Company Overview - Bionomics Limited is a clinical-stage biopharmaceutical company engaged in discovery and development of drug candidates focused on the treatment of central nervous system (CNS) disorders and cancer by using its platform technologies. The Company's segments include Drug discovery and development, and Contract services. The Drug discovery and development segment includes the discovery, development and commercialization of compounds to match a target product profile. The Contract services segment includes the provision of scientific services on a fee for service basis to both external and internal customers. Its product candidates include BNC210, BNC375, BNC101 and BNC105. The Company provides treatments for CNS disorders, such as anxiety, depression and Alzheimer's Disease. Its oncology approach targets cancer stem cell therapies in solid tumors. Its technologies include ionX and MultiCore. It operates in three geographical areas, such as Australia, France and the United States.

Potential of BNC210 as a drug therapy for PTSD: Recently at PTSD (post-traumatic stress disorder) State of the Science Summit, Bionomics presented the potential of BNC210 as a drug therapy for PTSD, through the results of a Phase 2 clinical trial in patients with Generalized Anxiety Disorder (GAD). A Phase 1 clinical trial evaluating the effects of BNC210 on panic attacks induced in healthy volunteers and in preclinical models, including models of fear extinction and depression. In neuroimaging studies in GAD and in PTSD patients, the emotional faces task activates the amygdala. In anxiety, connections between the anterior cingulate cortex and the amygdala are strengthened. In a Phase 2 clinical trial in GAD patients, BNC210 significantly reduced both amygdala activation induced by viewing fearful faces and the resting state connectivity between the left amygdala and the anterior cingulate cortex. Patients suffering from PTSD also demonstrate deficits in fear extinction which has been proposed as an explanation for intrusive thoughts and why sufferers continue to re-experience the traumatic event. BNC210 has demonstrated efficacy in the contextual fear-conditioning extinction paradigm in C56BL6 mice where it significantly enhanced fear extinction, reducing fear behaviour, while diazepam (Valium) demonstrated an inhibitory effect resulting in prolonged fear behaviour.


BNC210 - Next Generation Drug Candidate to Treat Anxiety & Depression; (Source: Company reports)

In humans, BNC210 treatment reduced the emotional impact of a CCK-4 induced panic attack. Individuals who suffered an induced panic attack, and to whom BNC210 was administered, showed faster recovery following their unpleasant physical and emotional experience, compared to placebo. Notably, the data shown at PTSD Science Summit continues to demonstrate BNC210 is a potent anxiolytic compound with equivalent acute efficacy to benzodiazepines with anti-depressant properties and few side effects. It highlights the potential of BNC210 as a novel treatment for patients who are suffering with GAD and other anxiety related disorders and suggests a role for BNC210 in the treatment of stress and trauma related disorders.


Anxiety Market value; (Source: Company reports)
 
First milestone payment of US $10 million under agreement with Merck & Co: In February 2017, Bionomics announced the achievement of the first milestone payment of US $10 million under agreement with Merck & Co. to develop novel drug candidates for treatment of cognitive dysfunction associated with Alzheimer’s disease. This milestone validates the utility of its drug discovery platform and strategic approach to partner selected assets. The portfolio of products under collaboration with Merck & Co. are designed to address cognitive dysfunction in important CNS indications, and Alzheimer's disease is of chief importance among these as there remains an urgent need for new treatments. Partnership with Merck & Co in cognition generated US$20M in upfront payments in 2014, research payments 2014-2017 and US$10M first clinical milestone in February 2017. Deal was valued up to US$506M in upfront, research and milestone payments plus additional royalties on net sales of licensed drugs.


Proprietary Platform Technologies; (Source: Company reports)

BNC105 to be evaluated in a combination with Keytruda: A New BNC105 clinical trial is expected to initiate in 2017, which will enrol patients with advanced melanoma who are unresponsive to standard treatments. This will be the first study to combine vascular disrupting agent, BNC105, with Merck & Co.’s blockbuster immune-oncology drug, Keytruda. Grant funding to enable this trial has been provided by the Victorian Government, through the Victorian Cancer Agency, to the Peter MacCallum Cancer Centre. This collaboration continues to diversify partnerships and allows for the development of unique drug candidates such as BNC105.  The Victorian Cancer Agency Translational Research Project will target the problem of treatment resistance in advanced melanoma. Since no single approach is used to treat melanoma this translational research project will tackle three of the most important issues in the resistance to systemic therapy of patients with metastatic melanoma by performing entirely novel early phase clinical trials including the BNC105 trial to establish safety, biological and preliminary efficacy data to address the Prevention of resistance to combined BRAF & MEK inhibition; Extending the benefit of anti-PD 1 based therapies to higher proportions of patients; Improving the efficacy of immune checkpoint inhibitors in melanoma brain metastases.
 
BNC101 for the treatment of colon cancer and other solid tumours:  In April 2017, Bionomics presented new pre-clinical data from ongoing studies of BNC101, its anti-LGR5 cancer stem cell drug candidate, at the annual American Association for Cancer Research (AACR) medical meeting. The data demonstrated complementary anti-tumour activity between BNC101 and checkpoint inhibitors, therefore strongly supporting further clinical evaluation of BNC101 in combination with checkpoint inhibitors. LGR5 positive cancer stem cells are highly prevalent within metastatic colorectal cancer and lead to a higher tumour recurrence in patients. Emerging data shows that cancer stem cells can generate an environment in the tumour that suppress the immune system from functioning as it normally would to attack tumour cells. Checkpoint inhibitors are a form of immunotherapy that increase the ability of the immune system to recognise and destroy tumour cells that would otherwise escape immune surveillance. However, in the presence of cancer stem cell derived immune suppressive factors, checkpoint inhibitors may not be able to function to their highest potential. Moreover, the data provides preclinical evidence in a mouse model of colon cancer that treatment with BNC101 and a checkpoint inhibitor is associated with a greater reduction in T regulatory cells, an immune suppressive cell, and a modest increase in tumour attacking cytotoxic T cells compared to treatment with a checkpoint inhibitor alone. Further preclinical data highlights the ability of BNC101 to induce the recruitment of Natural Killer cells to the LGR5 positive cells through an effect known as Antibody dependent cell-mediated cytotoxicity (ADCC). Targeting the LGR5 positive cancer stem cell component of colorectal cancer with BNC101 may release potential suppression of checkpoint inhibitor activity to leverage greater therapeutic benefit to a colorectal cancer patient population. The data strongly supports further clinical evaluation of BNC101 in combination with checkpoint inhibitors.
 
Recommendation: BNO stock has moved up 25.7% as on August 08, 2017, led by improving sentiments on account of BNC210 clinical trial progress and ongoing developments of other molecules. We give a “Buy” recommendation at the current market price of $0.445
 
 

BNO Daily chart; (Source: Thomson Reuters)

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