On August 24, 2021 GenScript Biotech Corporation (HKEX: 1548.HK), a leading global technology and service provider of life science R&D and manufacture, reported its first half 2021 financial results for the six months ended June 30 (Press release, GenScript, AUG 24, 2021, View Source [SID1234586858]). It also announced that the Group has expanded its presence in the gene and cell therapy (GCT) industry, with aggressive investments from the Group’s life science services and products business, biologics CDMO business, and cell therapy business.

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In the first half of 2021, the Group maintained strong momentum across all business segments. Total revenue increased by 38% to USD 229.6 million, and gross profit increased by 28.1% to USD 138.6 million.

The Group’s non-cell therapy business revenue increased by 36.6% to USD 195.7 million, with gross profit of USD 104.7 million, a 23.0% YoY increase. This impressive success was driven by the launch of new products, advanced sales capability and capacity expansion, including its GCT CDMO business’ historic breakthrough in explosive revenue growth. This built on the Group’s early investments in the field and advantages in plasmid and lentivirus R&D and manufacturing solutions. For the Group’s cell therapy business, revenue increased by 46.8% YoY to USD 33.9 million, benefitting from continued recognition of its successes and milestone investments.

As the world’s No. 1 gene synthesis supplier, GenScript Biotech has been dedicated to the gene synthesis business for more than one decade and continues to hone its competitive edge in the field. It has laid a strong technical foundation for its GCT business, which also serves as a major revenue stream for the Group. As GenScript Biotech’s life science services and products business, biologics CDMO business, and cell therapy business are all achieving strong momentum and investing aggressively in the GCT industry, the Group’s is expanding its presence throughout the GCT value chain.

GenScript Biotech has been continuing its strategic investments in R&D and innovation. In the first half of 2021, R&D expenses increased by 51.6% YoY to USD 175.1 million. The non-cell therapy business invested about 10% of its revenue in GMP facility construction and other infrastructure expansion. The cell therapy business spent USD154.5 million on R&D, a 52.1% YoY increase, with an investment focus on clinical studies of cilta-cel and manufacturing facilities that support the business’ ongoing clinical trials and future commercialization.

GenScript Biotech is ushering in the rise of GCT as the next biotech industry revolution, tapping into the huge potential of CRO and CDMO platforms. Over the next two to three years, the life science business and biologics CDMO business will increase their strategic investments into the field. This includes investments in GCT-related ssDNA and sgRNA services, utilizing automation technology to upgrade production lines, and accelerate the launch of ongoing cell therapy products and R&D in new pipelines.

"While the global pandemic continues to impact the world and the life science community, GenScript Biotech was able to harness opportunity to maintain strong momentum. We especially made rapid progress GCT-related products and services, a key strategic field for the Group. This was made possible by our unwavering dedication to the frontier of life science technology and our market insights. As we look ahead, GenScript Biotech will continue to invest aggressively in the GCT industry to meet booming demand and fulfill our mission to make people and nature healthier through biotechnology," said Dr. Patrick Liu, Rotating CEO of GenScript Biotech.

First Half 2021 Business Highlights by Segment

The life science services and products business reported a remarkable boost in the first half of 2021. Revenue increased by 32.2% YoY to USD 152.0 million, and operating profit before unallocated central expenses and share based compensations increased by 25.5% to USD 55.2 million, maintaining great profitability.

The business has also further diversified. Gene synthesis services increased in cost efficiency, while services in protein, peptide, antibody and oligo businesses were also expanding fast, becoming the Group’s second growth driver.

Gene synthesis service costs were successfully reduced by about 10%. To enhance these services, GenScript Biotech built a fully-automated gene synthesis production line covering 5,000 square feet in the US, which is expected to increase its capacity tenfold, and save transportation costs and lead time for overseas customers.
Gene editing business increased by over 65% YoY.
Oligo business increased by over 90% YoY.
To support protein production capacity, GenScript Biotech will launch two facilities in Shanghai and Singapore.
Apart from gene synthesis services, the life science services and products business is also accelerating development across the GCT industrial chain, strengthening GenScript Biotech’s presence in this field. In the coming years, the business will deepen its investments in two GCT directions: customized products and services to meet GCT needs, including developing laboratory-level ssDNA and sgRNA, reagents and instruments; and specification upgrades made possible by industrial line automation to improve market share and profitability.

