Aligos Therapeutics Inc., of South San Francisco, said its lead compound, ALG-097111, demonstrated potent SARS-CoV-2 3CLpro inhibition without inhibiting human cathepsin L protease activity up to the highest concentration tested (IC50 > 10 µM). Cathepsin L has been shown to be involved in a highly redundant entry pathway of SARS-CoV-2 into different cell types, the company said. As the competition between the viral 3CLpro and the host cathepsin L might eventually act as a decoy mechanism in vivo, Aligos added, the identification of potent inhibitors selective for the viral 3CLpro represents an important breakthrough.
Arecor Ltd., of Cambridge, U.K., said its partner, Inhibrx Inc., of La Jolla, Calif., exercised an option to license an enhanced formulation of Inhibrx's therapeutic candidate, INBRX-101, developed by Arecor. This is the first license under a multiproduct development agreement between them. INBRX-101 is a recombinant human alpha-1 antitrypsin fc-fusion protein for treating alpha-1 antitrypsin deficiency, a genetic orphan disease that can cause serious lung disease in adults and/or liver disease at any age.
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, entered a collaboration and license agreement with Otsuka Pharmaceutical Co. Ltd., of Tokyo, to develop and commercialize oral voclosporin for treating lupus nephritis in the EU, Japan, the U.K., Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. Aurinia will receive $50 million cash up front and could receive up to $50 million in regulatory and reimbursement milestone payments. Aurinia will receive tiered royalties ranging from 10% to 20% on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka.
Avery Therapeutics Inc., of Tucson, Ariz., and I Peace Inc., of Palo Alto, Calif., will collaborate in a service agreement to advance cell therapy for heart failure. I Peace will generate and supply GMP-grade induced pluripotent stem cells (iPSCs) and related services while Avery will use them to derive cells. The IPSCs are manufactured at I Peace’s GMP facility in Kyoto, Japan. Avery said it expects to expand the application of its regenerative technology to various types of heart disease.
Bio-Thera Solutions Ltd., of Guangzhou, China, said it reached a licensing agreement with Biomm SA , of São Paulo, Brazil, for BAT-1706, a bevacizumab biosimilar. Biomm will have exclusive rights to distribute and market the drug in Brazil. BAT-1706 is proposed for treating metastatic colorectal cancer, metastatic or locally recurrent breast cancer, locally advanced, metastatic or recurrent non-small-cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube or primary peritoneal cancer. BAT-1706 has completed a global phase III comparative clinical study vs. EU-bevacizumab plus chemotherapy in patients with advanced non-squamous non-small-cell lung cancer.
New preclinical data from EIP Pharma Inc., of Boston, demonstrated that neflamapimod, a brain-penetrant, oral small molecule that inhibits the intracellular enzyme p38 MAP kinase alpha, promotes functional recovery after ischemic stroke in rats. Neflamapimod was administered to rats at either 1.5 mg/kg or 4.5 mg/k twice daily for six weeks, starting 48 hours after stroke was induced via transient middle cerebral artery occlusion. The major findings showed that neflamapimod treatment, relative to vehicle treatment, significantly improved behavioral outcomes assessed by the modified neurological severity score at week four and at week six post stroke in a dose-dependent manner (p<0.001).
Evotec SE, of Hamburg, Germany, said it achieved key milestones in its partnership with Bristol Myers Squibb Co., of New York, in the field of targeted protein degradation, with the first two targets transitioning into drug discovery after completing a comprehensive target validation process. Evotec and BMS, the successor in interest to Celgene Corp., initiated their long-term drug discovery and development partnership in the field of targeted protein degradation in 2018. The partnership leverages Evotec's platform, which combines enhanced throughput proteomics, high-throughput transcriptomics and cell imaging with an integrated data analysis platform.
Fusion Pharmaceuticals Inc., of Hamilton, Ontario, is making a financial investment in Triumf, Canada's particle accelerator center, to help the center upgrade its actinium-225 production infrastructure. In exchange for the investment, Fusion will get preferred access to actinium-225 for use in its cancer therapies.
