Aeterna Zentaris Inc., of Charleston, S.C., said it received notice from Nasdaq that it is not in compliance with the minimum $1 per share bid price and has 180 calendar days, through Oct. 5, 2020, to regain compliance. The company also no longer satisfies the minimum net income requirement for continued listing as well as the alternative requirements of market value of listed securities or stockholders’ equity. The company intends to submit its plan to regain compliance.
AI Vivo, of Cambridge, U.K., said its systems pharmacology platform powered by artificial intelligence has identified the top candidate drugs that are highly likely to be effective in treating COVID-19 disease. Its prediction engine took 15 days to rank 90,000 candidate compounds in order of efficacy, identifying a shortlist of 31 candidate drugs that are already approved and in use for other human diseases/conditions or in phase II/phase III trials. Five of the top-ranked drugs on the list that have already entered clinical trials for COVID-19, include: chloroquine, dexamethasone, sirolimus, tacrolimus and thalidomide. The company said it has already begun talks with the U.K. government and others to initiate trials of the approved drugs.
Azurrx Biopharma Inc., of New York, said it entered a manufacturing agreement with CDMO Delpharm for the clinical drug product supply of its MS-1819 therapy for exocrine pancreatic insufficiency (EPI). Under the terms, Delpharm will manufacture Azurrx’s MS-1819 cGMP batch that will be used in the phase IIb Option 2 trial for the treatment of EPI in patients with cystic fibrosis.
Biogen Inc., of Cambridge, Mass., said that, together with Broad Institute of MIT and Harvard and Partners Healthcare, a consortium has been established that will build and share a COVID-19 biobank that will help scientists study a large collection of de-identified biological and medical data to advance knowledge and search for potential vaccines and treatments. Biogen will help employees who wish to volunteer connect with the project. According to researchers, this clustered group of patients with a common exposure will offer a valuable lens into why some people show signs of disease and others are asymptomatic. It may also shed light on why among those with symptoms, some have more severe symptoms than others. Researchers will also examine blood samples from recovered patients to evaluate the levels of neutralizing antibodies against SARS-CoV-2 and other aspects of their immune profiles, which may point the way toward short- and long-term therapeutic options.
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn., and Medison Pharma Ltd., of Petach Tikva, Israel, said they entered an agreement to distribute Nurtec ODT (rimegepant), a calcitonin gene-related peptide for the acute treatment of migraine, in Israel.
Botanix Pharmaceuticals Ltd., of Sydney, provided an update of its business. Increased focus will be devoted to its antimicrobial platform, with the dermatology platform continuing to progress in a cost-effective but clinically constrained manner, the firm said. Significant reduction in operational costs and overhead has been implemented with a view to ensuring that cash reserves can support planned programs, Botanix said.
Cerespir Inc., of New York, identified a possible heretofore unknown link between COVID-19-induced brain inflammation and acute respiratory distress syndrome, the most common cause of death among infected patients. The company aims to test its clinical-stage compound, itanapraced, as a possible early intervention treatment for COVID-19 patients showing evidence of brain infection. A retrospective study of COVID-19 patients in Wuhan, China, recently published in JAMA Neurology suggests that as many as 34% of patients with COVID-19 showed neurologic signs and symptoms. Those phenomena have also been reported in the U.S. and other countries, and include headache, nausea, vomiting, loss of taste and smell, delirium and seizures, the company noted.
Cevec Pharmaceuticals GmbH, of Cologne, Germany, signed a license agreement with Evox Therapeutics Ltd., of Oxford, U.K., for the development and commercialization of therapeutic exosomes using Cevec’s CAP technology. The license agreement is the result of an ongoing collaboration between Evox and Cevec that has demonstrated the utility of CAP in making exosomes. Evox intends to develop CAP-derived exosomes for several disease areas and indications. Cevec will be eligible for milestone payments and royalties, but exact financial details of the agreement were not disclosed.
Clinigen Group plc, of Burton Upon Kent, U.K., signed an exclusive licensing and distribution agreement with Porton Biopharma Ltd., of Salisbury, U.K., to commercialize Erwinase/Erwinaze (asparaginase Erwinia chrysanthemi). The compound is approved for patients with acute lymphoblastic leukemia who have developed hypersensitivity to E. coli-derived asparaginase in 19 countries, including the U.S., Europe and Japan. The treatment will be Clinigen’s third biologic and fits well within the firm’s existing hematology and oncology product portfolio and customer base, the company said. Clinigen will pay Porton £5 million (US$6.2 million) up front in cash consideration plus future sales-based milestone payments of up to £20 million, alongside tiered royalty payments based upon worldwide net sales.
