Adlai Nortye Ltd., of Hangzhou, China, opened its new U.S. headquarters in North Brunswick, N.J. following the launch of its first international translational medicine laboratory in Boston last month.
Anaeropharma Science Inc., of Tokyo, said it entered a collaborative research agreement with Astellas Pharma Inc., of Tokyo, for the creation of antitumor drugs that utilize characteristic features of Bifidobacterium longum as a drug delivery carrier. Under the agreement, Anaeropharma will utilize its in situ delivery and production system (i-DPS) technology and conduct joint research to create drug candidates for cancer therapy. Astellas has the right of first negotiation regarding the exclusive licensing necessary for commercialization based on the results of that research. APS-001F, a recombinant Bifidobacterium to express cytosine deaminase, which converts a prodrug, 5-fluorocytosine (5-FC), to a cancer drug, 5- fluorouracil (5-FU), is being tested in a U.S. a phase I trial.
Astrazeneca plc, of Wilmington, Del., said the first U.S. shipment has been made for Flumist Quadrivalent (influenza vaccine live, intranasal) doses for the 2018-2019 influenza season. The vaccine is sprayed into the nose to help protect against influenza and can be used in children, adolescents and adults, ages 2 through 49.
Cerecor Inc., of Baltimore, said it has agreed to acquire New York-based Ichorion Therapeutics Inc., which focuses on developing treatments and increasing awareness of inborn errors of metabolism. The terms of the deal include the issuance of approximately 5.8 million shares of Cerecor common stock at closing, subject to an end of 2019 lock-up, and development milestones worth up to an additional $15 million, payable either in Cerecor stock or in cash in certain circumstances. Ichorion has established a pipeline of genetically targeted therapies that complement Cerecor's mission of developing treatments for pediatric and orphan indications.
Cobra Biologics, of Keele, U.K., an international contract development and manufacturing organization of biologics and pharmaceuticals, said it is collaborating with the Centre for Process Innovation, a U.K.-based technology innovation center and GE Healthcare Life Sciences. The partnership, funded by a £570,000 (US$751,220) Innovate U.K. grant, aims to increase the robustness and reduce costs for the manufacturing of adeno-associated virus vectors, a delivery vehicle used for emerging gene therapy treatments.
Gemphire Therapeutics Inc., of Livonia, Mich., said its board approved a reduction of approximately 33 percent of its workforce in order to cut costs and conserve its cash resources. The decision was made in light of a previously announced request by the FDA for additional preclinical data required in order to schedule an end-of-phase II meeting for gemcabene in the company's target dyslipidemia indications. The company expects to record severance-related charges totaling approximately $1.4 million.
Genervon Biopharmaceuticals LLC, of Pasadena, Calif., reported at the New York Academy of Science Symposium Neuroimmunology – The Impact of Immune Function on Alzheimer's Disease new findings that its drug candidate, GM-6, attenuates Alzheimer's disease (AD) in an early AD transgenic APP mice model. Application of GM-6 over a four-month period in young APP/PS1 double-transgenic mice resulted in attenuation in amyloid beta peptide levels, reduction of inflammation and amyloid load, increased cathepsin B expression, and improved spatial orientation. In addition, treatment with GM-6 increased brain nerve growth factor levels and tempered memory impairment by approximately 50 percent at the highest dose. In the AD mouse models, inflammation seemed to play a key role in the disease process, and GM-6 reduced cytokines (TNF-alpha, IL-1beta, TGF-beta, etc.) and inflammatory mediators (CD-68 and GFAP), which can contribute to pathogenesis, and modulated cathepsin B and cleavage of APP to amyloid beta.
The Institute for Clinical and Economic Review (ICER) released a draft evidence report assessing the clinical effectiveness and value of biologic treatments for asthma associated with type 2 inflammation and/or allergic asthma. The draft report will be open to public comment until 5 p.m. Eastern time on Oct. 22. ICER's report assesses the effectiveness and value of Dupixent (dupilumab, Sanofi SA/Regeneron Pharmaceuticals Inc.), Xolair (omalizumab, Roche Holding AG/Novartis AG), Nucala (mepolizumab, Glaxosmithkline plc), Cinqair (reslizumab, Teva Pharmaceutical Co. Ltd.) and Fasenra (benralizumab, Astrazeneca plc). The institute previously reviewed mepolizumab for its use in severe eosinophilic asthma and dupilumab for its use in atopic dermatitis. Dupilumab is under FDA review for use as add-on maintenance treatment in moderate to severe asthma, with an approval decision expected in October.
