On July 21, 2020 BostonGene Corporation (BostonGene), a biomedical software company focused on defining optimal precision medicine-based therapies for cancer patients, and NEC Corporation (NEC; TSE: 6701), a leader in IT and network technologies, reported a collaboration to conduct cancer patient analysis treated under NEC’s clinical trials (Press release, NEC, JUL 21, 2020, View Source [SID1234562133]). This collaboration brings together NEC’s artificial intelligence (AI)-driven approach to cancer immunotherapy with BostonGene’s sophisticated analytical tools.

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Under the terms of the collaboration agreement, BostonGene will perform tumor molecular profiling and microenvironment analysis for cancer patients identified in trials by NEC and or NEC affiliates across cancer types and disease stages. The collaboration aims to provide molecular characterization of patient tumors for improvement of treatment response, both in clinical trial settings and beyond.

BostonGene’s solution integrates next-generation sequencing (NGS) obtained from a patient’s tumor with a reference cohort of data from patients with similar diagnosis, simultaneously analyzing tumor and tumor microenvironment activity. The solution will identify all significant somatic alterations, protein expression, activity of tumor promoting and suppressing processes, tumor microenvironment cellular composition, tumor heterogeneity, tumor clonality, hereditary predisposition, viral infestation and pharmacogenomics among other molecular features.

"We are very excited to partner with NEC," said Andrew Feinberg, President and CEO at BostonGene. "The collaboration between NEC and BostonGene demonstrates the combined commitment to delivering truly breakthrough therapies that identify personalized, effective treatments to dramatically improve patients’ chances for survival and quality of life."

"We are partnering with BostonGene because of its advanced patient analysis services," said Osamu Fujikawa, Senior Vice President at NEC Corporation. "The strategic collaboration with BostonGene is reflective of our mission to improve cancer patient outcomes. BostonGene’s innovative data analytics platform combined with NEC’s cutting-edge AI technology gives us the tools needed to focus on advancing treatment options for cancer patients."

On July 21, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, and ImaginAb, Inc., a company that harnesses the specificity of monoclonal antibodies, reported that they have entered into a collaboration agreement to develop new targeted theranostic (diagnostic and therapy) products for a broad range of cancer types (Press release, ImaginAb, JUL 21, 2020, View Source;utm_medium=rss&utm_campaign=clarity-pharmaceuticals-and-imaginab-to-collaborate-on-new-cancer-targets [SID1234562118]).

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Clarity and ImaginAb will combine their proprietary technologies to develop novel minibody and cys-diabody radiopharmaceutical products using Clarity’s copper chelators to fully exploit the benefits of the theranostic pairing of copper-64 or copper-67.

ImaginAb’s CEO, Ian Wilson, said, "ImaginAb designs and engineers small, highly targeted proteins known as minibodies and cys-dibodies coupled with radioisotopes to image important molecular targets using standard Positron Emission Tomography (PET). We are excited to work together with Clarity on expanding the utility of ImaginAb’s technologies and entering the field of targeted radiotherapy."

Dr Alan Taylor, Clarity’s Executive Chairman, commented, "This collaboration will enable us to bring together ImaginAb’s unique expertise in designing minibodies, which are used to ensure rapid and highly specific targeting of tumours, with Clarity’s chelator technology, which will allow us to fully exploit the perfect pairing of copper-64 for diagnosis and copper-67 for therapy.

"The teams at Clarity and Imaginab are already working together to explore the synergies of combining their expertise in lead generation, manufacture, regulatory frameworks and clinical development to fast-track new theranostic products which will be the future of therapy. Combined, the companies will pursue their ultimate goal of developing better treatments for children and adults with cancer", Dr Taylor added.

On July 20, 2020 ISA Pharmaceuticals’ Chief Scientific Officer Professor C. Melief reported that it will present at the 33rd edition of the IPVC (Press release, ISA Pharmaceuticals, JUL 20, 2020, View Source [SID1234565549]).

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Title: Immunotherapy: Progress in the clinic

Date and time: Wednesday, 22 July 2020 at 18:45 – 19:05 CEST.

