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.

On July 20, 2020 Bioniz Therapeutics, Inc., a clinical stage biopharmaceutical company developing first-in-class peptide therapeutics that selectively and simultaneously inhibit multiple cytokines to treat immuno-inflammatory diseases and cancers, reported encouraging interim clinical data from its Phase 1/2 open-label clinical study of its lead product candidate BNZ-1 in patients with refractory Cutaneous T-Cell Lymphoma (rCTCL) (Press release, Bioniz Therapeutics, JUL 20, 2020, View Source [SID1234562144]). BNZ-1 is a multi-cytokine inhibitor targeting interleukin (IL)-2, IL-9, and IL-15, that has been successfully studied in two phase 1 studies in healthy volunteers where it demonstrated a favorable safety profile, dose proportionality and exposure-dependent pharmacodynamic activity .

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This study followed a phase 1/2, multi-center, open-label, dose-escalation clinical study of BNZ-1 and was designed to assess its safety and activity as a single systemic agent in rCTCL patients that have failed standard of care and other available treatment options. The study was designed to recruit a total of 15 patients across 4 doses of 0.5, 1, 2, and 4 mg/kg for intravenous weekly dosing. The primary endpoint was overall safety after 4 weeks of treatment. There was a 3-month treatment extension to further evaluate safety and clinical response. Long term extension was available for patients who benefited from BNZ-1 treatment.

Whereas efficacy was observed in all cohorts, the 2 mg/kg cohort was expanded to 19 patients based on a favorable initial clinical response. Overall, BNZ-1 was well tolerated with no dose-limiting toxicities. On average, these rCTCL patients had failed 7 prior skin-directed and systemic therapies. The 2 mg/kg cohort showed signs of clinical improvement with BNZ-1 treatment, as follows:

Over 80% of subjects showed some improvement in tumor burden as assessed by the modified severity weighted assessment tool (mSWAT) score in the absence of any concomitant therapy
About half achieved a partial response (at least a 50% reduction from baseline) in mSWAT score
5% of subjects achieved a complete response
For subjects achieving a partial or complete response, the mean duration of response was 277 days (9.2 months) at the time of the data cut off for this interim analysis
Dr. Christiane Querfeld, Director of the Cutaneous Lymphoma Program at the City of Hope, who was the principal investigator of this study, stated "I am pleased with the interim results of the BNZ-1 trial in a highly refractory patient population. Based on this interim analysis, BNZ-1 appears to be safe and well tolerated in CTCL patients. In this trial, BNZ-1 has shown efficacy in heavily pretreated and/or advanced stage patients who have failed standard of care and investigational drugs available to them. As a physician, I look forward to the continued development of BNZ-1 and hope to eventually have this drug in my practice to treat and manage my CTCL patients."

"Together with our investigators, we are excited to see the potential clinical benefit of BNZ-1 in highly refractory CTCL patients," said Dr. Nazli Azimi, Founder, President and Chief Executive Officer of Bioniz Therapeutics. "We are eager to further advance the clinical development of BNZ-1 towards approval in CTCL and to evaluate its potential clinical efficacy in other dermatological diseases such as alopecia areata and vitiligo." She added "these data provide additional validation of our platform technology and our approach for multi-cytokine inhibition".

Bioniz expects this study to conclude in early Q3 of this year and will submit a request for an end of phase 2 meeting in Q4. Based on the outcome of this meeting, Bioniz anticipates starting phase 3 in 1H 2021.

About T-Cell Leukemia and Lymphoma
T-cell leukemia and lymphoma include a group of rare and often aggressive diseases, including CTCL with limited treatment options and a poor prognosis. Bioniz’ product candidate BNZ-1 is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in this T-cell malignancy.

About BNZ-1
The Company’s lead development candidate, BNZ-1, is a PEGylated peptide that functions as a selective and simultaneous inhibitor of cytokines IL-2, IL-9, and IL-15. BNZ-1 is currently under investigation in a phase 1/2 clinical trial for refractory Cutaneous T-Cell Lymphoma (rCTCL) and Large Granular Lymphocyte (LGL) Leukemia (www.clinicaltrials.gov identifier: NCT03239392).