Advaxis Inc., of Princeton, N.J., said it received the second milestone payment related to its licensing agreement for ADXS31-164, also known as ADXS-HER2, to OS Therapies LLC, of Cambridge, Md., for evaluation in the treatment of osteosarcoma in humans. Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG), is responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. OS Therapies recently completed a financing, triggering the second milestone payment. Advaxis has the opportunity to receive additional clinical, regulatory and sales-based milestone payments as well as royalties on future product sales.
Ashvattha Therapeutics Inc., of Redwood City, Calif., presented preclinical data at the Association for Vision and Ophthalmology meeting, showing that a single subcutaneous or oral dose of D-4517, a sunitinib analogue using hydroxyl dendrimer technology, suppressed choroidal neovascularization comparable to Eylea (aflibercept, Regeneron Pharmaceuticals Inc.). A phase I study is expected to be completed by year-end, with initial phase II data in wet age-related macular edema patients expected in mid-2022.
Australia’s Victorian government said it will invest $50 million to establish mRNA vaccine and therapeutic manufacturing in Melbourne, via partnerships with universities in Victoria, leading researchers, and Australian and international manufacturing firms. Developing mRNA manufacturing capability locally in Victoria would provide vaccine security, ensuring manufacturing can be contracted locally to avoid global supply chain issues and creating a more robust defense against future pandemics, the government said. The Victoria investment follows news of a countrywide AU$1.3 billion (US$987.5 million) initiative designed to build up manufacturing and ensure supply chains for medical device and drugs in Australia.
Bugworks Research Inc., which has locations in the U.S., Australia and India, said it secured funding from the U.S. Defense Threat Reduction Agency (DTRA) to support development of its broad-spectrum antibiotic, BWC-0977, against critical bacterial biothreats. DTRA will provide funding, through its Bacterial Rapid Acquisition Platform program, to support nonclinical biodefense aspects of the development of BWC-0977, including execution of in vivo efficacy studies to test the drug against biothreat bacterial pathogens, beginning with Yersinia pestis/Bacillus anthracis/Francisella tularensis/Burkholderia pseudomallei/Burkholderia mallei. The University of Florida will take the lead on validating BWC-0977 to identify and measure the potency of Bugworks' antibiotic against ciprofloxacin-resistant B. anthracis, for which there is no identified therapy.
Carisma Therapeutics Inc., of Philadelphia, said it established a multiyear scientific collaboration with the University of Minnesota to investigate and develop allogeneic macrophage therapies. The focus will be optimizing and developing induced pluripotent stem cell-derived allogeneic CAR macrophages to further expand the potential of macrophage-based cell therapy for cancer and other diseases. Terms were not disclosed.
Cybin Inc., of Toronto, said it selected alcohol use disorder as the initial target indication for its deuterated psychedelic tryptamine, CYB-003. The company is targeting an IND filing by the end of 2021.
Daiichi Sankyo Co. Ltd., of Tokyo, disclosed routine clinical practice outcomes data confirming the effectiveness and safety profile of Lixiana (edoxaban) in protecting against the risk of stroke in people with atrial fibrillation (AF). Event rates for stroke and death were 0.69% and 3.8% per year, respectively. More than 13,000 patients were followed for two years in the ETNA-AF-Europe study, showing stroke and bleeding rates in line with rates seen after one year of follow-up. Data were presented at the European Heart Rhythm Association meeting. Additional data in 27,617 people with AF from the global ETNA-AF program were also presented, confirming that the stroke and bleeding rates under use of edoxaban at two years were also considered low and in line with randomized clinical trials. Patients with AF benefited from edoxaban treatment across age groups, including the very elderly (≥85 years), in routine clinical care.
Deerfield Management Co., of Albany, N.Y., a health care investment firm, and the Empire Discovery Institute said they formed a translational research partnership to accelerate the development of novel therapeutics. Through the partnership, Deerfield expects to invest up to $65 million over the next five years to translate scientific discoveries with potential applications for patients. Newly launched Empire Deerfield Discovery & Development LLC will provide funding and support for projects in high-need therapeutic areas, as well as those targeting patients who suffer from hard-to-treat and rare diseases, to accelerate them toward clinical validation in patients and commercialization.
