On April 1, 2021 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported the appointment of Jan M Van Tornout, MD, MSc, as acting Chief Medical Officer, effective April 1, 2021 (Press release, TYME, APR 1, 2021, View Source [SID1234577516]). Dr. Van Tornout will provide leadership and direction for all medical and related preclinical programs in development. He will be replacing Dr. Giuseppe Del Priore. "On behalf of the board of directors, we truly appreciate Giuseppe’s many contributions towards advancing our programs and we wish him continued success in his future endeavors," said Richie Cunningham, TYME’s CEO.

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Dr. Van Tornout brings over 25 years of medical experience in academia and industry, including over 15 years of global drug development in pharmaceutical and biotech settings and encompassing preclinical, IND, FIH, phase II-IV, (s)NDA, BLA, safety, medical affairs, clinical operations and regulatory experience. He has led clinical management and oncology teams at Natera, INOVIO Pharmaceuticals, Astellas Pharma, Bristol Myers Squibb and Amgen. Dr. Van Tornout has also served as a medical strategy consultant for various biotech companies including Cyclacel Pharmaceuticals, GlaxoSmithKline, Puma Biotechnology, Maverick Therapeutics, ERT, Huya Bioscience, and Gradalis.

Dr. Van Tornout previously held academic appointments at the University of Southern California (USC) with clinical appointments at Children’s Hospital Los Angeles as attending pediatric hematologist-oncologist. Dr. Van Tornout received his MD from the Katholieke Universiteit Leuven (KUL), Leuven, Belgium, an MS in classical philosophy from KUL, and a BS from the Faculté Notre-Dame de la Paix, Namur, Belgium. He obtained his certification as a paediatrician from the Gasthuisberg University Hospitals, KUL, and subsequently completed his training as a pediatric hematologist-oncologist at Children’s Hospital Los Angeles, USC. He earned an MSc. in applied biometry from USC and completed a post-doctoral fellowship in molecular epidemiology at USC. Subsequently his National Institutes of Health-sponsored laboratory focused on genetic epidemiology of childhood cancer (EWS) and the application of neural networks to the analysis of large pediatric cancer datasets.

"We are delighted and fortunate to be able to bring on an individual with Dr. Van Tornout’s vast experience at this important juncture for TYME. Jan has played an integral role in the approval of multiple drug candidates and has served as a key advisor in all facets of drug development. We will greatly benefit from his expertise on how best to advance our pipeline, as well as his guidance on the components that comprise high quality submissions to the FDA. We expect the end result to benefit both TYME and the patients we intend to help," said Richie Cunningham. Dr. Van Tornout stated, "I am excited to work with TYME and its leadership team during this pivotal period. TYME has multiple novel programs underway that have the potential to make a meaningful difference in the lives of many people with unmet medical needs. I am confident my background is very well-suited to help guide TYME in the next phase of clinical development across its various clinical and preclinical compounds."

On April 1, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported that Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer, and other members of the executive team will present at the following virtual banking and industry conferences (Press release, Synlogic, APR 1, 2021, View Source [SID1234577534]):

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20th Annual Needham Virtual Healthcare Conference: Dr. Brennan and Daniel Rosan, SVP & Head of Finance, will present at 3:00 pm on Monday, April 12, 2021.
Jefferies Microbiome-based Therapeutics Summit: Dr. Brennan will participate in a Fireside Chat that will become available on Thursday, April 22, 2021.
These are virtual events. A live webcast of the presentations, if available, can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.

On April 1, 2021 Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) reported it has acquired Zikani Therapeutics, Inc. in an all-stock transaction, with the potential to create a leader in ribosomal RNA-targeted therapies for treatment of rare diseases and oncology (Press release, Zikani Therapeutics, APR 1, 2021, View Source [SID1234577500]). Sumit Aggarwal, previously the President and Chief Executive Officer of Zikani, has been named President and Chief Executive Officer of Eloxx, and Vijay Modur, M.D., Ph.D., who was Zikani’s Chief Scientific and Medical Officer, has been named Eloxx’s Head of Research and Development.

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"With the strength of our ELX-02 program for cystic fibrosis, this acquisition provides us with the opportunity to amplify the potential of our innovative science by developing a new class of therapies to treat diseases with limited to no treatment options under the stewardship of leaders with a proven ability to translate technology into treatments for patients," said Tomer Kariv, Eloxx Chairman.

