On April 10, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that it will cooperate with The University of Texas MD Anderson Cancer Center, Houston TX, to work on NBTXR3, Nanobiotix’s lead product (Press release, Nanobiotix, APR 10, 2018, www.nanobiotix.com/download/news_en/2018/MD_ANDERSON_CANCER_CENTER_AND_NANOBIOTIX_HAVE_AN_AGREEMENT_TO_RUN_IMMUNOTHERAPEUTIC_PRE-CLINICAL_RESEARCH_COMBINING_NBTXR3_AND_NIVOLUMAB.pdf#new_tab [SID1234525370]). NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to induce immunogenic cell death leading to specific activation of the immune system.

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This project with MD Anderson, one of the world’s leading oncological research centers, will provide an unparalleled ability to develop pre-clinical data using NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine version of Opdivo).

Dr. Elsa Borghi, CMO, said: "The main objective of this collaboration is to analyze the micro environment of the tumors treated with NBTXR3 activated by radiotherapy, in order to increase and optimize the immune response."

Dr. James Welsh, MD, Associate Professor, Department of Radiation Oncology, will be the Principal Investigator and lead the research program. The project between MD Anderson and Nanobiotix will take place over the course of two years and will evaluate the use of NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine version of Opdivo), provided by Bristol-Myers Squibb (BMS) in lung cancer models (in vitro and in vivo). Lung cancer is one of the most common cancer worldwide, accounting for 1.69 million deaths annually (WHO 2015).

The joint program will focus on 3 aims, leading to the maximization of NBTXR3 potential benefits in triggering an immune response:

– Evaluate the abscopal response through the combination of NBTXR3 plus an anti-PD1 antibody and radiation therapy in specific and resistent murine lung cancer models, in order to measure NBTXR3’s potential to control metastatic disease. – Evaluate if NBTXR3 can further improve T cell activation for standard radiotherapy fractions compared to SBRT, notably by determining the STING activation in vitro in cancer cells with and without NBTXR3. – Continue the characterization of the different mechanisms and types of cell death induced by NBTXR3 activated by radiation.

The joint program will also further explore the potential future use of NBTXR3 in immuno-oncology with checkpoint inhibitors, as well as its potential to control metastatic disease.
As announced in December 26, 2017, the Company has received from the Food and Drug Administration the approval of its Investigational New Drug (IND) application and should launch its first clinical trial combining NBTXR3 with immune checkpoint inhibitors in the U.S. in Q2 2018. This will be a multi-arm trial targeting a sub-population of advanced lung cancer patients and head and neck cancer patients.

NBTXR3 positioning in IO Many IO combination strategies focus on ‘priming’ the tumor, which is now becoming a prerequisite of turning a "cold" tumor into a "hot" tumor.

Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology, a one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as a very good chronic

safety profile and well-established manufacturing process.

Published preclinical and clinical data indicate that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology.
Nanobiotix’s immuno-oncology combination program opens the door to new developments, potential new indications, and important value creation opportunities.

***

About NBTXR3

NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to immunogenic cell death leading to specific activation of the immune system.

NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and has the ability to fit into current worldwide standards of radiation care.

NBTXR3 is being evaluated in head and neck cancer (locally advanced squamous cell carcinoma of the oral cavity or oropharynx), and the trial targets frail and elderly patients who have advanced cancer with very limited therapeutic options. The Phase I/II trial has already delivered very promising results regarding the local control of the tumors and a potential metastatic control through in situ vaccination.

Nanobiotix is running an Immuno-Oncology program with NBTXR3 that includes several studies. 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). This trial aims to expand the potential of NBTXR3, including using it to treat recurrent or metastatic disease.

The first market authorization process (CE Marking) is ongoing in Europe in the soft tissue sarcoma indication.

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.

On April 11, 2018 Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that Molecular Partners and AstraZeneca (LON: AZN) will collaborate on Molecular Partners’ ongoing phase 1b/2 clinical study of MP0250 with osimertinib (Tagrisso) for the treatment of patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) pre-treated with osimertinib (Press release, Molecular Partners, APR 11, 2018, View Source [SID1234525260]). Under the collaboration, AstraZeneca will supply osimertinib (Tagrisso) required for the clinical study. The clinical study is planned to enroll approx. 40 patients and is taking place in the United States.

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"We are delighted to welcome AstraZeneca as collaboration partner for our second phase 2 study of MP0250. This underlines the growing interest in MP0250 and nicely documents the potential value of MP0250 in EGFR-mutated NSCLC," said Dr. Andreas Harstrick, Chief Medical Officer at Molecular Partners.

MP0250 offers the possibility of targeting two main tumor escape pathways by blocking both hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF) simultaneously while continued treatment with osimertinib suppresses EGFR-mutated NSCLC tumor cells.

