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 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that the United States Adopted Names (USAN) Council has approved "ateganosine" as the nonproprietary (generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class treatment for advanced non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, MAR 19, 2025, View Source [SID1234651273]).

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The USAN Council is responsible for selecting standardized, informative and unique nonproprietary (generic) drug names. It is made up of experts from the American Medical Association (AMA), the U.S. Pharmacopeial Convention (USP) and the U.S Food and Drug Administration (FDA).

"The designation of a new nonproprietary name for THIO is a key step along our development and regulatory pathway as we move forward with Phase 2 and 3 clinical trials," said Vlad Vitoc, M.D., CEO of MAIA. "We chose a name inspired by the mechanism of action of our molecule: altering telomeric guanosine of the cancer cells. The generic name ateganosine is a unique and consistent identity that will support clear communication between healthcare providers, patients and researchers."

Generic drug names are used in product information, drug regulation, labelling and prescribing as for promotional materials and scientific literature.

MAIA will retain the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On March 19, 2025 Immunovia (IMMNOV: Nasdaq Stockholm), the pancreatic cancer diagnostics company, reported positive results from the VERIFI study, the second clinical validation study of its next-generation pancreatic cancer test (Press release, Immunovia, MAR 19, 2025, View Source [SID1234651272]). The study met its primary endpoint, with the test successfully detecting 77% of stage I and II cases of pancreatic cancer.

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"The high accuracy of the Immunovia test in detecting stage I and II PDAC in a second independent clinical population of high-risk patients is very encouraging," said Dr. Patricio Polanco, Co-Director of the Pancreatic Cancer Program and the Pancreatic Cancer Prevention Clinic at the Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center. "Additional biomarkers to support the diagnosis of patients with early-stage disease are critical for improving long-term oncologic outcomes in pancreatic cancer."

"We are excited to see additional proof of the accuracy of our next-generation test," said Jeff Borcherding, CEO of Immunovia. "Completing a second successful clinical validation study will strengthen our efforts to secure insurance reimbursement for the test. We look forward to sharing additional data and analysis from the VERIFI study in upcoming scientific meetings and publications."

Immunovia is actively preparing to launch its next-generation test in the third quarter of 2025. The company will conduct additional clinical studies throughout the year to assess the test’s clinical impact and evaluate its accuracy in other high-risk populations. These studies will support regulatory submissions and payer reimbursement efforts. Immunovia is also engaging potential commercial partners to accelerate market adoption.

About the VERIFI Study

The VERIFI study was conducted using 385 blood samples from six leading pancreatic cancer centers in the U.S. Researchers analyzed 115 samples from patients with Stage I and II pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. These were compared to 270 control samples from people without pancreatic cancer classified as high risk. These high-risk individuals had a family history of pancreatic cancer, concerning genetic mutations, pancreatic cysts (fluid-filled sacs in the pancreas that sometimes develop into pancreatic cancer), or a combination of these risk factors.

About Pancreatic Cancer

Pancreatic cancer is one of the most aggressive cancers, with a five-year survival rate of just 13%. Early detection is critical for improving patient outcomes, particularly for individuals at high risk of pancreatic cancer. Individuals with certain genetic mutations or family history of PDAC face higher risk. Certain pancreatic cysts, such as intraductal papillary mucinous neoplasms (IPMNs), also pose a significant cancer risk, with up to 15% progressing to pancreatic cancer within 15 years.

On March 19, 2025 Jacobio Pharma (1167.HK) reported its 2024 annual results, with revenue of RMB160 million, R&D expense of RMB330 million (Press release, Jacobio Pharmaceuticals, MAR 19, 2025, View Source [SID1234651271]). Major operating and financing activities generated RMB320 million cash inflows. By the end of 2024, cash and bank balances and bank credit balances amounted to RMB1.45 billion. Jacobio also announced recent business progress and expected milestones.

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"2024 is a transforatmive year for Jacobio. We have submitted a New Drug Application (NDA) for the KRAS G12C inhibitor glecirasib and have licensed out the China rights of glecirasib and the SHP2 inhibitor sitneprotafib to our partner. This marks Jacobio’s successful transformation from the early R&D stage to an innovation-driven value realization stage," said Dr.Yinxiang Wang, the Chairman and CEO of Jacobio Pharma. "Looking ahead to 2025, glecirasib is expected to receive the official approval for marking, which will continuously generate cash flow to invest in Jacobio’ subsequent pipeline."