Dynavax Technologies Corp., of Emeryville, Calif., and Sinovac Biotech Ltd., of Beijing, signed a collaboration to develop a vaccine to prevent COVID-19. The collaboration will evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate with Dynavax’s advanced adjuvant, CpG 1018. The latter is the adjuvant used in Heplisav-B hepatitis B vaccine. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated with Heplisav-B.
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., said its product, Ryanodex (dantrolene sodium) for injectable suspension, inhibited the growth of SARS-CoV-2, the virus causing COVID-19, in a controlled in vitro laboratory test. Eagle has submitted its IND to the FDA for a phase II trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with SARS-CoV-2. The company has been in contact with the FDA’s Coronavirus Treatment Acceleration Program to request potential expedited review of the IND application and aims to begin the clinical trial as soon as possible. The drug is approved by the FDA for the treatment of patients with malignant hyperthermia (MH) in conjunction with appropriate supportive measures, and for the prevention of MH in patients at high risk.
Elicio Therapeutics Inc., of Cambridge, Mass., established a collaboration with the National Cancer Institute to characterize T-cell responses to ELI-002 in animals. Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell therapy activators to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses. ELI-002 is an amphiphile KRAS-vaccine containing seven amphiphile mKRAS peptides and a proprietary amphiphile adjuvant, administered subcutaneously.
Fairjourney Biologics SA, of Porto, Portugal, and Iontas Ltd., of Cambridge, U.K., will collaborate to identify antibodies for use in a COVID-19 therapy. Fairjourney will contribute its antibody library of recovering COVID-19 patients to isolate neutralizing SARS-CoV-2 antibodies. Iontas specializes in antibody discovery.
F-star Therapeutics Ltd., of Cambridge, U.K., said preclinical data published in Clinical Cancer Research highlights the potential mechanism of action of its lead asset, FS-118, a LAG-3/PD-L1-targeting tetravalent bispecific antibody currently in phase I testing in patients with late-stage solid tumors who have relapsed following prior successful PD-(L)1 therapy. The in vitro and in vivo studies demonstrated that FS-118 simultaneously bound LAG-3 and PD-L1 with high affinity. FS-118 showed a greater enhancement in T-cell activity, and reversal of LAG-3 and PD-L1 immunosuppression, than the combination of the single component parts of the bispecific antibody. In tumor mouse models, a bispecific antibody targeting LAG-3/PD-L1 significantly suppressed tumor growth, and the antitumor immune response was greater than using PD-L1 or LAG-3 antibody monotherapy and was also more effective than a combination of those monotherapies.
Fusion Antibodies plc, of Belfast, U.K., said it is working with Queen’s University Belfast (QUB) as part of The Northern Ireland Coronavirus Antibody Development Alliance, which has been established to seek new therapeutic and diagnostic approaches to help in the global fight against the coronavirus pandemic. The alliance’s goal is to develop new therapeutic molecules that can be evaluated for their ability to neutralize SARS-CoV-2, the virus that causes COVID-19 disease. Fusion and QUB have not agreed to any financial arrangements in respect of the research alliance, and the arrangement is not expected to impact Fusion’s revenue or working capital position.
Galapagos NV, of Mechelen, Belgium, and Ryvu Therapeutics SA, of Krakow, Poland, will collaborate to discover and develop small-molecule drugs to treat inflammation. Ryvu is responsible for early drug discovery. Galapagos will have an exclusive option to license intellectual property developed by Ryvu. Galapagos will be responsible for all remaining program development. In exchange for global development and commercialization rights, Ryvu will receive an up-front payment and will be eligible for further option, milestone and royalty payments.
Immutep Ltd., of Sydney, said its manufacturing partner, Batavia Biosciences, has developed a pharmaceutical-grade, stable Chinese hamster ovary cell line that produces significantly high product yields of IMP-761. The company will now complete the preparations for the GMP process compliance development phase, ahead of clinical testing of the compound in autoimmune disease. IMP-761 is an agonist antibody targeting immune checkpoint LAG-3 to treat autoimmune diseases.
The International Vaccine Institute (IVI) said the Coalition for Epidemic Preparedness Innovations granted $6.9 million in funding to Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., to work with the IVI and the Korea National Institute of Health in a phase I/II trial of INO-4800, Inovio’s COVID-19 vaccine candidate, in South Korea. The IVI plans to conduct the trial in parallel to Inovio’s phase I study, initiated in the U.S. on April 6.
