Category Archives: Science: Biology

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Maximizing Biorepositories for Research & Drug Discovery, Upcoming Webinar Hosted by Xtalks


Maximizing utility and sustainability are critical for the long-term success of biorepositories and biobanks.

Genuity Science is bringing together a distinguished panel of experts from academia, research and industry to discuss opportunities and challenges facing biorepositories and biobanks around the world seeking to maximize their resources for research and drug discovery. Whether the repository contains a small collection of samples or is a large-scale national or international repository, biobanking will continue to play a key role in accelerating the discovery and development of new drugs, as these efforts require access to a larger array of biological samples. At the same time, biobanks face a variety of challenges in meeting the different interests and unique needs of their collaborators and partners in order to support a growing number of research studies. Maximizing utility and sustainability are critical for the long-term success of biorepositories and biobanks.

This webinar will explore the enormous innovative potential for biobanks and biorepositories to support translational research using a variety of bio-sample types (tissue samples, tumor cells, DNA, RNA, blood samples) collected from population-based and/or disease-specific groups of individuals.

Join Professor Stephen Sawcer, University of Cambridge, Dept. of Clinical Neurosciences; Samantha Hutten, Staff Scientist, Michael J Fox Foundation for Parkinson’s Disease Research (MJFF); Gordon R. Bernard, MD, Executive Vice President for Research and Chief Research Officer, Vanderbilt University Medical Center (VUMC), and David Kavanagh, PhD, Director of Clinical Partnerships, Genuity Science in a live webinar on Tuesday, December 15, 2020 at 10am EST (3pm GMT/UK).

For more information, or to register for this event, visit Maximizing Biorepositories for Research & Drug Discovery.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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VoluMetrix Wins Annual BioPitch Competition at BioFlorida Conference 2020


VoluMetrix, a Nashville-based company dedicated to creating a new wave of solutions for vital monitoring to enhance well-being, today announced that it has won BioFlorida’s 2020 BioPitch competition. BioPitch takes place at the BioFlorida Annual Conference and is an annual competition for seed and early stage life science companies.

VoluMetrix is developing a novel form of vital monitoring, Non-Invasive Venous Waveform Analysis (NIVA), for a wide range of healthcare applications, with potential near-term clinical applications that include vital monitoring for heart failure and pulmonary disease.

As part of the competition, 12 semi-finalists pitched to a closed-door panel of judges. Three finalists were then selected to present a live pitch at BioPitch, held on October 28. VoluMetrix was announced the winner, receiving $10,000 in prize capital.

“Our BioPitch competition provides the opportunity for some of the most innovative companies currently seeking seed and early-stage investment to pitch to life science investors,” said Nancy K. Bryan, President & CEO of BioFlorida. “We’re excited about the unique VoluMetrix technology with its potential to enhance our ability to monitor heart failure patients’ volume status.”

Non-Invasive Venous Waveform Analysis (NIVA) technology represents a major paradigm shift from existing vital monitoring technology. NIVA optimizes hemodynamic assessment in three key ways: signal capture (using a non-invasive wrist sensor), signal deconstruction (mapping individual amplitudes within a patient’s waveform), and signal decoding (via a proprietary NIVA Score that corresponds to industry-standard pulmonary capillary wedge pressure, PCWP).

“Given the caliber of our fellow nominees, we’re honored to be chosen as this year’s BioPitch winner,” said Kyle Hocking, Ph.D., President & CEO, VoluMetrix. “We believe that our technology has the potential to empower healthcare providers and their patients in many care areas, and we look forward to announcing additional milestones as we develop NIVA for targeted clinical applications.”

The first anticipated clinical application of NIVA will be NIVAʜғ for venous waveform monitoring in heart failure patients. NIVAʜғ is currently in Verification and Validation, with submission to the FDA for clearance via the de novo pathway expected in Q1 2021. NIVA is also being investigated for venous waveform monitoring pulmonary function in patients suffering from pulmonary disease (including COVID-19). Future potential applications include pediatric care, kidney failure, trauma, sepsis, and mental and consumer health.

To date, NIVA technology has been studied for multiple potential clinical applications, including for hemodynamic-guided heart failure management; noninvasive assessment of congestion in spontaneously breathing patients; detection of early blood loss that may be useful in early triage and perioperative management; volume directed dialysis to prevent intradialytic hypotension; and measuring intravascular volume changes for children undergoing surgery.

What is the Venous Waveform?