Osimertinib is a third generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases, which demonstrated significant benefit in untreated EGFR-mutated NSCLC patients in a global phase 3 trial last year. Osimertinib is currently marketed globally, as Tagrisso, for the treatment of locally advanced or metastatic EGFR T790M NSCLC.

The clinical study[1] consists of two parts: the dose-escalation phase (Part A), to establish a safe
recommended dose for MP0250 in combination with osimertinib. In the subsequent treatment
expansion phase (Part B), patients will be further evaluated for efficacy and safety.

[1] ClinicalTrials.gov identifier NCT03418532

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.

Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and in Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On April 10, 2018 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, surgery and oncology, reported that it will present at the following two investor conferences in May (Press release, AngioDynamics, APR 10, 2018, View Source [SID1234525255]):

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Conference: Deutsche Bank 43rd Annual Healthcare Conference
Location: Boston, MA
Date: Tuesday, May 8, 2018
Presentation: 3:30 p.m. ET
Speakers: Jim Clemmer, President and Chief Executive Officer, and Michael C. Greiner, Executive Vice President and Chief Financial Officer

Conference: UBS Global Healthcare Conference
Location: New York, NY
Date: Monday, May 21, 2018
Presentation: 9:00 a.m. ET
Speaker: Jim Clemmer, President and Chief Executive Officer

A live webcast of each presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following each event.

On April 10, 2018 harles River Laboratories International, Inc. (NYSE: CRL) reported that its team of oncology experts is presenting 13 scientific posters, both independently and collaboratively with clients, and will highlight an enhanced oncology portfolio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Charles River Laboratories, APR 10, 2018, View Source [SID1234525254]). The meeting is taking place from April 14-18, 2018, at McCormick Place in Chicago, Illinois.

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Throughout the meeting, Charles River’s experts will present the Company’s industry-leading oncology capabilities and highlight the latest advancements by presenting innovative applications for CRISPR/Cas9, immuno-oncology, in vitro assays, and more.

Noteworthy posters include:

Determination of signal transduction pathway activity in patient-derived xenograft models in comparison with clinical patient tumor samples for a variety of human cancer types (Presented: Monday, April 16, 8:00 a.m.-12:00 p.m.) This project, completed with Philips Molecular Pathway Diagnostics, describes an analysis method which identifies and quantifies activity in the cell signaling pathways of Charles River’s patient-derived xenograft (PDX) tumor models.
A translational platform using primary human immune cells in vitro, syngeneic and humanized models in vivo to support and advance immuno-oncology drug discovery (Presented: Monday, April 16, 8:00 a.m.-12:00 p.m.) Researchers established a translational immuno-oncology platform with the capability of progressing biologics or small-molecule modulators of immune response from in vitro and ex vivo through in vivo assays, including humanized models.
Quantitative measurement of immune-modulatory mediators within tumors of freely moving mice utilizing in vivo microdialysis (Presented: Tuesday, April 17, 8:00 a.m.-12:00 p.m.) Leveraging microdialysis in tumors, researchers monitored changes in biochemical elements within tumors to better understand cancer biology in the development of novel therapies.
A full schedule of Charles River’s activities during AACR (Free AACR Whitepaper) 2018 is available online. Reprints of each poster will be available in Booth #1615 during the conference and Charles River experts will be available for meetings to discuss how an integrated approach can support drug discovery and development programs from hit ID to IND. Throughout the conference, Charles River will be providing live updates on the Eureka Blog, including reviews of scientific sessions and input on the research being presented.

Bioinformatic Additions to Compendium

In February 2018, Charles River announced the launch of its new online Tumor Model Compendium web interface. The new Compendium interface provides oncology researchers with an easily accessible, user-friendly resource to identify tumor models based on specific molecular and histological properties, accompanied by selected patient information. Ahead of AACR (Free AACR Whitepaper), Charles River will incorporate the signal transduction pathway activity, developed with Philips Molecular Pathway Diagnostics, as a characteristic of Charles River’s PDX models. The resemblance of these pathways to clinical samples will lead to better development and clinical application of targeted drugs for personalized cancer treatment.

Select Humanization Kit

Recently, Charles River and HemaCare Corporation (OTCBB: HEMA) formed a strategic partnership to advance human immune system research by developing a more efficient and reliable method of working with humanized mice. Through the partnership, HemaCare’s peripheral blood mononuclear cells (PBMCs) are paired with Charles River’s NCG triple immunodeficient mouse. This NCG/PBMC Select Humanization Kit is the first of its kind in the industry and provides both the NCG mouse and vials of prescreened human PBMCs, allowing researchers to efficiently develop humanized mouse models on their own timeline.

