AIkido Pharma Inc., of New York, said positive results from its artificial intelligence/machine learning sponsored research program in the field of pancreatic cancer have been published in Nature Scientific Reports. Pancreatic ductal adenocarcinoma (PDA) treatment is severely compromised because most diagnoses are made late in disease progression. Surgical resection remains the most effective therapeutic strategy but is restricted to early stage diagnosis and is rarely, if ever, curative. Effective therapeutics and early detection strategies are needed to enhance the long-term survival of patients with PDA. The paper discusses the company’s strategy to identify better therapeutics by screening drugs in primary cell culture, followed by validation in a mouse model of early disease progression.
Alzecure Pharma AB, of Stockholm, said it received positive preclinical in vivo effect data for the pain project TrkA-NAM based on the company's research platform Painless. The project’s objective is to develop a TrkA-negative allosteric modulator that can reduce movement-induced and spontaneous pain in patients with severe pain conditions. The target mechanism has strong preclinical and clinical validation, and the company's compounds aim to differentiate from antibody treatments with a selective effect on the relevant signaling pathway so that optimal analgesic effect can be achieved without inducing side effects.
Alzheon Inc., of Framingham, Mass., said a first report of longitudinal hippocampus atrophy rates in Alzheimer’s disease (AD) patients homozygous for APOE4/4, and their correlation with cognitive decline has been published in Alzheimer’s & Dementia: Translational Research and Clinical Interventions. The hippocampus is affected by amyloid oligomer-mediated neurodegeneration early in AD, resulting in atrophy detectable on volumetric magnetic resonance imaging (MRI) scans. This study provides quantitative analysis of hippocampal volume and cortical thickness in APOE4/4 and APOE3/3 subjects with either mild cognitive impairment (MCI) or mild AD. Key findings include: at baseline, APOE4/4 subjects with MCI were approximately five years younger and had significantly smaller hippocampal volumes and worse cognitive scores than APOE3/3 subjects; APOE4/4 subjects with MCI and mild AD (collectively called early AD) showed significantly faster hippocampus atrophy and cortical thinning over two years compared to APOE3/3 subjects; and, atrophy rates of hippocampal volume and cortical thinning were significantly correlated with cognitive decline in MCI subjects, but not in mild AD.
Applied Biomath LLC, of Concord, Mass., said it is collaborating with Antengene Corp., of Shanghai and Hong Kong, for the development of a systems pharmacology model for a PDL1/41BB bispecific antibody, ATG-101, in immuno-oncology indications. The model will be used to predict clinical starting and efficacious doses for first-in-human studies.
Assembly Biosciences Inc., of South San Francisco, said it will wind down its microbiome program and prioritize its resources and focus on the advancement of its pipeline of novel core inhibitors for chronic hepatitis B virus (HBV). The company expects to be well resourced with the personnel and capital to advance its portfolio of HBV candidates, including multiple clinical development programs focused on core inhibitor therapies and preclinical programs exploring additional complementary HBV targets. As of Sept. 30, the company had cash, cash equivalents and marketable securities totaling approximately $238 million that is projected to fund planned operations into the second half of 2022.
Cohbar Inc., of Menlo Park, Calif., which is developing mitochondria-based therapeutics to treat chronic diseases and extend healthy lifespan, said new data confirm the efficacy of its apelin agonist peptides in a preclinical model of acute respiratory distress syndrome (ARDS). In the study, acute lung injury was induced in mice by administration of lipopolysaccharide (LPS), a bacterial toxin that produces similar symptoms to other causes of ARDS, including fluid accumulation and cytokine secretion. A single dose of CB-5064 analogue was administered one hour prior to the LPS exposure and effects on lung weight and levels of pro-inflammatory cytokines were measured four hours after LPS exposure. Treatment with CB-5064 analogues reduced fluid accumulation in the lungs and a corresponding broad reduction in levels of key pro-inflammatory cytokines secreted into the lung fluid, when compared to treatment with a placebo control.