Evotec SE, of Hamburg, Germany, said partner Bristol Myers Squibb Co., of New York, decided to exercise its option to extend its partnership with Evotec in the field of targeted protein degradation. Evotec and BMS, which inherited the 2018 collaboration through its acquisition of Celgene Corp., are using Evotec’s Panomics platform, which combines enhanced throughput proteomics, high-throughput transcriptomics and cell imaging with the integrated data analysis platform Panhunter. The approach has generated a pipeline of potentially first-in-class targeted protein degradation projects, two of which have transitioned into lead optimization after completing respective validation processes on Evotec's platforms. The extension triggers an undisclosed payment to Evotec to further expand screening efforts and continue to grow the pipeline.
Geneleap Biotech, of Boston, a subsidiary of Luye Life Sciences Group, presented preclinical data at the American Chemical Society meeting showing that its tri-antennary GalNAc moieties are more convenient and affordable vs. traditional GalNAc. Compared with the traditional GalNAc, the novel GalNAc has a similar effect on hepatic delivery in rodents and can be used for clinical development of antisense oligonucleotides, siRNA and other nucleic acid-based drug candidates for liver diseases.
GW Pharmaceuticals plc, of London, and Jazz Pharmaceutical plc, of Dublin, said GW’s shareholders voted to approved the $7.2 billion acquisition of GW by a subsidiary of Jazz.
Immunome Inc., of Exton, Pa., reported preclinical data showing that IMM-BCP-01 neutralized CDC SARS-CoV-2 variants of concern in testing. In Syrian hamsters infected with live SARS-CoV-2 virus (USA-WA1/2020), the drug reduced lung viral load as a treatment and prophylaxis. Live virus studies showed full neutralization of South Africa (B.1.351) and U.K. (B.1.1.7) variants, as well as the U.S. and European reference strains USA-WA1/2020 and BavPat1/2020. Pseudovirus studies demonstrated full neutralization of Brazil (P.1) and California (B.1.429, which also contains B.1.427 mutations). Mechanistic studies showed the selected antibodies bind not only to SARS-CoV-2 spike proteins with complex mutations, including the U.K. (B.1.1.7), SA (B.1.351), Brazil (P1/P2) and California (B.1.429/427) variants, but also to those with several individual mutations, including E484Q and L452R, which are associated with the recently emerged double mutant (B.1.617, or the India variant). Two of the three selected antibodies bind to areas of the Spike protein that may be resistant to evolutionary change, the company said. IMM-BCP-01 contains three monoclonal antibodies that bind to non-overlapping regions of the spike protein with picomolar affinity.
Landos Biopharma Inc., of Blacksburg, Va., reported preclinical data showing that BT-11 (omilancor), a topical therapeutic for psoriasis, ameliorates disease severity and inflammation through activation of the LANCL2 pathway. The drug significantly decreased the presence of TNF+, IL-17+, IL-6 and IL-21+ cells in the spleen, elements that are critical factors in the pathogenesis of psoriasis. LANCL2 activation regulated metabolism of skin cells (keratinocytes), inhibiting the metabolic activation reported in keratinocytes from psoriatic skin, and resulted in more than 60% reduction of Psoriasis Area and Severity Index. The company also reported preclinical data showing that another candidate, PX-69, ameliorates rheumatoid arthritis severity, resulting in decreased paw inflammation and size in a rat model of collagen-induced arthritis. The treatment group also showed enhanced structure preservation of hind ankles, reduced cartilage damage and decreased immune cell infiltration and number of blood vessels compared to placebo. PX-69 treatment resulted in a twofold decrease of TNFα-producing cells while up-regulating the proportion of IL-10+ myeloid cells and regulatory T cells in draining lymph nodes.
Lantern Pharma Inc., of Dallas, said data published in Oncotarget describes the efficacy profile of LP-184 in a variety of non-small-cell lung cancer models. The data highlight LP-184's nanomolar in vitro potency in primary and metastatic models and also demonstrate that LP-184 is generally more potent in vitro than commonly prescribed platin- and taxane-based chemotherapeutics. The activity profile of LP-184 is not influenced by the presence of mutations in key oncogenes such as KRAS or KEAP1 and tumor suppressors such as TP53 and STK11, that otherwise underlie resistance to other drugs. Additionally, LP-184 showed tumor growth inhibition in a mouse xenograft model of KRAS/KEAP1-mutant lung cancer.
