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Additional	Information
Market:	ASX
Sector:	Pharma & Biotech
Epic:	.BNO
News:	Latest news
Web Site:	Bionomics Limited
Other Articles:	25-02-201002-02-201027-01-2010

Bionomics CEO confident anti cancer and anxiety clinical milestones can be reached in 2010

by Andrew McCrea

Bionomics CEO and managing director Deborah Rathjen reported at the Annual General Meeting that the company had achieved significant clinical milestones in 2009.

These had now broadened the commercial opportunities for each of its lead assets - the anti cancer compound BNC105 and the anxiety treatment BNC210 in 2010.

BNC105 –  for the treatment of solid tumours

The Phase I clinical trial objectives were met with BNC105.  Blood levels were consistent with vascular disruption activity (VDA) and with anti-tumour activity - with no complicating cardiovascular side-effects.

Other VDAs in development induce QTc prolongation – an undesirable effect on the heart - at their maximum tolerated dose levels.

BNC105 does not have these side-effects and confirms what the company had hoped from its preclinical profile – that it would have a greater therapeutic window than its competitors, in particular Combretastatin A4 (CA4) which is in Phase III for the treatment of thyroid cancer.

In addition to these results a BNC105 dose of 12.6mg/m2 was identified as a dose level which could be taken into Phase II clinical trials.

With the information derived from this successful trial of BNC105, Bionomics has decided to progress BNC105 into Phase II clinical trials initially in renal cancer patients.

Deborah Rathjen said BNC105 has the potential for use across a large number of solid cancer types including breast, lung, prostate, colon.  The strategy is to license BNC105 to a major player to take it eventually to market once Phase II clinical trial data has been received.

After consultation with Australian cancer doctors and oncologists in the US, a top 5 priority list was devised, it was decided the first Phase II clinical trial of BNC105 will be in patients with renal cell cancer (a form of kidney cancer).

Renal Cancer market

Significant medical need:

- Renal cancer - 3% of human malignancies
- 200,000 cases diagnosed worldwide each year (55,000 in the USA)
- Five year survival rate in metastatic disease <2%
- Renal cancer is asymptomatic - 40% diagnosed at late stage

First line current treatments are “blockbuster drugs”:
- Sutent (Pfizer) – Approved in 2006.  Doubling relapse-free survival from 5 to 11 months.  Market leader, with market shares of 40% and 60% in Europe and 59% in the USA. US$847M in worldwide sales in 2008.
- Nexavar (Bayer and Onyx) – Progression-free survival improved from 3 to 6 months.  Recent approval in Japan (January 2008). US$677.8M in sales in 2008, almost exclusively in kidney cancer. Anticipated sales US$850M in 2009 and US$1B in 2010.

Significant clinical unmet need exists today in the treatment of renal cancer with 200,000 diagnosed worldwide each year, 55,000 in the US. The 5 year survival rate is still a very low 2% or less for patients with metastatic disease and a significant proportion of patients are diagnosed with advanced disease.

First line treatments Sutent and Nexavar extend the period of progression free survival however despite initial benefit patients relapse, which potentially provides an opportunity for treatment with BNC105.

Both drugs have significant yearly sales – in excess of US$800M anticipated this year – largely from their use in the treatment of kidney cancer.

A very recent option for renal cancer treatment is Afinitor which is marketed by Novartis. Afinitor was approved for the treatment of renal cancer by US and European drug regulatory authorities this year and analysts are projecting peak sales of Afinitor from its use in renal cancer of over US$500 million.

With key data from the Phase I clinical trial now available, the near term risk of the company's leading asset has been overcome.  The company is confident of both the feasibility of renal cancer as an initial clinical trial setting for BNC105 and the commercial potential – Bionomics has contracted the Hoosier Oncology Group to undertake the first Phase II clinical trial of BNC105.

The Hoosier Oncology Group, which is headquartered in Indianapolis, has an extensive network throughout the US and is well placed to undertake this clinical trial.

