Aptinyx Inc., of Evanston, Ill., said preclinical data published in Movement Disorders show its NMDAr modulator, NYX-458, resulted in a reversal of cognitive deficits in a nonhuman primate model of Parkinson’s disease. The reversal of cognitive deficits – back to healthy baseline levels on some measures – was observed as early as one day following a single dose and lasted for at least three weeks. Additionally, the positive effects were recovered following re-impairment, maintained with repeat dosing, and endured for up to three months following the last of the repeated doses. In a separate cohort of nonhuman primates, NYX-458 did not worsen motor symptoms associated with dopamine loss, did not interfere with the anti-parkinsonian effects of levodopa and did not worsen the side effects of levodopa.
Biocorrx Inc., of Anaheim, Calif., said it was awarded an additional $2.8 million as the second tranche from the total grant of about $5.7 million announced last year. The grant, awarded by the NIH's National Institute on Drug Abuse, is for the development of BICX-102, the company’s three-month, sustained-release naltrexone implant for the treatment of opioid use disorder. The company said its goal this year is to get IND approval and start clinical trials.
Cortexyme Inc., of South San Francisco, said data published in Pharmacology Research and Perspectives showed that lead candidate COR-388, a gingipain inhibitor targeting treatment of neurodegenerative diseases, engages the toxic proteases, or gingipains, released by the bacterium Porphyromonas gingivalis and the closely related species P. gulae. Researchers reported that COR-388 showed dose-dependent gingipain target engagement in naturally occurring P. gulae infection, including difficult-to-reach bacterial biofilm niches. COR-388 also showed the ability to improve downstream pathology of the infection, namely gingival pocket depth, a symptom of periodontal disease that affects approximately 65 million Americans. In addition, gingipain antigens and P. gulae DNA were found in the brains of aged dogs, indicating that P. gulae can migrate from the oral cavity to the brain in a manner similar to that seen for P. gingivalis in Alzheimer’s patients.
Ares Genetics GmbH, a unit of Curetis NV, of Holzgerlingen, Germany, and BGI Group, of Shenzhen, China, said they plan to collaborate to develop molecular testing in Europe for the coronavirus 2019-nCoV, responsible for the outbreak originating in the Chinese city of Wuhan. BGI said it sequenced the genome of the 2019-nCoV virus and developed a real-time fluorescent PCR kit to detect the virus that can provide results in a few hours, gaining approval from the Chinese NMPA. The DNBSEQ-T7 sequencing platform developed by BGI unit MGI Tech Co. Ltd. also gained emergency approval from the NMPA for surveillance, discovery and identification of unknown infectious diseases in China. In Europe, BGI and MGI will work with Ares to make the 2019-nCoV testing portfolio available to public health institutions and hospitals for outbreak monitoring, infection control and epidemiology. Beginning in February, Ares will provide next-generation sequencing services for 2019-nCoV from its NGS laboratory in Vienna for infection control and tracking of pathogen evolution, based on MGI’s DNBSEQ sequencing platform. Ares and Curetis also will support BGI in the distribution of its PCR and NGS reagent kits to molecular testing laboratories in Europe with the capability for 2019-nCoV testing. Financial terms were not disclosed.
Daré Bioscience Inc., of San Diego, said it was notified that it regained compliance with Nasdaq’s minimum bid price rule after its closing price met or exceeded $1 per share for 10 consecutive business days. On Jan. 30, shares (NASDAQ:DARE) closed at $1.13.
Evotec SE, of Frankfurt, Germany, and Bayer AG, of Leverkusen, Germany, are advancing a further program from their endometriosis multitarget alliance into a phase I study. Evotec will receive a milestone payment of €2 million (US$2.28 million) upon first dosing in the clinical trial and may be eligible for further clinical and sales milestones as well as royalties. The two companies began the collaboration in October 2012 to discover three clinical candidates. So far, the alliance generated six preclinical candidates.
Gladstone Institutes scientists received $4.8 million from the NIH to study apoE4, a protein associated with the risk of Alzheimer’s disease. ApoE4 a form of apolipoprotein E, a protein that helps repair neurons injured by aging, stroke or other causes. ApoE4 is found in one-quarter of the human population and in about two-thirds of all Alzheimer's patients. Gladstone will use CRISPR to try reversing the effects of apoE4 by activating or inhibiting genes that control their top candidate proteins in the hiPS cell-derived neurons.
Histogen Inc., of San Diego, and Allergan plc, of Dublin, expanded their partnership that began in 2017, when Allergan acquired exclusive rights to develop and commercialize Histogen's CCM technology to health care practitioners in the aesthetic field. In the past year, Allergan licensed additional rights to commercialize Histogen's CCM in new distribution channels such as digital platforms, spas and salons. In the latest expansion, Allergan gained exclusive rights to incorporate and commercialize Histogen's CCM in microdermabrasion therapies and exclusive rights to new Histogen intellectual property in the aesthetic field.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., and Advaccine Biotechnology Co., of Beijing, plan to advance Inovio's vaccine for the coronavirus 2019-nCoV. Inovio is developing INO-4800 through a phase I to evaluate safety and immunogenicity with the support of an initial grant up to $9 million from the Coalition for Epidemic Preparedness Innovations.
Iteos Therapeutics SA, of Gosselies, Belgium, received €15 million (US$19.65 million) from the Walloon Region to support the clinical development of its two cancer drug programs targeting mechanisms of immunosuppression. Iteos’ lead candidate, EOS-850, is an adenosine A2A receptor antagonist and is in an ongoing phase Ib/IIa trial at four sites across Europe. The second trial is a phase I trial of Iteos’ ADCC-enabled anti-TIGIT antibody, EOS-448, which is expected to start in Belgium in February.
Theraly Fibrosis Inc., of Germantown, Md., received a $3.9 million Small Business Innovation Research grant from the NIH to support a phase II study for developing TLY-012, a version of the recombinant human TRAIL protein, for treating chronic pancreatitis. The FDA granted it orphan drug designation in September.
Tonix Pharmaceuticals Holding Corp., of New York, reported preclinical results of TNX-801 (live virus vaccine for percutaneous administration) to potentially prevent smallpox and monkeypox in a poster at the 2020 ASM Biothreats Conference in Arlington, Va. Data show that all eight cynomolgus macaques vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intratracheal monkeypox. In contrast, two of three evaluable animals vaccinated with TNX-1200 (live virus vaccine based on synthesized vaccinia01) and all animals who received the vehicle control developed monkeypox lesions after challenge.