On August 24, 2021 Fusion Antibodies and Eurofins Discovery reported that sign co-marketing agreement to support timely and cost-effective development of innovative products for the benefit of global healthcare (Press release, Fusion Antibodies, AUG 24, 2021, View Source [SID1234586841])

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Fusion Antibodies are delighted to announce that is has entered into a commercial collaboration with Eurofins, a Eurofins Scientific SE group company; a leading provider of products and services to the drug discovery industry.

As leading global innovation-driven and customer-focused providers of antibody development services, Fusion Antibodies and Eurofins share common values in the culture of collaboration and the pursuit of scientific excellence and together, they aim to provide laboratories worldwide with high-quality, cost-effective and efficient services that work seamlessly with one another to support biotherapeutic discovery.

Under the agreement, Fusion Antibodies will provide comprehensive pre-clinical antibody development services from discovery, engineering, and critical reagent supply to Eurofins so that together they can provide a complete workflow solution for busy researchers. This includes Fusion Antibodies services for antibody generation, characterization, sequencing, engineering and expression, and Eurofins Discovery’s in vivo and in vitro services, such as efficacy models, bioanalytical services, biomarker development, phenotypic assays and safety assessment.

Commenting on the partnership, Dr Richard Jones, CEO of Fusion Antibodies, said:

"We are delighted to enter into this commercial collaboration with Eurofins which leverages the respective expertise of both partners, delivering on both our strategic objectives as well as providing a full client service package.

Eurofins are an established global provider of testing and laboratory services, and this partnership is a natural fit with Fusion’s mission to enable pharmaceutical and diagnostic companies to develop innovative products in the most efficient and cost-effective way."

Dr Julie Gormley, Commercial Senior Director of Fusion Antibodies, said: "This partnership brings together two world leaders in their respective fields and will enable scientists to focus on their research while our services ensure efficient and robust results. I look forward to working closely with colleagues at Eurofins Discovery throughout 2021 and beyond."

The collaboration between Fusion Antibodies and Eurofins Discovery will last for an initial two-year period and is a commitment to provide world-class scientific expertise, next-generation technology, and guidance to accelerate the delivery of the best possible antibody against a broad range of targets and therapeutic areas into the clinic.

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 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate, for an initial Phase 1/ 1b clinical trial that will evaluate the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients (Press release, Bio-Path Holdings, AUG 24, 2021, View Source [SID1234586842]).

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"AML patients that fail frontline venetoclax-based therapy have very poor prognosis with a median overall survival of less than three months and a novel treatment modality is urgently needed for such patients. Preclinical studies indicate that the BP1002 and decitabine combination is effective against venetoclax-resistant cell lines, suggesting that the BP1002 and decitabine combination therapy may provide benefits to patients who have relapsed from venetoclax-based treatment," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

By targeting Bcl-2 at the DNA level rather than the protein, BP1002 might overcome and prevent some of the mechanisms of resistance that affect venetoclax. The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with AML. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and its benign safety profile should enable BP1002 combination therapy with approved agents, such as decitabine.

"We are excited to move into these advanced clinical studies and look forward to generating data that not only support the DNAbilize platform but bring us one step closer to bringing these potentially lifesaving drugs to patients," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.

The Phase 1/1b clinical trial is anticipated to be conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center and the Georgia Cancer Center. Initially, a total of six evaluable patients are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.

Gail J. Roboz, M.D., will serve as Principal Investigator for the Phase 1/1b trial. Dr. Roboz is professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City.

The IND review process was performed by the FDA’s Office of Oncologic Diseases, Division of Hematologic Malignancies and involved a comprehensive review of data submitted by the Company covering pre-clinical studies, safety, chemistry, manufacturing and controls, and the protocol for the Phase 1/1b clinical trial.

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 AdAlta Limited (ASX:1AD) and Carina Biotech Pty Ltd reported that thay have entered a collaboration agreement to develop next-generation i-body enabled CAR-T cells, with the potential to bring CAR-T cell therapy to treat a far greater range of cancers than the small number of blood cancers that has been achieved today (Press release, AdAlta, AUG 24, 2021, View Source [SID1234586859]).

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CAR-T cell therapy is a fast-emerging form of cancer therapy that modifies a patient’s immune system to recognise and attack cancer cells that have resisted standard treatments such as chemotherapy and radiation.

