AGC Biologics Inc., of Seattle, said it partnered with Ono Pharmaceutical Co. Ltd., of Osaka, Japan, to manufacture biopharmaceuticals at the clinical development stage. Financial terms were not disclosed.
Ajinomoto Bio-Pharma Services, of Wetteren, Belgium, said it began expanding its small-molecule manufacturing capabilities by adding a new production facility in Visakhapatnam, India. Construction of the 8,500-square-meter facility began in July and should be completed in mid-2022. The facility doubles production capacity at the site to 310 m3 for active pharmaceutical ingredients and intermediates. Ajinomoto is a biopharmaceutical contract development and manufacturing services company.
Akcea Therapeutics Inc., of Boston, said the German Association of Statutory Sick Funds agreed on new pricing and reimbursement of Waylivra (volanesorsen) as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome who are at high risk for pancreatitis and in whom response to diet and triglyceride-lowering therapy has been inadequate. Waylivra has been commercially available in Germany since August 2019. As part of reimbursement and market access protocol in Germany, Akcea was required to renegotiate the Waylivra launch price 12 months after first commercialization, which goes effect Aug. 15. Familial chylomicronemia syndrome is an ultra-rare disease caused by impaired function of the enzyme lipoprotein lipase and characterized by severe hypertriglyceridemia and a risk of unpredictable and potentially fatal acute pancreatitis.
Alimera Sciences Inc., of Atlanta, said its Ireland-based European subsidiary, Alimera Sciences Europe Ltd., signed a distribution agreement with Nordic Prime ApS to serve as Alimera’s distribution partner in Denmark, Finland, Norway and Sweden for Iluvien 190 mcg intravitreal implant in applicator. Iluvien is approved in those territories for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. Under the agreement, Nordic Prime will engage in hospital tendering activities to secure purchasing agreements of Iluvien across the Nordic region and is responsible for shipping of orders and maintaining all back-office support for Nordic customers.
Anixa Biosciences Inc., of San Jose, Calif., and partner Ontochem GmbH, of Halle, Germany, identified additional COVID-19 candidates through their in silico screening study. In addition to four compounds that target an endoribonuclease (also known as NSP-15) and one additional core compound that targets the main protease (Mpro) of the virus, Anixa and Ontochem identified 26 compounds targeting Mpro.
Applied Stemcell Inc., of Milpitas, Calif., said it was awarded close to $2 million in a Small Business Innovation Research grant from the U.S. NIH. The fast track phase I/II award will support work to advance and improve the efficiency of the firm’s Targatt integrase technology for human gene therapies.
Biological E. Ltd., of Hyderabad, India, said it licensed the recombinant protein COVID-19 vaccine candidate developed at Baylor College of Medicine. The company will leverage its past experience for the further development and commercialization of the vaccine candidate, which currently is produced using a yeast-based expression technology. The current focus is on transfer of the technology for BE to initiate scale-up of the manufacturing process and undertake further development of the vaccine candidate.
Calliditas Therapeutics AB, of Stockholm, said it reached an agreement to acquire a controlling interest in Genkyotex SA, of Saint-Julien-en-Genevois, France. Genkyotex's lead candidate, setanaxib (GKT-831), is in development for primary biliary cholangitis (PBC), a chronic orphan liver disease resulting from progressive destruction of the liver’s bile ducts. In a phase II trial, setanaxib demonstrated evidence of antifibrotic activity combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue, Calliditas said. In April, Genkyotex completed an end-of-phase II meeting with the FDA and in June obtained guidance from the EMA’s Scientific Advice Working Party regarding late-stage development and potential registration of setanaxib in PBC. Calliditas will acquire 7.23 million ordinary shares of Genkyotex, representing 62.7% of the share capital and voting rights of its largest shareholders and management team, for a total consideration of €20.3M (US$26.55 million). Calliditas will also acquire nontransferable contingent rights to receive additional cash payments on confirmation of regulatory approvals or marketing authorizations of setanaxib.
Cerecor Inc., of Rockville, Md., said a paper published in mSphere reported elevated free levels of the inflammatory cytokine, LIGHT, in the serum of individuals hospitalized with severe COVID-19 infection, highlighting its potential role in the development of COVID-19-related acute respiratory distress syndrome (ARDS) and supporting Cerecor’s ongoing phase II program evaluating CERC-002, an anti-LIGHT (TNFSF14) monoclonal antibody, to treat individuals with severe COVID-19-related ARDS.
