Affibody AB, of Solna, Sweden, said its partner Daewoong Pharmaceutical Co. Ltd., a South Korea-based pharmaceutical company, has exercised an option to develop and commercialize an innovative half-life extended biotherapeutics product. Affibody will receive a license conversion fee and milestone payments as well as royalties. Further financial details were not disclosed.
Anixa Biosciences Inc., of San Jose, Calif., which is focused on the treatment, prevention and diagnosis of cancer and infectious diseases, said that, together with partner Ontochem GmbH, of Halle, Germany, it has identified its first therapeutic candidate against COVID-19, and has advanced the compound into biological testing. The candidate was identified from their research to evaluate more than 1.2 billion molecules through an in silico study to identify potential therapies for patients infected by SARS-CoV-2. The compound is expected to disrupt the interaction of the virus's endoribonuclease with a host human protein that is necessary for the virus to replicate upon infection.
Applied DNA Sciences Inc., of Stony Brook, N.Y., with its COVID-19 vaccine development partner, Takis Biotech Srl, of Rome, Italy, said the first injections of DNA vaccine candidates against the Spike protein (product of the S gene) of the SARS-CoV-2 virus have produced neutralizing antibodies in test animals. The studies were completed at the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome. Initial results were obtained using plasmids (the templates for Applied DNA’s LinearDNA platform) to baseline results. Applied DNA’s linear DNA dose-response trials begin this week.
Astellas Pharma Inc., of Tokyo, entered two new collaborations, one with Harvard University and the other with Insilico Medicine Inc., of Rockville, Md. Astellas and Harvard will partner in a three-year research alliance, with Astellas issuing one or more challenges based on its research scopes to inspire research proposals by Harvard faculty, a number of which will then be selected by Astellas for project funding based on scientific rationale and projected impact on value for patients. Projects may span a range of developmental stages, from early investigations into the biological mechanisms of disease, to identifying therapeutic targets, or to the generation and validation of new therapeutic entities. Insilico and Astellas plan to develop candidates against an unnamed target. Insilico will receive an undisclosed up-front payment and milestones. Astellas will synthesize, optimize and characterize molecules generated by the collaboration using AI.
Astrazeneca plc, of Cambridge, U.K., and the University of Oxford have entered an agreement for the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. It aims to advance the ChAdOx1 nCoV-19 vaccine, being developed by the Jenner Institute and Oxford Vaccine Group at the University of Oxford. Under the arrangement, Astrazeneca will be responsible for development and worldwide manufacturing and distribution of the vaccine, which entered phase I trials last week.
Atreca Inc., of South San Francisco, Beigene Ltd., of Beijing, and IGM Biosciences Inc., of Mountain View, Calif., said they plan to collaborate to help address the COVID-19 pandemic. The companies will leverage their combined technology and expertise to discover, develop and manufacture IgM and IgA antibodies targeting SARS-CoV-2. They will start work immediately and will work out financial details of the arrangement and other terms in the future. The alliance will utilize Atreca’s discovery platform to generate the sequences of antibodies made by particular B cells found in blood obtained from acutely infected COVID-19 patients. IGM’s technology platform will then be leveraged to develop and manufacture engineered IgM and IgA therapeutic antibodies from the identified sequences. Beigene has agreed to provide global clinical development support. If research, manufacturing and regulatory activities proceed well, the companies said they believe an antibody may be ready to begin clinical testing in the first half of next year.
Bioage Labs Inc., of Richmond, Calif., said it entered an exclusive worldwide license agreement with Tokyo-based Taisho Pharmaceutical Co. Ltd. to develop and commercialize its clinical-stage hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor, BGE-117 (named TS-143 by Taisho), to ameliorate multiple diseases of aging. Under the terms of the agreement, Bioage will make an up-front payment to Taisho, which is entitled to receive development and commercial milestone payments plus royalties based on annual net sales. Bioage will be responsible for all development, manufacturing and commercialization of BGE-117 worldwide, while Taisho has an option right for co-commercialization in Japan and several countries in southeast Asia. The company said it believes that BGE-117 can potentially treat multiple diseases of aging through the activation of HIF-1 target genes that are involved in numerous biological processes, including tissue regeneration, erythropoiesis, glycolysis, glucose uptake, vascular remodeling and angiogenesis. Inhibition of HIF-PH increases HIF pathway activation and has the potential to increase resilience, repair and regeneration across multiple body systems.
