INDUSTRY OUTLOOK

Expanding Diagnostics Business: SCHOTT Signs Agreement to Acquire Applied Microarrays Inc.

Applied Microarrays Inc. | September 30, 2021

SCHOTT MINIFAB, a subsidiary of SCHOTT that develops and manufactures microfluidic devices for point-of-care and life sciences consumables, has had a long-standing close customer relationship with Applied Microarrays Inc. (AMI). Together, they develop biotech substrates for diagnostics applications. The expertise of AMI will further strengthen SCHOTT’s ability to offer a single-source contract manufacturing solution. The deal is expected to close in early October.

Through this acquisition, SCHOTT MINIFAB significantly expands its biosensor printing capabilities. This is of particular importance as demand is growing for the manufacturing of point-of-care microarray consumables, especially in applications such as infectious disease detection.

“We pride ourselves on being an end-to-end partner for the global diagnostics industry. Our expansive offering allows us to provide an integrated single-source collection of value-intensive services and products. With the added bioscience knowledge of AMI, we become an even stronger partner, enhancing our capability in surface modification, functionalization and deposition for both glass and polymer products.”

- Greg Wolters, Head of SCHOTT MINIFAB.

AMI will soon be moving to a larger facility in the Phoenix, Arizona area. Its new location will greatly increase SCHOTT’s manufacturing footprint in the United States to serve its global customer base.

Pioneering – responsibly – together
These attributes characterize SCHOTT as a manufacturer of high-tech materials based on specialty glass. Founder Otto Schott is considered its inventor and became the pioneer of an entire industry. Always opening up new markets and applications with a pioneering spirit and passion – this is what has driven the #glasslovers at SCHOTT for more than 130 years. Represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy & Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. With the best teams, supported by the best digital tools, the group intends to continue to grow. SCHOTT AG is owned by the Carl Zeiss Foundation, one of the oldest foundations in Germany. It uses the Group's dividends to promote science. As a foundation company, SCHOTT has anchored responsibility for employees, society and the environment deeply in its DNA. The goal is to become a climate-neutral company by 2030.

About Applied Microarrays (AMI)
AMI is a company headquartered in Tempe, AZ, which designs, optimizes and manufactures DNA and protein biosensors, and other microarrays on glass, plastic and semiconductors. AMI operates under ISO 9001 and ISO 13485 certification. Since acquiring GE Healthcare’s microarray business in 2007, AMI has evolved to become a full service provider for RUO and Dx devices.

Spotlight

There are many different ways that crops are modified. Some of these methods have been used for centuries, others are more recent. The graphic below, which was coauthored together with Karl Haro von Mogel at Biology Fortified, highlights several of these methods. Each technique is further explained here.


Other News
INDUSTRIAL IMPACT

Four New Sets of Pre-Clinical Data Further Expands the Evidence Supporting Abelacimab

