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BioDuro-Sundia’s Partner, DigmBio Announced IND Clearance from Korea MFDS for its Selective PARP1 Inhibitor DM5167

SHANGHAI, March 26, 2024 /PRNewswire/ — BioDuro-Sundia’s partner, DigmBio, a South Korean biotechnology company, announced its selective PARP1 inhibitor for the treatment of triple-negative breast cancer has been approved by Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application. Founded in April 2020, DigmBio is a pioneering biotech company discovering and developing novel therapies to treat oncology, neurodegeneration, and fibrosis. The lead program DM5167 is the 2nd generation PARP1 selective inhibitor. According to preclinical study results, DM5167, a novel selective PARP1 inhibitor, exhibits superior in vivo safety, particularly in terms of hematotoxicity and demonstrates enhanced selectivity in enzyme assays, and possesses a more efficient DNA trapping capability. Notably, DM5167 showcases excellent brain permeability, rendering it suitable for treating brain metastasis and brain cancer. DigmBio CEO Kim Jung-min stated, “We are pleased to receive official approval from the Food and Drug Safety Department without the need for any ...
- Source: drugdu
- 78
- April 1, 2024
Innovent Dosed First Participant in Phase 3 Clinical Study (Neoshot) of IBI310 (Anti-CTLA-4 Monoclonal Antibody) in Combination with Sintilimab for MSI-H/dMMR Colon Cancer Neoadjuvant Therapy

ROCKVILLE, Md. and SUZHOU, China, March 27, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomized, controlled, multicenter Phase 3 clinical trial (Neoshot), for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy. Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Previously, in a randomized, controlled, multicenter Phase 1b study for neoadjuvant ...
- Source: drugdu
- 127
- April 1, 2024
Agile, responsive regulation helps early breast cancer patients to benefit from a study to potentially improve survival outcomes

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. Data published between 2016 to 2018 suggests that close to 56,000 new cases of breast cancer are diagnosed in the UK, mostly affecting females, and with 86% presenting with early disease. Most breast cancers have proteins (receptors). These include oestrogen receptor-positive (ER+), where breast cancers have receptors for the hormone oestrogen, and HER2-negative, where the protein is absent – human epidermal growth factor 2. Hormones, particularly oestrogen, can attach to these receptors and encourage the cells to grow. A pathologist can identify the receptors during biopsy or surgery, helping to determine treatment. Recent research has led to the development of new candidate drugs known as SERDS (selective oestrogen receptor degraders). These drugs are designed to attach to and disrupt these oestrogen receptors, preventing the growth of cancer. A new SERD molecular entity, ...
- Source: drugdu
- 110
- April 1, 2024
FDA Approves Akebia’s Vafseo for Anemia in Adults with Chronic Kidney Disease on Dialysis

Don Tracy, Associate Editor Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan in adults with chronic kidney disease.Akebia Therapeutics announced that the FDA has approved Vafsen (vadadustat) for the treatment of anemia in adults with chronic kidney disease (CKD) who are on dialysis. According to a company press release, the once-daily, oral tablet works as a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, activating the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. In other words, it copies the body’s response to low oxygen levels. The FDA based the approval was on positive outcomes from the INNO2VATE program and additional safety data from its use in Japan, where it was launched in August 2020. Now approved in 37 countries, Akebia stated that Vafsen has the potential to improve overall outcomes for patients struggling with ...
- Source: drugdu
- 148
- March 30, 2024
Boundless Bio’s ‘BOLD’ IPO Reels In $100M for a New Kind of Cancer Drug

Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year. By FRANK VINLUAN Targeted therapies and immunotherapies offer new treatment options for more types of cancer, but these drugs are less helpful when tumors produce multiple copies of a gene. This gene amplification contributes to drug resistance. Boundless Bio’s research into the what drives this phenomenon has yielded new understanding of cancer biology. The company now has $100 million in IPO cash to support two programs in early clinical development and more in its pipeline. Boundless Bio late Wednesday priced its offering of 6.25 million shares at $16 each, which was the midpoint of the preliminary $15 to $17 price range the San Diego-based company set last week. Those shares will trade on the Nasdaq under ...
- Source: drugdu
- 158
- March 30, 2024
Researchers discover a safer and more efficient technique for testing new drugs

