On January 14, 2020 GenScript Biotech Corp., a leading global biotechnology group and a pioneer in the field of gene synthesis, reported held its inaugural "Global Forum on Cell & Gene Therapy and the Booming China Market," during the JP Morgan Healthcare Conference week, attracting hundreds of industry leaders, investors and others to address the challenges and opportunities in this innovative field (Press release, GenScript, JAN 14, 2020, View Source [SID1234553191]).

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"As an industry, we are on the brink of achieving some extraordinary breakthroughs in cell and gene therapy for cancer and other diseases," said GenScript Biotech CEO Frank Zhang, PhD. "Four gene and cell therapies have recently been approved by the FDA, bringing new hope to patients, and this is only the beginning. Our vision is to make cancer a chronic or curable disease rather than a deadly one, and to transform the treatment of cancer, autoimmune and other diseases by leveraging the advantages of cell and gene therapy."

While significant advances are being made, the Forum also tackled some of the more pressing challenges, such as mitigating treatment side effects, improving treatment efficacy in solid tumors and scaling up manufacturing. Panelists from Kite Pharma, GE Healthcare Life Sciences, Ziopharm Oncology, Oxford Biomedica, Genethon, CARsgen Therapeutics, J&J Innovation Asia Pacific, the American Society of Gene & Cell Therapy, Loncar Investment, Lilly Asia Ventures, and many others participated in the event.

In the U.S. alone, the U.S. Food and Drug Administration is expected to approve 40-60 cell and gene therapies by 2030. During a panel discussion focused on regulatory issues, experts considered what regulators will need to do to keep up with the rapid pace of innovation, the new hospital-based regulatory pathway in China, how to ensure quality through the manufacturing process, and the challenges and opportunities that come with regulatory harmonization among different countries.

China continues to attract significant attention from industry and investors and is poised to grow even more. During his welcoming remarks, Zhang noted China’s emergence as a global economic leader, with a projected $1.1 trillion spend on healthcare this year, as well as the growing disease burden in China. By 2030, an estimated 4.3 million Chinese will be diagnosed with one of the 14 major cancers, according to research from IMS Health. Panelists addressed issues such as the amount of capital required to achieve scale in China, and advantages of the market in China.

"The drug development business is changing rapidly and China is at the fore in a number of ways," Zhang said. "Biotech and pharma companies do not need or desire to have the infrastructure to scale their drugs through commercialization. With lower costs, China is a natural place for companies to contract out costly development and manufacturing to organizations that have the expertise and experience to collaborate with them through the entire discovery to development lifecycle."

For its part, GenScript has put significant resources into its Contract Development and Manufacturing Organization (CDMO) business to meet the increasing demand. In 2018, the company officially launched its biologics CDMO segment, and last year opened a new GMP compliant biologics research center. GenScript is also leading the way in cell therapy through its antibody discovery service and plasmid and virus production capabilities.

In December 2017, Legend and Janssen, a Johnson & Johnson business, entered into a worldwide collaboration and license agreement to develop, manufacture and commercialize LCAR‐B38M (JNJ‐4528) in multiple myeloma. The companies are advancing this investigational B-cell maturation antigen (BCMA) targeted chimeric antigen receptor (CAR) T-cell therapy in previously treated patients with the disease. Clinical trials are ongoing in both the U.S. and China and the therapy has received orphan drug designation and breakthrough treatment designation from the FDA in the U.S. and PRIME designation from the European Medicines Agency.

GenScript is one of only a few Chinese companies to have a significant presence during JPM week. Based on the success of this year’s Forum and the interest in cell and gene therapy, GenScript will host its second annual Forum with influential leaders on the topic again next year during JPM week at the San Francisco Grant Hyatt.

On January 14, 2020 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its fourth quarter and fiscal year 2019 financial results after the market close on Monday, February 24, 2020 (Press release, Medpace, JAN 14, 2020, View Source [SID1234553190]). The Company will host a conference call the following morning, Tuesday, February 25, 2020, at 9:00 a.m. ET to discuss these results.

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To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 4168269.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Tuesday, February 25, 2020 until 12:00 p.m. ET on Tuesday, March 10, 2020. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 4168269.

On January 14, 2020 BostonGene Corporation (BostonGene), a biomedical software company, reported its collaboration with the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (Press release, BostonGene, JAN 14, 2020, View Source [SID1234553189]).

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BostonGene performs a computational analysis of a patient’s genomics and transcriptomics data from solid tumors including Lung Cancer and Head and Neck Cancer. In parallel, MGH VIC team conducts mass cytometry analysis of tissue of same patients. A correlation analysis is then employed to demonstrate the power of the computational algorithms in the assessment of the intratumoral cellular composition including stromal and immune components. The results of this collaboration highlight the powerful advantage of NGS data analysis in comparison to conventional techniques to more fully characterize the tumor.

Using small amounts of tissue, BostonGene provides an accurate, patient-tailored report for physicians. The report includes a visually-appealing and self-explanatory tumor schematics, called MF Portrait, depicting tumor activity, tumor cellular composition, activity of immune-microenvironment and other tumor-associated processes.

"Our collaboration with BostonGene is aimed at understanding the pathogenesis of each person’s cancer and ultimately having a positive impact on patient care by enabling personalized cancer treatments," said Mark Poznansky, MD, PhD, at Massachusetts General Hospital.

