On March 31, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that company management will participate in the 1-on-1 meetings at the upcoming 19th Annual Needham Virtual Healthcare Conference from Tuesday, April 14, 2020 through Wednesday, April 15, 2020 (Press release, Personalis, MAR 31, 2020, View Source [SID1234556052]).

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On March 31, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that the U.S. Food and Drug Administration (FDA ) granted Fast Track designation to ME-401, MEI’s investigational selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta for the treatment of adult Patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies (Press release, MEI Pharma, MAR 31, 2020, View Source [SID1234556035]). MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), a Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma ("FL"). TIDAL is intended to support an accelerated approval marketing application with the FDA.

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"We are pleased to report that we have received Fast Track designation for ME-401. This designation holds several important advantages to expedite the development and regulatory review of ME-401 as we work diligently to deliver it as a new potential treatment option for patients and their physicians," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We remain very encouraged by the maturing body of ME-401 clinical data, and we are excited to continue expanding the opportunity that ME-401 holds to provide a meaningful impact in the treatment of B-cell malignances."

About Fast Track

Fast Track is an FDA program intended to facilitate the development and review of new drugs to address unmet medical needs for the treatment of serious or life-threatening conditions so that a product may get approved and therefore can reach the market expeditiously.

To qualify for Fast Track designation, a drug must address an unmet medical need, demonstrated by nonclinical or clinical data, in a serious condition, and show some advantage over any available therapy, such as:

Having an improved effect on serious outcome(s) of the condition
Providing comparable efficacy while avoiding serious toxicity that occurs with the available therapy or avoiding less serious toxicity that is common and causes discontinuation of treatment of the serious condition
Features of fast track designation include:

Actions to expedite a drug’s development and review by frequent interactions with FDA
A rolling review process in which a Sponsor, in agreement with FDA, may submit portions of its New Drug Application (NDA) in advance of submission of a complete application. However, actual review of submitted portions may not commence until an application is complete. The FDA review clock starts upon receipt of a complete application.
Fast track designated products are eligible for consideration of priority review if supported by clinical data at the time of NDA submission.

About ME-401

ME-401 is an oral, once-daily, selective phosphatidylinositol 3-kinase (PI3K) delta inhibitor in clinical development for the treatment of B-cell malignancies. MEI owns worldwide rights in all geographies except Japan, which we licensed to Kyowa Kirin Company in 2018.

MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma ("FL") after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, we are planning a submission with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H.

In addition to TIDAL, MEI is also conducting a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies such as Rituxan or agents such as Zanubrutinib in patients with relapsed or refractory B-cell malignancies.

On March 31, 2020 GenScript Biotech Corp. (Stock Code: 1548.HK), a leading global biotechnology company, reported full year 2019 financial results and provided a corporate update (Press release, GenScript, MAR 31, 2020, View Source [SID1234556053]). In 2019, overall revenue of the Group was approximately US$273.4 million, representing an increase of 18.4% as compared with that for the year ended December 31, 2018. Gross profit was approximately US$180.3 million, representing an increase of 13.8% YoY.

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GenScript’s four major business segments continued to grow steadily in 2019. Revenue growth was primarily attributable to the continued stable growth of life science products and services, an increase in contract revenue from Legend’s collaboration with Janssen on CAR-T cell therapy (JNJ-4528), the rapid conversion of biologics CDMO service backlog, and an increase in customers and their purchase volumes of industrial synthetic biology products.

GenScript has made significant investments in R&D in each of its business segments. During the reporting period, the Company’s R&D expense increased by 151.0% to US$186 million compared with 2018.

"GenScript’s current investments and our bold initiatives across all four business units are significantly advancing our long-term goals and illustrate our ongoing commitment to building a strong foundation for high-quality growth," said Dr. Zhang Fangliang, Founder, Chairman & CEO of GenScript, "We intend to continue to invest heavily in R&D, talent and facilities to drive the growth of each business segment."

