NEW YORK (PRWEB)
November 16, 2020

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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CAMBRIDGE, Mass. (PRWEB)
November 16, 2020

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.

HOUSTON (PRWEB)
November 13, 2020

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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Over the past 37 years, we have built a strong reputation and valuable brand equity around spondylitis.

ENCINO, Calif. (PRWEB)
November 10, 2020

Effective immediately, the Spondylitis Association of America (SAA) will evolve its brand identity with a new tagline, “Serving the Spondyloarthritis Community” to fully represent the comprehensive and inclusive scope of the organization’s mission and the community it serves.

As a patient-focused organization, SAA values and respects the needs and concerns of all members of its community. SAA partners with medical and health care experts to provide the information, resources, and tools to help its community make informed decisions about their health and manage the complications of living with spondyloarthritis, the umbrella term for a family of related rheumatic diseases.

More than 3.2 million Americans are impacted by spondyloarthritis. The vast majority of SAA’s community lives with Ankylosing Spondylitis (AS), and spondylitis has been prominently featured within its name, branding, and messaging since its founding. “Over the past 37 years, we have built a strong reputation and valuable brand equity around spondylitis,” said SAA CEO Cassie Shafer. “But to be a true family, we must evolve our identify to be inclusive of members of our community who are living with Axial Spondyloarthritis (axSpa), Non-Radiographic Spondyloarthritis (nr-axSpA), Juvenile Spondyloarthritis (JSpA), Psoriatic Arthritis (PsA), Enteropathic Arthritis (EnA), Reactive Arthritis (ReA), and peripheral spondyloarthritis,” Shafer added.

Regardless of which disease an individual may be living with, SAA believes that as a family, it is on a shared journey together with its community. As with any family, there will be differences of opinions – even on issues such as the informal usage of spondylitis versus more formal medical references to the disease. But the new tagline is a reminder and symbol of the organization’s commitment and focus on what its constituents have in common, and that their shared vision, hopes, and challenges unite them together as one community.

About the Spondylitis Association of America

Since its founding in 1983, the Spondylitis Association of America has been the leading national nonprofit that provides educational resources, connections, and the critical support that people living with spondyloarthritis need. SAA is committed to increasing awareness of the disease, providing information and support to patients and their families, and funding research to ultimately uncover a cure for the disease.

SAA has a wealth of information, educational materials, and resources for medical practitioners, the newly diagnosed, those who are seeking a proper diagnosis, and those who have already been diagnosed and living with the disease.

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COPENHAGEN, Denmark (PRWEB)
November 12, 2020

Today, Octarine Bio ApS (“Octarine” or the “Company”), a synthetic biology company developing biosynthetic platforms for cannabinoids, psychedelics and their novel improved derivatives announced the successful closing of Seed financing led by the Danish State Growth Fund (Vækstfonden) with participation from Enexis AB, Oskare Capital and cannabis and psychedelic industry veteran Bruce Linton. This latest financing comes shortly after the company closed a pre-seed round earlier this year, bringing the total amount raised by the company to over $1.8M USD.

“In these uncertain times we’re thrilled to be able to close our next round of financing” said Octarine Co-founder and CEO Nethaji Gallage. “We’re excited to welcome new investors on board but also very pleased to receive follow-on investment from existing investors and greatly appreciate their continued support and belief in our team and the mission.”

“Octarine has shown significant progress since our first investment in the beginning of 2020” said Lene Gerlach, investment manager at Vækstfonden, “and we’ve experienced a great interest in the company both from investors and large market players. They, as well as us at Vækstfonden see great potential in Octarine’s platform technology, which is based on ground-breaking research from the University of Copenhagen and Technical University of Denmark. We believe Octarine will play an important role in improving both the manufacturing and the characteristics of complex natural compounds.”

“We identified Octarine in April of 2019 as a company with a very high potential to disrupt the medical cannabis market through its set of proprietary novel compounds. We are happy to be joining forces with Vækstfonden, Enexis and other business angels, who share the same vision as Oskare Capital on Octarine’s potential in the cannabinoid and psychedelic space,” said Alexandre OUIMET-STORRS, Co-Founder and Managing Partner of Oskare Capital.

Proceeds from the round will be used to obtain important pre-clinical validation of the company’s novel, improved cannabinoid derivatives in in vivo animal models. In vitro data has demonstrated significant improvements in solubility, stability, and bioavailability of these molecules over natural cannabinoids and the company expects to be able to generate a lead candidate for further clinical development.