"BostonGene provides the solution necessary for oncologists to evaluate NGS data in combination with all relevant clinical knowledge to determine the best personalized care for the individual patient," said Andrew Feinberg, President and CEO of BostonGene. "We are excited to collaborate with VIC at MGH to demonstrate how our unique solution for tailored treatment options improves outcomes for cancer patients."

On January 14, 2020 Singapore-based precision oncology startup Lucence, reported on the heels of its series A funding, is sharing early data highlighting the capabilities of its liquid biopsy technology to detect somatic variants in patients with blood cancers, with excellent matching between bone marrow and blood (Press release, Lucence, JAN 14, 2020, View Source [SID1234553187]). Lucence’s amplicon-based sequencing technology, known as AmpliMARK, can provide high sensitivity mutation detection in blood for multiple solid tumor types. This new study data demonstrates the performance of AmpliMARK in hematological malignancies, and suggests that it can provide high resolution, target-rich insights for clinicians and patients to better, and less invasively, manage these diseases.

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Liquid biopsy aims to use blood as a platform for cancer screening, diagnosis, treatment, and monitoring. In the case of hematological malignancies like leukemia, current bone marrow-based tests for detecting and monitoring disease progression offer limited sensitivity and are highly invasive. Lucence’s findings suggest that a blood-based liquid biopsy test could be a compelling, highly sensitive clinical alternative to these tests.

Lucence’s poster highlighting their recent study results, Ultrasensitive Detection of Diverse Genomic Alterations in Hematological Malignancies using a Targeted Amplicon-based Sequencing Approach, will be presented Tuesday, January 14th at 4:15 pm Eastern Time at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Liquid Biopsies meeting in Miami. Based on a study of 65 patients with hematological malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma, the poster reports high sensitivity of AmpliMARK in detecting genomic alterations in blood and bone marrow samples. The study results show that AmpliMARK detects mutations at a sensitivity down to 0.1% variant allelic frequencies (VAF) and fusion genes like BCR-ABL1 down to 1% VAF. The results also show excellent concordance between bone marrow and blood, suggesting blood could be a viable medium of detection when marrow is challenging to obtain.

AmpliMARK uses a unique molecular bar-code and error correction technology that improves test sensitivity across multiple mutation types for single nucleotide variants and fusion genes. AmpliMARK is the foundational breakthrough technology in Lucence’s offering of blood-based tests for both profiling hematological and solid tumors.

Dr. Zi Yi Lim, senior consultant haematologist at the Centre for Clinical Haematology and study co-author, said, "Molecular diagnostics are an essential part of the workup and an important follow up tool in patients with blood cancers. Bone marrow assessments remain the gold standard investigation to evaluate the genomic disease profile of these patients. However, bone marrow assessments are costly, invasive and uncomfortable for the patient. The finding that Lucence’s technology can detect even low-level mutations in peripheral blood of patients with a high level of concordance to bone marrow is an exciting development. This could facilitate more convenient, cost-effective and regular disease assessments of such patients with a blood test."

Lucence is currently preparing to open their Silicon Valley laboratory to make their liquid biopsy tests more widely available to US clinicians and patients. While the Company’s initial focus in the US will be in profiling late-stage lung cancer patients for treatment selection, the data presented at the AACR (Free AACR Whitepaper) conference provides early validation of the core technology of Lucence’s liquid biopsy tests. Lucence announced their $20 million Series A led by IHH Healthcare, one of the world’s largest integrated private healthcare groups, in November 2019, and their executive team will be attending the upcoming 38th Annual J.P. Morgan Healthcare Conference in San Francisco.

On January 14, 2020 Celsee, Inc., a leading provider of single-cell isolation technology, and Kindstar Global, the largest medical esoteric testing service group in China, reported a purchase agreement to provide scientists at the Kindstar Laboratory System in China with Celsee’s Genesis System for monitoring circulating tumor cells (CTCs) in lung, breast, and bladder cancers as well as single-cell research (Press release, Celsee, JAN 14, 2020, View Source [SID1234553186]). In addition, Kindstar will become a distributor of Celsee’s products in China.

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For this cancer research, Kindstar scientists will use the BioINK kit, which was developed by IncellDx for CTC enumeration in therapeutic monitoring and is performed on Celsee’s Genesis System utilizing the Celselect Technology. Now, researchers will gain access to Celsee’s Genesis System, which has better capture efficiency and detection of CTCs compared to other CTC enumeration platforms.

"Kindstar Global is leading the way for oncology research and testing in China, and we are committed to implementing the most advanced tools for that work," said Dr. Shiang Huang, Founder and CEO of Kindstar. "We are truly impressed by the capabilities of Celsee’s single-cell isolation and enumeration technology and are eager to use it in our own laboratories as well as to make it available to scientists throughout China."

John Stark, Chief Executive Officer of Celsee, commented: "We are very excited to announce the partnership with Kindstar and the opportunity to bring Celsee technology to the clinical research market in China. Our team has worked closely with IncellDx to develop workflows that combine our single-cell tools with their flow cytometry classification assays and BioINK assays for CTC enumeration to assess disease progression and response to therapy."

Celsee’s technology enables high-throughput analysis of single cells with industry-leading capture rates. The Genesis System supports two slide technologies. Celselect slides enrich and enumerate CTCs with high capture efficiency and detection rates. Celsingle slides use a gentle, gravity-based method to capture and isolate thousands of individual cells while maintaining viability and structural integrity for robust downstream analysis in both genomic and proteomic applications and improved sensitivity compared to other single-cell technologies.