The venous waveform is an energy-based signal generated by heart and respiratory activity that reflects numerous physiologic conditions, including pulse and respiratory rate, as well as intravascular and extravascular dynamics.

About VoluMetrix

VoluMetrix is a Nashville-based company, closely aligned with Vanderbilt University in Nashville, TN and a member of the Mayo Clinic Innovation Exchange in Jacksonville, FL, that is dedicated to creating a new wave of solutions for vital monitoring to enhance well-being. As pioneers of non-invasive venous waveform technology, we are partnering closely with patients and practitioners to develop the pathway towards the optimal implementation and utilization of our technology, from hospital to home.

The NIVA technology is investigational and is not available for sale in the United States.

For more information, please visit our website at https://www.volumetrix.com/ or Linkedin at https://linkedin.com/company/volumetrix.

About BioFlorida

BioFlorida is the voice of Florida’s life science industry, representing 6,700 establishments and research organizations in the biopharmaceutical, medical technology, and bioagriculture sectors that collectively employ 94,000 Floridians. BioFlorida’s member driven initiatives provide a strong business climate for the advancement of innovative products and technology that improve lives and promote economic benefits to the state. Learn more by visiting http://www.bioflorida.com.

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Sentien Biotechnologies Announces First Subject Dosed in Phase 1/2 Trial of Ex Vivo MSC Therapy for the Treatment of Severe COVID-19


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Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced that the first subject has been enrolled in its Phase 1/2 study of SBI-101 for the treatment of severe COVID-19 at the University of New Mexico (UNM) Hospital. SBI-101, Sentien’s innovative cell-based therapy, is being evaluated in COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT).

“We are excited to have enrolled the first subject in Sentien’s study of SBI-101 for the treatment of severe COVID-19,” said Christos Argyropoulos, MD, Chief of Nephrology at UNM Hospital. “Patients with severe COVID-19 still have few therapeutic options; we are pleased to partner with Sentien to evaluate SBI-101, an investigational therapy which has the potential to significantly lessen the severity of this challenging disease.”

J. Pedro Teixeira, MD, principal investigator for the study at UNM, added, “The scientific rationale for studying SBI-101’s effect on COVID-19 is compelling. We are learning more and more that AKI is a systemic disease. COVID-19, especially in its most severe cases, is also very much a systemic disease. SBI-101 offers a cutting-edge systemic therapeutic approach to patients with AKI and COVID-19.”

SBI-101 is a combination product that integrates allogeneic mesenchymal stromal cells (MSCs) within an extracorporeal, blood-contacting device. MSCs are a unique source of therapeutic secreted factors that modulate the immune-mediated inflammatory response to acute organ injury. By keeping the MSCs confined within a blood-contacting device, SBI-101 enables controlled, dynamic, and sustained delivery of MSC-secreted factors to the patient’s blood, without the need for direct injection of the MSCs themselves. SBI-101 integrates into a standard blood circuit such as used with renal replacement therapy, thereby providing patients with both standard-of-care and MSC-mediated blood conditioning in a single session.

“Enrolling the first subject in this COVID-19 study is an important milestone for Sentien,” said Sentien Chief Medical Officer, Allen R. Nissenson, MD. “SBI-101 is designed to restore balance to a dysregulated immune system. If SBI-101 can calm the hyperinflammatory cytokine storm associated with severe COVID-19, its therapeutic impact could be significant.”

The multi-center trial is a randomized, controlled, ascending dose Phase 1/2 study in patients with COVID-19 requiring RRT. The primary objective of the trial is to evaluate the safety and tolerability of SBI-101; endpoints for efficacy and pharmacodynamic responses to SBI-101 therapy will also be evaluated.

Please visit https://clinicaltrials.gov/ct2/show/NCT04445220 for more information about the study.

About Sentien Biotechnologies

Sentien Biotechnologies, Inc. is a privately-held, clinical-stage company developing novel ex-vivo cell therapy applications to treat conditions caused by systemic, immune-mediated inflammation. Sentien’s lead product, SBI-101, integrates allogeneic mesenchymal stromal cells (MSCs) within an extracorporeal, hollow-fiber device. By immobilizing MSCs within a blood-contacting device, SBI-101 enables controlled, dynamic, and sustained delivery of MSC-secreted factors to the patient’s blood, without the need for direct injection of the MSCs themselves.

SBI-101 has been evaluated in a Phase 1b/2a study in subjects with dialysis-requiring acute kidney injury (AKI-D). An initial readout from the study provides preliminary evidence of anti-inflammatory and wound healing effects consistent with the SBI-101 therapeutic hypothesis. Building on this data, SBI-101 is being evaluated in COVID-19 patients suffering from severe systemic inflammation.

