Adaptive Biotechnologies Corp., of Seattle, said it launched Immunecode with Redmond, Wash.-based Microsoft Corp., which provides detailed views of the immune response to COVID-19 in real time based on de-identified data generated from thousands of COVID-19 blood samples from patients around the globe. The open database contains detailed information on the diverse set of T cells shown to specifically recognize unique features of the COVID-19 virus. The resource could help diagnose and manage COVID-19 from exposure through clearance of the virus, and potentially offer an accurate assessment of immunity. Thousands of de-identified geographically and ethnically diverse patient blood samples from institutions around the world are being collected and analyzed alongside samples from Immunerace (Immune Response Action to COVID-19 Events), the companies' prospective study enrolling 1,000 U.S. participants to decode how immune systems detect and respond to the virus. Using Microsoft Azure's hyperscale cloud and machine learning capabilities, the T-cell response signature will be continuously refined by extending the number of matches of COVID-19-related T cells to antigens and directly associating that T-cell signature with disease and outcomes. In addition to making those data freely available, Adaptive said it is conducting its own research to develop a new kind of diagnostic looking specifically at the T-cell response to the COVID-19 virus. The companies partnered in 2018 to create a TCR-Antigen Map, an approach to translating the genetics of the massive adaptive immune system to understand how it works.
AVM Biotechnology LLC, of Seattle, said it was awarded a National Cancer Institute Small Business Innovation Research grant to study the use of lead molecule AVM-0703 as a preconditioning agent to allow safe and efficient delivery of therapeutic immune cells for cancer treatment. The grant will be used to validate the efficacy and safety of preconditioning by AVM-0703 in established tumor mouse models of multiple myeloma.
Bold Therapeutics Inc., of Vancouver, British Columbia, said it expanded its COVID-19 collaborations to include four more academic researchers: Francois Jean and Ted Steiner from the University of British Columbia; Stephen Barr, a researcher at Western University; and Len Seymour, a researcher at the University of Oxford in the U.K. The company is working on BOLD-100, a potentially first-in-class anti-resistance ruthenium-based small-molecule drug designed to selectively inhibit stress-induced up-regulation of GRP78 – an important resistance, survival and proliferation pathway common across cancers. In addition, there is extensive and rapidly growing literature suggesting that GRP78 plays a critical role in host recognition, viral entry and viral replication, the company said.
Celltrion Healthcare Co. Ltd., of Incheon, South Korea, said it signed an agreement to acquire product assets for the Asia Pacific region from Tokyo-based Takeda Pharmaceuticals International AG for $278.3 million. Specifically, it will acquire Takeda’s primary care businesses and secure rights for patent, trademark, approval and sales of a total of 18 prescription and over-the-counter brands currently available in nine markets in the region, namely South Korea, Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia and Australia. The companies have also entered a manufacturing and supply agreement under which Takeda will continue to manufacture the portfolio of divested products and supply them to Celltrion.
Chrysalis Biotherapeutics Inc., of Galveston, Texas, said it received $912,157 from the National Institute of Allergy and Infectious Disease (NIAID), part of the NIH, to fund preclinical development of its investigational drug, TP-508, for SARS-CoV-2 infection. The contract award includes an option to conduct a phase I trial to demonstrate safety prior to initiating efficacy trials in COVID-19 patients. TP-508 has already been tested in multiple clinical trials for bone repair and healing of diabetic foot ulcers, with no drug-related adverse effects observed. The compound is also being developed with NIAID funding as a medical countermeasure for acute and delayed effects of radiation exposure. Preclinical data have demonstrated that TP-508 significantly increases survival when injected 24 hours after radiation exposure by restoring vascular and progenitor cell function.
Cullinan Oncology LLC, of Cambridge, Mass., and PDI Therapeutics Inc., of La Jolla, Calif., a portfolio company of Avalon Ventures, are collaborating to bring CLN-619, a potentially first-in-class monoclonal antibody reinvigorating the MICA/NKG2D axis, into clinical testing. As a result of the transaction, Cullinan MICA Inc., a Cullinan Oncology portfolio company, will assume operational control of the asset. Cullinan MICA is financed by a recently completed $26 million series A, with participation from Cullinan Oncology LLC, Avalon Ventures, Bregua Corp. and the Myeloma Investment Fund, a venture philanthropy fund for the Multiple Myeloma Research Foundation.
