On April 16, 2018 JHL Biotech reported that the China Food and Drug Administration (CFDA) has accepted for review JHL’s Clinical Trial Application for a proposedbevacizumab biosimilar, JHL1149, to treat cancer (Press release, JHL Biotech, APR 16, 2018, http://www.jhlbiotech.com/press-release/jhl-biotechs-clinical-trial-application-accepted-by-china-for-bevacizumab-biosimilar-to-treat-colorectal-lung-and-ovarian-cancers/ [SID1234525358]).
JHL1149 is a biosimilar to bevacizumab and would provide an affordable alternative to treat several cancers, the most common of which are metastatic colorectal cancer, non-small cell lung cancer, andovarian cancer, as well as cervical cancer, renal cell carcinoma, and glioblastoma.

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JHL is planning to conduct a Phase 1 pharmacokinetic study in healthy volunteers in China followed by a multinational Phase 3 efficacy study in non-small cell lung cancer patients. Currently, a Phase I clinical trial for JHL1149 is ongoing in Europe. The data from these trials will support the global registration and commercialization of JHL1149. Once approved, JHL1149 will be manufactured at JHL’s facility in Wuhan, China, the world’s largest biopharmaceutical manufacturing plant based on single-use technologies, which will provide a high-quality supply of products worldwide.
JHL1149 is an anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody. The reference biologic, bevacizumab, is marketed by Roche under the trade name, Avastin. In 2017, bevacizumabgenerated worldwide revenues of approximately US$7 billion.

"JHL 1149 has been demonstrating a high level of similarity to the innovator product in physicochemcial and biological characteristics and in comparative preclinical studies," said Dr. Rong Chen, Chief Medical Officer, JHL Biotech. "Clinical trial for JHL1149 in China is a milestone in delivering quality and accessible products to patients worldwide who suffer from high unmet medical needs."

"Bevacizumab is an important biologic that is unfortunately very expensive for patients suffering from certain cancers, and JHL1149 would provide an affordable treatment for these patients," said Mr. Racho Jordanov, CEO, JHL Biotech. "JHL’s clinical trial in China is a step forward in our mission to become a global leader in developing, manufacturing, and commercializing biologics."

In addition to JHL1149, JHL has several other biosimilars currently in or expected to be in clinical trials. These include:
Rituximab biosimilar, JHL1101, to treat rheumatoid arthritis and non-Hodgkin lymphoma. Currently in Phase I trial in Europe.
Dornase alfa biosimilar, JHL1922, to manage symptoms of cystic fibrosis. Currently in Phase I trial in Europe.
Trastuzumab biosimilar, JHL1188, to treat breast cancer.
JHL1211, to treat asthma and chronic idiopathic urticaria.
JHL1199, to treat breast cancer.
JHL1266, to treat osteoporosis.
Media Contact:
Ellis Chu: [email protected] phone: +886 3-658-3899
Jill Liu: [email protected] phone: +886 3-658-3899
Amber Chen: [email protected] phone: +886 3-658-3899

On April 16, 2018 Telix Pharmaceuticals Limited (ASX.TLX) ("Telix", the "Company"), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted
radiopharmaceuticals or "molecularly-targeted radiation" (MTR), has reported a research partnership with the French National Institute of Health and Medical Research (Institut national de la santé et de la recherche médicale or "INSERM") and the "Accelerator for Research in Radiochemistry and Oncology at Nantes Atlantic" (ARRONAX) (Press release, Telix Pharmaceuticals, APR 16, 2018, View Source [SID1234525562]).

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INSERM is a leading translational research organization with a strong track record of industry engagement and technology development to benefit human health. ARRONAX is a unique cyclotron (particle accelerator) facility and a world-leader in the production of certain novel radioactive isotopes, including 211At (astatine). Together, INSERM and ARRONAX have created a highly capable nuclear medicine research cluster in Nantes with a track record of
cutting-edge translational research.

Under the research partnership, Telix will explore the feasibility of using several of its clinical targeting agents with astatine. Astatine is an "alpha emitter", a very high-energy radionuclide that is capable of significantly altering the tumour microenvironment when attached to a molecular targeting agent that is specific for cancer cells. The agreement will fund sufficient staff and facility time to conduct a number of studies over a two-year period, including
preparation for pilot clinical studies in the nuclear medicine department of University Hospital of Nantes. The agreement also accesses a portfolio of intellectual property that has been developed within the Nantes cluster that may lead to new products and indications for Telix’s therapeutic pipeline.

