Akari Therapeutics plc, of New York, said results from a two-year research collaboration with the University College of London Institute of Ophthalmology showed that intravitreal administration of the long-acting engineered form of nomacopan that binds only to LTB4 was at least as effective as the steroid dexamethasone to reduce retinal inflammation. Nomacopan, a complement C5 factor inhibitor and leukotriene BLT receptor antagonist, decreased proliferation, differentiation and infiltration of Th17 and Th1/17 effector CD43 T cells and reduced activated macrophage cell populations. In addition, results showed the presence of inflammatory cells expressing both complement C5 and LTB4 receptors in retinal tissue from donor patients with uveitis compared to healthy donor eyes, supporting the likely role of LTB4 and C5 in disease pathology. The findings were published in the American Journal of Pathology.
Amring Pharmaceuticals Inc., of Berwyn, Pa., said it reached agreement with Ferring International Center SA, of Saint-Prex, Switzerland, to acquire global rights to Lysteda (tranexamic acid), a plasmin inhibitor approved to treat women with cyclic heavy menstrual bleeding. Amring had marketed the authorized generic version of Lysteda in the U.S. since March 14, 2016. Financial terms were not disclosed.
Aqualung Therapeutics Inc., of Tucson, Ariz., said proof-of-concept studies by the company published in EBio Medicine identified extracellularly secreted NAMPT (eNAMPT) as a key innate immunity regulator and inflammatory cytokine related to invasive prostate cancer through its binding to Toll-like receptor 4. The publication showed eNAMPT to be a highly druggable target amenable to eNAMPT-neutralizing biologic therapy. Therapeutic targeting of eNAMPT may antagonize and potentially delay the switch to aggressive, invasive disease in androgen deprivation therapy-resistant prostate cancer and prevent its progression, according to the company.
Bayer AG, of Leverkusen, Germany, said it launched a cell and gene therapy (C>) platform within its pharmaceuticals division to consolidate its position in the field. Bayer plans to strengthen its internal C> capabilities while also pursuing external strategic collaborations, technology acquisitions and licensing to build platforms with application across multiple therapeutic areas. The pharma plans to focus on selected areas, including stem cell therapies – especially induced pluripotent cells – as well as gene augmentation, gene editing and allogeneic cell therapies. Bayer cited the 2019 acquisition of Bluerock Therapeutics and the October 2020 acquisition of Asklepios Biopharmaceutical as examples of strategic priorities for its C> platform.
The U.S. government bought 650,000 additional doses of Indianapolis-based Eli Lilly and Co.'s neutralizing antibody, bamlanivimab (LY-CoV555) 700 mg. The purchase agreement is for $812.5 million and doses will be delivered through Jan. 31, 2021, with at least 350,000 of the additional doses delivered in December. Bamlanivimab has emergency use authorization for treating mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Evofem Biosciences Inc., of San Diego, said the U.S. Department of Veterans Affairs awarded the company a contract for the purchase of the non-hormonal female contraceptive Phexxi (lactic acid, citric acid and potassium bitartrate) for a five-year period beginning Dec. 15. Financial terms were not disclosed.
Eyepoint Pharmaceuticals Inc., of Watertown, Mass., reported findings from its GLP preclinical toxicology study of EYP-1901, a potential six-month sustained delivery intravitreal anti-VEGF using the company’s bioerodible Durasert technology to treat wet age-related macular degeneration. No study drug-related adverse ocular or systemic toxicology findings were seen at any dose level studied in a rabbit model, no changes were observed in ocular measurements such as intraocular pressure and no changes occurred in liver function enzymes, together providing additional rationale to advance the tyrosine kinase inhibitor into development.
Fusion Antibodies Inc., of Belfast, Northern Ireland, and Queen’s University Belfast were awarded a £453,000 grant (US$610,573) from Invest Northern Ireland to accelerate discovery of novel therapeutic and diagnostic antibodies with validated anti-infective properties against COVID-19. The antibodies will have a SARS-CoV-2 virus neutralization ability, while also aiding diagnostic testing efforts, according to Fusion.
