The next 12 months should deliver some timely progress for German biotech Affimed Therapeutics. The private company is expecting data from a phase I trial of its experimental antibody treatment AFM13 for Hodgkin’s lymphoma by the end of the year and is set to put a second product for non-Hodgkin’s lymphoma into the clinic in 2013.
It is hoped that this much needed movement in clinical development could start to get the company, which is underpinned by its novel TandAb antibody platform, not only a fresh set of investors, but ultimately partnering interest from a large pharma player.
One of the role models that Affimed must surely be hoping to emulate is Micromet, which earlier this year accepted a $1.1bn offer from Amgen over its novel BiTE antibody technology and in particular blinatumomab, its drug for advanced acute lymphocytic leukaemia (Amgen BiTEs at the chance to buy Micromet, January 26, 2012).
Speaking to EP Vantage Adi Hoess, Affimed's new chief executive, reveals the group is set to decide in the next month whether to bring on new investors to help fund planned clinical work. “There is significant interest now from investors, maybe driven by the Micromet sale.”
If new investors are found - the group is believed to be in talks with a number of interested parties - they will be joining existing investor's including aeris Capital and Novo A/S. Mr Hoess says they are hoping to raise between €25m-€30m for what would be a series D funding.
This money would be used to not only complete the current phase I trial for AFM13, but also kick start development of the group’s biggest hope for success, AFM11, a pre-clinical antibody for non-Hodgkin’s Lymphoma a much larger and lucrative market.
Affimed’s TandAb technology produces bispecific antibodies that have two binding sites for each antigen. They work by targeting the CD16A receptor on natural killer cells and the CD3 receptors on T-cells to stimulate a natural immune response to cancer cells. It is thought that this action could make TandAb antibodies more potent than older style antibodies.
The first indication of the technology’s potency will be revealed at the end of the year when AFM13 reports results in Hodgkin’s patients who have lapsed on at least two prior treatments. Alongside safety and tolerability, activity and signs of efficacy are also being measured.
But progress in getting AFM13 to even this fledgling stage has been slow, something that Mr Hoess readily admits. He points to the time of Affimed’s formation as one of the reasons behind the delay. “The company was established in 2000 in the time when funding for European biotech industry disappeared. Over the first seven years the company only raised €7m, so at that time the company really spent its efforts to develop antibody libraries and screen antibodies from libraries,” he says.
More recently the group was hindered by problems scaling up quantities of AFM11 for clinical trial, an issue that has now been resolved.
This slow rate of progress could have been the impetus for the catalysts that have recently happened in the boardroom. It was announced last September that Mr Hoess, then chief commercial officer, and chief executive Dr Rolf Guenther would be swapping roles.
The moves play to Mr Hoess’s strengths in commercialisation and Mr Guenther’s in clinical development. Mr Hoess' move up the corporate ladder came a mere six months after his initial appointment as chief commercial officer. “It’s a normal natural evolution that we are now more driven by the commercial aspect,” he says.
The next steps
This focus on commercialisation is hoped to bring both AMF13 and AMF11 to a “value inflection point” by 2014. By this time both drugs should have revealed their safety profiles, in the case of AFM13 both safety and efficacy, following another 18-month phase II study. It is also the point when the group will start to look for partners.
Given that phase I deals are not uncommon now, particularly in oncology, and the fact that Affimed is one of the few remaining independent cancer antibody groups, some have questioned why partners have not emerged before now.
It is a criticism that Mr Hoess is keen to dispel. “Things have changed in terms of the attraction of Affimed there is much more interest and companies are looking much deeper into the technology.”