Abbvie Inc., of North Chicago, said it extended the expiration date of the offers to exchange all outstanding notes of certain series issued by Allergan Finance LLC, Allergan Inc., Allergan Sales LLC, and Allergan Funding SCS for new Abbvie notes, from May 1 to May 8.
Arcturus Therapeutics Holdings Inc., of San Diego, reported immunogenicity data from its preclinical study for its COVID-19 vaccine, LUNAR-COV19, as measured by Duke-NUS Medical School in Singapore. Rodents were immunized with a single dose (0.2 µg, 2 µg and 10 µg, i.m.) of the vaccine, and the results showed self-transcribing and replicating (STARR) mRNA induced higher seroconversion relative to conventional mRNA at equivalent doses. It was found that 100% of animals seroconverted by day 19 at a low dose (2 µg). The company said the vaccine remains on track to begin human clinical trials this summer. Shares of Arcturus (NASDAQ:ARCT) gained $7.96, or 35%, to close April 27 at $30.53.
Bioaegis Therapeutics Inc., of Morristown, N.J., said recently published gene expression data in animal studies showed recombinant human plasma gelsolin (rhu-pGSN) significantly increased survival in pneumonia due to severe influenza. The gene expression analysis of lung tissue showed that gelsolin treatment down-regulated genes associated with the overexuberant production of cytokines and other proinflammatory mediators often seen with infections such as COVID-19, the company said. Gelsolin-treated subjects have been shown to have less lung damage than those not treated. The genetic analysis in that study also found that gelsolin treatment up-regulated specific genes known to promote tissue repair. Those data together with the substantial body of previously published research gives substantial support to the potential for gelsolin supplementation to prevent the morbidity and mortality seen in the ongoing COVID-19 pandemic, Bioaegis said.
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn., said it entered an agreement with Genpharm Services to distribute Nertec ODT (rimegepant), a calcitonin gene-related peptide receptor antagonist available in a fast-acting orally disintegrating tablet approved for the acute treatment of migraine, in the Middle East and Gulf countries.
The Coalition for Epidemic Preparedness Innovations will invest an initial $3.5 million in Clover Biopharmaceuticals AUS Pty Ltd., a wholly owned subsidiary of China-based Sichuan Clover Biopharmaceuticals Inc., bringing its total investment in COVID-19 vaccine R&D to $39.6 million. The investment supports Clover’s initiation of a phase I trial in Australia using the company platform to produce the spike proteins of the COVID-19 virus in a native trimeric form for use in a vaccine.
Crestone Inc., of Boulder, Colo., received a grant from the NIH for the preclinical evaluation of Crestone’s drug candidate, CRS-3123, a small molecule that selectively inhibits methionyl-tRNA synthetase and is not affected by resistance to any existing classes of antibiotics. The candidate will be tested for pharmacokinetic properties and efficacy in an established preclinical model of H. pylori infection of the stomach. CRS-3123 will be compared to standard triple or quadruple drug therapy, with or without the addition of proton pump inhibitor to reduce stomach acid.
Preclinical data from Effector Therapeutics Inc., of San Diego, showed antitumor activity of zotatifin in preclinical models of FGFR1, FGFR2 and HER2-driven cancers, demonstrating the potential of zotatifin in receptor tyrosine kinase (RTK)-driven cancers. In a HER2-positive breast cancer model, tumor regression was sustained long after cessation of therapy, the company said. Evaluation of predictive markers of sensitivity or resistance showed that RTK tumor models with mTOR-mediated activation of eIF4A are most sensitive to zotatifin.
Faron Pharmaceuticals Oy, of Turku, Finland, will donate supplies of its investigational intravenous interferon beta-1a for 2,000 patients in the World Health Organization's Solidarity trial investigating potential COVID-19 treatments. The global Solidarity trial is comparing four treatment options against standard of care to assess their relative effectiveness against COVID-19 - remdesivir; lopinavir/ritonavir; lopinavir/ritonavir with IFN beta-1a; and chloroquine or hydroxychloroquine. More than 90 countries are involved in the trial.
New clinical data from Flexion Therapeutics Inc., of Burlington, Mass., show FX-301, its locally administered peripheral nerve block candidate for control of postoperative pain, demonstrated sustained analgesic effect in a preclinical surgical pain model for the duration of the study following a single injection of FX-301 with no impairment of motor function. The study evaluated the efficacy and pharmacokinetic profile of FX-301 following ultrasound-guided sciatic nerve block in a validated postoperative pain model in pigs. The pigs were divided into three study groups, anesthetized and given a single 10-ml injection of either FX-301 (13 mg/mL; total dose 130 mg), liposomal bupivacaine (13.3 mg/mL; total dose 133 mg) or placebo (normal saline) in close proximity to the sciatic nerve prior to receiving a surgical incision on the hind limb. Pain was assessed at one, four, eight, 12, 24, 36, 48 and 72 hours post-injection. Motor function was evaluated at two and 24 hours post-injection. FX-301 is a locally administered NaV1.7 inhibitor product candidate, known as funapide, formulated for extended release in a thermosensitive hydrogel.