Jaguar Health Inc., of San Francisco, and Atlas Sciences LLC, of Montreal, plan to develop NP-500, a plant-based type 2 diabetes drug candidate. The deal involves the receipt of $1.5 million by Napo Pharmaceuticals Inc., Jaguar's wholly owned South San Francisco-based subsidiary, for sale of NP-500's technology and intellectual property to Atlas. Concurrent with the sale, Jaguar received an exclusive 10-year license to develop and commercialize NP-500 technology in all territories worldwide except greater China, inclusive of the right to sublicense NP-500 development and commercialization rights. Derived from a plant found in North America, NP-500 is a hormone-sensitive lipase inhibitor.
Kubota Vision Inc., of Seattle, said it signed an open innovation agreement with Leo Pharma A/S, of Ballerup, Denmark, to screen vascular adhesion protein-1 (VAP-1) inhibitor compounds discovered by Kubota. Leo will evaluate the compounds in disease assays for potential therapeutic use in inflammatory skin diseases such as psoriasis and atopic dermatitis. VAP-1 inhibitors can potentially be used for multiple inflammatory conditions, including acute respiratory distress syndrome induced by viral infections such as COVID-19, psoriasis, atopic dermatitis, diabetic kidney disease, osteoarthritis, nonalcoholic steatohepatitis, certain cancers and several other diseases. Kubota is the former Acucela Inc.
Legochem Biosciences Inc., of Daejeon, South Korea, and Iksuda Therapeutics Ltd., of Newcastle upon Tyne, U.K., entered a research collaboration and license agreement to develop antibody-drug conjugates in oncology. Iksuda gains certain rights to Legochem’s antibody-drug conjugate (ADC) technology to research, develop and commercialize cancer therapeutics. Iksuda has the rights to use the technology to develop therapeutics directed to up to three undisclosed targets. Legochem will receive development, regulatory and commercial milestone payments of up to $407.25 million as well as royalties on the sales of any resulting products. Legochem is eligible to receive a prearranged percentage of sublicense revenue if Iksuda enters a license agreement with third-party companies.
Novartis AG, of Basel, Switzerland, said data published in Neurology confirm Aimovig’s (erenumab) real-world and long-term safety and efficacy benefit in patients with episodic and chronic migraine. Data from the real-world Telescope study in 109 patients in Germany showed that 80% taking Aimovig reported a reduction of migraine intensity and 92% had fewer attacks, with an average reduction of eight monthly migraine days. Interim results from the real-world Periscope study in 19,740 migraine patients, including 91 patients taking Aimovig with an overall mean disease duration of 18 years, also conducted in Germany, showed that 85% taking Aimovig could cope better with daily activities, and 83% lost fewer days to migraine since starting the treatment.
Octapharma USA, of Paramus, N.J., said it is supporting an investigator-initiated trial at the Sharp Memorial Hospital in San Diego focused on treating the most critical patients at the heart of the coronavirus pandemic, those experiencing respiratory failure who become ventilator dependent. The trial, titled “Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection,” aims to identify whether IVIG can halt coronavirus progression to respiratory failure requiring transfer into the intensive care unit and mechanical ventilation in admitted COVID-19 patients; and whether adding IVIG to the standard of care will reduce days requiring oxygen therapy and total hospital days.
PDS Biotechnology Corp., of Princeton, N.J., said it expanded its infectious disease pandemic development program, including novel vaccines for COVID-19 and universal influenza, in addition to its previously announced tuberculosis development collaboration with Farmacore Biotechnology Ltd. The company also initiated trials for a COVID-19 vaccine and universal influenza vaccine. Shares of PDS (NASDAQ:PDSB) closed April 16 at $1.10, up 27 cents, or 32.5%.
Pulmatrix Inc., of Lexington, Mass., said it entered a collaboration and license agreement granting Sensory Cloud Inc., a company that specializes in the delivery of aerosolized products for over-the-counter (OTC) health care, an exclusive, worldwide, royalty-bearing license to PUR-003 and PUR-006 (Nasocalm), Pulmatrix’s salt formulations for aerosol nasal administration. The licensed products include OTC nasal delivery to potentially reduce the pathogenic risk and transmissibility of contagions, including with respect to COVID-19. Terms call for Pulmatrix to out-license intellectual property of Nasocalm to Sensory Cloud for worldwide distribution, commercialization and marketing with escalating royalties of 7% in 2020, 14% in 2021 and 17% over the remaining life of the agreement. Pulmatrix has the right to terminate the agreement in the event that Sensory Cloud has failed, within six months after April 9, 2020, to meet certain milestones related to the rapid development and commercialization of the nasal prophylactic and anti-contagion product. Pulmatrix also is entitled to receive a milestone payment of $1 million following the achievement of aggregate net sales of all licensed products of $20 million.
