Aytu Bioscience Inc., of Englewood, Colo., closed its merger with Neos Therapeutics Inc., of Grand Prairie, Texas, and the combined company has begun operating under the name Aytu Biopharma Inc.
Aeglea Biotherapeutics Inc., of Austin, Texas, and Immedica Pharma AB, of Stockholm, disclosed a license and supply agreement for pegzilarginase, a recombinant human arginase 1 enzyme that has been shown to lower toxic levels of the amino acid arginine in patients with arginase 1 deficiency. Immedica will make an up-front payment of $21.5 million to Aeglea, which will be eligible to receive up to approximately $130 million in regulatory and commercial milestone payments as well as mid-20s percentage royalties on net sales. Immedica receives commercialization rights in Europe and several Middle East countries. Aeglea will continue to be responsible for certain clinical development activities and the manufacturing of pegzilarginase, and retains commercialization rights in the U.S. and rest of the world.
Altimmune Inc., of Gaithersburg, Md., retained Summit Biosciences Inc., of Lexington, Ky., to manufacture a metered nasal spray presentation of AdCOVID, its intranasal COVID-19 vaccine candidate. AdCOVID is an adenovirus-vector vaccine designed to stimulate a broad immune response following a single vaccination that includes both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract. AdCOVID is being evaluated in a phase I trial.
Antengene Corp. Ltd., of Shanghai, will offer preclinical data showing the synergistic effect of the combination of XPO1 and mTORC1/2 inhibition for the treatment of triple-hit diffuse large B-cell lymphoma at the American Association for Cancer Research. ATG-010, also known as selinexor, is the world's first approved selective inhibitor of the nuclear export protein XPO1. ATG-010 induces the apoptosis of cancer cells in vitro and in vivo through the targeted inhibition of the nuclear export protein XPO1 that leads to the nuclear storage and activation of tumor-suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins without affecting normal cells.
Bavarian Nordic A/S, of Copenhagen, Denmark, said the Public Health Agency of Canada has ordered Imvamune smallpox vaccine to the national stockpile at a total value of $31.2 million. Deliveries of the vaccines are expected to occur from the first quarter 2022 with anticipated completion in 2023.
Citrine Medicine Inc., of Shanghai, said its holding company, the Rarestone Group, has signed a five-year strategic partnership with the Chinese Alliance for Rare Diseases, a nonprofit organization.
Cybin Inc., of Toronto, signed a drug development agreement with Catalent Inc., of Somerset, N.J., to develop a therapy for treatment-resistant psychiatric disorders. Cybin will be applying Catalent’s Zydis orally disintegrating tablet technology for the delivery of its deuterated tryptamine. Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water.
Dyadic International Inc., of Jupiter, Fla., and Medytox Inc., of Seoul, South Korea, have expanded their partnership to co-develop C1 manufactured COVID-19 vaccines and/or boosters, which could be used to immunize people against two or more of the current and future COVID-19 variants. Medytox developed a botulinum toxin product for the first time in Korea, and development, manufacture, marketing and sales of neurotoxin products comprise its core business.
Edesa Biotech Inc., of Toronto, signed a definitive license agreement under which the company, through a subsidiary, has acquired additional global rights to a nonsteroidal anti-inflammatory technology that forms the basis of the company's EB-01 and EB-02 drug candidates. The license agreement, with the technology's inventor, provides Edesa with development and commercialization rights to multiple patent families as well as know-how related to the underlying technology. Edesa previously licensed this drug technology from Hebrew University of Jerusalem for topical dermatology and certain gastrointestinal indications.
Enlivex Therapeutics Ltd., of Ness Ziona, Israel, with Yale Cancer Center disclosed a research collaboration for the assessment of the potential of Allocetra to enhance the activity of checkpoint inhibitors in solid tumors. Allocetra is a macrophage-reprogramming immunotherapy product candidate currently in clinical development by Enlivex, as, among other things, a potential therapy in combination with approved immune checkpoint inhibitors for hard-to-treat solid tumors. The parties intend to develop and execute preclinical programs to investigate the potential synergies between Allocetra and commercially approved checkpoint inhibitor therapies for select solid cancers.
