Ordaōs and NonExomics | September 29, 2022
Ordaōs, a biotechnology company designing novel miniPROTM mini-proteins to help drug hunters deliver life-saving treatments, and NonExomics, a company specializing in the identification of novel targets from non-conventional protein-coding regions, announced a proof-of-concept research collaboration. As part of this endeavor, Ordaōs will use its proprietary design engine to generate and rank novel miniPRO™ candidates that meet specific target product profiles, beginning with three targets. NonExomics will conduct pre-clinical certification of these identified MinPRO™ proteins to demonstrate their promising commercial value.
"This partnership allows us to spotlight the power of our Design Engine to create customized miniPRO™ proteins that are more configurable, penetrable and stable, and easier to manufacture. Our collaboration with NonExomics also allows us the mutual opportunity to underscore the potential of our specialties utilizing machine-driven technology."
David Longo, CEO of Ordaōs
NonExomics identifies whether novel proteins can function as drug targets for therapeutic purposes or can be used for diagnostic processes. The company has developed a technology that effectively combines artificial intelligence, proteomics, transcriptomics, and genomics to identify novel targets for quicker diagnosis and treatment of diseases that are currently considered to be incurable or difficult to manage. NonExomics plans to develop new therapies and diagnostics based on its proprietary nonexomic targets.
"We at NonExomics are thrilled to be embarking on this exciting collaboration between our companies to fuel our shared goal of pursuing and developing new therapies for poorly treated or currently deemed incurable diseases," said Sudhakaran Prabakaran, PhD, CEO and Co-Founder of NonExomics.
To select miniPRO™ candidates, Ordaōs will use its multitask meta-learning Ordaōs Design Engine to generate, appraise, and rank hundreds of thousands of proteins on their structures and drug-like properties for novel miniPRO™ candidates that meet the requirements of the desired specifications of NonExomics' product profile. NonExomics will then conduct a series of pre-clinical demonstrations of the selected Ordaōs miniPRO™ designs to prove they meet the specified product profiles.
More About The Ordaōs Design Engine
Ordaōs uses The Ordaōs Design Engine, to deliver true protein property design - leveraging continuous learning loops and proprietary data sets to translate human-targeted product criteria into machine-designed mini-proteins. Starting with amino acids, the Design Engine generates, appraises, and ranks billions of protein sequences and hundreds of thousands of protein structures and properties to create customized miniPRO™ proteins. These proteins are then rapidly evaluated in vitro to provide intelligent feedback on multiple design objectives including protein structure, binding specificity and affinity, solubility, stability, immunogenicity, and developability. This iterative process delivers optimized mini-proteins to meet the client's specific molecular target product profile (mTPP). They are also less likely to cause adverse side effects and are easier and less expensive to test, develop, and manufacture than traditional proteins. Using this approach, the Ordaōs Design Engine creates more ideal, unseen protein leads than others and can accelerate drug candidate development, increasing the probability of more therapeutically effective candidates. All of this provides clients with a high level of confidence in their investigational new drug (IND) applications.
Ordaōs is a human-enabled, machine-driven drug design company that helps birth novel therapies to reduce patient suffering, improve health, and extend life. Our flagship solution, miniPRO™ mini-proteins, enable drug hunters to deliver safer and more effective treatments in a fraction of the time of traditional discovery methods.
NonExomics science and platform developed over eight years of rigorous academic and industry research, mines novel disease-associated proteins using the dark genome. NonExomics has opened up a new area of science with unlimited possibilities to cure diseases.
CELL AND GENE THERAPY
BioFluidica, Inc. | September 28, 2022
Biofluidica, Inc., and Hamilton Company, announced a co-marketing agreement to bring advanced Liquid Biopsy capabilities to laboratories worldwide. Biofluidica has developed the next-generation liquid biopsy platform, enabling Hamilton liquid handlers to process biological samples to isolate extremely rare circulating tumor cells, circulating Leukemic cells, fetal cells, cfDNA, and exosomes. The Biofluidica platform, LiquidScan™, integrates seamlessly into the Hamilton pipetting robots. The high precision fluid control provided by the Hamilton automated pipetting channels is designed to avoid processing loss using the Biofluidica proprietary closed-loop pipetting interface with the Biofluidica microfluidic biomarker selection chips.