GenScript ProBio, the biologics CDMO business, generated USD 31.5 million in revenue, a 65.8% YoY increase, in the first of 2021. Gross profit yielded USD 10.0 million, representing a 112.8% YoY increase, and gross margin rose from 24.7% last year to 31.7% this year. Revenue growth was mainly driven by successful ongoing antibody CDMO projects and rapid expansion of the GCT CDMO business.

The business has advanced its capabilities in challenging molecule development, driving revenue from antibody and protein CDMO services to increase by 58.3%. Revenue from emerging GCT CDMO services skyrocketed YoY, maintaining GenScript ProBio’s leading position in the GCT CDMO industry:

In terms of plasmid services, GenScript ProBio is the only company in China equipped with a GMP certified linearized plasmid production platform. GenScript ProBio has virtually cornered the pre-clinical and clinical plasmid supply market for mRNA vaccine R&D companies in China.
On viral vectors, GenScript ProBio developed China’s first proprietary lentivirus suspension production platform, with a virus yield that is equivalent to or higher than that of the most widely used cell line on the market. The business will also soon be launching its proprietary AAV suspension production platform.
With its independent financing capabilities, GenScript ProBio is prioritizing investments in capacity upgrades and infrastructure for its both GCT CDMO business and antibody CDMO business.

The second GMP certified plasmid facility in Zhenjiang, China, is expected to be up and running within the year, which will enable GenScript ProBio to more than double its current plasmid production capacity.
A new R&D building in Nanjing will be added to further enhance GenScript ProBio’s antibody discovery and development capabilities in upstream services.
The biologics fill-and-finish line is now under construction and is expected to be operational in the second half of 2022 to better meet customer needs for commercial production.
A 12,000 L-capacity production center in Zhenjiang, China is under construction to accelerate capacity expansion in commercialization.
Legend Biotech, the cell therapy business, continued to progress in the first half of 2021 and yielded USD 33.9 million in revenue, a 46.8% YoY increase, mainly from amortization of upfront and milestone payments received from its collaboration with Johnson & Johnson. Legend’s R&D expenses rose to USD 154.5 million in the first half of 2021, mainly on cilta-cel clinical trials in the US and China.

As Genscript Biotech continues to expand its business in the GCT industry, Legend Biotech has leveraged cilta-cel to enhance its in-depth industry experience and insights, which also betters the Group’s understanding of client demands in its non-cell therapy business. Legend Biotech is expected to obtain commercialization approval for cilta-cel from the US FDA for end-line treatment before the end of this year. Legend will submit BLAs for cilta-cel in China and Japan in the second half of 2021, and strives to acquire commercialization approval in Europe and China in 2022.

The company also has several CAR-T therapies in the pipeline targeting hematologic malignancies, solid tumors and infectious diseases, along with a variety of autologous CAR-T, allogenic CAR-T and TCR-T R&D platforms. Legend Biotech is pushing forward its LB1901 program for the treatment of refractory and recurring T-cell lymphoma.

In addition, Legend Biotech has established production facilities in New Jersey (US), Belgium (Europe), and Nanjing (China), expanding its capacity for upcoming global commercialization.

Bestzyme, the industrial synthetic biology products business, generated USD 18.0 million in revenue, a 60.7% YoY increase, and USD 5.1 million in gross profit, a 18.6% YoY increase. Revenue growth was mainly driven by a series of new product launches and continued implementation of major account strategies. In the future, Bestzyme plans to deepen its reach in the F&B, home care and chemical substitution fields. By leveraging synthetic biology, the company aims to construct new functional proteins and functional small molecules to create new value for its customers.

On August 24, 2021 GT Medical Technologies, Inc. reported it is presenting clinical data in two oral presentations on the company’s breakthrough GammaTile Therapy for patients with brain tumors at the 2021 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting (Press release, GT Medical Technologies, AUG 24, 2021, View Source [SID1234586857]). The presenting authors, Dr. David Brachman, co-founder and CTO at GT Medical Technologies and Dr. Mehee Choi, director of Medical Affairs at GT Medical Technologies, will discuss new data in patients with recurrent glioblastoma (GBM), and access-to-care for patients with resectable brain tumors.

