Aerami Therapeutics Inc., of Durham, N.C., licensed its tyrosine kinase inhibitor, AER-901, for the treatment of pulmonary arterial hypertension in mainland China, Hong Kong, Macau and Taiwan to Hangzhou Chance Pharmaceuticals Co. Ltd., of Hangzhou, China. Aerami will receive an up-front license fee and is eligible for development and sales milestone payments. Aerami will supply the drug to Chance at an agreed transfer price and will receive a high single-digit royalty on net sales.
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia, signed an agreement with Charles River Laboratories International Inc., of Wilmington, Mass., for preclinical studies of AP-188, which Algernon is developing as a treatment for stroke.
Alterity Therapeutics Ltd., of New York, was awarded a $495,000 grant from The Michael J. Fox Foundation for Parkinson's Research to support the development of its Parkinson's disease drug, ATH-434. Alterity will use the funds to evaluate the pharmacologic profile of ATH-434 in a primate model to determine the optimal dose for human trials.
Antibe Therapeutics Inc., of Toronto, licensed its pain drug, otenaproxesul, to Shanghai-based Nuance Pharma Co. Ltd. for commercialization in China, Hong Kong, Macau and Taiwan. Antibe will receive $20 million up front and is eligible for $80 million in development and milestone payments, as well as a double-digit royalty on sales.
Apollomics Inc., of Foster City, Calif., licensed the rights to EO-1001, a pan-erbB inhibitor of EGFR, HER2 and HER4, from Edison Oncology Holding Corp., of Menlo Park, Calif. Apollomics will have global rights to the drug, except in China, Hong Kong and Taiwan. Edison will receive an undisclosed up-front payment and is eligible for development and sales milestone payments, as well as tiered royalties on net sales.
Applied Biomath LLC, of Concord, Mass., and Revitope Oncology Inc., of Cambridge, Mass., extended their collaboration to include developing a systems pharmacology model for Revitope's dual antigen-targeting platform, Twogate, for the treatment of solid tumors.
Arch Oncology Inc., of Brisbane, Calif., and Merck & Co. Inc., of Kenilworth, N.J., are collaborating to test the combination of Arch's anti-CD47 antibody, AO-176, with Merck's anti-PD-1 antibody, Keytruda (pembrolizumab), as a treatment for relapsed, platinum-resistant ovarian cancer, endometrial cancer and gastroesophageal cancer. The patients treated with the combination will be enrolled in Arch's ongoing phase I/II study.
Atea Pharmaceuticals Inc., of Boston, published preclinical data on its antiviral, AT-527, in Antimicrobial Agents and Chemotherapy. The freebase of AT-527 inhibited replication of SARS-CoV-2 in several in vitro assays. The drug was activated by human primary cells, nasal and bronchial epithelial cells. AT-527 is currently being tested in a phase II trial for hospitalized patients with moderate COVID-19 and in a phase II virology study in the outpatient setting.
Azurrx Biopharma Inc., of Delray Beach, Fla., entered an agreement with contract research organization PPD Inc., of Wilmington, N.C., to run its phase II trial testing FW-1022, a formulation of micronized niclosamide, as a treatment for COVID-19-associated gastrointestinal infections. The study is scheduled to begin in the first half of 2021. Terms of the agreement weren't disclosed.
Basilea Pharmaceuticals Ltd., of Basel, Switzerland, will receive a $10 million payment from New York-based Pfizer Inc. after sales of antifungal Cresemba (isavuconazole) in Europe and Israel exceeded the threshold for triggering a milestone payment.
Bostongene Corp., of Waltham, Mass., and Weill Cornell Medicine published data on the tumor microenvironment of 4,655 patients with diffuse large B-cell lymphoma (DLBCL) in Cancer Discovery. Researchers identified four distinct microenvironments that had different clinical outcomes and prognoses. In preclinical models, the biochemical composition of the extracellular matrix could be exploited to slow DLBCL proliferation.
Cellular Biomedicine Group Inc., of Rockville, Md., said its shareholders approved the company's merger agreement that will take the company private. Shareholders will receive $19.75 per share when the deal closes, which is expected to occur in February 2021.
Compass Pathways plc, of London, added the laboratories of Adam Halberstadt, of UC San Diego, School of Medicine, and John McCorvy, of the Medical College of Wisconsin, to its Discovery Center, a group of researchers working together virtually. The labs, together with the laboratory of Jason Wallach, of the University of the Sciences, will develop psychedelic compounds for unmet medical needs. Compass will have an exclusive license for all new compounds that are generated through the Discovery Center.
