Bio-link Australia Pty. Ltd.

Therapeutics

Therapeutic molecules, drug discovery programs and medical devices in the Bio-Link portfolio that are available for licensing  and partnership include the following:

KT009: A Novel Biological Therapy for the Treatment of Degenerative Disk Disease

Kunovus Technologies is developing KT009, a recombinant human growth factor as a therapeutic candidate for the regeneration of spinal intervertebral disk (IVD) tissue in patients with debilitating Degenerative Disk Disease (DDD). Kunovus Technologies has generated a strong proof of concept preclinical data set which is supported by a compelling biological rationale. KT009 induces the mobilisation and differentiation of stem cells, culminating in de novo regeneration of IVD tissue and ultimately leading to stabilisation of the affected spine. KT009 therapy has the potential to preclude much more invasive, costly and risky spinal surgery as the standard of care for refractory DDD. Summary (PDF)

Xanamem™: A phase II 11β-HSD1 Inhibitor for the treatment of Alzheimer’s disease

Actinogen Medical is developing Xanamem™ (UE2343), for the treatment of Alzheimer’s disease (AD), diabetes cognitive impairment (DCI) and other indications associated with cognitive decline. Xanamem is a phase II, first-in-class, orally active, brain penetrant, potent and selective 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) inhibitor, designed to reduce regeneration of the glucocorticoid stress hormone cortisol within the brain. A growing body of scientific evidence indicates that elevated brain levels of cortisol have a detrimental effect on cognitive function and may contribute to AD pathogenesis, including amyloid-β (Aβ) and tau pathology. Summary (PDF)

Irofulven : A Precision Medicine DNA Damaging Agent

A phase II/III DNA damaging drug candidate under development by Oncology Venture, together with a companion diagnostic technology (Irofulven DRP®) to identify patients highly likely to respond to therapy. Irofulven has previously demonstrated promising efficacy in a range of oncology indications, including prostate, ovarian and liver cancer. Oncology Venture will soon commence a focused phase II trial of irofulven in highly likely patient responders with castration-resistant prostate cancer. Summary (PDF)

LiPlaCis™, Tumour Targeted Precision Cisplatin

Oncology Venture ApS is developing LiPlaCis™, a liposomal nano-encapsulated cisplatin designed to selectively target tumours in pre-screened highly likely responder patients. LiPlaCis liposomes have optimised stability and enhanced payload capacity to deliver higher doses of cisplatin to tumours. Consequently, LiPlaCis exhibits an enhanced therapeutic window compared to cisplatin, greater potency and an increased maximum tolerated dose. Phase I clinical investigation has achieved Partial Responses (PR) and Stable Disease (SD) in multiple heavily pre-treated patients. LiPLaCis is de-risked and positioned for accelerated clinical development in metastatic breast cancer (mBC), due to its proprietary LiPlaCis DRP® companion diagnostic technology which predicts highly likely responders. With an ongoing phase I/II clinical study in mBC showing promising signs of clinical efficacy, Oncology Venture is now seeking commercial partners to develop LiPlaCis as the next generation cisplatin therapy. Summary (PDF)

APO010: A phase II FAS/CD95 Agonist for Precision Oncology Therapy

A phase II, highly potent Fas / CD95 / Apo1 agonist which mimics cytotoxic T-lymphocyte signalling to induce direct cancer cell apoptosis, and indirect stimulation of “second wave” innate and adaptive immune system tumour attack. Combined with an immuno-companion diagnostic technology (APO010 DRP®) to identify patients highly likely to respond to therapy, Oncology Venture is currently investigating APO010 in a focused phase II multiple myeloma clinical trial with a second trial in metastatic breast cancer to commence soon. Summary (PDF)

CNC332: a precision cancer chemotherapy that specifically targets mitochondria to exploit a recently recognised vulnerability of tumour cells

Mitocans’ lead candidate CNC332 selectively targets tumour cells’ mitochondria, the cellular substructures responsible for bioenergy production. Mitochondria are critical for cell survival, and recognised as potentially valuable drug targets for cancer therapy. CNC332 is a vitamin E analogue and proven anti-cancer agent, both in the laboratory and in animal models. CNC332 targets a mitochondrial component critical to tumour survival. As this component (Complex II in the electron transport chain) is less critical to non-tumour cells, CNCC332 spares normal cells but is lethal to cancer cells. CNC332 is the only developmental drug in its class, offering hope for the resolution of difficult-to-treat tumours including malignant mesothelioma.

