In January, Scancell Holdings Plc. (LSE:SCLP.L) announced an important collaboration with the Addario Lung Cancer Medical Institute (ALCMI
) and the Addario Lung Cancer Foundation (ALCF
). The joint work will help develop Scancell’s second ImmunoBody platform agent SCIB2 for treating non-small cell lung cancer (NSCLC).
Lung cancer has the highest death rate of any cancer with an estimated 156,000 deaths in 2017, according to the American Cancer Society. NSCLC comprises the vast majority of this total, with about 85% of new cases. Chemotherapy is less effective in NSCLC and survival rates are generally low compared to other cancer types, further incentivizing the search for alternative therapies including immunotherapy and vaccines. The need for more effective therapies sets the stage for important joint efforts between biotechnology companies and patient-centered organizations.
Scancell is currently developing plasmid-delivered cancer vaccines that stimulate both parts of the cellular immune system: the helper cell (CD4+) system where inflammation is stimulated at the tumour site and the cytotoxic T-lymphocyte or CD8+ response where immune system cells are primed to recognise and kill specific tumour cells. The two leading vaccines employing this mechanism of action are SCIB1 and SCIB2 which have been developed using the ImmunoBody platform.
Scancell’s first ImmunoBody, SCIB1 is being developed for the treatment of melanoma. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumor load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence. Scancell is now in the process of launching a US based clinical trial in which SCIB1 will be combined with a checkpoint inhibitor in patients with late stage melanoma.
They are also developing a follow-up ImmunoBody vaccine coded SCIB2, which targets the lung cancer antigen NY-ESO-1. The agent is able to stimulate immune responses using specific lung cancer antigens and, it is hoped, lead to improved survival rates for NSCLC patients. This focus on lung cancer and cutting edge technology created a natural alignment between Scancell and ALCMI/ALCF. In addition to emphasis on the disease, the deep reach of Addario into the research community and its contribution to patient support places them in a crucial position to help design and develop the first in-man trials for SCIB2 in patients with NSCLC. Additional help with recruiting investigators and development of protocol based on key opinion leader input will lend valuable benefits to the process. The combination trial with SCIB2 and pembrolizumab or another checkpoint inhibitor is anticipated to begin in 2018 and last for 18 months.
ALCMI and ALCF were founded by Bonnie Addario, who is a lung cancer survivor, and her husband Tony Addario. The two groups work toward identifying promising treatments for lung cancer and introducing them to patients as quickly as possible. Bonnie and Tony’s background in business has created a well-run organization that serves to increase survival in lung cancer patients. Their work has helped develop a scientific and medical board, a strong fundraising presence, and a seat at the table in many of oncology’s principal organizations.
There are a number of ways in which the relationship with Addario can bring additional attention and resources to bear on Scancell’s technology. The Institute and Foundation have deep relationships with thought leaders and with physicians that can recruit and treat patients. One of the primary goals of the collaboration will be to introduce Scancell’s technology to partners globally and to introduce Scancell at many American Society of Clinical Oncology (ASCO) events such as satellite meetings at symposia and public discussions.
ALCMI has a team of investigators that are associated with a wide range of institutions in the US and Europe that are integrated into the lung cancer research space. Connections with scientific leaders, clinical associations and government agencies are helpful in optimizing the process to enter drug candidates in clinical trials and ensure they are designed to anticipate the needs of approving regulatory bodies. These relationships open up a diverse lung cancer population that can be a source of enrollees for the upcoming trials for SCIB2. The intimate knowledge and database of patient information will allow the trial to be designed with a high degree of selectivity and to enroll quickly. ALCMI and ALCF both have a broad following of friends, family members and stakeholders in the lung cancer community who can quickly spread the word regarding new and potentially revolutionary therapies.
ALCMI efforts to increase collaborations among academia, laboratories, bio-pharmaceutical companies and other stakeholders have yielded results in many areas. Just in January, ALCF partnered with Antidote, a service that allows patients and trials to be easily matched. The tool is able to screen for disease, location, inclusionary and exclusionary characteristics as well as other factors potentially providing a useful database that can help populate clinical trials.
These relationships are valuable in that they can help identify specific populations of lung cancer patients and help develop clinical trial protocols that will be recognized by physicians and regulatory agencies in terms of relevant endpoints and study construction.
Scancell has been fortunate that its vaccine technology has shown sufficient promise to attract the attention of the ALCMI and ALCF leading to what we believe will be a fruitful collaboration. Exposure to stakeholders in a variety of areas, combined with expert guidance on trial design and access to vetted clinical trial enrollees are valuable advantages from this relationship with Addario.
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