Sentien’s technology can be applied to additional systemic inflammatory indications in both acute and chronic diseases, focusing on complex conditions where single-factor agents have not been effective.

For more information, please visit http://www.sentienbiotech.com.

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Microbial Discovery Group Raises the Bar in Wastewater Treatment for Large Systems and Lagoons


Before and after image of a lagoon being treated with Biotifx 40B.

After treatment with Biotifx 40B, this lagoon experienced a 60% FOG cap reduction.

It’s the strongest, ready-to-use bioaugmentation product that exists today.

Microbial Discovery Group (MDG), a leading Bacillus fermentation company, announced the newest addition to their Biotifx® wastewater treatment line – 40B Water Soluble Packets.

The Biotifx 40B Water Soluble Packet is a highly concentrated, microbial treatment for lagoons and other large wastewater systems. The powder is pre-measured and the packaging dissolves in water, making it easy for operators to apply.

Effective within a variety of wastewater applications, the Biotifx 40B Water Soluble Packet alleviates challenges associated with sludge, fats, oils, grease (FOG), odor and hydrogen sulfide (H2S).

“These packets are 10 times the strength of MDG’s standard treatments and are 10-40 times the strength of some of our competitors,” said Sona Son, Director of Research and Development.

The product is formulated with MDG’s Biotifx blend of bacterial strains that are scientifically selected for their ability to degrade a broad range of organic material. It is enhanced with the addition of a proprietary blend of micronutrients and wastewater biostimulants to heighten performance of the microorganisms. “There’s nothing like it on the market. It’s the strongest, ready-to-use bioaugmentation product that exists today,” says Mike King, President.

Relative to competing chemical and microbial products, Biotifx 40B Water Soluble Packets save costs by reducing labor of application, waste (pails), storage and inventory needs, dosing equipment and maintenance and shipping.

Ideal for treating systems in:

  • Large Municipalities
  • Food and Beverage Manufacturing
  • Pulp and Paper Manufacturing
  • Refineries and Chemical Manufacturing

In addition to the product, Biotifx distributors receive a new level of program support. This includes classroom training, ongoing access to technical service partners (including on-site), application guides and more to help their customers easily resolve wastewater issues.

For more information on the new Biotifx 40B Water Soluble Packets, please visit: https://www.mdgbio.com/40B/

About Microbial Discovery Group

Microbial Discovery Group is a Bacillus fermentation company focused on the commercialization of microbials for wastewater, bioremediation, aquaculture, consumer and institutional markets while additionally partnering with customers to fulfill their custom fermentation needs. MDG refines and delivers products and ideas by applying Real Science to a Trusted Process, yielding Proven Success. For more information on Microbial Discovery Group, visit http://www.mdgbio.com.

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Laboratory Analysis of the ePlex® Blood Culture Identification Panels for Timelier Diagnosis of Gram-Negative and Gram-Positive Bacteremia, Webinar Hosted by Xtalks


The microbiology laboratory can benefit from sample-to-answer multiplex systems to streamline workflows at the blood culture bench and provide more rapid information to the clinical team managing patients.

Conventional microbiology has been the backbone for diagnosing bacteremia, yet in the past decade, new technologies have emerged. Molecular techniques are now an important tool in the clinical microbiology laboratory to provide organism and resistance-mechanism identification quickly using rapid multiplex panels. These panels can be used directly on positive blood cultures to deliver information to clinicians for timelier management of patients with bloodstream infections due to bacterial and fungal pathogens.

The microbiology laboratory can benefit from sample-to-answer multiplex systems to streamline workflows at the blood culture bench and provide more rapid information to the clinical team managing patients. Members of the clinical team can utilize faster molecular identification results delivered by the laboratory to properly provide care and therapeutic management for each patient, instead of waiting for traditional culture and antimicrobial susceptibility results, which can take more than 24-48 hours.

In this webinar, the audience will hear a microbiology laboratory director and an infectious diseases physician from a tertiary care facility describe their experience testing positive blood cultures from the clinical microbiology laboratory on the ePlex Blood Culture Identification Gram-Negative and Gram-Positive Panels.

Join experts from The University of Alabama at Birmingham, Sixto M. Leal Jr., MD, PhD, Assistant Professor, Director, Clinical Microbiology, Fungal Reference Laboratory, Department of Pathology Division of Laboratory Medicine; and Todd McCarty, MD, Assistant Professor, Division of Infectious Diseases, Department of Medicine, for the live webinar on Wednesday, December 9, 2020 at 3pm EST (12pm PST).

