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Polatuzumab With Rituximab and Lenalidomide Shown Safe and Effective for Relapsed/Refractory DLBCL – Targeted Oncology

Posted: June 6, 2021 at 1:58 am

In patients with relapsed/refractory diffuse large B-cell lymphoma treated with the triplet combinaton of polatuzumab vedotin (Polivy), rituximab and lenalidomide, therapy was considered to be safe and effective, according to data presented at the 2021 ASCO Annual Meeting.

In this first report of a triplet combination of polatuzumab, rituximab and lenalidomide, the triplet combination showed notable efficacy in a challenging-to-treat relapsed and refractory diffuse large B-cell lymphoma population, said Catherine S.M. Diefenbach, MD, associate professor of medicine, translational director of hematology and director of clinical lymphoma at Perlmutter Cancer Center at NYU Langone Health, during the virtual presentation.

In this phase 1b/2 trial, researchers analyzed the safety of this combination in 57 patients (median age, 71 years; 67% men) with relapsed/refractory diffuse large B-cell lymphoma, were ineligible for or failed prior autologous stem cell transplantation and were treated with at least one prior anti-CD20-containing chemo-immunotherapy regimen. Efficacy of the treatment was assessed in 49 patients (median age, 72 years; 63% men).

The median age was 71, as is typical for this lymphoma, but the age range was from between 28 and 92 years, Diefenbach said.

Most patients in the safety and efficacy groups (86% and 84%, respectively) had stage 3 to 4 disease, nearly a quarter had two lines of therapy (28% and 27%) and nearly a third had three or more lines of therapy (33% and 31%). In addition, some patients underwent previous CAR T-cell therapy (5% and 6%, respectively) or prior bone marrow transplant (11% and 12%).

At induction, all patients received induction during 6 28-day cycles with 1.8 mg/kg of intravenous polatuzumab vedotin, 375 mg/m2 of intravenous rituximab and either a dose escalation of oral lenalidomide (between 10 mg and 20 mg) or the recommended daily dose of the drug on days 1 through 21. Patients who responded to the treatment at the end of induction received 6 months consolidation of 10 mg of lenalidomide (days 1 through 21, monthly) and 375 mg/m2 of rituximab (day 1 every 2 months).

Primary endpoints for this trial included the safety and tolerability of this triplet combination, in addition to complete response rates at the end of induction as assessed by positron emission tomography (PET) scans. Follow-up was conducted for a median of 9.7 months in the safety population and for 9.5 months in the efficacy population.

In the safety population, 75% of patients experienced grade 3 to 4 adverse events, with the most common including neutropenia (58%), thrombocytopenia (14%) and infections (14%). Adverse events led to 26% of patients undergoing a lenalidomide dose reduction and 67% had treatment interruption. One grade 5 adverse event related to the treatment neutropenic sepsis was reported.

The additional (adverse events) were not considered related to study drug, Diefenbach said. For example, a patient who had a fatal gastric hemorrhage who had been enrolled but not yet treated, and a patient with COVID-19 who contracted this disease 167 days after his last dose of the study therapy.

In the efficacy population, the overall response rate was 39% with a complete response rate of 29%. Ten percent of patients had a partial response. Median progression-free survival for the entire population was 6.3 months (95% CI, 4.5-9.7) with a median duration of remission of 8.1 months (95% CI, 4.7-not evaluated) and a median overall survival of 10.9 months (95% CI, 10.9-not evaluated).

However, for the patients who obtained a (complete response) this is 13 patients who were evaluable, the median progression-free survival at 9 months had not been reached, nor has the median overall survival, Diefenbach said. Nearly all patients remain in complete remission.

Additional follow-up is needed to assess the impact of consolidation therapy on the duration of long-term response, Diefenbach said. In summary, the triplet combination of polatuzumab, rituximab and lenalidomide represents a potential novel regimen for patients with transplant-ineligible relapsed and refractory diffuse large B-cell lymphoma and is worthy of further study.

Reference

Magid Diefenbach CS, Abrisqueta P, Gonzalez-Barca E, et al. Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial. J Clin Oncol. 2021;39(suppl 15):Abstract 7512.

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HSCT-Sparing, Chemotherapy-Free Treatment of Ph+ ALL With Ponatinib/Blinatumomab Leads to 100% CR Rate – Cancer Network

Posted: June 6, 2021 at 1:58 am

Combination therapy with ponatinib (Iclusig) and blinatumomab (Blincyto) induced a complete response in all patients with Philadelphia chromosome (Ph)positive acute lymphocytic leukemia (ALL) who were treated on a phase 2 study (NCT03263572), according to a presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.1

The chemotherapy-free, hematopoietic stem cell transplant (HSCT)sparing regimen for patients receiving systemic therapy in the first-line (n = 20) led to a complete response (CR) rate or pathologic CR rate of 100%, while patients with relapsed/refractory Phpositive ALL had a rate of 89%. Moreover, patients in the frontline Phpositive cohort had a major molecular response (MMR) of 100% and a complete molecular response (CMR) of 85%.

