Adjuvance Technologies Inc., of Lincoln, Neb., was awarded supplemental contract funding from the National Institute of Allergy and Infectious Diseases. The funds will be used to evaluate TQL-1055, manufactured by Adjuvance, with SARS-CoV2 antigen, manufactured by the NIH. TQL-1055 is a saponin vaccine adjuvant, the company said, and the total funding in the contract is $1.47 million.
Adma Biologics Inc., of Ramsey, N.J., said it started a collection of convalescent plasma through its wholly owned subsidiary, Adma Biocenters Georgia Inc., from individuals who have recovered from COVID-19. The company is seeking U.S. citizens who have recovered from coronavirus (SARS-CoV-2) or COVID-19, to donate plasma, which can be used to produce an immune globulin to potentially help infected patients with COVID-19. Adma is a member of the CoVIg-19 Plasma Alliance, established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19.
Aetion Inc., of New York, signed a research collaboration agreement with the FDA to use real-world data to advance the understanding of and response to COVID-19. The research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns, by making possible the use of relevant new data sources and analyzing the data according to well-established principles. Aetion and the FDA will identify and analyze fit-for-purpose data sources to characterize COVID-19 patient populations and their medication use, identify risk factors for COVID-19-related complications, and contribute to the scientific evaluation of potential interventions. The collaboration will make use of the Aetion Evidence Platform, which includes structured workflows and transparent reporting to allow efficient sharing, examination and reproduction of findings.
Airway Therapeutics LLC, of Cincinnati, and Basel, Switzerland’s Celonic Group will collaborate to produce the human recombinant protein AT-100 (rhSP-D) as a COVID-19 therapy. Celonic will be responsible for process optimization and GMP manufacturing of AT-100 for clinical study. Production of AT-100 is expected to begin in June. AT-100 is an engineered version of an endogenous protein that has been shown in preclinical studies to reduce inflammation and infection in a range of bacterial and viral respiratory diseases by modulating the body's immune response, Airway said. Airway has previously filed a pre-IND submission with the FDA for AT-100 as a preventive treatment of the serious respiratory disease bronchopulmonary dysplasia in very preterm infants, with an IND filing expected in the third quarter of 2020 and plans to enter the clinic in late 2020.
In a trial sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, Amarin Corp. plc, of Bridgewater, N.J., and Dublin, is studying icosapent ethyl (Vascepa) on inflammatory biomarkers and other patient outcomes in COVID-19 patients. The primary endpoint is the effect of Vascepa vs. usual care on high-sensitivity C-reactive protein levels from baseline to 14 days in adults with a COVID-19-positive diagnosis. The study design also includes endpoints to assess rates and COVID-19 infection severity.
Ampio Pharmaceuticals Inc., of Englewood, Colo., said it has filed INDs for Ampion with the FDA for treatments that include inhalation and intravenous applications for COVID-19 patients. In vitro studies on cell cultures confirmed Ampion’s mechanism of action may be suitable to inflammatory conditions such as acute respiratory distress syndrome and the cytokine storm associated with COVID-19, the company said.
Be The Match Biotherapies LLC, of Minneapolis, is providing donor material for El Segundo, Calif.-based Nantkwest Inc.’s phase Ib trial to address acute respiratory distress syndrome (ARDS), a cause of COVID-19 deaths. Nantkwest’s allogeneic cell therapy, derived from human bone marrow, is designed to treat ARDS resulting from severe COVID-19. The therapy, BM-Allo.MSC, uses mesenchymal stem cells, multipotent progenitor cells known to have immunomodulatory properties, for reducing ARDS-associated lung inflammation.
Beigene Ltd., of Beijing, said it signed an exclusive distribution agreement for Medison Pharma Ltd., of Petach Tikva, Israel, to commercialize its BTK inhibitor, Brukinsa (zanubrutinib), in Israel. In addition, a new drug application has been submitted in Israel for Brukinsa for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
Beximco Pharmaceuticals Ltd., of Dhaka, Bangladesh, a manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, said it launched remdesivir (under the brand name Bemsivir), an antiviral drug, which has been recently granted emergency use authorization by the FDA for the treatment of COVID-19. The company said it is the first in the world to launch a generic version of remdesivir for the treatment of COVID-19. The launch follows the granting of an emergency use authorization by the Directorate General of Drug Administration, the regulatory authority in Bangladesh, for remdesivir I.V. injection.