Biocon Ltd., of Bengaluru, India, and Mylan NV, of Hertfordshire, U.K., said they launched Fulphila, a biosimilar to Neulasta (pegfilgrastim, Amgen Inc.), in Canada following its approval to decrease the incidence of infection, manifested by febrile neutropenia, in individuals with non-myeloid malignancies who are receiving myelosuppressive antineoplastic drugs.
Catalent Inc., of Somerset, N.J., said it will increase manufacturing capacity and prep for large-scale commercial production at its 875,000-square-foot facility Bloomington, Ind., location to manufacture New Brunswick, N.J.-based Johnson & Johnson Inc.’s COVID-19 vaccine candidate. Catalent plans to hire about 300 additional employees at the site for the program. Under an accelerated timeline, J&J plans to initiate a phase I trial in September, with clinical data on safety and efficacy expected by year-end. That could allow vaccine availability for emergency use in early 2021, the company added.
Clearside Biomedical Inc., of Alpharetta, Ga., said it revised its Xipere (triamcinolone acetonide suprachoroidal injectable suspension) NDA resubmission timeline until the fourth quarter of 2020 due to a filling line equipment update at its manufacturing facility and to COVID-19-related issues. Clearside and Bausch + Lomb, of Bridgewater, N.J., also amended and revised their collaboration to develop and commercialize Xipere, a suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for treating macular edema associated with uveitis. Bausch + Lomb now has exclusive options for the right to commercialize and develop Xipere in Europe, the U.K., Australia, New Zealand, South America and Mexico. In the amended agreement, Bausch + Lomb also extended the time allowed for Clearside to obtain Xipere approval in the U.S.
Cytodyn Inc., of Vancouver, Washington, reported updates on 49 COVID-19 patients who have received leronlimab (PRO-140), a CCR5 antagonist with the potential for multiple therapeutic indications, under the FDA emergency investigational new drug program. All treated patients (11) were in intensive care units in a New York hospital because of acute respiratory failure, eight of whom were intubated. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, the company said it believes they were able to save the lives of four patients. All patient blood samples were evaluated, and results from the effect of leronlimab were demonstrated in almost all of those patients. Another NY hospital patient was taken off oxygen and discharged from hospital after leronlimab treatment. Of 17 severe condition (but not critical) patients, in a southern California hospital, 11 patients demonstrated improvement in respiratory parameters (eight of them were discharged from hospital, two patients remain relatively stable, two have shown deterioration in respiratory parameters and information is pending for two recently treated patients), the company said.
New data from Edigene Inc., of Cambridge, Mass., and Beijing, showed significant enzyme α-L-iduronidase (IDUA) enzymatic activity with long duration in mucopolysaccharidosis type I (MPS I) patient-derived cells. Edigene’s program uses an RNA base editing technology. Oligonucleotides of various design, called arRNA, were developed to produce precise and sequence-specific A-to-I conversion in the mRNA sequence for codon 402, leading to generation of the wild-type IDUA mRNA and protein. MPS I is a rare and potentially fatal lysosomal storage disorder that can affect organs and tissue throughout the body. It is a genetic condition that results in a deficiency of the IDUA. As a result, metabolic waste accumulates in cells and cause progressive damage.
Evergreenhealth Inc., of Kirkland, Wash., is preparing to move forward with the next phase of clinical research studying Foster City, Calif.-based Gilead Sciences Inc.’s antiviral remdesivir as a potential treatment for COVID-19. The trial known as the Adaptive COVID-19 Treatment Trial, sponsored by the National Institute of Allergy and Infectious Diseases, part of the NIH, is the first clinical trial launched in the U.S. to evaluate an experimental treatment for COVID-19. The second phase of the trial will eliminate the placebo group, and instead provide all study participants with remdesivir to further evaluate its effectiveness against the virus.