Approved Quotes

"Our scientists are exploring groundbreaking applications of innovative tools and technologies across oncology research. From CRISPR to in vitro immuno-oncology to microdialysis, our deep scientific bench affords us a unique opportunity to leverage learnings from different therapeutic areas and apply them to oncology. We’re proud to showcase our body of work at AACR (Free AACR Whitepaper) this year." –Birgit Girshick, Corporate Executive Vice President, Discovery and Safety Assessment, Charles River
"The continued expansion of our Tumor Model Compendium highlights the significant role bioinformatics plays in oncology research. Scientists require data to conduct their research efficiently and effectively. Our Compendium puts the power of our data in their hands—eliminating steps and driving the development process forward." –Aidan Synnott, Executive Director, Discovery Oncology, Charles River
About the American Association for Cancer Research (AACR) (Free AACR Whitepaper)

The mission of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) is to prevent and cure cancer through research, education, communication, and collaboration. Through its programs and services, the AACR (Free AACR Whitepaper) fosters research in cancer and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer etiology, prevention, diagnosis, and treatment throughout the world.

On April 10, 2018 Asana BioSciences, LLC, an oncology focused, clinical stage biopharmaceutical company, reported that it will present updates for two of its lead molecules in clinical development at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in Chicago, IL, April 14-18, 2018 (Press release, Asana BioSciences, APR 10, 2018, View Source [SID1234525253]).

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The presentation details are as follows:

1. ASN003, a novel highly selective BRAF and PI3K dual inhibitor: Phase I PK/PD results in patients with advanced solid tumors.

Authors: D. Rasco1, N. Lakhani2, R. Sullivan3, M. Mita4, J. Shah5, H. Usansky5, S. Reddy5, N. S. Rao5, L. Denis5, K. Flaherty3, Anthony Tolcher6. 1START Med. Oncology, San Antonio, TX; 2START Med. Oncology, Grand Rapids, MI; 3MGH, Boston, MA; 4Cedars Sinai Med. Oncology, Los Angeles, CA; 5Asana BioSciences, Lawrenceville, NJ, 6NEXT Oncology, San Antonio, TX.
Session: PO.CT01 – Phase I Clinical Trials 1; Section 42
Abstract: #CT019 / 12
Date/Time: Sunday, April 15 at 1:00pm – 5:00pm

2. Strong antitumor activity of ASN007, an oral ERK1/2 inhibitor, in PDX tumor models with MAP kinase pathway alterations including KRAS mutations.

Authors: Sanjeeva P. Reddy, Niranjan S. Rao, Roger A. Smith, Scott K. Thompson, Sarper
Toker. Asana BioSciences, Lawrenceville, NJ.
Session: PO.ET06.10 – Canonical Targets 2; Section 36
Abstract: #5783 / 9
Date/Time: Wednesday, April 18 at 8:00am – 12:00pm

ASN003 is a potent and highly selective inhibitor of both B-RAF and PI3 kinases. RAS-RAF-MEK and PI3K-AKT-mTOR are two major pathways involved in tumor cell signaling and growth. Components of these pathways are frequently mutated in a broad range of tumors. Selective BRAF inhibitors induce dimerization of RAF proteins, leading to paradoxical activation of the RAF-MEK-ERK cascade. This activation is a major limitation for the clinical use of selective RAF inhibitors, as it leads to resistance and results in side effects in the skin limiting their use in patients with BRAF mutant tumors. In addition, elevated signaling through the PI3K/AKT pathway, with or without concomitant MAPK reactivation, represents an alternative path to resistance to BRAF inhibitors. ASN003 demonstrates broad anti-proliferative activity in tumor cell lines and strong tumor growth inhibition in tumor xenograft models, including BRAF inhibitor resistant models. ASN003 is currently in Phase I clinical development in patients with advanced solid tumors, including melanoma, colorectal cancer and non-small cell lung cancer (clinicaltrials.gov NCT02961283). ASN003 is well tolerated and shows the potential to be developed as a monotherapy or in combination with checkpoint inhibitors or other standard of care.

ASN007 is a potent inhibitor of the extracellular-signal-regulated kinases, ERK1 and ERK2 (ERK1/2), key players in the RAS/RAF/MEK (MAPK) signaling pathway. This pathway is frequently hyper-activated in a wide range of cancers through mutations in upstream targets such as BRAF and RAS proteins. Inhibition of ERK1/2 offers a promising therapeutic strategy for such cancers. ASN007 shows potent and selective anti-proliferative activity in cancer cell lines that are driven by the MAPK-pathway, including RAS mutant cell lines. Furthermore, ASN007 demonstrates strong inhibition of tumor growth in multiple BRAF and KRAS mutant patient-derived and cell-line-derived xenograft models, including those that are resistant to BRAF and MEK inhibitors. ASN007 is currently in Phase I clinical development in patients with advanced solid tumors, including melanoma, colorectal cancer, non-small cell lung cancer and pancreatic cancer (clinicaltrials.gov NCT03415126).