Cansino Biologics Inc., of Tianjin, China, and Precision Nanosystems Inc., of Vancouver, British Columbia, agreed to co-develop an mRNA lipid nanoparticle vaccine against COVID-19. Precision will develop the mRNA-LNP vaccine, and Cansino is responsible for preclinical testing, clinical trials, regulatory approval and commercialization. Cansino has rights to commercialize the vaccine in Asia (except Japan), with Precision retaining rights for the rest of the world. The agreement includes undisclosed payments and royalties.
Centivax Inc., of South San Francisco, said three independent laboratories confirmed multiple Centivax antibody therapeutic candidates are potent neutralizers of COVID-19. Viral neutralization directly demonstrated that the antibodies are able to completely block the coronavirus from infecting human cells, the company added. Scientists at the U.S. Army Medical Research Institute of Infectious Diseases are testing the antibodies for their ability to prevent the coronavirus from infecting human cells.
The Russian Direct Investment Fund (RDIF), of Moscow, a sovereign wealth fund, and the Chemrar Group, also based in Moscow, said they started the final stage of a multicenter, randomized, open comparative clinical trial of the drug favipiravir on patients hospitalized with COVID-19. The study will involve 330 patients as well as additional research and medical centers. An application for the accelerated registration of favipiravir has been submitted to the Russian Ministry of Health.
Microbiologists at the China Agricultural University’s College of Veterinary Medicine have developed new broad-spectrum, short linear antibacterial peptide (SLAP) antibiotic adjuvants, one of which, SLAP-S25, was effective against multidrug-resistant (MDR) gram-negative bacteria, including carbapenem- and colistin-resistant Escherichia coli, when combined with antibiotics. SLAP-S25 alone showed weak antibacterial activities against gram-positive and gram-negative bacteria. But broad synergies were seen between SLAP-S25 and other major classes of antibiotics against E. coli B2, including tetracycline, ofloxacin, rifampicin, cefepime and vancomycin. For example, the minimum inhibitory concentration of colistin decreased 32-fold in the presence of SLAP-S25, which also showed synergies with multiple antibiotics against antibiotic-sensitive E. coli isolates. SLAP-S25 was shown to damage bacterial membranes, allowing more antibiotics to accumulate in the bacteria. The team reported its findings in the May 18, 2020, online issue of Nature Microbiology.
Cytodyn Inc., of Vancouver, Washington, is providing leronlimab to the Mexican National Institutes of Health for a trial in Mexico’s severe/critical COVID-19 patients. Cytodyn is enrolling 390 patients for the randomized, placebo-controlled phase IIb/III trial. Cytodyn is also enrolling a phase II randomized clinical trial with 75 patients in the mild to moderate COVID-19 population. The FDA granted leronlimab fast track designation as a combination therapy with HAART for HIV-infected patients and for those with metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases and other diseases, including nonalcoholic steatohepatitis.
Miramar, Fla.-based Generex Biotechnology Corp. said its COVID-19 vaccine program reached a milestone by manufacturing 33 Ii-Key-SARS-CoV-2 peptides using antigenic epitopes predicted by computational vaccinology algorithms. Once the peptides pass quality assurance testing, they will be shipped to clinical laboratories for screening using blood and plasma samples from recovered COVID-19 patients. The studies will provide data to select Ii-Key-SARS-CoV-2 peptides for a vaccine to promote B-cell production of neutralizing antibodies and activate CD4+ T-cell responses promoting immune memory and potential long-term protection from coronavirus infection. Additionally, the vaccine screening program will address safety of the Ii-Key-SARS-CoV-2 peptides using an in vitro assay modeling the cytokine storm associated with COVID-19.
