Alteogen Inc., of Daejeon, South Korea, said it entered a nonexclusive, global license agreement with a top 10 pharmaceutical company, to use ALT-B4, its hyaluronidase derived utilizing the Hybrozyme technology. The enzyme enables large-volume subcutaneous administration of biologics that would otherwise be administered as an I.V. injection. The agreement grants worldwide rights for the pharma to develop multiple products in combination with ALT-B4. In return, Alteogen will receive an initial payment of $16 million and is also eligible to receive additional milestones upon the achievement of specified development, regulatory and sales milestones, totaling up to $3.865 billion for the initial products under this agreement. At a future date the pharma can elect to develop additional products in combination with ALT-B4 upon achievement of the prespecified milestone. Alteogen will be responsible for regulatory development and commercial supply of ALT-B4.
Berlin Cures Holding AG, of Berlin, Germany, which is developing aptamers for autoimmune diseases, said it is evaluating BC-007, a β1-adrenoceptor autoantibody neutralizing ssDNA product, for the treatment of COVID-19. A phase II/III trial is scheduled to start in the second half of the year. Results from an earlier phase I study of BC-007 in a cardiac indication confirmed that it was safe and well-tolerated.
Brainstorm Cell Therapeutics Inc., of New York, said it is starting a new clinical program focused on the development of Nurown as a treatment for Alzheimer's disease and is planning a multinational phase II trial to evaluate the safety and efficacy of Nurown treatment in patients with prodromal to mild Alzheimer's disease. In the 52-week study, 40 participants with prodromal to mild Alzheimer's disease will receive three intrathecal Nurown doses eight weeks apart.
Chemocentryx Inc., of Mountain View, Calif., said it has identified an orally administered checkpoint inhibitor, CCX-559, and plans to initiate clinical development in the first half of next year. The data presented during the virtual meeting of the American Association for Cancer Research showed that the company’s optimized checkpoint inhibitors led to marked inhibition of the PD-1/PD-L1 interaction and signaling in vitro and potent antitumor effects in animal models. The company optimized several small-molecule PD-L1 inhibitors it designed to disrupt the interaction of PD-1 with PD-L1. Active compounds were found to be highly potent in several functional cell-based assays. Potential clinical candidate compounds were selected for potency and oral bioavailability and were evaluated in vivo using murine tumor models. Assessment of the tumor microenvironment demonstrated the lead compounds almost completely blocked the interaction of PD-L1 on tumor cells with PD-1 on immune effector cells, thus enhancing the immune responses against the tumor. Importantly, the in vivo antitumor effects of the company’s small molecules were consistently as good or better than the antibody therapeutics to the PD-1/PD-L1 pathway in those models.
The Critical Path Institute said it launched the public-private partnership CURE Drug Repurposing Collaboratory (CDRC) funded by the FDA, in collaboration with the National Center for Advancing Translational Sciences (NCATS), part of the NIH. CDRC has been created to provide a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in those areas. The collaboratory will also create a network connecting major treatment centers, academic institutions and researchers, private practitioners, government facilities and health care professionals around the world. It will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID platform. The objective is to accelerate the identification and development of potentially effective drugs for patients with diseases that lack adequate approved treatment options with the goal of helping identify drug candidates for additional study and potentially drug labeling in the future. In a pilot project focused on COVID-19, CDRC will use data collected via the CURE ID platform to aggregate global clinician treatment experiences to identify existing drugs that demonstrate possible treatment approaches that should be studied further in randomized trials. Critical updates have been made to the CURE ID case report form for capturing relevant details related to COVID-19.
Delmar Pharmaceuticals Inc., of San Diego, said it received a $500,000 loan from the National Brain Tumor Society and the National Foundation for Cancer Research to support VAL-083's preparation for participation in the Global Coalition for Adaptive Research's (GCAR) sponsored trial, Glioblastoma (GBM) Adaptive Global Innovative Learning Environment (GBM AGILE) study. Earlier this month, VAL-083 was selected by GCAR as the third investigational therapy to participate in GBM AGILE, in which the compounds will be simultaneously evaluated across multiple international trial sites of which 25 are currently activated. Delmar intends to utilize GBM AGILE, which is an adaptive registration clinical trial, to serve as the basis for the compound’s new drug application submission and registration.
