MEDICAL

Mission Bio Announced the Launch of First Single-Cell Genomics Solid Tumor Solution on the Tapestri Platform

Mission Bio | March 30, 2022

Mission_Bio_Announced
Mission Bio, Inc., a pioneer in high-throughput single-cell DNA and multi-omics research, announced the commercial availability of the Tapestri Solution for Solid Tumor Research. On the Tapestri Platform, this new end-to-end single-cell DNA sequencing process comprises a nuclei isolation prep technique, pre-designed research panels for breast cancer and glioblastoma multiforme, and an enhanced single-cell copy number variation (CNV) bioinformatic analysis tool. Mission Bio currently covers solid tumors in addition to hematologic malignancies, where Tapestri is widely used to study tumor heterogeneity and gain new insights into the clonal variety and architecture driving disease progression, biomarkers, and therapeutic management.

Recent high-profile research studies utilizing custom Tapestri assays for breast cancer, non-small cell lung cancer, colorectal cancer, and melanoma have demonstrated the utility of high-resolution tools for assessing solid tumor heterogeneity and clonal evolution, which contribute to disease onset, progression, and relapse. However, bulk next-generation sequencing technologies cannot offer the cell-by-cell mutational data required to detect disease-causing biological drivers — they are confined to population-level average metrics and lack information on clonal diversity.

Tapestri quantifies DNA mutations at the individual cell level in thousands of cells simultaneously, simultaneously detecting SNVs, indels, and CNVs, conclusively identifying variant zygosity and mutational co-occurrence recognizing unusual cell populations. As a result, researchers studying solid tumors may now make use of a comprehensive workflow designed for the Tapestri Platform, which includes the following:

  • Sample preparation assistance with an enhanced nuclei isolation process for both fresh and frozen samples
  • New study panels for breast cancer and glioblastoma were meticulously selected to contain hotspot genes, copy number variants, and chromosomal arm aneuploidies linked with each illness. Additionally, users may create custom panels that target specific human or mouse genome regions.
  • Enhanced capacity for CNV bioinformatics analysis with the development of a new visualization tool (in collaboration with Mission Bio's Field Application Scientist team).

This integrated workflow approach has the potential to significantly advance our knowledge of disease progression and enable the development of more specific medicines.

The commercial introduction of Mission Bio's Tapestri Solution for Solid Tumor Research demonstrates the company's ongoing commitment to allowing more precise cancer research using single-cell DNA sequencing. In addition, mission Bio has announced the establishment of its first Center of Excellence for solid tumor single-cell DNA profiling at Memorial Sloan Kettering Cancer Center (MSKCC).

The impressive results already seen from our early work with solid tumor researchers helped guide the development of these new workflows and underscored our commitment to providing unique and indispensable tools for solid tumor researchers. Just as Tapestri has been an invaluable tool for hematologic malignancy researchers, we're confident that our research panel pair, new prep protocol, and improved bioinformatics analysis capabilities will demonstrate the platform's value in solid tumors."

CEO of Mission Bio, Yan Zhang, Ph.D., said.

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MEDICAL

Kintor Pharma Provides Update on One of its Three Multi-Regional Phase 3 Trials of Proxalutamide for COVID-19

