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

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Spotlight

Zymergen’s software infrastructure provides microbiologists with a powerful platform for parallel genome design, and couples this with workflow systems that guide our factory’s production. This fuels our lab’s capability to coordinate the many steps required in constructing thousands of genomes in parallel: a quantum leap in our ability to quickly construct and test microbial genomes.

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INDUSTRIAL IMPACT

Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Anthos Therapeutics | July 11, 2022

Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced that the U.S. Food and Drug Administration has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis Congress in London, UK. The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby, addressing unmet medical needs. Drugs that are included in this program may be eligible for more frequent interactions with the FDA to discuss the development path, and if the program criteria are met, eligibility for a potential Rolling Review, Accelerated Approval, and Priority Review. Venous Thromboembolism including both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself.1 However, treatment of Cancer Associated Thrombosis (CAT) can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding.2,3 "We believe that abelacimab has the potential to provide patients with cancer associated thrombosis an enhanced safety profile and overall low risk of bleeding, without sacrificing any efficacy of currently available agents. This unmet need is particularly true in patients with gastrointestinal / genitourinary (GI/GU) cancers who are at an even higher risk of bleeding and can be further burdened by the inconvenience of daily injections. Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients. We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need." Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics "Caring for cancer patients is a delicate and complex process, requiring a fine balance between the risks and benefits of their anticoagulant treatments. Managing thrombosis episodes is of the utmost importance for physicians, patients, and their caregivers, as untreated blood clots or bleeding episodes associated with currently available anticoagulants, can have dire consequences," said Jean Marie Connors, M.D., Associate Professor of Hematology at Harvard Medical School. "The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward." About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT) The abelacimab phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2700 patients across 220 sites in more than 20 countries -- the largest program of any anticoagulant performed in Cancer-Associated Thrombosis. ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism recurrence and bleeding in patients with cancer associated VTE in whom DOAC treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; Apixaban 10 mg will be administered orally, twice daily (bid) for the first 7 days, followed by 5 mg bid up to 6 months. Enrollment in this trial began in May 2022. MAGNOLIA is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study in patients with gastrointestinal (GI) / genitourinary (GU) cancer in whom DOAC treatment is not recommended. The study will compare the effect of abelacimab relative to dalteparin on VTE recurrence and bleeding in patients with cancer associated VTE who are at a high bleeding risk with non-resectable, locally or regionally invasive GI / GU tumors. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; dalteparin administered subcutaneously will be given daily, 200 IU/kg/day for the first month, and then 150 IU/kg/day up to 6 months. About the AZALEA-TIMI 71 Phase 2 Trial The AZALEA-TIMI 71 trial is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The trial completed enrollment in December 2021, with 1287 patients across 95 global study sites including the U.S., Canada, as well as from parts of Europe, and Asia. About Abelacimab Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Abelacimab targets the active domain of Factor XI, demonstrating dual inhibitory activity against both Factor XI and its activated form, Factor XIa. Abelacimab can be administered intravenously (IV) to achieve rapid inhibition of Factor XI activity and then used subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting. In a PK/PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days. 4,5 In a Phase 2 study whose results were published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.4 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.6 Abelacimab is an investigational agent and has not been approved for any indication. About Anthos Therapeutics Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic diseases. Anthos Therapeutics aims to combine the agility of a biotech with the rigor of a large pharmaceutical company.

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CELL AND GENE THERAPY

Ultima Genomics and Olink collaborate to develop solution for high-throughput proteomics

Ultima Genomics | June 09, 2022

Olink Holding AB (publ) ("Olink") (Nasdaq: OLK) and Ultima Genomics ("Ultima") today announced that they have entered into a collaboration to enable the use of the Olink® Explore high-throughput proteomics platform with Ultima's sequencing architecture. Ultima Genomics and Olink are working towards a seamless pairing of the existing Olink® Explore assay and Ultima Genomics' sequencing system, and are collaborating with joint customers to enable larger-scale projects. The companies expect this will be accomplished by offering Ultima-specific library modules, along with an Olink-provided data analysis solution. Initial proof of concept data gathered by the companies shows similar performance to the existing Explore assay, signaling its potential for high-throughput proteomics customers. Additional information will be provided by Ultima during a panel discussion today, June 8, at the Advances in Genome Biology and Technology (AGBT) general meeting in Orlando, Florida. With the next-generation sequencing market expected to undergo a significant evolution in the months and years ahead, Olink is committed to enabling broad access to its unique and industry-leading Explore technology, As more labs embrace the promise of proteomics, we believe we are approaching an inflection point; and efforts such as our collaboration with Ultima will be a critical factor in developing the market and reaching as many customers as possible." Jon Heimer, CEO of Olink. This non-exclusive collaborative framework is a continuation of Olink's strategy it has executed in NGS since 2020 and combines the strengths of both companies' technologies. These efforts are in line with Olink's previously communicated operational planning and are intended to provide customers with options in choosing the sequencing platform that is optimal for their needs. About Olink Olink Holding AB (Nasdaq: OLK) is a company dedicated to accelerating proteomics together with the scientific community, across multiple disease areas to enable new discoveries and improve the lives of patients. Olink provides a platform of products and services which are deployed across major biopharmaceutical companies and leading clinical and academic institutions to deepen the understanding of real-time human biology and drive 21st-century healthcare through actionable and impactful science. The Company was founded in 2016 and is well established across Europe, North America, and Asia. Olink is headquartered in Uppsala, Sweden. About Ultima Genomics Ultima Genomics is unleashing the power of genomics at scale. The Company's mission is to continuously drive the scale of genomic information to enable unprecedented advances in biology and improvements in human health. With humanity on the cusp of a biological revolution, there is a virtually endless need for more genomic information to address biology's complexity and dynamic change—and a further need to challenge conventional next-generation sequencing technologies. Ultima's revolutionary new sequencing architecture drives down the costs of sequencing to help overcome the tradeoffs that scientists and clinicians are forced to make between the breadth, depth, and frequency with which they use genomic information. The new sequencing architecture was designed to scale far beyond conventional sequencing technologies, lower the cost of genomic information and catalyze the next phase of genomics in the 21st century.