Anthos Therapeutics | July 14, 2022

Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced that four new research updates were presented on abelacimab during the Venous Thromboembolism poster session at the ongoing International Society on Thrombosis and Haemostasis 2022 Congress in London, UK. "Coagulation is a complex multilayered process and the potential benefits of inhibiting Factor XI are becoming increasingly clear. These preclinical studies add important information characterizing the pharmacodynamic effects of abelacimab and further extend our understanding of the biological effects of Factor XI inhibition. With a growing body of evidence from ongoing studies both in the clinic and the lab, and a recent FDA Fast Track designation granted for abelacimab in thrombosis associated with cancer, we are becoming increasingly confident about the potential of our novel dual-acting Factor XI/XIa inhibitor may offer in the future as a treatment advance." Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics PB0927 - Abelacimab does not influence the effects of two commonly used antiplatelet agents in vitro This study investigated the effects of clinically relevant doses of abelacimab on the inhibition of platelet aggregation by commonly used antiplatelet agents, aspirin and ticagrelor, in vitro. It demonstrated that abelacimab did not affect the level of antiplatelet inhibition achieved either by aspirin or ticagrelor confirming that abelacimab will not interfere with the benefits of these antiplatelet agents. PB0925 - Abelacimab has no effect on platelet aggregation induced by TRAP-6 and collagen FXI has been identified as a ligand to platelet receptors ApoER2 and GPIbα on the surface of stimulated platelets. This study demonstrated that abelacimab did not interfere with normal platelet aggregation following stimulation with collagen or thrombin receptor activating peptide-6 (TRAP-6) and compared with vehicle and active control (abciximab, anti-GP2b3a) suggesting that the binding of FXI to the platelet surface has no effect on primary hemostasis. PB0548 - Abelacimab, a Factor XI/XIa Antibody Inhibits Clotting in Hemodialysis Circuits Ex Vivo This study compared the effect of a combination of abelacimab and enoxaparin with enoxaparin alone, in an ex vivo model of hemodialysis that is aggressive due to the frequent re-circulation of blood and a lack of endothelial cells. Inhibition of FXI/FXIa by abelacimab combined with enoxaparin (but not enoxaparin alone) reduced and prevented device malfunction. This provides support for testing abelacimab in patients on hemodialysis. While patients with severe factor XI (FXI) deficiency rarely have spontaneous bleeding, low doses of recombinant activated factor VII (rFVIIa) have been used and are effective in managing bleeding should it occur. This study was designed to evaluate whether low concentrations of rFVIIa could revert the changes in abelacimab-induced coagulation parameters as measured by rotational thromboelastometry (ROTEM) in whole blood in vitro assays from healthy individuals. As expected and similar to what has been observed in patients with Factor XI deficiency, these data suggest that low doses of rFVIIa can be used to manage bleeding in Factor XI inhibited patients being treated with abelacimab. 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 (CVM) diseases. Anthos Therapeutics aims to combine the agility of a biotech with the rigor of a large pharmaceutical company. Anthos Therapeutics was launched by Blackstone Life Sciences in 2019. 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. 1,2 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.

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MEDICAL

Bio-Manufacturing Partner BioElpida Completes Next Phase of BVX-0918 GMP Production for EU Clinical Study

BioVaxys | June 09, 2022

BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company"), announced today that its Lyon, France-based bioproduction partner, BioElpida ("BioElpida"), has completed the creation of multiple OVCAR-3 cell banks as the next step in the GMP manufacturing process development for BVX-0918, BioVaxys' vaccine for treatment of platinum-resistant ovarian cancer. The OVCAR-3 cell line is mandatory for creating the identity assays that will have to be performed on every batch of ovarian cancer vaccine. This assay is required by regulatory bodies in the EU and United States. The cell line is derived from a human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapeutic agent used in late-stage ovarian cancer. Patients whose tumors are innately cisplatin-resistant at the time of initial treatment generally have poor prognosis, which is the patient population target for BVX-0918. Completion of OVCAR-3 cell banks is another step towards our ability to produce GMP yields of BVX-0918, and brings us closer to our Phase I study in the EU planned for later this year." BioVaxys President and Chief Operating Officer Kenneth Kovan. BioVaxys recently entered collaborations with Hospices Civils de Lyon in France and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU. Tumor samples from HCL will also be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production. BioVaxys' vaccine platform is based on the established immunological concept that modifying surface proteins---whether they are viral or tumor---with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient's immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys' cancer vaccines are created by extracting a patient's own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors. A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results. About BioVaxys Technology Corp. Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing vaccines for SARS-CoV-2, SARS-CoV-1, and a pan-sarbecovirus vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents, and multiple US and international patent applications related to its cancer vaccines, antiviral vaccines, and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

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RESEARCH

Lunaphore and Indica Labs announce partnership to provide complete technology solution for spatial biology and image analysis