"We are excited about the potential of ELX-02 and combining the companies opens the door to build a leadership position in genetic therapy by rapidly developing treatments that can restore functional proteins in patients with nonsense mutations in their RNA," said Aggarwal. "The combined capabilities of Eloxx and Zikani in chemistry, biology, regulatory and drug development, including Zikani’s TURBO-ZMTM synthetic chemistry platform for designing macrolide-based Ribosome Modulating Agents (RMAs), along with a committed leadership team and talented employees, will further accelerate our ability to impact the lives of those who have rare diseases with the type of urgency and novel thinking that they deserve," added Aggarwal.

ELX-02 is currently in Phase 2 clinical trials in Cystic Fibrosis (CF) patients affected by nonsense mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The investigational therapy has shown strong activity across a full range of mutations in CF preclinical models. In Phase 1 testing, ELX-02 was generally well- tolerated and demonstrated high bioavailability with consistent pharamacokinetics across both single and multiple-dose studies.

"The Phase 2 trials are designed to validate the safety of ELX-02 and assess its biological activity. We look forward to completing enrollment in the first four treatment arms by mid-year and reporting data from these treatment arms in the second half of this year," said Dr. Modur.

In addition to CF, the company plans to file an IND in 2022 for what could potentially become the first oral therapy for protein restoration for patients with nonsense mutations in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB). RDEB is an incurable, extremely painful and often fatal skin blistering condition caused by a lack of collagen type VII that is estimated to affect more than 3,000 people worldwide. JEB is the most severe form of EB, with most patients dying in infancy.

By extending the application of ribosomal RNA modulation to the readthrough of nonsense mutations in tumor suppressor genes, the company is also rapidly advancing preclinical research for familial adenomatous polyposis (FAP), an inherited pre-cancerous colorectal disease frequently caused by nonsense mutations in the adenomatous polyposis coli (APC) gene.

Nonsense mutations cause approximately 10-12 percent of rare inherited diseases. ELX-02 along with the TURBO-ZM library of compounds are anticipated to significantly expand to include the treatment of many other rare diseases and certain cancers.

Acquisition Terms

Under the terms of the merger agreement, stockholders of Zikani received approximately 7.6 million Eloxx common shares and own approximately 16 percent of the combined company.

Board and Management Changes

In connection with the acquisition, Silvia Noiman, Ph.D., and Martijn Kleijwegt have stepped down from the Eloxx Board. Alan Walts, Ph.D., and Raj Parekh, Ph.D., who have both served as Zikani directors, were appointed to fulfill the vacancies and serve out the remaining terms of office.

"We’re pleased to welcome Sumit and Vijay to the Eloxx leadership team. They demonstrated their ability to transform Zikani by following the science and pursuing the creation of a new class of therapies on behalf of patients with unmet medical need. We want to extend our thanks and appreciation to Dr. Greg Williams for his stewardship of Eloxx and his commitment to advancing the critical work of the company. We are pleased that Greg will continue to advise Eloxx to facilitate a smooth transition," said Kariv.

Live Webcast: accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or by clicking here. A replay of this conference call will be available on the Eloxx and Zikani websites.

Leadership Profiles

Sumit Aggarwal

Sumit Aggarwal served as Zikani’s President and CEO. He has led the transformation of Zikani from an early-stage technology company to a development-stage rare disease and oncology-focused organization. Under Aggarwal’s leadership, Zikani has concentrated its focus on demonstrating pre-clinical proof of efficacy across several disease states using its TURBO-ZM technology platform.

In his more than 20 years in pharmaceutical and biotechnology commercial operations, investment management and management consulting, Aggarwal has been successful in transforming companies by re-invigorating innovation, growth and profitability, and raising capital for promising technology companies.

Prior to joining Zikani, he reinvigorated growth and profitability at Progenity, raised $125 million in capital and built a novel drug delivery-based GI pipeline. He also held leadership roles in healthcare and biotechnology at Adage Capital and as an Associate Partner at McKinsey & Company in its healthcare practice.

Aggarwal has an MBA with distinction from the Johnson School, Cornell University, and a Bachelor of Technology with Honors in Chemical Engineering from the Indian Institute of Technology, Kharagpur.

Vijay Modur, M.D., Ph.D.

Vijay Modur, M.D., Ph.D., served as Zikani’s Chief Scientific and Medical Officer and has led the scientific efforts to transform medicines based on ribosomal modulation using Zikani’s proprietary TURBO-ZM technology platform.

