PharmaCyte Biotech Announces IND Submitted to U.S. FDA for Clinical Trial in Locally Advanced, Inoperable Pancreatic Cancer

PharmaCyte Biotech | September 02, 2020

PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “Submitting this IND is the most important milestone the Company has met thus far in the clinical development of our leading product candidate. That’s our therapy to combat what is truly a global unmet medical need for those patients with LAPC whose tumors no longer respond to the first line treatments of either Abraxane® plus gemcitabine or FOLFIRINOX. “Now that the IND has been submitted, we must wait a minimum of 30 calendar days before initiating our clinical trial. During this time, the FDA has an opportunity to review the IND to ensure that it’s complete and that the planned clinical trial research patients will not be subject to unreasonable risk. It also gives the FDA time to ask for more information and clarification about the information submitted.

Spotlight

The highest number of NCEs approved by the FDA…the fastest growing small molecule clinical pipeline reported in 20 years…the increasing numbers of small and virtual pharma taking their products further through clinical trials…these are exciting times for our industry.

Spotlight

The highest number of NCEs approved by the FDA…the fastest growing small molecule clinical pipeline reported in 20 years…the increasing numbers of small and virtual pharma taking their products further through clinical trials…these are exciting times for our industry.

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CELL AND GENE THERAPY

Xylyx Bio partners with Inventia Life Science to develop tissue-specific, digitally-printed bioinks for drug discovery

Xylyx Bio, Inc. | September 02, 2021

Xylyx Bio, a New York-based leader in advanced biomaterials, and Inventia Life Science, a Sydney-based biotechnology company, today announced their strategic partnership following promising results developing more realistic, scalable, and reproducible 3D cell cultures for drug discovery and biomedical research. As researchers seek to develop more physiologically relevant in vitro models, 3D bioprinting provides promising tools to quickly and more precisely culture cells to develop more effective drugs. Inventia Life Science differentiates from other bioprinting solutions with their RASTRUM™ 3D cell culture platform, which empowers biologists with easy access to reproducible and tunable tissue models at scale. By incorporating liver-specific extracellular matrix (ECM) components developed by Xylyx Bio, the partners are developing robust 3D bioprinted liver tissue models. Inventia will complete product development and offer these solutions for research and drug discovery applications, with plans to expand offerings to other tissue types. Dr. John O'Neill, Xylyx Bio Co-Founder and Chief Scientific Officer, stated: "Xylyx is collaborating with groundbreaking companies like Inventia to lead the industry transition to physiologically relevant disease modeling and compound testing 'in matrico'." Dr. Julio Ribeiro, Co-Founder and Chief Executive Officer of Inventia Life Science, is very enthusiastic about this partnership. He stated, "At Inventia Life Science we strive to provide an automated 3D cell culture solution to accelerate drug discovery and biomedical research. This partnership with Xylyx is a significant step in the right direction in further expanding our matrix portfolio to enable the generation of complex tissue models in a reproducible and tissue specific manner." About Xylyx Bio Xylyx Bio is a pioneer in advanced biomaterials, serving customers across research, clinical and commercial applications. The Company's products provide the full suite of components from the natural cell microenvironment essential for the most accurate and actionable results for scientists working in pharmaceutical development, cell biology research, and regenerative medicine. About Inventia Life Science Inventia Life Science is a fast-growing biotech start-up based in Sydney, Australia, that is revolutionizing biomedical research, drug discovery and regenerative medicine. The award-winning RASTRUM™ 3D cell culture platform has already been adopted in leading medical research institutes and biotechnology and pharmaceutical companies worldwide, which are creating bioprinted tissue models that mimic real human biology.

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CELL AND GENE THERAPY

Elastrin Therapeutics Announces Newly Formed Scientific Advisory Board

Elastrin Therapeutics Inc. | January 17, 2022

Elastrin Therapeutics Inc., a privately held biotechnology company leveraging a platform technology to develop therapeutics that render calcified tissue and organs supple again, announced the formation of its Scientific Advisory Board. The Board is comprised of leading industry and university experts in cardiovascular research and clinical development. Former CMO of Elastrin Therapeutics, Dr. Pedro M. Quintana Diez, will act as chairman. Elastrin Therapeutics’ lead asset ELT-001 is an EDTA-loaded nanoparticle conjugated with a proprietary monoclonal antibody for the treatment of vascular calcification. “We are fortunate to work with such an amazing group of medical scientists, cardiovascular experts and pharma executives on our Scientific Advisory Board,” said Dr. Matthias Breugelmans, CEO of Elastrin Therapeutics. “The members bring a remarkable understanding of cardiovascular research, as well as deep expertise in the development of clinical drugs.” “Elastrin is a prime example of what Kizoo is looking for in its investments: Not delaying an age-related disease but reversing it,” Patrick Burgermeister, Partner at Kizoo Technology Capital and member of Elastrin Therapeutics’ Board of Directors Elastrin Therapeutics’ Scientific Advisory Board is comprised of: Prof. Charles O'Neill, MD: Dr. O’Neill has had an active basic and clinical research program in vascular calcification for the past 20 years and has published over 45 articles on this subject. 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Prof. Linda Hands, MD: Linda Hands was appointed Clinical Reader in the University of Oxford and Honorary Consultant Vascular surgeon in 1992 after training in London, Oxford and Chicago. She was Clinical Director of Vascular and cardiothoracic surgery for three years and also served on the Health Authority and a NICE committee. Linda retired in late 2017 as Associate Professor and remain an Hon. Emeritus Professor at the John Radcliffe Hospital Oxford and Emeritus Fellow of Green College, Oxford. Dr. Pedro M. Quintana Diez, M.D.: Pedro is an internal medicine doctor with over 20 years of clinical development experience in the international biotech and pharmaceutical industry. Prior to joining Elastrin Therapeutics, Pedro served as CMO of Sensory Sciences LLC and held VP and leadership positions at Grunenthal, Abbvie and ParinGenix. Pedro managed Phase II and III developments in cardiovascular and lung diseases. 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INDUSTRIAL IMPACT

Sutro Biopharma and Tasly Biopharmaceuticals Enter into Exclusive License Agreement for STRO-002 in Greater China

Sutro Biopharma | December 28, 2021

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