Leeds, U.K.-based 4D Pharma plc published new data outlining the ability of its candidates, MRx-0005 and MRx-0029, to modulate neuroinflammatory and neurodegenerative processes in vitro. MRx-0029 also induced a mature phenotype in undifferentiated neuronal cells. Founded in February 2014, 4D develops biological products that contain a live organism, such as a bacterium, applicable to the prevention, treatment or cure of a disease. The paper, "In vitro Characterization of Gut Microbiota-derived Bacterial Strains with Neuroprotective Properties," was published in Frontiers in Cellular Neuroscience.
Amydis Inc., of San Diego, received a $1.5 million phase IIa Small Business Innovation Research grant from the NIH's National Institute on Aging for continued funding of an ophthalmic diagnostic compound for treating cerebral amyloid angiopathy. Amydis' platform is designed to provide a retinal imaging test for the disease, in which amyloid proteins accumulate in the walls of arteries and increase the risk of stroke and dementia.
Athenex Inc., of Buffalo, N.Y., completed construction of its 440,000-square-foot active pharmaceutical ingredients facility in Chongqing, China. The company will produce validation batches in the fourth quarter of this year and commence operations in the first half of 2020. The facility is designed to ensure the supply of active pharmaceutical ingredients for commercial launches. Athenex develops drugs for treating cancer.
Auransa Inc., of Palo Alto, Calif., released data showing its lead candidate, AU-409, produced antitumor activity in a preclinical model. The compound was tested in cells derived from patients' tumors. AU-409 is designed to treat hepatocellular carcinoma. The data were presented at the International Liver Cancer Association meeting in Chicago.
Beer-Sheva, Israel-based BGN Technologies, the technology transfer company of Ben-Gurion University of the Negev, entered an exclusive license with Vaxil Bio Ltd., of Ness-Ziona, Israel, to develop and commercialize targeted cancer therapies. The platform includes an E-selectin targeted polymer to inhibit tumor growth and the metastatic spread of cancer. Selectins are a family of cell adhesion molecules that mediate interaction between circulating cells and blood vessel endothelium. E-selectin is a cytokine-inducible molecule on the surface of inflamed blood vessels. No financial details were announced.
The New York Stock Exchange granted Biopharmx Corp., of San Jose, Calif., until March 24 to regain compliance standards regarding stockholders' equity balance. In September 2018, the Exchange notified Biopharmx it was not in compliance with Section 1003(a)(i)-(iii), which required companies to maintain stockholders' equity of $6 million or more if they have reported losses from continued operations and/or net losses in their five most recent fiscal years. Biopharmx's stock continues to be listed and traded on the NYSE.
Clovis Oncology Inc., of Boulder, Colo., entered a global licensing and collaboration agreement with 3B Pharmaceuticals GmbH, of Berlin, to develop a peptide-targeted radionuclide therapy and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90% of breast, lung, colorectal and pancreatic carcinomas, the companies noted. Clovis will conduct global clinical trials and has obtained U.S. and global rights, excluding Europe (inclusive of Russia, Turkey and Israel), where 3B retains rights. The parties have also agreed to collaborate on a discovery program directed at three additional targets for radionuclide therapy, to which Clovis will have global rights. Terms of the deal include about $12 million in up-front payments to 3B. Upon achievement of certain development and regulatory milestones, additional potential milestone payments and single- to low-double-digit commercial royalties would be paid as well.
Deinove SA, of Paris, said it expanded its platform with the CRISPR/Cas9 system to enhance its ability to optimize various microorganisms. The objective is to be able to directly manipulate the strains producing antimicrobial activities or to transfer those activities into phylogenetically close frames.
Dyne Therapeutics Inc., of Waltham, Mass., made known its support for the Resolve study, an ongoing natural history experiment designed to inform the development of therapies for facioscapulohumeral muscular dystrophy (FSHD). The effort is an observational study run by the FSHD Clinical Trial Research Network, a network of medical centers across the U.S. and Europe that aims to validate new clinical outcome assessments and refine trial planning strategies in FSHD, the company said. The 18-month, longitudinal study is enrolling about 160 patients across eight sites in the U.S., plus 60 patients across three sites in Europe.
Eloxx Pharmaceuticals Inc., of Waltham, Mass., said the Cystic Fibrosis Therapeutics Development Network has sanctioned its phase II trial protocol in the U.S. for ELX-02 in cystic fibrosis, and the Cystic Fibrosis Foundation will provide funding and additional resources for the program. Top-line data are expected later this year. The drug is a eukaryotic ribosomal selective glycoside designed to increase the read-through activity in patients with nonsense mutations and enable the production of sufficient amounts of full-length functional protein to restore activity
Enlivex Therapeutics Ltd., of Ness Ziona, Israel, disclosed the first presentation of its preclinical studies, which were designed to evaluate the combination of Enlivex's Allocetra-OTS immunotherapy and chimeric antigen receptor T (CAR T) therapy designed for treating solid tumors. The results, detailed in an oral presentation at the Joint IIS-ISCR Special 2019 Conference – The Cutting Edge of Immunology, Cancer and Immunoncology Research in Tel-Aviv, Israel – showed significantly increased duration of survival and overall survival for study subjects who were treated with the combination therapy, as compared to standalone solid tumor CAR T therapy. The results also showed that the mechanism of action significantly increased the antitumor macrophage population surrounding the human solid tumor microenvironment in the subjects who were treated with the combo therapy.
Eyegate Pharmaceuticals Inc., of Waltham, Mass., said it regained compliance with the Nasdaq listing rule concerning minimum bid price.
