Could you introduce NMS Group and its affiliate companies?

NMS is one of the largest kinase inhibitors-focused oncology drug discovery companies in Italy, and one of the early pioneers of the technology in the mid-1990s. The group is made of three entities: NMS Oncology is the drug discovery and development arm of the group, made of about 140 highly skilled scientists; Accelera is our R&D-enabled company, supporting all stages of drug discovery and development for our own pipeline, as well as externally. Finally, NerPharma is a small but fully-fledged API and CMO company, providing scale-up and development of the synthetic route of APIs and FDFs. Today, we are about 420 people in the company, 80% of which have been with us for over a decade.

Could you walk us through some recent milestones?

Since becoming an independent company in 2010, NerPharma developed and manufactured innovative drugs like Eribulin with EISAI, Cladribine with Merck, Encorafenib with Pfizer, and Entrectinib with Roche. Eribulin recently received authorization in China, and Entrectinib entered the American and Japanese markets in 2019, and the European one in 2020.

In 2017, Shanghai-based Hefei SARI bought a 90% holding in NMS. The acquisition and newly injected financial resources allowed NMS to change its previous business model from that of early out-licensing of products to embarking much more comprehensively in the independent clinical development of our pipeline. The period 2019-2021 has seen the opening of clinical trials for the molecules NMS-088 (multikinase inhibitor), NMS-293 (PARP inhibitor), NMS-153 (MPS-1 inhibitor) and NMS-812 (PERK inhibitor), all targeting different BIC/FIC mechanisms, and with multinational clinical development programs taking place in Europe, the US and in China. 

What are NMS’s strengths in kinase inhibitors and ADCs?

Kinases, over 1000 of them, are the largest classes of enzymes, and they are involved in the cell cycle, including the oncogenesis - or the malignant proliferation of cells. Therefore, kinases control the body’s inflammatory and immunological reactivity by controlling the gene expression. NMS has been a key institution in antibiotics like Anthracycline, which is still used today for treating cancers. Our kinase platform comprises more than 100 biochemical assets.

Meanwhile, we are also developing a proprietary payload platform for the generation of novel ADCs (antibody drug conjugates). ADCs are extremely potent and selective biopharmaceuticals designed to specifically target cancer cells. Our scientists developed a library of about 80 chemotypes, which expand to a total of 150,000 end-to-end analogues and intermediates. Because of the high toxicity of chemotherapeutic agents, their side effects are unbearable for many people; ADCs have more targeted toxicity against cancer cells. NMS capitalized on our experience in cytotoxic drug discovery to create new toxins tailored to ADC production.

What are your thoughts on Italy and Lombardy as a drug development base?

Italy has a long-standing history in medicine. Today, it has top-tier universities associated with hospitals, and very gifted doctors and scientists. Our clinical teams interact with doctors and medical centers for patient access in clinical trials. However, Italy cannot compete with the US, Japan, China, or other European countries, because it doesn’t have a large innovative pharma industry, though the government looks to strengthen this sector.

We are lucky to be located in Lombardy, which is a cluster for centers of excellence. For the discovery and validation of TRK fusions of our Entrectinib in colorectal cancer, we collaborated with Niguarda Cancer Center in Milan; the result was the development of one of the first precision medicine drugs with agnostic indication.

What is your pipeline strategy and vision going forward?

My mission is to rejuvenate NMS by revisiting both early and late-stage pipeline strategies. For what goes into the pipeline, it’s worth looking at targeting agents and generate more value. We are also exploring the possibility of drug discovery in non-oncology indications. Overall, we are shifting the business model to carry the project later in the development phase through to PLC (proof of concept) or Phase 2 clinical trial, at which stage we can look for a global pharma partner. The second priority is China: Taking note of interethnic genetic differences, we started to focus on cancers that are more common in Asia, such as lung, liver, and stomach cancers.

With the royalties picking up, we will be self-sufficient in about 3-5 years and we can look into new areas of research, completing the transformation of the company. Our vision is to be self-standing, with a healthy pipeline and healthy financials. In the future, we don’t exclude an IPO.