For more information, or to register for this event, visit Laboratory Analysis of the ePlex Blood Culture Identification Panels for Timelier Diagnosis of Gram-Negative and Gram-Positive Bacteremia.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Lumicell Granted Fast Track Designation Approval by the FDA for Breast Cancer Treatment


Lumicell Logo

Lumicell

We are very excited with the progress as we continue enrollment in our Breast Cancer Pivotal Trial which we expect will further build on the strong clinical data Lumicell demonstrated in our multi-center feasibility clinical study.

Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has received Fast Track designation with rolling review from the FDA Center for Drug Evaluation and Research (CDER) to expedite the development and review of the LUM Imaging System in the treatment of Breast Cancer. Fast Track designation represents another major milestone in Lumicell’s path to FDA approval.

“The FDA’s decision to grant Fast Track Designation is an important step in bringing the Lumicell Imaging System closer to FDA approval and providing surgeons with this innovative technology to detect and remove cancerous tissue more confidently and efficiently than ever before,” said Kevin Hershberger, President and CEO at Lumicell. “We are very excited with the progress as we continue enrollment in our Breast Cancer Pivotal Trial which we expect will further build on the strong clinical data Lumicell demonstrated in our multi-center feasibility clinical study.”

Fast Track is a program designed to facilitate the development and expedite the review of new drugs that treat serious conditions and fill an unmet medical need. Filling an unmet need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapies. As a Fast Track designee, Lumicell will have access to early and frequent communications with the FDA to discuss Lumicell’s development plans and ensure collection of appropriate data to support the approval process. Additionally, with rolling review Lumicell plans to submit modules for the New Drug Application (NDA) for FDA review as they are ready, rather than submitting the full NDA package upon the completion of clinical trials.

This latest milestone complements our previously received FDA Breakthrough Device designation for breast cancer and all solid tumors from the FDA Center for Devices and Radiological Health (CDRH). Similar to Fast Track, Breakthrough Device Designation is awarded to medical devices or combination products that provide more effective treatment of life-threatening diseases or conditions with the goal of providing physicians and patients access to these technologies.

“Lumicell’s technology is a paradigm shift – we’re now looking at the surface of the cavity instead of lumpectomy margins,” said Irene Wapnir, MD, Surgical Oncologist at Stanford Health Care. “It’s a fresh approach to in-vivo cancer surgeries. Instead of focusing on what was in the lumpectomy specimen, we prioritize what’s left behind in the cavity.”

Existing surgical tools often fail to identify and remove all of the cancerous tissue in the initial surgical intervention, resulting in 20 – 40% of breast cancer patients requiring a second surgery to remove additional cancerous tissue. The LUM Imaging System was developed to allow surgeons to see and remove residual cancer in real-time—significantly reducing the risk of leaving cancer behind, second surgeries and cancer recurrence.

For more information about the LUM Imaging System and Lumicell’s clinical trials, visit http://lumicell.com/clinical-trials/clinical-trials.php.

About Lumicell, Inc.

Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s LUM Imaging System has unprecedented ability to see and guide removal of cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the LUM Imaging System in patients undergoing surgery for breast cancer, ovarian cancer, prostate cancer, brain cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include perfusion, wound care and infection, and surgeries for lung, and liver cancers. For more information, please visit http://www.lumicell.com.

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Mount Sinai Researchers Discover How to Boost Efficacy of Vaccine Designed to Prevent Melanoma Recurrence


A vaccine created to prevent the recurrence of the deadly skin cancer melanoma is about twice as effective when patients also receive two components that boost the number and effectiveness of immune system cells called dendritic cells, according to phase 2 clinical trial results published in Nature Cancer in November.

These results are important because most cancer vaccine trials have failed to show clinical efficacy. These results show that adding two immune-boosting components can boost the immune response for not only melanoma patients but possibly also others whose cancers express a protein called the vaccine antigen, which is common in some cancers.

Researchers at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, working with colleagues at the National Cancer Institute-funded Cancer Immunotherapy Trials Network (CITN) based at the Fred Hutchinson Cancer Research Center, found that adding the small molecule Flt3L, which increases the number of dendritic cells, boosted the vaccine’s effectiveness at producing antibodies and T cells that can later fight melanoma. Adding a second component, called poly-ICLC, also strengthened the dendritic cells’ ability to promote antibodies as well as helper and killer T cells.

