ADC Therapeutics SA, of Epalinges, Switzerland, said preclinical data related to camidanlumab tesirine (Cami, formerly ADCT-301) has been published in the Journal for ImmunoTherapy of Cancer. The study evaluated the antitumor activity of a pyrrolobenzodiazepine dimer-based, CD25-targeted antibody-drug conjugate (ADC), either alone or in combination with a checkpoint inhibitor, in CD25-negative syngeneic colon cancer models that exhibit tumor infiltration of CD25-expressing regulatory T cells (Tregs). Data demonstrated that single low doses of the CD25-targeted ADC resulted in potent and durable antitumor activity against established CD25-negative solid tumors with infiltrating Tregs, both as a monotherapy and in combination with an anti-PD-1 checkpoint inhibitor. Cami is being evaluated in a pivotal phase II trial in patients with relapsed or refractory Hodgkin lymphoma (HL), as well as in a phase Ia/Ib trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma, and a phase Ib trial in solid tumors.
Astrazeneca plc, of Cambridge, U.K., said it will transfer the listing of its American depositary receipts (ADRs) and its U.S.-listed debt securities from the New York Stock Exchange to Nasdaq, effective market close Thursday, Sept. 24. The ADRs will continue to be listed under the ticker AZN.
Axon Neuroscience SE, of Bratislava, Slovakia, said positive preclinical results for ACvac-1, its vaccine candidate against SARS-CoV-2, confirmed the efficacy of the vaccine on the live SARS CoV-2 virus. Vaccinated mice generated a high titer of antibodies in the blood. Those antibodies selectively targeted a specific, vulnerable part of the Spike protein that allows the virus to infect the cells and replicate. In addition, the study demonstrated that the raised antibodies efficiently neutralized the live SARS-CoV-2 virus.
Brink Biologics Inc., of San Diego, a Nantkwest Inc. affiliate and exclusively licensed distributor of its off-the-shelf NK-92 natural killer cells in certain fields, said its next-generation natural killer-based bioanalytical testing solution has been licensed to Fresenius Kabi Swissbiosim GmbH, a Switzerland-based health care company focusing on autoimmune diseases and oncology. Brink offers GLP and research-grade NK-92-based cell lines as part of its Neukopanel portfolio of products for laboratory testing applications.
Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, reported the progression of its drug, Scenesse (afamelanotide 16 mg), to treat the disease xeroderma pigmentosum. The aim of the development program is to confirm the drug’s ability to regenerate DNA of skin exposed to ultraviolet damage. The first clinical results from the DNA repair program are expected to be reported next year.
Cmab Biopharma Inc., of Suzhou, China, and Laekna Therapeutics Shanghai Co. Ltd.. of Shanghai, said they entered a strategic collaboration agreement to speed development of an immune checkpoint inhibitor drug candidate to clinical studies and future commercialization. Cmab will provide a full spectrum of CMC services for Laekna's anti-PD-L1 antibody, LAE-005.
Cobra Biologics, of Keele, U.K., part of the Cognate Bioservices, and Lund, Sweden-based Combigene AB said they signed agreements covering good manufacturing practice production of two essential plasmids needed for the manufacture of CG-01, a gene therapy designed for the treatment of drug-resistant focal epilepsy.
Gain Therapeutics Inc., of Bethesda, Md., signed a collaboration with Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, for the research and development of structurally targeted allosteric regulators to restore functional activity of defective lysosomal enzymes in rare genetic and demyelinating diseases. Gain and Sumitomo will identify and develop small molecules targeting allosteric sites. Financial terms were not disclosed.
Generate Biomedicines Inc., of Cambridge, Mass., was unveiled by Flagship Pioneering. The new company uses machine learning to invent new drugs that include antibodies, peptides, enzymes and cytokines to heretofore undiscoverable protein therapeutics. The Generative Biology platform learns from all known proteins in order to encode and apply the fundamental principles of how genetic sequences lead to protein structure and function. The company has demonstrated that its approach can be applied to all protein modalities and generate novel proteins with desired functions and those that interact potently and specifically with therapeutic targets.
Havn Life Sciences Inc., of Vancouver, British Columbia, said its wholly owned subsidiary, Havn Research Inc., was granted a section 56 exemption by Health Canada, pursuant to which it now has the ability to possess certain amounts of pure psilocybin for scientific purposes, specifically for the research and development of quality control methods. Havn intends to immediately begin work on experiments with the objective of developing a set of methods for the safe, standardized, quality-controlled production of medical compounds extracted from the Psilocybe spp. mushroom.