Telix Europe President Ms. Odile Jaume stated, "The Nantes nuclear research cluster is one of the finest translational environments in Europe, with a particular strength and capability in astatine, including production facilities and processes that are capable of making materials for human research. This collaboration has the potential to expand the clinical utility of Telix’s technology and build a set of ‘next generation’ products that may deliver even greater clinical utility to cancer patients."

Professor Michel Chérel (team leader, INSERM University of Nantes) and Dr Jean-Francois Gestin (radiochemistry development) noted, "We are pleased to be working with Telix to progress the use of astatine in a clinical setting. This partnership is a great example of translational research aiming at truly personalized medicine in France and beyond. The clinical translation of astatine therapy will be performed in the nuclear medicine department of
Nantes Centre Hospitalier Universitaire (CHU) and l’Institut de Cancérologie de l’Ouest (ICO) chaired by Professor Françoise Kraeber-Bodéré, in collaboration with the Labex IRON network (Innovative Radiopharmaceuticals in Oncology and Neurology) and "Le SIRIC ILIAD" (Imaging and Longitudinal Investigations to Ameliorate Decision-making in Multiple Myeloma and Breast Cancer)."

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Professor Ferid Haddad, Director of ARRONAX added, "Our facility has been established with the development of alpha-nuclide therapy in mind. To this end, this highly innovative partnership with Telix is an important step forward and we believe that it will result in the development of new cancer treatment strategies.

On April 16, 2018 Exicure, Inc., the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported that it will present preclinical data in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in Chicago, Illinois from April 14-18, 2018 (Press release, Exicure, APR 16, 2018, View Source;p=RssLanding&cat=news&id=2342684 [SID1234525342]). The poster titled "TLR9 agonist SNA-induced innate and adaptive immune responses in tumor microenvironment enhance checkpoint inhibitor antitumor activity in mouse tumor models" supports the ongoing clinical development of the company’s proprietary SNA technology and highlights its potential impact in the tumor microenvironment in potentiating antitumor effects of anti-PD-1.

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The data presented in the poster, in combination with many other preclinical studies, provided the basis for advancing Exicure’s drug candidate, AST-008, into its Phase 1 clinical trial. We began subject dosing in our Phase 1 clinical trial for AST-008 in the fourth quarter of 2017 and expect this trial to be completed in mid-2018.

AST-008 utilizes Exicure’s proprietary spherical nucleic acid (SNA) technology designed in this case to agonize toll-like receptor 9, or TLR9, for application in immuno-oncology. Exicure has observed that administration of AST-008 as a monotherapy can have anti-tumor activity in colon cancer, breast cancer, lymphoma and melanoma mouse models. The company has also observed that, in preclinical studies in a variety of tumor models, AST-008 applied in combination with certain checkpoint inhibitors exhibited anti-tumor responses and survival rates that were greater than those demonstrated by checkpoint inhibitors alone.

Details on the poster presentation are as follows:

Title: TLR9 agonist SNA-induced innate and adaptive immune responses in tumor micro-environment enhance checkpoint inhibitor antitumor activity in mouse tumor models
Abstract No: 3758
Session Title: Immunomodulatory Agents and Interventions 1
Date/Time: April 17, 2018; 8:00 AM – 12:00 PM CT
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Full abstracts are available on the AACR (Free AACR Whitepaper) conference website at View Source

On April 16, 2018 A proprietary,precision cancer therapy platform from SRI International has reported that identified new molecular targets for the treatment and prevention of an aggressive and difficult-to-treat type of breast cancer (Press release, SRI International, APR 16, 2018, View Source [SID1234525359]). Subarna Sinha, Ph.D., bioinformatics program leader at SRI, presented new data describing the platform and the validated target today during a minisymposium at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

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Identification of new molecular targets for drug therapy is an area of active investigation and continued need in oncology. The Mining Synthetic Lethals (MiSL) platform offered by SRI may accelerate the discovery of new targeted oncology drugs by integrating a computational approach that mines patterns from primary tumor data with pre-clinical validation of potential targets.

The MiSL platform works by "looking" for synthetic lethal (SL) partners among primary tumor data and then validating them in vivo. Synthetic lethality offers a new approach to finding targeted therapies for previously "undruggable" tumor mutations. In SL interactions, a diseased cell with a mutation is dependent on a second gene for cell survival. Inhibiting activity of the second gene in these cells leads to cell death.

