Acelrx Pharmaceuticals Inc., of Redwood City, Calif., will acquire Watertown, Mass.-based Tetraphase Pharmaceuticals Inc. in an all-stock deal giving Tetraphase equity owners 14.6% of the company and up to $12.5 million in contingent value rights. The deal is expected to close in the second quarter of 2020.
Akebia Therapeutics Inc., of Cambridge, Mass., said business and operational continuity plans are in effect during the COVID-19 outbreak and the company remains confident that its resources are sufficient to perform the work needed to complete clinical programs for vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor. The company reported cash, equivalents and marketable securities of $147.7 million as of Dec. 31, 2019, and said this month that its cash runway extends well into 2021. Akebia does not plan to use its at-the-market financing program until, at the earliest, it reports top-line data from the fully enrolled phase III Inno2vate program.
Amarin Corp. plc, of Dublin, said the coronavirus is not expected to have a major impact on its ability to supply Vascepa (icosapent ethyl) to patients. The company said its diversified supply chain mitigates geographic risks posed by the COVID-19 pandemic, since it does not manufacture product in China and previously built stockpiles of Vascepa for use in the U.S. and in other countries where the product is approved for sale.
Privately held generics manufacturer Armas Pharmaceuticals Inc., of Manalapan, N.J., said it was taking steps to ensure that products were consistently available in its supply channel to mitigate any shortages caused by COVID-19 and that it does not expect any disruptions to customers.
Athenex Inc., of Buffalo, N.Y., provided an update in light of the coronavirus pandemic, stating that its operational plans remain on track and its current assessment is that the NDA submission for oral paclitaxel and prelaunch preparations for oral paclitaxel and tirbanibulin ointment should not be affected. While the company’s China operations in Chongqing were impacted by the coronavirus situation, it reported that operations resumed in the first week of March.
Brainstorm Cell Therapeutics Inc., of New York, said it secured funding to allow the company to complete strategic business milestones and activated a senior management team to provide timely responses to external events surrounding the COVID-19 pandemic, enabling it to ensure continuity of operations and timely completion of clinical and preclinical milestones.
Correvio Pharma Corp., of Vancouver, British Columbia, said it agreed to the acquisition of its issued and outstanding shares by Advanz Pharma Corp. Ltd., of London. The deal, which will be executed through Advanz Pharma’s wholly owned subsidiary, Mercury Pharma Group Ltd., represents a total consideration of approximately $76 million, including repayment of Correvio’s outstanding debt of approximately $48 million. Advanz agreed to pay 42 cents per issued and outstanding share, valuing Correvio’s equity at approximately $28 million on a fully diluted basis. Advanz expects to fund the acquisition with cash on hand, reported as $243 million as of Sept. 30, 2019. The boards of both companies unanimously approved the transaction. The deal is expected to close during the second quarter of 2020. In connection with the transaction and subject to closing, Correvio will apply to have its shares delisted from the Toronto Stock Exchange and Nasdaq, where shares (NASDAQ:CORV) gained 3 cents on March 16 to close at 34 cents.
Homology Medicines Inc., of Bedford, Mass., said preclinical data showed that a single administration of its PAH gene therapy, HMI-102 (AAVHSC15-PAH), reduced serum phenylalanine (Phe) concentrations to normal levels within one week in a phenylalanine murine model and that mean levels remained in the normal range, below 120 µM, over the course of the 48-week study. A corresponding increase in Tyr concentration also was observed, indicating restoration of the Phe/Tyr metabolic pathway, and administration of HMI-102 was associated with an increase in 5-HIAA and a decrease in Phe in the brain to normal levels. The findings were published in Molecular Therapy: Methods & Clinical Development.
Medivir AB, of Stockholm, said it inked a license agreement covering one of its preclinical programs with Tango Therapeutics Inc., of Cambridge, Mass., in exchange for up-front, development and commercial milestone payments, all undisclosed, and low single-digit product royalties.