Indica Labs | May 13, 2022

Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, and Indica Labs, a leading provider of computational pathology software and services, today announced a partnership to co-market an end-to-end solution that combines Lunaphore's flagship COMET™ spatial biology platform and Indica's HALO® and HALO AI™ digital pathology image analysis software. Lunaphore's COMET™ platform provides superior multiplex staining and image acquisition capabilities facilitating the automated detection of up to 40 separate spatial markers per tissue slide without human intervention. In contrast to other spatial biology solutions, COMET™ works with off-the-shelf, label-free antibodies and is designed to provide researchers with flexibility for their workflow. COMET™ has a wide range of research applications across immuno-oncology, neuroscience, and infectious diseases. Indica Labs' industry-leading HALO® and HALO AITM software enable fast, AI-based quantitative analysis of whole slide images. In combination with the COMET™ platform, the HALO Highplex FL module allows researchers to quantify an unlimited number of fluorescent markers and cell phenotypes defined by their biomarker expression. HALO Spatial Analysis and HALO AI deep learning classifiers are used in combination with Highplex FL to explore the distribution and spatial relationships between different cell phenotypes in the context of the tissue, such as tumor and immune cells. This additional spatial data is particularly important in immuno-oncology and neuroscience disease research. We are excited to partner with Lunaphore to address the growing needs of our research customers for highly multiplexed assays, Combining Lunaphore's superior multiplexing technologies upstream with our powerful AI-based analysis downstream, together we provide a streamlined workflow for high dimensional imaging and image analysis." Steven Hashagen, CEO of Indica Labs. Our partnership with Indica Labs is another key aspect of our strategy to combine our COMET™ technology with industry-leading image analysis technologies, Indica Labs' solutions are used by a large set of researchers in the field, thanks to their ease of use and analysis capabilities. Combining Indica's solutions with the class-leading capabilities of COMET™ will help us pursue our shared goal of making tissue image analysis easier and more accessible to labs around the world." Deborah Heintze, Chief Marketing Officer of Lunaphore. About Lunaphore Lunaphore Technologies S.A. is a Swiss company born in 2014 with the vision of enabling spatial biology in every laboratory. Lunaphore has developed a game-changing chip technology which can extract spatial proteomic and genomic data from tumors and transform any simple assay into multiplex spatial biology without complexity. Lunaphore empowers researchers to push the boundaries of research to ultimately develop the next generation personalized therapies. About Indica Labs Indica Labs is the world's leading provider of computational pathology software and image analysis services. Our flagship HALO® and HALO AI™ platform facilitates quantitative evaluation of digital pathology images. HALO Link™ facilitates research-focused image management and collaboration while HALO AP® enables collaborative clinical case review. Our Pharma Services team leverages all our image analysis platforms to partner with you to advance tissue-based research, clinical trials, and diagnostics.

