INDUSTRIAL IMPACT, MEDICAL
Inscripta, Inc. | January 24, 2023
Inscripta®, a leading global life science technology firm, recently announced the acquisition of two synthetic biology pioneers, Infinome Biosciences and Sestina Bio, which will advance Inscripta's strategy of developing and commercializing biomanufactured products for a wide expanse of industrial and consumer markets.
The acquisitions show Inscripta's belief in the bioeconomy's commercial potential and the power of genome engineering to expedite biomanufacturing innovation. Inscripta's CEO, Sri Kosaraju, commented, "Tackling the unprecedented opportunity to improve global health and sustainability through biomanufacturing requires a strong combination of talent, experience, technology, and commercial assets." He added, "Infinome and Sestina Bio allow us to advance our strategy and complement our technological innovation and capabilities needed for creating the next generation of biobased manufacturing products and processes."
(Source- PR Newswire)
Before the acquisition, Infinome was closely associated with Inscripta. By utilizing Inscripta's genome engineering technology, it created the GenoScaler™, a proprietary strain engineering platform designed to optimize microorganisms for biomanufacturing rapidly.
Sestina Bio brings an innovative, data-driven approach to developing and identifying strains that survive the rigors of commercial scale-up.
Inscripta is building on its tradition of technological innovation with the inclusion of Infinome and Sestina Bio and has already begun applying its cutting-edge technology to develop products for a diverse set of industrial and consumer markets. In addition, Inscripta has a number of collaborative and proprietary products in various phases of development. One such example of an announced partnership to develop and commercialize multiple bio-manufactured goods is Kalsec® Inc., a food and beverage ingredient solutions firm. Separately, Inscripta is engaging in commercial discussions about its previously announced development of a ready-to-scale microbial strain that produces Bakuchiol, a natural retinol alternative.
About Inscripta, Inc.
Founded in 2015, Inscripta is a life science technology firm dedicated to using biomanufacturing to create a cleaner, healthier, and more sustainable world. It enables scientists to strengthen and expand domestic biomanufacturing and encourages the development of novel, safe, and secure biotechnology technologies. Its automated OnyxTM platform, which includes an instrument, consumables, tests, and software, makes CRISPR-based genome engineering accessible to any research lab. Inscripta supports customers globally through its facilities in Boulder (Colorado), San Diego and Pleasanton (California) and Copenhagen (Denmark)
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Axcella | February 16, 2023
On February 15, 2023, Axcella Therapeutics, a clinical-stage biotechnology firm that develops innovative approaches to complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a phase 2b/3 trial in the United States for AXA1125 for the treatment of Long COVID Fatigue.
The company stated that it has obtained FDA regulatory guidance in favor of a trial that would serve as the registration trial for patients with Long COVID Fatigue. The trial now has acceptance from both the U.K. and U.S. regulatory authorities.
Last month, the company also announced a regulatory path to registration for the treatment of Long COVID Fatigue with AXA1125, having received regulatory guidance from the U.K.'s regulatory agency, The Medicines and Healthcare products Regulatory Agency (MHRA), supporting a single trial that can serve as the registration trial for patients suffering from Long COVID Fatigue.
The guidance follows the company's submission of data to both regulatory agencies, including results from the Phase 2a randomized, double-blind, placebo-controlled study, which showed that patients who received AXA1125 experienced statistically and clinically significant improvements in both physical (p=0.0097) and mental fatigue (p=0.0097) scores compared to those on the placebo.
Consistent with the Ph2a trial, the trial for phase 2b/3 will register patients with fatigue lasting at least 12 weeks post-COVID-19 infection. The primary endpoint will use the same patient reported outcome tool, the Chalder Fatigue Questionnaire (CFQ-11), to measure fatigue improvements alongside physical function, quality of life, and ability to return to work as additional endpoints. The trial participants will receive AXA1125 or a placebo for three months.
Long COVID is a persistent long-term effect of the pandemic, which affects a large number of patients worldwide, estimated to be around one hundred million. Fatigue is the most frequently reported symptom, with recent estimates indicating that 15-20% of Americans with COVID suffer from ongoing health problems, and up to four million Americans are unable to work because of Long COVID symptoms. In addition, Long COVID has caused approximately $1 trillion in lost earnings and $544 billion in increased medical expenses.
About Axcella
Founded in 2010, Axcella is a clinical-stage biotechnology firm dedicated to introducing a novel approach to treating complex diseases using endogenous metabolic modulator (EMM) compositions. Its product candidates contain EMMs and derivatives that are engineered in distinct ratios and combinations to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. The company's pipeline includes lead therapeutic candidates undergoing Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH).
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Center for Breakthrough Medicines | February 27, 2023
Center for Breakthrough Medicines (CBM), a leading contract development and manufacturing organization dedicated to addressing the challenges of commercializing cell and gene therapies, and Virion Therapeutics, a clinical-stage biotech firm focused on developing accessible and adaptable CD8+ T cell-based technologies for cancer and infectious diseases, have recently announced a strategic collaboration agreement.
CBM will partner and manufacture with Virion Therapeutics on their checkpoint modifier clinical development programs, including the First-in-Human VRON-0200 immunotherapy, designed to treat chronic Hepatitis B Virus (HBV) infection.
The collaboration aims to develop VRON-0200, a pan-genotypic, global therapeutic immunotherapy that targets chronic HBV infection, which affects over 295 million people worldwide. HBV impairs CD8+ T cells, which results in the loss of viral control. VRON-0200 induces a broad CD8+ T cell response, which includes responses to the core and pol regions not generally induced by the infection. Therefore, VRON-0200 is designed to stimulate a highly functional immune response to help clear the virus.
CBM's Co-Founder and Chief Business Officer Audrey Greenberg commented, "Virion is working to revolutionize the immunotherapy treatment landscape, and we are honored to partner with them on this bold mission as we share a common goal – to create a future free of cancer and chronic infectious diseases." She further emphasized, "We have assembled best-in-field technical teams, supported by industry-leading product and process development, manufacturing, and testing capabilities, all located within a single, world-class manufacturing facility. We look forward to working with Virion to bring their life-saving therapies to the patients who need them most, as quickly as possible."
(Source – PR Newswire)
About Center for Breakthrough Medicines
The Center for Breakthrough Medicines is a pioneering contract development and manufacturing organization (CDMO) situated in the center of "Cellicon Valley," with a focus on cell and gene therapies. It offers an all-in-one solution to expedite the speed of delivering advanced treatments to the market. Its customer-oriented approach, combined with a culture that prioritizes the needs of patients, guarantees dependable and high-quality process and analytical development, GMP testing, viral vector manufacturing, plasmid production, cell therapy bioprocessing and cell banking services throughout the entire life cycle of a product.
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