On October 6, 2008 Oncalis AG (Oncalis), a privately-owned Swiss biotechnology company, and ChemDiv Inc. (ChemDiv), a privately-owned, California-based discovery services company reported that they entered into an exclusive agreement for a license to Oncalis a family of PI3K inhibitors (Press release, Oncalis, OCT 6, 2008, View Source [SID1234521054]). ONC-201, the first development candidate from this family, is a potent and selective orally-bioavailable member of a new class of drugs targeting PI3-kinase. ONC-201 has demonstrated highly promising anti-cancer efficacy in pre-clinical cancer models.

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Under the terms of the agreement, Oncalis receives a family of compounds targeting different forms of PI3-kinase (PI3-K). PI3-K is an enzyme known to be important in cancer disease progression and potentially in the regulation of certain immune and inflammation-related diseases. The potential of PI3-K inhibitors has been recently confirmed by advancing development programs from top-tier pharmaceutical companies with this class of compounds. Under the terms of the agreement ChemDiv will perform R&D activities for Oncalis’ lead compounds. Financial terms of the agreement were not disclosed.

Commenting on the license, Dr. Didier Coquoz, CEO, and Dr. Alcide Barberis, CSO/COO, said that "the in-licensing of the PI3-kinase program represents a major evolution for Oncalis, a company dedicated to the development of oral inhibitors of kinases for the treatment of cancer. This program expands Oncalis’ internal portfolio and we are extremely excited to successfully move ahead with the development of the PI3-kinase inhibitor ONC- 201 in addition to the triple RAF/EGFR/EPHB4 inhibitor ONC-101. We aim to enter clinical trials within the next two years with very promising new anticancer drugs in an extremely promising segment of oncology treatment".

"ChemDiv successfully provided research services to Oncalis over the past two years. We are excited about this new collaboration with our established partner. I am pleased that Oncalis shares our enthusiasm for the therapeutic potential of PI3-kinase inhibitors and ONC-201 in particular for multiple cancer indications," said Dr. Nikolay Savchuk, President and CEO of ChemDiv. "Oncalis has a significant development and business expertise in oncology which we believe will help accelerate the development of these novel small molecules designed to inhibit the important cancer and inflammation related PI3K-Akt pathway."

On September 29, 2008 Cancer Research UK, Cancer Research Technology (CRT) – the charity’s development and commercialisation arm – and Astex Therapeutics Limited reported that they have agreed to take into development a potential new anti-cancer treatment (Press release, Cancer Research Technology, SEP 29, 2008, View Source [SID1234523360]).

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AT13148 – a protein kinase B inhibitor* – is the second drug to enter the charity’s Clinical Development Partnerships (CDP) programme. This deal follows the first CDP agreement with AstraZeneca** in May 2008.

The CDP initiative was set up in 2006 to advance promising anti-cancer agents into the clinic – offering companies with compounds an alternative model to traditional out licensing by allowing them to retain rights to the compound throughout the development process.

Under the terms of this new agreement, Cancer Research UK’s specialised Drug Development Office will carry out further development work on the agent. Some of this work will be undertaken by The Institute of Cancer Research and if successful it will be taken into phase I clinical trials at the Royal Marsden Hospital.

Dr Victoria John, head of clinical partnerships at Cancer Research UK, said: "We’re very excited to be entering this deal with Astex Therapeutics. This agent has been identified as a promising development candidate, which has the potential to impact on a wide range of cancers. Entering into this partnership is an excellent example of how the charity can work with industry to help bring much needed new treatments to cancer patients."

This work will be funded primarily by Cancer Research UK with the charity receiving a share of any revenues including a royalty on sales. The molecule was originally discovered by scientists on the PKB drug discovery programme, a collaboration between Astex Therapeutics, CRT and The Institute of Cancer Research, which ran from 2003 through to 2006.

Harren Jhoti, Astex Therapeutics’ chief executive officer said: "This agreement with Cancer Research UK builds on the previous PKB drug discovery collaboration with The Institute of Cancer Research and CRT, which began in 2003 and first identified this agent.

