On April 4, 2017 Nativis, Inc. (Nativis), a clinical-stage life science bio-electronic company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, reported that the company has entered into an exclusive licensing agreement for the development and commercialization of Nativis’ proprietary ultra-low Radio Frequency Energy (ulRFE) technology for the potential treatment of Glioblastoma Multiforme (GBM) in the Japanese market, with Teijin Limited (Teijin), a comprehensive Japanese company expanding businesses in high-performance materials, pharmaceuticals, home healthcare, product converting and information technology (Press release, Nativis, APR 4, 2017, View Source [SID1234518476]).

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Under the terms of the agreement, Teijin will receive an exclusive license to the Nativis Voyager System for the indication of GBM in Japan. Nativis will receive an undisclosed upfront payment, payments based on the achievement of specific regulatory and commercial milestones, and royalties on the sales of the product in Japan. Teijin will sublicense its rights under the agreement to Teijin Pharma Limited (Teijin Pharma), Teijin’s wholly-owned subsidiary and the core company of Teijin Group’s healthcare business, under which Teijin Pharma will develop and commercialize the licensed technology in Japan.

Nativis and Teijin also anticipate expansion of the scope of the alliance and will continue discussions for potential licensing opportunities of the Nativis ulRFE technology for other indications in Japan.

"We are very pleased to enter into this exclusive licensing agreement with Teijin for GBM; the company has a strong track record of successfully commercializing pharmaceuticals and medical devices in Japan. We believe that this partnership further validates our technology, while their investment in Nativis reinforces our belief in the broader potential of the Voyager platform. With their support, we look forward to further developing and refining the Voyager System for GBM, as well as additional indications in the future," commented Chris Rivera, President and Chief Executive Officer of Nativis. "This agreement also brings us one step closer to reaching our goal of becoming cash flow positive through strategic partnerships and licenses, and we are excited to work closely with Teijin to bring the Voyager System to market in Japan."O

On April 4, 2017 CBT Pharmaceuticals, Inc. (CBT), a life sciences company focused on developing innovative oncology therapeutics, presented preclinical data on CBT-101 (bozitinib, PLB-1001, CBI-3103), a highly specific small molecule inhibitor of c-MET receptor tyrosine kinase, demonstrating its selectivity, safety, and efficacy in suppressing tumor growth in lung, gastric, hepatic and pancreatic human primary tumor models (Press release, CBT Pharmaceuticals, APR 4, 2017, View Source [SID1234518475]). The data were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) being held from April 1 – 5, 2017 in Washington, D.C.

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Presentation Highlights:

CBT-101 inhibited c-MET activation in a range of human primary cancer cell lines.
CBT-101 inhibited in vivo dephosphorylation of c-MET in a dose-dependent manner in a human gastric cancer model.
CBT-101 demonstrated improved tumor growth inhibition as compared to other selective c-MET agents in lung, gastric, hepatic, and pancreatic cancer models.
"These preclinical data support our commitment to advancing the clinical development of bozitinib as a targeted therapy for c-MET dysregulated tumors," said Sanjeev Redkar, Ph.D., President and Chief Executive Officer of CBT Pharmaceuticals. "Based on these promising findings, we plan to submit an Investigational New Drug Application soon and initiate a Phase 1 dose escalation and dose and disease expansion study in 2017."

Bozitinib (CBT-101)

Bozitinib is an orally available tyrosine kinase inhibitor that is expected to potently target tumors in patients with c-MET driver alterations (amplification and mutation) that occur in varying percentages across a variety of tumor types, including, but not limited to, breast, colorectal, gastric, gliomas, head and neck, hepatocellular, lung, ovarian as well as hematologic malignancies. MET is a receptor tyrosine kinase located on the cell surface and is activated by the binding of its ligand, hepatocyte growth factor (HGF). MET activates a variety of signaling pathways within the cell, and in normal circumstances, is involved in embryonic development and wound healing. However, in cancer cells, MET can be aberrantly active and cause abnormal signaling, which leads to tumor growth, angiogenesis, and metastasis. CBT-101 has demonstrated high-affinity to MET irrespective of hepatocye growth factor (HGF) dependency and excellent activity in preclinical models of human cancer. CBT-101 was developed by Crown Bioscience. Beijing Pearl Biotechnology owns development and commercialization rights in People’s Republic of China. CBT retains rest of the world (ROW) rights. An investigational new drug application has been approved by the China Food and Drug Administration (CFDA), and two Phase 1 trials are ongoing in China – non-small cell lung cancer (NSCLC) (NCT02896231) and high grade gliomas with PTPRZ1-MET fusion gene (NCT02978261).