Fujifilm Diosynth Biotechnologies, of Hillerod, Denmark, said it will reserve manufacturing capacity for a future COVID-19 therapy for the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation, Wellcome Trust and Mastercard to speed up the response to the global pandemic. The company will work with a selected pharmaceutical partner in supporting the fast manufacture and dedicated supply for patients with COVID-19 in lower-income countries. Under the agreement, production volumes are secured for 2021 with options for several years thereafter.
Generex Biotechnology Corp., of Miramar, Fla., said it submitted a contract proposal to the U.S. Biomedical Advanced Research and Development Authority to develop a vaccine against the SARS-CoV-2 coronavirus and began manufacturing synthetic peptides to SARS-CoV-2 epitopes predicted by computational vaccinology algorithms. The peptide epitopes, which contain target amino acid sequences from the virus, will be screened against blood samples collected from COVID-19 convalescent patients to select peptides that activate the immune system to fight the coronavirus infection. The blood screening program incorporates T-cell assays, B-cell assays, antibody and virus neutralization tests and an in vitro cytokine storm cellular assay to identify peptide vaccines most likely to stimulate the T-cell (CD4 and CD8) response, modulate appropriate immune system responses to minimize potential for dysregulated cytokine-related inflammation, stimulate a neutralizing antibody response and provide broad-spectrum coverage for the vast majority of people, the company said.
Geovax Labs Inc., of Atlanta, said that Beijing- and Philadelphia-based Sino Biological Inc. will be its exclusive supplier of SARS-Cov-2 (COVID-19) bioreagents such as recombinant proteins, antibodies and detection kits for use in COVID-19 vaccine development. It will also obtain exclusive rights to research-use-only reagents developed jointly by the companies. Financial terms were not disclosed.
Researchers at Utrecht University, Erasmus Medical Center and Harbour Biomed Therapeutics Ltd., of Cambridge, Mass., said they identified a fully human monoclonal antibody that prevents the SARS-CoV-2 virus from infecting cultured cells. The antibody could alter the course of infection in the infected host, support virus clearance or protect an uninfected individual that is exposed to the virus, the researchers said. The antibody binds to a domain that is conserved in both SARS-CoV and SARS-CoV-2, explaining its ability to neutralize both viruses, they concluded.
Heat Biologics Inc., of Durham, N.C., said it continues to advance its COVID-19 vaccine program. The firm’s gp96 COVID-19 effort is focused on providing prophylactic protection to elderly patients and those with underlying health conditions. New data suggest that T-cell and antibody immunity are required for effective prophylactic protection against COVID-19. Heat's vaccine is being designed to clear virus-infected cells by promoting long-term cellular immunity, the company noted.
Hebrew University of Jerusalem said its researchers developed an injectable antibiotic with a new mode of action that could impact the morbidity rate for pandemics such as COVID-19. Mupirocin, a topical antibiotic, was reformulated by Hebrew University researchers for intravenous delivery and new properties to fight drug-resistant bacteria were created, the university said. According to the European Antibiotic Resistance Organization, 700,000 people die every year from resistant infections and if no significant improvement is made in the field, that number will rise to 10 million by 2050.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., said it is expanding its partnership with Richter-Helm Biologics GmbH & Co. KG to support large-scale manufacturing of Inovio's COVID-19 DNA vaccine INO-4800, which is in a phase I study in the U.S. The agreement is partly funded by a $1.3 million grant from the Coalition for Epidemic Preparedness Innovations, bringing the coalition’s total support for INO-4800 development to $17.2 million.
Junshi Biosciences Co. Ltd., of Shanghai and Eli Lilly and Co., of Indianapolis, said they will co-develop therapeutic antibodies for COVID-19 prevention and treatment. At the beginning of the pandemic, Junshi launched R&D efforts to discover therapies to combat COVID-19. Multiple neutralizing antibodies have been engineered, with the lead asset poised to enter clinical testing in the second quarter. Lilly receives an exclusive license to conduct clinical development, manufacturing and distribution of products outside of greater China. Junshi will maintain all rights in greater China.