Certara LP, of Princeton, N.J., said it launched an international registry of health care workers to collect information on risk factors for developing COVID-19 and using preventive therapies. The registry will enable prevention policies to be informed by real-world data collected from 10,000 health care workers in low- and middle- income countries. The registry is for assessing the association between the use of preventive treatments and the occurrence of SARS-CoV-2 infection in health care workers caring for patients with COVID-19. Additional countries preparing for launch of the registry include South Africa, Nigeria, Kenya, Uganda, Senegal, Zambia and Zimbabwe. The registry collects information on a weekly basis from enrollees across a 12-week period. Data collection includes medications being taken by health care workers, their level of exposure to COVID-19 patients, their health status and other factors such as the use of personal protective equipment. In addition, the registry will record SARS-CoV-2 antibody test results.
Dynavax Technologies Corp., of Emeryville, Calif., said it received a grant from the Bill & Melinda Gates Foundation of $3.4 million to scale up production batch size to allow for increased capacity of Dynavax’s CpG 1018 advanced adjuvant to support the global COVID-19 response. Those efforts will support capacity of up to 750 million adjuvant doses annually, which can be further increased if needed.
Geovax Labs Inc., of Atlanta, said it will collaborate with the University of Texas Medical Branch and Battelle Memorial Institute to develop Sudan Ebolavirus and Marburg virus vaccine candidates. Both cause viral hemorrhagic fevers. The candidates will be tested for immunogenicity and efficacy in the benchmark nonhuman primate model. Studies will include two vaccine regimens – single-dose and prime/boost immunization – for each vaccine. Animals will receive a lethal dose of either following corresponding vaccine inoculations and will be monitored for morbidity and mortality. Additionally, the humoral and cellular immune responses to vaccination will be evaluated.
Heat Biologics Inc., of Durham, N.C., reported preclinical data, generated at the University of Miami Miller School of Medicine, showing the firm’s gp96-based COVID-19 vaccine demonstrated robust T-cell-mediated immune response directed against the spike protein of SARS-CoV-2. The vaccine induced the expansion of both killer CD8+ T cells that destroy virus-infected cells, as well as helper CD4+ T cells that assist in producing highly specific antibodies. Both T-cell subsets were shown to release cytokines that amplify the antiviral immune response and, upon vaccination, memory CD8+ T cells migrated to the lungs and airways, the tissue-specific site of interest for SARS-CoV-2 infection.
Isofol Medical AB, of Gothenburg, Sweden, said it entered a license agreement with Solasia Pharma KK, of Tokyo, to develop and commercialize Isofol’s late-stage candidate, arfolitixorin, in Japan. Under the terms, Isofol will receive a total amount of SEK890 million (US$100 million) as up-front, development, regulatory and sales-based milestone payments and clinical development cost. Isofol also will receive tiered royalties on net sales in double-digit figures.
Micurx Pharmaceuticals Inc., of Foster City, Calif., said the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has committed up to $7.78 million of nondilutive financing for a phase I trial and related R&D activities of its new antimicrobial agent MRX-8. Previously, CARB-X has funded IND-enabling studies for MRX-8 in the U.S.
Newly published research from Olaregen Therapeutix Inc., a subsidiary of Generex Biotechnology Corp., of Miramar, Fla., described using the Excellagen wound conforming collagen matrix as part of a hybrid surgical protocol to repair a femoral artery pseudoaneurysm. Femoral artery pseudoaneurysms are the most common complication following cardiac and peripheral angiographic procedures, with an incidence ranging from 2% to 6% following interventional procedures. A pseudoaneurysm occurs when a blood vessel wall is injured and the leaking blood collects in the surrounding tissue. While small pseudoaneurysms (< 2 cm) often clot spontaneously, larger pseudoaneurysms involving blood sac expansion, vascular symptoms and surrounding hematoma confer a risk of rupture and warrant surgical intervention to prevent serious complications including death, the company said. The hybrid technique avoided surgical exploration in the face of active hemorrhage, expedited culprit vessel identification, avoided the need for remote percutaneous arterial puncture, reduced blood loss and minimized overall operative time, the company said. Excellagen is a 3D wound conforming matrix that supports wound healing. It is designed to activate collagen, accelerate granulation and promote new tissue growth by providing a structural scaffold for cellular migration and proliferation.