BNC210 - anxiety treatment now in clinical trials

Bionomics gained approval and initiated the first human clinical trial of BNC210 – ahead of schedule. Recently, the company announced that the first stage of this clinical trial has been successfully completed.

The results obtained indicate that BNC105 is well absorbed with dose levels measured in the blood of trial subjects equal to that required to show efficacy in rodent models of anxiety.

The Phase I trial has been able to overcome a significant near-term risk for this key asset which has be shown to be safe and well tolerated.

Stage 2 of this study, will provide data on expanded evaluations of BNC210 effects, is due for completion by the end of this year.

A single dose proof of concept study in volunteers is due to begin next year, providing another significant step forward for the program.

Importantly for investors, the company has reported that licensing interest in BNC210 has "intensified". The strategy is to partner with Phase I data - process underway.

The anxiety market affects approximately 40 million adults in the US and nearly 1 in 10 Australians each year.  The anxiety market is worth an estimated US$15 billion.

Many of the largest current blockbuster drugs for treating anxiety are also subject to serious side-effects. The opportunity for BNC210 is significant to gain a significant market share - in a market where there have been no fundamentally new and effective treatments for decades.

In the space of less than 2 years the Rathjen said the Bionomics team had been able to progress two newly discovered drugs into clinical trials.

Illustrating the capacity of the company's powerful drug discovery engine to generate high value drug candidates, and also the disciplined approach employed to effectively to progress new drugs into the clinic.

The profile of BNC210 relative to current drugs used to treat anxiety, including Valium, Prozac and Buspar, has significantly increased.

In animal tests BNC210 shows no evidence of inducing sedation, addiction or memory loss. It is fast acting and the pharmacokinetics of BNC210 observed in our current clinical trial favor once a day dosing in humans.

Merck Serono

Bionomics has a partnership with Merck Serono in Multiple Sclerosis. The deal with Merck Serono was signed in June last year and has progressed according to the project plan developed jointly by Bionomics and Merck Serono.

While alot cannot be said on the partnership for commercial reasons, the deal with Merck Serono is potentially a lucrative one of Bionomics.

Merck Serono is a major player in the field of neurodegenerative diseases, including Multiple Sclerosis (MS).

The partnership is fully funded by Merck Serono and Merck must also contribute substantial internal resources to the joint effort. Under the deal Bionomics stands to earn up to US$47 million in development milestone payments for each selected compound as well as royalties on product sales of licensed compounds.

Bionomics has a partnership with Merck Serono in Multiple Sclerosis. The deal with Merck Serono was signed in June last year and has progressed according to the project plan developed jointly by Bionomics and Merck Serono.

Financial

Overall revenue for the June 30 financial year was $4.29 million. This reflects an increasing inflow of license fees and payments under the Merck Serono agreement.  These are expected by the company to become more substantial as the licensed compounds progress through clinical development and to market.

Neurofit income from contract research services increased by 108% to $1.94M.

Non R&D expenses were reduced by 27% - tight cost control, careful cost management.  Cash at 30 June 2009 was $4.76M.

However, cash levels have been significantly boosted since then by a major capital raising, now completed.

Milestones / News pipeline

Bionomics can reach a number of important value-add milestones over the next 12 months.

BNC105

- Initiation of Phase II renal cancer trial Q4/Q1, 2009/2010
- Contract to enter into second Phase II cancer clinical trial Q4, 2009
- Initiation of second Phase II clinical trial Q1, 2010
- Presentation of BNC105 clinical data at ASCO Q2, 2010
- Presentation of BNC105 data at AACR Q2, 2010
- Interim Phase II clinical data Q4, 2010

BNC210

- Complete Stage 2 of current Phase I clinical trial Q4, 2009
- Initiate second Phase I clinical trial Q1, 2010
- Complete second Phase I clinical trial Q2, 2010

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