Medical
CCM Biosciences | January 01, 2024
Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime’s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics.
5Prime has two focus areas: 1) in vitro diagnostic (IVD) tests: a wide array of companion diagnostics (CDx) tests for targeted cancer, rare disease, and prenatal/preimplantation diagnostics, developed using the droplet digital Polymerase Chain Reaction (ddPCR) and Next-Generation Sequencing (NGS) methodologies, which accompany the personalized medicine therapeutic (Rx) pipeline of CCM Bio; 2) synthetic biology: engineered DNA- and RNA-manipulating enzymes that improve upon the enzymes used in IVD tests, in PCR reagents, and also in enzymatic DNA/RNA synthesis.
Proven technology behind market-leading DNA sequencing products and diagnostic tests; including one of the 5 highest revenue-generating technologies invented in the history of Princeton University
Focus areas 1 and 2 are based on the company’s patented technology originating in the PhD thesis work of Co-Founder and CEO Dr. Raj Chakrabarti at Princeton University. According to the Princeton University Office of Technology Licensing, patents in this portfolio, which are now controlled by 5Prime, are among the top 5 revenue-generating patents in the history of the university, having been commercialized in collaboration with companies such as Celera Diagnostics, Quest Diagnostics, Abbott, New England Biolabs, and Toyobo Life Sciences. Diagnostic tests and products based on the company’s intellectual property include the XSense test from Quest Diagnostics, which is the leading DNA-based carrier screening test for autism (Fragile X syndrome); and the Q5 polymerase kit marketed by New England Biolabs, which is the leading high-fidelity polymerase kit for DNA sequencing.
In the context of molecular diagnostics, NGS is typically applied to diagnose in high-throughput the patterns of DNA mutations in genes. A related method called RNA-Seq, which applies NGS to RNA rather than DNA to measure real-time gene expression levels, has emerged as a foundation for modern personalized medicine. However, a notorious difficulty in both traditional NGS and RNA-Seq is sequence bias, which results in inaccurate estimates of the relative copy numbers of different genes and associated disease-causing mutations, and which has limited the transformative potential of these methods. ddPCR is a sensitive method for diagnosing mutations in specific disease-associated genes that is also limited by problems of sequence bias.
5Prime’s technology enables the efficient polymerization and amplification of nearly any DNA or RNA sequence to overcome sequence bias in nucleic acid amplification and associated diagnostic methods like NGS and ddPCR, the global markets for which were valued at $10B and $6B, respectively, in 2022 and expected to surpass $44B and $14B, respectively, by 2032. Its state-of-the-art synthetic biology platform for polymerase enzyme engineering generates proprietary polymerases with optimal properties for NGS or PCR-based diagnostic tests, by applying machine learning algorithms to the big data generated from ultrahigh-throughput, microfluidic experimental screening of enzyme activity. In addition, the company’s technology platform applies proprietary nonaqueous media and computational systems biology methods in conjunction with such enzymes to dramatically improve nucleic acid polymerization and amplification efficiency.
About CCM Biosciences
CCM Biosciences, Inc. is a biotechnology company dedicated to discovering and developing novel drugs - including small molecules, gene therapies, biologics, and nanomedicines - as well as associated companion diagnostics. CCM Bio’s patented molecular discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, American Chemical Society journals and Nature Publishing Group journals. CCM Bio is partnered with the global chemical and pharmaceutical services company PMC Group, Inc. for fully integrated discovery, development and manufacturing of drugs and diagnostics.
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Medical
Heron Therapeutics, Inc. | January 29, 2024
Heron Therapeutics, Inc. a commercial-stage biotechnology company announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.
This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following ZYNRELEF administration.
"The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures. The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle ("VAN") later this year, are expected to have a significant positive impact for ZYNRELEF and the Company," said Craig Collard, Chief Executive Officer of Heron.
"We're excited for the opportunity to give even more healthcare providers and patients a new, safe and effective option for achieving long-lasting non-opioid pain control after painful surgical procedures," said Bill Forbes, Executive Vice President, Chief Development Officer at Heron. "This new approval further reinforces our commitment to providing meaningful solutions to address unmet medical needs in the acute care and oncology settings."
ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. ZYNRELEF demonstrated superiority compared to bupivacaine with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. ZYNRELEF was initially approved by the FDA in May 2021 and received approval of the first supplemental NDA for an expanded label in December 2021.
"Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like ZYNRELEF now available for additional orthopedic procedures is a great benefit to have in my practice," said Alexander Sah, M.D., orthopedic surgeon at Sah Orthopaedic Associates. "ZYNRELEF helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use."
Important Safety Information for Patients
ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which
Can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
Cannot be used during heart bypass surgery.
Can increase the risk of gastrointestinal bleeding, ulcers, and tears.
ZYNRELEF should also not be used
if you are allergic to any component of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines.
as a paracervical block, during childbirth.
The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache.
The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia).
Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you.
Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611
The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning.
About ZYNRELEF
ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.
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MedTech
PanGIA Biotech, Inc. | January 05, 2024
PanGIA Biotech, a US based biotechnology company with a mission to develop true liquid biopsy technology that is scalable for global impact, today announced that it is finalizing its three-year, prospective, multicenter, clinical study on prostate cancer liquid biopsy. This announcement comes as the company prepares to launch additional clinical studies in multi-cancer early detection using the PanGIA® Liquid Biopsy Platform. “The PanGIA urine based true liquid biopsy technology has been developed for global impact by diagnosing, monitoring, and managing cancers earlier to save lives using urine as the sample type to create vastly improved availability and scalability in cancer diagnostics,” according to PanGIA Biotech’s CEO, Holly Magliochetti.
In 2020, the company received IRB approval and launched a novel AI integrated urine based liquid biopsy study. The company immediately began recruiting urologists in US-based academic as well as large and small group community practices to enroll men who were scheduled for prostate biopsy. Results of the study are pending publication.
“Based on the high sensitivity and high specificity of the PanGIA prostate study, PanGIA Biotech is now preparing to significantly expand the platform by launching follow-on studies in ten additional cancer types,” said Tricia Schumann, Chief Investment Officer of PanGIA Biotech. Additional cancer types in the PanGIA follow-on study will include breast, ovarian, lung, renal, bladder, colorectal, stomach, pancreas, liver, and brain. The company will begin recruiting experienced medical professionals across the United States as clinical study sites as well as listing the study on ClinicalTrials.gov.
PanGIA Biotech intends to launch the expanded study in mid-2024. Interested researchers may contact the company for additional information.
About PanGIA Biotech, Inc.
PanGIA Biotech develops novel, AI integrated, true liquid biopsy technology that is scalable for global impact. The PanGIA® platform allows rapid development of non-invasive testing for detecting, monitoring response to therapy, and managing a variety of diseases and disorders, including cancers as early as Stage 1. The company combines expertise in molecular biology with advanced computational biology and machine learning to detect disease-associated patterns using proprietary technology.
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