MEDICAL

Genetic Leap and Astellas Establish Research Collaboration to Develop RNA-targeted Small Molecules for Oncology Target

Genetic Leap | March 11, 2022

Genetic_Leap_and
Genetic Leap today announced a research collaboration agreement with Astellas Pharma, Inc. to develop novel RNA-targeted small molecule therapeutic candidates against an undisclosed oncology target.

Under the terms of the agreement, Genetic Leap will deploy its platform to discover and validate RNA-targeted small molecules against an undisclosed oncology target selected by Astellas. The agreement provides Astellas with certain rights to intellectual property on candidates discovered and developed under the collaboration that are directed against the program target. Further details of the collaboration were not disclosed.    

About Genetic Leap
Genetic Leap's vision is to lead the next giant leap in human healthcare by developing today the incredible therapeutics of the future. To accomplish this, Genetic Leap built paradigm-shifting AI technologies that find the causal factors in disease and correct these factors with precision RNA therapy that is safe, convenient, and reversible. The company is leveraging its platform to advance a pipeline that spans internal as well as partnered programs, across both novel and known (but traditionally undruggable) targets.

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INDUSTRIAL IMPACT

Cyclica launches Perturba Therapeutics, a spin out from the University of Toronto, creating the next-generation oncology biotech

Cyclica Inc. | February 10, 2022

Cyclica Inc. a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, launches Perturba Therapeutics Inc. a spin out from the Stagljar Lab at the University of Toronto, Donnelly Centre for Cellular and Biomolecular Research. Perturba is advancing a rich pipeline of assets from undrugged protein-protein interactions (PPIs). Only a small subset of biologically important drug targets are currently being explored within the pharma industry. Perturba is taking this challenge on by integrating Cyclica’s comprehensive AI-augmented proteome-wide drug design technology with two first-in-class live cell-based assays from the Stagljar Lab. With this integrated AI-augmented drug design and empirical phenotypic approach, Perturba is developing precision therapies that modulate PPIs and PPI-mediated biological processes with a focus on difficult-to-treat cancers. Perturba will initially focus on advancing two EGFR triple mutant inhibitors for non-small cell lung cancer, and four programs targeting small GTPases for various intractable cancers. Naheed Kurji, Co-Founder, CEO and President of Cyclica indicates that “More than half of all human disease-related proteins are considered undruggable using conventional approaches. As a result, patients suffering from life threatening diseases are left waiting for treatment. What others view as “undruggable”, we see as potential. Perturba represents an important franchise in the pursuit of our cancer strategy. We’re so excited to partner with Professor Stagljar and the world class Stagljar Lab in driving forward our shared vision.” "over the past two years, my lab has developed two high impact, live cell-based technologies for studying protein-protein interactions and identifying novel drug molecules – MaMTH-DS and SIMPL. Combining these two technologies with Cyclica’s world-class AI-drug design approach will usher in a new way to conduct drug discovery for highly intractable targets in an unprecedented way at scale. I’ve known Naheed and the team at Cyclica for years and jointly have shown multiple proof points using our platforms with a program targeting an osimertinib resistant EGFR triple mutant that we will be progressing in Perturba, and a program targeting an oncogenic KRAS in a separate collaboration that gave us confidence to target other small GTPases in Perturba.” Dr. Igor Stagljar, Professor at University of Toronto’s Temerty Faculty of Medicine and Principal Investigator at the Donnelly Centre Seasoned drug developer Rick Panicucci, PhD, SVP at BridgeBio Pharma and a long time advisor at Cyclica has been appointed as non-executive Chairman of Perturba to help oversee the company's strategy. Su Dharmawardhane Flanagan, PhD, Tony Hunter, PhD and Ming Tsao, MD, have been appointed to Perturba’s Scientific Advisory Board. Cyclica will provide initial funding for Perturba and will seek external funding from strategic partners as required. “I’ve been involved in drug discovery & development for over 25 years. What I can say with certainty is that the way things will be done going forward is going to be very different from how it was done before. I’ve been an advisor at Cyclica for 6 years and have witnessed first hand the power of AI and data-first approaches to drive drug discovery fast and with quality. Now, with Perturba and integrating AI drug design and phenotypic assays opens a whole new way of design-make-test-analyze at scale for target classes that have been ignored for too long,” shares Panicucci. About Perturba An integrated oncology focused biotech company for unaddressable and undrugged targets. Founded in 2021 as a venture between Cyclica and the Stagljar Lab at the University of Toronto, Perturba integrates Cyclica’s AI-augmented drug discovery platform with sensitive, live-cell drug screening assays, MaMTH-DS and SIMPL from the Stagljar lab. Perturba is developing precision therapies at scale that modulate PPIs and PPI-mediated biological processes. About Cyclica Cyclica advances molecules that embrace the complexity of disease. A neo-biotech whose work spans dozens of collaborations with large pharma, biotech and several joint ventures. We are a passionate team of biotech and pharma professionals, biologists, chemists, and computer scientists who live and labour at the intersection of our collective expertise. About the Stagljar Lab and the Donnelly Centre The Stagljar lab at the University of Toronto is one of the world leading labs in the field of proteomics/chemical genomics, developing high-throughput technologies to facilitate the study of the protein-protein interactions (PPIs) of various human membrane proteins involved in cancer and rare genetic diseases such as cystic fibrosis. The Stagljar lab is currently directing major proteomics/chemical genomics projects to map how integral membrane proteins interact to produce either healthy or diseased cells, to identify novel therapeutic targets, and to screen for novel drugs using artificial intelligence platforms, in particular to target lung, colon, breast and pancreatic cancer. In close collaboration with medicinal chemists and clinical investigators, the Stagljar lab investigates the molecular mechanisms behind challenging, unexplained observations on drugs and on pathological events.

