ThinkCyte Inc. | July 12, 2022
ThinkCyte Inc., a biotechnology company pioneering novel cell analysis and sorting instruments, announced that applications of its Ghost Cytometry technology were presented at several leading industry meetings. In May, the company was selected to present applications of the platform to experts in drug discovery at the prestigious Keystone Symposia. The company was also selected to deliver a podium presentation at the 2022 International Association for the Advancement of Cytometry's annual meeting, sharing applications in clinical medicine and cellular therapy with a talk entitled 'Machine vision-based label-free cell analysis and sorting for clinical diagnosis and cell therapy.' The company and its Ghost Cytometry platform were also selected as one of three finalists for the Technology Showcase at CYTO, which highlights innovative and disruptive cytometric technologies.
"We are incredibly pleased to be able to share our most recent work using Ghost Cytometry with the broader scientific community. It's an exciting time to be in the field of drug and cellular therapy with innovative approaches being developed to extract novel information from cells. We look forward to showcasing more of our internal work and collaborations with existing partners in the months ahead."
ThinkCyte's CEO Waichiro Katsuda
Ghost Cytometry is a novel flow-cytometry based platform for cell analysis and sorting. Using a combination of proprietary optical designs and artificial intelligence, Ghost Cytometry provides researchers with an entirely new data lens for capturing complex single-cell phenotypes into a "cellular fingerprint" and enables the isolation of live target cells, untouched by external labels, for downstream research and development applications.
About ThinkCyte Inc.
ThinkCyte, founded in 2016 with offices in Tokyo, Japan and San Carlos, California is a biotechnology company that develops innovative instruments based on integrated, multidisciplinary technologies to enable life science research, diagnostics, and therapeutic development. The company pioneered Ghost Cytometry, a proprietary AI-based, label-free cell sorting technology and works with major global biopharmaceutical companies and leading academic research institutes to further drive pioneering research.
Aruna Bio | June 01, 2022
Aruna Bio, Inc., a leader in the development of neural exosome based therapeutics for the treatment of neurodegenerative diseases, today announced that it has received funding from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health of Health to advance AB126™, a multimodal neuroprotective and regenerative neural stem cell extracellular vesicle (NSC EV) product, to treat Traumatic Brain Injury (TBI).
The successful completion of the proposed study is intended to provide key information pertaining to AB126™ dosage, and therapeutic effects on TBI pathophysiology (edema, hemorrhage) and functional outcomes, toxicity, and potential adverse side effects.".
Aruna Bio Chief Scientific Officer, Steven Stice.
Traumatic brain injury (TBI) is a "silent epidemic" as 2.53 million patients visit the emergency department every year of which 56,800 patients die. We are pleased to receive this award from the National Institutes of Health, to further investigate the safety and efficacy of our AB126™ biologic. Our early proof of concept studies demonstrated significant efficacy in TBI indications, and the data generated from this new study is intended to support the basis for an IND submission and future clinical trials."
Stephen From, Aruna Bio's Chief Executive Officer.
About Aruna Bio
Aruna Bio is a leader in the development of neural exosomes for the treatment of neurodegenerative diseases. The company is utilizing its proprietary neural exosome platform and manufacturing capability to develop a pipeline of neural exosome-based therapeutics able to cross the blood brain barrier and enhance the body's anti-inflammatory, self-repair and protective mechanisms to treat a range of neurodegenerative disorders where significant unmet medical need exists today. Additionally, the company's neural exosome platform can be combined with therapeutics, such as small molecules, siRNAs and proteins, across the blood brain barrier and to the site of disease.
Lygos Inc | July 26, 2022
Lygos Inc., a vertically integrated biotechnology provider of sustainable specialty ingredients, and Flexible Solutions International Inc. a developer and manufacturer of biodegradable products, today announced that FSI has filed a registration statement on Form S-4 with the U.S. Securities and Exchange Commission on July 25, 2022 in connection with its proposed merger with Lygos.
On April 18, 2022, Lygos and FSI announced a definitive merger agreement in an all-stock transaction to form a leading sustainable specialty ingredient company for agricultural, industrial, and consumer applications. The merger transaction followed a fully funded $160 million of growth capital investment in Lygos. The agreement has been unanimously approved by the boards of directors of both companies and is subject to, among other things, the approval of Lygos and FSI stockholders and the satisfaction or waiver of other customary closing conditions.
FSI is an environmental technology company involved in research, development, and manufacturing of supplies that are designed to increase crop yield, conserve energy, and reduce environmental impact. Lygos’ proprietary fermentation technology platform, which utilizes the latest advances in bioengineering and data science to convert sustainable sugars into multi-functional organic acids, helps improve the performance of FSI’s biodegradable, water-soluble cleaning and water treatment solutions. These bio-based ingredients are designed to make existing products more sustainable, while also offering performance, supply chain, and environmental advantages over traditional industrial chemicals.
The registration statement on form S-4, which contains a preliminary proxy statement/prospectus, is available on the SEC’s website at www.sec.gov. These documents contain important information about Lygos, FSI, and the proposed acquisition. The registration statement has not yet become effective and the information contained therein and in the preliminary proxy statement/prospectus is subject to change.
Lygos has created a biological engineering platform focused on sustainable production of organic acid bio-monomers. Lygos’ bio-based ingredients offer alternatives to traditional industrial suppliers, enabling customers to create better, environmentally safer products.
Participants in the Solicitation
FSI and its directors and executive officers and Lygos and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of FSI in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the joint proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of FSI is also included in FSI’s Annual Report on Form 10-K for the year ended December 31, 2021.
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.
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.
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.