MEDTECH

Sorrento Announces COVISTIX COVID-19 Virus Rapid Antigen Detection Test Detects the Omicron Variant

Sorrento Therapeutics, Inc. | December 28, 2021

Sorrento Therapeutics, Inc. announced that initial testing of COVISTIX on recombinant N proteins demonstrated its ability to detect the Omicron variant, in addition to detecting the original SARS-CoV-2 virus and its other major VoCs such as the delta and delta-plus strains. The COVISTIX detection levels were similar for all variants. The ease of use and timely detection of Omicron infection was demonstrated by a recent case report of a Mexico patient infected with the Omicron variant detected first with COVISTIX in about 15-minutes test time. This result was confirmed a day later by RT-PCR and sequence verified a few days later to be Omicron infection.

In a laboratory setting, Sorrento has also studied the ability of COVISTIX to detect the Omicron variant compared to other Emergency Use Authorization approved, commercially available COVID-19 virus rapid antigen tests. Initial lab results demonstrate that COVISTIX was able to detect the Omicron N protein at a significantly lower level than other commercially available tests. With a difficulty to detect the Omicron N protein at low levels, some of the EUA-approved and marketed rapid tests may have a tough time detecting the Omicron infection at a reasonable sensitivity. False negative readings for infected asymptomatic patients could lead to a false sense of security and the inability to control outbreaks and achieve normal social and business routines.

Sorrento currently has the capacity to produce 30,000,000 COVISTIX tests a month and is currently building up its manufacturing capacity in the US. The company anticipates having a fully automated assembly line capable of producing 6,000,000 COVISTIX units per month up and running in Q1 2022. Pending US and global demand, this capacity could potentially be increased to over 100 million monthly in 2022.

About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain, autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies, immuno-cellular therapies , antibody-drug conjugates, and oncolytic virus. Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVISTIX™.

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class non-opioid pain management small molecule, resiniferatoxin, and SP-102 corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase 1B trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.

Spotlight

To better predict the future of HIV pharmaceuticals, we must understand the past – that’s the premise behind Horizons in HIV Drug Development – What’s Past is Prologue, the free whitepaper from Citeline, part of the Informa Pharma Intelligence suite of industry intelligence solutions.


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MEDICAL

Pharmactive Enters Strategic Partnership with Nutraconnect for APAC

Pharmactive | June 08, 2022

Pharmactive Biotech Products, S.L.U., announces a new strategic partnership with Singapore-based Nutraconnect Pte, Ltd. to bring innovative, scientifically backed nutraceutical ingredients to the Asia-Pacific marketplace (not including Australia and New Zealand). The partnership will combine the strengths of both companies into a greater whole. Pharmactive will provide its well-supported, clean-label botanical extract ingredients, while Nutraconnect will function as a growth engine for the region, connecting Pharmactive with local and regional nutraceutical players seeking high-quality, pure ingredients. Nutraconnect Pte., Ltd. is a start-up led by Rohit Noronha, co-founder and Chief Growth Officer, and Nikhil Prabhakar Sawant, co-founder and CEO. Both are highly experienced leaders in the nutraceutical industry. We are very fortunate to partner with Nutraconnect, as their team possesses a great deal of market and customer information and strategic insight, allowing for quick responses to potential customers in their local time-zone, Asia is a tremendous growth-hub for Pharmactive. We already have had successes in Korea, Japan, Vietnam, and Malaysia with Affron® pure saffron extract and Aged Black Garlic [ABG+®]. Many Asian industry players, formulators, and brand owners approach us about new compounding formats or innovative product concepts to cross the nutraceutical/functional food and beverage divide. Asia is clearly the frontrunner in terms of new ingredient concepts." Jean-Marie Raymond, CEO and Founder of Pharmactive. About Pharmactive Pharmactive Biotech Products, S.L.U., is a Madrid-based pioneering biotechnology company that develops and manufactures differentiated natural ingredients supported by science, such as pure saffron extract and aged black garlic. The company's mission is to make a daily positive and significant impact on people's health and well-being through premium botanical ingredients backed by scientific studies and approved by ethics committees. Pharmactive grows, cultivates, and produces farm-to-fork botanical ingredients with a minimal ecological footprint. About Nutraconnect Founded in 2022, Nutraconnect Pte., Ltd., is a nutraceutical business growth acceleration service headquartered in Singapore. The company provides end-to-end solutions for global nutraceutical ingredient manufacturers that are looking to establish a foundation for sustainable growth in the fragmented, but booming APAC market.

