On June 7, 2021 IASO Biotherapeutics, a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases, reported that its clinical trial application for the in-house developed CD19xCD22 fully human dual-targeted CAR T-cell therapy (CT120) for treatment of its second indication for relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL), has been accepted by the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2101088, CXSL2101089) (Press release, IASO BioMed, JUN 7, 2021, View Source [SID1234583671]). This acceptance came just one day after the acceptance of the drug’s first indication for treatment of CD19xCD22 positive relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). These successful clinical trial applications highlight the company’s speed and strength in developing innovative novel CAR-T therapies.

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CT120 is developed on IASO Bio’s fully human antibody platform IMARS and high throughput CAR-T drug selection platform. IMARS is one of the industry’s top antibody discovery platforms in terms of database capacity. With over 240 billion candidate antibodies, the platform has powerful capacity and provides speedy antibody screening. The company’s high-throughput CAR-T drug selection platform, which uses cutting-edge single-cell analysis and next-generation sequencing (NGS) technology, can implement cost effective, high efficiency functional CAR-T candidate screening. CT120 is prepared at IASO Bio’s integrated good manufacturing practice (GMP) compliant manufacturing facility in Nanjing, which is fully equipped to produce high quality plasmids, viral vectors and gene edited cellular products cost-efficiently.

B-cell non-Hodgkin’s lymphoma (B-NHL) is a group of hematologic malignancies of B-lymphocytes origin. Current standard of care (SOC) include chemotherapy, radiotherapy, hematopoietic stem cell transplant, molecular targeted drug, and more. While most patients can achieve short-term remission following standard care, relapsed or refractory disease is common. For such patients, conventional therapies are limited, and CAR-T therapy is considered to be a promising alternative. And while CD19-targeted single-targeted CAR-T therapy has shown good efficacy in clinical studies, some patients still experience progression or recurrence a short time after such therapy (Nature). It is thought that CD19 antigen escape on the surface of tumor cells is one of the possible reasons.

Studies have shown that both CD22 and CD19 are generally expressed on the surface of multiple B-cell tumors, including B-NHL. Similar to CD19, CD22 is also expressed on tumors with certain specificity, which makes it another ideal therapeutic target. In light of this, CD19xCD22 dual-targeted CAR-T therapy theoretically can reduce the risk of treatment evasion due to missing a single target. As a result, it shows good potential for further reducing disease recurrence and thus, yielding long-term survival benefits for patients.

"Investigator initiated trials (IITs) underway at Tongji Hospital – which is affiliated with Tongji Medical College of Huazhong University of Science & Technology and the First Affiliated Hospital, College of Medicine, Zhejiang University – show that fully human dual-targeted CT120 not only benefits CAR-T naïve relapsed/refractory B-ALL patients but also those whose disease progressed during or after murine single-targeted CD19 CAR-T. Therefore, the therapy shows promise in terms of both market landscape and patient benefits," said Dr. Wang Wen, CEO, IASO Biotherapeutics. "Importantly, our IND submission for this product marks the maturation of the company’s phage antibody library-based antibody discovery platform. We expect that fully human antibody products based on this antibody library will continuously contribute to the company’s cell therapy and antibody therapy pipelines. At IASO Biotherapeutics, we will continue to expand and exploit new product pipelines to benefit more patients in the future."

About CT120：

CT120 is an autologous dual-target CAR-T therapy. Its extra cellular domain contains two fully-human scFv sequences that can specifically recognize CD19 and CD22. Dual-antigen specific CAR-T cells, which have the potential to persistent in vivo longer than mono-specific CAR-T cells, enhance therapeutic effects by reducing relapse resulting from antigen escape.

CT120 proves to be significantly effective in an ongoing IIT trial in China. Results show that CT120 not only has a durable response on CAR-T treatment-naive relapsed/refractory B-ALL patients, but also has a curative effect on relapsed patients who have previously received mono-specific CAR-T treatment. CT120 can reduce the risk of antigen escape and tumor relapse as a result of lower/loss of CD19 or CD22 expression following mono-specific CAR-T treatment, resulting in better therapeutic outcomes and longer survival benefits for patients.

About Non-Hodgkin Lymphoma (NHL):

Lymphomas of immune system cells origin may cause damage to any organ in the body and give rise to a variety of accompanying complicated pathologic processes. Lymphomas are divided into two categories: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Approximately 85% of non-Hodgkin’s lymphomas are of B-cell origin. Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL. DLBCL accounts for 31% of NHLs in European and American countries and more than 40% of NHLs in Asian countries. The incidence of the disease increases with age. According to statistics from 2006 to 2016, the standardized morbidity and mortality rates of NHLs in China were 4.29/100,000 and 2.45/100,000, respectively (Biomed Central).

On June 7, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that Derek Maetzold, president and chief executive officer, is scheduled to present a company overview at the Baird 2021 Healthcare ESG Symposium on June 17, 2021, at 11:20 a.m. Eastern time (Press release, Castle Biosciences, JUN 7, 2021, View Source [SID1234583669]).

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A live audio webcast of the company’s presentation will be available by visiting Castle Biosciences’ website at View Source A replay of the webcast will be available for two weeks following the conclusion of the live broadcast.