Just-Evotec Biologics Inc, of Seattle, and Ology Bioservices Inc., of Alachua, Fla., will collaborate to evaluate and characterize antibodies to fight SARS-CoV-2. Just-Evotec will screen a panel of anti-SARS-CoV-2 antibodies from convalescing COVID-19 patients and provided by Ology. Just-Evotec will help filter the antibodies into a smaller set with predicted desirable characteristics for manufacturing and long-term storage. Once the final antibody panel has been selected and produced at a small scale by Ology, material will be sent to Just-Evotec for evaluation of biophysical properties and potential post-translational modifications.
Marinomed Biotech AG, of Vienna, said it received funding from the Austrian Research Promotion Agency to develop a SARS-CoV-2 therapy based on its Carragelose inhalation platform, designed to target viral infections of the respiratory tract. Tolerance of the Carragelose inhalation solution will be evaluated first in healthy volunteers, followed by a proof-of-concept study at the Medical University of Vienna on individuals with viral pneumonia. In parallel, existing data on the effectiveness of Carragelose will serve as the basis for in vitro tests to establish safety and effectiveness, also performed in collaboration with the Medical University of Vienna. The project, part of Austria’s emergency call for research on COVID-19 in the wake of the SARS-CoV-2 outbreak, is expected to be funded at more than €4 million (US$4.3 million).
Moderna Inc., of Cambridge, Mass., and Lonza Ltd., of Basel, Switzerland, entered a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine, mRNA-1273, against SARS-CoV-2 and additional Moderna products in the future. They plan to establish manufacturing suites at Lonza’s facilities in the U.S. and Switzerland. Technology transfer is expected to begin in June with the first batches of mRNA-1273 manufactured at Lonza U.S. in July. The companies plan to establish additional production suites across Lonza’s worldwide facilities to manufacture the material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide.
Nanoviricides Inc., of Shelton, Conn., said it signed a confidential disclosure agreement with an unnamed leading pharmaceutical company in the Asian region to explore collaborating on the company’s COVID-19 program. Nanoviricides said it is developing an antiviral drug candidate specifically targeting the coronavirus SARS-CoV-2, with broad-spectrum activity against other coronaviruses.
Oragenics Inc., of Tampa, Fla., said it acquired Noachis Terra Inc., of Gainesville, Fla., following its entry into a stock purchase agreement, to develop and commercialize TerraCoV2, a vaccine candidate that could provide specific immunity from the SARS-CoV-2 coronavirus. Noachis Terra holds a worldwide, nonexclusive license to the TerraCoV2 vaccine candidate from the National Institute of Allergy and Infectious Diseases, an institute within the U.S. NIH. As a result of the acquisition, Oragenics paid an aggregate of $1.925 million in cash, issued 9.2 million shares of its common stock and warrants to purchase 9.2 million shares and may be obligated to pay Joseph Hernandez, the founder and former sole shareholder of Noachis Terra, certain contingent cash consideration in the future.
Oxford Biodynamics plc, of Oxford, U.K., said it is participating in the Chief Scientist Office of Scotland-funded biomarker study’s randomized controlled study of the antiviral favipiravir as an early treatment arm of Asterix in COVID-19 hospitalized patients. The study concerns COVID-19 disease severity and response to the antiviral therapy, which is a selective inhibitor of viral RNA-dependent RNA polymerase. It is one of the COVID-19 research projects at the University of Glasgow. The company focuses on discovering and developing epigenetic biomarkers.