“Solubility, stability, and bioavailability are significant issues currently limiting the therapeutic application of cannabinoids” said Octarine Co-founder and CSO Nick Milne. “With the improved derivatives in our pipeline we’re confident that we can realise the full potential of cannabinoids to treat a range of debilitating conditions.”

Proceeds will also be used to continue development of the company’s fermentation-based production platforms for pharmaceutical-grade psychedelics including psilocybin and a range of other rare and novel derivatives. These platforms will be used to supply molecules for strategic partners as well as for Octarine’s own drug development efforts.

About Octarine

Octarine’s mission is to solve our greatest health challenges by enabling innovative cannabinoid and psychedelic therapeutics. Many neurological and psychological conditions are poorly served by current drugs, leaving physicians, patients, and their families desperately seeking alternative therapies, sometimes illegally. Cannabinoids and psychedelics are poised to offer breakthrough therapies for these debilitating conditions, but to realize the full potential of these molecules, issues with their production and undesirable properties must first be solved.

Octarine is perfecting a biological approach to producing improved & novel cannabinoid and psychedelic molecules with tailored modes-of-action. Our proprietary technology combines synthetic biology, yeast fermentation and enzymatic derivatization to develop IP protected drug candidates that are validated in pre-clinical models.

Octarine was founded in September 2018 by Nethaji Gallage (CEO) and Nick Milne (CSO) based on foundational research conducted at the University of Copenhagen and Technical University of Denmark (DTU). Octarine is also an alumnus of the BioInnovation Institute, an initiative run by the Novo Nordisk Foundation.

For more information visit http://www.octarinebio.com

About Oskare Capital

https://oskarecapital.com

About Enexis

https://www.enexis.se

About Vækstfonden

https://vaekstfonden.com

About BioInnovation Institute

https://bioinnovationinstitute.com

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BOSTON (PRWEB)
November 09, 2020

Robert A. Sherman, senior counsel in the Boston office of global law firm Greenberg Traurig, LLP and former U.S. Ambassador to Portugal, was a featured speaker at the Massachusetts Biotechnology Council (MassBio) Town Hall on Thursday, Nov. 5, 2020. The Town Hall focused on the election results of the 2020 United States presidential election and what they mean for the biopharma industry.

The Town Hall panel included:

• 
  Robert K. Coughlin (President & CEO, Massachusetts Biotechnology Council)
• Jennifer Nason (Senior Director of Communications, Massachusetts Biotechnology Council)
• Tamar Thompson (Vice President of U.S. Government Affairs, Alexion Pharmaceuticals, Inc.)

Sherman focuses his practice on government and regulatory investigations and litigation, internal corporate investigations – with an emphasis on Foreign Corrupt Practices Act (FCPA) compliance – as well as consumer protection and class action defense. He has broad experience representing clients in complex, high profile cases including those that have generated significant media attention.

From 2014-2017, Sherman served as the United States Ambassador to Portugal, having been nominated by President Barack Obama and unanimously confirmed by the United States Senate. As Ambassador, he focused heavily on bilateral economic development and international security issues, such as cybersecurity, refugees, narcoterrorism and NATO. In recognition of Sherman’s work in the country, Portuguese President Marcelo Rebelo de Sousa decorated him with the Grand Cross of the Order of Prince Henry the Navigator in March 2017.

About Greenberg Traurig’s Life Sciences & Medical Technology Group: Greenberg Traurig’s Life Sciences & Medical Technology Group advises clients ranging from start-ups to large multinational public companies to leading research institutions. The group’s attorneys work closely with clients, providing innovative legal counsel to help them achieve their objectives – from discovery through commercialization and product marketing.

About Greenberg Traurig’s Boston Office: Established in 1999, Greenberg Traurig’s Boston office is home to approximately 75 attorneys practicing in the areas of bankruptcy and restructuring, corporate, emerging technology, energy, environmental, financial services, gaming, governmental affairs, intellectual property, labor and employment, life sciences and medical technology, litigation, public finance, and real estate. An important contributor to the firm’s international platform, the Boston office includes a team of nationally recognized attorneys with both public and private sector experience. The team offers clients the value of decades of helping clients in complex legal matters and hands-on knowledge of the local business community, supported by the firm’s vast network of global resources.

About Greenberg Traurig: Greenberg Traurig, LLP (GT) has approximately 2,200 attorneys in 40 locations in the United States, Latin America, Europe, Asia, and the Middle East. GT has been recognized for its philanthropic giving, diversity, and innovation, and is consistently among the largest firms in the U.S. on the Law360 400 and among the Top 20 on the Am Law Global 100. The firm is net carbon neutral with respect to its office energy usage and Mansfield Rule 3.0 Certified. Web: http://www.gtlaw.com

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