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INDUSTRY OUTLOOK

Curocell, Breaks Ground on 'CAR-T Manufacturing GMP Facility'

Curocell, Inc. | December 24, 2021

Curocell, currently on PhaseⅠCAR-T Therapy clinical trial with CRC01 has recently broken ground for the new CAR-T Center in Dungok Residential & Industrial Area in Daejeon International Science & Business Belt. The GMP Facility for commercial manufacturing CAR-T Cell therapy and R&D Center for further pipeline development are constituting the 17,325 square-meter site of CAR-T Center. By the first half of 2023, construction is expected to be completed and in 2024, when the CAR-T Center is fully operational, supply of advanced cure should be possible for patients in pain. Also, Curocell is expecting to expand their business to global market by in-housing all processes of CAR-T therapy development and production. About CRC01 (anbalcabtagene autoleucel) CRC01, recognized CD19 and is based on OVIS™, a first-in-class CAR-T platform. OVIS™ technology downregulates PD1 and TIGIT expression on CAR-T cells. Through overcoming the immune suppression by PD-1 and TIGIT ligands, OVIS™ CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. Phase II clinical trial of CRC01 will start in South Korea in the first half of 2022. About Curocell Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVIS™ technology with the goal of improving clinical efficacy of CAR-T therapies.

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Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy

Illumina | May 27, 2022

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling. TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment. This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina's broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine, We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don't want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy." Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa. Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient's biopsy, to inform treatment with larotrectinib. Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer, The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for VITRAKVI is an important advance in enabling precision oncology for patients in Europe. Assays that enable precision oncology through comprehensive genomic testing are crucial for informing optimal treatment plans and help to ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions." Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Bayer's Oncology Strategic Business Unit. The performance of TSO Comprehensive (EU) with NTRK fu­sions was assessed by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687), were used to demonstrate the clinical effectiveness and safety of TSO Comprehensive (EU) in identifying NTRK1, NTRK2 and NTRK3 gene fusion positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was the overall response rate (ORR), measured as the patient presenting either a complete response, a surgical complete response or partial response, to larotrectinib. We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel, TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines." Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

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DIAGNOSTICS

NEOGEN® and Gencove Launch InfiniSEEK™ -- The First Whole Genome and Genotyping Sequencing Solution for Cattle Breeders

NEOGEN | May 16, 2022

NEOGEN® Corporation (NASDAQ: NEOG) and Gencove, the leading low-pass whole genome sequencing and analysis software company, today announced the launch of InfiniSEEK™, an innovative, cost-effective solution for whole genome sequencing and targeted SNP analysis. Combining NEOGEN's world-class genomic solutions and services with Gencove's low-pass sequencing and analytics software, the solution can deliver genomic insights to help advance cattle breeding programs worldwide. NEOGEN offers innovative, high quality, value-added genomic technologies to the agrigenomics industry, With the launch of InfiniSEEK, our customers now have a data-rich, cost-efficient way to get genome-wide sequence data, specific genetic traits, and parentage markers simultaneously with excellent accuracy to characterize cattle across the world. We are excited to add this new solution to NEOGEN's portfolio." Dr. Jason Lilly, NEOGEN's Vice President of International Business. Gencove developed a process that simultaneously yields low-pass whole genome sequencing and high coverage genotyping at pre-selected loci in a single molecular reaction, InfiniSEEK is NEOGEN's first commercial product built on the Gencove software and analysis platform, and we are thrilled it will be deployed through NEOGEN's best in class genomics offering services." Dr. Joseph Pickrell, co-founder and CEO of Gencove. With InfiniSEEK, the industry now has a platform to: Minimize selection bias by sequencing more or all of a population Discover new traits impacting desired phenotypes Reliably manage more than 400 bovine genetic traits and conditions InfiniSEEK has been rigorously validated, and results demonstrate low-pass genome-wide sequencing to be greater than 99 percent concordant to deep whole-genome sequencing and can offer even higher, clinical-grade accuracy at specific regions of interest. About Gencove With additional opportunities to improve human health and the challenge of feeding the world's growing population, demand for genomic information has skyrocketed. To meet the need, Gencove combines low-pass whole genome sequencing (reading the DNA at shallower depths) with a proprietary software-as-a-service computation layer. The result is a high-throughput, cost-effective, accurate sequencing and analysis solution. As evidence of the technology's value, the company has hundreds of customers, and the largest genomics service providers in the world partner with Gencove. About NEOGEN NEOGEN Corporation develops and markets comprehensive solutions dedicated to food and animal safety, operating with the intention to "everyday, protect the people and animals we care about." The company's Food Safety segment markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases, and sanitation concerns. NEOGEN's Animal Safety segment is a leader in the development of genomic solutions along with the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care, and disinfectants, as well as rodent and insect control solutions.

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