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INDUSTRIAL IMPACT

Akili Announces Public Company Board of Director Nominees

Akili Interactive | July 11, 2022

Akili Interactive a leading digital medicine company pioneering the development of cognitive treatments through game-changing technologies, announced the nominees for its future board of directors, effective upon the closing of Akili’s business combination with Social Capital Suvretta Holdings Corp. I subject to customary closing conditions. Shares of the new public company’s common stock are expected to trade on Nasdaq under the symbol “AKLI.” Akili’s public company board of directors is expected to consist of seven directors, with several new and recent additions, including William (BJ) Jones, Chief Commercial Officer of Biohaven Pharmaceuticals; Christine Lemke, Co-Chief Executive Officer of Evidation Health; Ken Ehlert, former Chief Scientific Officer at UnitedHealth Group; and Chamath Palihapitiya, founder and CEO of Social Capital and Chairman and Managing Partner of SCS. Nominees also include existing Akili directors Bharatt Chowrira, Ph.D., J.D., Adam Gazzaley, M.D., Ph.D. and Eddie Martucci, Ph.D. These director nominees bring industry leadership and deep expertise in access and reimbursement, innovative go-to-market approaches and groundbreaking research that will guide Akili as the company enters its next phase of growth to commercialize digital therapeutics at scale. “Akili is creating a new class of medicine that has the potential to fundamentally change how we think about cognitive health. As we forge this new path, it’s important to have a broad range of expertise, from pioneering leading-edge science to navigating our healthcare system to establishing new standards of patient care. The board and I look forward to supporting Eddie and his team as they bring their first product to market, and hopefully many more breakthrough therapeutics in the coming years.” Chamath Palihapitiya, incoming chair of Akili’s board of directors Eddie Martucci, co-founder and Chief Executive Officer of Akili, added: “We look forward to becoming a publicly-traded company through our merger with SCS and we are proud to nominate this impressive slate of life sciences and technology leaders to constitute Akili’s new public board and help guide our corporate and clinical strategy.” Board Member Biographies Chamath Palihapitiya founded Social Capital in 2011 and has been its Managing Partner since its inception. Mr. Palihapitiya also serves as the Chief Executive Officer and the Chairman of the board of directors of DNAB, DNAC and DNAD. In addition, Mr. Palihapitiya currently serves as the Chief Executive Officer and the Chairman of the board of directors of each of Social Capital Hedosophia Holdings Corp. IV and Social Capital Hedosophia Holdings Corp. VI. Mr. Palihapitiya previously served as the Chief Executive Officer and the Chairman of the board of directors of Social Capital Hedosophia Holdings Corp. from May 2017 until the consummation of its business combination with Virgin Galactic in October 2019, and served as the Chairman of the board of directors of Virgin Galactic until February 2022. Mr. Palihapitiya also previously served as the Chief Executive Officer and the Chairman of the board of directors of Social Capital Hedosophia Holdings Corp. II until the consummation of its business combination with Opendoor Labs Inc. in December 2020 and as the Chief Executive Officer and the Chairman of the board of directors of Social Capital Hedosophia Holdings Corp. III until the consummation of its business combination with Clover Health Investments, Corp. in January 2021 and as the Chief Executive Officer and Chairman of the board of directors of Social Capital Hedosophia Holdings Corp. V until the consummation of its business combination with Social Finance, Inc. in May 2021. Mr. Palihapitiya also served as a director of Slack Technologies Inc. from April 2014 until October 2019. Prior to founding Social Capital in 2011, Mr. Palihapitiya served as Vice President of User Growth at Facebook, and is recognized as having been a major force in its launch and growth. Mr. Palihapitiya was responsible for overseeing Monetization Products and Facebook Platform. Prior to working for Facebook, Mr. Palihapitiya was a principal at the Mayfield Fund, one of the United States’ oldest venture firms, before which he headed the instant messaging division at AOL. Mr. Palihapitiya graduated from the University of Waterloo, Canada with a degree in electrical engineering. William Jones, Jr. has served as Chief Commercial Officer of Biohaven Pharmaceuticals Holding Company Ltd., a publicly traded biopharmaceutical company, where he has been responsible for building the company’s commercial capability and launching their first FDA-approved product (Nurtec ODT), since April 2019. Prior to Biohaven, from January 2016 to March 2019, Mr. Jones served as Vice President, Head of Sales and Commercial Operations for the general medicine business unit of Takeda Pharmaceutical Company Limited, a publicly traded pharmaceutical company. Mr. Jones holds a B.S. in human factors engineering from the United States Air Force Academy, an M.S. in industrial engineering from Texas A&M University and an MBA from the Stanford University Graduate School of Business. Christine Lemke has served as a member of Akili’s board of directors