Global Roundup: DBI and Bayer Partner on Sleep Apnea Solution and More

Switzerland’s DBI announced a collaboration with life sciences giant Bayer AG, based in Germany. The companies will collaborate on the SPRAY SMART study of a new nasal drug for Obstructive Sleep Apnea Syndromes (OSAS).

The goal of the collaboration between DBI and BAYER is to broaden insight into the dynamics of metabolites whose levels in the exhaled breadth of patients with OSAS are changed by the disease and in response to therapeutic intervention. Applying DBI’s technology and algorithm could provide early signs of treatment efficacy and potentially help the identification of sub-populations of OSAS patients responsive to specific treatments.

DBI combines Secondary Electrospray Ionization (SESI) and High-Resolution Mass Spectrometry with advanced bioinformatics tools to provide unprecedented breath metabolic profiling. This allows for real-time breath analysis and study molecules that are untraceable by traditional methods. It opens a new path to advancing precision medicine and improving future clinical outcomes.

Bayer’s first clinical study applying DBI’s technology is the placebo controlled SPRAY-SMART study. The apnea-hypopnea-index (AHI) will be measured to determine the severity of OSA after treatment with a new nasal spray for OSA treatment. The drug aims at preventing the collapse of the upper airways as one pathological mechanism in OSA.

Elsewhere around the globe:

LivaNova PLC – London-based LivaNova received the greenlight from the FDA to begin its investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation (OSPREY).” The OSPREY study will seek to demonstrate the safety and effectiveness of the aura6000 System, the LivaNova implantable hypoglossal neurostimulator intended to treat adult patients with moderate to severe obstructive sleep apnea (OSA). An innovative alternative to the traditional continuous positive airway pressure (CPAP) machine, the aura6000 System generates stimulation through a programmable, rechargeable and implantable pulse generator (IPG). The IPG is implanted in a subcutaneous pocket near the clavicle of the patient via an outpatient surgery. Mild stimulation pulses from the IPG are delivered via a lead to the hypoglossal nerve to stimulate the tongue during sleep and help keep the patient’s airway open.

Dxcover Limited – Scotland’s ClinSpec Diagnostics has rebranded as Dxcover Limited. The company continues to focus on become a world-leader in liquid biopsy and artificial intelligence for early detection of cancer and other diseases. Dxcover is a spinout from the University of Strathclyde. Its technology has received the backing from well-known investors, including Scottish Enterprise, Mercia Asset Management, Norcliffe Capital, SIS Ventures, Eos Advisory and the University of Strathclyde. Coinciding with its rebranding, the company has taken over a 2,000-square-foot lab in the University’s Royal College Building in the heart of the Glasgow City Innovation District. At three times the size of Dxcover’s previous labs, the new site will accommodate the company’s ongoing growth, but will also permit its critical development work to continue while social distancing measures remain in place.

Debiopharm– Switzerland-based Debiopharm announced Phase II results of a clinical study assessing naratuximab emtansine for the treatment of DLBCL and other B-cell malignancies. In the trial, naratuximab emtansine, which targets the CD37 antigen on the surface of B cells, was paired with rituximab, an anti-CD20 antibody. Data from the study revealed the combination treatment demonstrated meaningful efficacy and high complete response rates (CRR), especially in heavily pre-treated patients with more than two prior lines of treatment. The Objective Response Rate (ORR) in all efficacy-evaluable patients was 44.7%, complete response rate (CRR) was 31.6%. In patients with two or more prior therapies, non-primary refractory ORR was 46.4% and CRR was 32.1%.

Veraxa Biotech GmbH – Formerly known as Velabs, Germany-based Veraxa forged a partnership with Swiss-based Quadira Biosciences Ag to develop a suite of novel ADCs for the treatment of various cancers. The collaboration will leverage both the advantages of Veraxa’s proprietary position-true click-chemistry-based drug conjugation technology in combination with Quadira’s superior 3D cellular assay and assessment systems.