Pneumagen Ltd., a spin-out of the University of St. Andrews (U.K.), said three in vitro studies showed that Neumifil and other multivalent carbohydrate binding modules (mCBMs) generated from its Glycotarge platform reduced the number of SARS-CoV-2 plaques in assays evaluating the mCBMs both for prevention and treatment of coronavirus infection. Pneumagen said the research conducted at Public Health England's Porton facility and at the University of Glasgow's MRC Centre for Virus Research extended its internal experiments with a clinically relevant coronavirus that can cause the common cold, where a plaque reduction assay also showed antiviral activity for mCBMs. Neumifil is in development for the universal treatment of respiratory tract infections, including influenza virus and respiratory syncytial virus in addition to those related to COVID-19.
Proteogenix SA, of Strasbourg, France, disclosed the first human immune COVID-19 library for the fast discovery of antibodies against the virus. The library, created using blood samples from dozens of recovered patients, is adapted for screening with phage display and strives to meet the rising demands for effective antibodies for a broad range of applications. Its diversity (1.2 x 1010 different clones) allied to the fast turnaround time and sensitivity of the screening technology are intended to fast-track the discovery of antibodies with the strongest affinity, specificity and viral blocking activity, the company said.
Puma Biotechnology Inc., of Los Angeles, licensed rights to Nerlynx (neratinib) in South Korea to Bixink Therapeutics Co. Ltd., of Seoul, South Korea. Bixink will be responsible for gaining regulatory approval. Puma is eligible for up-front and milestone payments of $6 million, as well as significant double-digit royalties on sales of the drug in South Korea.
Recce Pharmaceuticals Ltd., of Sydney, reported preclinical data showing significant antibacterial activity against Neisseria gonorrhoeae bacteria in mice treated with its lead compound, RECCE-327. The recognized vaginal infection model met its primary endpoint of a reduction in bacterial load compared to vehicle infected control evaluated on the seventh day following dosing. Three groups of 10 female mice each showed efficacy at different dose levels with significant reduction in bacterial load in the vaginal infection as compared to the vehicle control (p<0.05).
Sarepta Therapeutics Inc., of Cambridge, Mass., said it inked a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) involving use of its phosphorodiamidate morpholino oligomer (PMO) platform in a collaboration to identify antisense oligonucleotides with activity against SARS-CoV-2 for the potential treatment of COVID-19. The agreement calls for Sarepta to design, synthesize, manufacture and provide to USAMRIID multiple peptide-conjugated PMO constructs based on genetic sequencing of SARS-CoV-2 for COVID-19. USAMRIID will evaluate the constructs on characterized wild-type SARS-CoV-2 viruses for their potential to inhibit viral infection. Based on results, Sarepta and USAMRIID will consider collaborative funding proposals to advance development of treatments for COVID-19.
Secarna Pharmaceuticals GmbH & Co. KG, of Munich, said it inked a cooperative agreement with First Affiliated Hospital at Guangzhou Sun Yat-sen University (SYSU) to develop a treatment or prophylactic for SARS-CoV-2 viral infections using Secarna’s locked nucleic acid (LNAplus) platform to develop antisense oligonucleotides (ASOs) that suppress the expression of a certain host factor essential for the viral infection cycle. Feasibility of the concept was demonstrated in 2019, when Secarna employed LNAplus to develop ASOs targeting the host factor NPC1 to reduce Ebola virus infection in vitro. Applicability to SARS-CoV-2 is being assessed by researchers at Belgium’s University of Ghent and the First Affiliated Hospital at SYSU. Financial terms were not disclosed.
Shionogi & Co. Ltd., of Osaka, Japan, said it is working with public institutions, academic researchers and partner companies to accelerate development of vaccine and therapeutic candidates against COVID-19. The company initiated a collaborative research effort with the Hokkaido University Research Center for Zoonosis Control to identify drugs active against COVID-19 and identified multiple potential lead compounds from internal in vitro studies. Shionogi said it aims to start clinical trials of one or more of those agents by year-end. Additionally, UMN Pharma Inc., a Shionogi unit, is pursuing discovery and development of a recombinant protein vaccine for COVID-19 using its Baculovirus Expression Vector System technology. The project, which began in March 2020, is supported by the Japan Agency for Medical Research and Development. Shionogi plans to start clinical trials in Japan within the year.