AdAlta’s CEO, Dr Tim Oldham commented, "We believe that by combining our i-bodies with Carina’s world-class CAR-T platform, we can make this important new therapeutic approach accessible to more patients and a greater range of cancers than is possible today. We are well past the starting line, having worked previously on the first two targets selected for our collaboration, and with Carina on one of these."

Carina’s CEO, Dr Deborah Rathjen commented, "This collaboration with AdAlta gives us the capability to generate bi-specific CAR molecules and then next-generation CAR-T cell products with enhanced cancer targeting and efficacy – something we are very excited about. The collaboration is off to a great start with Carina having already successfully inserted an AdAlta i-body into a CAR-T cell with functional cancer killing capability."

About the collaboration
Under the Collaboration Agreement, AdAlta will discover and optimise panels of i-bodies that bind to designated solid tumour antigen targets, from which Carina will generate bi-specific CAR-T cells and identify optimal CAR-T product candidates. Carina and AdAlta will jointly fund pre-clinical proof of concept studies in mouse tumour models.

The Collaboration Agreement contemplates commencing work on up to five tumour antigen targets during the next two years and will continue until completion of research on the final target. The first two targets have been selected enabling research to commence within the next three months. AdAlta’s initial contribution will leverage its established laboratory resources and is not anticipated to have a material impact on current cash runway.

AdAlta and Carina will jointly own the products developed through the collaboration. On a product-by-product basis: the companies may elect to continue to co-develop any product; out-license any product to third parties; or either company may exercise an option to license the other party’s share of the collaboration assets.

Dr Tim Oldham continued, "A core part of AdAlta’s strategy is to enter collaborations with partners where we can further the use of our i-bodies to address disease targets previously thought undruggable. The i-body-directed CAR-T cells will be the second example of this, complementing our collaboration with GE Healthcare where i–bodies are being used to deliver a PET imaging agent. The Carina collaboration contributes multiple potential products to our pipeline expansion goals."

AdAlta and Carina will host a Webinar to discuss the collaboration results at 2.30pm AEST Wednesday, 25 August 2021. Register here:
View Source;qzeohAXAGQ

About CAR-T cell therapy
Chimeric antigen receptor T cell (CAR-T) therapy is a revolutionary and targeted cancer treatment option that harnesses a patient’s own immune system to fight their cancer, providing a personalised cancer treatment. It was named by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) as its Advance of the Year in 2018.

Chimeric antigen receptors (CARs) are human-engineered molecules expressed on the surface of a patient’s T cells – key cells of the immune system. These CAR molecules are "targeted" at molecular markers on cancer cells. T cells armed with CARs (CAR-T cells) can more easily "home in" on cancer cells and destroy them.

There are already five approved CAR-T therapies available in the US today. These are generating transformational outcomes for patients with a small number of blood cancers that have failed multiple prior lines of therapy. Even with these limited early applications, the market is forecast to grow at 20.2% per year, and to be worth $20.3 billion by 2027[2] . Revenues from solid tumour CAR-T cell therapies are forecast to exceed revenues from blood cancer CAR-T cell therapies by 2030[3] .

About i-bodies
i-bodies are an example of a "next-generation antibody". Antibodies are large protein molecules playing a key role in the immune system’s response to the presence of a foreign substance (antigen). Next generation antibodies are smaller proteins engineered to replicate key functions of full-sized antibodies and are predicted to have a major impact on human health, particularly in oncology, autoimmunity and chronic inflammatory diseases[4].

AdAlta’s proprietary i-bodies are approximately one tenth of the size of conventional monoclonal antibodies. They were engineered using a human protein backbone and synthetic antigen binding regions to mimic small, very stable "single domain antibodies" found in sharks. The result is a range of unique and versatile proteins capable of interacting with high selectivity, specificity and affinity with previously difficult-to-access targets in the human body that have been implicated in many serious diseases.

Benefits of combining CAR-T and i-bodies
The small size and unique targeting of i-bodies provides greater flexibility and design options for CAR-T cells and are ideally suited for the production of bi-specific CARs with increased precision and efficacy. i-bodies can be utilised as the binding domain of a CAR receptor that engages the tumour antigen. i-bodies are approximately half the size of traditional binding domains and are capable of accessing and engaging antigens in unique ways.