Sixty patients who had stage 2 or 3 melanoma, and whose cancer was successfully removed via surgery, received the vaccine. Half of the patients received the vaccine alone while the other half received the vaccine with Flt3L and poly-ICLC.

The vaccine is designed to target dendritic cells and is composed of an antigen found in melanoma bound to an antibody to increase the chances of binding with dendritic cells.

The cocktail of the vaccine, Flt3L, and poly-ICLC nearly doubled the vaccine’s efficacy, according to analysis of the T cells detected in patients’ blood samples after they received four doses over four months. That immune response was seen significantly earlier in the patients who received the cocktail and at much higher levels in many more patients compared to those who received only the vaccine. Researchers found antibodies were still present in blood samples tested 12 weeks after the last dose.

“This is the first randomized clinical trial to show that an immune response to a cancer vaccine can be potentiated by the addition of Flt3L,” says Nina Bhardwaj, MD, PhD, Director of the Immunotherapy Program at The Tisch Cancer Institute, and first author and a corresponding author on the study. “The response was achieved because Flt3L mobilized dendritic cells, which are the gold standard in promoting cancer immunity, and improved the overall immunogenicity of the vaccine. This may change the approach of increasing efficacy in other cancer vaccines in the future.”

“These positive results are significant not only for improving cancer vaccines, but also potentially for application to other vaccine platforms,” reported the study’s co-corresponding and senior author Steven Fling, PhD, Director of the CITN Laboratory and Senior Staff Scientist in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center, “and we are extremely grateful and indebted to the patients whose unwavering participation made this demanding clinical protocol a success.”

These findings also provide a basis for adding immunotherapies called checkpoint inhibitors, which have been successful in treating metastatic melanoma, to vaccines in order to further increase the success in fending off melanoma recurrence. Researchers also plan to follow trial participants over time and measure how many have cancer recurrence to further study the vaccine’s efficacy in each group.

“Immunotherapy has already shown great promise for patients with metastatic melanoma who would normally have a difficult, sometimes grave, prognosis,” said Philip Friedlander, MD, PhD, Director of the Melanoma Medical Oncology Program at The Tisch Cancer Institute at Mount Sinai and site investigator of the trial. “It’s important to work toward developing effective cancer vaccines that can prevent cancer on their own or in addition to the drugs already available.”

This research was funded by the National Cancer Institute and Celldex. Celldex also manufactured the vaccine and Oncovir manufactured the poly-ICLC.

About the Mount Sinai Health System

The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report’s “Honor Roll” of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

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SynDevRx Announces Positive Data from Phase 1 Safety Trial of SDX-7320 in Late Stage Cancer Patients


The results of our Phase 1 trial suggest that SDX-7320 has a safety profile that supports future combination studies. These data provide us with the scientific rationale for clinical studies in tumors that are sensitive to metabolic hormones, i.e., metabo-oncology.

SynDevRx, Inc., a clinical-stage oncology company, has submitted results of its Phase 1 dose escalation safety study in late-stage cancer patients with progressive, metastatic solid tumors to the United States Food and Drug Administration (FDA) [1]. The study’s primary endpoint was to establish the maximum tolerated dose and dosing schedule and the recommended Phase 2 dose for SDX-7320, the company’s lead drug candidate for the treatment of metabolically sensitive cancers [2]. Secondary and exploratory endpoints included analysis of anti-tumor efficacy and changes in key angiogenic and metabolic biomarkers.

The study evaluated data from 32 patients, whose disease progression and new lesion formation were measured at intervals of every 2 months from the initiation of treatment. Exploratory changes from baseline to metabolic hormones were measured, including leptin and adiponectin, as well as changes to insulin levels and insulin sensitivity (HOMA-IR). Exploratory changes from baseline to angiogenesis biomarkers bFGF, VEGF, and IGF-1 were also evaluated. A total of 28 patients had at least one tumor burden assessment performed, of whom 21 (75%) had at least one stable disease determination before leaving the study or experiencing progressive disease. Of these 21 patients, the period of measurable stable disease averaged 85 days. There were no objective partial or complete responses.