Stabilitech Biopharma Ltd., of Burgess, U.K., is seeking an investment of £6 million (US$7.56 million) to fund clinical development and manufacturing of its oral coronavirus vaccine, OraPro-COVID-19. The DNA-based vaccine is delivered via an adenovirus, which induces expression of the spike protein of the novel coronavirus.
Teva Pharmaceuticals USA Inc., of Parsippany, N.J., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare Co. Ltd., of Incheon, South Korea, said Truxima (rituximab-abbs), its biosimilar to Rituxan, is now available in the U.S. for treatment of rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis, following its January approval by the FDA. Truxima gained FDA approval initially in November 2018 for use in CD20-positive, B-cell non-Hodgkin lymphoma, and was launched for that indication a year later. The companies said Truxima is the only Rituxan biosimilar available for RA in the U.S. Earlier this year, the Centers for Medicare and Medicaid Services granted pass-through status for Truxima in the hospital outpatient setting. The wholesale acquisition cost (WAC) will be 10% lower than the reference product, and is expected to be available through primary wholesalers at a WAC of $845.55 per 100-mg vial and $4,227.75 per 500-mg vial.
Union Therapeutics A/S, of Copenhagen, Denmark, is collaborating with Institut Pasteur Korea to test an optimized salt form of niclosamide as a treatment of COVID-19. In vitro studies showed the drug was 25 times more potent than chloroquine and more than 40 times more potent remdesivir (Gilead Sciences Inc.).
Vaxart Inc., of South San Francisco, reported preclinical data for its COVID-19 vaccine candidates, several of which induced immune responses after a single dose. The company plans to start a phase I study in the second half of 2020.
Verndari Inc., of Sacramento, Calif., said it plans to start preclinical testing of a potential COVID-19 coronavirus vaccine, which will be administered using Vaxipatch, a microneedle array dermal patch.
Vir Biotechnology Inc., of San Francisco, and Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said they selected a development candidate for VIR-2703 (also referred to as ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 genome. The companies plan to soon meet with the FDA and other regulatory authorities to discuss a potential accelerated path for filing an IND or IND-equivalent application at or around year-end 2020. The companies said they plan to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19.
Viralclear Pharmaceuticals Inc., a subsidiary of Westport, Conn.-based Biosig Technologies Inc., submitted an article highlighting preclinical data on the use of merimepodib with remdesivir (Gilead Sciences Inc.) as a treatment for COVID-19 to an online peer-reviewed life sciences journal. The combination reduced replication of SARS-CoV-2 replication to undetectable levels in vitro. Viralclear plans to start clinical development of merimepodib in the second quarter of 2020.
Vistagen Therapeutics Inc., of South San Francisco, said it plans to expand clinical development of its vomeropherin compound-based PH-94B to include treatment of adjustment disorder due to stressors related to the COVID-19 pandemic. It plans to submit its proposed protocol for a phase II study of the candidate in the indication through the FDA's new Coronavirus Treatment Acceleration Program. The regulator previously designated PH-94B for fast track development for treatment of social anxiety disorder, an indication in which Vistagen is preparing for phase III development.
Wuxi Biologics Co. Ltd., of Shanghai, is collaborating with Aravive Inc., of Houston, to develop antibodies targeting CCN2. Wuxi will be responsible for discovery and manufacturing. Aravive will do the preclinical and clinical development. Financial terms of the deal weren't disclosed.
Xbiotech USA Inc., of Austin, Texas, has identified patients with antibodies to the novel coronavirus that causes COVID-19 who didn't have serious illness. The company plans to use its True Human antibody platform to identify the genes responsible for producing the antibodies in those individuals.
Xortx Therapeutics Inc., of Calgary, Alberta, contracted with Lonza Pharma & Biotech, a unit of Lonza Group AG, of Basel, Switzerland, to manufacture oxypurinol, the active ingredient for XRx-101 and Xrx-008. Xortx is discussing the development of XRx-101 for COVID-19 and Xrx-008 for autosomal dominant kidney disease with regulatory agencies and plans to begin clinical development in May.