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MEDTECH

Carl Zeiss Meditec and Precise Bio Announce Partnership in the Development and Commercialization of Tissue-Based Implants for Ophthalmology

Precise Bio | July 19, 2022

Carl Zeiss Meditec and Precise Bio, a regenerative medicine company advancing the use of bio-printed tissues and organs, announced today that the companies have entered into a partnership to develop and commercialize fabricated corneal tissue for transplants in patients that require endothelial keratoplasty and natural lenticule transplants for treating keratoconus and vision correction. Under the terms of the agreement, Carl Zeiss Meditec will invest in Precise Bio and fund the further development of Precise Bio's two cornea transplant products and has exclusive worldwide commercialization rights for these products. Financial terms were not disclosed. "This investment in Precise Bio is expected to complement our leading portfolio of cataract and corneal refractive workflow solutions. The technology has the potential to advance treatment options for corneal disease, as well as for elective procedures – furthering enabling optimization of patient care." Euan S. Thomson, PhD, President of Ophthalmic Devices and Head of the Digital Business Unit for Carl Zeiss Meditec "We are very excited with this partnership that builds on our successful, ongoing collaboration with ZEISS for the development of corneal tissues to address unmet needs in the field of ophthalmology," stated Aryeh Batt, Co- Founder and CEO of Precise Bio. "This strategic agreement leverages ZEISS' global leadership in ophthalmology and Precise' innovative and unique 4D bio-fabrication platform technology. We are confident that the synergy between the two companies will allow us to develop breakthrough solutions for recovering patients' eyesight, bringing hope to hundreds of millions of patients worldwide." Precise Bio combines engineering, biomaterials, cell technology, bioengineering, and 3D printing into an unparalleled 4D bio-fabrication platform for transplantable organs and tissues. The Company's proprietary platform technology allows to fabricate tissues by 'printing' cells in a single-cell resolution and spatial accuracy, enabling complex organoid constructs with both structural integrity and long-term cell viability. Overcoming multiple technology challenges, Precise Bio's 4D bio-fabrication technology allows to reliably scale up tissue engineering for clinical use, and produce large quantities in a reproducible, quality controlled and cost-effective process. Precise Bio's ophthalmological pipeline consists of three products, the two cornea products that are the subject of the collaboration with Carl Zeiss Meditec and a retinal implant for age-related macular degeneration, all of which demonstrated successful results in animal models. The Company's ophthalmological products address global markets exceeding $10 billion annually. Bio-fabricated tissues comprised of human cells and natural materials, mimicking the anatomical structure and natural tissue components, can replace damaged or diseased tissue, substitute for donor tissue in cases where there is lack of tissue or solve unmet therapeutic needs. About ZEISS Carl Zeiss Meditec AG AX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With approximately 3,531 employees worldwide, the Group generated revenue of €1,646.8m in fiscal year 2020/2. The Group's head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research ore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 41 percent of Carl Zeiss Meditec AG's shares are in free float. The remaining approx. 59 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and optoelectronic industries. About Precise Bio Precise Bio develops regenerative medicine therapies that can transform patient care across a wide range of medical indications. Precise Bio's proprietary, break-through 4D bio-fabricating platform overcomes limitations of existing extrusion and ink-jet printers and paves the way for fabricating clinically viable tissues and organs. The Company's initial product pipeline is focused on ophthalmology and includes fabricated functional corneal grafts, intrastromal lenticules for treating keratoconus and vision correction, and a retinal implant for age-related macular degeneration. The Company also has earlier R&D programs to address unmet needs in additional medical indications, which are limited by the number of available donor tissues and organs, or where today's critical health problems can be solved using Precise Bio's naturally-based, hyper-accurate technology.

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