Kineta Announces Poster Presentation at the 2021 American Association for Cancer Research Conference on Tumor Immunology and Immunotherapy

On September 28, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it will present a poster on the company’s new anti-CD27 agonist antibody program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference: Tumor Immunology and Immunotherapy, to be held on October 5-6, 2021 (Press release, Kineta, SEP 28, 2021, View Source;utm_medium=rss&utm_campaign=kineta-announces-poster-2021-aacrc [SID1234590368]).

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Title: A promising cancer immunotherapy target: Novel fully human agonist antibodies against the human T-cell costimulatory receptor CD27
Date Poster Available: October 5, 2021

Leidos to Webcast Investor Day on Oct. 7, 2021, at 8:30 am ET

On September 28, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology company, reported that it will webcast its Investor Day starting at 8:30 a.m. ET on Thursday, Oct. 7, 2021 (Press release, Leidos, SEP 28, 2021, View Source [SID1234590396]). The event will include presentations by Chairman and Chief Executive Officer Roger Krone, Chief Financial Officer Chris Cage, and other executives. They will discuss the company’s vision, strategy, market position, and multi-year financial outlook.

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The live presentations, originating from New York City, will be available on the Leidos Investor Relations website at View Source A replay of the webcast will be available following the presentation at the same link listed above for one year afterward.

Oncoinvent Announces Advancement of Radspherin® to Fourth Dose Level Cohort in Ongoing RAD-18-001 Phase 1 Trial in Ovarian Cancer Patients

On September 28, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that the trial Safety Monitoring Committee approved its first-in-human Phase 1 clinical study of Radspherin in ovarian cancer patients suffering from peritoneal carcinomatosis to progress to the fourth level dose cohort (Press release, Oncoinvent, SEP 28, 2021, View Source [SID1234590413]). Enrollment in this cohort, where patients will receive 7 MBq of Radspherin, is expected to begin imminently.

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"The progression of the RAD-18-001 study to the fourth dose level, continues to build our confidence as we continue to develop Radspherin for treatment peritoneal carcinomatosis, an area of high unmet need," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "we will now start dosing patients at the 7 MBq dose level, a dose level that has been found to be safe in colorectal cancer patients."

About RAD-18-001

The phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

About Radspherin

Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.

Van Andel Institute scientist earns $2.4 million grant to investigate cellular communication in development and disease

On September 28, 2021 Van Andel Institute’s Stephanie Grainger, Ph.D., reported that it has been awarded a $2,375,000, five-year Maximizing Investigators’ Research Award from the National Institute of General Medical Sciences of the National Institutes of Health (Press release, Van Andel Institute, SEP 28, 2021, View Source;utm_medium=rss&utm_campaign=stephanie-grainger-maximizing-investigators-research-award [SID1234590448]). This prestigious grant will support Grainger’s exploration of a critical type of cellular communication that drives healthy development and, when disrupted, can spur cancer, osteoporosis, heart conditions and other diseases.

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Called Wnt (and pronounced "wint"), this vital molecular pathway is central to a host of important processes that guide the body’s construction early on and that continue throughout life, such as tissue regeneration during healing.

Stephanie Grainger, Ph.D.

"Much like the foreperson at a construction site, Wnt controls nearly everything the body does throughout development: for example, it communicates where the head should go versus the feet and, in adults, coordinates resources to heal wounds and replenish stem cells," Grainger said. "I am honored to receive this award, which will help us answer longstanding questions that have profound implications for correcting errors in the Wnt pathway as a means to treat disease."

Scientists have long been interested in Wnt as a potential target for new cancer therapies but developing such treatments has proven to be difficult. The problem lies in a lack of insight into the specific interactions between molecules in the vast Wnt network. A better understanding of these interactions could help scientists develop highly targeted approaches that fix specific problems while leaving the rest of the pathway untouched — and producing fewer side effects.

Grainger and her team will focus on two major players in the pathway: Wnt9a and Fzd9b. These molecules, which are found on the outside of cells, interact to convey chemical messages to and from cells. What isn’t clear, Grainger says, is how Wnt9a and Fzd9b enter the cell to deliver their information payload.