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CELL AND GENE THERAPY

Brazil’s SENAI CIMATEC Doses First Healthy Volunteers in Phase 1 trial of HDT Bio’s RNA COVID-19 Vaccine

HDT Bio Corp. | January 17, 2022

HDT Bio Corp., a U.S. developer of immunotherapies for oncology and infectious diseases and SENAI CIMATEC, an important Brazilian education, research, and innovation institute, have dosed the first healthy volunteers in Brazil in a Phase 1 trial of HDT Bio’s RNA COVID-19 vaccine, HDT-301. SENAI CIMATEC will conduct the clinical trial under the name Vaccine RNA MCTI-CIMATEC-HDT. The vaccine uses HDT Bio’s proprietary lipid nanoparticle RNA-delivery technology. “This clinical trial in Brazil is the second international study to get under way in our efforts to help partners in historically underserved nations fight this pandemic by transferring our unique technology to provide them local control over development, manufacturing and distribution of a COVID-19 RNA vaccine. The first was in India with our partner Gennova Biopharmaceuticals which has moved the vaccine into Phase 2 and Phase 3 trials.” HDT Bio CEO Steve Reed HDT Bio has other partnerships for its RNA COVID-19 vaccine, including in South Korea and China. “These partnerships are part of our company’s mission and business strategy aimed at bringing our advanced immunotherapies to underserved nations to help address global health inequities,” Reed explained. "Through the partnership with HDT Bio Corp., SENAI CIMATEC is incorporating in Brazil the development and qualification for a state-of-the-art technology in an exclusive way, as well as the first clinical study involving an RNA self-amplifying vaccine. This moment can be considered as an important demonstration of the potential of Brazilian science, represented in this study by SENAI CIMATEC,” said President of Federation of Industries of the State of Bahia Ricardo Alban “We also highlight the important funding received through the Ministry of Science, Technology and Innovations which has supported the execution of the initial clinical phases, “Alban added. “From the clinical studies of the Vaccine RNA MCTI CIMATEC HDT we expect to obtain sufficient data to demonstrate the efficacy and safety of this product to the population. In this way, the development of the Vaccine RNA MCTI CIMATEC HDT represents a crucial milestone for the modernization of the national health system, since it can later be produced in the country itself,” said infectious disease doctor and Principal Investigator of the clinical studies in Brazil Roberto Badaró. SENAI CIMATEC’s double-blind, placebo-controlled, dose-ranging Phase 1 clinical trial will enroll 90 healthy adult volunteers. The trial will assess the safety, tolerability, and immunogenicity of the vaccine at three dose levels, 1 µg, 5 µg and 25 µg. Safety and tolerability will be the primary endpoints assessed by incidence of adverse events for each dose through 12 months after the vaccination. Scheduled interim evaluations to measure immunogenicity also will be conducted. HDT Bio’s innovative vaccine, which also will undergo a Phase 1 trial in the U.S., uses its proprietary lipid nanoparticle carrier system for delivery of RNA. The vaccine is significantly different from existing commercially available RNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine activates the immune system at a much lower dose than commercially available vaccines, enhancing safety and reducing manufacturing costs. Second, the RNA attaches to the outside of the nanoparticle delivery system rather than being encapsulated within it, providing for enhanced stability. ABOUT HDT BIO CORP. HDT Bio is a biopharmaceutical company dedicated to providing immunotherapies to people around the world, including those in historically underserved areas. The company seeks to harness the body’s immune system to deliver therapies that narrowly target the specific areas of the body where they are needed. HDT Bio’s work focuses on oncological and infectious disease applications. HDT Bio’s founders are world leaders in the development of immune stimulants, including both therapeutics and therapy-enhancing adjuvants. One of the company’s core technologies, RNA/LION™, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses for therapy or vaccination. ABOUT SENAI CIMATEC SENAI CIMATEC focuses on higher education, research and innovation for the development of industry. Its manufacturing and technology integrated campus is one of the most advanced centers for education specialized services, applied research and innovation projects in Brazil. CIMATEC operates in more than 40 different areas of competence, with emphasis on computer technology, engineering, health and biotechnology, with the main objective to support industries, including the Brazilian Industrial Health Complex.

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DIAGNOSTICS

VeriSIM Life and Total Brain Announce Strategic Collaboration Agreement Applying AI to Develop New Drugs for Neurological Disorders