Business Highlights – Legend Biotech and Cell Therapy

GenScript’s cell therapy program received multiple international designations for expediting clinical development, as the company prepared to spin off Legend Biotech as a publicly listed company.

The ongoing clinical trials for the B-cell maturation antigen (BCMA)-directed Chimeric Antigen Receptor T-cell (CAR-T) (BCMA CAR-T) program continued to proceed smoothly in the U.S. and China in 2019. The program has received Breakthrough Therapy Designation and Orphan Drug Designation from the US FDA, as well as PRIME Designation from EMA. Legend Biotech’s BCMA CAR-T product has also recently obtained Orphan Drug approval from European Commission, which will be announced by EMA soon.

In December 2019, at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) annual conference, Johnson & Johnson and Legend presented for the first time the latest Phase Ib/II pivotal trial data of CARTITUTE-1 on JNJ-4528’s efficacy and safety. JNJ-4528 showed excellent efficacy in the treatment of 29 patients with relapsed/refractory multiple myeloma (R/R MM). With a median follow-up of 6 months, a 100% overall response rate (ORR) was achieved. Legend Biotech anticipates filing a Biologics License Application (BLA) with the FDA by the end of 2020. Legend Biotech has ongoing IIT trials treating DLBCL, AML, gastric cancer and pancreatic cancer, and is also conducting IIT on allogeneic anti-CD20 CAR-T therapy. Furthermore, Legend Biotech expects to file IND for CD4 CAR-T treating TCL in the second half of 2020 and another IND for Ovarian cancer in the first half of 2021.

To date, the cell therapy business has achieved four milestones related to the BCMA CAR-T LCAR-B38M program and received milestone payments of 110 million USD from Jassen. Going forward, Legend Biotech is eligible for up to 125 million USD payment if certain manufacturing milestone is reached and additional up to 1.115 billion USD payments if other milestones are reached.

Recently, GenScript has obtained conditional approval from the Hong Kong Stock Exchange to spin off its cell therapy business and seek a public listing in the US. This is intended to enable operational focus and strategy development at both GenScript and Legend Biotech, better align management responsibilities and increase the financial and operational transparency for both GenScript and Legend Biotech. It is anticipated that after a potential Legend IPO, Legend will continue to be consolidated under GenScript Group. Existing GenScript shareholders, through their interest in GenScript, will continue to own a majority interest in Legend Biotech.

In addition, GenScript announced this morning that Legend has just closed a round of private financing, a syndicate of highly reputable institutional investors have agreed to invest approximately 150.5 million USD into Legend, this deal values Legend at approximately 1.95 billion USD on a fully diluted basis. This round of financing is co-led by Hudson Bay Capital, JNJ Innovation, and Lily Asia Ventures, other participating investors included Capital Group, Vivo Capital, and RA Capital. These pre-IPO investors can also choose to invest more into Legend at the IPO stage. This is endorsement for Legend’s technology and commercial potential in the future.

Business Highlights – Life Sciences, Biologics CDMO, Industrial Synthetic Biology

In addition to Legend Biotech’s progress in the cell therapy segment, GenScript’s other segments continued to grow steadily.

GenScript’s life science services and products segment, as the traditional business of the Company, remains a strong and stable revenue source for the overall business. GenScript has maintained its position as one of the world’s largest molecular biology CRO companies. In 2019, the Company continued to focus on successful commercial operations in synthetic biology. The Company has grown its commercial operations by establishing sites in Europe and Asia Pacific, organizing a new management team and a local team, building its brand and launching an online service platform. The Company expanded its gene synthesis throughput by 50% through investments in automation and maintained its number one market share position globally. Commissioning the production facility in Zhenjiang, along with the automated peptide production line, boosted production capacity.

By the end of 2019, revenue from life science services and products segment was approximately US$170.4 million, representing an increase of 20.9% as compared with approximately US$141.0 million for the year ended December 31, 2018. During the same period, the gross profit was approximately US$110.6 million, representing an increase of 15.7% as compared with approximately US$95.6 million for the year ended December 31, 2018.

