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Kaiyue Biopharma’s independently developed small molecule new drug targeting RNA helicase has obtained clinical trial approval (IND) from the US FDA

On October 30, 2023 Shenzhen Kaiyue Life Science Co., Ltd. (hereinafter referred to as "Kaiyue Life"), a world-first RNA helicase drug target, has developed the first-in-class (FIC) drug with independent intellectual property rights worldwide for a wide spectrum of solid tumors, reported the first milestone event in drug development: obtaining clinical trial approval from the US FDA, achieving a leap from zero to one (Press release, KeYe Life Technologies, OCT 30, 2023, View Source;article_id=78 [SID1234644609]).

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Based on more than ten years of basic research, Kaiyue Life has developed a unique target for special RNA helicase proteins as cancer treatment, which is internationally leading and original, and is classified as a Class 1.1 original new drug. This is an original drug target developed by us. It took ten years from the start of basic research to target confirmation, and two and a half years from PCC to IND approval.

Kaiyue Life has been deeply involved in the field of RNA helicase and is a pioneer in the field of RNA helicase research and development. The founder of the team has been engaged in helicase research since 2008 and has published dozens of high-level scientific research papers to date.

RNA helicase plays an important role in the gene expression process of eukaryotes. Its functions involve embryonic development, cell proliferation, hematopoiesis, metabolism, cancer, immune regulation, inflammatory response and autoimmune diseases. Their disorders can cause a variety of human diseases, such as cancer, viral infection, inflammation, etc. Some DEAD/H box proteins are considered to be therapeutic targets for diseases. For example, inhibitors of eIF4A and DDX3X are currently being developed as new targeted drugs for the treatment of human cancer. In view of the close correlation between RNA helicase and human diseases, several helicase inhibitors have entered clinical research as drugs for indications such as tumors and antivirals.

Dr. Zhang Yandong, founder of Kaiyue Life, said: Drug research and development in the field of RNA helicase is in the ascendant.

2023 Third quarterly report

On October 30, 2023 Fosun Pharma reported its 2023 Third quarterly report (Filing, 3 mnth, SEP 30, Fosun Pharma, 2023, OCT 30, 2023, View Source [SID1234639227]).

Consolidated Financial Results for the six months ended September 30, 2023

On October 30, 2023 NEC reported its consolidated Financial Results for the six months ended September 30, 2023 (Press release, NEC, OCT 30, 2023, https://pdf.irpocket.com/C8793/MH4b/MZCP/o67J.pdf [SID1234639212]).

Institute for Systems Biology and NED Biosystems announce collaboration to show how cancer’s onset may be reversed

On October 31, 2023 Leroy Hood, MD, PhD, co-founder of Seattle’s Institute for Systems Biology (ISB) and a pioneer in systems biology, and Rebecca Lambert, founder and CEO of NED Biosystems, Inc. (NED), a public benefit corporation that is developing the first oral "systems treatment" for cancer, reported to have entered into a memorandum of understanding to collaborate on a clinical trial to show how cancer’s onset may be reversed (Press release, NED Biosystems, OCT 30, 2023, View Source [SID1234636544]).

NED’s cancer treatment, NED-170, takes a systems approach that combines repurposed, oral agents that are well documented in humans to affect critical cancer disease-driver processes at doses that lack customary toxicity and side effects.

"A systems biology approach is paramount – NED-170 is the multi-pronged treatment required to subvert cancer’s complex system," said Hood, who is inventor of the DNA Sequencer, technology which enabled the Human Genome Project.

The collaborative trial’s objective is to gather intelligence through a multi-dimensional monitoring of the tissue in which a tumor grows. A simple blood test utilizes the latest ultra-sensitive hyper-personalized proteomics technologies to measure the traces of more than 3,000 distinct proteins at once that reveal many processes in the tumor tissue, thereby offering an assessment of the specific efficacy of the individual agents in the multi-pronged approach.

NED-170’s Phase 1b/2 clinical trial is designed to treat patients concomitant to standard of care who lack an option for targeted therapy based on tumor genome sequencing in three indications representing large unmet needs: cholangiocarcinoma, triple negative breast cancer, and ovarian cancer.