"Astex Therapeutics is committed to the discovery of small molecule drugs and we already have a number of our candidate agents in development with pharmaceutical companies across the world. Given the productivity of our drug discovery approach, the challenge for Astex has been to find innovative ways to continue to fund the development of all of our compounds and the CDP programme clearly addresses that constraint. Our history of working with Cancer Research UK on AT13148 means they are uniquely placed to partner with us on the development of this potentially exciting new treatment and we await the outcome of their work with interest."

Dr Keith Blundy, chief executive of Cancer Research Technology, said: "We’re very pleased to be entering our second CDP agreement this year and this deal presents us with an opportunity to take forward an exciting new development candidate. Pharmaceutical and biotechnology companies have to prioritise which agents they take into clinical development and this agreement highlights the benefits of collaborating in research efforts to advance the development of new cancer treatments."

On July 31, 2008 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, reported it has agreed a non-exclusive licence with ArcticDx Inc. for the development of a Colo Risk test to help health professionals determine an individual’s predisposition to developing colorectal cancer (Press release, Cancer Research Technology, JUL 31, 2008, View Source [SID1234523362]).

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The agreement allows for some results from Cancer Research UK funded genome-wide association studies* to be integrated into the risk assessment technology. It is hoped this Colo Risk technology – which is currently in development – will prove effective in assessing people who may be at higher risk of developing bowel cancer so they can receive tailor-made screening and lifestyle advice.

The technology will be based on recent genome-wide association studies which were the first to identify a number of common ‘genetic variants’ that increase bowel cancer risk. These are known as single-nucleotide polymorphisms (SNPs). SNPs appear more frequently in the DNA of people who have developed bowel cancer than of those free from, or at low risk, of developing the disease.

Greg Hines, chief executive officer of ArcticDx Inc. said: "With eight years expertise in the field of in vitro diagnostics development, we’re well placed to take forward these findings and combine them with work we have already done to process information on other risk factors such as age and body mass index which we know also contribute to increased risk of developing the disease. This saliva-based test will be commercially available by the end of this year."

As part of this licensing deal, CRT will receive an upfront payment as well as royalties on any sales.

Dr Phil L’Huillier, CRT’s director of business management, said: "We are committed to ensuring that the most promising findings in the field of cancer research are developed into technology that can be used to fight cancer. This licence agreement with ArcticDx Inc. incorporates important genetic findings into potentially workable technology which could help identify and manage people at higher risk of bowel cancer – it’s an exciting development."

On July 22, 2008 Following a thorough review that concluded late yesterday, the Board of Progen Pharmaceuticals Limited reported that it had discontinued the PI-88 phase 3 study in liver cancer (Press release, Progen, JUL 24, 2008, View Source [SID1234519617]). Progen confirmed its strategic direction to develop its existing portfolio of compounds and the company will actively seek to acquire additional compounds and opportunities through Merger & Acquisition activity.

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The strategic review was triggered by a recent accumulation of a number of factors that impacted the commercial return for the phase 3 PATHWAY trial.

The trial is unlikely to meet the forecast patient recruitment timetable and further significant delays were expected due to:

— slower than expected regulatory processes in China, Korea and Vietnam;

— slower than expected initiation of clinical sites;

