Aegis Life Inc., of San Diego, was founded with a goal of developing a novel DNA vaccine that is differentiated from other COVID-19 vaccine approaches, using Edmonton, Alberta-based Entos Pharmaceuticals Inc.’s Fusogenix gene delivery technology. Fusogenix is an alternative to using electroporation devices to deliver DNA inside human cells. The flexibility of Fusogenix may enable Aegis Life’s investigational DNA vaccine to target and deliver simultaneously the spike (S) protein and the nucleocapsid (N) protein intracellularly, Aegis said.
Altimmune Inc., of Gaithersburg, Md., disclosed the successful completion of multiple-dose toxicity and toxicokinetic studies of ALT-801, a GLP-1/glucagon dual receptor agonist for the treatment of nonalcoholic steatohepatitis. The IND-enabling studies were conducted in rats and cynomolgus monkeys. The company said it believes the data provide clear validation of previously observed pharmacodynamic effects of the compound and pave the way for the anticipated phase I single and multiple ascending-dose trials to start in the fourth quarter of this year, following the submission of a clinical trial application in Australia.
Antios Therapeutics Inc., of Atlanta, disclosed the publication of preclinical results with ATI-2173, Antios' lead oral drug candidate for treating patients infected with hepatitis B virus (HBV). The manuscript, published in Antimicrobial Agents and Chemotherapy, describes ATI-2173 as a selective inhibitor of HBV with an anti-HBV 50% effective concentration of 1.31nM in primary human hepatocytes and minimal to no toxicity in hepatocytes, skeletal muscle, liver, kidney, bone marrow and cardiomyocytes. ATI-2173 showed good oral bioavailability with liver targeting in rat and cynomolgus monkey studies, leading to reduced systemic plasma and skeletal muscle exposure while still maintaining effective concentrations of the active 5'-triphosphate in the liver.
Applied Biomath Inc., of Concord, Mass., said it is collaborating with Flame Biosciences Inc., of New York, to develop systems pharmacology models for Flame’s lead therapeutic designed to treat cancers driven by inflammation. Terms were not disclosed.
Aptorum Group Ltd., of New York, disclosed data showing both significant in vivo activities of its lead compound, ALS-4, against methicillin-resistant Staphylococcus aureus in wound-infected and bacteremia mouse models, respectively, when compared to prevailing antibiotics. ALS-4 is currently undergoing final stages of IND-enabling studies, which involves a 14-day oral toxicity in rats and dogs, a functional observation battery study in rats and a cardiovascular telemetry and respiratory study in dogs. Subject to the final results, ALS-4 is on track for an IND submission in the fourth quarter of this year. In separate news, Aptorum disclosed further positive data from in vivo studies from showing significant activity against neuroblastoma tumor reduction when treated with its lead oncology compound, SACT-1, in combination with standard-of-care chemotherapy.
Avomeen, a contract research, development and manufacturing company, signed a three-year agreement to be San Diego-based Daré Bioscience Inc.’s preferred provider of product development laboratory services. Daré and Avomeen were collaborating on development-stage programs, including Ovaprene, an investigational hormone-free, monthly contraceptive, and said they plan to expand the partnership to include more programs in Daré’s women’s health pipeline. Central to the collaboration is Avomeen’s ability to develop customized protocols, test methods and formulations with processes tailored to product requirements and specifications, according to Daré.
Bavarian Nordic A/S, of Martinsried, Germany, disclosed the start of full commercial operations in Germany nine months after completing the acquisition of the manufacturing and global rights to Encepur (tick-borne encephalitis vaccine) and Rabipur (rabies vaccine) from Glaxosmithkline plc, of London. The move ensures complete distribution and marketing of Encepur and Rabipur in Germany, a major milestone in the commercial transformation at Bavarian, the company said.
Betterlife Pharma Inc., of Vancouver, British Columbia, received confirmation from the Canadian Stock Exchange that its common shares resumed trading Sept. 1. Betterlife’s new listing statement was approved after the company provided satisfactory documentation with respect to the merger with Altum Pharmaceuticals Inc., also of Vancouver.