Emisphere Technologies Inc., of Roseland, N.J., said its acquisition by Novo Nordisk A/S, of Bagsvaerd, Denmark, for $1.35 billion is complete. Emisphere, an oral drug delivery company, created its platform to facilitate absorption of small and large molecules without altering their chemical form, biological integrity or pharmacological properties. The technology enables transport of therapeutic molecules including large peptides and proteins across biological membranes such as those of the gastrointestinal tract.
Entheon Biomedical Corp., of Vancouver, British Columbia, said it entered a drug supply agreement with Psygen Labs Inc., which will supply non-GMP and GMP-quality N,N-dimethyltryptamine drug substances (DMT) for upcoming formulation, preclinical, clinical and post-approval commercialization phases under the EMA regulatory framework. Last month, Psygen successfully completed the production of a non-GMP DMT research batch for delivery to the company's contract research organization. In addition, Entheon said its shareholders exercised 533,359 warrants at 75 cents per share and 13,334 warrants at 45 cents per share for net proceeds of $406,019.
Evaxion Biotech A/S, of Copenhagen, said an article on how deep data on immune complex stability could optimize immunotherapy in cancer has been published in Nature Communications. The company has generated data on the thermostability of peptide-MHC complexes (pMHC), the biological context for antigen processing. The new data have already proved valuable in enabling Evaxion’s artificial neural networks to more readily predict the immunological behavior of the peptide epitopes. The company’s immuno-oncology platform uses sophisticated algorithms to identify and select tumor-specific mutations that it believes are most likely to generate a de novo T-cell activation and antitumor immune response. Those tumor-specific mutations, termed neoepitopes, are incorporated into patient-specific immunotherapies.
Evotec SE, of Hamburg, Germany, and Sartorius said they entered a partnership with Curexsys GmbH, of Goettingen, Germany, that specializes in the emerging field of therapeutic exosomes. Evotec and Sartorius have formed a consortium to jointly invest in Curexsys' €8.2 million (US$9.89 million) seed financing round with Evotec acquiring an equity stake of approximately 37% in Curexsys and Sartorius 21%. Under the terms of the agreement, Evotec and Curexsys will collaborate on the production of human mesenchymal stem cells, which serve as a source for exosomes that have immunomodulatory and anti-inflammatory effects, which makes them a promising approach for innovative regenerative therapies, as therapeutics in age-related conditions and for diagnostic purposes. Curexsys aims to develop targeted approaches for a variety of diseases, initially focusing on Sicca syndrome, commonly known as dry eye. Sartorius will support Curexsys to set up a GMP-compliant and scalable manufacturing platform.
Immunogenesis Inc., of Houston, said it acquired the rights to hypoxia-reducing agent evofosfamide and will initiate a phase II trial in 2021 investigating evofosfamide in combination with CTLA4 and PD-1 blockade in patients with castration-resistant prostate cancer, pancreatic ductal adenocarcinoma, and HPV-negative head and neck cancer. Evofosfamide, a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard, was originally developed as a hypoxia-activated prodrug and is based on Immunogenesis founder Michael Curran’s work at the University of Texas MD Anderson Cancer Center.
Inveniai LLC, of Guildford, Conn., and Tokyo’s Kyowa Kirin Co. Ltd. said they expanded their four-year collaboration agreement for use of Inveniai’s artificial intelligence platform. Kyowa Kirin will leverage Alphaeld for target discovery and validation to generate a pipeline of therapeutic antibodies addressing multiple diseases. Kyowa Kirin will select multiple programs to advance into clinical development. The company focuses on therapies in nephrology, oncology, immunology/allergy and neurology.
Fresh preclinical data on VISTA antagonist antibodies from Kineta Inc., of Seattle, showed they were highly expressed on myeloid cells granulocytes, NK and NKT cells, and expressed at moderate levels on Treg CD4 and CD8 T cells, while CD4/CD69 activated T cells are high expressers. VISTA is a driver of the immunosuppressive tumor microenvironment and is overexpressed on myeloid-derived suppressor cells and regulatory T cells, the company said. It is a critical myeloid cell immune-checkpoint and VISTA blockade can reprogram suppressive myeloid cells and reactivate antitumor immune function, according to Kineta.
