On March 19, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported a presentation of a new pre-clinical clinical data abstract at the upcoming Society of Surgical Oncology (SSO) 2025 Annual Meeting (Press release, Renovorx, MAR 19, 2025, View Source [SID1234651274]).

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The abstract, titled "Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial," is co-authored by Dr. Ramtin Agah, RenovoRx’s Chief Medical Officer. The abstract supports RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform via additional human PK data and pre-clinical data.

TAMP is designed to ensure targeted 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 locoregional treatment offers the potential for increased safety, tolerance, and improved efficacy.

RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial is evaluating the Company’s novel investigational drug-device combination product candidate, (intra-arterial delivery of gemcitabine via RenovoCath) known as IAG, utilizing the TAMP drug delivery platform in patients with Locally Advanced Pancreatic Cancer (LAPC). RenovoRx currently anticipates the completion of both patient enrollment and the second interim analysis for TIGeR-PaC in mid-2025. This abstract is a sub-study of the TIGeR-PaC clinical trial. The combination product candidate (IAG), which is enabled by the FDA-cleared RenovoCath device, is currently under investigation and has not been approved for commercial sale.

SSO 2025 Abstract Details:

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: ePoster P379 at Tampa Convention Center, Tampa, FL
Dates: March 27 – 29, 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 LAPC. RenovoRx’s first investigational drug-device combination product candidate (intra-arterial delivery of gemcitabine via RenovoCath, known as IAG) using the TAMP therapy platform enabled with 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 TIGeR-PaC study is investigating TAMP in LAPC. 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 the second quarter of 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 mid-2025.

On March 19, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") reported updated data confirming efficacy of its Targeted Hyperthermia Therapy ("THT") cancer treatment in an immunotherapy resistant cancer (Press release, Sona Nanotech, MAR 19, 2025, View Source [SID1234652834]). In this follow-up data to the previously released preliminary study (see press release dated December 11, 2024), again using an industry-standard, immunotherapy resistant, CT-26 colon cancer model, Sona’s THT cancer treatment was 100% effective in activating a strong, effective immune system response. In these experiments, animals treated with a PD-1 checkpoint inhibitor, a standard of care immunotherapy, experienced no benefit with tumors growing similarly to tumors in the control group of untreated animals. However, in a new, second cohort of eight animals first treated with Sona’s THT and then treated with a PD-1 inhibitor, 100% of animals responded demonstrating near complete arrest in tumor growth in the majority of animals as highlighted by the dashed green line in Figure 1, below.

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Sona Nanotech CMO, Dr. Carman Giacomantonio, commented, "In this study, Sona’s THT cancer treatment is clearly the difference maker in inhibiting the growth of this notoriously difficult-to-treat cancer. THT’s ability to cause the expression of new antigens causes the immune system to engage, which we show permits immunotherapies to work better, making THT a powerful potential immunotherapy in its own right."

Sona Nanotech CEO, David Regan, commented, "While still an early preclinical study, we are nonetheless very excited to see the repeatability of our earlier successful preclinical colorectal study results. This data gives us additional confidence as to THT’s ability to enhance the response rates of immunotherapies used in humans, which we expect to be able to assess shortly in our first-in-human early feasibility study."

Further data from this experiment can be found in the Company’s updated corporate presentation, which can be accessed in the Investor Section of its website.

Sona’s THT cancer treatment uses the Company’s patented, biocompatible gold nanorods ("GNRs") to treat certain solid cancer tumors, shrinking them and stimulating the immune system, which has been shown in preclinical studies to enhance the response rates of two different immunotherapy drugs, IL-2 and PD-1.

On March 19, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the full year ended December 31, 2024 and provided a business update (Press release, Immunome, MAR 19, 2025, View Source [SID1234651258]).

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"Immunome’s efficient execution in 2024 laid the foundation for a productive 2025," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We are pleased with the progress of our pipeline and, with multiple programs now in clinical development, we expect that our recent financing will support multiple clinical milestones. We particularly look forward to topline data in the second half of 2025 for the RINGSIDE trial of varegacestat, which we believe will demonstrate significant benefits for patients with desmoid tumors."

"Our highly capable team is achieving our vision of a broad, differentiated portfolio of ADCs. We recently dosed the first patient in the Phase 1 clinical trial of IM-1021, our ROR1-targeted ADC. Three additional novel ADCs, IM-1617, IM-1335 and IM-1340, are in IND-enabling manufacturing, with additional discovery-stage programs under evaluation. We recently submitted the IND for IM-3050, our FAP radiotherapy, and anticipate initiating a Phase 1 clinical trial for that program later this year."

Pipeline Highlights

Varegacestat: Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing the manufacturing and pharmacology work required to support a new drug application filing for varegacestat.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with the first patient dosed in February 2025. The Phase 1 trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors.

IM-3050: Immunome recently submitted an IND for IM-3050 and expects to initiate a clinical trial for the program in the second half of 2025.