On June 7, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported positive results from an analysis using its 70-gene MammaPrint assay on samples from the NSABP B-42 trial (Press release, Agendia, JUN 7, 2021, View Source [SID1234583668]). These results were reported as an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The abstract, titled "Utility of the 70-gene MammaPrint assay for prediction of benefit from extended letrozole therapy (ELT) in the NRG Oncology/NSABP B-42 trial" and presented by Dr. Priya Rastogi of the NSABP, detailed a retrospective evaluation of 1,866 samples, almost half of the original trial’s tissue samples, which were representative of the entire cohort. The data showed that genomic testing with MammaPrint could identify a subset of patients in the NSABP B-42 cohort who were most likely to benefit from ELT. Patients with a MammaPrint Low Risk profile had significantly better rates of distant recurrence (DR), disease-free survival (DFS) and breast cancer free interval (BCFI) when treated with extended endocrine therapy. Conversely, genomically High Risk patients did not see this same benefit and likely could have been spared extended endocrine therapy.

Patients with a genomic Low Risk result were stratified into Ultra Low Risk and Low Risk groups. The benefit of extended endocrine therapy was primarily observed in the Low Risk (non-Ultra Low) group. The benefit of extended endocrine therapy in these MammaPrint Low Risk patients ranged from a 4.0% improvement in DR rate to a 9.5% increase in DFS. MammaPrint was the only test that predicted a 52% relative benefit reduction in BCFI events (7.9% absolute benefit) and a 36% relative benefit reduction in DFS events (9.5% absolute benefit) with ELT. Another genomic test, the BCI-H/I ratio, evaluated samples from the NSABP B-42 trial and did not confirm the predictive value of BCI for the efficacy of extended endocrine therapy; further study is needed to evaluate the test’s predictive ability.

"By stratifying patients beyond High or Low Risk, we are able to see a larger breadth of difference in genomic signatures," said Adam Brufsky, MD, PhD, Co-Director of the Women’s Cancer Center at Magee Women’s Hospital of UPMC Hillman Cancer Center. "More granular information such as this allows us to better understand the biology of a tumor, and gets us closer to ensuring that each patient receives the data she needs to have informed discussions with her physician to decide on the best treatment path, even years after her initial treatment."

The original NSABP B-42 trial, designed to determine whether ELT improves DFS after a standard 5 years of aromatase inhibitor-based therapy, enrolled nearly 4,000 postmenopausal women with stage I-IIIA hormone receptor-positive breast cancer, who were disease-free after about 5 years of treatment with an aromatase inhibitor or tamoxifen followed by an aromatase inhibitor. The trial arms were randomly assigned to either receive 5 years of letrozole – an endocrine therapy used commonly in adjuvant settings – or a placebo. The trial showed a numerical DFS benefit of 3.3% at 10 years from ELT for the entire study cohort; however, no clinical features that indicated which women would achieve this benefit were identified in the trial. This led to the search for genomic biomarkers which could predict the benefit of ELT, and was the basis for this translational study.

"We are pleased to have contributed to the NSABP B-42 trial findings, with the important observation that genomic profiling with MammaPrint identifies the cohort most likely to benefit from ELT, and those who are unlikely to benefit," said William Audeh, MD, Chief Medical Officer at Agendia. "These data will be of value to clinicians, and women with breast cancer, as they make the challenging decision as to whether to undertake an additional five years of endocrine therapy, a decision for which clinical features offered little guidance."

At ASCO (Free ASCO Whitepaper) 2021, Agendia also presented additional data about the Ultra Low Risk threshold from the MINDACT study as well as a larger suite of data from the company’s groundbreaking FLEX registry, a large-scale, prospective, observational breast cancer study using whole transcriptome sequencing. FLEX enables true precision oncology by recruiting patients from various ethnicities, ages and genders representative of the total breast cancer population as part of an ongoing effort to increase representation of diverse populations and data in clinical trials.

On June 7, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported that Stanley C. Erck, President and Chief Executive Officer, will participate in a panel discussion at the BIO International Convention 2021 on June 14 (Press release, Novavax, JUN 7, 2021, View Source [SID1234583667]). BIO Digital 2021 is hosted by the Biotechnology Innovation Organization (BIO) and is taking place June 10-11 and June 14-18. Novavax’ COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

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Stanley C. Erck headshot

Panel details are as follows:

Date:

Monday, June 14, 2021

Time:

3:00 p.m. – 3:45 p.m. Eastern Time (ET)

Title:

Global Pandemic Preparedness – It Takes a Globe….

Moderator:

Phyllis Arthur, Vice President, Infectious Diseases and Diagnostics Policy, Biotechnology Innovation Organization

Panelists:

Stanley C. Erck, President and Chief Executive Officer, Novavax

Amanda Glassman, Executive Vice President, Chief Executive Officer, CGD Europe and Senior Fellow, Center for Global Development

Richard Hatchett, M.D., Chief Executive Officer, Coalition for Epidemic Preparedness

Rajeev Venkayya, M.D., President, Global Vaccine Business Unit, Takeda Pharmaceuticals

For more information or to register for the meeting, visit: View Source

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-M Adjuvant
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

On June 7, 2021 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported that management will participate in a virtual Fireside chat and hold 1×1 meetings at the Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 (Press release, Reata Pharmaceuticals, JUN 7, 2021, View Source(Nasdaq%3A%20RETA)%20(%E2%80%9C,Tuesday%2C%20June%208%2C%202021. [SID1234583666]).

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