RDIF, Sistema, Korea’s Macrogen Plan to Jointly Develop Biotechnology in Russia

The Russian Direct Investment Fund (RDIF), the sovereign wealth fund of Russia, and Sistema PJSFC, a publicly traded diversified Russian holding company, have agreed with South Korean firm Macrogen to cooperate to develop the biotechnology sector in the Russian Federation following the Eastern Economic Forum.

Macrogen, whose technology has been supplied to more than 100 countries for the last 20 years, has world-class expertise in the area of genetic analysis, including gene and capillary sequencing, microarray, oligo synthesis and bioinformatics. According the trilateral agreement RDIF, Sistema and Macrogen plan to jointly create conditions for the practical implementation of these developments in Russia and to conduct further research.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), noted:

“RDIF actively deals with industry and strategic investors to attract the most advanced technologies and to implement projects. The area of genetics in science and medicine has already proved not only its prospects, but also its consistency. Together with partners, we see great opportunities for combining practices and effective commercial use of leading global achievements in this field. This allows us to create an infrastructure to improve the quality of life and healthcare of our citizens, as well as for subsequent breakthrough scientific discoveries.”

Artem Sirazutdinov, Chairman of the Board of Directors of the Medsi Group of Companies, said:

“Our strategy to grow our healthcare business envisions establishing a broad network of partners and working jointly with other companies in the industry. On the basis of the clinical capacity of Medsi’s medical chain, owned by Sistema, and leveraging leading international expertise, we are focused on bringing the most advanced biotechnology to Russia, and to improving diagnostics and treatment of socially significant diseases such as cancer. The expertise of Korean R&D centres, which have made considerable progress in the areas of gene and cell-based technologies, will be extremely useful, including in the development of new targeted cancer therapies.”

Kap-seok Yang, CEO of Macrogen Inc, said:

“Sistema leads Russian healthcare market with its affiliate company, Medsi. And Macrogen is proud to be a part in multipartite R&D partnership with Sistema and RDIF. The partnership seems promising for the successful market access in Russia. With years of experience for genetic sequencing and analysis service, Macrogen aims to be the best partner to enhance total quality of life in Russia in terms of precision medicine along with clinical diagnostics and big data. That is only possible through collaboration encompassing from A to Z in healthcare industry.”

https://www.marketscreener.com/MACROGEN-INC-12872553/news/Macrogen-RDIF-Sistema-and-Korean-Company-Macrogen-Plan-to-Jointly-Develop-Biotechnology-in-Russia-27267166/

Pfizer Presents Positive Phase 2 Data in Alopecia

Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841, a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in patients with moderate to severe alopecia areata (AA), an autoimmune disease characterized by hair loss and often associated with profound psychological consequences. Both JAK inhibitors met the primary efficacy endpoint in improving hair regrowth on the scalp relative to baseline at week 24 (33.6 points and 49.5 points for JAK3 and TYK2/JAK1, respectively) as measured by the Severity of Alopecia Tool (SALT) score (100 point scale). The findings were presented during a Late-Breaking News session at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.

“We are pleased with these results and excited by the potential of kinase inhibition as a new therapeutic target for patients living with alopecia areata. This is the first well-controlled study of oral JAK inhibitors in alopecia areata, helping enhance our understanding of this disease with significant unmet need and advance the science of kinase inhibition,” said Michael Vincent, M.D, Ph.D., Senior Vice President and Chief Scientific Officer, Pfizer Inflammation and Immunology.

Based on the totality of the data and the emerging clinical profiles, the investigational JAK3 inhibitor, which was recently granted Breakthrough Therapy designation from FDA for alopecia areata, is advancing to the next phase of development for moderate to severe AA and will continue to be evaluated for rheumatoid arthritis (RA), Crohn’s disease (CD) and ulcerative colitis (UC). PF-06700841 will continue to be evaluated for psoriasis (PsO), CD and UC.

“People living with alopecia areata face a difficult journey as there are currently no approved treatments,” said study investigator Rodney Sinclair, MD, Sinclair Dermatology, Melbourne, Victoria, Australia. “The results seen with these JAK inhibitors are very encouraging for me as a clinician as they signal a potential new way to think about the treatment of alopecia, which may bring hope for patients with this distressing condition.”

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-Presents-Positive-Phase-2-Data-in-Alopecia-Areata-During-Late-Breaker-Session-at-the-27th-E-27266854/

Sanofi: Positive Phase 3 results presented for dermatitis med

Positive Phase 3 results presented for Dupixent(®) (dupilumab) show significant
improvement on multiple measures of disease severity in adolescents with
moderate-to-severe atopic dermatitis

* Results on skin clearing, itch and certain quality of life measurements were
presented today as a late-breaking oral presentation at the 27(th) EADV
Congress

Detailed results from a pivotal Phase 3 trial showed Dupixent(®) (dupilumab) monotherapy demonstrated a significant improvement in signs and symptoms of atopic dermatitis and certain quality of life measures in adolescent patients (12-17 years) with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. These data
were presented today at the 27(th) European Academy of Dermatology and
Venereology (EADV) Congress in Paris, France.

