BioSpace Global Roundup: July 3

World Map of Pills

Aimmune Therapeutics – Peanut allergies affect people across the globe and California-based Aimmune Therapeutics aims to market its oral immunotherapy AR101 in Europe. The company submitted a Marketing Authorization Application to the Europeans Medicines Agency for AR101 as a treatment for children and adolescents ages 4 to 17 who have severe peanut allergies. The MAA submission includes extensive data from the only Phase III clinical trial program to meet the primary endpoints in children and teens with peanut allergy. The pivotal European Phase III ARTEMIS study, which represents a key component of the MAA submission, reinforced the consistent clinical profile of AR101 after six months of dose escalation and a three-month therapeutic dosing phase. A Biologics License Application is under review by the U.S. Food and Drug Administration. The U.S. agency is expected to make a decision in early 2020.

Boehringer Ingelheim – Germany-based pharma giant Boehringer Ingelheim and South Korea-based Yuhan Corporation announced a collaboration agreement for the development of a first-in-class dual agonist for the treatment of NASH and related liver diseases that combines GLP-1 and FGF21 activity in one molecule. Preclinical evidence suggests high efficacy when combining the gut-derived hormone GLP-1 with FGF21. The dual GLP1R/FGF21R agonist is expected to reduce liver cell injury and hepatic inflammation by resolution of steatohepatitis as well as having direct antifibrotic effects and complements Boehringer Ingelheim’s R&D portfolio in NASH adding another potential first-in-class opportunity.

MODAG – With €12 million in a Series A financing, Germany-based MODAG emerged from stealth mode to develop treatments for neurodegenerative diseases, including Parkinsonian disorders. The company will use the funds to advance its lead candidate anle138b into clinical development in Multiple System Atrophy (MSA). Anle138b aims to halt the progression of MSA, an atypical form of Parkinsonism, by addressing the core disease pathology. Anle138b is a small molecule compound that specifically binds toxic oligomeric structures of alpha-synuclein, the core aggregating protein species in Parkinsonian disorders, the company said in a statement.

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Velabs Therapeutics – Germany-based Velab Therapeutics GmbH closed a €3 million Series B financing round. The funds will be used to advance the company’s functional antibody screening program and strengthen its pipeline of preclinical functional antibodies against diseases with poor treatment options. Velabs Therapeutics, a spin-off company of the European Molecular Biology Laboratory, is a pioneer of microfluidic technology for the screening of antibodies with modulatory function on complex signaling proteins such as GPCRs, ion channels or other regulatory signaling proteins. Velabs is currently building its own pipeline of therapeutic antibody candidates for further joint development with interested partners.

Kitov Pharma – Israel-based Kitov Pharma, a pharmaceutical company focused on advancing first-in-class oncology therapies to overcome tumor drug resistance, completed IND-enabling studies for NT219, a first-in-class, dual-inhibitor small molecule, designed to prevent and overcome cancer drug resistance. The preclinical GLP toxicology studies have demonstrated good tolerability at the highest dose levels expected to be tested in Kitov’s planned Phase I/II study treating patients with squamous cell carcinoma of the head and neck (SCCHN). Kitov is preparing for completion of the GMP manufacturing of the drug product and submission of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a dose-escalation Phase I/II study to treat SCCHN cancer patients with the combination of NT219 and cetuximab.

Chi-Med -- Hutchison China MediTech Limited (Chi-Med), which is based in London, announced the pricing of an upsized secondary offering of its American depository shares. The company said 12 million shares will be sold. HHHL, the largest shareholder of Chi-Med, will receive all of the proceeds from the offering. Morgan Stanley & Co. LLC is acting as sole underwriter for the offering.

Appili Therapeutics – Based in Nova Scotia, Appili Therapeutics announced it had completed its contract with the U.S. Department of Defense and secured a $3 million grant. Appili will use the funds to continue advancing its ATI-1503 antibiotic program, which targets drug-resistant, Gram-negative bacteria also known as “superbugs.” The ATI-1503 program has the ability to target four out of six “ESKAPE” pathogens, which are the leading cause of hospital-acquired infections worldwide1. PRMP grants support military health-related research that has the potential to make a strong impact on patient care. Appili’s ATI-1503 program is a new class of antibiotics based on the negamycin scaffold, which is a naturally occurring compound with intrinsic Gram-negative antibacterial activity. According to the World Health Organization, drug-resistant bacteria, particularly the superbugs that are resistant to most or sometimes all available anti-infectives, are among the highest threats to human health worldwide. The U.S. Centers for Disease Control and Prevention (CDC) report that they are responsible for more than 2 million infections and 23,000 deaths each year in the U.S. alone.

Cancer Research UK -- The world's largest independent funder of cancer research, London-based Cancer Research UK announced a partnership with SV Health Investors to boost development of new cancer drugs. Cancer Research UK is investing at least $25 million in SV’s seventh biotech-focused venture capital fund, SV7 Impact Medicine Fund, which is expected to raise $250 million. Oncology is an important component of the Fund, which will target investing 60% into companies focused on oncology or oncology-related opportunities. Cancer Research UK invests more than £400 million every year in cancer research, including through its UK network of 18 core-funded research centers, to accelerate the transition of lab-based discovery research into the clinic for the benefit of people affected by cancer.

Valneva SE – France-based Valneva initiated a Phase II study for its leading, unique Lyme disease vaccine candidate VLA15. The overall Phase II objectives for VLA15 are to determine the optimal dosage level and vaccination schedule for use in Phase III pivotal field efficacy studies, based on immunogenicity and safety data. Following the Run-In phase for Valneva’s first Phase II study VLA15-201, the two lead dosage levels have been selected for further development based on Data and Safety Monitoring Board clearance. The objective of the initiated second Phase II study VLA15-202 is to evaluate an alternative immunization schedule for the two lead dosage levels. The Phase II duration is expected to be approximately two years with initial data expected mid-2020.

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