— slower than expected recruitment of patients into active sites; and

— the recent launch of a competitive phase 3 trial, assessing Bayer/Onyx Nexavar(R) in the same indication.
Due to a lack of a global partner willing to meaningfully develop and commercialise PI-88, the commercial opportunity is much less than previously expected. Without a significant global partner contributing, Progen will be less able to expand into additional indications and exploit all potential PI-88 commercial opportunities.
These aspects would have delayed market entry significantly and seriously impacted on the commercial return of the phase 3 PATHWAY trial.
The next step is that Progen will seek expressions of interest in PI-88, at a regional level, initially from amongst those parties that had entered into Non-Disclosure Agreements and Due Diligence on PI-88.
The PI-88 trial had been facilitated through external agencies, and had resulted in 23 sites being opened for patient recruitment and 12 patients from 5 recruitment centres having been recruited to date. Existing patients receiving PI-88 will continue to receive the drug if they wish to do so, subject to regulatory approval. External costs of the trial in FY2008 are estimated at $9.8m. The cost of discontinuing this trial is estimated to be less than $4.0m.
As part of the strategic review, Progen has determined that the current phase 2b melanoma trial, will be completed but no further development in melanoma by Progen is anticipated at this stage. This trial is expected be finalised at an estimated additional cost of $300,000.
In addition, and as part of the strategic review, the Company has also decided to terminate further development of its phase 1 compound PI-166, based on a recent commercial assessment of the market and the approval of Nexavar(R) in this indication.
The Board of Progen has determined that it will increase its focus on the further development of molecules with high potential value.
Progen will focus its resources on aggressively pursuing its other compounds in development PG11047 (phase 1), the 500 series (late preclinical) and the epigenetics platform (early preclinical).
— Progen has previously announced the phase 1 trial of compound PG11047, for patients with advanced cancers, which had been the subject of an earlier phase 1 trial. This extended trial is already showing positive tolerability/dosing profiles.
— The 500 series is currently undergoing scale-up manufacture and animal safety studies.
— The Board of Progen has confirmed that it will continue to expand its gene expression modification – epigenetic – compounds platform, added to Progen’s technology platform through the CellGate acquisition.
In parallel, the Company will be actively pursuing merger and acquisition opportunities to expand its clinical stage pipeline.
Given its strong cash position, Progen will aggressively pursue M&A activities. As part of this process, Progen will announce in the next weeks the appointment of corporate advisers to assist with the identification of and initial discussion with potential acquisitions in Australia and the United States.
Cash Position as at 30 June 2008: $76.7m, excluding creditors and accruals of $6.2m (unaudited).

About Progen: Progen Pharmaceuticals is a globally focused biotechnology company committed to the discovery, development and commercialization of small molecule pharmaceuticals primarily for the treatment of cancer. Progen has built a focus and strength in anti-cancer drug discovery and development. Progen targets the multiple mechanisms of cancer across its three technology platforms, angiogenesis, epigenetics and cell proliferation. Progen has operations in Australia and the US.

On July 9, 2008 ValiRx plc (AIM:VAL, ‘ValiRx’), the cancer therapeutics and diagnostics company, reported it has secured a one year exclusive evaluation license from Cancer Research Technology Limited ("CRT") to a potentially significant new prostate cancer compound that has been shown in preclinical testing to successfully arrest prostate cancer growth in vivo (Press release, Cancer Research Technology, JUL 9, 2008, View Source [SID1234523377]). During the evaluation period ValiRx has an exclusive option to acquire worldwide exclusive rights in the cancer field.

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The Directors believe the compound – to be called VAL 201 – has the potential to add significant value to the Company in the near to mid-term as it has already been shown in preclinical trials to stop the growth of prostate cancer in situations where tumours are unresponsive to other treatments.

Currently, prostate cancer is the most common cancer amongst men with 35,000 men being diagnosed and 10,000 deaths each year in the UK. The estimated value of the global prostate cancer market is approximately USD3 billion.

Under the terms of the agreement with CRT, ValiRx will be responsible for performing the pre-clinical regulatory development of VAL 201 in readiness for entry into human trials. Once the option has been exercised, ValiRx will receive an exclusive licence to the compound and control the commercialisation and the process thereafter.

Satu Vainikka, CEO of ValiRx, commented: "This agreement extends further our relationship with Cancer Research Technology and expands our portfolio of late pre-clinical compunds."

Dr Phil L’Huillier, CRT’s director of business management, said: "We are very pleased to enter into an agreement for ValiRx to take forward into preclinical development this promising compound for the potential treatment of men with hormone resistant prostate cancer."