Egle Therapeutics SAS, of Paris, said it entered a research alliance with Takeda Pharmaceutical Co. Ltd., of Tokyo, to validate tumor-infiltrating regulatory T-cell (Treg) targets against which Takeda will develop potential therapies. Egle, which spun out of Institut Curie, has assembled a translational-based target discovery engine leveraging patient samples to map out, at the single cell level, transcriptomic signatures and targets specific for tumor infiltrating Treg subpopulations. Egle will receive an up-front payment and research funding, and will be eligible to receive additional development and sales milestone payments based on the exclusivity of targets selected by Takeda, which will invest €4.6 million (US$5.08 million) in convertible debt through its venture arm, Takeda Ventures Inc., to support Egle’s corporate growth and internal programs on IL-2-based Treg modulation.
Emergent Biosolutions Inc., of Gaithersburg, Md., said it will deploy its molecule-to-market contract development and manufacturing services to support the manufacturing of Cambridge, U.K.-based Astrazeneca plc’s vaccine candidate for COVID-19, AZD-1222, a viral vector-based, weakened version of adenovirus containing the genetic material of SARS-CoV-2 spike protein, developed by Oxford University’s Jenner institute working with the Oxford Vaccine Group. The vaccine is one of several candidates supported by Operation Warp Speed, the U.S. government’s program to accelerate the development, manufacturing and distribution of COVID-19 medical countermeasures that aims to have substantial quantities of a safe and effective vaccine available for Americans by January next year. Under the agreement, valued at approximately $87 million, Emergent will provide development services, technology transfer, analytical testing, drug substance process and performance qualification and will reserve certain large-scale manufacturing capacity through 2020.
Faron Pharmaceuticals Oy, of Turku, Finland, said it will receive a €2.5 million (US$2.86 million) grant from the European Innovation Council Accelerator pilot scheme to progress its ongoing phase I/II Matins trial that is investigating the tolerability, safety and efficacy of Clevegen, the company’s precision cancer immunotherapy targeting Clever-1-positive tumor-associated macrophages in selected metastatic or inoperable solid tumors.
Fortress Biotech Inc., of New York, reported the publication of a study, in Molecular Genetics and Metabolism Reports, that evaluated the prevalence of Menkes disease, an often lethal, if untreated, X-linked recessive disorder of copper metabolism caused by mutations in ATP7A, an evolutionarily conserved copper-transporting ATPase. Previous estimates of Menkes disease were based on confirmed clinical cases ascertained from specific populations and varied from one in 40,000 to one in 354,507. The authors reviewed the canonical ATP7A transcript in the current version of gnomAD (v2.1.1) to evaluate frequencies of loss-of-function and pathogenic missense variants in a diverse normal control population. Assuming Hardy-Weinberg genetic equilibrium, the allelic frequency of loss-of-function variants suggests a minimum birth prevalence for the disease of one in 34,810 males, higher than previously recognized. If likely pathogenic missense variants are included, the estimated birth prevalence could potentially be as high as one in 8,664 live male births. Based on those findings, it appears that Menkes disease is underreported in the population, the company said. Cyprium Therapeutics Inc., a Fortress partner company, is developing CUTX-101 for Menkes disease and is on track to begin submitting a rolling new drug application to the FDA in the fourth quarter of the year.
Grifols SA, of Barcelona, Spain, started production of its anti-SARS-CoV-2 hyperimmune immunoglobulin with specific antibodies using the plasma of people who have overcome the disease. Grifols is leading the production of the potential anti-COVID-19 passive immune therapy as part of a collaboration agreement with U.S. government entities, including the FDA, NIH and the Biomedical Advanced Research Development Authority, among other health care agencies. The agreement also encompasses the development of preclinical and clinical trials required to determine treatment efficacy. The company is also moving to establish collaborations in Europe.
Innovation Pharma Inc., of Wakefield, Mass., and researchers at a U.S. Regional Biocontainment Laboratory (RBL) are collaborating on a federal grant application to be submitted this week. The proposed research aims to evaluate brilacidin as a potential pan-coronavirus therapeutic, for treating SARS-CoV-2, SARS-CoV-1 and MERS-CoV, including extending the current in vitro testing of brilacidin to in vivo testing. Longer-term objectives include potentially performing additional research to develop brilacidin as a broad-spectrum antiviral, with possible application beyond coronaviruses, e.g., treating other viruses, such as encephalitic alphaviruses and filoviruses, the company said.
Magenta Therapeutics Inc., of Cambridge, Mass., and the National Marrow Donor Program/Be The Match, disclosed a clinical collaboration agreement to evaluate the potential utility of MGTA-145, Magenta’s investigational first-line stem cell mobilization program, for mobilizing and collecting hematopoietic stem cells from donors in a single day and then using them for allogeneic transplants in patients. The life-saving procedure is currently used in about 28,000 patients in the U.S. and Europe each year, but about 62,000 additional eligible patients do not receive an allogeneic transplant due to challenges, including difficulty with the donation process. The entities will run a phase II trial of MGTA-145 to mobilize and collect hematopoietic stem cells from donors which will then be transplanted into patients with blood cancers in need of a stem cell transplant. The number of stem cells mobilized, engraftment function and benefit to disease will be measured. Magenta retains all commercial rights to MGTA-145.
