Abivax SA, of Paris, said that Bpifrance and Région Occitanie /Pyrénées-Méditerranée have agreed to provide a loan of €390,000 to the company for the development of a cocktail of polyclonal antibodies against the Ebola virus. The loan specifically covers the implementation of production and purification processes for GP and for the specific IgG from immunized rabbits, as well as proof of concept studies in vitro and in vivo. Abivax's preclinical ABX544 program targets the generation of an Ebola hyperimmune serum, containing neutralizing antibodies produced from animals immunized with a specific Ebola antigen. In contrast to a vaccine that needs time to generate a protective response, ABX544 is expected to have an immediate effect when administered.

Alcobra Ltd., of Tel Aviv, Israel, said it entered a cooperation agreement with Brosh Capital Partners L.P. and certain of its affiliates that provides for two new directors to be appointed to their board immediately and the continuation of its ongoing review of strategic alternatives and existing proposals by inviting additional proposals from targeted candidates and conducting diligence on several additional prospects. The parties have also agreed that the company's upcoming AGM, previously scheduled to occur by July 20, will be postponed until Sept. 1, and, if needed, further postponed as long as the strategic review process is ongoing and satisfactory to both parties.

Alligator Bioscience AB, of Lund, Sweden, said it has advanced a checkpoint modulator program, ATOR-1017, into preclinical development. The agonistic antibody activates the co-stimulatory receptor 4-1BB (also known as CD137) expressed on T cells in the tumor area. ATOR-1017 is being developed for treatment of metastasizing cancer. Sartorius Stedim Cellca GmbH and Glycotope Biotechnology GmbH have been contracted to manufacture clinical material.

Artios Pharma Ltd., of Cambridge, U.K., said it signed a two-year research collaboration and option agreement with Masaryk University (MU) in the Czech Republic for the development of cancer treatments targeting DNA nucleases involved in the DNA damage response (DDR) process. Under terms of the agreement, Artios will fund and collaborate with the research group at MU to undertake a focused research and development program on a number of promising nuclease targets. The agreement provides the company with the opportunity to in-license one or more nuclease programs for further development and commercialization.

Bene-Arzneimittel GmbH, of Munich, said the EC has granted approval for elmiron for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner's lesions in adults with moderate to severe pain, urgency and frequency of micturition – a disease pattern also known as interstitial cystitis. Elmiron contains the active ingredient pentosan polysulfate sodium, which is recommended as a drug of choice for the treatment of bladder pain syndrome.

Biomarin Pharmaceutical Inc., of San Rafael, Calif., said the FDA has approved a bulk biologics manufacturing plant, located in Shanbally, Cork, Ireland for production of the formulated bulk substance N-acetylgalactosamine 6-sulfatase used in the production of Vimizim (elosulfase alfa) for the treatment of mucopolysaccharidosis IVA (MPS IVA, also known as Morquio A syndrome). The facility was acquired from Pfizer Inc., of New York, in 2011.

Dragonfly Therapeutics Inc., of Cambridge, Mass., said it has entered into global strategic collaboration with Celgene Corp., of Summit, N.J., to discover, develop and commercialize immuno-oncology treatment options for patients with hematological malignancies based on Dragonfly's natural killer (NK) cell based Trinket technology platform. Celgene has the exclusive option to in-license worldwide rights for up to four therapeutic candidates with potential utility in the treatment of acute myeloid leukemia, multiple myeloma, and additional hematological malignancies. The collaboration includes a $33 million upfront payment, and potential future milestone and royalty payments.

Hutchison China Meditech Ltd., of London, said the CFDA has acknowledged acceptance of their NDA for fruquintinib for the treatment of patients with advanced colorectal cancer, which triggers a milestone payment of ¥30.8 million (US$4.5 million) from Lilly & Co. The NDA is supported by data from the FRESCO study, a phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer in China.

Fibrocell Science Inc., of Exton, Pa., said the FDA has granted rare pediatric disease designation to FCX-013, their gene therapy candidate for the treatment of moderate to severe localized scleroderma. This is the company's second gene therapy candidate to be awarded this designation, its clinical-stage gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa, FCX-007, was the first.

Gilead Sciences Inc., of Foster City, Calif., said it submitted a NDA to the FDA for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), an investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in phase III trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens.

Helsinn Group, of Lugano, Switzerland, reported that it has returned the rights to elsiglutide, which treats chemotherapy-induced diarrhea, to Zealand Pharma AS, of Copenhagen. The license agreement was inked in 2008 and is now inactive. Zealand said it will evaluate further development of the drug.

Kamada Ltd., of Rehovot, Israel, said it received an undisclosed additional milestone payment under their supply and distribution agreement with Shire plc, of Dublin, for Glassia, the company's intravenous alpha-1 antitrypsin. The milestone reflects Shire achieving a defined sales level of the product.

Numerate Inc., of San Bruno, Calif., a computational drug design company, said it entered a multiyear agreement with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan. Under the terms, Numerate will undertake discovery programs aimed at identifying clinical candidates for Takeda's core therapeutic areas: oncology, gastroenterology and central nervous system disorders. Numerate will use its AI-driven platform, from hit finding and expansion through lead design/optimization and absorption, distribution, metabolism and excretion, or ADME/toxicity modeling. Financial terms were not disclosed, but include a combination of milestone payments and royalties.