“The results of our Phase 1 trial suggest that SDX-7320 may have potent anti-angiogenic activity, appears to induce favorable changes to insulin, leptin and adiponectin, and has a safety profile that supports future combination studies. These data provide us with the scientific rationale for future clinical studies in tumors that are sensitive to metabolic hormones, i.e., metabo-oncology,” said Brad Carver, President and CEO of SynDevRx. “Animal data we previously presented at the San Antonio Breast Cancer Symposium in 2019 showed that SDX-7320 attenuated the hyperglycemia and hyperinsulinemia caused by the PI3K inhibitor alpelisib, and showed synergistic tumor growth inhibition in mice. Considering the aforementioned data together with this clinical data, we believe SDX-7320 could provide real benefit to breast cancer patients taking a PI3K inhibitor. We expect to open enrollment for our upcoming clinical trial in metastatic ER+/Her2- breast cancer patients with a mutation in the PIK3CA gene early next year, followed by additional trials focused on triple-negative breast cancer and prostate cancer, tumor types that are highly sensitive to systemic metabolic dysfunction.”

About the Study:

SynDevRx’s Phase 1 dose escalation study was designed to assess the safety and tolerability of SDX-7320 in patients with advanced refractory or late-stage solid tumors (lung, colon, breast, rectal, pancreatic, appendiceal, carcinoid, cholangiocarcinoma, cervical, endometrial, hepatocellular, and urothelial cancers). [3] Patients were a mean age of 66 years old and had progressed following five prior lines of treatment for their metastatic disease, on average.

SDX-7320 was administered subcutaneously at doses ranging from 1.7–65 mg/m2 and induced primarily mild side effects including fatigue, GI symptoms (nausea, abdominal pain, diarrhea), and anemia. The dose-limiting toxicity event, thrombocytopenia, was generally reversible without intervention and was observed only at the highest doses tested. Results of the study suggest that the dose of SDX-7320 at 49 mg/m2 on a once every two weeks (i.e., Q14D) schedule may be appropriate for future studies. [3]

SDX-7320 acts by inhibiting MetAP2, a clinically validated target that appears to play a key role in tumor growth, metastasis, angiogenesis, and metabolic dysfunction. “Many solid tumor types are highly sensitive to dysregulated metabolic hormones, such as insulin, leptin, or adiponectin. These hormones signal through known oncogenic pathways, like PI3K/Akt/mTOR or STAT3. Given the epidemic of metabolic syndrome in the world plus the frequency of tumors that are sensitive to metabolic hormones (e.g., breast and prostate cancers), we believe that SDX-7320 could help clinical oncologists treat their cancer patients with concomitant, systemic metabolic dysfunction in combination with standard-of-care therapies,” said James Shanahan, Co-Founder and Chief Business Officer of SynDevRx.

About SDX-7320:

SynDevRx believes that SDX-7320 is the first drug being developed specifically for cancer patients with metabolic complications, such as obesity, diabetes, high blood glucose or HbA1c, pre-diabetes or insulin resistance. For certain tumor types, metabolic hormones stimulate oncogenic pathways, making the cancer more aggressive and deadlier. SDX-7320 acts by binding irreversibly to the target enzyme MetAP2, triggering improvements in the metabolic hormones, insulin, leptin and adiponectin. Additionally, SDX-7320 inhibits the important angiogenic proteins bFGF and VEGF, and in preclinical studies, inhibited multiple cell cycle signaling pathways and reversed immune suppression within the tumor micro-environment. SDX-7320 is being developed for use in combination with clinically indicated standard-of-care cancer therapies.

SynDevRx and Metabo-oncology:

SynDevRx is pursuing the research and development of therapeutic interventions for cancer patients that also have background metabolic dysfunction. Metabo-oncology is the emerging field of research into, and treatments for cancer patients with tumors that are sensitive to metabolic hormones. Many common cancers are highly sensitive to dysregulated metabolic hormones stemming from overweight/obesity, pre-diabetes (hyperinsulinemia), type 2 diabetes and metabolic syndrome. An estimated 600,000+ patients in the United States alone are diagnosed each year with tumors that fit this category, yet little attention is given to the influence of systemic metabolic dysfunction on cancer progression. While diet and exercise can be effective at mitigating these effects, patients undergoing cancer treatment often find it difficult to adhere to these regimens. Therapeutic interventions are needed.

