Zetagen Therapeutics Expands IP Portfolio, Achieving a Milestone of 64 Worldwide Patents in 2024

On January 8, 2025 Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing proprietary carriers delivering tumoricidal therapies for metastatic and primary breast cancer, which may minimize patient side effects with the potential to increase survival rates, reported in 2024 they nearly doubled their worldwide IP portfolio to 64 patents, spanning across 36 countries including the United States, Europe, Canada, Australia, Japan, United Kingdom, India, Sweden and Switzerland (Press release, Zetagen Therapeutics, JAN 8, 2025, View Source [SID1234649530]).

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"It is heartening to witness this significant scientific research being acknowledged with these latest patent grants," said Joe C. Loy, member of the Executive Board and CEO of Zetagen Therapeutics. "Our ambition is to continue growing our intellectual property portfolio with discoveries around the development of Zeta-BC-003 and Zeta-BC-005 for the treatments of metastatic breast cancer, but also for future discoveries towards primary breast cancer treatments."

Details of the latest patent awards for the company’s Life Science business are as follows:

New molecular pathways, proprietary carriers, and optimum dose ranges to treat breast cancer.
Zetagen has enlisted Foley & Lardner LLP as its intellectual property counsel and maintains a collaborative professional relationship with Steve Maebius, Esq. Foley & Lardner LLP is a prominent law firm with global reach and specialized expertise in Life Sciences intellectual property and strategic counsel.

"The technologies patented by Zetagen in 2024 contain landmark science, which includes new chemicals and describes novel chemistries, and formulations of their proprietary drug-carrier platform, specific to locoregional delivery of these new chemical entities, improving breast cancer treatments," said Bryan S. Margulies, MS, PhD, CSO, Zetagen Therapeutics, Inc.

NorthStar Medical Radioisotopes and YAP Therapeutics Enter Into Collaboration Agreement for the Development and Production of Radiopharmaceutical Products

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."

RenovoRx Announces Acceptance of Abstract for Presentation at ASCO Gastrointestinal Cancers Symposium 2025

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.

Tempus Announces a Collaboration With Genialis to Develop RNA-Based Biomarker Algorithms

On January 8, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported a collaboration with Genialis, the RNA-biomarker company (Press release, Tempus, JAN 8, 2025, View Source [SID1234649527]). The multi-year agreement allows Genialis to leverage Tempus’ multimodal dataset to develop new RNA-based algorithms across cancer types.

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Clinical care for cancer patients is hindered by insufficient biomarkers that fail to accurately predict patient response to treatment. To address this, Genialis has developed an AI foundation model using data from ~1 million RNA-sequencing samples representing globally diverse patients. This large molecular model (LMM), dubbed the Genialis TM Supermodel, yields accurate and information-rich biomarker algorithms to help biopharma improve therapeutic development. Validating Genialis’ LMM using Tempus real-world multi-modal data is essential to demonstrate the clinical utility and broad applicability of these biomarkers in drug development and clinical practice. As part of the collaboration, Genialis can now leverage Tempus’ analytics platform, Lens, which provides a development platform accessing de-identified multimodal patient records and a suite of tools to validate signatures to accelerate the company’s efforts to bring its clinical algorithms to market. In return, Tempus gains the right to evaluate and potentially license Genialis-developed algorithms for commercialization as a component of the xR platform.

Tempus multimodal dataset has already proved pivotal in the launch of GenialiskrasID, the first commercially available algorithm that stratifies patients who benefit from KRAS inhibition. Presented at the 6th Annual Targeting-RAS Drug Development Summit in September 2024, Genialis krasID uniquely predicts patient response to KRAS-targeted therapies across cancer types and driver mutations. Independently validated using Tempus’ real-world data, Genialis krasID stratifies patients into high and low likelihood response groups that have been evaluated in real-world studies1,2.

"We look forward to working with Genialis and demonstrating new ways in which our data can be applied to further a new kind of research, one that embraces the power that RNA-based biomarkers can have on the future of cancer care," said Kate Sasser, Ph.D., Chief Scientific Officer at Tempus. "Multimodal algorithms, including RNA signatures, are demonstrating rapid advancement in clinical utility for personalized treatment decisions, and we are excited to partner with Genialis to fuel this data-driven precision medicine future with our xR assay and vast multimodal dataset."

"Biomarkers have the potential to transform how cancer is diagnosed and treated, but today’s standard of care leaves a lot to be desired in terms of accuracy, information richness, and patient reach," said Rafael Rosengarten, Ph.D., CEO of Genialis. "With this strategic agreement with Tempus, Genialis will have access to an unparalleled data resource to validate our cutting-edge patient classifiers."