Mallinckrodt plc, of Staines-upon-Thames, U.K., disclosed publication of findings from a medical chart study to assess the real-world use of terlipressin and other vasopressors in hospitalized patients with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. The study, funded by Mallinckrodt, found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine. The results of the study were published in Alimentary Pharmacology and Therapeutics. Mallinckrodt is investigating terlipressin for the treatment of HRS-1 in the U.S.
Milliporesigma, of Burlington, Mass., and 10x Genomics Inc., of Pleasanton, Calif., said they have developed a new option for biological experiments. The collaboration provides a linking of two technologies: single cell transcriptomics and pooled CRISPR screening. The first commercially offered, ready-to-use tool enables simultaneous measurement of gene perturbation and unbiased gene expression from single cells. Milliporesigma provides fully tested and validated reagents and workflows to run single-cell screening on 10x Genomics’ platform, the pair noted. The companies will work together as part of 10x Genomics’ 10x Compatible Partnership Program, a global ecosystem of technologies and solutions that provide customers with the ability to enhance their research applications and accelerate discovery.
Mymetics Corp., of Epalinges, Switzerland, said its subsidiary, Mymetics SA, has received the confirmation to receive access to the European vaccine infrastructure TRANSVAC2 services for the evaluation and development of virosome-based vaccines against COVID-19. Since April, Mymetics has been working on the development of a COVID-19 virosome-based vaccine and is partnering with leading academic institutions to start evaluating the most suitable antigens. Through TRANSVAC2, Mymetics will gain access to pre-agreed services that Mymetics has requested and are specifically related to SARS-CoV-2 antigen production and animal models, the company said.
Naari Pte Ltd., of Singapore, said it completed acquisition of 10 ANDAs from Intas Pharmaceuticals Ltd., of Ahmedabad, India. The portfolio comprises eight FDA-approved ANDAs and two products pending approval, including generic products in female hormones that will be manufactured at Naari’s female hormone facility in India and commercialized during the next 24 months. Naari received an $17.5 million equity investment from Ascent Capital in February.
Oblique Therapeutics AB, of Gothenburg, Sweden, said its proof-of-concept study has identified an epitope, part of the spike protein that mediates SARS-CoV-2’s entry into cells. Oblique said the epitope may facilitate a generation of neutralizing antibodies to treat COVID-19 patients. The company said it will continue mapping additional epitopes on the SARS-CoV-2 virion surface and make all results freely available for vaccine and antibody developing pharmas and biotechs.
Outlook Therapeutics Inc., of Monmouth Junction, N.J., said it regained compliance with the minimum bid price for continued Nasdaq listing by keeping the closing bid on its common stock at $1 or greater for 10 consecutive trading days. Outlook is developing an ophthalmic formulation of bevacizumab for treating retinal indications.
Ovid Therapeutics Inc., of New York, said it will begin a research collaboration with Columbia University Irving Medical Center researchers to advance genetic-based therapies for a range of rare neurological conditions. Ovid and Columbia scientists plan to identify molecular targets for developing genetic/molecular therapeutic approaches for rare neurological conditions such as KIF1A-associated neurological disorder and other rare conditions.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said Science accepted two papers describing creation of REGN-COV2, a two-antibody cocktail designed to bind COVID-19’s spike protein into two separate, non-overlapping locations. "High-Throughput Effort Using Both Humanized Mice and Convalescent Humans Yields SARS-CoV-2 Antibody Cocktail" describes Regeneron's parallel efforts using both humanized mice and blood samples from recovered COVID-19 patients to generate antibodies targeting multiple different regions of the receptor-binding domain of the SARS-CoV-2 spike protein. "Antibody Cocktail to SARS-Cov-2 Spike Protein Prevents Rapid Mutational Escape Seen with Individual Antibodies" further defines the protective value of the multiple-antibody approach against SARS-CoV-2, the company said.
Sinovac Biotech Ltd., of Beijing, and Instituto Butantan, of Sao Paolo, will collaborate to advance clinical trials of Coronavac, Sinovac’s inactivated vaccine candidate against COVID-19. Sinovac said it received approval from China’s National Medical Products Administration to conduct phase I/II trials in China to determine the vaccine candidate’s safety, tolerance, dosage and immunization schedule. Sinovac said it is constructing a commercial vaccine production plant in China that is expected to manufacture up to 100 million doses of Coronavac annually. Instituto Butantan will sponsor phase III trials in Brazil.