Eikonizo Therapeutics Inc., of Cambridge, Mass., formed a collaboration with the McQuade Center for Strategic Research and Development LLC, part of Otsuka Pharmaceutical Co. Ltd., of Tokyo, to develop inhibitors of histone deacetylase-6 focused on treating amyotrophic lateral sclerosis and other diseases. The pair will advance candidates though preclinical and phase Ib studies, with the opportunity to expand the collaboration after those studies.
Eloxx Pharmaceuticals Inc., of Waltham, Mass., said a scientific manuscript, titled “Targeting G542X CFTR Nonsense Alleles With ELX-02 Restores CFTR Function in Human-Derived Intestinal Organoids,” was published in the Journal of Cystic Fibrosis. The article details the results of the company’s evaluation of ELX-02 mediated read-though, using the CFTR-dependent Forskolin-induced swelling assay across a selection of G542X homozygous and heterozygous patient-derived organoids,
Evotec SE, of Hamburg, Germany, signed an integrated multitarget drug discovery agreement with biotech venture firm Related Sciences Inc., of Denver, to generate multiple drug development candidates, biomarkers and IND filings over a multiyear period. In addition to substantial investment from Related and its companies to support Evotec-led research and discovery efforts across portfolios of promising new drug programs, Evotec will be eligible to receive milestones, royalties and a founding equity stake in all Related’s assets developed under the partnership.
Freeline Therapeutics plc, of London, is presenting data at the 17th annual Worldsymposium from its gene therapy programs in Gaucher disease. FLT-201 data suggest that the gene therapy candidate for Gaucher disease is capable of delivering β-glucocerebrosidase variant 85 (GCasevar85) to tissues not sufficiently addressed by standard-of-care enzyme replacement therapy, the company said. In wild-type mice, the product resulted in robust GCase expression in the liver and sustained GCase secretion into the plasma, with enhanced and sustained GCase uptake observed in key tissues involved in Gaucher disease including spleen, bone marrow and lung, Freeline said.
Homology Medicines Inc., of Bedford, Mass., made the first scientific presentation of data from IND-enabling studies with its HMI-203 gene therapy development candidate for Hunter syndrome (MPS II). The results from Homology’s in vivo approach demonstrated the potential of HMI-203 to address peripheral manifestations in the murine disease model and showed that HMI-203 crossed the blood-brain barrier following a single intravenous administration. These data will be presented at the 17th annual Worldsymposium, where Homology will also present long-term data from its HMI-202 in vivo gene therapy program for metachromatic leukodystrophy. In a murine model, HMI-203 led to robust biodistribution and sustained human I2S enzyme expression, which resulted in significant reductions in key Hunter syndrome biomarkers of heparin sulfate glycosaminoglycans and lysosomal-associated membrane protein 1 in the brain, liver, heart, spleen, lung and kidneys compared with vehicle.
Hoth Therapeutics Inc., of New York, signed an agreement with Camargo Pharmaceutical Services Inc., of Cincinnati, to facilitate the writing and submission of the IND application for HT-001 topical product to the FDA. Camargo will write, prepare and submit an IND in the electronic common technical document format. Initiation of the IND is in anticipation of FDA feedback expected for HT-001 from the pre-IND meeting, Hoth said. HT-001 is a topical product being developed for the treatment of rash and skin disorders associated with initial and repeat courses of EGFR inhibitor therapy.
Scientists from Jemincare Shanghai Research Institute, part of the Jemincare Group, of Nanchang, China, published a preprint paper on BioRxiv, titled "A human antibody with blocking activity to RBD proteins of multiple SARS-CoV-2 variants including B.1.351 showed potent prophylactic and therapeutic efficacy against SARS-CoV-2 in rhesus macaques.” The paper said Jemincare's neutralizing antibody, JMB-2002, now in a phase I trial, showed broad-spectrum in vitro blocking activity against the hACE2 binding to the RBD/S protein of multiple SARS-CoV-2 variants, including the South African mutant (B.1.351).
Jubilant Biosys, of Bengaluru and Noida, India, and Yale University will collaborate on multiple small-molecule research programs, including medicinal chemistry, structural biology, and in vitro and in vivo pharmacology. Jubilant specializes in contract R&D services. Yale’s Office of Cooperative Research facilitates research from Yale’s labs into products and services.
Lannett Co. Inc., of Philadelphia, and the HEC Group of companies said they will co-develop the biosimilar insulin aspart for treating adults with type 1 and type 2 diabetes. The product is in development, and Lannett will help manage remaining clinical and regulatory steps for FDA approval. Lannett will fund most clinical development requirements, while HEC continues to develop the product and related manufacturing infrastructure. Lannett and HEC will share in the profits.
