AGC Biologics A/S, of Soborg, Denmark, said it is partnering with Molecular Partners AG, of Zurich-Schlieren, Switzerland, to develop MP-0420, a multispecific Darpin anti-COVID-19 program. Molecular Partners plans to initiate studies for the program in the second half of 2020.
Aim Immunotech Inc. (formerly Hemispherx Biopharma Inc.), of Ocala, Fla., said it concluded a clinical trial agreement with Roswell Park Comprehensive Cancer Center to support Roswell Park's phase I/IIa trial of Ampligen (rintatolimod) in combination with interferon alfa-2b in cancer patients with mild to moderate COVID-19 infection. The trial will test the safety and effectiveness of the combination regimen to clear the SARS-CoV-2 virus from the upper airway of participants. Aim is providing the study drug at no charge and additional financial support. The program also is supported by grants from the NCI and institutional support from Roswell Park. Trial enrollment is expected to open by early August 2020.
Alimera Sciences Inc., of Atlanta, said it started the New Day trial to generate prospective data for Iluvien (fluocinolone acetonide intravitreal implant), its approved corticosteroid delivered via sustained-release intravitreal implant, as a baseline therapy for treating patients diagnosed with diabetic macular edema (DME). The study is designed to demonstrate Iluvien’s advantages over using the current standard of care of repeat anti-VEGF injections. The study is planned to enroll 320 treatment-naïve, or almost naïve, DME patients in about 42 sites around the U.S.
Altimmune Inc., of Gaithersburg, Md., said it inked a teaming agreement with Dynport Vaccine Co. LLC, a unit of General Dynamics Information Technology Inc., of Fairfax, Va., to coordinate U.S government funding efforts and, if successful, to provide program management, drug development activity integration and regulatory support for Adcovid, Altimmune’s single-dose intranasal COVID-19 vaccine candidate. Additional details were not disclosed.
Anergis SA, of Epalinges, Switzerland, and Virometix AG, of Schlieren, Switzerland, said they formed a research collaboration to investigate the use of synthetic virus-like particles (SVLPs) for ultra-fast allergy immunotherapy. The preclinical program will evaluate the immunogenicity profile of Anergis’ peptide vaccine candidate to treat house dust mite allergy, developed using the company’s contiguous overlapping peptide antigen technology, when presented on Virometix’ SVLP, with and without undisclosed Toll-like receptor ligands and built-in adjuvants. The results will be compared to an Anergis vaccine candidate with aluminum hydroxide as an extrinsic adjuvant. More broadly, the study is expected to inform the applicability of combining the technology platforms to combat allergies. The study will be conducted at the Helmholtz Centre for Infection Research as part of TRANSVAC2, the European Network of Vaccine Research and Development funded under the EU’s Horizon 2020 program.
Ardigen SA, of Krakow, Poland, and COVID-19 Vaccine Corp. (CVC), of Auckland, New Zealand, said they formed a research collaboration to develop a SARS-CoV-2 vaccine. Ardigen will apply its neoantigen prediction platform, Ardimmune Vax, which uses bioinformatics and artificial intelligence, to select viral epitopes that are the most suitable to boost cellular immune response. Financial terms were not disclosed.
Bioxcel Therapeutics Inc., of New Haven, Conn., said it initiated an expanded access program at Massachusetts General Hospital to provide its alpha 2A adrenoceptor agonist, BXCL-501, a sublingual thin-film formulation of dexmedetomidine, to individuals diagnosed with COVID-19 who are critically ill in the intensive care unit and may require calming or arousable sedation.
Chromadex Corp., of Los Angeles, said preclinical findings indicated Niagen (nicotinamide riboside) inhibits replication of a form of coronavirus in mouse cells. The research, conducted jointly at the University of Iowa, Oregon Health & Science University and the University of Kansas, previously showed that levels of the coenzyme NAD+ were depleted up to 80% in coronavirus-infected cells in a preclinical cell model. The new study showed that loss of NAD+ appeared to disrupt genes involved with cell defense, which can impair the innate immune response of those cells. Cell lines infected with a type of coronavirus had decreased viral replication when supplemented with Niagen. The activity of antiviral PARP enzymes also was up-regulated by boosting NAD pharmacologically. The findings were published on the scientific website biorxiv.org.
Cytodyn Inc., of Vancouver, Washington, said preclinical results from a macaque study testing CCR5 antagonist leronlimab as pre-exposure prophylaxis presented at the 23rd International AIDS Conference showed the equivalent 700-mg bimonthly dose completely prevented rectal transmission of simian-human immunodeficiency virus.
Hemoshear Therapeutics LLC, of Charlottesville, Va., said it is set to receive an undisclosed milestone payment for achieving a research milestone under a collaboration formed in 2019 with Horizon Therapeutics plc, of Dublin, to discover and develop therapeutics to treat gout.
Ilya Pharma AB, of Uppsala, Sweden, said it was selected for financial support under the EU’s Start-up Rescue Instrument accelerator. Managed by EIT Health, the program provides €500,000 (US$564,743) in grants-for-options to growth-stage biotechs previously funded by EIT whose series A or B financings were affected by the COVID-19 pandemic. Ilya is developing chemokine gene therapies, with lead candidate ILP-100, a CXCL12 gene modulator, targeting treatment of nonhealing wounds.
