Advanz Pharma Corp. Ltd., of London, said it closed its acquisition of Correvio Pharma Corp., of Vancouver, British Columbia, for a total purchase price of about $76 million, which includes the repayment of certain Correvio indebtedness, pursuant to a plan of arrangement under the Canada Business Corporations Act.
Ajinomoto Bio-Pharma Services, of San Diego, said it entered a manufacturing agreement with Humanigen Inc., of Burlingame, Calif., for the fill finish supply of lenzilumab, which is being studied in a phase III trial in adult, hospitalized patients with COVID-19. Ajinomoto will provide drug product aseptic fill finish services for Humanigen. Lenzilumab, Humanigen's anti-human GM-CSF monoclonal antibody, is being administered as part of a U.S. multicenter, randomized, placebo-controlled, double-blinded phase III study for COVID-19 patients. Lenzilumab neutralizes GM-CSF, a key cytokine in cytokine storm initiation.
Aqualung Therapeutics Corp., of Tucson, Ariz., said it received a three-year, $1.7 million NIH Fastrack Award to develop an immune-based anti-inflammatory therapeutic antibody for critically ill patients with acute lung injury. The company also received National Heart Lung and Blood Institute approval for fast track phase II funding. Aqualung has begun IND-enabling pharmacodynamic, pharmacokinetic and toxicology studies to advance its lead therapeutic, ALT-100, into human studies for treating acute respiratory distress syndrome (ARDS). ALT-100 is a humanized monoclonal antibody designed to neutralize circulating extracellular NAMPT as a biologic to suppress lung and systemic inflammatory cascades, inclusive of COVID-19-induced ARDS.
Betterlife Pharma Inc., of Vancouver, British Columbia, said it secured what it termed “hard” lock-up agreements from shareholders of Vancouver, British Columbia-based Altum Pharmaceuticals Inc., representing 67.12% of the outstanding common shares of Altum. Betterlife said it will approach the Altum’s board to discuss what it called a "merger of equals" transaction and if they cannot agree, Betterlife said it will launch a takeover bid to acquire all common shares of Altum. Betterlife said it would issue 4.582 of its common shares for each Altum common share, representing about $36.1 million in value based on the proposed share exchange. Privately held Altum has three products in its pipeline, including an interferon-alpha2b inhalation formulation for slowing viral replication, a topical interferon product for treating human papillomavirus infection and an oral gallium-based small molecule, AP-002, which is in a phase I/II trial to treat patients with advanced or recurrent solid tumors.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Indianapolis-based Eli Lilly and Co. will collaborate with the Duke Clinical Research Institute on a randomized clinical trial examining the effect of Jardiance (empagliflozin) following an acute myocardial infarction. The study will include about 3,300 adults across at least 16 countries. The primary endpoint is to assess the effect of Jardiance on all-cause mortality and hospitalization for heart failure.
Bold Therapeutics Inc., of Vancouver, British Columbia, said it executed an option agreement with an undisclosed publicly traded company for exclusive rights to BOLD-100 in South Korea. BOLD-100 is a potentially first-in-class anti-resistance ruthenium-based small-molecule drug, designed to selectively inhibit stress-induced up-regulation of GRP78, a resistance, survival and proliferation pathway common across cancers. Under the terms of the agreement, Bold and its new partner will collaborate on the former’s upcoming phase Ib/IIa adaptive trial in gastric, pancreatic, colorectal and bile duct (cholangiocarcinoma) cancers and will explore the potential development of BOLD-100 in triple-negative breast cancer. Financial terms were not disclosed.
Computer scientists and pathologists trained an artificial intelligence tool to determine which patients with lung cancer have a higher risk of their disease coming back after treatment as part of Cancer Research UK’s landmark TRACERx study. The tool differentiated between immune cells and cancer cells, enabling researchers to build a detailed picture of how lung cancers evolve in response to the immune system in individual patients, according to Cancer Research UK. The tool was developed by researchers at The Institute of Cancer Research in London, and with scientists at University College London Cancer Institute and the Francis Crick Institute.
Ceapro Inc., of Edmonton, Alberta, said it entered an additional research project, “PGX-processed yeast beta-glucans as an inhalable immunomodulating therapeutic for COVID-19 patients,” with McMaster University. Ceapro began the collaboration with the school in 2019 using the company’s pressurized gas expanded technology to optimize drug formulations in areas such as idiopathic lung fibrosis and antibiotic-resistant infections.