Nanoviricides Inc., of Shelton, Conn., said it completed the synthesis of multiple nanoviricide drug candidates for testing following identification of virus-binding ligands associated with SARS-CoV-2. The company acquired and expanded two low-threat circulating coronaviruses in its BSL2 lab and expanded them to enable testing of drug candidates. One of those, NL63, uses the same ACE2 receptor on human cells as SARS-CoV-2 but does not cause similarly severe disease in humans. Effectiveness of test candidates in the cell culture studies against coronaviruses would provide a rationale for effectiveness against SARS-CoV-2, according to Nanoviricides. The company is seeking to establish collaborations to enable additional testing of its drug candidates against the current coronavirus. In the meantime, Nanoviricides expects to begin testing its drug candidates against the BSL2 coronavirus strains in its BSL2 virology lab. Despite the plummeting markets, on March 16 the company’s shares (NYSE American:NNVC) gained 6%, adding 42 cents to close at $7.28.
Pharmamar SA, of Madrid, said that in vitro studies of Aplidin (plitidepsin) on the human coronavirus HCoV-229E, which has a multiplication and propagation mechanism similar to the SARS-CoV-2 virus that causes COVID-19, were positive, with potency of the nanomolar order. The studies, performed at the National Biotechnology Centre of the Spanish National Research Council, confirmed the hypothesis that the therapeutic target of Aplidin, elongation factor 1 alpha 2, is key to the multiplication and spread of the coronavirus. Pharmamar plans to contact regulatory authorities to discuss the possibility of conducting studies of Aplidin, originally advanced to treat cancer, on individuals with COVID-19.
Protalix Biotherapeutics Inc., of Carmiel, Israel, said it agreed to conduct a feasibility study with Kirin Holdings Co. Ltd., of Tokyo, to evaluate production of a complex protein using its Procellex plant cell-based protein expression system. Kirin agreed to provide research funding for Protalix scientists to conduct cell line engineering and protein expression studies on the target protein. If the study succeeds, Kirin and Protalix expect to discuss a licensing agreement of Procellex to Kirin to continue the program’s development.
Spherix Inc., of New York, said it completed its name change to Aikido Pharma Inc. and began trading on Nasdaq under the ticker AIKI. The change reflects the company's increased focus on using artificial intelligence and machine learning to accelerate drug development. The company said Aikido also is a martial art known for using an opponent's efforts against that opponent, alluding to its vision to develop technologies that use cancer's own attributes against the disease.
Therapeuticsmd Inc., of Boca Raton, Fla., said it does not expect a shortage in its product supply line due to COVID-19, adding that it has an inventory of finished products to meet demand through at least the early third quarter of 2020. The company also said its wholesale and retail distribution chains remain uninterrupted. Therapeuticsmd products include Bijuva for reducing moderate to severe hot flashes and Imvexxy, an estrogen hormone for treating menopausal symptoms.
Twist Bioscience Corp., of South San Francisco, Calif., announced the availability of research-use only target enrichment next-generation sequencing panels for viral detection and characterization of samples from patients testing positive for SARS-CoV-2, which causes COVID-19. The panels can be used for environmental monitoring and surveillance testing, while also providing insight into full sequence information to track viral evolution and strain origin. The target enrichment panels are in three reaction sizes for various workflows, with synthetic double-stranded DNA probes covering the length of the SARS-CoV-2 virus. Next-generation sequencing offers high-throughput, specific identification of infections in several sample types, including blood, nasal swab and feces. For viral infections, obtaining genetic material sufficient for sequencing can be a challenge due to low levels of virus often present. For those infections, target enrichment using DNA-based hybridization probes to isolate specific sequences out of a mixed genomic sample can increase the sensitivity and specificity of NGS-based efforts.
Earlier this year, Xavier Saelens (the VIB-UGent Center for Medical Biotechnology) said it discovered a single-domain antibody (VHH) capable of binding the SARS-CoV-2 spike protein of COVID-19. The lab team said it established that Fc fusions of the VHH can neutralize pseudotyped SARS-CoV-2 and that the neutralizing VHH can be produced in large-scale production processes common in the biopharmaceutical industry.
Xortx Therapeutics Inc., of Calgary, Alberta, is researching the use of XRx-101, a formulation of oxypurinol, to treat acute kidney and lung injury accompanying coronavirus infection and specifically for COVID-19 infection. The company, which reviewed recent studies characterizing the outbreak of COVID-19 in mainland China, reported illustrating that acute kidney injury and acute pulmonary injury are key factors in the most serious cases of COVID-19 hospitalization and death. Xortx said it plans to manufacture and submit INDs for XRx-008’s planned phase III trial in autosomal dominant polycystic kidney disease.