Enzolytics Inc., of College Station, Texas, filed U.S. NIH updated grant applications seeking funding for its production of monoclonal antibodies targeting the identified conversed epitope sites on both the HIV-1 and the SARS-CoV-2 viruses. In the case of the HIV viruses, eight conserved sites on the HIV-1 virus, some with more than 98% conserved sequences, have been identified using artificial intelligence to analyze over 87,336 HIV isolates now known. In the case of the coronavirus, 11 conserved sites have been identified, with conserved sequences of from 97.68% to 99.28%. Patent applications have been filed covering both discoveries.
Etherna Immunotherapies NV, of Niel, Belgium, said it was awarded a TIGER grant of €6.9 million (US$8.2 million) from the EU commission, provided to a consortium led by the company. It will be used to accelerate development of a potentially best-in-class mRNA cancer vaccine for treating recurrent/metastatic human papillomavirus strain 16-positive cancers, such as head and neck cancer, cervical cancer and anogenital cancer.
Evotec SE, of Hamburg, Germany, said it entered a multi-RNA target alliance with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, focused on discovering and developing RNA-targeting small-molecule therapeutics against targets difficult to address via more conventional approaches. The companies will jointly identify and develop small molecules against RNA targets aligned with Takeda’s research and development areas, using Evotec’s RNA targeting platform. Under the terms, Evotec will receive significant research funding and will be eligible to receive discovery, preclinical, clinical, commercial and sales milestone payments of up to $160 million per program. Evotec also is entitled to tiered royalties on net sales of any products resulting from the collaboration.
Fortress Biotech Inc., of New York, said partner company Journey Medical Corp. in-licensed and launched an oral isotretinoin under the brand name Accutane (isotretinoin capsules USP) in the U.S., indicated for treatment of severe recalcitrant nodular acne.
Ico Therapeutics Inc., of Vancouver, British Columbia, and Satellos Bioscience Inc., of Toronto, said they executed an agreement, providing for the business combination of the firms in which Satellos will become a wholly owned subsidiary of Ico. The parties expect to complete an amalgamation of the two firms, with the resulting entity named Satellos Bioscience Inc. Following the deal and a concurrent financing, shareholders of Ico will hold about 27.7% ownership, while Satellos shareholders will hold about 58.8%.
Immunitybio Inc., of Culver City, Calif., said preclinical data published in the Journal for ImmunoTherapy of Cancer showed that when subpopulations of tumors cells escape T-cell detection or killing, they up-regulate PD-L1 in the process because of interferon in the tumor microenvironment. That increase in tumor cell PD-L1 expression sensitizes them to killing by PD-L1 t-haNKs. Immunitybio is developing a PD-L1 t-haNK natural killer cell-based therapy in combination with T cell-based immunotherapy against heterogeneous tumors.
Moderna Inc., of Cambridge, Mass., said the Philippines secured 7 million additional doses of COVID-19 Vaccine Moderna through a new supply agreement, bringing its confirmed order commitment of up to 20 million doses. The 7 million additional doses are secured through a partnership in the private sector. The vaccine is not yet approved for use in the Philippines.
Nanostring Technologies Inc., of Seattle, said it was awarded a Technology Access Program grant with Illumina Accelerator startup Doloromics, focused on gaining a deeper understanding of chronic pain diseases by spatially characterizing the dorsal root ganglion. Nanostring will partner with at least one startup from each global Illumina Accelerator funding cycle for a Geomx Digital Spatial Profiler Technology Access Program grant.
Oramed Pharmaceuticals Inc., of New York, said it entered definitive agreements to form a joint venture focused on the development of oral COVID-19 vaccines. The new company, Oravax Medical Inc., is based on Oramed's POD oral delivery technology and Premas Biotech Pvt. Ltd.'s vaccine technology. In a pilot animal study, the oral COVID-19 vaccine promoted both systemic immunity through immunoglobulin G and immunoglobulin A. Oravax anticipates commencing a clinical study during the second quarter of 2021.
