Adaptive Biotechnologies Corp., of Seattle, signed a multiyear, global collaboration agreement with Abbvie Inc., of North Chicago, to utilize Adaptive’s next-generation sequencing-based Clonoseq Assay to assess minimal residual disease (MRD) status in response to venetoclax (Venclexta, Abbvie Inc.) across multiple myeloma (MM) clinical trials. Venetoclax is a small-molecule selective B-cell lymphoma-2 inhibitor being studied in investigational trials for the treatment of MM patients. Adaptive and Abbvie will evaluate the depth and duration of response to venetoclax by using Adaptive’s assay to measure and monitor MRD negativity in MM-treated patients.
Aqilion AB, of Helsingborg, Sweden, is selling its entire stake in the portfolio company Glactone Pharma AB to Daniel Lifveredson Invest AB, of Onsala, Sweden. The purchase price is divided into a smaller amount as initial payment at the time of takeover and an additional payment that would be based on Glactone’s future performance. The firm develops candidates for late-stage prostate cancer.
Bavarian Nordic A/S, of Copenhagen, said Johnson & Johnson, of New Brunswick, N.J., will provide up to 200,000 regimens of its investigational Ebola vaccine to the Republic of Rwanda to support a new immunization program led by the Rwanda government. The vaccine regimen, which consists of the MVA-BN Filo vaccine from Bavarian Nordic and the Ad26.ZEBOV vaccine from J&J unit Janssen Pharmaceuticals, will help protect the citizens of Rwanda from the current Ebola outbreak in the neighboring country, the Democratic Republic of Congo, the companies said.
Cybrexa Therapeutics Inc., of New Haven, Conn., expanded the application of its Alphalex platform to include toxin conjugates and additional next-generation synthetic lethality targets. Two of Cybrexa’s new preclinical pipeline programs include CBX-12 (Alphalex-exatecan) and CBX-13 (Alphalex-DM4). Exatecan and DM4 are highly toxic to cells and require targeted delivery to be used as cancer therapies, making them prime opportunities for the Alphalex platform, the company said. Both programs are expected to have efficacy across a variety of solid tumors. Preclinical work is ongoing, with publication of initial data expected by mid-2020.
Epidarex Exeed Ltd., of Edinburgh, Scotland, was launched by Epidarex Capital. Focused on advancing early stage life science assets, Exeed said it will pair science with leading drug discovery, project management and contract research organization partners, using seed funds provided by Epidarex Capital. Exeed has been founded to transform life science innovations into investable assets over a period of 12 to 18 months, Epidarex said.
Healx Ltd., of Cambridge, U.K., signed an agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to identify indications related to rare neurological diseases. The project will leverage Healx’s artificial intelligence-based drug discovery platform, Healnet, and expertise in rare diseases and pharmacology, to identify potential new indications for assets from Boehringer’s pipeline. Healx will use data analysis and technological capabilities to assist Boehringer’s efforts in prioritizing selected indications for further research.
Kamada Ltd., of Rehovot, Israel, signed a binding term sheet for a 12-year contract manufacturing agreement with an undisclosed partner to manufacture an FDA-approved and commercialized specialty hyperimmune globulin product. Following the execution of the required technology transfer from the current manufacturer, and pending obtaining all required FDA approvals, Kamada is expected to commence commercial manufacturing of the product in early 2023.
Roche Holding AG, of Basel, Switzerland, and Spark Therapeutics Inc., of Philadelphia, extended the offering period of the former’s previously announced tender offer to purchase all of the outstanding shares of common stock of Spark for $114.50 per share to 5 p.m. ET on Dec. 16, 2019.
Sanofi SA, of Paris, said Sanofi Pasteur, its vaccines global business unit, has entered an agreement with the U.S. Department of Health and Human Services to increase the company's domestic pandemic influenza vaccine production capabilities based in Swiftwater, Pa. The contract will support the clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine to help enhance U.S. and global pandemic preparedness. This investigational pandemic vaccine will utilize the same recombinant technology as Sanofi's Flublok Quadrivalent influenza vaccine.
Stoke Therapeutics Inc., of Bedford, Mass., disclosed preclinical data from studies of STK-001 that showed significant improvements in survival and reductions in seizure frequency in a mouse model of Dravet syndrome (DS). New data from electroencephalography recordings showed 76% (16/21) of DS mice treated with STK-001 were seizure-free compared to 48% (10/21) that were treated with a placebo. An 80% reduction in the average number of spontaneous seizures (three seizures vs. 16 seizures) was also observed among treated DS mice compared to placebo. Data were presented in a poster session at the American Epilepsy Society annual meeting in Baltimore.
Unlearn AI Inc., of San Francisco, presented results generated from the company’s latest Alzheimer’s disease model at the Clinical Trials on Alzheimer’s Disease meeting in San Diego. The results presented during a late-breaking session demonstrated that the company’s platform can provide digital patient records designed to supplement actual control patients in Alzheimer’s disease (AD) clinical trials. Unlearn is addressing patient recruitment, one of the biggest challenges associated with AD studies, through its machine learning-based model that incorporates Digital Twins into intelligent control arms of clinical studies. A Digital Twin is a comprehensive, longitudinal and computationally generated clinical record that describes what would have happened if a specific patient had received a placebo. The Digenesis process leverages historical clinical trial datasets from thousands of patients, disease-specific machine learning models and rigorous statistical analysis to create digital records that are perfectly matched to patients in the investigational-treatment arm of studies, Unlearn said.
Xphyto Therapeutics Corp., of Vancouver, British Columbia, said the development of epilepsy treatment products using its oral thin film delivery system will be a priority initiative for 2020. The company is focusing on generic cannabidiol (CBD)-based dissolvable oral wafers for the treatment of severe childhood forms of epilepsy, specifically Dravet syndrome and Lennox-Gastaut syndrome. Current FDA/EMA-approved cannabidiol-based treatment for the conditions is founded on a plant extract oil containing 100 mg of CBD per milliliter. Based on initial dissolution testing using Xphyto's thin film drug delivery system, the approach may yield as much as a 10- to 20-fold increase in bioavailability of CBD over existing oil delivery methods.