CNC225: a first-in-class “check point” immunotherapy designed for use in combination with other immunotherapies to maximise patient response rates

Secreted by tumour cells, galectins protect the tumour from immune attack by destroying immune cells. Galectin inhibitors reduce this protection by promoting immune cell survival, thereby restoring immune response to the tumour and increasing the likelihood of tumour elimination. Cancure’s lead Galectin CNC225 reduces the activity of Galectins when used in combination with immuno-therapeutics. CNC225 has a dual mechanism – a secondary effect of this drug candidate is inhibition of the growth of blood vessels to the tumour. The next stage of development for CNC225 is formal preclinical toxicology in large animal models, to ensure that the drug candidate is suitable to administer to humans prior to commencement of a Ph1 clinical study.

CD5-2: A First-in-Class Immuno-Oncology Combination Therapy

CD5-2 is a preclinical drug candidate which normalises tumour vasculature, leading to a more immuno-supportive environment, facilitating immune surveillance and tumour engagement. CD5-2 has potential applications as a combination therapy to enable and enhance a broad range of immuno-therapies, including checkpoint inhibitors (e.g., antiPD1), adoptive T-cell transfer therapies (e.g., CAR-T) and cancer vaccines. Summary (PDF)

Dynamin II Inhibitors: An Immuno-Oncology Adjuvant Therapy

An alliance of Australian institutions has developed an adjuvant therapy strategy for co-treatment with therapeutic monoclonal antibodies (mAbs); leading to reversal of tumour innate resistance, stimulation of antibody-dependent cellular cytotoxicity (ADCC) and enhanced efficacy, including in non-responders to existing drugs such as cetuximab and trastuzumab. Dynamin inhibitor co-treatment has the potential to significantly improve the outcomes and survival for the majority of patients that do not respond to mAb therapy alone. Summary (PDF)

Dynamin I Inhibitors for Refractory Epilepsy

A unique drug discovery program focused on modulation of the GTPase activity of dynamin isoform 1 for the treatment of epilepsy and other CNS indications. An extensive collaboration involving the Children’s Medical Research Institute, the University of Newcastle and the University of Melbourne has shown that inhibition of dynamin can prevent synaptic vesicle endocytosis (SVE), leading to anti-convulsant activity in industry standard in vivo epilepsy models. Summary (PDF)

Deflexifol: A 5-FU/leucovorin Formulation to Replace Current Standard of Care for Colorectal and Other Solid Tumours

FivepHusion is developing Deflexifol, an innovative 5-FU/leucovorin formulation, which allows their co-administration and is designed to replace current standard of care in solid tumour indications. 5-FU and leucovorin are chemically incompatible, requiring different pH environments for solubilisation, and are therefore administered separately in regimes that often fail to capitalise on their synergistic potential. Deflexifol resolves the 5-FU and leucovorin incompatibility, facilitates their co-formulation and allows their simultaneous dosing. Deflexifol is associated with significantly fewer side effects and equivalent or better pharmacokinetic and toxicological properties than the conventional standard of care. FivepHusion has participated in a pre-IND meeting with the FDA and has received advice that Deflexifol would be eligible for a Section 505(b)(2) NDA, potentially allowing for amarket debut in 2020. A Phase II clinical in colorectal carcinoma trial is planned. Summary (PDF)

JCU303: Preclinical Peptide for Chronic Wounds

A small peptide being developed by James Cook University for the treatment of difficult-to-heal and chronic wounds. JCU303 is a 24-mer peptide derived from Ov-GRN-1 protein, an ortholog of the human granulin protein that has a well-established role in inflammation, wound repair and tissue remodelling. It has potential for compelling medical utility in the treatment of a range of indications with large unmet clinical need, and blockbuster potential in the market for advanced wound care therapeutics. Summary (PDF)