RhoVac AB – Sweden’s RhoVac will initiate a follow-up study of patients that took part in a Phase I/II prostate cancer trial assessing RV001. The objective of the long-term follow study, to be conducted in the coming months, is to find out to what extent these patients still have the appropriate level of RhoC specific immune response, what their PSA development has been, and to what extent they have progressed to additional therapy. Following a one-year review, the company’s drug candidate was considered safe and also induced a prevalent and long lasting immune RhoC-specific immune response in 86% of the patients who participated. The Phase IIb study is to show that RV001 can significantly prevent or procrastinate disease progression in these patients, something for which no standard therapy is available today.

AlzeCure Pharma AB – A presentation at the IASP 2021 World Congress on Pain showed the company’s preclinical TrkA-NAM asset for osteoarthritic pain and other severe pain disorders is a promising new treatment. The company concluded that potent TrkA-NAM’s could potentially avoid some of the side effects observed for anti-NGF antibodies due to a more selective mechanism of action, while retaining the analgesic efficacy.

Gesynta Pharma AB – Sweden-based Gesynta submitted an Investigational New Drug Application to the U.S. Food and Drug Administration for its oral drug candidate GS-248 in patients with systemic sclerosis. The study investigates the safety of GS-248 and its efficacy on Raynaud’s phenomenon and peripheral vascular blood flow. Top-line data is expected in the first quarter of 2022. GS-248 provides a combination of anti-inflammatory, vasodilatory and platelet inhibitory effects by potently and selectively inhibiting microsomal prostaglandin E synthase-1 (mPGES-1). The randomized, placebo-controlled, double-blind Phase II study will include approximately 80 patients at clinical sites in four European countries. Patients will receive GS-248 orally once daily, or placebo, for four weeks.

Enterprise Therapeutics Ltd. – Based in the U.K., Enterprise Therapeutics dosed the first patients in a Phase I study for its novel inhaled cystic fibrosis therapy, ETD001. The first-in-man safety study is being conducted in healthy participants. ETD001 is an ENaC ion channel inhibitor with best-in-class potential aimed at treating all people with CF. ETD001 has previously been shown to have long duration of action in the lung and is therefore expected to provide a superior efficacy and safety profile compared to other ENaC drug candidates. ETD001 targets the epithelial sodium ion channel ENaC, which controls fluid volume and mucus clearance from the airways. By increasing the amount of airway fluid available to hydrate mucus, ETD001 addresses the underlying mechanisms of mucus congestion, and is expected to restore lung function, reduce the frequency of lung infections and improve patient quality of life.

The Native Antigen Company – Also based in the U.K, the Native Antigen Company won ‘The Best COVID-19 Responder’ at OBN 2020 Awards. The award recognizes the company’s outstanding contribution to the fight against COVID-19.

Domainex – The OBN awards also recognized U.K.-based Domainex as the best contract research organization. Over the past year, Domainex has made significant investment in new technology to support its clients’ research needs. The company grew its top line by approximately 45% in 2020 and welcomed over 30 new colleagues to its team to further extend its drug discovery offering, despite the challenges faced as a result of the pandemic.

SAGA Diagnostics AB – Sweden’s SAGA announced that it has successfully been accredited to the ISO 17025 standard for its leading-edge mutation detection laboratory services designed to radically improve cancer diagnosis, monitoring, and treatment outcomes. Granted by SWEDAC, the Swedish Board for Accreditation and Conformity Assessment, ISO 17025 is an international quality management standard used to assess the competency of analytical laboratories.

Genetic Analysis AS – The Norwegian Research Council approved Oslo-based Genetic Analysis’ grant application of 16 million kronor for its project developing new innovative microbiome-based diagnostics to be used to aid selection and treatment of IBD patients. The company plans to develop an easy-to-use, in vitro diagnostic test that profiles gut microbiota to predict disease progression and treatment regimes in patients with ulcerative colitis.

Pilloxa – Swedish digital startup company Pilloxa today announced that it will collaborate with the Nordic office of Chiesi Global Rare Diseases to harness the capabilities of the Pilloxa platform to support the treatment journey for patients with nephropathic cystinosis across Scandinavia. Nephropathic cystinosis is an ultra-rare, multisystemic, genetic disorder characterized by the accumulation of the amino acid cystine in the lysosomes within the cells.

Adlib – Toronto-based Adlib completed the SOC 2 Type I Service Organization Control (SOC 2) audit for its Content Intelligence platform in accord with the attestation standards established by the American Institute of Certified Public Accountants.