Glycostem Therapeutics BV, of Oss, the Netherlands, and Ghent University signed a license agreement for an innovative NK cell production technology. The agreement impacts the production time of Glycostem's lead product, Onkord, and its second (CAR-NK) and third (TCR-NK) generation therapies. Glycostem's NK-cell based therapies are manufactured in its in-house GMP licensed facility. Ghent University's technology has the potential to almost halve the time needed for NK cell progenitor cells to differentiate into fully functional NK-cells, according to Glycostem.
GT Biopharma Inc., of Beverly Hills, Calif., said Cytovance, a subsidiary of the Shenzhen Hepalink Pharmaceutical Group Co. Ltd., of Shenzhen, China, reached an agreement for license rights to use certain bacterial and mammalian cell lines and for GMP manufacturing services performed to date regarding the company's TriKE product candidates. Under the terms, Cytovance is the exclusive GMP manufacturer for three of the company's TriKE candidates. Subject to the completion of certain milestones by Cytovance, GT has the option to pay Cytovance up to $6 million for licenses to use certain of Cytovance's bacterial and mammalian cell lines and for manufacturing services performed in either cash or in shares of the company's common stock valued at the time Cytovance achieves each of several milestones over the next 12 months. GT issued $1 million of restricted common stock to Cytovance.
Horizon Therapeutics plc, of Dublin, said it expects a short-term disruption in Tepezza (teprotumumab-trbw) supply as a result of recent government-mandated COVID-19 vaccine production orders related to Operation Warp Speed that have dramatically restricted capacity available for the production of Tepezza at its manufacturer, Catalent Inc., of Somerset, N.J. Horizon anticipates that this drug supply shortage will begin at the end of December and could last through the first quarter. The length of the Tepezza supply disruption will depend on whether future manufacturing slots are successfully completed as well as decisions by the FDA. The company expects to submit data in January from the first increased scale manufacturing lot to the FDA for its review and approval. Tepezza is approved for thyroid eye disease.
Imetabolic Biopharma Corp., of Tempe, Ariz., disclosed the expansion of its partnership with Ligand Pharmaceuticals Inc., of San Diego, building on an earlier alliance agreement initiated in 2018 that provided access to Ligand’s Omniab platform. In the new agreement, Imetabolic gains access to additional Omniab species and technologies, enabling the acceleration of development of assets through its Iplatform technology. Molecules in the works can be selectively engineered to improve target pathogen binding, and to elicit specific biological function for enhanced efficacy, clearance and/or administration, Imetabolic said.
Lantern Pharma Inc., of Dallas, disclosed a collaboration and research agreement with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Kennedy Krieger Institute in Baltimore. The collaboration will focus on the further development of Lantern's LP-184 in glioblastoma multiforme (GBM). Specifically, the deal will focus on advancing the targeted use of LP-184 in defined subtypes of GBM and clarifying the most promising clinical applications.
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, entered a collaboration enabling the use by AC Bioscience Ltd., of Lausanne, Switzerland, of preclinical and clinical data for LX-2931, without granting any right or license under any of Lexicon’s patent rights for the compound. LX-2931 is a small-molecule sphingosine-1-phosphate lyase inhibitor that is currently not in active development at Lexicon. Under the terms of the agreement, Lexicon will receive an up-front payment and is eligible to receive milestone payments totaling up to $5.3 million.
Merus NV, of Utrecht, the Netherlands, and Sema4, of Stamford, Conn., a patient-centered health intelligence company, signed a deal to use Sema4’s genomic testing to identify patients with tumors harboring neuregulin 1 gene (NRG1) fusions who may be eligible for investigational treatment with the bispecific antibody zenocutuzumab in the phase I/II trial called Enrgy, sponsored by Merus. Sema4 will perform genomic testing to identify patients with advanced NRG1-positive solid tumors who might need novel clinical options and raise awareness of Merus’ experiment. NRG1 gene fusions are a group of rare genomic alterations emerging as a potential actionable driver of tumorigenesis and growth across many types of solid tumors, including lung, breast, pancreatic, ovarian and colorectal cancers, Merus noted.
