On January 18, 2023 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.* (the "Company") reported that has received the Acceptance Notice (《受理通知書》) issued by the National Medical Products Administration of the PRC (the "NMPA") (Filing, Shanghai Fudan-Zhangjiang, JAN 18, 2023, View Source [SID1234633120]). The board of directors (the "Board") of the Company is pleased to announce that, the Company has received the Acceptance Notice (《受理通知書》) issued by the National Medical Products Administration of the PRC (the "NMPA"). The investigational new drug (the "IND") application for Phase I clinical trial of FZ-AD004 antibody drug conjugate for injection (Trop2-BB05 ADC, the "Drug") for the treatment of advanced solid tumors has been accepted. Relevant information is as follows: ABOUT THE DRUG Drug name: FZ-AD004 antibody drug conjugate for injection Registration type: Class 1 therapeutic biological products Application matter: Registration of Clinical Trial of Domestic Production of Pharmaceutical Product Acceptance No. CXSL2300047 Applicant: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd Review conclusion: Accepted upon review according to the requirements of Article 32 of the Administrative License Law of the People’s Republic of China.-2-In recent years, the Company has built a new Linker-Drug platform ("BB05 Platform") with independent intellectual property rights in respect of small molecule. The Drug is the second new generation antitumor antibody-drug conjugate (ADC) drug on the BB05 Platform. It is composed of monoclonal antibodies against human trophoblast cell surface glycoprotein antigen ("TROP-2") target coupled with BB05. TROP-2 is expressed at different levels, and its expression level is significantly increased in various carcinomas, such as breast cancer, lung cancer, and stomach cancer. The Drug can bind to high TROP-2-expressed tumor cells and endocytosis, releasing small molecule cytotoxic drugs (topoisomerase I inhibitors) in lysosomes by protease cleavage to kill the tumor cells. The Drug is intended to be developed for the treatment of advanced solid tumors including but not limited to lung cancer, breast cancer, gastric cancer, esophageal cancer, colorectal cancer, urothelial cancer, bladder cancer and endometrial cancer, etc. Due to the high-tech, high-risk and high-value-added characteristics of pharmaceutical products, and the long cycle and numerous stages in the process, there are uncertainties in drug pre-clinical research, clinical trial and commercialization. These many stages make it susceptible to uncertainties and therefore, investors are advised to make cautious decisions and pay careful attention to investment risks. The Company will actively facilitate the above research and development project and fulfill its information disclosure obligations in a timely manner for subsequent progress in strict accordance with relevant regulations.

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On January 18, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) and Rznomics Inc., a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, reported a viral vector contract development and manufacturing organization (CDMO) partnership (Press release, Charles River Laboratories, JAN 18, 2023, View Source [SID1234626365]). Rznomics will leverage Charles River’s viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients.

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RZ-001 is the first ribozyme-based RNA reprogramming approach approved by the US Food and Drug Administration (FDA) for evaluation in patients. The treatment was developed utilizing Rznomics’ proprietary RNA reprogramming and editing technology and takes the form of an adenoviral vector that expresses an hTERT targeting ribozyme to treat hepatocellular carcinoma (HCC) patients. HCC is the most common type of primary liver cancer, accounting for 80 percent of cases worldwide.

Rznomics received Phase I/IIa IND approval for RZ-001 from the FDA in October, allowing the initiation of an international clinical study in HCC patients. Early-phase trials have also commenced in Korea following IND approval for RZ-001 from the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA) in June.

Adenoviral Vector Manufacturing Services

Charles River has standardized protocols for cell culture, transfection, and downstream purification, as well as a validated platform process with a proven track record. These high-yield, optimized methods increase speed to clinical manufacturing by reducing process development time and costs while ensuring the highest quality production.

Expanding its comprehensive cell and gene therapy portfolio to span viral vector, plasmid DNA, and cell therapy production, through the acquisitions of Vigene Biosciences, Cobra Biologics, and Cognate BioServices in 2021, Charles River offers end-to-end support and supply chain simplification for advanced therapy medical product (ATMP) developers.