Development of core clinical stage products

Glecirasib (JAB-21822, KRAS G12C inhibitor) and sitneprotafib (JAB-3312, SHP2 inhibitor)

The commercialization and further clinical development in China of glecirasib and sitneprotafib were licensed to Allist on August 30, 2024.
Non-small cell lung cancer (NSCLC)
The NDA application of glecirasib monotherapy in second-line and above NSCLC was submitted to the CDE (China Drug Evaluation Center) in May 2024 and the priority review designation was granted in the same month. Glecirasib is expected to be approved in the first half of 2025.
The Phase III pivotal trial of glecirasib combined with sitneprotafib in front-line NSCLC enrolled the first patient in China on August 7, 2024.
Multi-tumor basket
The multi-tumor basket registration phase II trial of glecirasib for the treatment of pancreatic cancer, biliary tract cancer, gastric cancer, small bowel cancer, appendiceal cancer and other indications has been initiated in China. Glecirasib has received orphan drug designation (ODD) from FDA and EMA for pancreatic cancer.
Colorectal cancer
The Phase III trial of glecirasib mono or in combination with cetuximab in third line was approved by the CDE in May 2024
JAB-23E73 (pan-KRAS inhibitor)

The IND (Investigational New Drug) applications were approved in China and the United States in September 2024
The first patient was enrolled in November 2024
The dose escalation phase is expected to be completed in the second half of 2025
JAB-30355 (p53 Y220C activator)

The IND application of FIH (first-in-human) global trial of JAB-30355 was approved by the FDA in March 2024 and by the CDE in June 2024.
The first patient was enrolled in July 2024
The dose escalation is expected to be completed in the second half of 2025
JAB-8263 (BET inhibitor)

The dose escalation for JAB-8263 in solid tumors and hematologic malignancy were completed in the U.S. and China, respectively. The RP2D (phase II recommended doses) was obtained.
Dose expansion in patients with myelofibrosis is ongoing.
Solid tumor portion with specific biomarkers is being explored. .
JAB-2485 (Aurora A inhibitor)

A Phase I/IIa global trial of JAB-2485 is ongoing in the U.S. and China.
Dose escalation phase is expected to be completed in the first half of 2025
The expansion of monotherapy and combination with chemotherapy are being planned.
Development of pre-clinical pipelines

JAB-BX467 (HER2-STING iADC)

Clinical candidate of HER2-STING iADC has been nominated in the second half of 2024.
The IND application is being planned to be submitted in 2026.
JAB-BX600 (KRAS G12D ADC)

The clinical candidate is expected to be nominated in the second half of 2025.
As of December 31, 2024, Jacobio has filed more than 360 patent applications worldwide, including 126 authorized patents.

Conference call information

Jacobio Pharma will hold a conference call at 9:30 AM (Beijing time) on March 20, 2024. Participants, please register in advance through this link: View Source

On March 19, 2025 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company’s innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer (Press release, Shanghai Henlius Biotech, MAR 19, 2025, View Source [SID1234651270]).

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According to the U.S. FDA, the drug or biological product receives an ODD will be eligible for certain development incentives, including but not limited to: 1) tax credits for clinical trial costs; 2) waiver of application fees for new drugs; and 3) seven years of market exclusivity without being affected by patent, aiming to accelerate the development process so that patients can benefit from the products as soon as possible. Receiving an Orphan Drug Designation for HLX22 recognizes its potential to treat patients with gastric cancer and marks another milestone for HLX22, following the initiation of its multicenter phase 3 clinical trials in multiple countries and regions worldwide, and signifies a crucial step forward in its global presence.

Until now, gastric cancer still constitutes a major global health problem. According to GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally[1]. Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6%[2,3]. Despite significant advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1/PD-L1 mAbs) for gastric cancer treatment in recent years[4], the disease’s high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes[5]. This underscores the urgent unmet clinical needs in the overall management of gastric cancer.

HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, thereby promoting the internalization and HER2 dimer degradation. The phase 2 clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe) demonstrate that the addition of HLX22 to trastuzumab plus chemotherapy significantly improves survival and anti-tumour efficacy in first-line treatment of HER2-positive gastric/gastroesophageal junction cancer (GC/GEJC) patients, with manageable safety profiles[6-8]，expected to redefine the first-line standard treatment for advanced gastric cancer. At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC have been approved in China, the U.S, Japan and Australia, etc. This international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally.

Looking forward, Henlius will adhere to patient-centricity, accelerating the multi-regional clinical trials of HLX22 to deliver this innovative therapy to patients worldwide. Meanwhile, the company will continue to delve into the oncology field, driving the development of more innovative therapeautics to provide high-quality and affordable treatment options.