Pieris Pharmaceuticals Inc., of Boston, and Boston Pharmaceuticals Inc., of Cambridge, Mass., entered an exclusive product license agreement to develop PRS-342, a 4-1BB/GPC3 preclinical immuno-oncology Anticalin-antibody bispecific fusion protein. Boston Pharmaceuticals exclusively licensed worldwide rights to PRS-342, and Pieris will receive an up-front payment of $10 million and is entitled to receive up to approximately $353 million in development, regulatory and sales-based milestone payments, and tiered royalties on sales of PRS-342. Pieris will also contribute an undisclosed amount toward manufacturing activities.
Probiogen AG, of Berlin, said Asher Biotherapeutics Inc., of South San Francisco, entered a service agreement covering all aspects of cell line development, process development and GMP manufacturing at 1,000-liter bioreactor scale. Probiogen will now advance the development of Asher's lead candidate in immuno-oncology, applying its transposase technology, Directedluck. Terms were not disclosed.
Psybio Therapeutics Corp., of Coconut Creek, Fla., said it will provide $1.5 million in funding until May 2023 to boost research at Miami University, of Oxford, Ohio. The company and school collaborated on the discovery and scaled production of two tryptamine molecules in psychoactive magic mushrooms, psilocybin and norbaeocystin. The school’s labs are developing microbes capable of efficient production of a range of medically relevant alkaloids. The compounds originate from a variety of plants and fungi.
The Russian Direct Investment Fund (RDIF) and Turkish pharmaceutical company Viscoran İlaç have agreed to collaborate on production of the Sputnik V COVID-19 vaccine in Turkey. Viscoran İlaç plans to launch production “in the upcoming months” at several facilities, according to RDIF.
Samsung Biologics Co. Ltd., of Incheon, South Korea, and TG Therapeutics Inc., of New York, expanded their contract manufacturing deal for the supply of TG’s ublituximab, an anti-CD20 monoclonal antibody. TG has completed a rolling submission of a BLA requesting approval of ublituximab, in combination with Ukoniq (umbralisib), its oral once-daily inhibitor of PI3K-delta and CK1-epsilon, for treating chronic lymphocytic leukemia. The BLA was based primarily on the positive results from the UNITY-CLL phase III study. Ublituximab targets an epitope on CD20-expressing B cells.
Sanofi SA, of Paris, said it will help manufacture Cambridge, Mass.-based Moderna Inc.´s COVID-19 vaccine by performing fill and finish of up to 200 million doses starting in September 2021 in Ridgefield, N.J. Earlier in 2021, Sanofi said it would provide support to Mainz, Germany-based Biontech SE for 125 million doses for the EU. In February, Sanofi said one of its manufacturing sites in France would support New Brunswick, N.J.-based Johnson & Johnson for the production of its COVID-19 vaccine at a rate of approximately 12 million doses per month.
Seneca Biopharma Inc., of Germantown, Pa., said it passed the final proposal required for approval of the proposed merger between Seneca and Leading Biosciences Inc., of Carlsbad, Calif. The merger is expected to close on or about April 27 and the new combined company, Palisades Bio Inc., is expected to begin trading on Nasdaq on or about April 28 under the ticker symbol PALI. Seneca and Leading are developing therapies to protect the gastrointestinal mucosal barrier.
Therapeutic Solutions International Inc., of Elk City, Idaho, said new data demonstrated a synergy between its inducible pluripotent stem cell-derived immunotherapy product with low-dose cyclophosphamide in evoking potent immune-mediated cancer regression. In a series of experiments, the company said its stem cell-derived tumor endothelial-like cell vaccine enabled non-toxic doses of cyclophosphamide, a chemotherapeutic agent, to induce reduction of established lung cancers, brain cancers and skin cancers in animal models. It also demonstrated that reduction of tumors was associated with increased infiltration of immune cells, the company added.
X-Biotix Therapeutics Inc., of Waltham, Mass., said it is suspending its antibacterial research and will focus on submitting manuscripts that describe its progress in developing small molecules that demonstrate inhibitory activity against multidrug-resistant gram-negative bacteria and on strengthening its intellectual property position with additional filings. X-Biotix said it has developed intellectual property covering a wide range of chemical matter for its research programs and will continue to explore out-licensing or new funding opportunities for those programs. X-Biotix was founded in 2016 to screen targets using chemical matter from DNA-encoded libraries containing hundreds of billions of molecules to treat infections caused by gram-negative multidrug resistance bacteria, including Acinetobacter, Pseudomonas and various Enterobacteriaceae.