This announcement represents early commercialization for BioFluidica and a unique alliance for Hamilton Company. The STARlet offers a custom application-configurable liquid handling robot with sensitive programmable pneumatic features that enable walk-away automation for precision biological procedures. LiquidScan utilizes these features to isolate and enrich rare biomarker populations directly from biological samples such as a blood draw potentially replacing the need for surgical biopsies and making testing available for cancer types not previously amenable to surgical biopsy.
"LiquidScan is a novel platform that enhances the ability to perform diagnostic testing applied to many diseases, including several types of cancer, prenatal diagnostics, stroke, and infectious diseases. We have worked with Hamilton to ensure seamless automation allowing for high-throughput and lower-cost testing than current surgical biopsy procedures. There is a win-win scenario here for patients, physicians, and the healthcare system. Because LiquidScan uses a standard blood draw, and non-invasive screening, patients can receive closer monitoring of treatment regimens, and physicians can attain higher quality and earlier patient results. Expensive and time-consuming surgical procedures can be removed from the health-care system."
Rolf Muller, BioFluidica CEO
Hamilton is a leading global manufacturer, providing automated liquid handling workstations and laboratory automation technology to the scientific community. With a focus on innovative design, Hamilton products incorporate patented liquid handling technologies into a portfolio that includes liquid handling platforms, standard application-based solutions, small devices, consumables, and OEM liquid handling solutions.
Known for advancing life science, clinical diagnostics, forensics, and biotechnology industries, Hamilton products offer reliability, performance, and flexibility. Ensuring a continuous commitment to quality, Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world.
BioFluidica Inc. is a privately held biotechnology company that has developed a revolutionary liquid biopsy platform.
CELL AND GENE THERAPY
TEMBEXA and Smallpox | September 27, 2022
Emergent BioSolutions Inc. announced that it has completed its acquisition of exclusive worldwide rights to TEMBEXA® the first oral antiviral approved by the U.S. Food and Drug Administration for all age groups for the treatment of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.
The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent.
“The addition of TEMBEXA to our smallpox medical countermeasure franchise, which consists of our smallpox vaccine and therapeutic for smallpox vaccine complications, creates a more comprehensive offering to combat this deadly public health threat. We look forward to supporting the U.S. government’s smallpox preparedness strategy on a broader scale by executing on this BARDA contract.”
Paul Williams, SVP government/MCM business at Emergent
The 10-year contract valued at up to $680 million, to supply up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA® to the U.S. government, was awarded to Chimerix on August 29, 2022. The contract includes an initial product procurement valued at approximately $115 million, with optional future procurement, valued at up to approximately $551 million, exercisable at the sole discretion of BARDA. In addition to product procurement, the contract includes reimbursed post marketing activities of approximately $12 million.
Based on the terms of the final BARDA agreement, Emergent is expected to pay Chimerix
An upfront payment of $238 million;
Potential milestone payments of up to $124 million contingent on the potential exercise by the U.S. government of procurement options following the base period;
15% royalty on gross profit from sales of TEMBEXA outside the U.S.;
20% royalty on gross profit from sales of TEMBEXA in the U.S. that are in excess of the 1.7 million treatment courses as contemplated in the existing BARDA contract; and
Up to an additional $12.5 million upon achievement of certain development-based milestones.
TEMBEXA is an oral antiviral approved by the FDA in June 2021 for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease.
The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. TEMBEXA has a BOXED WARNING for increased risk for mortality when used for longer duration.
Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30%. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention variola virus is ranked in the highest risk category for bioterrorism agents due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption. Based on a recent report – The Department of Health and Human Services Fiscal Year 2023 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee – smallpox remains a threat of high concern to both the domestic and international community.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.