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GammaTile is an implantable radiation therapy consisting of bioresorbable collagen tiles embedded with Cesium-131 sources provided by Isoray, Inc. It is the first medical device cleared for brain tumor treatment in the U.S. in the last ten years. "GammaTile Therapy improves the lives of patients with newly diagnosed malignant and recurrent brain tumors," said Matthew Likens, president and CEO of GT Medical Technologies, Inc. "Data presented at AANS highlights clinical efficacy of the therapy, but also important access-to-care and quality-of-life benefits that GammaTile provides these patients. It’s the first device of its kind, and its ability to deliver safe and effective Surgically Targeted Radiation Therapy (STaRT) for patients is groundbreaking in the neuro-oncology community."

The in-person AANS meeting was cancelled due to Covid-19. As the pandemic disrupts travel and events, it is vital to remember that cancer treatment is not elective. GammaTile is a one-and-done radiation option for patients with brain tumors that eliminates the need for daily, ongoing radiation treatments. Patients receive ongoing, therapeutic radiation from the safety of their own home, protecting them from unnecessary exposure to Covid-19, and delivering life-extending treatment. This and other access to care benefits will be featured in the abstracts presented at AANS.

Register today here and watch the following oral presentations online:

"Resection and Surgically Targeted Radiation Therapy (STaRT) for treatment of recurrent GBM," presenting author: David Brachman, MD, Radiation Oncologist, GT Medical Technologies, Inc.
"Access to specialty radiotherapy care for patients with resectable brain tumors," presenting author: Mehee Choi, MD, Radiation Oncologist, GT Medical Technologies, Inc.
In addition to the abstracts presented at the AANS Annual Scientific Meeting, GammaTile Therapy was featured in two scientific abstracts at the 2021 Society of Neuro-Oncology (SNO) Conference on Brain Metastases last week. Read the following abstracts online:

"A multicenter observational study of Cs-131 seeds embedded in a collagen carrier tile for newly diagnosed and recurrent operable intracranial neoplasms –Trial in progress," presenting author: Erin Dunbar, MD, Neuro-Oncologist, Piedmont Atlanta Health, Atlanta, GA
"Intracavitary carrier-embedded Cs131 brachytherapy for recurrent brain metastases: A randomized phase II study," presenting author: Nelson Moss, MD, Neurosurgeon, Memorial Sloan Kettering Cancer Center, New York, NY

On August 24, 2021 Investigators at Nagourney Cancer Institute in collaboration with colleagues at the Federal University of Sao Paulo, Brazil, University of California, Irvine and Todd Cancer Institute reported in a paper published by Gynecologic Oncology that metabolic signatures found in the blood of gynecologic cancer patients can identify those at the highest risk of relapse (Press release, Nagourney Cancer Institute, AUG 24, 2021, View Source [SID1234586855]). The results could herald a future in which oncologists could use a blood test done at the time of diagnosis to better manage patients with advanced gynecologic malignancies.

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Platinum resistance, defined as the lack of response or evidence of clinical relapse within six months of platinum-based chemotherapy, is an important determinant of survival in gynecologic cancer.

"We used quantitative Mass Spectrometry to identify metabolic signatures that predict platinum resistance in patients receiving chemotherapy for ovarian and uterine cancers," said Dr. Robert Nagourney, Founder and Medical Director of the Nagourney Cancer Institute. "The study provides a window into human biology that offers the opportunity for better patient outcomes and more rapid and efficient drug targeting."

With the growing interest in human metabolism as an important component of cancer biology, this study in gynecologic cancer is the most recent of several of the team’s analyses in breast cancer, multiple myeloma and other cancers that confirms metabolomics’ role as one of the most promising platforms in cancer research.

In the study, 47 patients with adenocarcinoma of the ovary or uterus who were candidates for carboplatin plus paclitaxel submitted blood for quantitation of metabolites and surgical specimens for the isolation 3-dimensional organoids used to measure individual patient platinum resistance, ex vivo. Results were correlated with response, time to progression and survival.

The study identified patients with the highest risk of relapse and death with a sensitivity of 92 percent and a specificity of 86 percent.