Approved Quotes

"This collaboration with Rznomics will tap into our industry-leading CDMO capabilities and we are thrilled that our expertise will help to bring RZ-001, a potentially curative therapy, to HCC patients." – Birgit Girshick, Corporate Executive Vice President and Chief Operating Officer, Charles River
"We are proud to have achieved FDA approval to begin Phase I/IIa trials and excited to take this next step with Charles River. A reliable and experienced manufacturing partner is of utmost importance, and we are keen to continue building this relationship to enable us to bring our leading pipeline, RZ-001, into clinical development." – Seong-wook Lee, President and Chief Executive Officer, Rznomics

On January 18, 2023 Johnson & Johnson (NYSE: JNJ) reported it will participate in the SVB Securities Global Biopharma Conference on Wednesday, February 15th. Biljana Naumovic, Worldwide Vice President, Oncology and Peter Lebowitz, Global Therapeutic Head, Oncology will represent the Company in a virtual session scheduled at 1:00 p.m. (Eastern Time).

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This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

The audio webcast replay will be available approximately 48-hrs after the webcast.

On January 18, 2023 IntraOp Medical Corporation reported that doctors at Vanderbilt University Medical Center (VUMC) treated a pancreatic cancer patient using IntraOp Mobetron Intra-Operative Radiation Therapy (IORT) (Press release, IntraOp Medical, JAN 18, 2023, View Source [SID1234626363]). Based in Nashville, Tennessee, and serving the southeast region of the United States, Vanderbilt University Medical Center is the only hospital in the state with this first-of-its-kind technology and the only Center of Excellence for pancreatic cancer as designated by the National Pancreas Foundation.

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The procedure marks the first time VUMC — the largest comprehensive research, teaching and patient care health system in the Mid-South region — has utilized IORT with electrons in treating a patient with pancreatic cancer. The procedure was performed by surgical oncologist, Kamran Idrees, MD, MSCI, MMHC, FACS, and radiation oncologist, Natalie A Lockney, MD.

"We are encouraged by the results of the IORT with electrons in treating localized pancreatic cancer," said Dr. Kamran Idrees. "We serve our patients by implementing the latest innovations at Vanderbilt to improve outcomes."

Pancreatic cancer remains one of the deadliest forms of cancer. As the safest and most advanced portable LINAC available, the IntraOp Mobetron has established itself as an essential treatment tool for this most challenging indication. But it’s the precision of the device that makes it so effective. Due to the location of the pancreas and its proximity to major vessels, duodenum, spinal cord, stomach, small and large bowel, liver and kidneys makes precision critical. IORT with electrons makes precise surgery available for more patients than ever before.

"While this procedure is a first for the extraordinary team at Vanderbilt University Medical Center, it is yet another chapter for the promise of IORT with electrons and our collective fight to better treat pancreatic cancer," added Sanjay Arora, CEO at IntraOp. "We’re excited to see where this important milestone leads us."

About Vanderbilt University Medical Center

Vanderbilt University Medical Center is the largest comprehensive research, teaching and patient care health system in the Mid-South region, with the highest ranked adult and children’s hospitals in the Southeast by U.S. News & World Report. Based in Nashville, Tennessee, VUMC sees over 3 million patient visits per year in over 200 ambulatory locations, performs 88,000 surgical operations and discharges 75,000 inpatients from its main-campus adult, children’s, psychiatric and rehabilitation hospitals and three regional community hospitals. The Medical Center is the largest non-governmental employer of Middle Tennesseans, with nearly 40,000 staff, including more than 3,000 physicians, advanced practice nurses and scientists appointed to the Vanderbilt University faculty. For more information and the latest news follow VUMC on Facebook, LinkedIn, Twitter and in the VUMC Reporter.

Kamran Idrees, MD, MSCI, MMHC, FACS is an Associate Professor of Surgery, Ingram Associate Professor of Cancer Research, Chief, Division of Surgical Oncology & Endocrine Surgery, and Director, Pancreatic and GI Surgical Oncology. Natalie A Lockney, MD is an Assistant Professor in Radiation Oncology at Vanderbilt University Medical Center and the Program Director for the radiation oncology medical residency.

