On April 17, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) reported the presentation of preclinical data exploring the mechanism of action of APTO-253, the company’s clinical stage product candidate (Press release, Aptose Biosciences, APR 17, 2018, View Source;p=RssLanding&cat=news&id=2343016 [SID1234525432]). The data, demonstrating heightened sensitivity of BRCA1 or BRCA2 mutated cancer cells to APTO-253, were presented in a poster Tuesday, April 17 at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14-18, in Chicago, IL.

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The poster, entitled APTO-253 is a new addition to the repertoire of drugs that can exploit DNA BRCA1/2 deficiency, explored the mechanism of action of APTO-253, a small molecule with anti-proliferative activity against cell lines derived from a wide range of human malignancies. This study investigated the mechanism of action of APTO-253 to identify synthetic lethal interactions that can guide combination drug studies.

The research team found that APTO-253 stabilizes certain quadruplex DNA structures, causes DNA damage, and exhibits synthetic lethality comparable to olaparib – an FDA-approved targeted therapy that acts against cancers in people with hereditary BRCA1 or BRCA1 mutations, including some ovarian, breast and prostate cancers – albeit through a different mechanism. Unlike other drugs for which loss of this DNA repair function results in hypersensitivity, APTO-253 does not produce myelosuppression even at the maximum tolerated dose. The observations reported also identify γH2AX as a potential biomarker of clinical effect and open the window to more detailed studies of how APTO-253 promotes DNA damage and how it might be used clinically to treat patients with tumors harboring deficiencies in DNA repair.

The presentation will be published in the AACR (Free AACR Whitepaper) Conference Proceedings. The poster can also be accessed here or at the Publications & Presentations section of the Aptose website, www.aptose.com.
"We have clarified the mechanism of APTO-253 during the past year or so, including its mechanism to inhibit expression of the MYC gene, an oncogene that promotes tumor growth and resistance to drugs in AML and other cancers," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "AML remains our primary focus for APTO-253, and we hope to re-initiate dosing of AML patients with APTO-253 in an open phase Ib trial during the 2nd quarter of 2018. In the current presentation at AACR (Free AACR Whitepaper), we report that cancer cells deficient in the BRCA1/2 DNA repair functions are hyper-sensitive to APTO-253, analogous to the FDA-approved PARP inhibitor olaparib, but acting through a different mechanism. The findings reveal potential new solid tumor indications for APTO-253. Importantly, APTO-253 does not produce myelosuppression even at the maximum tolerated dose, which significantly distinguishes it from other cancer chemotherapies."

About APTO-253
APTO-253 is a clinical-stage small molecule targeted therapeutic agent that inhibits expression of the c-Myc oncogene, leading to cell cycle arrest and programmed cell death (apoptosis) in human-derived solid tumor and hematologic cancer cells, without causing general myelosuppression of the healthy bone marrow. The c-Myc oncogene is overexpressed in hematologic cancers, including acute myeloid leukemia (AML). Aptose researchers have reported the ability of APTO-253 to induce cell death, or apoptosis, in multiple blood cancer cell lines including AML, as well as in vitro synergy with various classes of conventional approved and investigational therapies for AML or myelodysplastic syndromes (MDS). New findings reveal that APTO-253 might also serve certain solid tumor patients with BRCA1/2 mutations, but without causing toxicity to the normal bone marrow functions.

On April 17, 2018 Elios Therapeutics, a biopharmaceutical company developing innovative particle-delivered, dendritic cell vaccines in oncology, reported initial open-label results from the ongoing Phase 2b clinical trial of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with stage III and IV (resected) melanoma (Press release, Orbis Health Solutions, APR 17, 2018, View Source [SID1234529911]). Results were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting held April 14-18, 2018 in Chicago, Illinois.

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"We are encouraged by these initial open-label results from our Phase 2b trial which demonstrate a compelling safety profile and provide early evidence that the TLPLDC vaccine may enhance the efficacy of commonly used FDA-approved systemic therapies, including checkpoint inhibitors," said George E. Peoples, M.D., chief medical officer at Elios Therapeutics. "We look forward to continuing our assessment of the TLPLDC vaccine in this ongoing study as we evaluate opportunities for further clinical development of combination therapies."