In the biologics CDMO segment, the Company entered into significant collaborations at home and abroad and leveraged its R&D strength to efficiently expand capacity. Bringing in Berkeley Lights optofludic single cell platform, the company became the first CDMO in Asia Pacific to apply this global leading digital cell biology technology in the antibody development technology service. In late 2019, China’s largest plasmid and virus facility for clinical sample production began operations. During the reporting period, revenue from the biologics CDMO business was approximately US$22.5 million, representing an increase of 8.7% as compared with approximately US$20.7 million for the year ended December 31, 2018. During the same period, the gross profit was approximately US$7.0 million, representing a decrease of 20.5% as compared with approximately US$8.8 million for the year ended December 31, 2018. Total backlog for biologics development services increased by 172.9% from US$18.1 million from the year ended December 31, 2018 to US$49.4 million for the year ended December 31, 2019.

The Industrial synthetic biology products business continued its rapid growth. In 2019, the Company launched several innovative products and entered the bio-synthesis market, shifted its marketing strategy from a product seller to a solution provider in order to expand market share, and optimized the production process for cost reduction and quality improvement. During the reporting period, revenue from industrial synthetic biology products was approximately US$23.1 million, representing an increase of 30.5% as compared with approximately US$17.7 million for the year ended December 31, 2018. Excluding impact from foreign currency conversion, constant currency revenue increased by 34.6%. During the same period, the gross profit was approximately US$5.3 million, representing an increase of 112.0% as compared with US$2.5 million for the year ended December 31, 2018.

GenScript 2020

In January 2020, GenScript hosted the GenScript Biotech Global Forum during the J.P. Morgan Healthcare Conference in San Francisco, drawing thousands of attendees. According to media coverage, "At the top global industry event, GenScript’s role has changed from an attendee to a speaker to an independent sponsor… As an emerging innovative pharmaceutical company in China, GenScript is narrowing the gap in terms of global biological innovation… As China’s innovation ecosystem continues to improve, ‘China’s rising power’ will stand the test of time."

The life science services and products segment, GenScript’s traditional business, has significant growth opportunities around the world. GenScript will focus on expanding its industrial customer base, relying on the Europe and Asia Pacific Divisions to support global expansion, investing in automation to improve CRO business efficiency, and leveraging its leading R&D strength to develop higher industry standards.

The company’s cell therapy segment will focus on moving the BCMA program towards commercialization in last line R/R MM patients and clinical trials in earlier line MM treatment. The next-generation cell therapy pipeline will target malignant hematological tumors, solid tumors and infectious diseases, using autologous and allogeneic CAR-T technology. This will create new growth potential for Legend Biotech and help grow the business to become the world’s leading biopharmaceutical company.

GenScript’s Biologics CDMO segment has become a new growth driver of the Company. With well-defined strategic positioning, GenScript’s CDMO segment focuses on biologics CDMO and gene and cell therapy CDMO. The Company’s planned and implemented construction projects are intended to increase the GMP capacity to meet the manufacturing requirements of Phase I/II/III clinical trials and commercialization, to offer end-to-end biologics CDMO services to customers, and to make the Company a leading biologics and gene and cell therapy CDMO provider.

For the industrial synthetic biology products segment, the Company will continue to focus on industry key accounts, optimizing capacity, and combining R&D and applications to maintain rapid growth.

"GenScript aims to be one of the leaders in global gene and cell therapy in five years, while maintaining our leadership and commitment to our fundamental business of gene synthesis technology. In the next decade, our main course business will focus on biologics CDMO, cell and gene therapy, life science services and products, and bio-enzyme and synthetic biology products. To this end, we must invest resolutely. To make breakthroughs in the most prospective cell therapy for cancer treatment and even get far ahead, a Chinese biotech company must be committed to bold continued investment," said Dr. Zhang Fangliang.