There continues to be a significant unmet need for adolescents with moderate-to-
severe atopic dermatitis, whose disease cannot be controlled with topical
treatments. There are no systemic biologic medications approved for this patient
population. Dupixent is currently approved for use in certain adult patients
with moderate-to-severe atopic dermatitis in countries including the U.S.,
European Union, Canada and Japan. The results from this trial in adolescents
form the basis of regulatory submissions for patients ages 12 to 17.

“Limited treatment options leave adolescents with uncontrolled moderate-to-
severe atopic dermatitis to cope with intense, unrelenting itch and skin
lesions,” said Amy S. Paller, M.D., Director of the Northwestern University Skin
Disease Research Center and principal investigator of the trial. “The results we
are presenting today show the potential for Dupixent in adolescents to not only
help clear the skin and reduce itching, but also improve certain aspects of
quality of life in adolescents who may be dealing with these unbearable
symptoms.”

https://www.marketscreener.com/SANOFI-4698/news/Sanofi-Positive-Phase-3-results-presented-for-Dupixent-dupilumab-27266859/

Inovio, Geneone Lifesciences announce Phase 1 study of Hep C vaccine

Inovio Pharmaceuticals and Korea`s GeneOne Life Science have announced that they have dosed the first patient in a Phase 1 study designed to evaluate a preventive vaccine against hepatitis C infection. Recruitment has already begun in South Korea, where GeneOne is responsible for conducting and funding this Phase 1 trial to assess the ability of Inovios hepatitis C vaccine (GLS-6150) to boost immunity in people who have been treated and cleared of the virus. Pending study results, Inovios vaccine could be employed to prevent infection and re-infection.

Dr. J. Joseph Kim, Inovios President & CEO, said, Developing the first successful vaccine against hepatitis C virus is a highly ambitious endeavor but a truly impactful effort for global health as well as being transformative for us commercially. The key to a successful hepatitis C vaccine will be its ability to activate the bodys immune system to prevent or treat infection by a virus with multiple or ever-changing strains. Inovios innovative DNA-based technology platform is uniquely positioned to address this challenge and it has been optimizing over the last several years in demonstrating strong in vivo immune responses against very tough-to-treat viruses like HIV, Zika and flu. We are very excited to launch this study with GeneOnes funding and execution in Koreaand we look forward to the data in 2019.

Many insurers and governments, including the U.S., are seeking ways to control the high medical costs of treating hepatitis C infection and frequent re-infections especially in at-risk patient populations. Efforts to develop a hepatitis C vaccine started more than 25 years ago when the hepatitis C virus was first identified.

Progress has been slow because the hepatitis C virus is more variable than are the viruses that cause hepatitis A and B. The hepatitis C virus occurs in at least six genetically distinct forms (genotypes) with multiple strains. About 50 subtypes have been identified to date. Inovios synthetic DNA vaccines have an advantage over inactivated or attenuated virus products since they are not limited to one specific strain of virus. As such, they are well matched against viruses with multiple strains and have demonstrated in clinical trials the ability to produce broad-spectrum immune responses against numerous strains of targeted pathogens.

https://www.marketscreener.com/INOVIO-PHARMACEUTICALS-IN-17937428/news/Inovio-Pharmaceuticals-Pharma-Geneone-Lifesciences-announce-Ph1-study-of-Hep-C-vaccine-27266926/

New US survey shows some progress against opioid abuse, with offsets

Figures from a U.S. government survey released Friday show some progress in the fight against the ongoing opioid addiction crisis with fewer people in 2017 using heroin for the first time compared to the previous year.

The number of new users of heroin decreased from 170,000 in 2016 to 81,000 in 2017, a one-year drop that would need to be sustained for years to reduce the number of fatal overdoses, experts said.

Fewer Americans are misusing or addicted to prescription opioid painkillers. And more people are getting treatment for heroin and opioid addiction, the survey found.

The Trump administration said the positive trends show government efforts are working.

Messages are reaching people about the dangers of heroin and the deadly contaminants it often contains on the street, Dr. Elinore McCance-Katz, an administration health official, said in a video presentation released with the figures.

Among the other findings:

—Marijuana use climbed in all age groups except young teenagers, with 2.5 percent of those 26 and older, or 5.3 million adults, reporting they use marijuana daily or almost daily last year.

—Methamphetamine and cocaine use climbed in young adults, ages 18 to 25. The uptick may indicate that users are shifting from opioids to other drugs, said Leo Beletsky, a public health policy expert at Northeastern University in Boston.

—Young adults have increasing rates of serious mental illness, major depression and suicidal thoughts.