SAB Biotherapeutics Inc., of Sioux Falls, S.D., said it was awarded expanded scope on its Rapid Response contract for a new therapeutic drug candidate to treat COVID-19, from the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense Joint Project Lead for Enabling Biotechnologies. This work, funded by up to $9.4 million, is supported by the Biomedical Advanced Research Development Authority. SAB’s therapeutic candidate, SAB-185, is an immunotherapy generated from the company’s DiversitAb platform to produce fully human polyclonal antibodies that target SARS-CoV-2, the virus that causes COVID-19.
Scitech Development LLC, of Detroit, said it submitted a proposal to the U.S. Biomedical Advanced Research and Development Authority (BARDA) for the use of its lead product, nanofenretinide (ST-001), in the treatment of patients infected with COVID-19 (SARS-CoV-2). Fenretinide, which has demonstrated preclinical in vitro antiviral activity against a number of viruses, including MERs, dengue, Zika, West Nile, HIV and HCV, has been combined with Scitech’s SDV intravenous, phospholipid-based, nanoparticle product designed to enable drugs that are water insoluble to be distributed through the circulatory system in sufficient quantities and doses to reach the target cells and produce a therapeutic effect while maintaining low toxicity levels.
Soligenix Inc., of Princeton, N.J., said it executed an agreement for the exclusive worldwide license of Covaccine HT, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corp., for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu. Covaccine HT has been shown to enhance both cell-mediated and antibody-mediated immunity. Soligenix and its collaborators have demonstrated the utility of Covaccine HT in the development of its heat stable filovirus vaccine program, with vaccine candidates against Ebola and Marburg virus disease. Terms of the deal were not disclosed.
Starpharma Ltd., of Melbourne, Australia, said its Vivagel active astrodimer sodium (SPL-7013) was shown in laboratory studies to have significant antiviral activity against the coronavirus that causes COVID-19. SPL-7013 inhibited the infection of cells with the SARS-CoV-2 virus, a finding that was validated by replicate testing against a positive control compound, remdesivir (Gilead Sciences Inc.), which is considered a leading candidate for the treatment of COVID-19. With those results, Starpharma said it is evaluating product concepts and formulation options for SPL-7013, which may have potential applications in the prevention and management of COVID-19. SPL-7013 is marketed in two products: Vivagel BV for bacterial vaginosis and the Vivagel antiviral condom.
Synthon Biopharmaceuticals BV, of Nijmegen, the Netherlands, said it is relaunching as Byondis, focusing on developing precision medicines targeting intractable cancers and autoimmune diseases.
Turning Point Therapeutics Inc., of San Diego, said preclinical data published in Clinical Cancer Research showed repotrectinib demonstrated potent in vitro and in vivo activity in patient-derived preclinical models compared with proxy chemical compounds for other tyrosine kinase inhibitors against ROS1 and the ROS1 G2032R solvent-front mutation. The CNS activity of repotrectinib was studied in an in vivo model and demonstrated significant reduction of metastatic brain lesions with longer survival compared to a proxy chemical compound for entrectinib.
Urogen Pharma Ltd., of Princeton, N.J., priced its newly approved low-grade upper tract urothelial cancer therapy, Jelmyto (mitomycin, UGN-101), at $21,376 per dose, or $128,256 over six doses. The orphan drug received priority review approval April 15 and provides the first non-surgical option for between 6,000 and 7,000 U.S. patients annually. The filing was based on the phase III Olympus trial in which 58% of patients achieved a complete response. They were treated with six weekly instillations of Jelmyto administered by a standard catheter.
Valbiotis SAS, of La Rochelle, France, said it is accelerating clinical development of its plant-derived active substances in new indications: cardiovascular and hepatic steatosis risk. Totum-070 is in development for reducing LDL-cholesterol, with a phase II trial set to begin in the third quarter of 2020. Totum-854, for reducing blood pressure, is expected to begin a phase II trial in the fourth quarter of 2020, and Totum-448, for reducing hepatic steatosis, will begin a phase II study in the second half of 2021.
Vivoryon Therapeutics AG, of Halle, Germany, said it entered a research collaboration with the Fraunhofer Institute for Cell Therapy and Immunology (IZI) and acquired related patents from the institute for a meprin protease inhibitor and assay platform. The two will work together to advance first-in-class small-molecule meprin inhibitors, combining Vivoryon’s expertise in translating basic research into marketable small-molecule therapeutics with the department’s focus on discovery and development of new therapeutics that target putative pathologic post-translational modifications. Terms were not disclosed.