Evotec SE, of Hamburg, Germany, life sciences investment firm Samsara Biocapital and KCK Ltd., a family investment fund, have together launched Autobahn Labs, a virtual incubator intended to catalyze early stage drug discovery and development. The incubator, which will partner with academic and research institutions, started off with a tie to the University of California, Los Angeles, Technology Development Group. The model, which will provide principal investigators with scientific and strategic support, will also offer as much as $5 million in investment per project and access to Evotec's drug discovery and development resources.
GW Pharmaceuticals plc, of London, said, effectively immediately, the U.K. Home Office has reclassified Epidyolex (cannabidiol) as a Schedule 5 drug under the Misuse of Drugs Regulations 2001. The medicine is approved in the EU for adjunctive therapy of seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients 2 and older.
Ignova GmbH, of Visbek, Germany, said it filed a patent application covering the use of passive immunization to control SARS-CoV-2 infection in humans. The IgY binds the spike protein of SARS-CoV-2, neutralizing the virus when it enters the mouth or nose and, therefore, inhibiting the infection process. Ignova said its technology is designed to offer a safe, economical and unlimited source of polyclonal antibodies to control SARS-CoV-2. The patent is based on proprietary IgY technology, a process that involves immunizing chickens against target pathogens and extracting antibodies from eggs.
Inxmed Co. Ltd., of Shanghai, disclosed research data with focal adhesion kinase (FAK) inhibitor IN-10018 in overcoming drug resistance with KRAS G12C inhibitors, which are in phase II development. IN-10018 is an ATP-competitive small molecule in clinical development in the U.S., Australia and China. The combination of KRAS G12C inhibitors and IN-10018 was evaluated in vitro and in vivo. The data show that FAK signaling is significantly induced by KRAS G12C inhibition, that IN-10018 can significantly decrease the FAK signaling, rendering synergistic antitumor effects on various types of cancer. The findings were disclosed at the American Association for Cancer Research virtual meeting.
Kymera Therapeutics Inc., of Cambridge, Mass., offered positive preclinical data on its STAT3 degraders as well as the first data from its IRAKIMiD degraders combining IRAK4 and IMiD substrate degradation at the virtual meeting of the American Association for Cancer Research. STAT3 is an attractive but elusive target known to regulate genes implicated in oncogenesis, tumor immune evasion, inflammation and fibrosis, the company noted. The company disclosed data demonstrating that its STAT3 degraders down-regulated immune checkpoint signals on tumor cells and positively modulated composition and activity of immune cells in the tumor microenvironment, leading to in vivo antitumor activity in a solid tumor model refractory compared to standard anti-PD-1/L1 immunotherapy. Kymera also presented the first data from its potent IRAKIMiD degraders in development for the treatment of MYD88-mutant lymphomas. IRAKIMiDs demonstrated improved cell death and breadth of activity relative to IMiDs or IRAK4-selective degraders, and drove strong in vivo tumor regressions in multiple models of MYD88-mutant B-cell lymphoma that Kymera believes are superior to what has been observed in preclinical studies with other agents.
La Jolla Pharmaceutical Co., of San Diego, and Tetraphase Pharmaceuticals Inc., of Watertown, Mass., signed a definitive merger agreement. Under the terms, La Jolla would acquire Tetraphase, through a tender offer, for $43 million in up-front cash plus potential future cash payments of up to $16 million pursuant to contingent value rights. The board of Tetraphase unanimously recommends that stockholders tender their shares in the La Jolla tender offer once it is commenced, the companies said.
International Business Machines Corp. (IBM) granted Mateon Therapeutics Inc., of Agoura Hills, Calif., access to the IBM Clinical Development platform at no charge for a clinical trial evaluating OT-101, a wide spectrum antiviral, for treating COVID-19 patients. The platform is a cloud-based clinical development system designed to reduce clinical trials’ time and cost by using electronic patient-reported outcomes, data integration, reporting and analytics, quality and compliance, medical coding, endpoint analysis, randomization and clinical trial supply management. The platform is also capable of remote patient monitoring.
