Collaboration with SRI Provides QBioMed Expertise in Formulation Development and Preclinical Work in Autism, as well as CMC and Manufacturing capability
Q BioMed Inc., a biotechnology accelerationcompany, announced a collaborative agreement with SRIInternational to provide formulation development, preclinical development, andearly clinical manufacturing of QBM-001, in support of Q BioMed’s AutisticSpectrum Disorder (ASD) drug development program for non-verbal or minimallyverbal autistic children.
SRI has broad expertise in solving formulation, drug delivery, and characterization challenges of small molecule drugs and biologics. The formulation team, led by Dr. Gita Shankar, is experienced in the development of novel formulations that have reached clinical trials. They are currently developing a formulation for QBM-001 with relatable chemical properties and formulation requirements.
The preclinicalstudies for QBM-001 will be led by Dr. Stephen Morairty and his team in SRI’sCenter for Neuroscience. Dr. Morairty and his colleagues are experienced in working with several pre-clinical autism models.
“We are pleased to have found both experience with autism models and expertise in formulation ofproducts like QBM-001 in SRI International,” said Denis Corin, CEO of Q BioMed Inc. “This important step will be the catalyst for several milestones forQBM-001 over the next few months as we prepare clinical product for the trialswe anticipate starting in 2019.”
QBM-001 targets toddlers with pediatric developmental nonverbal disorder, where an underlying commonality may lead to developmental delay, an autism diagnosis and eventual nonverbal or very minimally verbal capability for the rest of their lives.
There are approximately 18,000 new cases of pediatric developmental nonverbal disorder in the US each year and a similar amount in Europe. The majority of the children are diagnosed as young children and fall within the autism and epilepsy spectrum disorders. Individually, the economic cost for toddlers that become non- or minimally verbal is ten million dollars on average per person over a life span. Collectively, an estimated 200 billion dollars is spent yearly on individuals who have become nonverbal in the US. Not all individuals who become nonverbal will benefit from QBM-001. However, with validated biomarkers,testing from trained specialists and genetic testing, children who fall into this targeted population can be identified, and will have a higher likelihood of responding to treatment.