Nerviano Medical Sciences and Italfarmaco Announce Licensing of Linker-Payload Technology to Develop and Commercialize a Novel Peptide-Drug Conjugate

NERVIANO, Italy & MILAN--(BUSINESS WIRE)--Nerviano Medical Sciences S.r.l. (NMS), a clinical-stage biotechnology company member of NMS group, announced the signing of a license agreement with Italfarmaco S.p.A. (ITF), a specialty pharmaceutical company, to develop and commercialize a novel peptide-drug conjugate (PDC).

Under the terms of the agreement, ITF will use NMS’s proprietary linker-payload technology to develop a novel PDC product candidate. NMS has implemented linker-payload GMP manufacturing and supply at a CDMO referred by NMS. ITF will be responsible for generating the target peptide and all non-clinical, clinical, and commercialization activities related to any resulting proprietary product candidates. Financial details of the agreement have not been disclosed.

“NMS’s cutting-edge linker-payload technology will allow us to develop new peptide drug conjugates for the treatment of oncology indications with high unmet medical need, leveraging Italfarmaco’s state-of-the-art GMP peptide production capabilities,” stated Christian Steinkühler, PhD, Italfarmaco Group’s Chief Scientific Officer. “This is an important milestone in our mission to generate a highly diversified pipeline of innovative medicines.”

“We are pleased that ITF, a company with a long-standing heritage both from pharmaceutical and chemical sectors, has selected our linker-payload first platform for developing a truly novel peptide-drug conjugate. This is a significant step to broaden the applicability of our technology,” said Hugues Dolgos, PharmD, Chief Executive Officer of NMS and NMS Group.

NMS is focused on discovery and development of innovative cancer therapies based on proprietary kinase and linker-payload platforms, with approved targeted drugs licensed to pharma companies and proprietary innovative small molecule candidate drugs undergoing clinical studies. The development program will leverage NMS’s proprietary innovative linker-payload platform technology and ITF’s peptide-based oncology therapeutics technology. It will also allow NMS technology exploitation in conjugation with peptides. NMS’s linker-payload platform is carefully designed to generate more stable, efficacious, and safer drug conjugates to treat heterogeneous and chemotherapy-resistant solid tumors. The licensed linker payload includes optimized features, showing sub-nanomolar antiproliferative activity across a large panel of tumor cell lines and greater potency than MMAE and DXd (deruxtecan) in chemo-resistant cell lines expressing MDR system (Valsasina B. et al., Mol Cancer Ther 2023). In conjugation with targeting moieties, it shows an excellent therapeutic window and it is highly active in heterogeneous tumors thanks to the bystander effect, promotes immune system recognition of tumor cells to induce immunogenic cell death, and demonstrates activity in chemotherapy-resistant and poorly proliferating tumors.

About Italfarmaco Group
Italfarmaco Group is a specialty pharmaceutical company engaged in the discovery, development, manufacturing and marketing of branded prescription and nonprescription products in more than 60 countries on 5 continents. Italfarmaco Group’s research and development expertise is best demonstrated through its HDAC inhibitor development programs, addressing new therapeutic treatments of specialty and rare diseases. Through both marketed drugs and compounds in development, Italfarmaco Group is dedicated to serving patients whose needs remain largely unmet.

About Nerviano Medical Sciences
Nerviano Medical Sciences S.r.l. (NMS) is focused on discovery and clinical development of small molecule NCEs for oncology. We take innovative approaches on novel mechanisms of action and drug targets to bring first- and best-in-class personalized medicines to cancer patients. Our current pipeline consists of NCEs, which originate from our industrially renowned kinase inhibitor drug discovery platform comprising an ever-evolving chemical collection with broad intellectual property coverage, discovery know-how and technologies. Our kinase platform has enabled us to out-license IP rights on approved innovative medicines such as encorafenib and entrectinib and currently includes preclinical to clinical stage products, which are being developed both in house and with partners, including four proprietary clinical assets in Phase I/II studies. Moreover, the development of our payload linker platform allows an extension of our pipeline with innovative payload linkers for next generation ADC production.

NMS combines the flexibility of a biotech with the quality of a big pharma. Here, an experienced management team leads a highly skilled staff of professionals with a global vision and a broad range of expertise in drug discovery and development. We collaborate with academia and clinical investigators as well as industrial partners worldwide to advance our programs from early discovery to clinical development of new drugs. NMS signed a collaboration agreement with licensing option with Merck Healthcare KGaA for the next-generation highly selective and brain penetrant PARP1 inhibitor NMS-293 and, more recently the four target out-licencing of the linker-payload technology to Solve Therapeutics, Inc.

We seek further strategic collaborations to develop and commercialize our products in different territories as well as in-licensing opportunities of promising pre-clinical assets.

About NMS Group
NMS Group is the largest R&D company in Italy committed to the discovery and development of novel oncological therapies and through its three subsidiaries is the only institution able to manage the entire integrated R&D chain: from the first steps of the pre-clinical phase to the packaging of the finished product with more than 400 employees of whom more than half are highly educated individuals dedicated to innovative research, development and manufacturing.

NMS Group three subsidiaries are: NMS S.r.l., focused on discovery and clinical development of new drug for oncology at Nerviano (Italy) and Boston (US) sites, Accelera, one of the few Italian CROs capable of providing support through all phases of drug research and development, and NerPharMa, a CDMO owing a wide and cutting edge organizational structure able to manage and handle highly active compounds, and to ensure the full development and production of active principles and finished products.