DBV Technologies SA, of Montrouge, France, is restructuring while it waits for the FDA to make a decision on the BLA for its peanut allergy drug, Viaskin Peanut. The company plans to scale down spending on clinical and preclinical programs other than Viaskin Peanut, which will allow the €262.4 million (US$295 million) the company had in cash and cash equivalents at the end of the first quarter of 2020 to fund operations significantly beyond management's prior guidance of the first quarter of 2021.
Diversigen Inc., of St. Paul, Minn., and Alimentiv Inc., of London, Ontario, are collaborating to study infliximab in patients with acute severe ulcerative colitis. The companies will co-fund the study.
Helix Biopharma Corp., of Richmond Hill, Ontario, entered a nonbinding term sheet with Caiac Fund Management AG, of Gamprin, Liechtenstein, to divest its 51% stake in its Polish subsidiary, Helix Immuno-Oncology SA (HIO), for up to PLN6.7 million (US$1.7 million). The transaction is scheduled to close on Aug. 31, 2020. Helix also plans to sell 2.2 million shares in HIO, raising PLN2.97 million. Helix has canceled CA$2.7 million (US$1.98 million) of intercompany debt owed to Helix by HIO.
Hemogenyx Pharmaceuticals plc, of London, signed an agreement with an undisclosed global pharmaceutical company to supply biological materials and related confidential information for the discovery of a treatment for systemic lupus erythematosus and possibly other autoimmune diseases.
Medicinova Inc., of La Jolla, Calif., published preclinical results relevant to ibudilast (MN-166), which it’s developing as an adjunct treatment for glioblastoma, in Frontiers in Immunology. The study showed that the monocytic subset of myeloid-derived suppressor cells (MDSCs) expressed high levels of the macrophage migration inhibitory factor (MIF) cognate receptor CD74 in the tumor microenvironment. Ibudilast inhibits the interaction between MIF and CD74.
Novan Inc., of Morrisville, N.C., said its current cash position is sufficient to fund the phase III Besimple4 pivotal study for SB-206 in patients with molluscum. The company plans to start the study in September 2020.
Siga Technologies Inc., of New York, delivered $32 million worth of smallpox treatment Tpoxx (tecovirimat) to the U.S. Department of Health and Human Services under its contract with the Biomedical Advanced Research and Development Authority. The remaining deliveries under the $101.3 million procurement option are expected to be complete by April 2021.
Vaxart Inc., of South San Francisco, said its oral COVID-19 vaccine has been selected to participate in a nonhuman primate challenge study funded by the U.S. government's Operation Warp Speed.