Boston Pharmaceuticals Inc., of Cambridge, Mass., disclosed an agreement with Novartis AG, of Basel, Switzerland, through which Boston will license worldwide development and commercial rights to the drug candidate BOS-580, for the treatment of nonalcoholic steatohepatitis. With an optimized, well-tolerated dosing regimen that demonstrates significant hepatic fat reduction and reduced circulating markers of fibrosis, BOS-580 has the potential to be a best-in-class FGF21 agonist, Boston said.
Domain Therapeutics SA, of Strasbourg, France, and Pfizer Inc., of New York, said they plan to profile downstream signaling pathways of a set of GPCRs potentially involved across multiple therapeutic areas using Domain’s technology consisting of BRET-based cellular assays for investigating GPCR’s native form. Domain could receive an up-front payment and research support, as well as potential discovery and clinical milestone payments for future Pfizer programs related to any drug targets identified through the collaboration. Additional financial details were not disclosed.
Elix Inc., of Tokyo, and Astellas Pharma Inc., also of Tokyo, said they plan to develop algorithms that use artificial intelligence to predict compound activity, generate compound structures and conduct retrosynthetic analysis. They plan to use AI for predicting the pharmacological activity and properties of compounds such as absorption, distribution, metabolism, excretion, physical properties and toxicity to generate compound structures and conduct retrosynthetic analysis.
Elixirgen Therapeutics Inc., of Baltimore, said Fujita Health University received a contract from the Japan Agency for Medical Research and Development to initiate phase I/II trials of the company's COVID-19 vaccine candidate, EXG-5003. Clinical trials are expected to begin at Fujita Health University Hospital in Aichi, Japan, in the first quarter of 2021. EXG-5003 is a temperature-sensitive self-replicating RNA vaccine expressing the receptor binding domain of the SARS-CoV-2 spike protein. It was optimized for intradermal injection with potential dose-sparing and safety benefits, the company said.
Emergex Vaccines Holding Ltd., of Abingdon, U.K., said it formed a U.S. subsidiary, Emergex USA, by acquiring the laboratories, technology and assets of Immpronano Inc., of Doylestown, Pa., a specialist CRO in human leukocyte antigen T-cell immunology and immunoproteomics. Immpronano uses mass spectometry to determine class I major histocompatibility complex expression libraries of viral infected cells. Emergex develops novel synthetic set-point T-cell priming vaccines for pathogenic infectious diseases. Financial details were not disclosed.
Genoskin, of Toulouse, France, and Salem, Mass., said it launched Nativeskin access, a ready-to-use standardized skin model. The skin biopsy will be embedded in Genoskin's gel-like matrix, where it can be maintained alive and functional for at least seven days. Ready-to-use and standardized models will be available on demand and sold in kits with culture medium. Access will be sold in two sizes, 8- and 11-millimeter diameter models. This product is an alternative to animal testing, according to Genoskin.
HDT Bio Corp., of Seattle, was awarded an $8.2 million grant from the U.S. National Institute of Allergy and Infectious Disease to support the development of HDT-301, a vaccine to prevent COVID-19. HDT plans to start a phase I study testing the RNA-based vaccine in 2020 .
Humanigen Inc., of Burlingame, Calif., published results from a case-control study of lenzilumab in Mayo Clinic Proceeding. Of the 12 patients treated with lenzilumab, a monoclonal antibody targeting granulocyte macrophage-colony stimulating factor, 8% progressed to invasive mechanical ventilation or died, compared to 41% of a contemporaneous matched group of 27 patients who received standard of care (p=0.07). Median time to resolution of acute respiratory distress syndrome was one day for patients treated with lenzilumab compared to eight days for the control group (p<0.001). Patients treated with lenzilumab were discharged from the hospital in a median of five days compared to 11 days for the control group (p=0.008).
Immunobrain Checkpoint Inc., of New York, was awarded a $1 million grant from the Alzheimer’s Association under the 2020 Part the Cloud-Bill Gates Partnership Grant Program to support a phase I study of its anti-PD-L1 antibody, IBC-Ab002.
Medicinova Inc., of La Jolla, Calif., reported progress on its intranasal formulation of a SARS-CoV-2 vaccine to prevent COVID-19. Using the BC-PIV viral vector platform, Medicinova has confirmed SARS-CoV-2-specific protein antigen on the membrane surfaces can bind to ACE2, the receptor for SARS-CoV-2. In mice, the vaccine candidates were able to induce antibodies to the virus. The company is currently testing for the presence of neutralizing antibodies in the mice.