Lassen Therapeutics Inc., of San Diego, said it will collaborate with the Olivia Newton-John Cancer Research Institute in Melbourne, Australia, to study IL-11 signaling and assess the potential of monoclonal antibodies that block IL-11 signaling in preclinical models of triple-negative breast cancer. Combating tumor progression through inhibition of cytokines that play a key role in the tumor microenvironment, such as IL-11, is the goal, the company said. Lassen’s lead candidate is LASN-01, a monoclonal antibody targeting IL-11 receptor alpha. IL-11, a member of the IL-6 family of cytokines, is a mediator of fibrosis.
Nanoform Finland plc, of Helsinki, and Herantis Pharma plc, of Espoo, Finland, signed a biologics proof-of-concept agreement for formulation proof-of-concept projects for enhancing nasal drug delivery to the brain of Herantis' CDNF therapies for Parkinson's disease using Nanoform's biological nanoparticle technology. Herantis is developing therapies to treat nervous system and lymphatic diseases.
Respirerx Pharmaceuticals Inc., of Glen Rock, N.J., said it was uplisted from the OTC Pink Market and returned to the OTCQB Venture Market on Feb. 8. The company’s ticker symbol returned to RSPI and is no longer RSPID. Respirerx is developing therapies to treat disorders caused by disruption of neuronal signaling.
New preclinical data from studies of chronic lysosomal diseases, including MPS-1, Fabry, MPS-2 and MPS-6, by Sigilon Therapeutics Inc., of Cambridge, Mass., showed sustained release of a desired protein and the ability to reach multiple organ systems, regardless of disease. Sigilon’s therapies comprise engineered human cells shielded in spheres designed to avoid immune rejection and fibrosis. The data were presented at the 17th Annual Worldsymposium.
Sorrento Therapeutics Inc., of San Diego, said it formed a subsidiary, Adnab Inc., to develop and commercialize a Mayo Clinic-developed technology platform to manufacture antibody-drug conjugates (ADCs) called Adnabs. The ADCs are an immune complex of nanoparticle albumin-bound drug products that are non-covalently conjugated with tumor-targeting monoclonal antibodies. Utilizing Sorrento’s library of fully humanized monoclonal antibodies, the platform is designed to generate a portfolio of product candidates targeting liquid and solid tumors.
Stemedix Inc., of St. Petersburg, Fla., and the University of South Florida will collaborate to advance stem cell treatments. The goal, according to Stemedix, is to collect the appropriate data to create targeted and enhanced protocols that may then be used for an IND.
Synaptogenix Inc., of New York, said it submitted a formal application to list its common shares on Nasdaq. Shares currently are traded on the OTC under the ticker SNPX.
Taysha Gene Therapies Inc., of Dallas, said it inked multiyear collaborations with Cleveland Clinic and UT Southwestern Gene Therapy Program (UTSW) to advance next-generation mini-gene payloads for AAV gene therapies for the treatment of genetic epilepsies and additional CNS disorders. Taysha will have an exclusive option on new payloads, constructs and intellectual property associated with, and arising from, the research conducted under the agreement. A team of researchers from Cleveland Clinic Lerner Research Institute will create mini-gene payloads designed to address some of the longstanding limitations in AAV gene therapy. UTSW will create and evaluate vector constructs in in vivo and in vitro efficacy models of genetic epilepsies and additional CNS disorders.
Tmunity Therapeutics Inc., of Philadelphia, said it expanded its T-cell engineered therapy collaboration with the Center for Cellular Immunotherapies at the Perelman School of Medicine at the University of Pennsylvania (Penn). Under the terms, Tmunity receives further access and rights to certain platform and manufacturing technologies, as well as the exclusive licensing of a Penn-developed clinical-stage asset, a mesothelin CAR T-cell therapy product. Tmunity has also committed to further funding of T-cell engineering research programs at Penn and will receive exclusive rights, subject to certain limitations, to products and technologies resulting from those programs. Tmunity will continue to have certain rights to intellectual property originating from the laboratories of its scientific founders at Penn, including Carl June, Bruce Levine and James Riley.
Tryp Therapeutics Inc., of La Jolla, Calif., said it is collaborating with Jennifer Miller, of the University of Florida, as the principal investigator in a clinical trial to treat symptoms associated with eating disorders. Tryp and Miller have begun designing a phase IIa open-label, exploratory study utilizing psilocybin-based therapeutic TRP-8802 in patients suffering from rare and orphan overeating disorders.
Yingli Pharma Co. Ltd., of Shanghai, said it entered a collaboration with Hengrui Medicine Co. Ltd., of Jiangsu, China, in which Hengrui will invest $20 million in Yingli as an equity investment in exchange for joint development rights and exclusive commercialization rights to PI3K-delta inhibitor YY-20394 in greater China.