MEDICAL

Alligator Bioscience Announces IND Approval for CD40 Targeting Antibody Mitazalimab

Alligator Bioscience | December 07, 2020

Alligator Bioscience declares an affirmed IND (Investigational new Drug) for the CD40  targeting antibody mitazalimab. IND endorsement by the US Food and Drug Administration (FDA) is an essential to begin clinical preliminaries in the USA. As of late, new benchmark information was distributed indicating that mitazalimab can possibly be top tier in the CD40 field. The comparison demonstrated the potent immune-activating properties and anti-tumor effects of mitazalimab.

"While the upcoming clinical Phase Ib/II study in pancreatic cancer, OPTIMIZE-1, will be starting in Europe, the IND opens up for later expansion in the US. This is essential for the future success of the product", said Per Norlén, CEO of Alligator Bioscience.", said Per Norlén, CEO of Alligator Bioscience. "Our key focus right now is to complete the submission of the CTA for start of OPTIMIZE-1 in the EU", he added.

The mitazalimab drug candidate has recently reported positive clinical information from a Phase I study performed by Janssen Biotech Inc., showing a manageable safety profile just as early signs of efficacy.

Spotlight

The global demand for plasmid DNA has increased
dramatically in recent years, fueled by a surge in the
clinical development of next-generation cell and gene
therapy products and more recently by the success of
COVID-19 vaccines.

Spotlight

The global demand for plasmid DNA has increased
dramatically in recent years, fueled by a surge in the
clinical development of next-generation cell and gene
therapy products and more recently by the success of
COVID-19 vaccines.

Related News

INDUSTRIAL IMPACT, MEDICAL

Emulate Publishes Landmark Study Validating Organ-on-a-Chip Technology for Predictive Toxicology in Preclinical Development

