MEDICAL
Pfizer | June 10, 2022
Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV).
ReViral brings to Pfizer a portfolio of promising therapeutic candidates, including sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell. Sisunatovir has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). It significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. A second program is focused on the inhibition of RSV replication targeting the viral N protein. The lead candidate in this program is currently in phase 1 clinical development.
We are excited to bring ReViral’s promising investigational treatments for RSV into our anti-infective pipeline at Pfizer. This acquisition further demonstrates our commitment to advancing pioneering science – both through our in-house expertise and our work with leading, innovative companies – with the goal of delivering new breakthroughs to patients suffering from serious infectious diseases, We believe these therapeutic candidates – and the scientific expertise that has advanced their development – will complement our ongoing work to help combat RSV infections, and we look forward to welcoming our new colleagues to further support these endeavors.”
Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer.
RSV is a respiratory pathogen, which can lead to severe and life-threatening lower respiratory tract infections (LRTIs) in high-risk populations, including young children, immunocompromised individuals, and older adults. It is estimated to cause infections in approximately 64 million people, resulting in about 160,000 deaths, globally each year. Currently, treatment options for RSV are limited, with care management focused primarily on supportive measures for people with the illness.
About Pfizer:
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.
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INDUSTRIAL IMPACT
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
ABC | May 19, 2022
Advanced BioCatalytics (ABC) is pleased to announce the opening of our new biosurfactant commercial pilot plant in Irvine California. The plant reflects the successful collaboration of the ABC R&D team and Dr. Wenjie Xia, professor of Microbiology at Nankai University in Tianjin China. The commercial pilot plant is the first step in commercial scale up of new glycolipid (biosurfactants) and is the first plant to produce commercial quantities of mannosylerythritol lipids (MEL) in North America.
ABC pioneered the use of microbiology to produce metabolites and sustainable chemistry in 1996. Our products are used in water treatment, the energy sector, for agriculture uses, and in personal and home care applications. By using microbiology, we can create natural alternatives to petrochemicals. For our production we upcycle waste feed stocks such as used vegetable oils or other sources of bio-waste material. As a result, our chemistry also offers an alternative to plant based materials which have the unfortunate reliance on certain plant species which are contributing to global deforestation and destruction of biodiversity.
The MEL material can be used in a variety of ways in the homecare and personal care sectors. MEL is free of 1,4 dioxane, mild on the skin, and produces minimal foam. This superfatting agent is ideal for delivering moisture in personal care products and can be used along with anionic and amphoteric surfactants for improved efficacy. The addition of MEL production compliments ABC's rhamnolipid and BioSS RL fermactant production.
About Advanced BioCatalytics:
Advanced BioCatalytics is an industrial biotechnology company that leverages its innovative Fermactant technology for applications in the Home and Personal Care, Energy, Agriculture, and Wastewater markets. These products have demonstrated the ability to be highly cost-effective, without depending on harmful chemistries such as caustics, acids or dangerous solvents, which can be harmful to the user and/or the environment. Advanced BioCatalytics was founded in 1996 and we are excited to be introducing a new technology that will change the future performance, and cost, of the world's cleaning products.
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INDUSTRIAL IMPACT
Lygos Inc | July 26, 2022
Lygos Inc., a vertically integrated biotechnology provider of sustainable specialty ingredients, and Flexible Solutions International Inc. a developer and manufacturer of biodegradable products, today announced that FSI has filed a registration statement on Form S-4 with the U.S. Securities and Exchange Commission on July 25, 2022 in connection with its proposed merger with Lygos.
On April 18, 2022, Lygos and FSI announced a definitive merger agreement in an all-stock transaction to form a leading sustainable specialty ingredient company for agricultural, industrial, and consumer applications. The merger transaction followed a fully funded $160 million of growth capital investment in Lygos. The agreement has been unanimously approved by the boards of directors of both companies and is subject to, among other things, the approval of Lygos and FSI stockholders and the satisfaction or waiver of other customary closing conditions.
FSI is an environmental technology company involved in research, development, and manufacturing of supplies that are designed to increase crop yield, conserve energy, and reduce environmental impact. Lygos’ proprietary fermentation technology platform, which utilizes the latest advances in bioengineering and data science to convert sustainable sugars into multi-functional organic acids, helps improve the performance of FSI’s biodegradable, water-soluble cleaning and water treatment solutions. These bio-based ingredients are designed to make existing products more sustainable, while also offering performance, supply chain, and environmental advantages over traditional industrial chemicals.
The registration statement on form S-4, which contains a preliminary proxy statement/prospectus, is available on the SEC’s website at www.sec.gov. These documents contain important information about Lygos, FSI, and the proposed acquisition. The registration statement has not yet become effective and the information contained therein and in the preliminary proxy statement/prospectus is subject to change.
About Lygos
Lygos has created a biological engineering platform focused on sustainable production of organic acid bio-monomers. Lygos’ bio-based ingredients offer alternatives to traditional industrial suppliers, enabling customers to create better, environmentally safer products.
Participants in the Solicitation
FSI and its directors and executive officers and Lygos and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of FSI in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the joint proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of FSI is also included in FSI’s Annual Report on Form 10-K for the year ended December 31, 2021.
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