Cumberland Pharmaceuticals Inc., of Nashville, published clinical data in Drugs – Real World Outcomes, showing a record of population characteristics, prescription information and real-world clinical outcomes of patients with gram-positive infections treated with Vibativ (telavancin). The study assessed 151 patients with endocarditis and/or bacteremia with a known or unknown primary source. Of 132 patients with an available assessment at the end of telavancin therapy, a positive clinical response was achieved in 74%, while 10.6% failed therapy and 15.2% had an indeterminant outcome. There was no change in creatinine clearance for 75.3% of patients with values recorded at the beginning and the end of telavancin therapy. The data suggest telavancin is a promising and viable option for patients with bacteremia or endocarditis, including those with MRSA or another S. aureus pathogen, according to Cumberland.
Edigene Inc., of Beijing, and Immunochina Pharmaceuticals Co. Ltd., of Hong Kong, formed a research and development collaboration to develop allogeneic CAR T therapy to treat cancer. Terms were not disclosed. Edigene has ex vivo genome-editing platforms for hematopoietic stem cells and T cells, an in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover targeted therapies. Immunochina has an integrated CAR T platform and technologies such as large-scale viral vector production and primary immune cell processing. Its pipeline includes several CAR T candidates for treatment of advanced cancer.
Fujifilm Corp., of Tokyo, and Merck & Co. Inc., of Kenilworth, N.J. are collaborating in a clinical trial evaluating a combination therapy with Keytruda (pembrolizumab), an anti-PD-1 therapy, and Fujifilm's FF-10832, a liposome drug candidate. The liposome formulation is designed to use drug delivery system technology for delivering drugs to affected sites. Fujifilm plans to initiate a U.S. clinical trial no later than March 2021. The goal of the study will be to confirm the combination tolerability, pharmacokinetics and preliminary estimates of clinical activity of FF-10832 with Keytruda in selected tumor types.
Heat Biologics Inc., of Durham, N.C., said it is collaborating with Waisman Biomanufacturing in Madison, Wis., to establish a partnership for the manufacture of Heat's COVID-19 vaccine. Waisman specializes in the manufacture of cellular therapeutics and other biologics for early stage trials and is part of the University of Wisconsin. It has manufactured more than 320 clinical-grade products, Heat noted. The company previously worked with Waisman to manufacture Heat's HS-130, which is in a phase I trial.
Histogen Inc., of Morrisville, N.C, completed its previously disclosed merger with Conatus Pharmaceuticals Inc., of San Diego. The combined company changed its name to Histogen Inc. and will focus on developing patented technologies that replace and regenerate tissues in the body. Histogen was slated to begin trading May 27 on Nasdaq under the ticker HSTO.
Homology Medicines Inc., of Bedford, Mass., disclosed the peer-reviewed publication of methods used to evaluate the on-target efficiency and precision of the firm’s in vivo phenylketonuria (PKU) gene editing program. The quantitative molecular methods provide a framework to characterize homologous recombination-based, nuclease-free gene integration and evaluate whether any unintended on-target mutations or viral insertions occurred. In the paper, one of Homology’s family of 15 adeno-associated viral vectors derived from human hematopoietic stem cells (AAVHSC15) was used to deliver the human PAH gene into the murine model with human hepatocytes. That construct is designed to leverage the body’s natural DNA repair process of homologous recombination, without requiring a nuclease to cut the DNA. Findings were published in Plos One.
Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, provided an update on the preclinical results from its INM-088 drug development program that indicate a potential neuroprotective effect of cannabinol (CBN) on nerve cells located in the eye. INM-088 is being developed as a potential treatment option for ocular diseases, such as glaucoma, where neuroprotection may provide an added therapeutic benefit. The first in vitro study evaluated the neuroprotective effects of several individual cannabinoids, including CBN, tetrahydrocannabinol (THC) and cannabidiol (CBD), on differentiated retinal ganglion cells (RGCs), that form a thin layer of neurons responsible for relaying visual signals in the eye. The study examined the effects of cannabinoids on RGCs under normal atmospheric pressure and elevated pressure conditions as a model of raised intraocular pressure (IOP), a key characteristic of glaucoma. Elevated pressure mimicking high IOP had a cytotoxic effect on the RGCs. However, the combination of CBN and elevated pressure, within the same time period, resulted in a high level of cell survival in a dose-dependent fashion. CBN was superior to both CBD and THC under identical testing conditions. The data indicate a potential neuroprotective effect of CBN in ocular disease, the company said. Inmed also examined the potential effect of CBN on reducing or preventing natural RGC cell death. Data indicate that CBN has a significant anti-apoptotic effect on differentiated RGCs subjected to elevated pressure conditions.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., received data from a leading public health research institute showing its brilacidin inhibits SARS-CoV-2, the coronavirus responsible for COVID-19, in a human cell line. Brilacidin, in comparison to vehicle control, exhibited an inhibitory effect on SARS-CoV-2 in a dose-dependent manner – an average 29% inhibition at 0.1 ug/ml (the lowest concentration) to an 85% inhibition at 100 ug/ml (the highest concentration). The research being conducted at the institute is separate from research being performed at a U.S. regional biocontainment laboratory, Innovation said.
Kantum Pharma Inc., of Cambridge, Mass., disclosed the publication of new research demonstrating the therapeutic potential of the company's lead program for preventing and treating acute kidney injury (AKI). The paper, which describes research on the uridine diphosphate-glucose/P2Y14 receptor signaling pathway in the kidney, was published in the Journal of Clinical Investigation. In addition, the journal Nature Reviews Nephrology has published a research highlight describing the significance of the findings. The paper elucidates the early and central role of the P2Y14 receptor in initiating inflammation within the kidney after an insult such as ischemia or trauma.
Merck KGaA, of Darmstadt, Germany, said its Milliporesigma arm and Baylor College of Medicine disclosed an extension of their ongoing collaboration to advance a manufacturing platform to fight COVID-19, accelerating the transition to phase I trials. Using lessons from the work on a schistosomiasis vaccine, Milliporesigma, along with researchers at Baylor College of Medicine and the Texas Children's Hospital Center for Vaccine Development, are optimizing the production process to advance two COVID-19 vaccine candidates, including CoV RBD219-N1, expected to enter clinical trials later this year.
Nantkwest Inc., of El Segundo, Calif., and Immunitybio Inc., of Culver City, Calif., said the latter was selected to participate in Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021. Efforts will focus on the development, testing and large-scale manufacturing of Immunitybio’s COVID-19 human adenovirus vaccine candidate. The companies said it is the first vaccine designed to deliver both Spike (S) and nucleocapsid (N) DNA, offering the potential for patients to develop long-lasting immunity to the virus. The E1, E2b, E3 deleted, human adenovirus vector has demonstrated safety in more than 125 patients in 13 phase I and II trials to date. Clinical studies performed by the National Cancer Institute have demonstrated the Ad5 may induce antigen-specific T-cell immunity in patients, even in the presence of pre-existing adenoviral immunity.
The National Institute for Innovation in Biopharmaceutical Manufacturing, of Newark, Del., said it received $8.9 million from the U.S. Department of Commerce's National Institute of Standards and Technology to fund projects supporting the nation's response to the COVID-19 pandemic. Some of the institute's planned projects include providing virus proteins and improving blood testing capabilities and the development of automated contact tracing technology within pharmaceutical manufacturing facilities to limit the spread of coronavirus in essential workers. The money is part of the first round of funding made available to the National Institute of Standards and Technology through the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
Novavax Inc., of Gaithersburg, Md., has acquired Praha Vaccines a.s., a company based in the Czech Republic, in an all-cash transaction of about $167 million. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. Novavax said the facility is expected to provide an annual capacity of more than 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, its COVID-19 vaccine candidate. The acquisition is being supported by Novavax's funding arrangement with the Coalition for Epidemic Preparedness Innovations. The Cyrus Poonawalla Group, from which Novavax is buying the company, is the parent company of Serum Institute of India Pvt. Ltd. (SII). In March, SII and Novavax announced a commercial license agreement for the use of Novavax’s Matrix-M vaccine adjuvant with SII’s malaria vaccine candidate, currently in a phase IIb trial.