"With such insight, we are on the cusp of more accurately determining the best course of treatment for those with gynecologic tumors," said Dr. Nagourney.

On August 24, 2021 Atavistik Bio ("Atavistik", "Company"), a pre-clinical biotechnology company pioneering the identification of metabolite-protein interactions that have the potential to lead to the discovery and development of first-in-class drug candidates powered by distinct allosteric control mechanisms, reported that the Company had completed a $60 million Series A financing round (Press release, Atavistik Bio, AUG 24, 2021, View Source [SID1234586854]). The financing was led by The Column Group and joined by Lux Capital, and Nextech Invest, Ltd.

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The new financing will support development of Atavastik’s drug discovery platform, and future identification of select drug candidates based on deep knowledge of disease relevant pathways that have evolved over millions of years by nature to be allosterically regulated by metabolites.

The Company will be helmed by John A. Josey, PhD, Acting CEO of Atavistik Bio, who was formerly CEO at Peloton Therapeutics, which was acquired by Merck in 2019. Dr. Josey is an experienced CEO with a long track record of novel drug discovery. Marion Dorsch, PhD, has been appointed President and CSO. Dr. Dorsch is a highly accomplished scientist and senior executive with more than twenty years of biotech and pharma experience in oncology, inflammation and rare genetic diseases. She is known for her innovative drug discovery that has contributed to several accelerated drug approvals in oncology. Prior to this role, Dr. Dorsch was CSO at Blueprint Medicines.

"Our unique approach marries a validated platform with structure-aided drug design capabilities and cutting-edge insights into the regulation of metabolic systems, which will be applied to genetically validated targets in metabolic disease and cancer," said John A. Josey, PhD, CEO of Atavistik Bio and Venture Partner at The Column Group. "We are delighted to gain the support of such an esteemed collection of venture investors in our quest to find first-in-class drug compounds in metabolic diseases and cancer."

Atavistik was co-founded by prominent scientific investigators and members of the Howard Hughes Medical Institute. Atavistik’s platform is built on technology developed by co-founder Jared Rutter, PhD, Professor of Biochemistry at the University of Utah. Professor Rutter is well-known for his work regarding novel protein metabolite interactions that has resulted in identification of novel allosteric regulatory sites for proteins of interest in disease. Additionally, co-founder Dr. Ralph DeBerardinis, MD, PhD is a professor at the University of Texas Southwestern Medical Center. He is a leading medical geneticist with a deep understanding of human metabolism with a focus on pediatrics. Dr. DeBerardinis still attends to patients and has a unique understanding of the high unmet need in this critical area of human health. The co-founders will stay closely involved with the scientific direction at Atavistik as advisors.

"Atavistik has a differentiated platform that has tremendous potential to identify novel regulatory sites to tackle the underlying cause of many diseases," said Marion Dorsch, PhD, President and Chief Scientific Officer, Atavistik Bio. "Our technology was founded by a leading metabolism expert and validated by the discovery of numerous known and novel metabolite-protein interactions. We look forward to building on this technology and utilizing our drug discovery platform to identify first-in-class drug candidates."

"Atavistik has positioned itself at the forefront of allosteric regulated metabolic drug discovery, a novel and exciting new area of drug discovery and medicine, that has immense potential," said Tim Kutzkey, Managing Partner at The Column Group and Atavistik Bio board member. "The company is built around Marion’s drug-discovery expertise and successful track record of bringing experimental medicines to market quickly. She will be joined by a team of experts in metabolism and a robust investment syndicate that will support Atavistik’s scientific focus."

Atavistik has opened a new office in Cambridge at 38 Sidney St. To learn more, please visit AtavistikBio.com.

On August 24, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that it will host its fifth annual virtual R&D Day for analysts and investors at 8:00 a.m. ET on Thursday, September 9 (Press release, Moderna Therapeutics, AUG 24, 2021, View Source [SID1234586853]).

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Moderna’s R&D Day will include presentations from Stéphane Bancel, Chief Executive Officer, Paul Burton, M.D., Ph.D., Chief Medical Officer, Stephen Hoge, M.D., President, clinical team leaders and key opinion leaders with a focus on the Company’s clinical development pipeline.

Register for the virtual event here. The webcast will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.