Paraza Pharma, Inc.

Company on track to commence Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) before year end May 01, 2024 -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, announced today the successful completion of its analysis to determine the effects of bioactivated PALI-2108 on TNF-α production in a whole blood (WB) assay. PALI-2108 is Palisade’s orally administered, locally acting, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC. "These important data bolster our confidence in the robust anti-inflammatory potential of PALI-2108 in the management of UC," said Dr. Mitch Jones, CMO of Palisade Bio. "The superior efficacy of PALI-2108, as demonstrated by its lower half-maximal inhibitory concentration (or IC50) compared to the approved PDE4 inhibitor apremilast, underscores its potential as a next-generation therapeutic option for patients with inflammatory bowel disease." This study included WB samples from 14 clinically healthy adults (five women and nine men). Twelve samples meeting the inclusion criteria were included for TNF-α measurement and calculation of IC50 values. Donor whole blood was treated with different concentrations of PALI-2108 and two control compounds known to inhibit the PDE4 pro-inflammatory pathway. Blood was then challenged with the pro-inflammatory molecule lipopolysaccharide (LPS). Anti-inflammatory potency was determined by calculating the IC50 values for TNF-α inhibition. Findings from the study demonstrated that PALI-2108 exhibited efficacy in inhibiting TNF-α production induced by LPS in this ex-vivo peripheral whole blood assay. Pre-treatment of human whole blood samples with bioactivated PALI-2108 resulted in a significant reduction in LPS-induced TNF-α production compared to non-pretreated samples. Specifically, the Company’s proprietary PDE4 inhibitor, shown to be released by the local bioconversion of PALI-2108 prodrug in the colon, demonstrated a mean IC50 for TNF-α inhibition of 0.022 µM, compared to 0.41 µM for apremilast, showcasing its potent anti-inflammatory activity. The study was conducted in collaboration with Paraza Pharma, Inc based in Montreal, QC. JD Finley, CEO of Palisade Bio, added “Our team’s exceptional operational execution is driving the clinical development of PALI-2108 towards our first-in-human study, which is on track to start later this year. We are committed to advancing our pioneering research initiatives aimed at improving the lives of patients suffering from UC and other inflammatory conditions.” Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com. The content above comes from the network. if any infringement, please contact us to modify.