—The number of new heroin users in 2017—81,000—was lower than the numbers in most years from 2009 to 2016. But it was similar to the numbers of new heroin users in 2002 through 2008.

Experts said there’s still work to be done before success can be declared.

“Taken together, this does not look like the portrait of a nation with improving mental health and addiction issues,” said Brendan Saloner, an addiction researcher at Johns Hopkins Bloomberg School of Public Health. “It’s hard to look at this and not think we need to be doing a better job than we’re doing now.”

Earlier this month, the Centers for Disease Control and Prevention released preliminary figures that appear to show a leveling off in overdose deaths in late 2017 and the first two months of this year.

Health officials have said it’s too soon to say whether the nation’s drug crisis has peaked. But in an interview with The Associated Press this week, U.S. Health and Human Services Secretary Alex Azar said several measures of the crisis are improving.

“We are making progress,” he said. “We are seeing a flattening of our deaths from overdose.”

 Explore further: Daily use of marijuana among non-college young adults at all-time high

https://medicalxpress.com/news/2018-09-survey-opioid-crisis.html

An accurate biosensor that uses a single drop of blood

Scientists from the Max Planck Institute and EPFL have developed a new type of biosensor able to precisely quantify metabolites using a single drop of blood. The accuracy and simplicity of the procedure could make it a tool of choice for diagnosing and monitoring several diseases.

Diseases or injuries can result in dramatic changes in the blood levels of metabolites, which are chemical compounds produced by the body’s metabolism. For example, an increase in the level of the amino acid phenylalanine in the blood is characteristic of the genetic disorder phenylketonuria (PKU). Phenylalanine levels in infants suffering from PKU need to be controlled through diet to avoid irreversible brain damage. It is therefore essential to be able to regularly monitor phenylalanine levels in the blood.

However, such monitoring currently requires blood samples to be sent to laboratories, and the results take several days to reach the patient. This delay often complicates disease management for PKU patients and their physicians. The treatment of numerous diseases could be improved if the blood concentration of disease-relevant metabolites were monitored at the point of care – ideally by the patient.

To address this problem, a team of scientists led by Professor Kai Johnsson of the Max Planck Institute for Medical Research (MPIMR) in Heidelberg and EPFL’s Laboratory of Protein Engineering has developed a way to measure metabolite concentrations in small blood samples within minutes. The approach was validated with patients from the Heidelberg and Lausanne University Hospitals. The research was published today in Science.

Molecular engineering

“We introduce a fundamentally new mechanism to measure metabolites through blood analysis,” says Qiuliyang Yu, the first author of the paper and a scientist at the Department of Chemical Biology at the MPIMR. “Instead of miniaturizing available technologies, we developed a new molecular tool.” The tool is a light-emitting protein that changes color in the presence of the reduced cofactor nicotinamide adenine dinucleotide, known to biochemists by its acronym NADPH. This molecule can be produced in an enzyme-catalyzed reaction specific to the metabolite of interest, which means that the metaboliteconcentration can be determined by analyzing the color of the emitted light. Using different enzyme-catalyzed reactions, the same sensor can carry out quantitative assays of various metabolites, such as phenylalanine, glutamate and glucose.

Fast and accurate

In practice, the procedure is quite simple. In the case of phenylalanine, a drop of blood is taken from the patient through a painless finger prick. A fraction of the blood sample is then added to a reaction buffer and applied to paper containing the biosensor. When phenylalanine is consumed and NADPH is produced, the light emitted by the sensor changes color from blue to red – a change that can be detected by an everyday digital camera or smartphone. The change in color is then used to calculate the phenylalanine concentration.

The whole procedure takes only 10 to 15 minutes and can be done at the point of care. It is so easy and accurate that patients should eventually be able to test themselves, which is something the scientists are working on. “We are now looking for ways to further automate and simplify the test,” concludes Qiuliyang Yu.

 Explore further: Cheating on your diet? This blood test can tell

More information: Qiuliyang Yu et al. Semisynthetic sensor proteins enable metabolic assays at the point of care, Science(2018). DOI: 10.1126/science.aat7992

https://medicalxpress.com/news/2018-09-diagnosis-biosensor.html

2nd guilty plea in conspiracy to steal Glaxo cancer research, sell it in China

A second scientist pleaded guilty Friday to taking part in a conspiracy to steal trade secrets — in the form of cancer drug research — from the pharmaceutical giant GlaxoSmithKline. Tao Li admitted to one felony count in a federal indictment that alleged he received proprietary information from a biochemist inside GSK, and set up a company called Renopharma to market and sell the science in China. Li faces up to 10 years in prison, and his sentencing is scheduled for Jan. 4. Defendant Yu Xue, who worked at GSK’s Upper Merion lab, entered a guilty plea in the case last month.

https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/GlaxoSmithKline-Second-guilty-plea-in-trade-secrets-conspiracy-to-steal-cancer-research-from-Glaxo-27264495/