McGill researchers have discovered a safer and more efficient technique for testing new drugs while they are in development. “Because this approach is so much more streamlined, it could help accelerate this step in the drug development process and make it less dangerous, since probing the distribution and fate of a drug in the body is required for any pharmaceutical candidate to be approved,” says Bruce A. Arndtsen, a James McGill Professor who teaches in the Department of Chemistry at McGill and is the senior author on the paper describing the new process, published recently in Nature Chemistry. “This research replaces what can be a days’ long, dangerous and costly process with a simple and safe one requiring only a few hours,” adds José Zgheib, a PhD candidate in the Arndtsen Group at McGill University who worked on the project. Making sure medication reaches its target Before a drug makes ...
- Source: drugdu
- 142
- March 30, 2024
New smartphone-based method for high-quality gait analysis

Researchers at Kennedy Krieger Institute and Johns Hopkins Medicine have developed a new, accessible approach to analyze a patient’s walking ability and stances more effectively. Following numerous tests, they determined that a simple video recorded on a personal pocket device, such as a smartphone or tablet, can be used to measure gait at a clinical, high-quality level. Experts say current state-of-the-art approaches to gait analysis are often expensive and inaccessible due to time constraints and extensive efforts required for assessments. However, there is a significant need for this analysis in patients experiencing conditions such as traumatic brain injury, physical injury, or disorders. Through freely available software they created, walking abilities can now be assessed more conveniently, enhancing the comprehensiveness of rehabilitation. Dr. Ryan Roemmich, a research scientist at the Kennedy Krieger Institute, assistant professor of physical medicine and rehabilitation at the Johns Hopkins University School of Medicine, and co-principal investigator ...
- Source: drugdu
- 146
- March 30, 2024
Jacobio Pharma Announces 2023 Annual Results

Beijing, Shanghai & Boston, Mar. 28, 2024 — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results. The revenue was RMB63.5 million, the R&D investment was RMB372 million, the cash and cash equivalent at the end of 2023 was RMB 1.2 billion. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: “In the past year, Jacobio continued to make progress in our projects. We received approval for registrational phase III clinical trial of the combination therapy between our SHP2 inhibitor JAB-3312 and KRAS G12C inhibitor glecirasib. Our JAB-3312 became the first SHP2 inhibitor to enter into registrational trial. This milestone is consistent with our mission of ‘drugging the undruggable’. Meanwhile, the patient enrollment for pivotal trial of our core product glecirasib has been completed, and the NDA application expected to ...
- Source: drugdu
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- March 30, 2024
The latest data of Akesobio’s “PD-1/VEGF dual antibody” Ivonescimab combined with chemotherapy for first-line treatment of NSCLC are announced

At the high-profile European Lung Cancer Conference (ELCC) 2024, Akesobio and its partner Summit Therapeutics (Summit) jointly released the PD-1/VEGF dual antibody Ivonescimab(AK112/SMT112) combined with chemotherapy for the first-line treatment of advanced non-cancer lung cancer. Updated data from Cohort 1 (EGFR/ALK wild type) of the Phase II small cell lung cancer (NSCLC) clinical study (AK112-201). Previous research results have been published at the 2023 ASCO Annual Meeting and eClinical Medicine, a subsidiary of the top international medical journal “The Lancet”. Cohort 1 included a total of 135 patients with EGFR/ALK wild-type NSCLC who received Ivonescimab combined with chemotherapy, including 63 patients with squamous cell carcinoma and 72 patients with non-squamous cell carcinoma. As of October 2023, the median follow-up time has been further extended to 21.3 months. As the follow-up time is extended, the clinical advantages of Ivosib in the first-line treatment of advanced or metastatic NSCLC become more obvious. ...
- Source: drugdu
- 118
- March 30, 2024
SINOVAC initiates Phase I clinical study for SINOVAC’s hexavalent reassortant rotavirus vaccine

On March 27, 2024, the oral hexavalent reassortant rotavirus live attenuated rotavirus vaccine (Vero cell), jointly developed by SINOVAC’s Beijing Kexing Zhongwei Biotech Co. and Kexing (Dalian) Vaccine Technology Co. SINOVAC’s hexavalent reassortant rotavirus vaccine was approved for entry into the clinic in January 2024. This study is intended to be a single-arm, open design in adults and children, and a randomized, double-blind, placebo-controlled design in infants, to assess the safety and tolerability of the vaccine in adult and pediatric populations, as well as the immunogenicity of the vaccine in healthy infants. Rotavirus (RV) is a virus of the family Eutheroviridae, whose primary mode of transmission is fecal-oral, with the possibility of respiratory transmission also present, and which primarily infects the epithelial cells of the small intestine, thereby causing cellular damage and diarrhea. Rotavirus gastroenteritis (RVGE) is the leading cause of severe, fatal diarrhea in children under 5 years of ...
- Source: drugdu
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- March 30, 2024

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