Miragen Therapeutics Inc., of Boulder, Colo., licensed the rights to use the Xtend half-life extension technology from Xencor Inc., of Monrovia, Calif., for use in antibodies targeting insulin-like growth factor-1 receptor. Miragen plans to use the technology in VRDN-002 to reduce dose and/or dosing frequency. The company plans to file an IND for a clinical trial of VRDN-002 in patients with thyroid eye disease by the end of 2021.
Nanoform Finland plc, of Helsinki, Finland, and Herantis Pharma plc, of Espoo, Finland, said they signed a letter of intent for a collaboration to enhance nasal drug delivery to the brain of Herantis’ CDNF and xCDNF therapies for Parkinson’s disease using Nanoform’s biological nanoparticle technology. The goal is to increase the probability of success for enhanced blood-brain barrier penetration in the nasal drug delivery route for CDNF and x-CDNF. Specific terms were not disclosed.
Novavax Inc., of Gaithersburg, Md., and the government of New Zealand signed an advanced purchase agreement for 10.7 million doses of NVX-CoV2373, Novavax’s candidate vaccine to prevent COVID-19. Financial terms of the deal weren't disclosed.
Onk Therapeutics Ltd., of Galway, Ireland, licensed a CLEC12A scFv binder from Cellerant Therapeutics Inc., of San Carlos, Calif. Onk plans to incorporate it into ONKT-104 a CLEC12A CAR with a TNF-related apoptosis-inducing ligand variant targeting death receptor 4. The company also licensed a tumor-specific antibody targeting an aberrantly glycosylated tumor-associated form of MUC1 from Glycotope GmbH, of Berlin. The antibody will be integrated into Onk’s preclinical program, ONKT-103, for solid tumors. Finally, through a license from the NIH, Onk is working on expressing CCR7 in natural killer cells, which the company believes will improve the homing of the cells to lymph nodes.
Open Care Pty. Ltd., of Melbourne, Australia, is in early stage discussions with contract research organizations to run a clinical trial for Immubiocv, its nanoparticle-based COVID-19 vaccine. The company plans to start a phase I study in the second quarter of 2021.
Oryzon Genomics SA, of Madrid, Spain, is collaborating with researchers from Columbia University to study the effects of LSD1 inhibitors in preclinical Setd1a models. The group will also perform functional psychometric characterization of individuals carrying mutations in the SETD1A gene, which has been linked to schizophrenia. Oryzon is developing vafidemstat, an LSD1 inhibitor.
Prep Biopharm Ltd., of London, completed 12-week toxicology study of PrEP-001 in dogs. There were no mortalities and no changes in clinical signs, body weight, food consumption or other systemic nor macroscopic adverse effects up to the highest dose tested of 15 mg/day. The company plans to run a phase IIb field study of PrEP-001 against all circulating respiratory viruses.
Rheos Medicines Inc. and Patientslikeme LLC, both of Cambridge, Mass., are partnering to understand the metabolic drivers of immune-mediated diseases. Rheos will use Patientslikeme's database of proteomic, metabolomic, transcriptomic and genetic data from patients to identify novel targets for treating immune-mediated diseases.
Seneca Biopharma Inc., of Germantown, Md., and Leading Biosciences Inc., of Carlsbad, Calif., signed a definitive agreement under which a wholly owned subsidiary of Seneca will merge with Leading in an all-stock transaction. The combined company will focus on advancing Leading's lead pipeline asset, LB-1148, in clinical studies to evaluate its potential to improve restoration of normal gastrointestinal function following major surgery and reduce certain postoperative complications such as abdominal adhesions. Upon completion of the merger, the company is expected to operate under the name Palisade Bio Inc. and trade on Nasdaq under the symbol PALI. Altium Capital has agreed to invest $22.5 million at the close of the merger. The private placement financing will help fund continued development of the combined company's programs, including LB-1148, and is expected to close immediately prior to the completion of the merger. The drug is a phase III-ready, patent-protected, oral formulation of a broad-spectrum serine protease inhibitor.
Vectura Group plc, of Chippenham, U.K., said partner Hikma Pharmaceuticals plc, of London, launched its generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder, Glaxosmithkline plc), following FDA approval, triggering an $11 million milestone payment to Vectura, which also will earn a midteens royalty on net sales.