Preclinical Pipeline – Immunome’s preclinical pipeline also includes three novel ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, which are currently undergoing IND-enabling work, and additional, undisclosed ADCs in discovery and lead optimization.

Fourth Quarter and Recent Corporate Highlights

· Successfully completed an upsized underwritten public offering for gross proceeds of $172.5 million in January 2025, providing capital that is expected to support achievement of clinical milestones for varegacestat, IM-1021 and IM-3050 and the advancement Immunome’s preclinical pipeline.

· Nominated IM-1617, IM-1340 and IM-1335 as novel ADC candidates, with IND-enabling work initiated in late 2024.

· Presented data highlighting preclinical efficacy for IM-1021 and a differentiated profile for HC74, Immunome’s proprietary TOP1 ADC payload, at the 36th ORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in October 2024.

Full-year 2024 Financial Results

· As of December 31, 2024, cash, cash equivalents and marketable securities totaled $217.3 million, which does not include gross proceeds of $172.5 million from the January 2025 financing. Immunome’s current cash runway is expected to extend into 2027.

· Research and development expenses for the year ended December 31, 2024 were $129.5 million, including stock-based compensation costs of $5.1 million.

· In-process research and development expenses for the year ended December 31, 2024 were $152.3 million. These expenses were related to Immunome’s business development activity.

· General and administrative expenses for the year ended December 31, 2024 were $33.0 million, including stock-based compensation expense of $10.6 million.

· Immunome reported a net loss of $293.0 million for the year ended December 31, 2024.

On March 19, 2025 Mindpeak reported collaboration that aims to assess the transformative potential of AI in digital pathology, with a specific focus on accelerating primary breast cancer diagnosis (Press release, AstraZeneca, MAR 19, 2025, View Source [SID1234651275]). Breast cancer remains one of the leading causes of cancer-related deaths in women worldwide.

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Early and accurate diagnosis is essential for significantly improving clinical outcomes and patient survival rates. However, this process is often hindered by a limited pathology workforce and time-consuming case prioritization. To address these challenges and improve primary breast cancer diagnosis, Mindpeak and AstraZeneca have launched an observational study aimed at understanding the potential of Mindpeak Breast H&E solution.

Mindpeak’s Breast H&E solution, utilized in the study, is an AI-powered software designed to analyze H&E-stained images of breast cancer patient samples. It evaluates the presence of invasive breast cancer as well as ductal carcinoma in situ (DCIS).

A multi-site validation study of Mindpeak’s Breast H&E solution involves a cohort of 900 H&E slides from suspected breast cancer cases.

Key Objectives of the Study:

Assessing Current Practices: Gaining insights into existing breast cancer pathology workflows in different regions and identifying areas for improvement.
Evaluating AI-Powered Tools: Studying the benefits of integrating AI solutions into pathology workflows to streamline primary breast cancer diagnosis, improve efficiency, and facilitate early treatment interventions.
Analyzing Diagnostic Accuracy: Validating the performance of computational pathology algorithms to support pathologists in primary cancer diagnosis.
"The collaboration with Mindpeak underscores our commitment to transforming care by improving diagnosis speed and accuracy," said Susan McCutcheon, International Medical Head of Oncology of AstraZeneca. "Innovative technologies like this have the potential to address critical global health challenges by optimizing diagnostic workflows for breast cancer patients and, ultimately, improving patient care and outcomes."

"We are thrilled to partner with AstraZeneca to further validate this groundbreaking technology," said Felix Faber, CEO of Mindpeak. "Integrating Mindpeak’s H&E solution into pathology workflows as a screening and diagnostic-support tool could make treatment decisions faster and more precise, holding the potential to improve primary breast cancer patient outcomes worldwide."

The companies hope that the study findings will help bridge diagnostic gaps and improve healthcare outcomes in areas with limited resources worldwide.

On March 19, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported the successful completion of its inaugural Rated Public Bond of €500 million with a coupon of 3.875%, maturing in March 2032 (Press release, Ipsen, MAR 19, 2025, View Source [SID1234651259]).

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Following the disclosure of the Investment Grade ratings with BBB- from S&P and Baa3 from Moody’s, both with a stable outlook, this transaction was very well received and largely oversubscribed by a diversified and solid institutional investor base.

"We are pleased with the outcome of this inaugural Rated Public Bond that reinforces and demonstrates investor’s confidence in Ipsen’s Investment Grade credit profile and long-term strategy," said Aymeric Le Chatelier, Executive Vice President and Chief Financial Officer, Ipsen. "While we remain committed to a disciplined financial approach, this issuance will further support our ambition to deliver ongoing sustained growth, driven by our internal pipeline and external innovation."

This transaction is an important component of Ipsen’s refinancing plan which included the successful renewal of €1,5 billion syndicated Revolving Credit Facility completed earlier this month for a period of 5 years with two possible extensions of one year each, significantly extending Ipsen’s debt maturity profile.