Kintor Pharma | December 29, 2021

Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, provided an update on its multi-regional study of proxalutamide for the treatment of COVID-19 infection. Statistical criteria were not met at an interim analysis of the phase III outpatient study, designed for testing efficacy and safety of proxalutamide for treating COVID-19 in non-hospitalized COVID-19 patients. At the interim analysis, 348 patients with mild-to-moderate COVID-19 symptoms were enrolled. Kintor Pharma will seek for Health Authorities including the U.S. Food & Drug Administration's consent to amend the protocol and continue to enroll higher risk COVID-19 patients only with multiple comorbidities and/or patients with no COVID-19 vaccination history. Based on the interim analysis, there were no safety concerns and no drug-related serious adverse events reported during the study. As of December 23, 2021, Kintor Pharma had completed the enrollment of this pivotal study according to the original protocol. More than 95 percent of the enrolled patients were from the U.S. For the interim analysis, all patients were from the U.S., where the hospitalization rate is very low. "The COVID-19 pandemic continues to evolve with the Omicron variant highlighting the need for therapeutics. It is important to investigate new modalities to treat those infected with the virus. We believe proxalutamide could become an important tool in the fight against COVID-19 infection and will continue to investigate its use. We will provide updates on the final data analysis from this outpatient clinical trial in due course." Dr. Youzhi Tong, founder, Chairman, and Chief Executive Officer of Kintor Pharma The outpatient study is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of proxalutamide in outpatients with mild to moderate COVID-19 illness. For the interim analysis, the trial enrolled 348 male and female patients with one or more mild COVID-19-related symptoms within five days of symptoms onset. Participants were randomized to receive proxalutamide or placebo orally twice daily for 14 days. The enrolment covers the whole population including patients with a vaccination history, as well as without any risk factors. Both the treatment arm and placebo arm were given standard of care. The primary endpoint was the percentage of all-cause death and hospitalization for a period exceeding 24 hours by day 28. About Kintor's Multi-Regional Clinical Trials for Proxalutamide Kintor Pharma is conducting two registered Phase III multi-regional clinical trials of proxalutamide for the treatment of COVID-19 outpatients, and one Phase III MRCT for COVID-19 inpatients in countries and regions that include the United States, South America, Asia and the European Union. The second outpatient study plans to enroll 724 patients, with the primary endpoint of percentage of subjects requiring oxygen by day 28. The inpatient study is a randomized, double-blind, placebo-controlled Phase III study. Male and non-pregnant female hospitalized adults are included. The primary endpoint is time to sustained recovery, and the key secondary endpoint is percentage of all-cause mortality. Kintor Pharma was granted an emergency use authorization for proxalutamide for the treatment of COVID-19 infection in hospitalized patients in Paraguay. About Proxalutamide Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer. Targeting AR-ACE2/TMPRSS2 signal axis by proxalutamide could significantly inhibit the entry of the virus into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2. Proxalutamide promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, which inhibits the overproduction of IL-6, proinflammatory cytokines, and chemokines. This mechanism of action reduces the intensity of the cytokine response, which may be of clinical benefit to patients with COVID-19 infection. About Kintor Pharmaceutical Limited Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne.

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CELL AND GENE THERAPY

Enzychem Lifesciences Announces Formation of Corporate Advisory Committee

Enzychem Lifesciences | March 03, 2022

Enzychem Lifesciences a clinical-stage biotechnology company, announced today the formation of its Corporate Advisory Committee. Composed of four eminent physicians, its mission is to support and guide corporate activities including technology transfer for its lead compound, EC-18, seeking strategic partnerships, and preparing U.S. phase 3 clinical trials to successfully commercialize EC-18. After the completion of its phase 2 U.S. clinical trial with EC-18 in Chemoradiation–induced Oral Mucositis (CRIOM), Enzychem is actively negotiating licensing deals with several partnering candidates while also preparing a phase 3 trial under a US FDA IND. To reinforce such corporate initiatives, and to start supporting the company’s next stage activities, Enzychem has formed the Corporate Advisory Committee. Enzychem Lifesciences recognizes the need for engagement of key opinion leaders at an earlier stage in the process of developing new therapeutics for a large population with high unmet needs such as Chemoradiation-induced Oral Mucositis (CRIOM). Enzychem is proactively bringing more experts to the company to strengthen its new drug development capabilities. The newly appointed corporate advisors will actively influence the development of strong business strategies to successfully meet corporate objectives. The four physicians appointed are Dr. Alexander Fleming, a former FDA reviewer and supervisory medical officer, as head of the metabolic group, Dr. Frank Castellana, a market value assessment expert, Dr. Joe McMenamin, a health lawyer, and Dr. Richard Hamrick, a former healthcare provider executive. Based on their extensive experience, the corporate advisors will assist Enzychem in accomplishing its business milestones. For two years, until 2018, Dr. Fleming served as Enzychem’s Chief Technology Officer (CTO). During his term, Dr. Fleming had recommended CRIOM as the lead indication for EC-18 and introduced Dr. Steve Sonis of Harvard School of Dental Medicine as Enzychem’s key advisor for the U.S. phase 2 CRIOM Study. Enzychem Lifesciences is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for patients with unmet medical needs in oncology, metabolic, and inflammatory diseases. Founded in 1999, the company’s lead compound, EC-18, acts as an immunomodulator, facilitating the resolution of inflammation and the early return to immune homeostasis. Enzychem is headquartered in South Korea, with an office in the United States.