Immunomic Therapeutics Inc., of Rockville, Md., opened its first office in South Korea. The firm aims to advance research in the glioblastoma field and to deploy ITI-1000 to the Asian population. ITI-1000 is a cell therapy powered by the company’s Unite platform that is being evaluated in a phase II trial called Attac-II in collaboration with researchers at the University of Florida and Duke University. ITI-1001 is an alternative, cell-free approach to treating the brain cancer.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, commenced the application process to dual-list its stock on Nasdaq. The listing remains subject to approval of the exchange. The company said it would provide updates as progress is made.
Kempharm Inc., of Celebration, Fla., said its commercial partner for pain drug Apadaz (benzhydrocodone and acetaminophen tablets), KVK-Tech Inc., of Newtown, Pa., signed an agreement with Sure Med Compliance Inc., of Atlanta, which is focused on supporting physicians in combating the opioid epidemic through greater prescribing education and compliance. The program aligns Apadaz with Sure Med’s Care Continuity Program in a new study program designed to generate anonymized patient outcome and utilization data that will measure the impact of switching patients from other hydrocodone/acetaminophen products to Apadaz, where appropriate.
Know Bio LLC, of Research Triangle Park, N.C., said it generated the first definitive evidence that nitric oxide can inhibit viral reproduction of SARS-CoV-2, the human coronavirus that causes COVID-19. Nitric oxide is a molecule produced naturally to regulate blood flow, control inflammation and defend against invading microorganisms. The company’s in vitro experiments were conducted by testing multiple nitric oxide-releasing compounds against wild type SARS-CoV-2 virus. Therapeutic doses (<200 µM) were applied to infected VERO E6 cells and showed a dose-dependent effect on viral replication, the company said. There was a greater than 99.9% reduction in virus observed after 24 hours vs. virus observed on untreated cells and there was no cytotoxic impact (cell damage or cell death) on uninfected cells, the company added.
Ligand Pharmaceuticals Inc., of San Diego, said it acquired two privately held companies, Xcella Biosciences Inc., of Menlo Park, Calif., for $7 million in cash plus potential earnouts and Taurus Biosciences LLC for $5 million in cash plus non-transferable contingent value rights. Ligand also said it will invest $2.5 million in a new company, Minotaur Therapeutics, in exchange for royalties on products from future programs. Ligand said the acquisitions secured technology to enhance its single B-cell screening platform as well as technologies to discover and humanize antibodies from immunized cows or cow-derived libraries.
Nabriva Therapeutics plc, of Dublin, said CMS granted it a new technology add-on payment for Xenleta (lefamulin) for injection when administered in the hospital inpatient setting. Xenleta is a pleuromutilin antibacterial indicated for treating adults with community-acquired bacterial pneumonia. Both the I.V. and oral formulations of Xenleta were granted qualified infectious disease product and fast track designations by the FDA.
Orion Corp., of Espoo, Finland, said it plans to refocus its R&D to speed up its research projects. The company said a reorganization will change responsibilities, cause transfers to new roles and locations, changes terms of employment and possible lead to layoffs on production grounds. The plan is to implement some of the personnel reductions through retirement, part-time work and training opportunities. The company may also transfer persons affected by the negotiations to other roles in the group.
As part of its ongoing plan to dissolve the company, the board of PDL Biopharma Inc., of Incline Village, Nev., has approved the separation of Lensar Inc., a majority owned subsidiary of PDL, in the form of a dividend involving the distribution of all outstanding shares of Lensar common stock owned by PDL to holders of PDL common stock. Lensar common stock is expected to be distributed Oct. 1 to PDL stockholders.
Rockwell Medical Inc., of Wixom, Mich., said it entered an exclusive license agreement with Jeil Pharmaceutical Co. Ltd., of Seoul, South Korea, for the rights to commercialize Triferic (ferric pyrophosphate citrate) in South Korea. Jeil will be the exclusive development and commercialization partner for Triferic in South Korea and Rockwell Medical will supply the product to Jeil. In consideration for the license, Rockwell Medical will receive an up-front fee and will be eligible for milestone payments and royalties on net sales.
Totient Inc., of Cambridge, Mass., said it will leverage the bioengineering platform at Ginkgo Bioworks Inc., of Boston, to express and screen thousands of antibody candidates with the aim of identifying broadly neutralizing therapeutic antibodies against COVID-19 for further development. Totient leverages tertiary lymphoid structures to identify novel tissue-specific antigens and develop matching high-affinity antibody therapeutics.