BioSpace Global Roundup, Sept. 10
Avacta Group – U.K.-based Avacta Group will launch an ELISA laboratory test for the SARS-CoV-2 spike protein to support global research efforts into the coronavirus that causes COVID-19. Enzyme-linked immunosorbent assays (“ELISAs”) are common research tools used to detect and quantify a target of interest in a wide range of samples. Using the same Affimer reagents that are incorporated into its rapid coronavirus saliva test being developed with Cytiva, Avacta has developed in-house a high-performance ELISA laboratory test to detect the SARS-CoV-2 virus. Avacta will make the ELISA test available as a kit so that researchers globally can use it in their own laboratories to support research into the coronavirus.
IcanoMAB – Privately-funded IcanoMAB, based in Germany, secured an undisclosed amount of funding, as well as three clinical candidates in IND-enabling stage and funding from MAB Discovery GmbH. IcanoMAB will use the proceeds to advance the clinical candidates to allow IND-enabling activities and respective partnering activities with selected third parties.
Everest Medicines – Shanghai-based Everest announced that the first patient has been randomized in China into the NefIgArd Phase III global registrational study evaluating Nefecon as a treatment for IgA Nephropathy (IgAN). NefIgArd will evaluate the efficacy and safety of Nefecon in 360 patients with primary IgA nephropathy at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). Nefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy.
Immune Regulation – London-based Immune Regulation Ltd. received a notice of allowance from the U.S. Patent and Trademark Office for a patent covering IRL201805. The asset is a first-in-class compound derived from the endogenous immuno-regulatory protein Binding Immunoglobulin Protein (BiP) and is in development to treat rheumatoid arthritis and other inflammatory and autoimmune diseases. The new patent provides Immune Regulation with additional intellectual property protection covering the composition of matter of ‘1805. A Phase II clinical study with ‘1805 is currently being planned in adult patients with moderate to severe rheumatoid arthritis to further assess remission rates and longevity of action.
CN Bio – U.K.-based CN Bio struck a collaborative deal with Imperial College London to advance CN Bio’s Liver-on-Chip technology and the understanding of the underlying mechanisms of alcoholic hepatitis and uncover novel targets for drug discovery and development. CN Bio’s proprietary Liver-on-Chip technology enables longer term in vitro culture (>1 month) of primary liver cells in 3D microtissue structures for modelling a range of human liver diseases and their progression. The Company has developed assays for Non-Alcoholic Fatty Liver Disease (NAFLD)/steatosis and Non-Alcoholic Steatohepatitis (NASH) disease states, both of which are available as fee-for-service work.
Intravacc – Vaccine-focused Intravacc, based in The Netherlands, was awarded a contract with the U.S. National Institute of Allergy and Infectious Diseases for the development of a prophylactic vaccine against enterovirus D68 (EV D68). EV D68 is a respiratory virus that can cause childhood paralysis, Acute Flaccid Myelitis (AFM). Intravacc will develop an inactivated EV D68 vaccine, based on Intravacc’s proprietary Vero cell technology, from early product selection through to Phase I clinical testing.
PhoreMost – PhoreMost Ltd. and XtakPi Inc. entered into a drug discovery collaboration agreement to rapidly identify and develop compounds to advance a drug discovery program against targets that epigenetically regulate tumor progression, and have been previously classified as “undruggable.” The companies will pursue this challenging goal with a unique combination of machine learning and physics-based computation methods, using XtalPi’s intelligent digital drug discovery and development (ID4) platform, to explore novel sites discovered by PhoreMost’s SITESEEKER platform. Financial details of the deal were not disclosed.
VBL Therapeutics – Israel’s VBL announced a completion of a Type B pre-IND meeting with the U.S. Food and Drug Administration regarding the development plan for VB-601, the company’s lead anti-MOSPD2 antibody for immune-inflammatory indications. The company aims to begin human testing in 2021.
Cynata Therapeutics – Australia’s Cynata announced positive data from a study of its induced pluripotent stem cell (iPSC)-derived Cymerus mesenchymal stem cells (MSCs) in a preclinical rodent model of idiopathic pulmonary fibrosis (IPF). IPF is a currently incurable disease of unknown cause, which results in extensive scarring or fibrosis of the lungs. Lung damage is often advanced by the time the condition is initially diagnosed, and existing treatment options have very limited efficacy.
ENvizion – Israel-based ENvizion struck an agreement with a U.S.-based hospital network for the company’s feeding tube placement navigation devices. Each year, nearly eight million feeding tubes are placed blindly inside patients in the United States for a variety of medical cases, but many of them are not placed with any sort of technical guidance. Blind placement can lead to a mistaken placement of the tube in the lungs, resulting potentially in pneumothorax, pneumonia, or even death.