Novavax Inc., of Gaithersburg, Md., and SK Bioscience, a vaccine business subsidiary of Seoul, South Korea-based SK Group, said they inked a development and supply agreement for the antigen component of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, for supply to global markets, including the COVAX facility. In addition, the companies have signed a letter of intent with the Republic of Korea’s Ministry of Health and Welfare to work toward broad and equitable access to NVX-CoV2373 for the global market as well as to make the vaccine available in South Korea. Under the terms, SK Bioscience will manufacture the vaccine antigen component for use in the final drug product globally during the pandemic period. It will initiate the production beginning this month.
Photocure ASA, of Oslo, Norway, said it appointed privately held Genotests SpA, of Santiago, Chile, as exclusive partner for commercializing Hexvix in Chile. Genotests will fund all regulatory and commercialization costs. Photocure will manufacture the product and support Genotests with regulatory file, training and promotional materials. Hexvix is selectively taken up by tumor cells in the bladder making them glow bright pink during blue light cystoscopy to detect tumors.
Qbiotics Group Ltd., of Brisbane, Australia, said it entered an agreement with Merck & Co. Inc., of Kenilworth, N.J., (MSD outside the U.S.) to evaluate use of its lead molecule, tigilanol tiglate, in combination with Keytruda (pembrolizumab) in patients with unresectable melanoma. The phase I/II open-label trial is designed to determine the maximum tolerated dose or maximum feasible dose of the combination therapy. Secondary measures include assessing tumor responses in both injected tumors and uninjected tumors, as well as clinical efficacy parameters. Tigilanol tiglate is a small molecule administered by intratumoral injection directly into the solid tumor mass.
Redhill Biopharma Ltd., of Tel Aviv, Israel, said it entered a binding term sheet with Cosmo Pharmaceuticals NV, of Dublin, for an exclusive licensing and manufacturing agreement for multiple products. The transaction is expected to close in the coming weeks. Pursuant to the agreement, the companies will co-develop a next-generation therapy for the eradication of H. pylori infection. Cosmo is to receive the exclusive European rights to the new drug and will pay Redhill $7 million upon signing of the license agreement and an additional $2 million upon approval in Europe, and 30% royalties. The companies plan to jointly execute clinical trials pursuing simultaneous regulatory approvals in the U.S. and Europe, with a cost split of 70% for Redhill. Cosmo will become the exclusive worldwide manufacturer for Movantik (naloxegol), which Redhill recently acquired from Astrazeneca plc, of Cambridge, U.K., and RHB-204 for pulmonary nontuberculous mycobacteria infections. Cosmo will be paid €5.5 million (US$6.5 million) for tech transfer, formulation and development work with respect of those products. Additionally, Cosmo will finance the planned pivotal phase III study with RHB-204, which recently received FDA clearance to proceed, with a payment of $5 million upon signing of the agreement and an additional $7 million in two milestone payments. Cosmo will be entitled to 15% royalty payments.
Sorrento Therapeutics Inc., of San Diego, said it believes it has uncovered fraudulent attempts to manipulate the company’s stock. On Aug. 11, it was reported that an organization calling itself “Hindenburg Research” published claims regrading one of Sorrento’s COVID-19 diagnostic products. The report is believed to include false and/or misleading statements for the sole apparent purpose of negatively manipulating the company’s stock price. Sorrento said it will collaborate with law enforcement and regulators to ensure that any criminal activity is investigated and rectified.
Strata Oncology Inc., of Ann Arbor, Mich., said it signed a deal with Mirati Therapeutics Inc., of San Diego, to broaden patient identification and enrollment for Mirati's phase I/II study of MRTX-849 in patients with cancer having a KRAS G12C mutation. Under the terms of the agreement and through the Strata Trial, Strata Oncology will identify patients with advanced solid tumors who have a KRAS G12C mutation and meet other eligibility criteria, to be considered for enrollment. The Strata Trial is an ongoing observational study providing tumor molecular profiling for patients with advanced cancer paired with a portfolio of biomarker-guided clinical trials.