Immune-therapy refers to a group of
treatments called biologics. Biologics have two main modes of action: flagging
and blocking. Antibodies that constitute immune therapy can work by flagging
the hidden cancer cells to the immune system, for example Campath attaching to
CD52 on T-cell leukaemia. Alternatively they can physically block a receptor,
negating proliferation signals in cancer cells. For example, Herceptin binds Her2
receptor on mammary cancer cells and blocks epithelial growth factor (EGF) from
activating a proliferation signal. These type of biologics have been designed
to target specific molecules on cancer cells and this approach is now being
replaced by more holistic approach which utilises the immune system.
Naturally, the immune system fights cancer. It is
only when the immune system does not detect developing tumours that cancer
prevails. For example, some of the side effects immune suppressants have are
malignancies, or the incidence of non-Hodgkin’s lymphoma in (immunosuppressed) HIV
patients. All of these indicate the role of the immune system in defending
against cancers.
But the immune system has a complex status quo to
keep. It has to attack pathogens, intrusions, and cancers, whilst at the same
time avoid attacking the body. To that
end, the immune system has to train itself through life to give rise to immune
cells that defend the body against pathogens and at the same time to rid itself
of immune cells that may attack healthy organs (which is what happens in autoimmune
diseases). The immune system has a complex mechanism with a lot of stops and
guards to assure its efficient and safe operation. Some cancers evolve to find
ways to utilise the stops and guards which provide immune tolerance to healthy
tissues in order to evade detection.
Now Scientists in several pharmaceutical companies
have chosen to try and kick start the immune system to fight cancer. Initial
research even involved using a bacterial infection to activate an immune
response that will kill the bacteria and then move on to the cancer. In the last ASCO meeting a more clever way to ‘switch-on’
the immune system has taken over with several products in late development. All
these new products target one or another of three molecules in the immune cycle
pathway. PD-1 (Programme Death-1), PD-1L (Programme Death-1 Ligand) and (Cytotoxic
T-lymphocyte associated protein 4 (CTLA-4). In this new approach, the
treatments target the immune cells and their inhibitory markers, instead of
attacking the tumour directly, once the immune system switches-on, it starts
fighting the tumours. These revolutionary class of treatments could be used in
various indications, because they are not cancer specific.
The main players in this field are BMS who have already launched Yervoy, an anti CTLA-4 antibody, and has an anti-PD-1 product in late stages (Nivolumab), which is currently being tested as a combination therapy with Yervoy in phase III trials. Additional competitors to enter the immune-cycle market are Merck (who received a breakthrough designation for their MK-3475), Teva/Curetech, GSK/Amplimmune and Roche who also received a breakthrough designation for their product.
The fact that so many companies chose to develop
treatments to target the immune cycle indicate its importance, as this means
that these treatments could be used to help in a wide variety
of indications. It also means that late stage cancers that
were previously untreatable because of a lack of specific therapies, can
now be treated. Moreover, the healthy competition that is likely to
arise through the introduction of several biologic treatments in this class, will
certainly have an effect on price, market access, and the uptake of each
product that will be licensed. We wait with baited breath for future
developments.
But with the potential for broad indications,
devising the right marketing strategy will become all the more vital to product
success.
We leave you with this question: How can these pharmaceutical companies create brand stories for their broadly licensed biologics that resonate with their key customers in each of the specific therapy areas?
We leave you with this question: How can these pharmaceutical companies create brand stories for their broadly licensed biologics that resonate with their key customers in each of the specific therapy areas?
In case you want to follow up
Merck’s MK-3475
Roche’s drug
MPDL3280A
BMS’ Nivolumab and Ipilimumab (Yervoy)
GSK/Amplimmune’s Amp-224
Teva/Curetech’s CT-011
This article
was written by Shai Senderovich, Research Executive at Branding Science