Vir Biotechnology Announces Encouraging Safety and Efficacy Data in Ongoing Dose Escalation Trials for Dual Masked T-Cell Engagers VIR-5818 in Solid Tumors and VIR-5500 in mCRPC

On January 8, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR) reported initial Phase 1 data from two of its dual-masked T-cell engagers (TCEs): VIR-5818, targeting a variety of HER2-expressing solid tumors; and VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC) (Press release, Vir Biotechnology, JAN 8, 2025, View Source [SID1234649526]). Data show encouraging preliminary safety and efficacy profiles with no dose-limiting cytokine release syndrome (CRS), maximum tolerated dose (MTD) not yet reached as dose escalation continues, and early clinical response signals observed in heavily pretreated participants. These initial results provide clinical support for Vir Biotechnology’s in-licensed PRO-XTEN masking technology, which is designed to enable the selective activation of TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity.

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"Overcoming the toxicity-driven limitations of traditional T-cell engagers could address an important unmet medical need in cancer care," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "Preliminary safety and efficacy data for our dual-masked T-cell engagers VIR-5818 and VIR-5500 are compelling, and we will continue dose escalation with an opportunity to expand the therapeutic window. We are encouraged that our candidates may enable efficacious and well-tolerated treatment regimens, potentially improving outcomes for people living with a range of solid tumors."

VIR-5818: PRO-XTEN Initial Proof-of-Concept and Potential First-in-Class HER2 Immunotherapy

Despite availability of HER2-targeting therapies, there remains a significant unmet need for treatments with novel mechanisms of action to improve tolerability and extend survival. Currently, no HER2-directed immunotherapies are approved for solid tumors. The preliminary safety and efficacy data of VIR-5818 support the tumor-specific activation of PRO-XTEN dual-masked TCEs and the potential of this technology to broaden the therapeutic index of TCEs.

VIR-5818 is being evaluated in a Phase 1 clinical trial (NCT05356741) designed to study its safety and pharmacokinetics alone, and in combination with pembrolizumab, in participants with a variety of HER2-expressing cancers, including breast and colorectal cancer (CRC). The study has enrolled 79 heterogeneous and heavily pretreated participants in monotherapy cohorts.

Early efficacy data indicate that 50% (10/20) of participants receiving VIR-5818 doses ≥400 µg/kg experienced dose-dependent tumor shrinkage across multiple HER2-positive tumor types. This includes participants who had received up to 9 prior lines of therapy. Strong anti-tumor activity was observed in a subset of participants with HER2-positive CRC who have exhausted standard of care. In this subset, confirmed partial responses (cPRs) were seen in 33% (2/6) of participants at early doses, and one patient continued in cPR for more than 18 months as of the data cut-off.

Preliminary safety data demonstrate that VIR-5818 is generally well-tolerated, with minimal grade 1 or 2 CRS (20% and 10%, respectively) and no grade 3 or greater CRS observed in any of the 79 participants across doses up to 1000 µg/kg. Most treatment-emergent adverse events (TEAEs) were low grade, reversible and manageable. The MTD has not yet been reached. Preliminary pharmacokinetics and safety data indicate low systemic unmasking of the TCE, suggesting tumor-specific activation. Dual masking results in a half-life of approximately 6 days, which may enable a less frequent dosing regimen. As a result, Vir Biotechnology is currently evaluating a Q3W dosing regimen.

VIR-5500: First Dual-Masked PSMA-Targeting TCE

Prostate cancer is the second most diagnosed cancer in men1. Despite advancements, there is still a significant unmet need for efficacious, well-tolerated treatments that can extend survival and improve quality of life.

VIR-5500 is being evaluated in a Phase 1 clinical trial (NCT05997615​) designed to assess its safety, pharmacokinetics, and preliminary efficacy in participants with mCRPC. The study has enrolled 18 participants with significant disease burden who have received 3 to 6 prior lines of therapy.

Early efficacy data show encouraging signs of prostate-specific antigen (PSA) responses, and PSA reductions were observed in 100% (12/12) of participants after an initial dose ≥120 µg/kg. PSA50 response was confirmed in 58% (7/12) of participants receiving a first dose ≥120 µg/kg.

Preliminary data show a promising safety profile, with no dose-limiting toxicities observed up to 1000 µg/kg without prophylactic corticosteroids. Safety findings showed minimal grade 1 or 2 CRS (17% and 11%, respectively) and no grade 3 or greater CRS at any dose. Most TEAEs were low grade. No hearing loss has been reported, suggesting safety benefits of dual masking in preventing on-target, off-tumor toxicities. Dose escalation is ongoing, and the MTD for VIR-5500 has not yet been reached. Preliminary pharmacokinetics and safety data indicate tumor-specific activation with minimal unmasking outside the tumor. The dual-masked TCE shows a desirable half-life of 8-10 days, which is enabling Vir Biotechnology to evaluate a Q3W dosing regimen. The safety and tolerability profile observed for VIR-5500 in ongoing dose escalation, together with the observed signs of early anti-tumor activity at low doses, may enable a wide therapeutic index.

About VIR-5818, VIR-5500, VIR-5525

VIR-5818, VIR-5500, VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR, respectively.

TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.