In an ongoing prospective, randomized, double-blind, placebo-controlled Phase 2b trial, patients with resected Stage III and IV melanoma were randomized (2:1) to received either TLPLDC vaccine or placebo to prevent recurrence. All patients who recurred on the trial (met study endpoint) were then offered open-label TLPLDC along with standard of care therapy as determined by the patient’s treatment team.

The initial open-label results presented were from 22 patients. Seven patients had their recurrences resected and were treated with the TLPLDC vaccine to prevent a second recurrence. At 12.5 months of median follow-up, only one patient has recurred.

The remaining 15 patients were on a variety of FDA-approved systemic therapies for their non-resectable recurrences. Of these patients, two patients withdrew from the study and one was not treated. In the remaining 12 patients treated with the TLPLDC vaccine in combination with their standard of care systemic therapy, two patients had a complete response (median follow-up 8.6 months), seven had stable disease and two had progressive disease. One patient progressed initially on TLPLDC vaccine alone but was converted to a complete response once checkpoint inhibitor therapy was initiated. Importantly, the addition of the TLPLDC vaccine did not increase the toxicity of checkpoint inhibitors, BRAF/MEK inhibitors, or TVEC in these patients.

To view the full abstract, please visit the AACR (Free AACR Whitepaper) website at View Source

About TLPLDC
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is an autologous, personalized, therapeutic cancer vaccine designed to stimulate the immune system to recognize tumor cells and fight a patient’s specific cancer. TLPLDC is made from the patient’s own tumor cells and dendritic cells – the most potent antigen-presenting cells in the body. Once TLPLDC is injected, the tumor lysate-loaded dendritic cells present the tumor antigens to the immune system, stimulating the induction of tumor-specific, activated T cells that are able to find and destroy tumor cells that may remain in the body. TLPLDC is currently being studied as a monotherapy and in combination with standard of care checkpoint inhibitor therapy in a Phase 2b clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.

On April 16, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported in a late-breaking poster session the presentation of new research from Endocyte’s chimeric antigen receptor T-cell (CAR T) adaptor molecule (CAM) platform at the AACR (Free AACR Whitepaper) Annual Meeting 2018 in Chicago, IL (Press release, Endocyte, APR 16, 2018, View Source [SID1234525341]).

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"We are pleased to present data that support the utility of our unique CAR T platform, which potentially enables us to control cytokine release syndrome (CRS), manage T-cell exhaustion and address heterogeneity in both solid and liquid tumors through the administration of multiple CAMs," said Chris Leamon, vice president, research and development of Endocyte. "These findings are critical towards identifying the dosing regimen and confirming the anti-tumor activity of EC17/CAR T, our folate-targeted CAM-based therapy, as we look to initiate a phase 1 trial in osteosarcoma later this year."

Endocyte’s CAM-based therapies consist of a single universal autologous CAR T-cell, designed to bind with high affinity to FITC. This universal CAR T-cell can be specifically directed to cancer cells through the administration of a bi-specific adaptor molecule targeted to both FITC and a tumor target, which acts to bridge the universal CAR T-cell with the cancer cells. This allows for control of the antigen target through the administration of the CAM, in contrast to current CAR T-cell therapies, in which the antigen targets are not controlled.

The data presented at AACR (Free AACR Whitepaper) show that EC17 penetrates solid tumors within minutes and is retained due to high affinity for the folate receptor (FR), while unbound EC17 rapidly clears from the blood and receptor-negative tissues. When tested against human xenografts, EC17/CAR T-cell therapy has shown consistent antitumor activity with low or no adverse reactions. For translation into first-in-human testing, clinically relevant dosing regimens were evaluated using tumor-free and tumor-bearing mice to study CAR T-cell proliferation, cytokine production and the onset/mitigation of CRS. Preclinically, EC17/CAR T-cell therapy has demonstrated meaningful efficacy against some of the more aggressive and chemo-resistant FR+ tumors of various histology.

Although CRS could be triggered in this study, it could also be mitigated, or even prevented, using intermittent dosing and/or dose titration of the EC17 CAM. Under extreme conditions where dose cessation failed, intravenous sodium fluorescein (NaFl) could be used as a fast-acting rescue agent to temporarily displace CAR T-cells from their targets and reverse the CRS.

Website Information
Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

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.