On January 18, 2023 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported initial results from a pharmacokinetic (PK) substudy within the phase III un-blinded randomized control TIGeR-PaC clinical trial to be presented at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium this week (Press release, Renovorx, JAN 18, 2023, View Source [SID1234626362]). The TIGeR-PaC clinical trial is evaluating intra-arterial (IA) administration of gemcitabine (chemotherapy) using the proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) platform for targeted treatment of Locally Advanced Pancreatic Cancer (LAPC). The substudy provides clinical support that RenovoTAMP may increase local drug delivery and thus concentration at the tumor site while decreasing the debilitating side effects often associated with systemic intravenous (IV) delivery, which is the current standard of care.

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Three additional abstracts supporting the use of RenovoTAMP with gemcitabine for treatment of LAPC will also be presented at the ASCO (Free ASCO Whitepaper) GI on January 19-21, 2023 in San Francisco, California, and available online.

"Intra-arterial Gemcitabine vs IV Gemcitabine PK Substudy in Patients with Locally Advanced Pancreatic Cancer," presented by Amer H. Zureikat, MD, et al., evaluates RenovoTAMP for IA delivery of gemcitabine (chemotherapy) directly into tumors for higher local drug concentration and decreased systemic drug concentration and associated side effects. The PK substudy evaluates a sample of LAPC patients (N=13) participating in the TIGeR-PaC study and demonstrates that the cohort had an average greater than 50% reduction in systemic drug exposure with IA delivery of gemcitabine using RenovoTAMP when compared with IV administration. The substudy concludes that RenovoTAMP may increase local gemcitabine concentration, which may be beneficial in decreasing gemcitabine-related systemic side effects. Five TIGeR-PaC clinical sites participated in this substudy.

"The upcoming presentation of our TIGeR-PaC clinical trial substudy at ASCO (Free ASCO Whitepaper) GI highlights significant potential benefits for patients with LAPC," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "Targeted local delivery of standard dose gemcitabine via the RenovoTAMP therapy platform may be associated with significantly less systemic drug exposure. The clinical implications may be decreased side effects and enhanced chemotherapy delivery. Ongoing studies are quantifying the resulting impact on improving patients’ quality of life and extending lifespan."

"This substudy data, and the additional three studies to be presented at ASCO (Free ASCO Whitepaper) GI, enhance the strong clinical momentum of our therapy platform as we prepare for our most significant milestone to date: the initial interim analysis for our randomized phase III TIGeR-PaC trial." said Shaun Bagai, CEO of RenovoRx.

Three additional clinical data abstracts presented by researchers at ASCO (Free ASCO Whitepaper) GI with data from the induction phase of the TIGeR-PaC study help to advance the science behind pancreatic cancer. In one abstract, Dr. Amer H. Zureikat, et al. investigates Mesenteric Venous Thrombosis (MVT), often identified on routine imaging studies performed with LAPC, and concludes that severe MVT is more prevalent in this patient population than previously reported. Anticoagulation is also underutilized in this cohort; however, chemotherapy may have a beneficial effect in downstaging MVT beyond anticoagulation. In a second abstract, Dr. Karyn A. Goodman, et al. performs an exploratory analysis to compare the toxicity and efficacy between patients receiving either stereotactic body radiation therapy (SBRT) or intensity-modulated radiation therapy (IMRT) during the induction phase (prior to randomization) of the TIGeR-PaC study. When compared to IMRT, SBRT demonstrates improved tolerability for treatment of patients with LAPC with comparable clinical efficacy. It was this finding that led to the modification of the TIGeR-PaC study design in 2021. Finally, a third abstract presented by Michael J. Pishvaian, et al. focuses on the TIGeR-PaC trial design and status.

The poster presentations for the four RenovoRx abstracts to be presented at the ASCO (Free ASCO Whitepaper) GI Symposium will be available on RenovoRx’s website once available: View Source