Melior Pharmaceuticals Inc., of Exton, Pa., said it has been selected by SFA Therapeutics Inc., of Philadelphia, as a partner on SFA’s recently awarded grant from Ben Franklin Technology Partners of Southeastern Pennsylvania and the state of Pennsylvania. The two companies will use microbiome-derived SFA-005 to target cytokine storm linked to acute respiratory distress syndrome (ARDS) experienced by patients with COVID-19. SFA-005 is being evaluated both as a preventative and a treatment in a validated liposaccharide challenge animal model of ARDS.
Repertoire Immune Medicines, of Cambridge, Mass., said it received funding from the COVID-19 High Performance Computing (HPC) Consortium, a private-public sector effort offering computing capabilities to support COVID-19 research. Repertoire plans to identify viral epitopes most likely to induce durable immunity to SARS-CoV-2, the virus that causes COVID-19, through induction of long-term memory in T cells. Under this grant, Repertoire will leverage the cloud computing resources of Amazon Web Service (AWS) to simulate and predict immunological interactions across patient populations leading to clearance of SARS-CoV-2. Repertoire’s platform, which measures T cell receptor-antigen interactions at single-cell resolution, will simulate the interactions on AWS.
Replicate Bioscience Inc., of Rockville, Md., and privately held Immunomic Therapeutics Inc. (ITI), of San Diego, entered a research and licensing option agreement to combine their platform technologies to combat infectious diseases and cancers. The two plan to develop candidates combining ITI’s technology, which fuses pathogenic antigens with lysosomal associated membrane protein, an endogenous protein in humans, for immune processing, with Replicate’s self-replicating RNA to treat COVID-19, human papillomavirus and EBV. ITI will be responsible for all development costs and will also invest in Replicate.
Roivant Sciences Ltd., of Basel, Switzerland, said it's joining Roche Holding AG, of Basel, Switzerland, and venture fund BB Pureos Bioventures in extending support to a new phase of the Basel-based biotech venture accelerator and incubator Baselaunch. The effort, which helps build companies from inception through series A funding, will increase its funding per venture to a maximum of $500,000 from an earlier $250,000 and will accept applications year-round, rather than once per year, as earlier.
Singapore Edevelopment Ltd., of Singapore, said its wholly owned subsidiary, Impact Biomedical Inc., has announced proven in vitro success with Equivir and 3F Biofragrance against COVID-19 in independent laboratory testing. Impact Biomedical and Global Research and Discovery Group Sciences, of Bethesda, Md., in independent Biosafety Level 3 containment facilities, challenged its compounds with the SARS-CoV-2 virus. Equivir proved successful as a treatment, as well as a prophylactic protecting the cells from infection by the virus. 3F Biofragrance proved successful as a surface disinfectant, killing the virus in concentrations as low as 1/5,000 after 15 seconds, the company said.
Scancell Holdings plc, of Oxford, U.K., highlighted the publication in the Journal for Immunotherapy of Cancer of an article describing its first Moditope vaccine, Modi-1, and its ability to stimulate T-cell responses in melanoma and ovarian cancer models. The article, "Combination vaccine based oncitrullinated vimentin and enolasepeptides induces potent CD4-mediated anti-tumor responses," was first published June 18. A phase I/II trial of the candidate is expected to start in the U.K in the first half of 2021, the company said.
Zealand Pharma A/S, of Copenhagen, said it will receive a €20 million (US$22.5 million) milestone payment from Boehringer Ingelheim GmbH, of Ingelheim, Germany, related to the first patient dosed in the phase II trial testing BI-456906 in patients with obesity and type 2 diabetes.
Zelluna Immunotherapy AS, of Oslo, Norway, said it will work with Singapore-based Lion TCR Pte. Ltd. on the development of TCR-NK products for the treatment of virally induced cancers. The collaboration will initially focus on the development of TCR-NK products targeting hepatitis B virus, a leading cause of liver cancer. Zelluna will lead early stage product development. Financial terms weren’t disclosed.