On April 4, 2017 Intensity Therapeutics, Inc., a privately held biotechnology company developing proprietary immune cell-activating cancer treatments, reported that tumor regression and immune activation data generated by the Company’s lead drug, INT230-6, will be presented in a poster session at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) meeting on April 5, 2017 (Press release, Intensity Therapeutics, APR 4, 2017, View Source [SID1234518474]). The research being presented indicates that INT230-6 results in complete response of tumors in rodent models, induces protective T cell immunity and is synergistic with checkpoint inhibitors. Dr. Anja Bloom from the Vaccine Branch of the National Cancer Institute (NCI) and Lewis H. Bender, CEO of Intensity Therapeutics will present the poster presentation.

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tumor regression & immune activation data for INT230-6 being presented at #AACR2017 on 4/5 http://bit.ly/2nHyrOX
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A series of preclinical studies conducted in collaboration with scientists from the Vaccine Branch at the NCI showed INT230-6 treatment leads to complete responses in rodents and a durable response. The subsequent protective effect against re-inoculation decreased when CD4- and CD8-positive T cells were depleted prior to treatment or re-challenge. The data indicate that the observed complete response and durable, vaccine-like anti-cancer effect of INT230-6 is immune mediated.

Intensity’s Chief Executive Officer Lewis H. Bender explained, "The direct killing action and immune response data generated in rodent models from our lead drug INT230-6 are impressive. We hope these animal results translate into an equally potent response in our clinical study, IT-01 for INT230-6, which is now recruiting patients in both the U.S. and Canada. Should the protective T cell immunity occur in humans, then INT230-6 could represent an important advance in the treatment of certain solid tumor cancers, potentially providing oncologists with a less toxic means to destroy visible tumors, eliminate metastases and prevent disease recurrence."

Presentation Details

Poster Title: Tumor cell death caused by INT230-6 induces protective T cell immunity
Session Category: Clinical Research
Session Title: Innate Immunity to Generate Adaptive Immunity
Session Date and Time: Wednesday Apr 5, 2017 8:00 AM – 12:00 PM
Location: Convention Center, Halls A-C, Poster Section 28
Poster Board Number: 14
Permanent Abstract Number: 5660

About INT230-6

INT230-6 is a novel, anti-cancer drug product able to disperse through tumors and diffuse into cancer cells. The product was identified from Intensity’s DfuseRxSM platform technology and is currently in a clinical trial; IT-01. In preclinical studies conducted in by Intensity Therapeutics alone and in collaboration with the Vaccine Branch of the National Cancer Institute (NCI), INT230-6 administration was shown to increase recruitment of dendritic cells to the tumor micro-environment followed by T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer completely cleared large tumors in animal models and generate substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responders in these preclinical studies with long-term, durable protection from multiple re-inoculations of the cancer, demonstrating the potential to eliminate metastases and prevent disease recurrence.

About Study IT-01

IT-01 is entitled A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects with Advanced Refractory Cancers. The trial aims to enroll patients with different types of advanced solid tumor malignancies in a multicycle dosing regimen. IT-01 plans to include a cohort combining INT230-6 with an anti-PD-1 antibody. Currently the study is recruiting in the U.S. at the University of Southern California (USC) and in Canada at the University Health Network (UHN) in Toronto. The principal investigator at USC is Dr. Anthony El-Khoueiry; the principal investigator at UHN is Dr. Lillian Siu. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. Secondary assessments are to understand preliminary efficacy of INT230-6. The study will characterize the pharmacokinetic profile of multiple doses of INT230-6 components. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. Data will be used to assess the progression free and overall survival in subjects receiving INT230-6. Further information can be found at www.clinicaltrials.gov (NCT#03058289).

