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Servier and Nerviano Medical Sciences announce the entry of S 81694, an MPS1 inhibitor, in a first in Human clinical trial
Surenes (France), and, Nerviano, 24th September, 2015 – Servier and Nerviano Medical Sciences together announced today the start of a first in Human clinical trial of the drug S 81694 (NMS-P153), an inhibitor of the mitotic checkpoint kinase MPS1 discovered by Nerviano Medical Sciences and thereafter acquired and further developed by Servier.

The study is an open-label, non-randomized, multicenter international trial in patients with advanced or metastatic solid tumors who have failed previous therapies. An initial dose-escalation stage will be followed by expansion in specific solid tumors. The study is designed to confirm the safety and pharmacokinetics of S 81694, administered as a single agent. Secondary objectives include initial assessment of efficacy and determination of the recommended dose for phase 2.
Servier is the sponsor of the study, which is being conducted in Belgium and The Netherlands by Nerviano’s clinical affiliate Clioss. S 81694 is supplied by Nerpharma, the CMO affiliate of Nerviano.
Jean-Pierre Abastado, Ph.D., Director of the Oncology Innovation Therapeutic Pole at Servier, said: “We are very enthusiastic about the initiation of this study as S 81694 (NMS-P153) is a novel potent inhibitor of MPS1. MPS1 represents an original target overexpressed during the M phase in many types of cancers. S 81694 is highly selective for MPS1 and a brief exposure to S 81694 is sufficient to commit cancer cells to death”.

Emmanuel Canet, M.D., PhD, President of Servier R&D stressed that “With the entry in clinical phase of this new antitumoral compound, Servier is reinforcing its commitment to provide innovative therapeutic solutions for unmet needs in patients with serious illnesses”.

Arturo Galvani, Ph.D., Director of Drug Discovery at Nerviano Medical Sciences commented: “we have been working together with Servier, a company engaged in cutting-edge research in oncology, in an outstanding collaboration to successfully advance S81694 to clinical development and hope that this first step will further translate into clinical benefit for patients with cancer”.

About MPS1:
MPS1 (also known as TTK) is a conserved kinase which is highly expressed in a number of human tumors of different origin. MPS1 plays a critical role in the control of a stage of the cell division cycle known as mitosis. During mitosis, MPS1 is involved in regulation of the spindle assembly checkpoint, a mechanism required for chromosome alignment and segregation. The activity of this checkpoint has been shown to be up-regulated in aneuploid tumors, comprising approximately 90% of solid and 70% of hematological cancers. In accelerating mitosis, MPS1 inhibitors have a novel mode of action as compared to currently available drugs targeting this stage of cell division.









Ignyta announces phase 1 clinical trial data for Entrectinib
Nerviano, June 1, 2015 - Well tolerated, with no drug-related serious adverse events. Recommended phase 2 dose determined. 91% response rate in patients meeting expected phase 2 eligibility criteria  (see Ignyta press release).
Nerviano Medical Sciences: new personalized treatments active on acute myeloid leukemia, gastrointestinal and female tumors, with innovative...
Nerviano, April 21, 2015 - Efficacy in leukemia with no cardiotoxicity or ‘gatekeeper’ mutation resistance for NMS-P088. Several opportunities among PARP-1 inhibitors, active in breast and aovary tumors with BRCA1 e BRCA2 mutation. Presented the establishment and characterization of a chordoma cell line, relevant for the knowledge of this rare cancer and the research of new therapies.

Nerviano Medical Sciences presented at the American Association for Cancer Research annual meeting in Philadelphia efficacy and tolerability data of new candidates treatments of acute myeloid leukemia and gastrointestinal, breast and ovary cancer, acting as potent inhibitors of tumor cells growth through specific molecular targets.

The molecule NMS-P088 - developed entirely in Nerviano laboratories - is a potent and selective inhibitor of both kinases FLT3 and KIT, whose mutations are involved in the pathogenesis of acute myeloid leukemia (AML), gastrointestinal stromal tumors (GIST), as well as other solid tumors including specific melanoma subtypes.

Nerviano Medical Sciences commitment in research new treatments for acute myeloid leukemia is answering to an important unmet clinical need. In fact, no therapeutic treatments for AML are approved for patients, often young people, presenting the FLT3 kinase constitutively activated and not responding to chemotherapy.
On this regard, new evidences presented at Philadelphia show that in this disease NMS-P088 has an excellent and selective inhibitory activity of tumor growth, associated to a good tolerability profile and a good synergy with chemotherapy that suggest, therefore, a possible and more effective combination with standard chemo treatments.

In GIST NMS-P088 has demonstrated to be more active and powerful, even at lower doses, than current approved treatment.

On the whole, the profile of NMS-P088 has showed to not generate cardiotoxicity including QT prolongation and to not develop resistance to ‘gatekeeper’ mutation (as usually occurs in patients presenting this specific mutation, becoming resistant to all kinase inhibitors approved).
Studies, preparatory for clinical phase beginning, are being completed.

A further research line of Nerviano Medical Sciences presented at AACR meeting is related to PARP enzyme inhibitors, which are involved in the replication and reparation of DNA, also effective, for example, in the treatment of breast and ovary tumors with BRCA1 and BRCA2 mutation.

Among these inhibitors, those active for PARP-1 and able to not inhibit simultaneously PARP-2 are resulting more effective in terms of better ‘Time To Progression’, thanks to their excellent pharmacokinetic profile. Moreover they show a better toxicity profile compared to the only one currently approved for relapsing BRCA ovarian cancer.