Organicell Regenerative Medicine Inc., of Miami, said two critically ill COVID-19 patients treated with Organicell Flow under emergency compassionate use allowances from the FDA are no longer intubated, are alert and oriented with stable vital signs and oxygenation. The company may now seek approvals to treat other severely ill patients, it said.
Rentschler Biopharma SE, a Laupheim, Germany-based contract development and manufacturing organization, said it entered a strategic collaboration with Copenhagen-based Genmab A/S for the process development and manufacture of bispecific antibodies generated with Genmab's Duobody technology platform.
Sanofi SA, of Paris, has agreed to sell 11.8 million shares of Tarrytown, N.Y.-based Regeneron Inc. (NASDAQ:REGN) common stock through a registered offering at a price of $515 per share. Regeneron will repurchase 9.8 million shares or $5 billion in common stock from Sanofi at the offering price. Sanofi expects to use net proceeds of the offering and the repurchase to further execute on its strategy to drive innovation and growth. In connection with the offering, the underwriters have been granted an option to purchase up to 1.2 million additional Regeneron shares within the next 30 days. If the option is fully exercised, the offering and repurchase will together result in gross proceeds to Sanofi of $11.7 billion and the sale of Sanofi’s entire holding in Regeneron, excluding 400,000 Regeneron shares that Sanofi is retaining.
Sensei Biotherapeutics Inc., of Gaithersburg, Md., acquired Seattle-based Alvaxa Biosciences Inc., a camelid antibody therapeutics company with technology licensed from Fred Hutchinson Cancer Research Center. Under the terms of the agreement, Sensei will acquire Alvaxa and its existing camelid nanobody libraries, expertise in nanobody discovery, as well as its partnership with Hope Farms LLC, a USDA-licensed alpaca farm, for the generation of future alpaca-derived nanobodies. Financial terms of the deal were not disclosed.
Sonoma Pharmaceuticals Inc., of Petaluma, Calif., established a 10-year license, distribution and supply agreement with Brill International SL, of Barcelona, Spain, to market Microdacyn60 Eye Care under the private label Ocudox in Italy, Germany, Spain, Portugal and the U.K. Brill already sells the product in Spain and Portugal under an earlier agreement. The product will be launched in Italy, Germany and the U.K. in a phased roll-out over the next 12 months.
Synthetic Biologics Inc., of Rockville, Md., received an option from Massachusetts General Hospital to license intellectual property and technology related to the use of intestinal alkaline phosphatase (IAP) to maintain gastrointestinal and microbiome health, diminish systemic inflammation and treat age-related diseases. If the option is executed, Synthetic would use the license to advance its preclinical bovine IAP SYN-020. Financial terms of the deal weren't disclosed.
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., and Acelrx Pharmaceuticals Inc., of Redwood City, Calif., amended their merger agreement to increase the payment for Tetraphase shareholders who will now receive $0.2434 in cash, 0.7217 of a share of Acelrx and a contingent value right (CVR) for each share of Tetraphase they own. The CVRs will pay up to an aggregate of $14.5 million in cash upon the achievement of Xerava (eravacycline) net sales milestones starting in 2021.
Triplet Therapeutics Inc., of Cambridge, Mass., said it initiated a natural history study of Huntington’s disease (HD) to assess clinical outcomes and biomarkers that will inform upcoming interventional clinical trials. The study, called SHIELD HD, enrolled its first patients last week in Toronto. The prospective, longitudinal natural history study will enroll about 60 HD gene expansion carriers and follow them for up to two years at clinical sites in North America and Europe. The study will assess a range of clinical outcomes and biomarkers, including cognitive, motor and functional measures such as the composite Unified HD Rating Scale, brain MRI data, DDR gene expression, and the blood and spinal fluid biomarker known as neurofilament light chain.
Virna Therapeutics Inc., of Boston, licensed the rights to neutralizing antibodies to treat COVID-19 from the University of Toronto. Financial terms of the deal weren't disclosed.
Vistagen Therapeutics Inc., of South San Francisco, and Nuformix plc, of Cambridge, U.K., are partnering to develop cocrystal-based formulations of Vistagen's drug candidates for central nervous system diseases. The partnership will start with Nuformix applying its crystalline technology to AV-101, an N-methyl-D-aspartate receptor agonist, to improve delivery and the therapeutic profile of the drug.