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 Guardant Health, Inc. (Nasdaq: GH) announced that the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has approved the Guardant Reveal liquid biopsy test for the detection and monitoring of minimal residual disease (MRD) in patients with early-stage cancer (stage II and III). Guardant Reveal is the first blood-only test able to detect, with 7-day turnaround time, a patient’s status for residual disease, without the need for a tissue biopsy.

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The Guardant Reveal blood test was introduced earlier this year and is Guardant Health’s first commercially available liquid biopsy for clinical use in the management of early-stage cancer. The test is focused first on one indication where the unmet medical need exists, early-stage colorectal cancer (CRC), with additional cancer types to follow. The Guardant Reveal blood test improves the management of CRC by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.1-6

The test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic and epigenomic alterations. The test accurately reports genomic alterations down to allele frequencies of 0.01 percent and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect residual disease in early-stage cancers including CRC.

"Securing New York State CLEP approval for Guardant Reveal means that oncologists in New York can now use the test to identify high-risk patients with colorectal cancer, our first indication, who may benefit from adjuvant therapy after surgery, and to detect recurrence earlier as part of regular surveillance," said, Helmy Eltoukhy, Guardant Health CEO. "This approval is consistent with our commitment to improving care for all cancer patients by expanding access to our tests by complying with appropriate clinical laboratory regulations."

There are over 1.5 million colorectal cancer survivors today in the U.S. and an estimated 10 percent to 30 percent of early-stage patients recur.8 An unmet medical need exists to offer new tests that can overcome the limitations of current tools.

On April 1, 2021 AbCellera (Nasdaq: ABCL) reported agreements to expand its collaboration with Gilead Sciences, Inc. (Gilead) including a multi-year, multi-target antibody discovery collaboration and access to AbCellera’s humanized mouse technology, the Trianni Mouse (Press release, AbCellera, APR 1, 2021, View Source [SID1234577539]). Under the financial terms of the agreements, AbCellera will receive an upfront payment and is eligible for milestone payments and royalties based on the development and commercialization of antibodies generated by AbCellera under this collaboration.

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Building on the successful completion of the first collaboration together, under the new agreement AbCellera will generate panels of antibodies for up to eight new targets, across multiple indications, selected by Gilead. The expanded collaboration will leverage the full breadth of AbCellera’s technology stack, including the recently added capabilities for sourcing diverse, fully-humanized antibodies using the Trianni Mouse platform and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.

"We are excited to build on the success of the first program and deepen our relationship with the team at Gilead," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We are particularly pleased to see the value created for our partners by quickly integrating the Trianni Mouse and OrthoMabTM platforms, which we acquired in second half of 2020."

AbCellera’s partners benefit from an operating system designed to support many antibody modalities, unlock new targets, and increase the speed and the probability of success of their therapeutic antibody discovery programs. AbCellera’s AI-powered technology stack brings together microfluidics, single cell analysis, machine learning, computation, custom robotics, and automation to compound the power of each step in the discovery process.