Mirum Pharmaceuticals Inc., of Foster City, Calif., opened an expanded access program for maralixibat, an apical sodium dependent bile acid transporter inhibitor, for the treatment of cholestatic pruritus in patients with Alagille syndrome. The program is open for patients in the U.S. and Canada.
Neuclone Pharmaceuticals Ltd., of Sydney, disclosed two additional biosimilars in active development, referring PD-1 inhibitors Opdivo (nivolumab, Bristol Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co. Inc.). Both candidates are in advanced preclinical development and are being co-developed by Neuclone and its strategic manufacturing partner, Serum Institute of India (Serum Institute).
Northwest Biotherapeutics Inc., of Bethesda, Md., said it acquired Flaskworks, a company that has developed a system to close and automate the manufacturing of cell therapy products such as Dcvax. Flaskworks was previously owned by its technical founders and Corning Inc., and its technical team has joined NW Bio as part of the acquisition. It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of Dcvax products and substantial reduction of production costs. The total purchase price of the Flaskworks deal, which was executed and closed on Aug. 28, was about $4.33 million, of which $1.6 million was paid in cash at closing, with up to $2.01 million to be paid in stock subject to milestone-based vesting and $670,000 to be paid in either cash or stock, or combination thereof, within 120 days after closing.
Oxford Biomedica plc, of Oxford, U.K., and Astrazeneca plc, of Cambridge, U.K., signed an 18-month supply agreement for Oxford to manufacture Astrazeneca's adenovirus vector-based COVID-19 vaccine candidate, AZD-1222. The deal contains an option to extend the supply period for an additional 18 months by mutual agreement. Astrazeneca will pay Oxford £15 million (US$20 million) up front as a capacity reservation fee. Oxford expects to receive more than £35million plus certain materials costs for manufacturing AZD-1222 until the end of 2021.
PCI Biotech AS, of Oslo, Norway, and Dcprime BV, of Leiden, the Netherlands, said they plan to develop cancer vaccination concepts based on tumor-independent antigens. The collaboration builds on preclinical proof-of-concept results presented by Dcprime at the 34th Annual Meeting of the Society for Immunotherapy of Cancer in November. The partnership is governed by a research collaboration agreement, in which they will evaluate the technology compatibility and synergy based on preclinical studies. The companies said they also will evaluate the results to determine the potential for further development and partnership.
Recce Pharmaceuticals Ltd., of Sydney, received an Innovation Connections grant of AU$37,508 (US$27,650) plus goods and services tax from the Australian government's Department of Industry, Science, Energy and Resources as part of its Entrepreneurs’ Programme. The grant will support the development of RECCE-327 as a treatment for COVID-19. The company is eligible for a grant of up to AU$50,000 in additional funding upon successful completion of milestones.
Relation Therapeutics Ltd., of London, and Mila (Quebec AI Institute) launched Project RE, which will use machine learning to identify repurposed drug combinations as potential therapies for COVID-19. The project is supported by a $1.3 million grant from the Bill & Melinda Gates Foundation.
Revision Therapeutics Inc., of Ridgewood, N.J., licensed technology for the treatment of Stargardt disease from Cornell University. Financial terms of the deal weren't disclosed.
Rodeo Therapeutics Corp., of Seattle, selected RTX-1688 for its inflammatory bowel disease program (IBD). RTX-1688, an inhibitor of 15-prostaglandin dehydrogenase, demonstrated efficacy in an injury-induced IBD model and favorable in vitro and in vivo characteristics.
Sonnet Biotherapeutic Holdings Inc., of Princeton, N.J., reported preclinical data on SON-1010, which combines interleukin-12 with Sonnet's Fully Human Albumin Binding technology. In mice, SON-1010 had enhanced pharmacokinetics compared to naked/unbound IL-12. Interferon-gamma levels responded in a dose-dependent manner. Sonnet plans to submit an IND for SON-1010 in 2021.
Tavanta Therapeutics, of Media, Pa., launched as a reorganization from Druggability Technologies Holdings Ltd., of Budapest, Hungary. The company is developing TAVT-45, which is in the planning stages for a phase III study in prostate cancer, as well as phase II programs for TAVT-119 for anal fissures and TAVT-18 for tuberous sclerosis complex.