(MENAFN- ProactiveInvestors)The chief executive of one of the world's leading drug companies took to the stage proclaiming humanity's battle with cancer was almost over thanks to breakthroughs being made in his lab. He said in the next decade fatalities would drop significantly with the disease managed as a chronic illness rather than imposing an immediate death sentence. That was 15 years ago. And as a journalist that fell for that piece of well-crafted sales and marketing spiel I've tended since then to be a sceptical if not a little cynical when I hear people promising huge advances in oncology. A lot has been written and said about a new field of medicine called immunotherapy which uses the body's own immune system to fight disease. And in some quarters it is being touted as spelling the end to cancer as we know it. These days I recoil when I hear the 'c-word'. Not cancer the other c-word: cure. Cure implies cancer is one uniform disease that can be taken down with a silver bullet drug. How many of those have crashed and burned in the last decade and half It also assumes the human body reacts in exactly the same way when plied with new small molecule treatment or biologic. However the commercial success of the first wave of immuno-oncology drugs such as Merck's Keytruda and Bristol Myers Squibb's Yervoy which are taking on blockbuster status suggests researchers are mining a rich vein. The excitement around the science of training the body to fight off cancer in the way it might a cold is reflected in the deals being done. Pfizer Novartis Merck and Bristol Myers have all been active recently deploying their riches to replenish frighteningly empty drugs pipelines with the most promising candidates created by the industry's minnows. There are two interesting points about the deal flow. First is the amount of cash being forked over. Upfront payments have ranged from US$80mln to an eye-watering US$850mln. That's a lot of dosh to get a foot in the door. The second point to note is just how early Big Pharma has become involved in these deals. The movers and shakers of the pharmaceuticals and biotechnology world tend not to look at drugs unless they have completed a phase II clinical trial. Yet at least four of the most recent transactions including Pfizer's US$345mln tie-up with cellectis have been done at the preclinical stage meaning there is no human data on the would-be treatment. Three more have been completed with the results of only a cursory phase I study in the bag. What does this tell us about the world of drugs development Well actually it is quite revealing. It says the large pharmas are falling over themselves to get into immuno-oncology because it is potentially a huge market. Competition for new innovations is driving up the price. So far so predictable for a spendthrift industry pre-occupied with fashion and fads. But this seeming willingness to take drugs candidates on at a riskier phase of their development also reveals that the regulatory landscape is changing. That's because bodies such as the US Food & Drug Administration appear more willing these days to fast-track the most promising treatments. So for instance a Merck PD-1 inhibitor a drug that activates the immune system to attack tumours was sanctioned in certain indications with just phase I data in only three years. 'The traditional regulatory paradigm is shifting' says Ian Walters chief executive of SalvaRx Group Plc (LON:SALV). A former senior executive at Bristol Myers he should know. He helped bring five blockbusters to market including Yervoy and Opdivo which use the immune system to fight cancer. At SalvaRx he and chief scientific officer Robert Kramer are using decades of knowledge and experience gleaned at big companies to bridge the gap between small entrepreneurial R&D firms and cash-rich potential benefactors. 'I know how big companies look at opportunities; I know the challenges when and where people skimp where they invest too much and where they don't need to invest to make these things well packaged for big pharma' Walters told Proactive Investors. The company joined the AIM market in March valued at around £13mln and has the multi-millionaire investor Jim Mellon as one of its backers. It owns 60% of iOx Therapeutics with the remainder held by the originators of the technology Oxford University and the Ludwig Institute for Cancer Research. And it recently paid £1.36mln for a 9.2% stake in Intensity Therapeutics which has developed an injection for solid tumours that has delivered some impressive pre-clinical results. The beauty of SalvaRx is it requires minimal funding to get it to the point where it is negotiating partnerships. Including the £1.95mln raised when it reversed into former oiler 3Legs it has an 18-month runway. Also worth noting is the amount that has been spent or is committed in research grants which is well in excess of the current value of the business. Looking at the science behind this whole area of immuno-oncology Walters compares it with driving a car. In order to move safely in the correct direction one needs to disengage the brakes apply the accelerator and steer the vehicle. The current crop of drugs such as Yervoy Opdivo and Keytruda remove the brakes and in some patients there is enough latent power to achieve the desired effect. iOx developments such as IMM 60 and IMM 65 apply the gas by stimulating the T-cells while IMM 65 and the Intensity technology create the antigens that do the steering. 'To have the maximum impact on the on the immune system you need all three' says Walters. 'We have these two components we can combine with an approved PD-1 inhibitor to take the foot off the brakes.' As mentioned earlier the Intensity product used in mice has given some remarkable results. Injected directly into large tumours it has not only eradicated them it has inoculated the animals against a recurrence of the cancer. In other words it has trained the immune system. If that can be replicated in man then it could lead to a significant advance in cancer treatment. Directly injecting the substance into the tumour means only a small amount of the drug is needed. So it is expected to 'non-toxic' to the normal tissue. The US FDA has agreed that researchers start with a 'clinically relevant' dose enabling them to assess efficacy at the same time as they evaluate the safety profile. This should make early studies 'very very efficient' says Walters. 'So I think we will have a good sense as to whether this is working and start discussions for partnering next year' he adds. A phase I/II trial is planned for IMM60 designed to treat melanoma and IMM65 for bladder ovarian lung and prostate cancers; this should be enough to provide data packages required to kick off partnering discussions. The structure of the listed company SalvaRx - parent company with operating companies separately below them - means that each drug or asset can dividend back to investors any capital gains made in partnering and commercialising a drug. In other words investors stand to benefit early directly from any clinical success. 'This is the type of return a venture capitalist gets to see; a public investor never gets to see it.'
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