New name reflects the company's pipeline of paired fluorine-18 PET diagnostics and radioligand therapies to find and treat cancer, led by a GRPR-targeting program for prostate cancer THE WOODLANDS, Texas--(BUSINESS WIRE)-- Fuzionaire Diagnostics, Inc. announced today that it has changed its name to Fuzionaire Theranostics, Inc. (“Fuzionaire Tx”). Originally directed to make diagnostic radiopharmaceuticals for PET scans, the company's HetSiFA® library has become a powerful theranostics platform that can also make radioligand therapies. HetSiFAs, or heteroaromatic silicon-fluoride acceptors, are modular radiolabeling moieties that enable rapid prototyping of peptide-based theranostics and the rapid manufacturing of fluorine-18 (18F) PET companions at large scale. HetSiFA-based radioligand therapies use leading alpha- and beta-emitting radionuclides. The HetSiFA® platform creates chemically identical diagnostic and therapeutic companions, a feature that enables a personalized therapeutic dose for each cancer patient. The name change marks a milestone in the company's growth plan and reflects a developing theranostic pipeline in oncology. Preclinical Oncology Pipeline Beginning With GRPR-Positive Prostate Cancer The company's first theranostic development program aims to improve the care of patients with metastatic prostate cancer by targeting the gastrin-releasing peptide receptor (GRPR) with a chemically identical and scalable 18F/ lutetium-177 (177Lu) theranostic pair. GRPR has emerged as a promising and validated target for prostate cancer to complement the widely utilized target prostate-specific membrane antigen (PSMA). In recent years, several PSMA-targeting radiopharmaceuticals have become available to patients worldwide. Novartis's PSMA-targeting radioligand therapy Pluvicto®, Lantheus's 18F PET imaging agent Pylarify®, Blue Earth Diagnostics' 18F PET imaging agent Posluma®, and ABX's PET imaging agent 18F-PSMA-1007 have been approved by regulatory agencies. Like Pylarify, Posluma, and 18F-PSMA-1007, Fuzionaire Tx's HetSiFA-based PET diagnostics use the nuclide 18F, which offers superior availability, production scalability, and image resolution as compared to gallium-68 (68Ga), often used in theranostics. Like Posluma, Fuzionaire Tx's HetSiFA-based radiopharmaceuticals are enabled by silicon. Posluma is the first drug approved by the FDA with a silicon-fluoride acceptor (SiFA) moiety. Fuzionaire Tx's patented HetSiFAs share the manufacturing advantages of SiFAs but with additional features, including an ability to create a more comprehensive array of theranostic candidates with different physicochemical and labeling properties. HetSiFAs are protected by a portfolio of issued and pending patents covering HetSiFAs and HetSiFA-containing candidates and the underlying silicon chemistry. In the context of the growth of PSMA radiopharmaceuticals and recent evidence that not all patients can benefit from them, GRPR has emerged as the most promising target to complement PSMA. The success of 18F/177Lu theranostics targeting PSMA underscores the need for an 18F/177Lu theranostic targeting GRPR. In this context, Fuzionaire Tx’s lead program targeting GRPR could occupy a key space in the portfolio of radiopharmaceuticals for prostate cancer. Additional Programs and Possibilities With origins in Robert Grubbs' lab at Caltech and the Crump Institute for Molecular Imaging at UCLA, the company's programs are advancing through a multi-party collaboration with McGill University, McMaster University, and Montreal-based contract research organization Paraza Pharma. The company is also advancing its programs in consultation with Prof. Mathias Schreckenberger, Director of the Nuclear Medicine Department at the University Medical Center Mainz in Germany, and the radiopharmaceutical contract development and manufacturing organization AtomVie Global Radiopharma Inc. The company's pipeline can expand further. The modularity of the HetSiFA platform enables the company to expand its pipeline rapidly with existing collaborators and new partners. In addition to the GRPR program, the company has discovery-stage programs for lung cancer and PSMA/GRPR-positive prostate cancer. Initial preclinical data from the GRPR program will be presented by Alexey Kostikov, PhD, Associate Professor at McGill University, at the American Chemical Society Fall Conference in August 2023. “We are motivated to continue to innovate in how we collaborate with new partners to expand the use of HetSiFAs and the ecosystem supporting these important new labeling moieties, and to advance our GRPR and other programs through clinical trials,” said Nick Slavin, CEO of Fuzionaire Tx. “By doing so, we can create new ways to treat cancer and make new theranostic medicines more accessible.” About Fuzionaire Theranostics Fuzionaire Theranostics is a radiopharmaceutical company on a mission to make theranostic treatments more accessible to people with cancer. With origins in Nobel laureate Robert Grubbs' lab at Caltech, the company's patented HetSiFA® platform offers manufacturing advantages in a clinical setting and enables a personalized therapeutic dose for each cancer patient. Current development plans address pressing clinical needs in prostate and lung cancer. For more, visit us at:

MONTREAL, Sept. 6, 2022 /PRNewswire/ - Paraza Pharma Inc., a fully integrated drug discovery organization passionately committed to contributing to the life sciences sector today announced the appointment of Dr. Sultan Ahmad as Chief Business Officer reporting to Dr. Arshad Siddiqui, founder and CEO of Paraza Pharma. "We are pleased to announce that Dr. Ahmad is taking on this strategic role in order to support our next phase of growth'' said Dr. Siddiqui. ''His considerable expertise in business development, corporate strategy, and drug discovery research and development, will be very valuable as we continue to further expand our position as a leader in the small molecule integrated drug discovery service space''. Dr. Ahmad has a successful career in pharmaceutical R&D sector with more than 30 years of experience. He has held positions of increasing responsibilities at Astrazeneca, Neomed Institute and Purdue Pharma, Canada. Dr. Ahmad is uniquely qualified as a drug discovery researcher and business development professional to bring Paraza to the next level of growth. Dr. Ahmad completed his Ph.D. in Biomedical Sciences at McMaster University, Ontario, Canada. He has co-authored over forty (40) peer-reviewed publications and is a co-inventor on seven (7) patents. ''Paraza is a remarkable R&D organization with an exceptionally talented team of scientists and a culture of innovation and high performance,'' said Dr. Ahmad. '' I look forward to starting this new role and excited to work with the Paraza team to outline our business and growth strategy, and work towards establishing innovative partnerships.'' About Paraza Pharma Paraza Pharma is a Montreal, Canada based, fully integrated drug discovery organization passionately committed to contribute to the life sciences sector. As part of the growth strategy, it attracts worldwide best-in-class talent and continues to offer a unique collaborative model to help companies achieve their success milestones and accelerate their business growth. To learn more, visit Paraza Pharma Inc.: Arshad Siddiqui, PhD, CEO [email protected] SOURCE Paraza Pharma Inc.