89bio Inc., of San Francisco, reported that BIO89-100, its FGF receptor agonist and FGF-21 ligand, showed activity at low nanomolar concentrations in cells co-expressing beta-klotho and each of FGF receptors 1c, 2c or 3c in an in vitro study of receptor agonism. The company said the preclinical data suggested the candidate could reproduce the beneficial metabolic benefits of the native hormone.
Alimera Sciences Inc., of Atlanta, said it expects to report more than $14 million in consolidated net revenue for the first quarter of 2020 compared to $12.9 million in the first quarter of 2019. The growth occurred despite the increasing impact of the COVID-19 pandemic in the second half of the quarter, explained Rick Eiswirth, president and CEO. However, going forward, he expected the isolation and quarantine orders around the world will limit patient access to physicians and patients’ willingness to visit physicians, and that environment will have an adverse effect on business. The company said it believes it currently has sufficient inventory in its supply chain to meet demand for retinal diseases drug Iluvien and said it is working with its third-party manufacturers regarding the continued production of the drug during the pandemic.
Cannabics Pharmaceuticals Inc., of Tel Aviv, Israel, said it has completed preclinical development of a novel formulation containing cannabinoids, which have demonstrated antitumor properties in studies focused on gastrointestinal cancers conducted at its high-throughput screening facility. The formulation containing high concentrations of the cannabinoids CBDV and CBGA has demonstrated complex combinatorial antitumor properties with no psychoactive effect that will enable patients to be treated with high dosages without intoxication, Cannabics said.
Celltrion Group, of Incheon, Korea, said it selected the most potent antibody candidates to neutralize SARS-CoV-2. Through a partnership with the Korea Centers for Disease Control and Prevention (KCDC), the company initially identified and secured 300 different types of antibodies that bind to the SARS-CoV-2 antigen, which were screened based on their ability to bind to the virus spike protein. Celltrion said it was then able to capture a total of 38 potent neutralizing antibodies, of which 14 were determined as powerful neutralizing antibodies against SARS-CoV-2.
CNS Pharmaceuticals Inc., of Houston, said independent research by the University of Frankfurt found 2-deoxy-D-glucose (2-DG) reduced replication of SARS-CoV-2, the virus that causes COVID-19, by 100% in in vitro testing. The research shows, CNS said, that inhibiting glycolysis with non-toxic concentrations of 2-DG completely prevented SARS-CoV–2 replication in Caco-2 cells. Glycolysis is the process of cells converting glucose into energy, and infected cells are induced by viruses to increase their dependence on glycolysis. CNS has an agreement with WPD Pharmaceuticals Inc., of Vancouver, British Columbia, to develop several preclinical drug candidates to treat a range of viruses, including the SARS-CoV-2.
Coherus Biosciences Inc., of Redwood City, Calif., said it expects the COVID-19 pandemic to negatively impact administration of drugs, such as its pegfilgrastim, indicated for curable cancer treatment or other serious diseases against the risks associated with COVID-19. Patients who have already initiated chemotherapy, especially with curative intent, appear to be continuing on therapy, as any dose reduction or delay could have a significant impact on survival, the company said. Coherus added that it believes referrals and cancer diagnoses could recover as referring providers determine ways to navigate the new environment and previously delayed treatments are initiated.
Connectyx Technologies Holdings Group, of Boca Raton, Fla., said it filed all required annual reports from 2014 through 2019, making it current with OTC Markets filing requirements. The company’s board also evaluated the company’s business plan and said it identified business opportunities in the life sciences sector with an emphasis on biopharmaceuticals and medical devices.
Cytodyn Inc., of Vancouver, Wash., reported that more than 25 COVID-19 patients were administered leronlimab under the FDA’s emergency investigational new drug authorization. The rate of response, the company said, in mild to moderate patients has been “very promising,” with the first five patients treated being removed from oxygen. Twelve patients have been treated in the phase II trial for mild to moderate COVID-19 indications in the double-blinded, placebo-controlled trial. The first site cleared to enroll patients in phase IIb/III began April 13. 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.
Enlivex Therapeutics Ltd., of Nes Ziona, Israel, said the Israel Innovation Authority (IIA) selected the company’s planned COVID-19 and sepsis clinical programs to receive a nondilutive grant of about $1.5 million. Enlivex has received a total of approximately $4.31 million in grants from the IIA for its historical clinical trials and development. Following the positive results of Enlivex’s phase Ib trial in severe sepsis patients, Enlivex said it plans to initiate a clinical trial of Allocetra in COVID-19 patients and initiate a phase IIb/III trial of Allocetra to treat organ dysfunction associated with sepsis. The IIA is an independent, publicly funded agency fostering industrial R&D in Israel. It provides nondilutive grants that become repayable through royalties from future sales of products developed with the support of the IIA. The repayment, if any, is limited to the original grant amount plus interest.
Fulcrum Therapeutics Inc., of Cambridge, Mass., said it is on track to submit an IND in the second half of 2020 for FTX-6058 following the completion of preclinical safety studies and GLP toxicology work. In preclinical studies, the company said, treatment with FTX-6058 showed significantly increased HbF levels up to approximately 30% of total hemoglobin in erythroid progenitor cells from multiple human donors. FTX-6058, an oral therapy for treating sickle cell disease, also elevated HbF in vivo in efficacy models at plasma concentrations reasonably expected to be achieved in humans, the company said.