Emulate, Inc. | December 07, 2022

Emulate, Inc., the leading provider of next-generation in vitro models announced the publication of a landmark study, “Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology,” in Nature Communications Medicine demonstrating that the Emulate human Liver-Chip could improve patient safety and reduce small-molecule clinical trial failures due to liver toxicity by up to 87%. These findings conclude the single largest Organ-Chip study to date, in which researchers compared the performance of human Liver-Chips in predicting drug-induced liver injury (DILI) to those of animal in vivo models—the current industry standard—and primary human 3D hepatic spheroids. In addition to assessing and quantifying model performance, this study effectively qualifies the Emulate human Liver-Chip model against the guidelines defined by IQ MPS, an affiliate of the International Consortium for Innovation and Quality in Pharmaceutical Development. “This first-of-its-kind study demonstrates the Emulate human Liver-Chip can better predict drug safety than other methods for modeling liver toxicity. In light of these findings, the pharmaceutical industry and government agencies have a responsibility to both patients and researchers to bring efficient, accurate, and safe preclinical testing models—like Organ-Chips—into the drug development process.” Jim Corbett, Chief Executive Officer of Emulate Researchers assessed the performance of 870 Emulate human Liver-Chips across a blinded set of 27 known hepatotoxic and non-toxic drugs. In line with the IQ MPS guidelines, the tested drugs included seven matched pairs that demonstrate the chip’s ability to distinguish toxic drugs from their less toxic structural analogs. Furthermore, the study demonstrated that the Emulate human Liver-Chip was able to correctly identify 87% of the tested drugs that caused drug-induced liver injury in patients despite passing animal testing evaluations. At the same time, the Emulate human Liver-Chip did not falsely identify any drugs as toxic leading to a 100% specificity and supporting its use in toxicology screening workflows. Pharmaceutical companies can encounter many challenges in developing human drugs. Often, compounds showing promise in preclinical efforts face high attrition during human trials due to poor predictive validity of preclinical models, especially for biologics. Therefore, the researchers also modeled the potential economic impact that routine use of the Emulate human Liver-Chip could have on drug development productivity. By simply improving the ability to detect hepatotoxicity with 87% sensitivity, they estimated that broad adoption of the Emulate human Liver-Chip could increase research and development productivity by $3 billion dollars on an annual basis for the small molecule drug development industry. Additionally, their computational economic value analysis estimated that routine use of Organ-Chips to assess cardiovascular, neurological, immunological, and gastrointestinal small molecule toxicities could similarly generate approximately $24 billion dollars per year due to increased research and development productivity. With 40% of current drugs in the pipeline being biologics, this value is expected to increase even more as Organ-Chips are further incorporated into the biopharmaceutical drug development pipeline. “The predictive validity of a model is the rate limiting step in drug research and development,” said Jack Scannell, PhD, CEO of Etheros Pharma Corp, Author of Eroom’s Law. “These models are under-evaluated, and the financial value of good models remains opaque; consequently, model innovation is poorly incentivized. Two outcomes from the Emulate study have implications that extend well beyond toxicity. First, it sets the benchmark for model evaluation, and secondly it shows how to map from model validity to decision quality to dollar value. After all, if we want the scientific community to invest in better models, we need to work out how much they are worth.” The authors suggest that researchers could employ the Emulate human Liver-Chip in the lead optimization phase of their drug development pipeline, where projects have identified three to five chemical compounds that have the potential to become a candidate drug. By doing so, a chemical compound that produced a toxic signal in the Emulate human Liver-Chip could be deprioritized from early in vivo studies, thus reducing animal testing, and permitting safer candidates to progress through the development pipeline. “This study is one of the most critical developments in the field of Organ-on-a-Chip technology,” said Zaher Nahle, PhD, MPA, Chief Science Officer at the Center for Contemporary Sciences. “It shows the primacy and utility of the technology in predictive toxicology. It also demonstrates the immediate readiness of such technology to transform critical phases of the drug development process, in particular lead optimization and preclinical assessment, making the entire process safer, cheaper, faster, and more effective.” Full study: Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology, Nature Communications Medicine, December 6, 2022 Co-authors include: Lorna Ewart, Athanasia Apostolou, Skyler A. Briggs, Christopher V. Carman, Jake T. Chaff, Anthony R. Heng, Sushma Jadalannagari, Jeshina Janardhanan, Kyung-Jin Jang, Sannidhi R. Joshipura, Mahika Kadam, Marianne Kanellias, Ville J. Kujala, Gauri Kulkarni, Christopher Y. Le, Carolina Lucchesi, Dimitris V. Manatakis, Kairav K. Maniar, Meaghan E. Quinn, Joseph S. Ravan, Ann Catherine Rizos, John F.K. Sauld, Josiah Sliz, William Tien-Street, Dennis Ramos Trinidad, James Velez, Max Wendell, Prathap Kumar Mahalingaiah, Donald E. Ingber, Jack Scannell, Daniel Levner About Emulate, Inc. Emulate is igniting a new era in human health with industry-leading Organ-on-a-Chip technology. The Human Emulation System provides a window into the inner workings of human biology and disease, offering researchers an innovative technology designed to predict human response with greater precision and detail than conventional cell culture or animal-based experimental testing. Pioneered at the Wyss Institute for Biologically Inspired Engineering at Harvard University and backed by Northpond Ventures, Founders Fund, and Perceptive Advisors, Organ-on-a-Chip technology is assisting researchers across academia, pharma, and government industries through its predictive power and ability to recreate true-to-life human biology.

