26 Aug Immodulon Aims to Activate Both Arms of Immune System To Fight Broad Range of Cancers

MedicalResearch.com Interview with:
Dr Charles Akle, Chairman and
Dr. Linda Summerton, CEO
Immodulon Therapeutics
Short Hills, NJ 07078 and
London, UK

MedicalResearch.com: What is the background for Immodulon? Would you tell us a little about Dr. Charles Akle?

Response: Immodulon was established in November 2007. The founder and Chairman, Dr Charles Akle, was a Harley Street surgeon and pioneer of keyhole surgery who established Immodulon with the financial support of a former patient. His interest in immunology led him to the potential of cancer immunotherapy long before the term “immuno-oncology” was coined and when skepticism, rather than optimism was the norm.

His ambition from the start was to develop an affordable immunotherapy treatment that would transform the way that cancer is treated in the world today. Since then, Immodulon has become a leading, independent biopharmaceutical company with one of the longest running research projects into how to harness the power of the immune system in treating cancer. It also has its own R&D and manufacturing capability in Lyon, France.

The wider Immodulon senior team has extensive experience of bringing drugs to market and includes Dr James Shannon and Dr Jean Pierre Bizzari.

MedicalResearch.com: What is meant by immunotherapy? How is immunotherapy different from chemotherapy? What types of cancer can be treated with immunotherapy?

Response: Immunotherapy is a treatment for cancer which is designed to boost the body’s natural defenses to fight cancer. Our immune systems have two components; innate immunity – which is the oldest evolutionary protection system we have developed against foreign matter, and adaptive immunity – which is acquired and involves a learning process by the body’s immune system. Different immunotherapies tend to focus more on one of the two components, but Immodulon’s approach is slightly different (see below).

The types of cancer that immunotherapy can help treat can vary, but one of the most exciting things about it (and about Immodulon’s treatments in particular) is its ability to contribute to the treatment of particularly complicated forms of cancer, such as metastatic pancreatic cancer and advanced melanoma.

MedicalResearch.com: What is IMM-101? Is it related to early BCG vaccines for tuberculosis? How might it supplement treatment for pancreatic or other cancers?

Response: Immodulon’s flagship treatment, IMM-101 is a naturally-occurring, non-pathogenic (incapable of causing disease), heat-killed whole cell mycobacterium called M. obuense.

IMM-101 works by helping the body to identify the cancer cells it needs to fight, then tuning and modulating the body’s response and prompting the cells to respond to danger. In terms of its relationship with BCG vaccines, BCG is administered as an attenuated LIVE vaccine, aimed at inducing an immune response to shared mycobacterial antigens (M. bovis and M. tuberculosis) to induce protection against the development of tuberculosis mostly in its extra-pulmonary forms.

In contrast, IMM-101 is administered as a heat-killed preparation over a number of months, or even years, to modulate immune responses, prompting immune cells to respond to danger signals. It helps the body to amplify its response to the cancer while not inducing an overreaction that can destroy healthy cells, and it also helps the body to remember which cells it needs to fight in the future, working alongside other treatments to improve the overall outcome for patients.

IMM-101, differs from other treatments for cancer because it adjusts the level of the immune system’s response, thereby ensuring that the body does not ‘over-respond’, killing healthy cells as well as cancerous ones.

As such, IMM 101 is far gentler to the body than other treatments for cancer, including other immunotherapy treatments, and does not add a further burden to the patient’s health and quality of life. Side effects are limited to swelling and itching where the injection is administered, similar to a BCG injection. It also differs to more well-known treatments such as chemotherapy in its ability to tackle cancer cells on multiple fronts by triggering a range of reactions through the body’s pre-existing immune system.

IMM-101 is used alongside existing treatments, such as chemotherapy and radiotherapy, to make them even more effective. Whilst some immunotherapies focus only on adaptive immunity, IMM 101 helps the body to improve both innate and adaptive immunity making it even more effective.

MedicalResearch.com: Is there anything else you would like to add?

Response: Results to date:

Clinical studies indicate that IMM-101 has a potentially transformational impact on survival rates for cancer.

In 2010, IMM-101 was evaluated in a Phase 1 trial, which tests what a drug does to a patient’s body and how well it is tolerated. Of 18 patients with advanced melanoma where the disease had spread to the patient’s other organs, all tolerated the administration of IMM-101 well.

The unexpected result of this extended Phase 1 trial, however, was that six patients are still alive more than five years later. This is a 5-year survival rate of 33% and is exciting because it is comparable with leading approved immunotherapy treatments, but without adding to toxicity levels in the body and shows that IMM-101 has the potential to be used in combination with other treatments, further enhancing their impact on patient outcomes. Sadly, historically only approximately 10 out of 100 patients survive 5 years with this condition.

In 2013, IMAGE-1, a Phase 2 proof-of-concept study of 110 patients with locally advanced or metastatic (where cancer has spread to other parts of the body) pancreatic cancer was initiated. Patients were given the chemotherapy drug gemcitabine with and without IMM-101.

The study was designed to provide indicative rather than definitive efficacy results, but exceeded expectations by providing promising overall survival results as well as very limited additional side effects in the patients treated with both agents as compared to those receiving gemcitabine alone. The analysis showed a 70% (3.1 month) increase in survival for patients receiving IMM-101 in combination with gemcitabine (chemotherapy) against the gemcitabine alone standard of care.

The results of the Phase 2 study are soon to be published in the prestigious British Journal of Cancer (Dalgleish et al, BJC 2016, in press).

Coming up:

Building on the success of the Phase 1 & 2 trials of IMM-101 outlined above, Immodulon is now focusing on completing a Phase 3 trial of IMM-101 in the treatment of metastatic pancreatic cancer in approximately 350 patients, so as to bring IMM-101 to market in both Europe and the US.

In addition, Immodulon is planning additional trials to be run in parallel, to be announced in the coming months. One such trial is an innovative basket trial to test IMM 101 in combination with a wide range of other cancer therapies. The first patient will enter the trial over the autumn of 2016 and the study aims to recruit 100 patients per year for the next three years.

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Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Last Updated on August 30, 2016 by Marie Benz MD FAAD