"If you can inhibit the SL partner, you can very exquisitely kill cancer cells," said Dr. Sinha. "MiSL overcomes the limitations of cell line screening methods such as shRNA and CRISPR, and has previously demonstrated ability to identify valid SL partners in multiple tumor types, including acute myeloid leukemia and kidney cancer. Today we presented the first data demonstrating the platform’s ability to identify new targets in triple-negative breast cancer."
BRCA1 is mutated in 15 to 20 percent of triple negative breast cancer (TNBC). SRI researchers used MiSL to identify and predict 22 SL partners of the BRCA1 mutation in TNBC, including XRCC6. To test the prediction that XRCC6 is an SL partner of BRCA1 in TNBC, SRI researchers examined the effect of inhibiting XRCC6 in a BRCA1-mutated TNBC cell line. The researchers found that this XRCC6 "knockdown" significantly increased cell death (37.3 percent) and reduced viability (50 percent reduction, p < 0.0001) as compared to controls. SRI researchers are testing the remaining SL partners identified by MiSL in an effort to expand the set of available molecular targets that may become the focus of new drug discovery projects.

"This platform opens the door for discovering new options to treat BRCA1-mutated breast cancers and could lead to new chemo-prevention strategies for individuals carrying germline BRCA1 mutations," added Dr. Sinha.

On April 16, 2018 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare diseases, reported data from a presentation at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, X4 Pharmaceuticals, APR 16, 2018, View Source [SID1234525412]) The data, generated from serial tumor biopsies and blood draws taken from melanoma patients, demonstrated dramatic infiltration and activation of cytotoxic CD8+ T cells and increased inflammatory status in the tumor microenvironment (TME) following once-daily oral administration of X4P-001-IO. X4P-001-IO is an investigational CXCR4 allosteric antagonist. Findings highlight single agent X4P-001-IO has the ability to help restore immunity within the TME and has the potential to enhance the anti-tumor activity of agents such as checkpoint inhibitors.

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Results from the tumor biopsies taken from melanoma patients before and after receiving single agent X4P-001-IO treatment for 3 weeks, were analyzed and presented. Single agent X4P-001-IO showed evidence of enhanced immune cell infiltration and activation in the tumor microenvironment, including:

Increases in proliferating CD8+ cells, indicative of cytotoxic T cell activation,
Increases in Granzyme B, a marker of immune-mediated cell killing,
Decreases in distance between CD8+ T cells and the nearest tumor cells, indicative of increased CD8+ T cell infiltration,
Increases in antigen presentation/processing gene expression, suggesting enhanced antigen priming and activation, and
Increases in the Tumor Inflammation Signature (TIS), indicative of increased inflammation status in the TME.
After single agent X4P-001-IO treatment, patients received X4P-001-IO in combination with Keytruda (pembrolizumab) for an additional 6 weeks. Continued signs of positive immune cell changes in the tumor microenvironment were seen. The combination of X4P-001-IO alone and in combination with Keytruda was well tolerated.

"These results demonstrate that CXCR4 inhibition substantially alters the tumor microenvironment in a way that is consistent with the emerging understanding of tumor immunity and inflammatory response," said Robert Andtbacka, MD, CM, a surgeon and investigator with the Huntsman Cancer Institute of the University of Utah, Associate Professor in the Division of Surgical Oncology at the University of Utah School of Medicine, and Principle Investigator of the X4P-001-IO study in melanoma.

In a separate poster presentation, preclinical findings showed that CXCR4 inhibition increases CD8+ T cells in the tumor microenvironment and has potent anti-tumor activity in the syngenic B16-OVA murine melanoma model. The anti-tumor activities were associated with the increase in immunostimulatory CD8+/Perforin+ cells and the reduction of immunosuppressive myeloid derived suppressor cells (MDSCs) and Treg populations in the tumor microenvironment.

"Results from these posters demonstrate the unique mechanism of X4P-001-IO, as it impacts critical aspects of immune cell trafficking, infiltration and activation – playing a positive role in tumor immunity," said Sudha Parasuraman, MD, X4’s Chief Medical Officer. "These data, together with X4P-001-IO’s favorable safety and tolerability profile, support the potential for X4P-001-IO to improve outcomes for patients with tumors that are less responsive to checkpoint inhibitors."

The posters were presented in the Immune Response to Therapy Session at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 14-18, 2018 in Chicago, IL.

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule inhibitor of CXCR4 (C-X-C receptor type 4) that regulates the tumor microenvironment thereby enhancing endogenous anti-tumor responses. CXCR4 is a chemokine receptor that modulates immune function and angiogenesis through the trafficking of key immune cells such as T- cells, dendritic cells, and myeloid derived suppressor cells. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment. X4P-001-IO is being investigated in three separate clinical studies in solid tumors.