In his more than 20 years in pharmaceutical and diagnostic roles in R&D, he has successfully translated research discovery efforts into products that have impacted medical practice.

Prior to joining Zikani, Dr. Modur led the venglustat rare disease program at Sanofi across multiple rare disease indications into Phase 2 and Phase 3 clinical development along with leading other early development programs. Prior to Sanofi, he held leadership roles in HTG Molecular, Novartis Oncology and Merck Research Labs.

Dr. Modur obtained his MBBS from Karnatak University and his Ph.D. from the University of Utah. He was a resident in Clinical Pathology at Washington University School of Medicine where he also completed his post-doctoral fellowship.

On April 1, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that it will host a webinar featuring leading neuro-oncologists to discuss the use of the Company’s proprietary cerebrospinal fluid (CSF) assay for diagnosing and managing tumors that have metastasized to the central nervous system (CNS), including the brain or spinal column (Press release, Biocept, APR 1, 2021, View Source [SID1234577517]). Biocept’s CSF assay provides enhanced sensitivity compared with CSF cytology, the current standard of care, and has the added advantage of identifying actionable molecular targets for use in treatment decisions while providing quantitative information needed for assessing treatment response and monitoring disease progression.

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"Our goal is to establish our CSF assay as the new standard of care for the diagnosis of patients with suspected cancer metastasis to the CNS under National Comprehensive Cancer Network guidelines," said Michael Dugan, MD, Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. "We have already gained substantial interest among neuro-oncologists and other cancer specialists from nearly two dozen leading academic institutions across the country. Most of these physicians have already ordered our CSF assay with many becoming repeat users.

"The CSF assay addresses a high unmet clinical need as current diagnostic tools for patients with brain metastases are inadequate or imprecise for assessing therapy response; however, many therapies are now available that offer substantial promise for improved survival and resolution of symptoms," Dr. Dugan added. "Between 10% and 30% of adult patients with cancer, depending on the type, will develop brain metastases. We estimate this market opportunity at more than $1 billion annually."

Amir Azadi, MD is a medical oncologist specializing in neuro-oncology and an Assistant Professor in the Department of Neurology at Barrow Neurological Institute. His expertise includes the diagnosis and treatment of brain tumors. He is board certified in internal medicine and medical oncology by the American Board of Internal Medicine, and is a member of the American College of Physicians, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the Society of Neuro-Oncology. Dr. Azadi received his medical degree from Shahid Beheshti University of Medical Sciences in Tehran, Iran. He completed his residency in internal medicine at Banner – University Medical Center in Phoenix, and fellowships in hematology and oncology at the University of Louisville James Graham Brown Cancer Center and in neuro-oncology at Barrow Neurological Institute.

Nicholas Blondin, MD is Assistant Professor of Clinical Neurology at Yale School of Medicine. His clinical expertise is in treating benign and malignant brain tumors, brain and spine metastasis, and neurological symptoms of cancer such as seizures, cognitive impairment, headaches, gait disturbance and weakness. Dr. Blondin is an active investigator for clinical trials for brain tumor patients through Yale Cancer Center. He received his Medical Degree from the University of Connecticut School of Medicine and completed his neurology residency at Yale New Haven Hospital, where he was Chief Resident in Neurology, followed by a fellowship in neuro-oncology at Yale New Haven Hospital.

Priya U. Kumthekar, MD is a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist from Northwestern University and is serving as the principal investigator for Biocept’s Four C clinical study. She is dedicated to patient care and moving the study of brain tumors forward primarily through her leadership on clinical trials. Dr. Kumthekar serves in leadership roles with the National Clinical Trials Network, particularly with the Alliance for Clinical Trials, and was named as the Alliance’s national Executive Officer of Neuro-Oncology in 2016. In this role, she oversees the conception and development of clinical trials from early phase through registration studies. Dr. Kumthekar is board certified in neurology and is a member of the American Board of Psychiatry and Neurology. She received her medical degree from Northeastern Ohio University. She previously was Chief Resident at Northwestern University, McGaw Medical Center.

On April 1, 2021 Asgard Therapeutics reported that it was awarded with Sweden’s SWElife innovation grant. Swelife is a strategic innovation programe, funded by the Swedish Government via the Swedish innovation agency, Vinnova, and by the programe’s partners (Press release, Asgard Therapeutics, APR 1, 2021, View Source [SID1234580066]). Swelife supports collaboration within academia, industry and healthcare, with the goal to strengthen Life Science in Sweden and to improve public health.

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