For its mRNA-1273 vaccine research trials, Moderna Inc., of Cambridge, Mass., said it will use the Elecsys Anti-SARS-CoV-2 S antibody test from Roche Group, of Basel, Switzerland. The goal is to facilitate quantitative measurement of SARS-CoV-2 antibodies and establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies. Moderna said its vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein. Elecsys Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma.
Orgenesis Inc., of Germantown, Md., and Cure Therapeutics Inc., of South Korea, will collaborate in developing and commercializing Cure’s pipeline globally, as well as developing, commercializing and supplying Orgenesis’ pipeline in South Korea and Japan. Both will contribute at least $10 million into the joint venture to cover operating costs, $5 million of which may be provided in the form of in-kind contribution. Orgenesis focuses on cell and gene therapies while Cure is developing cell, gene and immune-oncology therapies.
Overland Pharmaceuticals, of Shanghai and Boston, said it has launched to bring new medicines to underserved patients in Asia and around the world. By leveraging its resources, global network and local expertise across Asia, Overland said it is establishing a portfolio of differentiated therapeutic candidates in a few carefully selected therapeutic areas. Overland was co-founded by Hillhouse Venture Partners.
Lantheus Holdings Inc., parent company of Tarrytown, N.Y.-based Progenics Pharmaceuticals Inc., said it entered a collaboration with Point Biopharma Inc., of Toronto, to use Lantheus’ investigational prostate-specific membrane antigen (PSMA)-targeted positron emission tomography imaging agent to determine PSMA-avidity during patient selection in Point’s phase III study to treat metastatic castration-resistant prostate cancer (mCRPC). Progenics will supply the imaging agent. Point’s multicenter, open-label, randomized clinical trial will evaluate the efficacy and safety of its PSMA-targeted radioligand, 177Lu-PNT-2002, in patients with mCRPC.
Sanofi SA, of Paris, and Kiadis Pharma NV, of Amsterdam, the Netherlands, said they have satisfied the competition condition related to their deal. In early November, Kiadis disclosed that Sanofi made a €5.45 (US$6.58) per-share offer for the firm. Sanofi’s offer represented a 272% premium on Kiadis’ closing share price of €1.46 on Oct. 30.
Seqirus Inc., of Summit, N.J., presented new real-world evidence (RWE) at the European Scientific Working Group on Influenza showing the clinical benefits of a cell-based, quadrivalent seasonal influenza vaccine (QIVc) in preventing influenza-related medical encounters compared to an egg-based quadrivalent influenza vaccine (QIVe) during the 2018/19 U.S. influenza season. A late-breaking poster presentation demonstrated that QIVc prevented significantly more influenza-related medical encounters among individuals age ≥4 years (n=about 2.1 million) with at least one health condition, compared to QIVe in the 2018/19 U.S. influenza season. An oral presentation highlighting results from a retrospective cohort analysis which indicate that among subjects ages 4 to 64, QIVc (n=669,030) was significantly more effective in reducing hospitalizations/emergency room visits caused by influenza and respiratory related illness compared with QIVe (n=about 3 million) in the 2018/19 U.S. influenza season.
Synaptogenix Inc., of New York, formerly Neurotrope Inc., said it spun off substantially all the legacy assets and liabilities of Neurotrope into the new company. Synaptogenix is developing therapies for neurodegenerative diseases. It has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease, and preclinical studies for rare diseases such as fragile X syndrome, Rett syndrome and Niemann-Pick type C disease as well as other indications including multiple sclerosis, stroke and traumatic brain injury.
Taiho Pharmaceutical Co. Ltd., of Tokyo, said its Taiho Oncology Inc. company in Princeton, N.J., plans to expand its commercial oncology business into Europe with an opening of a headquarters there. The headquarters is expected to be operational by early next year.
Tremeau Pharmaceuticals Inc., of Concord, Mass., said Gurnet Point Capital has agreed to fund the clinical development of its investigational drug, TRM-201 (rofecoxib), including a phase III trial in hemophilic arthropathy. The condition is a painful and degenerative joint disease caused by recurrent intra-articular bleeding in patients with inheritable bleeding disorders. Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug, previously marketed as Vioxx by Kenilworth, N.J.-based Merck & Co. Inc.