OT-1096: Lead candidate in TNBC

OT-1096 is a next-generation small molecule immunomodulator targeting advanced metastasized triple-negative breast cancer (TNBC). Preclinical studies have shown positive efficacy. While TNBC is being targeted first, given today’s huge lack of effective treatment options, the aim is to be able to extend into other types of cancers in the future.

About triple-negative breast cancer (TNBC)

Triple-negative breast cancer (TNBC) is a subgroup of breast cancer, the second most common cancer in women. This aggressive disease is characterized by the lack of over-expression of the human epidermal growth factor 2 (HER2) in addition to the absence of progesterone and estrogen receptors. Because the cancer does not depend on these hormones to support tumor growth, the disease is resistant to hormonal cancer treatment and is unlikely to respond to the standard of care therapies.

TNBC is highly likely to recur and also highly diverse, or heterogeneous, which has limited the development of targeted therapies. This leaves the patients with few effective options, e.g. only combination cytotoxic treatments. In general, the prognosis of TNBC is very poor and the median metastatic survival is less than 12 months1.

Market potential

It is estimated that over two million patients were affected by breast cancer in 2018: of them, around 10-20% would historically test negative for both hormone receptors and the HER2 over-expressions2. The market to address these 200 000 – 400 000 patients who are in dire need of new treatments is expected to grow, due to the introduction of premium priced therapeutics specifically targeting the disease, and the launch of immunotherapies.

Extrapolating* treatment ratios, pricing structures and rates of diagnosis for projections of market growth in the seven major markets of the US, EU5 (Germany, France, Italy, Spain, UK) and Japan: the annual worldwide market for TNBC was USD 1-2 billion in 2018, and is expected to grow to USD 3-6 billion by 20243.

* Incidence of cases of TNBC are expected to be treated only in the initial 12 months.

1. Abramson VG, Lehmann BD, Ballinger TJ, Pietenpol JA (2015) Subtyping of triple-negative breast cancer: implications for therapy. Cancer, 121(1), 8–16 Link

2. The International Agency for Research on Cancer (IARC), 2018 Update on Globocan. Link

3. DataMonitor Healthcare Report – TNBC, Treatment, Epidemiology and Market forecast 2018.