since September 2021. Since March 2012, Ms. Lemke has been employed by Evidation Health, Inc., a real-world health measurement and engagement platform, where she currently serves as Co-Chief Executive Officer and Director. Since February 2016, she has also served as co-founder and General Partner of Ensemble Labs, GP, an investor in early stage health technology companies. Prior to Evidation Health and Ensemble Labs, Ms. Lemke was co-founder and Chief Operating Officer of Sense Networks, Inc., developers of the first machine learning platform for mobile phone activity data. Ms. Lemke holds a B.A. in business from the University of Washington and an MBA from HEC Paris. Kenneth Ehlert has served as a member of Akili’s board of directors since December 2021. Previously, he held senior leadership positions at UnitedHealth Group, a publicly traded managed healthcare and insurance company, including most recently as Chief Scientific Officer from December 2017 to July 2021. From January 2009 until December 2017, Mr. Ehlert served as Chief Executive Officer of Savvysherpa Inc., a research and development firm. Mr. Ehlert holds a B.A. in economics and mathematics from Brigham Young University and an M.S. in applied economics from the University of Minnesota. Bharatt Chowrira, Ph.D., J.D., has served as a member of Akili’s board of directors since June 2021 and previously served as a member of Akili’s board of directors from November 2017 until September 2019. Since February 2017, Dr. Chowrira has served as President and as a member of the board of directors of PureTech Health plc. Prior to joining PureTech Health, Dr. Chowrira served as President of Synlogic, Inc., a biopharmaceutical company focused on developing synthetic microbiome-based therapeutics. Dr. Chowrira also previously served as Chief Operating Officer of Auspex Pharmaceuticals Inc., a biotechnology company, and as President and Chief Executive Officer of Addex Therapeutics Ltd., a biotechnology company. Prior to that, Dr. Chowrira held various leadership roles at Nektar Therapeutics, Merck & Co., Sirna Therapeutics and Ribozyme Pharmaceuticals. Since September 2018, Dr. Chowrira has also served as a member of the board of directors of Vedanta Biosciences, Inc., a clinical stage company. He was previously on the boards of Vor Biopharma, Inc., a publicly-traded cell and genome engineering company, between August 2018 and June 2020, and Karuna Therapeutics, Inc., a publicly-traded biopharmaceutical company, from August 2017 to December 2019. Dr. Chowrira received a J.D. from the University of Denver’s Sturm College of Law, a Ph.D. in molecular biology from the University of Vermont College of Medicine, an M.S. in molecular biology from Illinois State University and a B.S. in microbiology from the UAS, Bangalore, India. Adam Gazzaley, M.D., Ph.D., one of Akili’s co-founders, has served as a member of Akili’s board of directors since November 2014 and as Chief Science Advisor since January 2011. Dr. Gazzaley is the David Dolby Distinguished Professor of Neurology, Physiology and Psychiatry at the University of California, San Francisco (“UCSF”), and the Founder & Executive Director of Neuroscape at UCSF, where he has been employed since July 2005. Additionally, Dr. Gazzaley is co-founder and Chief Scientific Advisor of JAZZ Venture Partners LLC, a venture capital firm focused on technologies that improve human performance. Dr. Gazzaley has also been on the Board of Trustees of the California Academy of Sciences since May 2019, a Science Council Member there since August 2019, and a Science Fellow there since May 2020. From January 2015 to January 2018, he served as a Science Board member of the President’s Council on Fitness, Sports & Nutrition. Dr. Gazzaley holds a B.S. in biochemistry from Binghamton University, and a Ph.D. in neuroscience and an M.D. from Mount Sinai School of Medicine. He completed his postdoctoral fellowship in neuroscience at Mount Sinai School of Medicine and his residency in neurology at the hospital of the University of Pennsylvania. W. Edward Martucci, Ph.D., one of Akili’s co-founders, has served as Akili’s Chief Executive Officer and as a member of Akili’s board of directors since August 2015, including as Akili’s employee beginning in September 2017. From June 2009 to September 2017, Dr. Martucci was employed by PureTech Health PLC, a publicly traded biotherapeutics company, where he co-founded Akili in 2011 and served as Akili’s Chief Operating Officer from 2011 until August 2015. Since February 2017, he has served on the board of the Digital Therapeutics Alliance, a digital therapeutics industry advocacy organization. Dr. Martucci holds a B.S. in biochemistry from Providence College and a M.Phil. and Ph.D. in molecular biophysics and biochemistry from Yale University. About Akili Akili is pioneering the development of cognitive treatments through game-changing technologies. Our approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences.

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Spotlight

There are many different ways that crops are modified. Some of these methods have been used for centuries, others are more recent. The graphic below, which was coauthored together with Karl Haro von Mogel at Biology Fortified, highlights several of these methods. Each technique is further explained here.

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