Relief Therapeutics Holding AG, of Geneva, and Acer Therapeutics Inc., of Newton, Mass., said they entered a collaboration and license agreement for worldwide development and commercialization of ACER-001, a powder formulation of sodium phenylbutyrate designed to be both taste-masked and immediate release. Under the terms, Acer will receive a cash payment of about $10 million within 15 business days of the agreement execution, and Relief also will pay Acer up to $20 million in U.S. development and commercial launch costs for urea cycle disorders (UCDs) and maple syrup urine disease (MSUD) indications. Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from Acer’s territories 60%-40%, in favor of Relief. In addition, Relief licensed rights for the rest of the world, where Acer will receive from Relief a 15% royalty on all revenues received in Relief’s territories. Acer may also receive a total of $6 million in development milestone payments following the first European marketing approvals for UCDs and MSUD.
The Russian Direct Investment Fund (RDIF), of Moscow, and Virchow Biotech Private Ltd., part of the Virchow Group in India, inked an agreement to produce in the country up to 200 million doses per year of the Sputnik V COVID-19 vaccine. The technology transfer is expected to be completed in the second quarter of 2021 followed by full-scale commercial production of Sputnik V. Virchow Biotech capacities will help facilitate global supply of Sputnik V to international partners of RDIF, the companies said.
Semathera Inc., of Montreal, said it signed a multiyear research collaboration and licensing agreement with Roche Holding AG, of Basel, Switzerland, to focus on developing Semathera’s class of biologicals for the treatment of diabetic retinopathy and other ischemic retinal diseases. Terms were not disclosed.
Therapeutics Solutions International Inc., of Elk City, Idaho, reported data demonstrating its Stemvacs-V induced pluripotent stem cell-derived dendritic cell product stimulates two distinct immunological mechanisms responsible for its anticancer activity in animal studies. Company scientists observed that mice bearing B16 melanoma treated with Stemvacs-V possessed an increased T-cell response toward the tumor associated antigen Brother of the Regulator of Imprinted Sites. Additionally, examination of tumors regressing as a result of Stemvacs-V treatment revealed increased macrophage and natural killer cell infiltration. Depletion of either T cells or natural killer cells in treated mice abrogated the cancer-reducing activity of Stemvacs-V.
Twist Bioscience Corp., of South San Francisco, reported preclinical data showing that GLP-1R antibodies identified from its G protein-coupled receptor libraries showed potent blood glucose control. Data were published online in mAbs.
Verisim Life Inc., of San Francisco, said it launched its pharmaceutical subsidiary, Pulmosim Therapeutics, with the aim to address unmet needs in treating rare respiratory diseases, with an immediate emphasis on pulmonary arterial hypertension and idiopathic pulmonary fibrosis.
Virpax Pharmaceuticals Inc., of Berwyn, Pa., said preclinical studies of Probudur, an injectable, long-acting local anesthetic Liposomal Gel Technology for postoperative pain management, were initiated under an agreement with Charles River Laboratories. Under the terms, Charles River will perform seven preclinical animal studies as part of IND-enabling work.
Windtree Therapeutics Inc., of Warrington, Pa., said it is extending its collaboration with the University of Milan-Bicocca for the discovery and development of new SERCA2a compounds for the potential treatment of chronic and acute human heart failure. Over the next 12 months, the program will focus on the further characterization of Windtree's SERCA2a activators and their interaction with SERCA2a and associated regulatory proteins. Terms were not disclosed.
Xylonix Pte Ltd., of Singapore, said its drug, 010DS-Zn, has demonstrated potential for treating a variety of solid cancers and COVID-19 post-recovery complications, which include heart damage, diabetes and multisystem inflammatory syndrome in children. Xylonix demonstrated that 010DS-Zn markedly reduced the M2 population, while simultaneously boosting anticancer CD4 and CD8 T cells. That resulted in tumor suppression in animal studies. It also demonstrated consistent anticancer activity in 53 human patient-derived cancers tested ex vivo.