Read More

CELL AND GENE THERAPY, MEDTECH

Pear Therapeutics and Spero Health to Collaborate and Expand Access to PDTs

Pear Therapeutics | January 09, 2023

Pear Therapeutics, Inc., the leader in commercializing and developing software-based medicines known as prescription digital therapeutics (PDTs), announced the expansion of its collaboration with Spero Health, an integrated healthcare services organization. Spero Health, which has adopted reSET® and reSET-O® at 14 locations in Kentucky, plans to expand access to eligible patients at its remaining 99 locations in Kentucky, Indiana, Ohio, Tennessee, Virginia, and West Virginia. Offering new FDA-approved treatment options is a part of Spero Health's mission to promote patient engagement and retention in recovery. Steve Priest, Spero Health’s CEO said, “Spero Health continues to find innovative ways with new technologies to bring solutions to our communities that have been devastated by drug overdose, and we are looking forward to our collaboration with Pear Therapeutics to pursue even better outcomes in treatment.” Adding to this, he further said, “Pear’s technology equips our clinicians with vital measurements via a clinician dashboard that allows us to provide quality care to our patients who suffer from substance use disorders. We believe having access to patient reported data via Pear’s clinician dashboard gives us better insight into patient behaviors. We expect that this approach will help to increase compliance and create efficiencies in how our treatment teams deliver care.” (Source: BusinessWire) Spero Health's two implemented products, reSET® and reSET-O®, have been measured in real-world use, and their therapeutic content has been evaluated in randomized controlled trials, with the results published in peer-reviewed medical journals. reSET® is used for patients aged 18 or older with substance use disorder as a monotherapy, whereas reSET-O® is used in combination with buprenorphine-based medication-assisted treatment for patients 18 and older with opioid use disorder. About Pear Therapeutics Pear Therapeutics, Inc., the parent firm of Pear Therapeutics (US) Inc., is a leader in the development and marketing of software-based pharmaceuticals, also known as prescription digital therapeutics (PDTs). The company intends to transform care through the widespread adoption of clinically validated software-based therapeutics to provide improved patient outcomes, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers.

Read More

CELL AND GENE THERAPY, INDUSTRIAL IMPACT

Aldevron Launches Type-V CRISPR Nuclease, Eureca-V™ MAD7®

Aldevron | January 20, 2023

Aldevron®, a worldwide leader in the custom development and production of plasmid DNA, RNA, and proteins for the biotech sector, recently announced the launch of Eureca-V™ nuclease. Eureca-V™, licensed from Inscripta®, is the wild-type MAD7® CRISPR Type-V nuclease at research grade, with GMP to follow. The launch of Aldevron's Eureca-V nuclease at advanced therapies week expands the toolkit of accessible CRISPR nucleases for therapeutic, diagnostic, and agricultural workflows. In addition, a pass-through license for research use is conveyed with the purchase of Eureca-V nuclease, allowing customers to thoroughly examine the product without committing to a long-term licensing agreement. Vice President and General Manager of Aldevron's Protein Business Unit, Tom Foti, said, "The availability of Eureca-V drives forward the entire genomics medicine industry and enhances Aldevron's position as a supplier of choice for CRISPR drug substances and drug products." He added, "We are proud to work alongside our partners at Inscripta to bring the innovative, off-the-shelf catalog product to market now as well as provide a clear path to GMP in 2023." (Source – Cision PR Newswire) Eureca-V at the research grade level ensures the acceleration of CRISPR translational research. In addition, the product will assist academic and commercial scientists seeking a wild-type Type-V CRISPR nuclease that targets T-rich regions of the genome. Venkata Indurthi, Chief Scientific Officer at Aldevron, expressed, "We are thrilled to offer Eureca-V product at research grade starting today, and later this year, our clients can expect a smooth transition to our GMP product." He further added, "Aldevron's extensive history in CRISPR nucleases allows researchers to develop therapies that will eventually address global health issues." (Source – Cision PR Newswire) It will be the third GMP CRISPR nuclease by Aldevron and the first Type-V nuclease available as a GMP catalog product. It is a leader in supplying vital raw materials and reagents used for cell and gene therapy manufacturing. The company's portfolio of CRISPR nucleases is applied globally in preclinical and clinical research applications. About Aldevron Aldevron is a pioneer in advancing biological science. Its custom development and manufacturing services have provided scientists all across the world with the components they need to accelerate research and create labs for revolutionary science and breakthrough discoveries. The company aims to deliver products and services that contribute significantly to global biological research. It seeks to be the partner of choice forproducing high-quality plasmid DNA, proteins, enzymes, and other biologicals to support its clients' goals.

Read More