On March 31, 2020 Driven by its Intelligent Cancer Care approach in developing new solutions that use advanced technologies like machine learning, Varian (NYSE: VAR), reported the newest release of its treatment planning system, Eclipse v16 (Press release, Varian Medical Systems, MAR 31, 2020, View Source [SID1234556038]). This new release includes intelligent features such as RapidPlan PT, the first clinical application of machine learning in proton treatment planning, and RT Peer Review, which is a collaborative workspace designed to streamline and accelerate the peer review process for radiotherapy treatment plans.

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Previously only available for photon-based radiotherapy treatment planning, RapidPlan is knowledge-based treatment planning software that enables clinicians to leverage knowledge and data from similar prior treatment plans to quickly develop high-quality personalized plans for patients. This knowledge-based planning software is now available for proton treatment planning with RapidPlan PT. The software also allows dose prediction with machine learning models that can be used as a decision support tool to determine which patients would be appropriate for proton or photon therapy. Varian is the first vendor in the industry to offer machine learning capability in both proton and photon treatment planning.

"With the number of operational proton treatment rooms continuing to increase, there is a need for experienced proton therapy clinicians," said Kolleen Kennedy, chief growth officer, president, Proton Solutions, Varian. "RapidPlan PT helps bridge the learning curve, allowing established centers to share their models and clinical experience. The machine learning in RapidPlan PT has the potential to reduce proton treatment plan optimization from a one to eight hour process, as reported by clinical proton centers, to less than 10 minutes, while also potentially improving plan quality."

In many radiotherapy departments, radiation therapy peer review meetings have been routinely integrated into the clinical QA process for safer healthcare delivery for the patient. Although the relevant patient information is manually retrievable from the clinical database, there is currently no efficient and effective platform to support these peer reviews. The RT Peer Review feature in Eclipse v16 is designed for the oncology community to seamlessly integrate this review process into their normal clinical workflow by automatically presenting the necessary information that is required for peer review.

On March 31, 2020 IONpath, Inc. reported that it has jointly produced with Bristol Myers Squibb an article entitled Multiplexed Ion Beam Imaging (MIBI) for Characterization of the Tumor Microenvironment Across Tumor Types (Multiplexed ionic ray images to characterize the tumor microenvironment in different types of tumors) for the journal Laboratory Investigation of the scientific journal Nature (Press release, IONpath, MAR 31, 2020, View Source [SID1234556054]).

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The ability to understand all cells present within a tumor by differentiating different cell types at the same time in a single tissue section has been limited by the technology available. In the article, the authors demonstrate how Multiplexed Ion Beam Imaging (MIBI ) technology (multiplexed ion beam images) is able to detail the characteristics of a wide variety of tumor types by providing identification of the cell phenotype along with the analysis of their spatial relationships. For this collaboration, Bristol Myers Squibb provided samples of 50 tumor biopsies to IONpath, which were simultaneously marked with a panel of 15 antibodies, each labeled with a specific metal isotope. The highly detailed mapping of the tumor microenvironment generated an immunological profile(fig. 1) and a spatial organization (fig. 2) through a multi-step process that segmented the sample to the individual cell.

Such information was collected as an exercise to observe the characteristics of the samples in question. However, the implications of this new level of tumor mapping at the cellular level can be far-reaching. Scientists and drug developers can now measure the proximity between immune cells and cancer cells. Within the same sample, they can also measure protein expression levels of potential drug targets and other variables associated with the response to certain therapies, such as those that target immunological checkpoints.

"IONpath’s mission is to enable medical discovery, specifically in the field of immuno-oncology, by characterizing the tumor microenvironment down to the cellular level," said Dr. Jessica Finn , director of pathology and one of the authors of the article. She added that "examining these detailed and interrelated structures is a difficult but important job in the fight to cure certain types of cancer."

Exemplifying how this mission for IONpath can impact on real-world decisions, the study demonstrated the possibilities for calculating distances between different cell subsets, including tumor and immune cells, as well as subsets of immune cells that express PD-1 and PD -L1. Further studies in this area can be designed to support better results in the field of immuno-oncology.