Kancera AB, of Solna, Sweden, said an article, titled "Targeting PFKFB3 radiosensitizes cancer cells and suppresses homologous recombination," has been published by researchers from Karolinska Institutet and Kancera in Nature Communications. The article documents the molecular mechanisms that give small-molecule KAN-0438757 what the company calls a potent antitumor effect in preclinical models. In the study, researchers discovered that the enzyme PFKFB3 helps cancer cells resist radiation therapy. The discovery shows that PFKFB3 binds to the cancer cell's damaged DNA where the enzyme contributes to repair that leads to continued growth. The new knowledge supports the fact that a drug that blocks PFKFB3 could change a resistant cancer to one that is sensitive to radiation therapy, Kancera said.
Mersana Therapeutics Inc., of Cambridge, Mass., disclosed preclinical data involving the company's clinical candidate, XMT-1536, a NaPi2b-targeting antibody-drug conjugate. The poster was presented as part of the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer in Toronto. The antibody turned up differential expression patterns in lung cancer histologic subtypes
Minomic International Ltd., of Sydney, received shareholder approval for the demerger of its therapeutic subsidiary, Glytherix Ltd., at a recent extraordinary general meeting. The demerger followed consultation with the investment community and potential license partners in both Australia and the U.S., the company said. Following the consultation, Minomic's board and management determined that those parties view the diagnostic and therapeutic activities as separate and distinct businesses, wishing to invest in either one but generally not wishing to invest in both. Minomic's board formed the view that separation of the company's diagnostic and therapeutic businesses would assist the near-term commercialization of the Micheck test via a licensing deal. Additionally, the demerger will facilitate fundraising for the next steps for the therapeutics business, including a full phase I trial of miltuximab.
Novosteo Inc., a West Lafayette, Ind.-based startup developing fracture-targeted bone anabolic agents intended to selectively accumulate on the bone fracture surface to accelerate healing, has won a $1.7 million SBIR phase I/II grant from the NIH. The grant is expected to help the Purdue University-affiliated company with testing and preparation for phase I trials.
Onconova Therapeutics Inc., of Newtown, Pa., carried out a 1-for-15 reverse stock split of its common stock, effective Tuesday. Beginning Wednesday, the stock will trade on Nasdaq on a split-adjusted basis. The split is intended to improve the capital structure, increasing the per-share market price, and make the stock more attractive to a broader group of investors, Onconova said.
Phoenix Pharmalabs Inc., of Salt Lake City, won a $2.7 million grant from the U.S. Army to support preclinical studies of PPL-103, an opioid the company described as not causing death from overdose, physical dependence or withdrawal or constipation. The company expects to complete an investigational new drug application filing with the FDA within 18 months.
Siteone Therapeutics Inc., of Bozeman, Mont., was awarded a $1.4 million, two-year, phase II SBIR grant from the National Eye Institute, a member of the NIH. The award will be used to initiate IND-enabling studies for Siteone's ocular NaV1.7 program for pain associated with ocular surgery, injury and disease, such as dry eye syndrome. That is the third phase II SBIR grant that Siteone has received from the NIH, the first having been awarded in September 2014 to support the discovery and development of selective inhibitors of NaV1.7 as therapeutics for acute and chronic pain.
Tris Pharma Inc., of Monmouth Junction, N.J., acquired Nextwave Pharmaceuticals, a wholly owned subsidiary of New York-based Pfizer Inc., for an undisclosed amount. The purchase includes two attention deficit hyperactivity disorder treatments that Tris co-developed: Quillivant XR, the first and only marketed extended-release oral liquid methylphenidate, and Quillichew ER, the first and only extended-release methylphenidate chewable tablet.
Venatorx Pharmaceuticals Inc., of Malvern, Pa. secured an exclusive license agreement with Everest Medicines II Ltd., a C-Bridge Capital-backed company with operations based in China, to support the development, registration and commercialization of cefepime (VNRX-5133) in greater China, South Korea and Southeast Asia for complicated urinary tract infections, infections due to carbapenem-resistant pathogens and hospital-acquired and ventilator-associated bacterial pneumonia. Under terms of the agreement, Venatorx and Everest will collaborate on the global phase III development of cefepime while Everest will be solely responsible for its commercialization in the agreed territory. Venatorx will be eligible to receive royalties on net sales of cefepime.