"The Wnt pathway operates in a careful balance — too much or too little Wnt activity can have devastating consequences," Grainger said. "Solving the exact mechanism by which Wnt9a and Fzd9b carry out their job could have massive implications for therapeutic development and a ripple effect for understanding other parts of the pathway."

Maximizing Investigators’ Research Awards are highly competitive and provide scientists "with greater stability and flexibility, thereby enhancing scientific productivity and the chances for important breakthroughs," according to the NIGMS. Grainger is the second VAI investigator in the last four years to earn this award. She joined VAI’s Department of Cell Biology in August.

Research reported in this publication was supported by National Institute of General Medical Sciences of the National Institutes of Health under award no. R35GM142779 (Grainger). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

BioRay Infliximab for Injection (Anbaite®) received marketing authorization

On September 28, 2021 Hisun Biopharmaceutical Co., Ltd. (hereinafter referred to as "HisunBio"), a wholly-owned subsidiary of BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "Bioray") reported that the National Medical Products Administration (NMPA) of China approved the application for marketing of its own human-mouse chimeric monoclonal antibody targeting human tumor necrosis factor-α (TNF-α), Infliximab for Injection (Anbaite) on September 24 (Press release, Zhejiang Hisun Pharmaceutical, SEP 28, 2021, View Source;a=index&classid=43&id=5 [SID1234634621]). The National Medicine Permission Number (NMPN) of Anbaite is S20210039.

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The indications of Anbaite include rheumatoid arthritis, Crohn’s disease in adults and children over 6 years old, fistulizing Crohn’s disease, AS (ankylosing spondylitis), psoriasis, and adult ulcerative colitis. Anbaite is the second biosimilar for infliximab to enter China market. It also becomes the third commercialized biologics from BioRay following the launch of Anbainuo and Anjianning (Adalimumab). Including Anshuzheng (Tofacitinib Citrate Tablets), BioRay has entered the ‘Four-An’ era, expanding its leadership in the treatment of immune diseases.

Anbaite is a recombinant human-mouse chimeric monoclonal antibody targeting TNF-α. As an important cytokine, TNF-α is indispensable for immune homeostasis and fighting against various pathogens. However, it has also been found that the overexpression of TNF-α plays a great role in the pathogenesis of autoimmune diseases. The expression level of tumor necrosis factor-α is relatively low in healthy tissues. When its concentration increases pathologically, TNF-α could impair immune homeostasis by promoting excessive inflammation, resulting in damages to tissues and organs. Anbaite can specifically bind to both soluble (sTNF-α) and transmembrane tumor necrosis factor-α (tmTNF-α) with high-affinity, which blocks the binding of tumor necrosis factor with its receptor to alleviate inflammation and autoimmune disease.

Anbaite is the biosimilar of infliximab for injection (Remicade). Remicade was granted marketing authorization in China in 2006. The efficacy and safety of Remicade have been fully verified by its extensive clinical use. Its peak sale reached $9.24 billion. According to the data from Fierce Pharma, the global sale of Remicade was $4.196 billion in 2020, ranking among top 20 worldwide. The infliximab for injection has been recommended as one of the options to treat related diseases by guidelines such as those in the "Chinese experts’ consensus on the treatment of psoriasis with biological agents (2019)". Additionally, it has also been enlisted on the negotiated drug catalog by "China National Drug Catalog for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2020 Edition)" to further guarantee the drug’s accessibility.

As a drug supported by National Science and Technology Programs, Anbaite has been approved for all indications of Remicade in China. The number of people suffering from those indications exceeds 10 million in China and keeps increasing. With its approval by National Medical Products Administration, Anbaite will help alleviate the huge unmet medical needs. BioRay will also take this opportunity to enrich its product pipelines for the treatment of immune diseases, sharpen its leading edge in the field, and continue to develop affordable high-quality products, bringing more treatment options to patients and helping them improve their health and life quality.