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INDUSTRIAL IMPACT

Agilent and A*STAR’s SIFBI Sign Research Collaboration Agreement to Advance Singapore Agri-Food Industry

Agilent Technologies Inc. | January 27, 2022

Agilent Technologies Inc. recently signed a Research Collaboration Agreement with the Singapore Institute of Food and Biotechnology Innovation outlining their collaboration on developing food research knowledge advancement over the next two years. SIFBI is a research institute under the Agency for Science, Technology, and Research in Singapore. This collaboration aims to bring state-of-the-art science and technology to drive innovation in food, nutrition, ingredients, industrial biotechnology, and related applications. In Singapore, Agilent has been actively contributing to research development over the last two years in food sustainability, security, and innovation to enhance the quality of life. This work supports the Singapore Government’s ambitious plan of producing 30% of the nation’s nutritional needs by 2030. "SIFBI's end-to-end capabilities in the food innovation value chain aim to support Singapore's food resilience and security through advancements in science and technology. Collaborating with industry in public-private partnerships is essential to not only achieve this but also level up together with our partners. This collaboration with Agilent aims to develop enhanced, more efficient methods of biochemical analysis that are crucial to accelerating our common drive towards innovative, nutritious future foods," Dr. Hazel Khoo, executive director of SIFBI “At Agilent, we are committed to accelerating knowledge transfer and investing in the communities where we operate. This latest agreement reflects the benefit we can bring to human health and the environment through translating research findings into healthy food. We believe this initiative will drive science advancement in support of Singapore’s growing food innovation ecosystem—ultimately satisfying the demand for safer, healthier, and more sustainable food, both regionally and globally,” said Chow Woai Sheng, vice president and general manager for Agilent’s global instrument manufacturing and Singapore country general manager. Agilent will supply the mechanical elements for early food research into target compounds and high-value ingredients in this collaborative effort. Agilent brings innovative thinking, multidisciplinary technology expertise, and training on world-class analytical development to help improve agri-food systems in Singapore. Through this agreement, Agilent’s goal is to re-imagine data optimization and analytics to drive prioritization on the population’s health sustainably. Since establishing its Singapore site in 1999, Agilent has grown its local team to over 800 scientists, skilled engineers, and employees—delivering trusted answers for Singapore, Asia Pacific, and globally. Its Singapore hub hosts a Global Solutions Development Center to advance integrated methodologies and novel applications working for projects worldwide. Agilent is also committed to the development of Singapore’s future talent. Agilent has launched an Agilent University offering more than 200 courses to build local capabilities, as well as a translational R&D facility to boost clinical diagnostics through biochemical innovation. These efforts support Agilent’s vision of growing strong local roots in key growth markets. About Agilent Technologies Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation toward advancing the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

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MEDICAL

Cardea Bio completes planned launch of CRISPR QC

Cardea Bio | April 06, 2022

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What is a genome, and how are traits passed from generation to generation? Learn how pea plants helped launch the study of genetics and how the field of genetics research has evolved over time.

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