressing cancer-causing proteins that have eluded traditional small molecule drugs.

"The addition of Tavros will expand and strengthen our chemoproteomics drug screening capabilities and open up a new target space to fuel the growing pipeline of novel therapies across oncology and immunology", said Aleksandra Rizo, M.D., Ph.D., Chief Executive Officer of Vividion. "We have already seen the power of combining Vividion’s platform and compound library with Tavros’s functional genomics capabilities in uncovering druggable vulnerabilities in tumor cells. We are excited to take this next step to unlock the full potential of our work together for the patients in need."

"The acquisition of Tavros is an exciting next step as we seek to accelerate the development of previously undruggable targets to improve outcomes for patients with significant high unmet medical needs", said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. "It is also the first acquisition in the history of Bayer Pharmaceuticals for one of our ‘arms-length’ model companies, demonstrating the flexible operating model while Vividion continues to operate autonomously to drive breakthrough innovations in precision oncology and immunology."

"We are thrilled for the opportunity to combine forces with Vividion. We have enjoyed a highly productive partnership over the past two years and have seen the clear synergy between our platforms", said Eoin McDonnell, Ph.D., Chief Executive Officer and co-founder of Tavros. "We look forward to building on our success to date to develop novel small molecule therapeutics against elusive protein targets and maximize our ability to bring new treatment options to patients."

Financial terms are not disclosed.

On January 8, 2025 NorthStar Medical Radioisotopes, LLC and YAP Therapeutics, Inc. reported to have entered into a collaboration agreement to develop and produce radiopharmaceuticals aimed at treating cancer and other chronic diseases (Press release, NorthStar Medical Radiostopes, JAN 8, 2025, View Source [SID1234649529]).

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NorthStar is involved in the development, production, and commercialization of radiopharmaceuticals for therapeutic applications and medical imaging. YAP Therapeutics, a Fjord Ventures company, utilizes its advanced biologic and regenerative medicine technology platforms to develop treatments for chronic diseases.

Within this collaboration, NorthStar will support the development of YAP Therapeutics’ biologic products by supplying the radioisotope non-carrier added actinium-225 (n.c.a. Ac-225) and providing access to its radiopharmaceutical contract development and manufacturing (CDMO) services. NorthStar will also prepare clinical trial-ready doses of YAP Therapeutics’ investigational medicines. Additionally, upon regulatory approval, NorthStar may manufacture and supply radionuclides for YAP Therapeutics’ commercial use.

"NorthStar leads in medical radioisotope development and production. This agreement furthers our goal to deliver radiopharmaceuticals to patients," said Frank Scholz, President and Chief Executive Officer of NorthStar. "We are excited to partner with YAP Therapeutics, merging our technology with their biologics to target specific therapies. Our ability to provide key radioisotopes like Ac-225 and CDMO capabilities offers substantial support to YAP Therapeutics."

"We are thrilled about partnering with NorthStar to improve cancer treatment. Their radiopharmaceutical expertise complements our biologics development," said Olav Bergheim, Founder and Chairman of YAP Therapeutics. "This partnership offers the potential to expand our rich pipeline with leading radioisotope technology."

On January 8, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, reported that co-founder and CEO, Neil Kumar, Ph.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 13 at 7:30 am PT (Press release, BridgeBio, JAN 8, 2025, View Source [SID1234649498]).

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To access the live webcast of BridgeBio’s presentation, please visit the "Events & Presentations" page within the Investors section of the BridgeBio website at View Source A replay of the webcast will be available on the BridgeBio website for 30 days following the event.