SynDevRx expects to commence enrollment for clinical studies in breast and prostate cancers that will test whether SDX-7320, when added to standard-of-care treatment, will help these patients more than standard-of-care treatments alone. The first study is in 2nd line metastatic ER+/Her2- breast cancer patients with a PIK3CA mutation, in combination with the PI3Kα inhibitor Piqray® (Novartis). To learn more about SynDevRx upcoming clinical trials, visit: http://www.syndevrx.com/

References:

1. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016 Apr 19 – . Identifier NCT02743637, A Dose Escalation Study of SDX-7320 in Patients with Advanced Refractory or Late-Stage Solid Tumors (SDX-0101); 2020 Jan 27 [cited 2020 Oct 21]; Available from: https://clinicaltrials.gov/ct2/show/study/NCT02743637?term=syndevrx&draw=2&rank=1

2. Uzunlulu M, Telci Caklili O, Oguz A. Association between Metabolic Syndrome and Cancer. Ann Nutr Metab. 2016;68(3):173-9. doi: 10.1159/000443743. Epub 2016 Feb 20. PMID: 26895247.

3. Abstract CT153: SDX-7320 elicits improvements in tumor-related and metabolic biomarkers: Results of a phase 1 dose-escalation study in patients with advanced refractory or late-stage solid tumors. Mita M, Bendell J, Mita AC, Gordon M, Sachdev J, Carver BJ, Shanahan J, Mayes B, Awerkamp K, Browning D, Salomon N, Sullivan K, Anderson-Villaluz A, Johnson J, Petersen JS, Turnquist DJ, Cornelius P. J Cancer Res 2020 (80) (16 Supplement). DOI: 10.1158/1538-7445.AM2020-CT153

About SynDevRx:

SynDevRx is a privately held clinical-stage biopharmaceutical company based in Cambridge, Massachusetts focused on the research and development of treatments that address the underserved needs of cancer patients with systemic metabolic dysfunction – i.e., metabo-oncology. Obesity, pre-diabetes and type 2 diabetes are known to worsen certain cancer patients’ prognosis, but oncologists have no specific tools to treat systemic metabolic complications, except for diet and exercise. SynDevRx intends to initiate a series of clinical studies of its drug candidate SDX-7320 to address this major, unmet medical need. Preclinical studies have shown that SDX-7320 reduces tumor growth and angiogenesis, helps to control aberrant metabolic hormone signaling, and reduces treatment resistance to certain standard cancer therapies in metabolically sensitive cancers. SDX-7320 is being developed for use in combination with standard of care therapies for a variety of solid tumors.

Gateway Genomics Launches SneakPeek Early Traits DNA Test that Uses Genetics to Provide a Child’s Features


SneakPeek Traits provides physical features, nutrition & taste profile, and sleep behavior

The new traits DNA test helps parents with their child’s next stage in life – baby and early childhood, providing actionable advice for nutrition and sleep that’s tailored for the child’s DNA.

Gateway Genomics, leading provider of direct-to-consumer genetic tests focused on prenatal and pediatric information, launches the SneakPeek Early Traits DNA Test for parents of young children to learn more about their unique child. The test offers fun insights on adult physical features as well as helpful tips and advice for predicted nutrition levels and sleep behavior as gleaned from the child’s DNA.

“We’re dedicated to developing leading-edge DNA technology that provides parents with the information they need to help their children live their best lives,” says Gateway Genomics CEO, Chris Jacob. “Prior to this, we focused on making our prenatal gender DNA test as accurate, accessible, and easy as possible, as early in pregnancy as possible. The new traits DNA test helps parents with their child’s next stage in life – baby and early childhood, providing actionable advice for nutrition and sleep that’s tailored for the child’s DNA.”

SneakPeek Early Traits DNA Test focuses on three main categories of traits: 1) Physical Features such as height, eye color, and hair color, 2) Nutrition & Taste, providing predicted vitamin levels and BMI, and 3) Sleep Behavior, including night owl versus early bird tendencies, and how long a child takes to fall asleep, as indicated by genetics. The test is ordered online, and an easy swab of the child’s mouth is taken from the comfort of home and mailed back to SneakPeek Labs in a prepaid envelope. Extensive results that include background information on each trait, and tips and advice for nutrition and sleep as tailored for the child’s age and genes, are delivered through a secure portal within 2 to 3 weeks. Security and privacy are built into the entire process with data encryption and advanced server authentication.

“We’re very excited to offer this new test that gives parents more insight into their future children,” continues Mr. Jacob. “It provides answers to questions that could never be addressed before like how tall will my child be, with what color eyes? Will they sleep through the night or have multiple wakeups? At Gateway Genomics, we’re always pushing the envelope and innovating to provide leading-edge DNA-based tests that use the most current, scientifically-validated genetic studies for results parents can trust.”

SneakPeek Early Traits DNA Test is currently available through the SneakPeek website and the test kit will soon be launched in the company’s participating clinical locations.