Genscript Corp., of Piscataway, N.J., said it will provide research support to Harvard University scientist George Church for his contributions to the Ultra-safe Cell project, the first grand-scale, community-wide initiative being undertaken by Genome Project-write and The Center for Excellence in Engineering Biology. The project aims to develop a cell line that is completely resistant to all natural viruses, and thus could pave the way for many biomedical applications, from modeling cell and tissue behaviors to the production of better and safer biologics and therapeutics, Genscript said. The company will be providing research support, including DNA synthesis services, for the project.
I-Mab Biopharma Co. Ltd., of Shanghai, signed a clinical research collaboration agreement with Merck & Co. Inc., of Kenilworth, N.J., to evaluate the combination of I-Mab's TJC-4 and Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with multiple cancer types. Merck has agreed to supply Keytruda to I-Mab for use in studies in combination with TJC-4, a fully human anti-CD47 monoclonal antibody. The parties will collaborate on a phase I trial, based on an agreed and finalized protocol, to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the pair.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, unveiled its Abthena bispecific antibody platform and the complementary Artemis Intelligence Metadata (AIM) suite. The company said it has designed an advanced discovery platform for wild-type and fully human bispecific antibody components, which allows for the generation of heterodimer, optimized, IgG backbones with validated binding attributes. Abthena produces yields comparable to its monospecific equivalents, with a high degree of dimer formation, a platform which blends seamlessly with AIM capabilities to enable rapid turnaround on additional algorithmic outputs in therapeutic optimization, stability, affinity and manufacturability, the company said.
Immutep Ltd., of Sydney, said it will receive a milestone payment from London-based Glaxosmithkline plc (GSK) of £4 million (US$4.9 million) related to the first patient being dosed in the latter's phase II trial evaluating GSK-2831781 in ulcerative colitis. The drug is derived from Immutep's IMP-731 antibody, a depleting anti-LAG antibody technology that was exclusively licensed to GSK. Under the terms of the agreement, Immutep is eligible to receive up to £64 million in developmental milestone payments as well as single-digit tiered royalties, if GSK-2831781 is commercialized. GSK is responsible for all costs associated with the clinical development and commercialization of the compound. (See BioWorld, Jan. 12, 2011.)
Lipidor AB, of Stockholm, a Karolinska Development company, said it was approved for listing on Nasdaq First North Growth Market, with its first day of trading set for Sept. 27.
Oncolytics Biotech Inc., of Calgary, Alberta, said it received a notification letter from Nasdaq that it was not compliant with the minimum bid price requirement for continued listing, after the closing price for the company's common shares, listed as ONCY, fell below $1 for 30 consecutive trading days. The company said it will seek to remedy the deficiency within the compliance period of 180 calendar days. On Monday, shares closed at 69 cents.
Plus Therapeutics Inc. (formerly Cytori Therapeutics Inc.), of Austin, Texas, said it was notified that, based on retrospective changes in indirect cost rates under a 2012 contract, the Biomedical Advanced Research and Development Authority, or BARDA, plans to pay approximately $4.6 million to reimburse work performed during fiscal years 2012 through 2019. The company expects to receive the payment in October.
Preveceutical Medical Inc., of Vancouver, British Columbia, said its scientists completed the design and synthesis of a panel of Smart-siRNA constructs that, when screened, showed gene silencing potency comparable to native siRNA constructs. The company said the development confirmed that the chemistry applied when constructing the Smart-siRNAs did not compromise their efficacy and specificity. The Smart-siRNA constructs were designed in conjunction with the company's dual gene therapy program, where the construct's biostability next will be assessed in preclinical mouse models of type 2 diabetes and obesity.
Pharmacy benefit manager Prime Therapeutics LLC, of Eagan, Minn., said its health outcomes researchers analyzed real-world use of Botox (onabotulinumtoxinA, Allergan plc) and three similar botulinum toxins (BT) approved to treat several movement disorders and determined that shifting treatments to equally effective, lower cost BT therapies would save an estimated $6.3 million annually across members of a commercial health plan. Prime analyzed claims from 15 million commercially insured members that occurred in 2018 and found 58,000 BT claims totaling more than $76 million. BT drug claims to treat three movement disorders – cervical dystonia (CD), limb spasticity (LS) and blepharospasm (BS) – accounted for more than 32% of total BT spend, while 60% of the spend was for migraine treatments. Botox accounted for about 90% of BT spend and was the highest cost treatment for the three movement disorder conditions studied. AbobotulinumtoxinA (Dysport, Galderma Laboratories LP), prescribed for members with CD, had a 33% lower cost than Botox. IncobotulinumtoxinA (Xeomin, Merz Pharma GmbH & Co. KGaA), used to treat members with LS and BS, cost 26% and 29% less, respectively, than Botox. Prime said analysis of time between doses for all types of BT treatments showed no difference, so switching BT type was unlikely to change the annual number of office visits required to administer the drug. Prime's researchers plan to present the study data next month at the Academy of Managed Care Pharmacy's Managed Care & Specialty Pharmacy Nexus meeting in National Harbor, Md.
Symbiocelltech LLC, of Salt Lake City, said PLOS ONE published interim preclinical data on the safety and efficacy of its Neo-Islet cellular therapy, a technology that co-aggregates mesenchymal stem cells with culture-expanded pancreatic islet cells to form three-dimensional cellular clusters. A single dose of Neo-Islets implanted in the abdominal cavity of pet dogs that had naturally developed type 1 diabetes provided durable blood sugar control with reduced need for exogenous insulin and no need for anti-rejection drugs or encapsulation devices. Based on the preclinical findings, Symbiocelltech is preparing an IND submission to the FDA to begin testing Neo-Islet therapy in individuals with type 1 diabetes.
Whole Biome Inc., of San Francisco, said it changed its corporate name to Pendulum Therapeutics Inc. to reflect a broader commitment to developing therapeutic solutions that affect human health through microbiome interventions.