Genocea Biosciences Inc., of Cambridge, Mass., entered a material transfer agreement (MTA) and exclusive license option with Shionogi & Co., Ltd., of Osaka, Japan, to develop an HSV-2 vaccine using Genocea’s HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. Shionogi will pay $2 million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercising Shionogi’s option, terms are expected to include an up-front payment, regulatory and sales milestones, as well as tiered royalties. Final terms will be based on MTA evaluation results and overall diligence. If licensed, Shionogi will assume responsibility for global development and commercialization of the HSV-2 vaccine product. The Genocea platform profiles T-cell responses to targets on tumors.
Hoth Therapeutics Inc., of New York, licensed technology and intellectual property exclusively from Virginia Commonwealth University for a novel peptide therapeutic to prevent spike protein binding, which may be a leading cause of COVID-19, and slow its transmission. The research is being led by inventor Michael Peters, and is being aided, in part, by supercomputers as part of the COVID-19 High Performance Computing Consortium through a virtual system that scientists can use to interactively share computing resources known as the Extreme Science and Engineering Discovery Environment, Hoth said.
I-Mab Biopharma Co. Ltd., of Shanghai, and Genexine Co. Ltd., of Seoul, South Korea, said they expanded their agreement to include development of TJ-107/Hyleukin-7 (efineptakin alfa), a long-acting recombinant human interleukin-7, in glioblastoma multiforme. The companies received regulatory clearance in China for a phase II study in lymphopenic patients with newly diagnosed disease. Under the terms of the expanded collaboration, I-Mab will be mainly responsible for conducting the clinical trial in China, and Genexine will share the development strategies, data and costs for success of the clinical trial. Financial terms are not disclosed.
IMV Inc., of Dartmouth, Nova Scotia, said, based on positive preclinical results demonstrating robust immunogenic and antibody responses, it has selected multiple peptide epitopes to be formulated within its DPX platform to form a vaccine candidate against the novel coronavirus, DPX-COVID-19. In preclinical animal models, the company evaluated all 23 peptides formulated within the DPX platform. The majority of peptide epitopes tested generated targeted antibody responses after the first and second dose, without requiring an adjuvant.
Innocan Pharma Ltd., of Tel Aviv, Israel, a wholly owned subsidiary of Innocan Pharma Corp., of Calgary, Alberta, signed a letter of intent with Adva Biotechnology Ltd. to enter an exosome production and development agreement. Adva develops therapy manufacturing solutions. Innocan intends to load the produced exosomes with cannabidiol to develop a COVID-19 treatment and additional CNS indications.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said its anti-SARS-CoV-2 candidate, brilacidin, in an in vitro experiment using Vero cells, reduced the viral titer of SARS-CoV-2 by 75% after only one hour of preincubation prior to infection at a concentration of 10 μM as compared to vehicle control. Separately, the company and lab researchers agreed that brilacidin as a vaccine would not be studied further at this time.
The University of Texas MD Anderson Cancer Center and Innovent Biologics Inc., of Suzhou, China, formed a strategic collaboration agreement to co-develop Tyvyt (sintilimab), Innovent’s anti-PD-1 monoclonal antibody, in rare cancers in the U.S. Under the agreement, Innovent and MD Anderson will co-fund the development activities for the drug, which may include multiple clinical research studies to be conducted by MD Anderson, the partners said. Tyvyt won regulatory approval from China's NMPA for the third-line treatment of classical Hodgkin lymphoma in December 2018.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., disclosed the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T-cell immune responses against coronavirus SARS-CoV-2. The study was published in Nature Communications. The data build on previously reported phase I/IIa data on the firm’s vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from similarly designed vaccine INO-4700.
Iqvia Inc., of Danbury, Conn., said the Walter and Eliza Hall Institute of Medical Research, a leading biomedical research organization in Australia, has selected the firm to manage COVID Shield, a phase II/III randomized, double-blinded study of preventive care for front-line health care workers fighting the COVID-19 pandemic. The study will test an expanded indication for generic hydroxychloroquine as a prophylactic treatment to prevent high-risk health care workers from contracting COVID-19. Local hospitals across Australia will administer the drug or a placebo to about 2,250 health care professionals who are currently looking after COVID-19 patients.