Harpoon Therapeutics Inc., of South San Francisco, said dosing of the first participant in a phase I/II trial of its APRIL receptor/albumin/CD3 modulator HPN-217 in relapsed/refractory multiple myeloma triggered a $50 million milestone payment under its global license and option agreement with Abbvie Inc., of North Chicago. The deal, signed in November 2019, expanded an existing immuno-oncology research alliance formed by the companies two years earlier. A licensing option for HPN-217 may be exercised by Abbvie up to completion of the phase I/II trial. Harpoon’s shares (NASDAQ:HARP) gained on the news, adding $1.30, or about 10.5%, on April 27 to close at $13.73.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said it was told by researchers at the U.S. Regional Biocontainment Laboratory that continued COVID-19 testing of brilacidin, the company’s defensin-mimetic drug candidate, will begin May 4. Results from initial testing showed brilacidin had antiviral activity against SARS-CoV-2 in Vero cells, a screening assay using a monkey epithelial cell line. Innovation said preclinical and clinical data support brilacidin’s potential to inhibit production of IL-6, IL-1β, TNF-alpha and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of COVID-19 patients. Brilacidin’s antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20% of COVID-19 patients, the company added.
JCR Pharmaceuticals Co. Ltd., of Ashiya, Japan, said it has completed its acquisition of Armagen Inc., of San Diego, providing JCR with a full access to Armagen’s portfolio of intellectual property rights applicable to a broad disease spectrum, including lysosomal storage disorders (LSDs) in several key markets that Armagen owns. JCR said it plans to bring JR-141 as its first LSD program to global development, with pivotal trials planned for the U.S. and Europe. Other programs in the LSD pipeline that are also considered by JCR as a high priority for global development include JR-171 for mucopolysaccharidosis (MPS) I, JR-441 for MPS IIIA, JR-162 for Pompe disease, JR-443 for MPS VII and JR-446 for MPS IIIB. JR-141 is a fusion protein consisting of an antibody against the transferrin receptor and iduronate-2-sulfatase, an enzyme deficient in MPS II.
Kamada Ltd., of Rehovot, Israel, and Kedrion Biopharma Inc., of Castelvecchio Pascoli, Italy, will collaborate to develop, manufacture and distribute a human plasma-derived anti-SARS-CoV-2 polyclonal immunoglobulin to treat coronavirus patients. Kedrion will provide plasma from donors who have recovered from the virus and, upon receipt of regulatory approvals, will be responsible for commercialization of the product in the U.S., Europe, Australia and South Korea. Kamada is responsible for product development, manufacturing, clinical development, with Kedrion’s support, and regulatory submissions. Kamada will also assume distribution responsibility in all territories outside of those Kedrion is responsible for. Marketing rights for the product in China will be shared.
Merck & Co. Inc., of Kenilworth, N.J. and the Seattle-based Institute for Systems Biology announced a new research collaboration to investigate and define the molecular mechanisms of SARS-CoV-2 infection and COVID-19 and identify targets for medicines and vaccines. Findings generated from the study, funded in part with support from the U.S. Biomedical Advanced Research and Development Authority, will be made available to the worldwide scientific and biomedical community, Merck said.
Orgenesis Inc., of Germantown, Md., has completed its acquisition of assets from Tamir Biotechnology Inc., of Monmouth Junction, N.J., including the antiviral ranpirnase, a ribonuclease under development for the potential treatment of human papillomavirus, the world's leading cause of genital warts. Orgenesis plans to move the program through a phase IIb trial in the U.S.
Pharmacyte Biotech Inc., a Laguna Hills, Calif.-based company developing cellular therapies for cancer and diabetes, said it completed FDA-mandated pyrogenicity testing of the encapsulation material used to manufacture its Cell-in-a-Box capsules, or Cypcaps. Pyrogens are fever-inducing substances that can cause side effects and influenza-like symptoms. The capsules passed the test and are deemed non-pyrogenic.