VeriSIM Life | May 30, 2022

VeriSIM Life (VeriSIM), the leading artificial intelligence (AI)-enabled, unique R&D decisions de-risker for breakthrough drug development, today announced that it has entered into a partnership agreement with Total Brain www.totalbrain.com, an applied, integrative neuroscience company, to create breakthrough neurodata-driven actionable insights for developing novel drugs to treat a wide range of neurological disorders. The partnership will pioneer the integration of Total Brain’s proprietary mental health and brain performance database with VeriSIM Life’s BIOiSIM™ AI-enabled drug development decision engine to enable new psychiatric and neurological therapies. The Total Brain platform helps more than one million individuals improve overall mental health and brain performance using several semi-quantitative functional methods. The company’s data sets represent the world’s largest standardized brain database encompassing human electrical brain function, brain structure and blood flow, inclusive of full genetic assessments. We are excited to partner with Total Brain to combine the power of their high-dimensional data with our drug prediction engine to open new doors for drug discovery specifically addressing neurological conditions – something that has never been explored this way before, Using this first-ever combined computational/data capability, pharmaceutical partners will be able to more efficiently and effectively develop new drugs to treat illnesses like depression, anxiety, bipolar disorder, Alzheimer’s, Parkinson’s, schizophrenia, epilepsy, anorexia, ADHD and PTSD.” Dr. Jo Varshney, CEO of VeriSIM Life. With this partnership, the BIOiSIM platform will utilize its Translational Index to discover novel drug candidates with other capabilities such as: Evaluate efficacy and side effects of existing drugs and novel drug candidates used to treat various neurological conditions in specific patient subpopulations with differing genetic, biomarker and demographic profiles Develop highly differentiated patient stratification strategies Help biotechnology companies develop genetics prediction products related to neurological diseases Develop companion diagnostics tracking essential biomarker data during the development of new drugs treating neurological diseases VeriSIM Life’s exceptional AI platform and their understanding of complex biological interactions between drugs and living systems, including the central nervous system, makes them an ideal partner for exploring this exciting new approach to drug discovery.” Matthew Mund, CEO of Total Brain. The collaboration between Total Brain and VeriSIM has the potential to accelerate the pace of drug development, reduce costs and minimize failed drug discovery for neurological diseases, We are on the precipice of a new era in drug development. We are excited by the growing role that Total Brain’s proprietary data is playing in the future of biopharma.” Evian Gordon, Chief Medical Officer, Total Brain. About Total Brain (ASX: TTB): Total Brain Limited is a San Francisco and Sydney-based applied, integrative neuroscience company that has developed and offers Total Brain, a SaaS-based mental health platform powered by the world’s largest standardized brain database. Its SaaS platform has helped more than one million registered users to-date scientifically measure and optimize their brain capacities while managing the risk of common mental conditions. Benefits for providers include improved patient outcomes, tracking of evidence-based outcomes across the continuum of care, and a reduction in clinician fatigue. Benefits for employers and payers include better mental healthcare access, lower costs, and higher productivity. About VeriSIM Life VeriSIM Life has developed a sophisticated computational platform that leverages advanced AI and ML techniques to improve drug discovery and development by significantly reducing the time and money it takes to bring a drug to market. BIOiSIM™ is a first-in-class 'virtual drug development engine' that offers unprecedented value for the drug development industry by narrowing down the number of drug compounds that offer anticipated value for the treatment or cure of specific illnesses or diseases. The program reduces the time and cost of drug discovery and development and dramatically reduces the need for animal testing that, in the vast majority of cases, does not translate to humans.

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INDUSTRIAL IMPACT

Nuclera Announces Expansion With New US Subsidiary

Nuclera | January 19, 2022

Nuclera, a UK-based biotech company developing cutting-edge benchtop protein printing technologies, announces the opening of its US subsidiary in Boston, MA. The addition of this US facility in the rapidly growing biotechnology hub of greater Boston is a critical step in the company’s plans, paving the way for Nuclera’s revolutionary eProteinTM desktop bioprinter—that offers unprecedented speed and convenience for biotherapeutics, agribiotech and other markets of global importance. Nuclera’s eProtein™ bioprinter is born out of a strategic partnership with E Ink—the pioneers of ePaper—allowing the combination of biopolymer synthesis technologies with digital microfluidics. The US facilities are the result of a $4.5 million E Ink renovation, reinforcing Nuclera’s position as a technological innovator in the bioprinting space. “Our new laboratories and pilot manufacturing facilities in Boston will support Nuclera’s goal to commercialize its eProtein™ technology significantly accelerating drug discovery workflows”, says Dr Michael Chen, CEO and cofounder of Nuclera. “This site opening just outside one of the most important biotech markets is a big step towards Nuclera’s goal to make proteins accessible through desktop bioprinting”, added Chen. “Our new facility has been specifically designed to accommodate our expanding team and will support Nuclera’s ambitious roadmap. We are proud to have operations in both the UK and US, further strengthening our position in the global biotech space.” As part of Nuclera’s global expansion, Richard Paolini Jr, has been appointed Vice President of eDropTM R&D, the first of many US-based appointments. With over 20 years of R&D experience, Rick is an inventor named on over 100 US patents on technologies that have helped E Ink to enable and transform the eReader market. Rick is now leading the development of closely related technologies to enable Nuclera’s eDropTM digital microfluidic systems—requiring integration of complex chemical, biological, electronic, and mechanical elements. "E Ink is very excited about the continuing collaboration and partnership with Nuclera in this expanding biotechnology market sector that is of such global importance. The transfer of Rick and his talented microfluidics team of scientists from E Ink to Nuclera and the renovation of the US-based biotechnology R&D center that Nuclera will occupy will ensure ongoing biotechnology advancements leading to a successful commercial launch of the Nuclera eProtein platform.” Dr Michael McCreary, E Ink’s Chief Innovation Officer and Nuclera Board Director

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Spotlight

To better predict the future of HIV pharmaceuticals, we must understand the past – that’s the premise behind Horizons in HIV Drug Development – What’s Past is Prologue, the free whitepaper from Citeline, part of the Informa Pharma Intelligence suite of industry intelligence solutions.

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