Altimmune Inc., of Gaithersburg, Md., said it submitted an IND to the FDA for Nasovax, an intranasally administered recombinant flu vaccine, to run a phase II trial in 60 volunteers who will receive a single dose of the vaccine at one of three dose levels or placebo. Data from the trial, which will measure antibody response to both matched and divergent strains along with cellular and mucosal immunity, is expected in the first quarter of 2018.

Biolinerx Ltd., of Tel Aviv, Isreal, said it filed required regulatory submissions to start the phase III GENESIS registration trial of BL-8040 for the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma. The first part of GENESIS will enroll 10 to 30 patients to assess the efficacy and safety of treatment with BL-8040 and G-CSF followed by a placebo-controlled portion in approximately 180 patients. The primary endpoint is the proportion of subjects mobilizing greater than or equal to 6.0 x 106 CD34+ cells/kg with up to two apheresis sessions in preparation for autologous transplantation after a single administration of BL-8040 and G-CSF, compared to placebo and G-CSF. GENESIS is expected to start by the end of the year.

Cytodyn Inc., of Vancouver, Wash., said it enrolled 34 patients in its pivotal phase IIb/III trial testing PRO-140, a humanized IgG4 monoclonal antibody directed against CCR5, in combination with antiretroviral therapy, in individuals with HIV. Almost all, 33 patients, completed the one-week efficacy endpoint, with 11 patients having completed the full 25-week protocol; 10 of those have moved into a rollover study. Cytodyn plans to meet with the FDA on Oct. 17 to discuss the next steps in analyzing the trial data and filing a biologics license application for PRO-140.

Gamida Cell Ltd., of Jerusalem, said the first patient was transplanted in an investigator-initiated phase I/II trial testing Cordin in patients with severe aplastic anemia or hypoplastic myelodysplastic syndrome who have no available matched donor. The 62-patient trial, run by the NIH's Richard Childs, will measure the speed and durability of cord engraftment in patients transplanted with Cordin.

Immatics Biotechnologies GmbH, of Tuebingen, Germany, said the first patient was enrolled in a phase I trial testing its adoptive cellular therapy IMA-101, which uses its Actolog platform, in up to 20 patients with relapsed and/or refractory solid cancers for which no established treatment is available.

Immunomedics Inc., of Morris Plains, N.J., said data from a phase II trial testing labetuzumab govitecan (IMMU-130), an antibody drug conjugate targeting CEACAM5, in heavily pretreated patients with metastatic colorectal cancer were published in the Journal of Clinical Oncology. The 21 patients given 8 mg/kg of abetuzumab govitecan once weekly had a median progression-free survival (PFS) of 4.6 months and a median overall survival (OS) of 7.5 months while the 22 patients who received 10 mg/kg of abetuzumab govitecan once weekly had a median PFS of 3.6 months and a median OS of 6.4 months.

Matrisys Bioscience Inc., of San Diego, said the first patient was dosed in a phase IIa trial testing a lotion containing Staphylococcus hominis strain A9 as a treatment to decrease or eliminate Staphylococcus aureus on the skin of approximately 50 patients with moderate to severe atopic dermatitis. The primary endpoint will measure safety, with secondary efficacy endpoints including changes in the eczema area and severity index score, the scoring atopic dermatitis score and the pruritus visual analog scale score.

Novartis AG, of Basel, Switzerland, and Medicines for Malaria Venture started a phase IIb trial testing multiple dosing combinations of the imidazolopiperazine, KAF-156, with an improved formulation of the existing antimalarial, lumefantrine. The trial will initially enroll adults who have malaria, with plans to expand to children with malaria once safety is established.

Ovid Therapeutics Inc., of New York, said the first patient was randomized in its phase Ib/IIa trial testing TAK-935, also known as OV-935, in developmental and/or epileptic encephalopathies, including Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex. The dose-escalation trial, run in collaboration with partner Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, will enroll up to 20 patients to determine the safety and tolerability TAK-935, a cholesterol 24-hydroxylase inhibitor.