Recursion Pharmaceuticals Inc., of Salt Lake City, released its open-source RxRx19 dataset, which it said was the first human cellular morphological dataset of SARS-CoV-2. The dataset was derived from experiments the company led, in collaboration with Utah State University, to investigate the therapeutic potential of a library of 1,672 FDA- and EMA-approved or clinical-stage compounds for modulation of the effect of SARS-CoV-2 in human renal cortical epithelial cells.
Redhill Biopharma Ltd., of Tel Aviv, Israel, said six patients hospitalized with moderate to severe acute respiratory symptoms related to SARS-CoV-2 infection and treated with standard of care showed objective, measurable clinical improvement within days following initiation of compassionate use treatment with opaganib (Yeliva, ABC-294640), the company’s sphingosine kinase-2 inhibitor. Improvements included decrease in required supplemental oxygenation, higher lymphocyte counts and decreased C-reactive protein levels. Five of the patients were weaned from oxygen, and three were discharged from the hospital within days of treatment initiation. The sixth patient continues to improve. Redhill’s shares (NASDAQ:RDHL) rose 12.1% on April 27, gaining 94 cents to close at $8.54.
Santhera Pharmaceuticals Holding AG, of Pratteln, Switzerland, said it plans to collaborate with Cold Spring Harbor Laboratory (CSHL) to investigate the potential of lonodelestat (POL-6014), an inhibitor of human neutrophil elastase (hNE), as a therapeutic intervention for COVID-19-related acute respiratory distress syndrome. Researchers at CSHL are part of the NETwork to target neutrophils in COVID-19, a consortium of international experts assessing the role of neutrophils and neutrophil extracellular traps, or NETs, in the pathology of COVID-19, hNE and other potential targets for treating COVID-19. Santhera will provide the study drug and intellectual support for the CSHL scientists.
Selvita SA, of Krakow, Poland, said it signed a grant agreement with the National Centre for Research and Development to develop a cell-based phenotypic platform based on a high content imaging system integrated with artificial intelligence (AI) data analysis to explore multiple therapeutic areas, including neuroinflammatory and fibrosis drug discovery. The grant of approximately €1.05 million (US$1.1 million) will be executed in a consortium with Ardigen SA, also of Krakow, a bioinformatics company harnessing advanced AI to develop precision medicines. During the three-year project, Selvita will be responsible for developing two sets of cellular tests from specified therapeutic areas capable of generating images for AI analysis.
Tetra Bio-Pharma Inc., of Ottawa, said it plans to add management of cytokine release syndrome as a potential indication for PPP-003, a synthetic cannabinoid drug that selectively acts at the type 2 cannabinoid receptor and is in development by Tetra subsidiary Panag Pharma Inc. PPP-003, which has completed preclinical efficacy and proof-of-concept studies in sepsis, may be useful as a candidate to help reduce symptoms of acute lung inflammation and immune system dysregulation in individuals with COVID-19 infection, according to Tetra.
Trilink Biotechnologies Inc., of San Diego, a portfolio company of Maravai Lifesciences Inc., of San Diego, and Imperial College London said they formed a partnership in which Trilink will manufacture self-amplifying RNA for COVID-19 vaccine development led by Robin Shattock, head of mucosal infection and immunity in Imperial’s department of infectious disease.
Valo Therapeutics Ltd., of Oxford, U.K., said it is working to develop a potential COVID-19 vaccine with applications across future pandemics using its Pepticrad technology to coat an undisclosed adenovirus vaccine vector engineered to express coronavirus-associated spike proteins, with HLA-matched peptides optimized to boost CD8-positive T-cell immune responses.
An Institute for Clinical and Economic Review (ICER) report assessed the comparative clinical effectiveness and value of elexacaftor/tezacaftor/ivacaftor (Trikafta from Vertex Pharmaceuticals Inc.) to treat cystic fibrosis (CF). ICER also examined new data that have become available since its May 2018 review of three related CF treatments: ivacaftor (Kalydeco, Vertex), lumacaftor/ivacaftor (Orkambi, Vertex) and tezacaftor/ivacaftor (Symdeko, Vertex). All four therapies are CFTR modulators. Trikafta earned ICER’s highest “A” evidence rating: For the indicated populations where clinical data exist, the evidence provides high certainty that Trikafta provides a substantial net health benefit over standard care and over Symdeko, ICER concluded. In addition, although Trikafta has not yet been studied in patients who are heterozygous for the F508del mutation and a residual function mutation, ICER determined that using Trikafta to treat that subpopulation is likely to be at least as good as treating with Symdeko, and possibly better. For the other three related treatments, ICER said the evidence provides high certainty that Kalydeco provides a substantial net health benefit, Orkambi provides a small net health benefit and Symdeko provides at least a small net health benefit with the potential for a substantial benefit.