Kleo Pharmaceuticals Inc., of New Haven, Conn., and Celularity Inc., of Warren, N.J., a developer of allogeneic natural killer (NK) cell therapies, said they entered a preclinical research collaboration to advance synergistic combinations of each company’s technology platform as potential treatments for COVID-19 and multiple myeloma. Earlier this year, Kleo received IND authorization from the FDA to test its CD38-targeting antibody recruiting molecule (ARM) in combination with autologous NK cells in a clinical study. Celularity also received FDA authorization to evaluate one of its allogeneic NK cell products, CYNK-001, in COVID-19-infected adults. When used in combination with NK cells, ARM molecules behave similarly to chimeric antigen receptors, though their synthetic nature eliminates the need for genetic engineering.
Nanoviricides Inc., of Shelton, Conn., said strong effectiveness against infection by an ACE2-utilizing coronavirus in an animal model has been observed for the drug candidates it is developing against SARS-CoV-2 to treat the COVID-19 spectrum of diseases. The firm is developing an animal model for coronavirus infection using hCoV-NL63 as a surrogate for SARS-CoV-2. HCoV-NL63 is a circulating human coronavirus that causes a disease that is similar to SARS-CoV-2, but much milder. Both viruses utilize the same cell receptor, namely ACE2, to enter the cell.
Oragenics Inc., of Tampa, Fla., said that through its wholly owned subsidiary, Noachis Terra, it has entered an agreement with Aragen Bioscience, a contract research organization focused on accelerating preclinical biologics development, to advance TerraCov2 the company’s SARS CoV-2 vaccine candidate. Aragen will provide cell line development services to Oragenics.
Orion Corp., of Espoo, Finland, said it has received €28 million (US$30.8 million) in total milestone payments from Leverkusen, Germany-based Bayer AG tied to the first commercial sales of Nubeqa (darolutamide), an androgen receptor antagonist the companies jointly developed for the treatment of non-metastatic castration-resistant prostate cancer. Orion said the payments, €20 million tied to initial EU sales and €8 million tied to initial Japan sales, had already been included in its financial guidance.
Pharmajet Inc., of Golden, Colo., said its needle-free injection system technology will be used to deliver a mRNA vaccine against SARS-CoV-2, in development by Abnova Corp., of Taiwan. Terms were not disclosed.
Prellis Biologics Inc., of Hayward, Calif., said it generated 300 human IgG antibodies that bind to either the S1 or S2 spike protein of the SARS-CoV-2-Wuhan strain of the novel coronavirus. Using the Prellis Externalized Human Immune System technology, the team produced 960 synthetic human lymph nodes that were challenged with a SARS-CoV-2 vaccine-like cocktail, leading to virus-specific antibody generation. The company recently closed a $4.3 million investment round led by Future Ventures, Khosla Ventures and Indiebio to support the development of human anti-SARS-CoV-2 antibodies.
Progenabiome LLC, of Malibu, Calif., said it is starting two FDA-approved clinical trials that include hydroxychloroquine. A phase II study sponsored by the genetic research sequencing lab is testing whether treatment with a combination of hydroxychloroquine, vitamin C, vitamin D and zinc can prevent symptoms of COVID-19. Another phase II trial will treat people with confirmed cases of COVID-19 with the same interventions, plus azithromycin, to measure rate of recovery, among other outcomes. Neither study was listed as recruiting yet.
Promis Neurosciences Inc., of Toronto, said, in addition to its ongoing program to develop a high-throughput and accurate test for detection of antibodies to the causative agent of COVID-19, it has expanded its collaboration with BC Neuroimmunology to include development of highly sensitive and specific assays to support accurate screening and diagnosis of Alzheimer’s disease. Terms were not disclosed.
Qingdao Primedicine Pharmaceutical Co. Ltd., of Qingdao, China, and Primary Peptides Inc., of Vancouver, British Columbia, said they entered an exclusive license to develop and commercialize an innovative product for the treatment of heart attack. Under the terms of the agreement, Primedicine receives exclusive rights to develop and commercialize the product in China, including the mainland, Hong Kong, Macau and Taiwan, while Primary Peptides retains rights in all other markets. Additional product details and financial terms were not disclosed.