Liminal BioSciences – Canada’s Liminal, through its U.S. subsidiary Prometic Biotherapeutics, resubmitted its Biologics License Application with the FDA for Ryplazim (plasminogen) for the treatment of congenital plasminogen deficiency (C-PLGD). In 2017 the company received a Complete Response Letter (CRL) in response to a BLA submission for Ryplazim. The company believes that the resubmission addresses the deficiencies outlined in the CRL, which were related to certain manufacturing procedures. The company further believes that the amended BLA represents a Class 2 resubmission that would provide for a Prescription Drug User Fee Act (PDUFA) date for FDA review and action within six months from the date of the resubmission.
FAES Farma – Faes Farma, a Spanish pharmaceutical company headquartered near Bilbao, is using a Syrris Asia Flow Chemistry System to develop novel synthesis pathways for new and existing APIs.
Beroni Group – Australia-based Beroni Group announced it received the first commercial order for its proprietarily developed SARS-CoV-2 Antibody Detection Kit from Forsitech Inc., a pharmaceutical trading company based in Japan. Beroni’s SARS-CoV-2 Antibody Detection Kit is an in vitro diagnostic test for the qualitative detection of IgG and IgM antibodies to the SARS-CoV-2 virus in capillary “fingerstick” whole blood, venous whole blood, plasma (EDTA, citrate), and serum samples.
Evonetix Ltd. – U.K.-based Evonetix Ltd. announced a collaboration with Analog Devices, Inc. that will focus on the advancement and commercial scale-up of Evonetix’s proprietary microelectromechanical systems (MEMS)-based silicon chips and accelerate the development of Evonetix’s first product, a DNA desktop writer. Evonetix’s novel silicon chip controls the synthesis of DNA at many thousands of independently controlled reaction sites or ‘pixels’ on the chip surface in a highly parallel fashion. The two companies began working together in January 2019.
NanoMab – London-based NanoMab Technology Limited submitted a request to the MHRA for authorization for a Phase II Clinical Study Protocol for its NM-01 product. The study will investigate the assessment of programmed death ligand 1 (PD-L1) expression using 99mTc-NM-01 as a SPECT/CT radiotracer and its correlation to PD-L1 expression results based on routine immunohistochemical (IHC) testing in biopsy diagnostic specimens.
Enterome SA – France’s Enterom SA initiated a new clinical trial with EO2401, an innovative microbiome-antigen (‘OncoMimic’) based cancer immunotherapy candidate, in a second cancer indication. The new Phase 1/2 clinical trial, named ‘SPENCER’, is investigating EO2401 in combination with an immune checkpoint inhibitor (CPI) as a potential new treatment for adrenal malignancies.
AnGes – AnGes, Inc. announced a collaboration with Brickell Biotech. Brickell has the right to develop AnGes’ proprietary investigational adjuvanted plasmid DNA vaccine intended to prevent SARS-CoV-2 (COVID-19) in the U.S., South America and certain emerging markets. AnGes is currently conducting Phase I/II clinical studies with its vaccine candidate in Japan, with data readouts expected through the first quarter of 2021. The results from these studies will guide AnGes’ and Brickell’s global development efforts of this novel vaccine candidate.
RedHill Biopharma -- RedHill Biopharma announced that opaganib demonstrated potent inhibition of SARS-CoV-2, the virus that causes COVID-19, achieving complete blockage of viral replication in an in vitro model of human lung bronchial tissue. Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and anti-viral activity that targets a host cell component, unaffected by viral mutation. Opaganib is currently being evaluated in global Phase II/III and U.S. Phase II clinical studies for the treatment of severe COVID-19 pneumonia. Results from this study showed a clear and compelling antiviral effect of opaganib against SARS-CoV-2. Opaganib demonstrated the most potent activity compared to all compounds tested, including the positive control, remdesivir.
Grifols – Spain’s Grifols acquired the remaining equity of Alkahest, Inc. in exchange for a total price of $146 million, on a debt-free basis. In addition to the clinical development of specific plasma fractions and protein inhibitors, Alkahest is focused on developing a complete understanding of the human plasma proteome. This unique proteomic platform of targets will help Grifols and Alkahest to unlock new therapeutics and diagnostics, develop new plasma proteins, new indications for currently licensed plasma proteins, biomarkers for diagnostics, recombinant proteins and antibodies as well as small-molecule drugs.