Protecting the protector: The intersection of IP and Immuno-Oncology

Protecting the protector: The intersection of IP and Immuno-Oncology

Immuno-oncology is today’s cutting-edge cancer treatment. 

Immunotherapy uses the body’s natural immune system to fight cancer, rather than direct killing of cancer cells with chemo/radiation therapy which can lead to undesirable reduced immunity and may not prevent spread of the cancerous cells.
With the immune system having two main aspects (humoral, in which antibodies are responsible for the recognition and destruction of foreign bodies; and cell-mediated, in which T cells do this), immuno-oncology can use either or a combined approach for the treatment of cancer.
Immuno-oncology (also onco-immunology or cancer immunotherapy) harnesses the power and specificity of the immune system to treat cancer, promising a safe and highly effective personalized therapy. The promise is a process which treats cancer, including the elimination of micro tumours and metastatic cancer cells, preventing the recurrence of malignant tumours without harming healthy cells.

Future-proofing IP to save lives

With such promise of advancement in this field, and with lives at stake, who protects the protectors? And more importantly, how?
An integrated IP strategy should be employed, involving patent life cycle management, patents, patent term extensions (SPCs in Europe, with paediatric extensions also available), regulatory and data exclusivity and where available orphan drug protection, branding and even design protection.
The challenge of competitors’ market entry, freedom to operate and clearing the way are all essential aspects of the IP strategy.

Fighting against the world’s deadliest cancers 

Immunocore is a UK company that exploits the cell mediated immune system to provide first in class biological therapies to transform the lives of people with serious diseases. Immunocore’s main technology is a game changing bi-specific molecule; one part locating cancer cells in the body, the other part binding to the body’s own T cells which, when brought into close proximity with the cancer cell, kill them.  These bi-specific molecules are in clinical trials to treat some of the world’s top killer cancers, including melanoma, synovial, bladder, non-small cell lung, oesophageal, gastric, head & neck, bladder, breast, endometrial and ovarian cancers.
GITR (glucocorticoid-induced tumour necrosis factor receptor) agonistic antibodies to GITR have been reported to enhance both vaccine-induced and naturally-occurring tumour immunity.  European patent EP-B-2175884 was granted claiming a combination therapy employing a GITR agonistic antibody and a chemotherapeutic agent. A robust IP strategy was employed, involving convincing the EPO that the patent should not have been granted, enabling our client freedom to develop their GITR agonistic binding molecules for use in treating cancer in combination with chemotherapy. The result: our client can continue developing their promising therapy to treat cancer, which remains one of the world’s largest killers.   
Antibodies specific for CD25 (also known as Interleukin-2 receptor alpha) have been proposed to treat cancer for several years. Tusk Therapeutics (now a wholly-owned subsidiary of Roche), in collaboration with University College London and Cancer Research Technology, developed a new class of anti-CD25 antibodies with a novel mechanism of action.
These new antibodies are targeted towards the CD25 receptor but, crucially, still allow the CD25 ligand, IL-2, to bind and signal through it.  Hence these antibodies are known as “non-blocking” antibodies.  In this way, Tusk’s antibodies deplete regulatory T cells whilst increasing the effector T cell to regulatory T cell ratio, resulting in the improved control of established tumours. The importance of allowing the IL-2 signalling to take place in cancer therapy was not previously appreciated, meaning this new class of antibodies represents a potential first-in-class treatment for cancer in patients, in particular for solid tumours.
CAR-T therapy: Chimeric antigen receptors have shown great promise in treating cancer when inserted into a patient’s own T-cells. The resulting treatment is known as CAR T-cell or CAR-T therapy. The new medicine sold as “KYMRIAH” was developed at the University of Pennsylvania and licensed to Novartis. The medicine is acknowledged by the US Food and Drug Administration (USFDA) as a “breakthrough” therapy given the success rates in patients with various cancers.  The medicine is also authorised for use in Europe and approved in the UK for use by the NHS.

Conquering cancer

Rapid progress is being made in the immuno-oncology field, employing well-defined and data-driven approaches, designing the next generation of cancer treatment, that can save the lives of people suffering from serious diseases.
To realise the promise of immune-oncology in the commercial marketplace an integrated IP strategy is an integral part in protecting these truly transformational technologies and in doing so, protecting the lives of thousands of people.

For more information or advice, please contact our life sciences team or your usual Kilburn & Strode advisor.

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