Gilead Sciences Inc., of Foster City, Calif., said a cohort analysis showed most of the 53 individuals hospitalized with severe complications of COVID-19 infection who were treated with the antiviral remdesivir on an individual compassionate use basis improved clinically with no new safety signals. Nearly two-thirds (64%, n=34/53) were on mechanical ventilation at baseline, including four also on extracorporeal membrane oxygenation. Treatment resulted in improved oxygen support class for 68% (n=36/53) over a median follow-up of 18 days from first dose. More than half on mechanical ventilation were extubated (57%, n=17/30) and 47% (n=25/53) were discharged from the hospital following treatment. After 28 days of follow-up, the cumulative incidence of clinical improvement was 84% according to Kaplan-Meier analysis. Clinical improvement was less frequent among those on invasive vs. noninvasive ventilation (HR: 0.33 [95% CI 0.16, 0.68]) and among those at least 70 years of age (HR vs. < 50 years: 0.29 [95% CI 0.11, 0.74]). The overall mortality rate in the cohort was 13% (n=7/53). The findings were published in The New England Journal of Medicine. The phase III Simple studies of remdesivir underway in countries with high prevalence of COVID-19 are expected to report data in April 2020 on individuals with severe disease and in May on those with moderate disease.
La Jolla Pharmaceutical Co., San Diego, is providing Giapreza (angiotensin II) for an emergency medical program in patients with septic shock due to COVID-19 at the Centre Hospitalier Interrégional Edith Cavell (CHIREC) Delta Hospital in Brussels, Belgium. Giapreza has been recently approved by the European Commission but is not yet commercially available in Europe. It’s a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock.
Medgenome Inc., of Foster City, Calif., and Scigenom Research Foundation collaborated to analyze DNA sequence and variation data from more than 300,000 individuals to predict susceptibility to the COVID-19 virus. The group identified variations in the ACE-2 protein gene that are predicted to make individuals more susceptible to the virus. Findings published in Biorxiv also report variants in the ACE2 gene that will protect individuals carrying some of those variants.
Orgenesis Inc., of Germantown, Md., signed an agreement to acquire the assets of Tamir Biotechnology Inc., of South Brunswick Township, N.J., including ranpirnase, Tamir’s broad-spectrum antiviral platform. The acquisition will be completed for total stock and cash consideration valued at about $19 million, based on the value of the stock at closing. Orgenesis plans to combine ranpirnase with its co-developed Bioxome technology for enhanced payload delivery directly to cells.
Pluristem Therapeutics Inc., of Haifa, Israel, treated its first patient suffering from COVID-19 complications in the U.S. under the FDA’s compassionate use program, which is part of the U.S. Coronavirus Treatment Acceleration Program, an emergency program for possible therapies that uses every available method to move new treatments to patients as quickly as possible. The patient was treated with PLX cell therapy at Holy Name Medical Center in New Jersey, an acute care facility that is currently an active site for Pluristem’s phase III critical limb ischemia study.
Redhill Biopharma Ltd., of Tel-Aviv, Israel, said the first two patients with confirmed SARS-CoV-2 infection were treated with opaganib (Yeliva) in addition to standard-of-care therapy, including hydroxychloroquine as background therapy, in its compassionate use program in Israel. At the time treatment was initiated, both patients were diagnosed with moderate to severe acute respiratory symptoms related to the infection, required supplemental oxygenation and were hypoxic despite treatment with maximum flow of oxygen with cannulas. Preliminary findings showed need for supplemental oxygen was lowered and C-reactive protein levels decreased within days of treatment initiation, and lymphocyte levels increased. Redhill said approximately 160 patients with confirmed SARS-CoV-2 infection and life-threatening manifestations are expected to be treated under compassionate use at three sites in northern Italy under an expanded access program approved by the Italian National Institute for Infectious Diseases, and discussions are ongoing in other countries for compassionate use authorizations and emergency development programs for opaganib, a sphingosine kinase-2 inhibitor.
Thermogenesis Holdings Inc., of Rancho Cordova, Calif., said its joint venture, Immunecyte Life Sciences Inc., has completed the acquisition of worldwide intellectual property for developing fully human antibody therapeutics for COVID-19. The acquired intellectual property includes four high-affinity monoclonal antibody drug candidates against SARS-CoV-2 and tools for screening and quantifying efficacy of such neutralizing antibodies. The high-affinity neutralizing monoclonal antibodies were obtained from the screening of enriched B-cell libraries from individuals who have recently recovered from COVID-19 (i.e. from convalescent whole blood). The technologies were originally developed by a research team affiliated with East China Normal University. The acquisition includes an undisclosed up-front cash payment and low double-digit future revenue sharing for the candidates under development.
Vaxil Bio Ltd., of Ness Ziona, Israel, shared positive results of its preclinical experiment whose purpose was to test the immune response of its COVID-19 vaccine candidate. The results provide the first preclinical validation of the in silico modeling disclosed a few weeks ago. Vaxil discovered a potential peptide vaccine against COVID-19 in February 2020. The experiments done so far have not been independently verified; this will take place as Vaxil advances the program. The first experiment was performed on healthy donor blood cells to validate the immune response in a screening protocol. It was designed to establish that the firm’s signal peptides demonstrate a favorable immune response. The results of that test were positive, as proliferation was observed in varying degrees in T-cell population (CD3+) as well as in specific subpopulations: cytotoxic T lymphocytes (CD8+) and more prominently in T helper cells (CD4+).