NED is initially targeting the 50 percent to 80 percent of cancer patients whose tumors do not carry mutations for targeted therapy. Based on observational data, NED believes its systems treatment, when combined with standard of care therapies, may afford patients extended survival and enhanced quality of life. The data collected from NED’s initial trial and follow-on clinical trials will serve to develop a database for ISB’s large study utilizing proteomics and NED-170 to optimize the systems approach for suppression of cancer progression based on the driver processes in subclasses of patients.

"A truly comprehensive approach to a complex adaptive system like cancer, as the war on global terror has taught us, must be a multi-pronged approach that moderates, without adding stress, the various behaviors that promote cancer and allows the tissue to re-establish the balance of a normal cell community," said Sui Huang, MD, PhD, and ISB professor, cancer cell dynamics expert, and NED Biosystems Systems Advocate.

The envisioned high-dimensional profiling of a patient’s blood biochemistry baseline can inform doctors about how the tumor bed is preparing a tiny tumor for outgrowth before a tumor is clinically detectable, which can be different in different patients. It can also tell us precisely which biological processes a particular tumor relies on most to (re)grow in a given patient. Uncommon quality of life improvements (and cost savings) may be achieved when a cancer patient is treated with evidence-based agents efficacious against key pathways at doses that lack toxicity and side effects.

"By moderating multiple cancer progressing pathways and cancer stem cells at once, NED-170 affords a comprehensive systems approach never before available to cancer patients," said Lambert. "The comprehensive blood profiling utilized to measure NED-170’s impact on pathways advances a personalized measurement of each patient’s unique cancer signature."

Enable Medicine to Present Poster Presentations at the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting

On October 30, 2023 Enable Medicine, a leader in AI for biological research and drug discovery, reported that it will present a number of poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting being held November 1-5, 2023, in San Diego, California (Press release, Enable Medicine, OCT 30, 2023, View Source [SID1234636472]).

"These study results will advance our understanding of the tumor microenvironment and empower researchers to use our comprehensive maps of disease biology to understand how the organization of cells impact disease pathology, progression, and therapeutic response."

Post this
Title: From images to insights: Deep spatial profiling reveals disease and treatment biomarkers
Abstract Number: #95
Date / Time: November 3rd, 12–1:30 p.m. PDT & November 4th, 11:55–1:25 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: Integrative spatial multi-omics analysis of NSCLC tumor microenvironment identifies key features associated with response to immune checkpoint inhibitor therapy
Abstract Number: #222
Date / Time: November 3rd, 12–1:30 p.m. PDT & November 4th, 11:55–1:25 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Poster presentation details:
Title: emObject: domain specific data abstraction for spatial omics
Abstract Number: #899
Date / Time: November 3rd, 12–1:30 p.m. PDT & November 4th, 11:55–1:25 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: Quantitative cell morphology featurization in multiplexed immunofluorescence images reveals tumor subtypes in cancer microenvironments
Abstract Number: #1290
Date / Time: November 3rd, 12–1:30 p.m. PDT & November 4th, 11:55–1:25 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: A machine learning toolkit for automated processing of multiplexed immunofluorescence images
Abstract Number: #1302
Date / Time: November 3rd, 12–1:30 p.m. PDT & November 4th, 11:55–1:25 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: Polarity measurements from multiplex imaging suggest immune cell activation
Abstract Number: #1314
Date / Time: November 3rd, 12–1:30 p.m. PDT & November 4th, 11:55–1:25 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: Identification and generalization of tissue structures with spatial cellular graph partitioning
Abstract Number: #1315
Date / Time: November 3rd, 12–1:30 p.m. PDT & November 4th, 11:55–1:25 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

"We are excited to showcase the capabilities of Enable Medicine’s platform in analyzing pathology and other omic data to improve our understanding of cancer biology and predict potential treatment response in patients," said Sunil Bodapati, CEO, Enable Medicine. "These study results will advance our understanding of the tumor microenvironment and empower researchers to use our comprehensive maps of disease biology to understand how the organization of cells impact disease pathology, progression, and therapeutic response."

The full abstracts will be released on the SITC (Free SITC Whitepaper) website on Tuesday, October 31, 2023 at 9:00 a.m. ET.