Oncosec Medical Inc., of San Diego, said has engaged in a preclinical agreement through its technology access program with Jounce Therapeutics Inc., of Cambridge, Mass. Under this agreement, Jounce can use Oncosec's gene delivery technology to evaluate in vivo efficacy in murine models of intratumorally-delivered therapeutic candidates. The agreement includes the Genesis research generator and proprietary applicators developed for research use specifically for gene electro-transfer.

Oragenics Inc., of Tampa, Fla., said it received a notice from NYSE MKT that it was out of compliance with listing requirements in section 1003 regarding stockholders' equity. The company turned in a plan to regain compliance by Nov. 10. In the meantime, Oragenics stock will continue to trade as OGENBC.

OSE Immunotherapeutics SA, of Nantes, France, entered into a multi-year research collaboration on OSE-703, a cytotoxic monoclonal antibody against the alpha chain of Interleukin-7 Receptor (IL-7R), with Memorial Sloan Kettering Cancer Center, of New York. The alliance will support a research program using OSE-703 (Effi-3), a humanized monoclonal antibody directed against the extracellular domain of the alpha-chain of the receptor for interleukin-7 (CD127), cytotoxic for human cells expressing CD127. The goal of the research collaboration is to explore IL-7R directed immunotherapy OSE-703 for solid tumors with non-small cell lung cancer (NSCLC) as the primary cancer model.

Peptidream Inc., of Tokyo, reported that it inked an agreement with Shionogi and Co. Ltd., of Osaka, Japan, for a nonexclusive license of Peptidream's Peptide Discovery Platform System (PDPS). Under the terms, Shionogi will pay Peptidream an undisclosed up-front payment and additional technology access payments, plus Peptidream will be eligible to receive payments based on the achievement of particular predetermined development milestones for any constrained peptides and/or small molecules discovered via the PDPS technology. PeptiDream also will be eligible for royalties on sales of particular products that arise from use of the PDPS technology.

PGI Drug Discovery LLC, of Tarrytown, N.Y., said Sunovion Pharmaceuticals Inc., of Marlborough, Mass., filed an IND for SEP-378608 triggering a milestone payment to PGI in its drug discovery and development collaboration. The compound is the second to enter clinical development; the first SEP-363856 is an investigational psychotropic agent with a novel mechanism of action that is being studied in phase II clinical trials as a treatment for patients with schizophrenia and for Parkinson's disease psychosis.

Pieris Pharmaceuticals Inc., of Boston, said that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, expired regarding its collaboration with Astrazeneca plc, of London, to develop and commercialize Anticalin proteins for respiratory diseases. The agreement includes PRS-060, Pieris' Anticalin protein targeting IL-4 receptor alpha as well as four other therapeutic programs against unnamed targets. Astrazeneca will make up-front and near-term milestone payments to Pieris of $57.5 million. Pieris keeps the options to co-develop and co-commercialize PRS-060 and two of the four other therapeutic programs in the U.S. Pieris is eligible to receive development and sales milestone payments not exceeding $2.1 billion. Pertaining to co-developed programs, Pieris is eligible to receive increased royalties or a gross margin share of profits, depending on the amount of Pieris' co-development investment.

Saniona AB, of Ballerup, Denmark, reported that it has listed a prospective on its website, which has been approved and registered by the Swedish FSA. The company's last day of trading on Nasdaq in the U.S. is Wednesday, and its first day of trading on Nasdaq Stockholm will be Thursday. Pareto Securities AB acted as financial adviser for those actions.

Tarix Orphan LLC, of Cambridge, Mass., said the EMA has designated TXA127 orphan status to treat epidermolysis bullosa, a rare connective tissue disorder. Tarix's lead compound is a pharmaceutical grade formulation of the naturally occurring peptide Angiotensin. The drug is being develop for a number of orphan and genetic diseases.

Teneobio Inc., of Menlo Park, Calif., plans to leverage the Suretechnology platform developed by Selexis SA, of Geneva, through a service agreement between the companies to advance the development of Teneobio's human heavy-chain antibodies, or Uniabs, to treat cancer. Financial terms were not disclosed.

Tigenix NV, of Leuven, Belgium, said it made a €5 million (US$5.6 million) milestone payment in new Tigenix shares to Genetrix SL, of Madrid, in relation to the cardiac platform acquisition in July 2015. Tigenix acquired Genetrix company Coretherapix, with terms that include a €5 million milestone payment upon the study report of the CAREMI trial becoming available. CAREMI is the first-in-human trial with the primary objective being safety and evaluating the feasibility of an intracoronary infusion of 35 million of donor-derived expanded cardiac stem cells, or AlloCSCs, in patients with acute myocardial infarction (AMI) and left ventricular dysfunction treated within the first week post-AMI. (See BioWorld Today, July 31, 2015.)

Zymeworks Inc., of Vancouver, British Columbia, said that Eli Lilly and Co., of Indianapolis, has nominated two two bispecific immuno-oncology drug candidates for late-stage, preclinical development. Those candidates were developed by Lilly in collaboration with Zymeworks via Zymeworks' Azymetric platform. Under the terms, Lilly has a worldwide license to research, develop and commercialize particular drug candidates. For those programs, Zymeworks is eligible for further development and commercial milestone payments as well as tiered royalties on product sales.