About the Vaccine Branch of the NCI

The Molecular Immunogenetics & Vaccine Research Section (Berzofsky lab) within the Vaccine Branch studies, in animals and clinical trials, the immunology of antigen-specific T cell activation and regulation, and translation to strategies for design of vaccines for HIV, cancer, and viruses that cause cancer. Approaches include use of synergistic combinations of cytokines and TLR ligands in vaccines, approaches to increase CTL avidity, analysis of a new NKT cell immunoregulatory axis and regulatory circuit that inhibits tumor immunity and vaccine-induced immune responses against cancer and its interactions with other regulatory mechanisms and blockade of these to improve vaccine efficacy, strategies to induce mucosal immunity and mechanisms of mucosal trafficking and homing, epitope enhancement by sequence modification, and development of new cancer vaccines as well as AIDS vaccine strategies. Several basic discoveries are currently being translated into clinical trials.

On April 4, 2017 amcure, a biopharmaceutical company developing first-in-class cancer therapeutics, reported vivo and in vitro data on its lead development candidate, AMC303, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 in Washington DC (Press release, amcure, APR 4, 2017, View Source [SID1234518473]). The poster presentation highlighted AMC303’s unique and novel mode of action which inhibits CD44v6 and thus, signals three cancer relevant Receptor Tyrosine Kinases (RTKs), c-MET, RON and VEGFR-2. AMC303 is currently being evaluated in a Phase I/Ib clinical study as a monotherapy in patients with advanced metastatic malignant solid tumors of epithelial origin, for example pancreatic, head and neck, colorectal, gastric and lung cancer.

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"So far the data generated with AMC303 indicate that it combines a strong anti-tumor and anti-metastatic effect," said Klaus Dembowsky, CEO of amcure. "These encouraging results solidify our belief in AMC303’s potential as a novel solid tumor treatment option and bode well for the ongoing Phase I study results."

In the study, researchers elucidated the unique mechanism of action of AMC303, a CD44v6 inhibitor, demonstrating the specific inhibition of three key RTKs (c-MET, RON and

VEGFR-2) in vitro that play a significant role in tumor growth and metastasis formation. Furthermore, in a pancreatic tumor mouse model, a three-week treatment with AMC303 resulted in a clear inhibition of tumor growth and metastasis formation as well as a marked reduction of preformed metastases. Overall, this data confirms AMC303’s potential as a novel mechanism for the treatment of patients with advanced solid tumors that have already formed metastases.

The poster, "Allosteric inhibition of the Receptor Tyrosine Kinases c-MET, RON and

VEGFR-2 via the co-receptor CD44v6 by the novel compound AMC303" presented at the AACR (Free AACR Whitepaper) Annual Meeting 2017 is available on the Company’s website under "Research and Development" or by accessing the following link: View Source

About AMC303

amcure’s lead compound, AMC303, is being developed as a potential treatment for patients with advanced and metastatic epithelial tumors, e.g. pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer. AMC303 has a high specificity for inhibiting CD44v6, a co-receptor required for signaling through multiple cellular pathways (c-Met, VEGFR-2, RON) involved in tumor growth, angiogenesis and the development and regression of metastases. AMC303 has demonstrated strong effects in various in vitro and in vivo assays.

On April 4, 2017 Atossa Genetics, Inc. (NASDAQ: ATOS) reported that it has fully enrolled the first of six cohorts (eight participants per cohort) in its Phase 1 study of endoxifen, which is an active metabolite of tamoxifen, an FDA approved drug for breast cancer and breast cancer prevention in high risk women (Press release, Atossa Genetics, APR 4, 2017, View Source [SID1234518472]). The objectives of this double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects is to assess the pharmacokinetics of proprietary formulations of both oral and topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted in two parts based on route of administration.

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"Less than ten months ago we announced that we had begun a program to develop endoxifen for cancer patients who don’t benefit from taking tamoxifen and for women at high risk of developing breast cancer who are not taking tamoxifen, often due to concerns about side effects from system exposure. Through the hard work and dedication of Atossa’s employees and our collaborators we have obtained a qualified manufacturer of the active pharmaceutical ingredient, performed formulation development for both oral and topical dosage forms, established a manufacturer of the finished dosage forms, and launched the first human testing in a Phase 1 study," stated Steven Quay, CEO and President. "I am not aware of any oncology company that has completed the pre-clinical phase of drug development so quickly."