Inhibikase Therapeutics Inc., of Atlanta, said it found that c-Abl kinase plays a pivotal role in the alpha-synuclein-induced neurodegeneration underlying initiation and progression of multiple system atrophy (MSA). The study focused on further validating novel animal models of MSA and revealed that c-Abl activates and regulates alpha-synuclein aggregation in MSA patients and animal brains. Parkinson's disease and MSA are similar progressive neurodegenerative disorders in which abnormal accumulation and aggregation of neuronal protein alpha-synuclein is known to play a crucial role, self-propagating in the brain and other organ systems to drive neurological dysfunction and degeneration.
Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, said it secured an exclusive, worldwide license from Eyecro LLC, of Oklahoma City, for its eyedrop delivery technology targeting topical administration of cannabinoids to the eye. Eyecro is a contract research organization whose platform technology is designed to deliver lipophilic molecules to the anterior and posterior segments of the eye. Inmed is developing INM-088 as a cannabinol for treating ocular diseases, including glaucoma.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., said Kaneka Eurogentec SA, an affiliate of Tokyo’s Kaneka Corp., will manufacture Inovio's COVID-19 vaccine candidate, INO-4800. Terms were not disclosed. INO-4800 is a nucleic-acid-based vaccine that is stable at room temperature for more than a year and does not need to be frozen in transport of storage, according to Inovio.
Memo Therapeutics AG, of Schlieren, Switzerland, said MTX-COVAB, its human-derived antibody against SARS-CoV-2, has demonstrated efficacy in an animal model of the infection, both in treatment and prophylactic settings. MTX-COVAB was also found to have virus neutralizing potency (IC50 = 40pM), which is comparable or better to that of the leading antibody therapies in development, and cross-neutralizes all clinically relevant virus mutants. MTX-COVAB is a fully human antibody isolated from clinically selected convalescent COVID-19 patients.
Omeros Corp., of Seattle, said the Centers for Medicare & Medicaid Services (CMS) confirmed separate payment in ambulatory surgery centers (ASCs) for Omeros’ cataract surgery drug, Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3%. In its final rule directed to the Medicare outpatient prospective payment system and the centers payment system for calendar year 2021, CMS confirmed that the drug qualifies for separate payment under CMS’ policy for non-opioid pain management surgical drugs when used in the ASC setting. This separate payment for Omidria is effective retroactively beginning Oct. 1.
Oncolys Biopharma Inc., of Tokyo, was informed of the achievement of the first milestone in accordance with the license agreement for OBP-601 with Transposon Therapeutics Inc., of Westport, Conn. Transposon is conducting development of OBP-601, a small-molecule nucleotide reverse transcriptase inhibitor, for the treatment of life-threatening and debilitating diseases. The achievement entitles Oncolys to receive a milestone revenue in an undisclosed amount, but the deal is worth more than $300 million, Oncolys said.
Oncosec Medical Inc., of Pennington, N.J., disclosed the online publication of a case study investigating the efficacy of Tavo (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12, in combination with Keytruda (pembrolizumab, Bristol Myers Squibb Co.) in a patient with checkpoint-resistant advanced metastatic melanoma in the International Journal of Surgery Case Reports. All treated lesions were resolved in the study, and the combo led to a whole-body response.
Orsini Specialty Pharmacy, of Elk Grove Village, Ill., said it was selected by Alnylam Pharmaceuticals Inc., of Cambridge, Mass., as a limited distribution partner for Oxlumo (lumasiran), approved by the FDA in November to treat primary hyperoxaluria type 1 in children and adults.
Shape Therapeutics Inc., of Seattle, unveiled the AAVid capsid discovery platform and results from its first AAV5 variant library in a nonhuman primate selection campaign. The platform uses non-random mutational fitness to create massive capsid libraries of billions of AAV variants for direct-to-nonhuman-primate in vivo biological selection. By combining DNA synthesis, advanced synthetic biology, next-generation sequence barcoding and machine learning algorithms, Shape generates what it called industry-leading library size and diversity to enable the development of therapeutics.