On January 7, 2019 Merus N.V. (Nasdaq: MRUS), a clinical-stage immuno-oncology company developing Biclonics, innovative full-length human bispecific antibody therapeutics, reported the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for MCLA-145, a first-in-class PD-L1 x CD137 Biclonics being developed in collaboration with Incyte (Nasdaq: INCY), for the treatment of solid tumors (Press release, Merus, JAN 7, 2019, View Source;p=RssLanding&cat=news&id=2382290 [SID1234532560]).

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"We are pleased to announce the IND authorization to proceed from the FDA and to disclose more details around our latest Biclonics program today," said Andres Sirulnik, M.D., Ph. D., Executive Vice President and Chief Medical Officer of Merus. "Our preclinical work has demonstrated that MCLA-145 has the potential to overcome the known side effects of CD137 agonists currently in development and to address a significant unmet need in patient populations not benefitting from current immunotherapeutic agents. We expect to initiate the clinical trial program for MCLA-145 during the second quarter of 2019 and we look forward to continuing our collaboration with Incyte on MCLA-145’s global development."

Discovered through an unbiased functional screening of multiple immunomodulatory target combinations, MCLA-145 is a Biclonics T-cell agonist that binds with high affinity and specificity to human PD-L1 and CD137 in preclinical models. The unique immunostimulatory profile of MCLA-145 derives from the ability to potently activate immune effector cells in the context of the tumor microenvironment while simultaneously blocking inhibitory signals in the same immune cell population.

Merus is developing MCLA-145 as part of a collaboration entered into with Incyte in December 2016 to potentially develop and commercialize up to 11 bispecific and monospecific antibodies from the Merus Biclonics platform. Under the terms of the collaboration, Merus will retain all rights to develop and commercialize MCLA-145, if approved, in the United States, while Incyte has rights to develop and commercialize MCLA-145, if approved, outside the United States.

On January 7, 2019 Epigenomics AG (FSE: ECX, OTCQX: EPGNY) reported that a microsimulation model has been completed by external academic experts demonstrating positive results for the Epi proColon blood test (Press release, Epigenomics, JAN 7, 2019, View Source [SID1234532559]). The manuscript is being finalized and will be submitted for publication soon. Epigenomics will discuss the specific findings once the manuscript is published.

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Microsimulation models have been used to project the harms and benefits of various strategies for Colorectal Cancer Screening (CRC). These models are utilized by various screening guideline groups such as the United States Preventative Services Task Force (USPSTF) and the American Cancer Society to aid in the development of screening guidelines. To date, none of the previously completed models used for guideline development have incorporated the methylated Septin 9 blood test (Epi proColon) as one of the strategies. The model just completed incorporates the Epi proColon test and also factors in the key variable of adherence to testing. Adherence to testing is a critical element for the improvement of screening rates, and blood based testing holds promise for the approximately 35% of eligible people not up to date for screening according to the guidelines.

On January 7, 2019 NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205) and The University of Texas MD Anderson Cancer Center reported a large-scale, comprehensive clinical research collaboration to evaluate innovative strategies for treating patients with head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers (Press release, Nanobiotix, JAN 7, 2019, View Source [SID1234532558]).

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The collaboration will expand clinicaldevelopment of NBTXR3, a first-in-class agent designed to physically destroy cancer cells when activated by radiotherapy and to activate the immune system for both local control and systemic disease treatment.

MD Anderson will initially conductthe launch of nine new phase I/II clinical trials-involving around 340 patients-focused on evaluating the potential clinical benefit of NBTXR3 when activated by radiotherapy, either as a monotherapy or in combination with checkpoint inhibitors. The planned trials also will look at various disease stages, including low-risk/good prognostic patients, locally advanced disease, and metastatic disease. The trials will studyNBTXR3 across different radiation modalities such as radiation, re-irradiation, and compare different levels of intensity of radiation, to evaluate whether the addition of NBTXR3 to radiotherapy will improve progression-free survival, loco-regional control, quality of life and organ preservation.

Dr. Thomas Morris, Global Head of Development, Nanobiotix, said "It is important for Nanobiotix to collaborate with academic institutionsto develop a broad spectrum of clinical trials in an expedited fashion. This is a tremendous opportunity to strengthen our scientific and clinical understanding of the potential of NBTXR3 across the wide range of cancers treated with radiotherapy, with the goal of benefitting patients by applying novel research and bringing forward an innovative therapy. The collaboration between Nanobiotix and MD Anderson expands the number of NBTXR3 clinical trials to 16, illustrating our dedication to identify more effective treatments for cancer patients.

As part of the funding scheme for this collaboration, part of the payment will be made at the start of the collaboration. Other parts will be paid during development and the balance in case of FDA registration for a total of $12M investment.

This new collaboration between Nanobiotix and MD Anderson follows up the immunotherapeutic pre-clinical research collaboration, launched in April 2018, in lung cancer to explore NBTXR3 potential in immuno-oncology with checkpoint inhibitors, as well as its potential to control metastatic disease.

About NBTXR3 NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:
• tumors through physical cell death
• metastasis due to immunogenic cell death leading to activation of the immune system
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment.

NBTXR3 is a late clinical stage product which has shown the potential for clinical benefit in advanced STS phase III randomized clinical trial.

NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or 2 oropharynx in elderly and frail patients unable to receive chemotherapy. The other ongoing studies are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.

Nanobiotix is also running an Immuno-Oncology development program. In the U.S., the Company received the FDA’s approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).

On January 7, 2019 Genocea Biosciences (the "Company") is presented the corporate slide presentation (Presentation, Genocea Biosciences, JAN 7, 2019, View Source [SID1234532556]).

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On January 7, 2019 Unum Therapeutics Inc. (the "Company") is presented a corporate presentation (Presentation, Unum Therapeutics, JAN 7, 2019, View Source [SID1234532555]).

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