In 2020, Gateway Genomics ranked #296 in the Inc. 5000 list of fastest-growing private companies in the U.S., #22 in the Health sector. In this year’s Inc. 5000 California list, the company was ranked the 17th fastest-growing private company in the state, and #1 in the Health sector. Gateway Genomics’ principal product, SneakPeek, is an easy-to-use DNA test that lets parents know the gender of their babies as early as 8 weeks into pregnancy, with 99.1% accuracy.

About Gateway Genomics

Gateway Genomics is a personal genomics company with the mission to develop leading-edge genetic tests that give families a new level of understanding about their future children. Since inception, more than 300,000 SneakPeek Early Gender DNA tests have been provided to help new parents bond with their babies, make plans, and connect with friends and family around them. Gateway Genomics is located in La Jolla, CA.

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CUSABIO Exosome Isolation Kit, A Great Exosome Research Tool


CUSABIO Exosome Isolation Kits purify exosomes by affinity purification. The purity and yield are comparable to ultracentrifugation.

In 2019, the team at CUSABIO developed the first commercial Exosome Isolation Kit by affinity purification. Researchers can obtain the High Purity exosomes and other Evs (Extracellular vesicles) from the cell culture medium and body fluid (high yield by normal microfiltration) easily by this method. The exosomes obtained from CUSABIO kits are suitable for many downstream experiments, including Transmission electron microscope analysis, Nanoparticle tracking analysis, NanoFCM analysis, Western Blot, Fluorescence quantitative (qPCR), High-Throughput Sequencing, etc. But it only could extract exosomes from the cell culture supernatant at that time. To meet the requirements of researchers, CUSABIO adds another 5 sample types for the kit in 2020.

About CUSABIO Exosome Isolation Kit

CUSABIO exosome isolation kit can extract exosome from various sample types and cells with high purity and yield. It is suitable for many downstream experiments. This kit is very simple and efficient to use. No ultracentrifugation or phenol/chloroform step required. No large-scale equipment required. And the exosomes extracted by CUSABIO Exosome Isolation Kit are comparable to ultracentrifugation with High Purity and High Yield.

More details, please visit https://www.cusabio.com/Exosome-Isolation-Kit.html

About Exosomes

Exosomes are small, single-membrane, secreted extracellular vesicles of ~30 to ~200 nm in diameter that contains any of various biomolecules, such as proteins or nucleic acids. They allow for cell-to-cell communication, transporting molecules, and act as shuttles for certain genetic information and proteins to other cells. Intercellular communication by exosomes plays a critical role in diverse pathological processes, such as cancer, infectious and neurodegenerative diseases.

Exosomes were first discovered in the maturing mammalian reticulocyte by Stahl and group in 1983 and Johnstone and group in 1983, further termed ‘exosomes’ by Johnstone and group in 1987. In 2007, Jan Lotvall and the group made a great breakthrough in exosome research. The variable RNA and miRNA contained in the exosomes, and non-coding long RNAs and mRNAs can be transported between cells. In 2010, three research groups demonstrated that miRNAs can be transferred to standby cells and function in cells.

Since then, the importance of exosome comes out conspicuously. In addition, the Nobel Prize in Physiology or Medicine 2013 was awarded jointly to James E. Rothman, Randy W. Schekman and Thomas C. Südhof “for their discoveries of machinery regulating vesicle traffic, a major transport system in our cells.” More and more researchers start their study of the exosome. And exosomes are being explored as a tool for disease diagnosis and management.

Since exosomes are distributed in a broad range of biofluids, such as serum, plasma, ascites fluid, urine, saliva and tissue culture media, exosome isolation becomesthe first and the most important step in the research of exosome. There are many methods to isolate exosomes from the samples, such as Differential ultracentrifugation and Density gradient ultracentrifugation, Ultrafiltration method, Polypolymer precipitation method, Magnetic bead immunoassay, Aqueous two-phase system (ATPS) method, etc. They have their own pros and cons. Exosome isolation kit is the product that tries to develop the strong points and avoid the weak points. And it turns out the results are not bad. It is also one of the reasons why CUSABIO developed the Exosome isolation kit.

About CUSABIO

CUSABIO is a manufacturer of ELISA kits, Exosome isolation kits, antibodies, proteins, and related reagents, starting with a small lab. After 13 years of effort, CUSABIO has become a good partner to researchers worldwide. And thousands of products are used by the researchers and help them make more and more breakthroughs.

To know more about CUSABIO, please visit: https://www.cusabio.com/

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