With $9 million from the COVID-19 Therapeutics Accelerator, an international group of physicians and scientists is establishing a research network to evaluate promising therapies for COVID-19. The group, called the COVID-19 Research Outcomes Worldwide Network (CROWN) Collaborative, is testing whether the antimalaria drug chloroquine can prevent COVID-19 infection or decrease its severity in front-line health care workers, according to the Washington University School of Medicine in St. Louis, which is coordinating the study. An estimated 30,000 participants from across the globe will participate in the five-month trial, which the collaborative is calling the CROWN CORONATION trial. They'll be divided randomly into four groups, three of which will receive chloroquine at various doses, with the fourth receiving a placebo. Data from the trial sites will be compiled at University College London. Rising Pharma Holdings Inc., a privately held generics and OTC drug company based in East Brunswick, N.J., is donating chloroquine to the U.S. arm of the study.
In an agreement worth more than $231 million over the next eight years, Samsung Biologics Co. Ltd., of Yeonsu-gu, South Korea, will provide additional manufacturing and supply capacity to Glaxosmithkline plc, of London. The deal will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022.
Takara Bio Inc., of Kusatsu, Japan, and AGC Biologics, a contract development and manufacturing organization based in Søborg, Denmark, will collaborate on a prophylaxis DNA vaccine, with AGC manufacturing the vaccine’s plasmid DNA intermediate. The vaccine will be developed based on Osaka University and Anges Inc.'s expertise of developing plasmid DNA products.
Researchers at the University of Nantes and the University of Melbourne have discovered that the macrophage checkpoint SIRPa played an important role in reducing macrophage activity after inflammation, and that blocking SIRPa could restore their activity in cell culture, “which suggests a potential strategy to prevent hospital-acquired pneumonia,” according to the authors. Hospital-acquired pneumonia is the most frequent type of hospital-acquired infection. It has a 10% mortality rate, and is a major driver of broad-spectrum antibiotic use in intensive care settings, which in turn drives antibiotic resistance. Patients who are recovering from sepsis or trauma have a very high risk of developing pneumonia, and the authors hypothesized that this might be due to immunosuppression. They showed that macrophages from patients who had recovered from a critical illness functioned poorly for months afterward, due to epigenetic changes that induced high levels of tolerance. Mouse macrophages, too, were functionally impaired after dual infections, and that microenvironmental SIRPa signaling played a major role in that immune paralysis by reprogramming macrophage gene expression. “Our study prompts the development of therapies to treat hospital-acquired infections that are centered on restoration of host immunity rather than on avoidance of bacterial colonization, as is the case for most current strategies that seek primarily elimination of the pathogen” via antibiotics, the authors wrote. They published their findings in the May 18, 2020, issue of Nature Immunology.
In an open letter, Washington-based Vanda Pharmaceuticals Inc. CEO Mihael H. Polymeropoulos recommended sharing clinical trial data. “The reason for sharing of clinical data includes allowing the scientific community to independently form their own conclusions from their own analyses, develop new insights from the data, and accelerate discoveries in the field by not having to repeat the same experiments,” Polymeropoulos wrote. “In the case of remdesivir and COVID-19, this degree of data sharing is even more urgent given the finite amount of time within which a study can be conducted in the face of a declining number of new cases. There are a number of questions that could be answered by the existing remdesivir [National Institute of Allergy and Infectious Diseases] study that remain unanswered by the complete unavailability of the data. For example: Is there a subgroup of patients that performed better than others? Is this subgroup of a certain characteristic, such as age, sex, race, genetic makeup, time since infection, severity of disease, viral load, medication, underlying condition? And there are many others to be answered.”
Vaxart Inc., of South San Francisco, has selected its lead COVID-19 vaccine candidate. The company has started production of the oral vaccine to be used in a phase I study, scheduled to start in the second half of 2020. Vaxart selected San Francisco-based Kindred Biosciences Inc. as a second contract manufacturer of the vaccine. Terms of the deal weren't disclosed.