Studies on different origin cell lines, including those with the BRCA mutation and those resistant to standard chemotherapy, indicate also a unique activity profile of these inhibitors that can suggest further innovative therapeutic opportunities linked to DNA repair processes.
On this regard, translational and bioinformatics studies are in progress aiming to identify further sensitivity to the activity of these selective inhibitors and related specific patients populations.

During the event, scientists have also presented an important case of stabilization and characterization of a chordoma cell line, realised at Nerviano laboratories in collaboration with the National Cancer Institute of Milan, a worldwide excellence for the treatment of this rare bone tumor, for which there are no approved drug therapies.
In this context, a new stabilized cell line will allow to better understand and study this rare cancer and to test quickly and optimally the activity and efficacy of new molecules, understanding at the same time their mode of action.

Establishment and characterization of the new sacral chordoma cell line Chor-IN-1
Authors: Paola Magnaghi et al
Meeting: AACR Annual Meeting 2015, Abstract number 74
Presentation Time: Sunday, Apr 19, 2015, 1:00 PM - 5:00 PM

NMS-P088, a dual FLT3-KIT inhibitor active also on gatekeeper mutations and devoid of QTc prolongation
Authors: Ciomei, M et al
Meeting: AACR Annual Meeting 2015, Abstract number 798
Presentation Time: Sunday, Apr 19, 2015, 1:00 PM - 5:00 PM

Preclinical characterization of the novel TTK kinase inhibitor S81694 for the treatment of triple negative breast cancer
Authors: Riccardo Colombo et al
Meeting: AACR Annual Meeting 2015, Abstract number 1638
Presentation Time: Monday, Apr 20, 2015, 8:00 AM -12:00 PM

Preclinical characterization of NMS-P648, a novel and potent PARP-1/-3 inhibitor
Authors: Alessia Montagnoli et al
Meeting: AACR Annual Meeting 2015, Abstract number 2851
Presentation Time: Monday, Apr 20, 2015, 3:50 PM - 4:05 PM
Oral presentation: PARP and DNA Repair Inhibitors (Minisymposium)
Session Start/End Time: Monday, Apr 20, 2015, 3:00 PM - 5:00 PM
Location: Room 108, Pennsylvania Convention Center
SOT 2015: presented by Accelera and StemGen new data on treatment of glioblastoma, the most common brain tumor.
Nerviano, March 27, 2015 - Under study toxicity and safety profile of a new treatment designed with BMP4 of stemgen, a 'key' protein able to block the reproduction of stem cells in brain tumor. The results of pre-clinical reasearch show a good toxicity profile and suggest BMP4 as a possible innovative biological therapy against the most aggressive and resistant of brain tumors.

The administration of BMP4 in preclinical – in intracerebral or intravenous infusion over a period of 7 days - has showed good tolerability with no particular effects of local or systemic toxicity. These results were presented by Nerviano researchers at SOT 2015 in San Diego, the 54th annual meeting of the Society of Toxicology.

The relationship between glioblastoma growth and cancer stem cells has been already extensively studied by Prof. Angelo Luigi Vescovi and his team at StemGen in Milan. These stem cells are responsible for the growth of many tumors, including glioblastoma and are difficult to isolate and hit as they escape traditional oncology therapies. Cancer stem cells are also responsible for relapses of this tumor, absolutely the most lethal ones.

Thanks to its toxicological research, Accelera - of NMS Group - contributed to the development of the innovative therapeutic approach based on BMP4. As already reported by StemGen on Nature in 2006, this morphogenetic protein is able to force the mutation of glioblastoma stem cells into more differentiated nerve cells, unable to continue the disease growth. The concept is radically new and never conceived up to now in solid tumors.

“Manage to neutralize the 'bad' stem cells of glioblastoma
- sayd Professor Vescovi, Founder and Scientific Director of StemGen Spa - means to inhibit the tumor growth and also to reduce the relapse risk for this relevant cancer with a frequent lethal prognosis. Today BMP4 represents a hope and an important candidate treatment that has already received recognition as Orphan Drug by the European regulatory authorities.”

Glioblastoma is the most frequent and high malignant form of primary tumors affecting the central nervous system and represents 15% of all brain tumors. According to Italian Association of Cancer Registries (Airtum) data, in our country it affects over 1,200 people per year, on average between 45 and 70 years even if it has a youth and pediatric peak. In fact, glioblastoma is the most frequent histological type among rare pediatric brain tumors, with a lethal prognosis.
The average survival is unfortunately less than two years.

New data from preclinical toxicology phase presented by researchers of Accelera - among the few companies involved in preclinical research activities in Italy - and StemGen confirm that the administration of BMP4 could represent in the future a potential innovative therapy for this aggressive and resistant brain tumor.

“The research project developed for StemGen
- adds Enrico Pesenti, Managing Director of Accelera - confirms the exclusive expertise of Accelera as partner of major international players and public and private institutions involved in developing preclinical programs of biological and advanced cell therapies. Furthermore, it recognises the quality and the excellence of the research developed in Nerviano laboratories.”
Preclinical results are more than encouraging, now it's up to clinical phase trials to confirm the effectiveness of this new biological treatment.

S. G. M. Piccirillo, B. A. Reynolds, N. Zanetti, G. Lamorte, E. Binda, G. Broggi, H. Brem, A. Olivi, F. Dimeco and A. L. Vescovi. Bone morphogenetic proteins inhibit the tumorigenic potential of human brain tumor-initiating cells. Nature 444, 761-765 (7 December 2006)
G. Di Gallo, L. Nobili, M. Russo, E. Binda, C.I. Bernardi; A.L. Vescovi Human-recombinant Bone Morphogenetic Protein 4 (hrBMP4): Safety profile  after 7-day continuous Intracerebral (IC) and IV Administration in the mouse (Poster presentation, SOT 2015)
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