Innocan Pharma Corp., of Herzeliya, Israel, and Recipharm AB, of Stockholm, said they formed a collaboration to synthesize and analyze cannabinoid-loaded exosomes. Details and financial terms were not disclosed.
Kronos Bio Inc., of San Mateo, Calif., said a preclinical study showed that KB-0742, a selective cyclin-dependent kinase 9 inhibitor, inhibited tumor growth in a prostate xenograft model and in other cancers addicted to high levels of oncogenic transcription. In the study, conducted in collaboration with the Koehler Lab at the MIT Center for Precision Cancer Medicine and Koch Institute For Integrative Cancer Research at MIT, screening with a small-molecule microarray discovery platform identified KI-ARv-03, a small molecule that blocks androgen receptor-dependent gene expression and is a selective inhibitor of the androgen receptor co-factor CDK9. KB-0742 showed selectivity for CDK9 over other CDK family members, down-regulated AR-dependent oncogenic transcription and reduced tumor cell growth and promoted apoptosis in vitro. Oral administration of the agent to mice engrafted with castration-resistant prostate cancer cells inhibited tumor growth. In a subsequent mouse xenograft study using a MYC-dependent acute myeloid leukemia model, KB-0742 administration also resulted in tumor growth inhibition, with dose-dependent effects on pharmacodynamic markers of CDK9 inhibition.
Moderna Inc., of Cambridge, Mass., and Madrid, Spain-based Laboratorios Farmacéuticos Rovi SA, are collaborating on the large-scale, commercial fill-finish manufacturing of mRNA-1273, Moderna’s mRNA vaccine candidate against COVID-19. Rovi will provide vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection and labeling to support production of hundreds of millions of doses of the vaccine candidate intended in principle to supply markets outside of the U.S. starting in early 2021. Rovi will also hire additional staffing required to support manufacturing operations and production.
The court-appointed liquidator for Novelion Therapeutics Inc., of Vancouver, British Columbia, said the company ceased to be a reporting issuer and is no longer required to file financial statements or other continuous disclosure documents with Canadian securities regulators.
Optinose Inc., of Yardley, Pa., said it concluded an agreement with Kaléo Inc., of Richmond, Va., to co-promote Xhance (fluticasone propionate) nasal spray in the U.S. to treat nasal polyps in individuals 18 or older. Kaléo will promote the agent to an audience of office-based health care professionals that includes nearly 6,000 prescribers. Financial terms were not disclosed.
Orchard Therapeutics plc, of London, and Molmed SpA, of Milan, Italy, said they extended a gene therapy manufacturing collaboration initiated in April 2018 for a period of five years, through June 2025. Molmed will continue to support activities related to the development and manufacturing of vectors and drug products for Orchard’s ex vivo hematopoietic stem cell gene therapy candidates, including OTL-200 for metachromatic leukodystrophy and OTL-103 for Wiskott Aldrich syndrome, and for additional pipeline programs, including OTL-203 for mucopolysaccharidosis type I.
Promis Neurosciences Inc., of Toronto, and BC Neuroimmunology Lab Inc., of Vancouver, British Columbia, said they formed a revenue-sharing joint venture to develop and offer tests for the detection, diagnosis and monitoring of Alzheimer’s disease. The collaboration will begin by offering existing blood-based assays for neurofilament light protein and P-tau181, with subsequent assays potentially incorporating peptide antigens from Promis.
Proteinqure Inc., of Toronto, and Astrazeneca plc, of Cambridge, U.K., are collaborating to develop peptide therapeutics. Proteinqure will contribute its expertise in computational methods and structure-based drug design, while Astrazeneca will be responsible for experimental validation. Terms of the deal weren't disclosed.
Renovion Inc., of Chapel Hill, N.C., published preclinical data on ARINA-1 in the American Journal of Respiratory Cell and Molecular Biology. ARINA-1, which decreases the viscosity of mucus, was able to improve mucociliary transport alone and in combination with a CFTR modulator therapy in dF508 homozygous primary human bronchial epithelial cells isolated from cystic fibrosis patients.
Stoke Therapeutics Inc., of Bedford, Mass., published data on its Targeted Augmentation of Nuclear Gene Output (TANGO) antisense oligonucleotides in Nature Communications. Using TANGO molecules designed for four different genes that have nonproductive splicing events, the antisense oligonucleotides were able to reduce nonproductive mRNA and increase both productive mRNA and protein levels in a dose-dependent manner for each of the target genes.
Therapix Biosciences Ltd., of Tel Aviv, Israel, said its American depositary shares (ADSs) are now trading under the OTC Pink ticker symbol TRPXY after the ADSs was suspended by Nasdaq. The company also noted that the Israeli court removed a temporary injunction against the company prohibiting it from making any changes in its share capital or adopting any resolution which is not in the ordinary course of business.
Transgene SA, of Strasbourg, France, is using Hypertrust X-Chain for Clinical Trials blockchain solution designed by Hypertrust Patient Data Care GmbH, of Munich, Germany, to track ovarian and head and neck cancer patients and their TG-4050 individualized therapeutic vaccines.
Tris Pharma Inc., of Monmouth Junction, N.J., licensed rights to its product portfolio of FDA-approved attention deficit hyperactivity disorder treatments in Canada to Kye Pharmaceuticals Inc., of Mississauga, Ontario. Kye will be responsible for ongoing Canadian regulatory activities for the products. Financial terms of the deal weren't disclosed.