Author: Professor Cornelis Melief

Webcast:View Source

On July 20, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that four posters highlighting XERMELO (telotristat ethyl) will be presented at the virtual Cholangiocarcinoma Foundation Annual Conference (July 22-24) (Press release, Lexicon Pharmaceuticals, JUL 20, 2020, View Source [SID1234564395]).

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Kim, R. et al. Telotristat Ethyl and First-Line Chemotherapy for Advanced Biliary Tract Cancer (TELE-ABC): Safety Results of a Phase 2 Trial
Kim, R. et al. The TELE-ABC Clinical Trial: A Novel Drug in Combination with Chemotherapy for Advanced Biliary Tract Cancer (Presentation at Patient Session)
Wilson, A. et al. Antitumor Activity of Telotristat Ethyl in Combination with Gemcitabine and Cisplatin in Tumor Cell Line Xenograft Models
Awasthi, N. et al. Antitumor Efficacy of Telotristat Ethyl in Combination with Cytotoxic Therapy in Preclinical Cholangiocarcinoma Models*
*Investigator-initiated study (IIS) supported by a Lexicon Pharmaceuticals IIS grant

About XERMELO (telotristat ethyl)
Discovered using Lexicon’s unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

XERMELO (telotristat ethyl) Important Safety Information
Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

On July 20, 2020 Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, reported that David Meeker, M.D., the Chairman of Rhythm’s Board of Directors, has been appointed as the President and Chief Executive Officer (CEO) of the company, effective immediately (Press release, Rhythm Pharmaceuticals, JUL 20, 2020, View Source [SID1234562167]). Dr. Meeker succeeds Hunter Smith, the Company’s Interim President and CEO and Chief Financial Officer (CFO), who will continue in his role as CFO.

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"I am delighted to announce David’s appointment as Rhythm’s new CEO," said Hunter Smith, CFO of Rhythm. "Since he joined our Board in 2015, David has played a key role in shaping the clinical and commercial strategy for setmelanotide and in fostering our collaborative and patient-focused culture. As we continue to work toward the first potential approval of setmelanotide in pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities later this year, David’s extensive experience leading commercial organizations and managing the launches of new medicines for rare genetic diseases, coupled with his proven ability to build strong relationships with patient and clinician communities, will be invaluable. The Rhythm team is energized by the opportunity to work more closely with David in an effort to deliver setmelanotide and potentially transform the care of people living with rare genetic disorders of obesity."

"Rhythm is an exciting company that I have long admired, both for its scientifically-rigorous approach to drug development and its commitment to patients with rare genetic disorders of obesity," said David Meeker, M.D. "With setmelanotide, we have the opportunity to bring one of the first meaningful therapeutic candidates to a segment of that community in dire need. Moreover, we hope our efforts will create visibility for rare genetic disorders of obesity, enabling better care for the people affected and catalyzing ongoing research efforts globally. The current management team has done a great job leading the organization through the transition and I am honored to take the CEO role."

Dr. Meeker has served as Chairman of Rhythm Pharmaceuticals since April 2017 and as a member of the Board since November 2015. Most recently, he served as President and CEO of KSQ Therapeutics. Previously, Dr. Meeker was the Executive Vice President and Head of Sanofi Genzyme, the specialty-care global business unit of Sanofi that focuses on rare diseases, multiple sclerosis, oncology and immunology. Dr. Meeker joined Genzyme in 1994 as Medical Director and, over the course of his tenure, served the company as Vice President of Medical Affairs, Chief Operating Officer, and Chief Executive Officer. He led Genzyme’s commercial organization and global market access functions and managed the launch of several treatments for rare genetic diseases, including Aldurazyme, Fabrazyme and Myozyme. Prior to his tenure with Genzyme, Dr. Meeker was Director of the Pulmonary Critical Care Fellowship at the Cleveland Clinic and an Assistant Professor of Medicine at Ohio State University. Dr. Meeker earned his M.D. from the University of Vermont Medical School and completed the advanced management program at Harvard Business School.