The combination of ponatinib and blinatumomab is safe and effective in Ph-positive ALL, Nicholas James Short, MD, an assistant professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, said during an oral presentation of the data. Overall, the novel chemotherapy-free combination of ponatinib and blinatumomab appears to be a promising regimen in both frontline and relapsed/refractory Ph-ALL, as well as in chronic myeloid leukemia in lymphoid blast phase [CML-LBP]. Given the particularly favorable outcomes of newly diagnosed patients with frontline, Ph-positive ALL who were not transplanted in first remission, these data suggest that this regimen may serve as an effective transplant-sparing regimen in this population.

Chemotherapy plus a TKI has become the standard of care in newly diagnosed Ph-positive ALL, with first- and second-generation TKIs yielding 5-year overall survival (OS) rates of approximately 35% to 50%.2-4 Moreover, while ponatinib has yielded promising activity in patients with T315I mutations, which are present in up to 75% of patients at relapse,5 blinatumomab has demonstrated efficacy as a monotherapy in the relapsed/refractory setting, and in combination with dasatinib in newly diagnosed patients.6,7

The trial enrolled patients with newly diagnosed or relapsed/refractory Ph-positive ALL, as well as lymphoid accelerated or blast phase CML. Patients who had previously received 1 to 2 courses of chemotherapy with or without a TKI were able to enroll in the newly diagnosed cohort. Additionally, patients needed to be over 18 years of age, with a ECOG performance status of 0-1, and adequate hepatic function in order to enroll.

Patients with uncontrolled or active cardiovascular disease, including a history of myocardial infarction, cardiovascular accident, or revascularization within 3 months; congestive heart failure with reduced left ventricular ejection fraction; atrial of ventricular arrhythmia; a history of arterial or venous thromboembolism; or uncontrolled hypertension were not able to enroll on the study. Additional exclusion criteria included significant central nervous system (CNS) pathology with the exception of CNS leukemia.

Patients received a 30 mg induction dose of ponatinib and a standard dose of blinatumomab on a 4 weeks on, 2 weeks off schedule. From there, patients received up to 4 consolidation cycles of the regimen followed by maintenance ponatinib for 5 years, the dose of which decreased to 15 mg daily once patients achieved a CMR. All patients were given 12 doses of intrathecal chemotherapy with an altering administration of cytarabine and methotrexate.

The primary of end point of the trial was CMR rate in the frontline cohort, and CR/pathologic CR rate in the relapsed/refractory setting. Key secondary end points included event-free survival (EFS), OS, and safety.

To date, 20 frontline patients have been treated, 10 with relapsed/refractory disease, and 5 with CML-LBP, Short explained. The median age of the frontline cohort was 62 years [range, 34-83]. Among the 10 patients with relapsed/refractory Ph-positive ALL, 1 was primary refractory to [a] previous regimen, 4 were treated in first salvage, and 5 in second or later salvage. Among the 5 patients with CML-LBP, 3 had not received any prior therapy for blast phase disease, 1 was treated in first salvage, and 1 in second salvage.

Additional data indicated that the cohort of patients with CML-LBP had a CR or pathologic CR rate of 100%, as well as an MMR rate of 60%, and CMR rate of 40%. Moreover, the relapsed/refractory cohort achieved a rate of 88% in both MMR and CMR. In total, the overall patient population had a CR or pathologic CR rate of 96%, an MMR rate of 91%, and a CMR rate of 79%. No patients were reported to have an early death while on the study.

After the first cycle of treatment, the frontline ALL cohort had a CMR rate of 58%, an MMR rate of 26%, and 16% did not experience a response. Moreover, 75% of patients in the relapsed/refractory ALL cohort, and 20% in the CML-LBP cohort had a CMR after the first cycle, while 25% and 80% of patients from both cohorts did not respond, respectively.

Of the patients who experienced a CR or pathologic CR in the frontline ALL arm (n = 20), 1 died following CR due to post-procedural bleeding and hypovolemic shock, while 19 continue to experience ongoing responses without the need for stem cell transplantation. Notably, no patients in this have relapsed within 6 months.

In the relapsed/refractory ALL cohort, of the patients who responded (n = 9), 4 went on to receive HSCT, 1 of whom relapsed and died. Another patient relapsed and developed T315I and E255V mutations at relapse. Overall, 3 patients from this cohort are experiencing an ongoing response without the need for HSCT, while 1 patient died off study due to unknown causes.

In the CML-LBP arm, 2 responders (n = 5) relapsed, one of whom developed myeloid blast phase disease but is currently alive and in remission, while the other developed L248V and Y253H mutations at relapse but is currently alive and in remission following HSCT. Additionally, 3 patients continue to experience an ongoing response without HSCT.

After a median follow up of 12 months, the overall patient population is estimated to have 1- and 2-year EFS of 76% and 70%, respectively. Moreover, the estimated 1-year and 2-year OS were 93% and 80%, respectively. Notably, the relapsed/refractory AML cohort had an estimated 1- and 2-year EFS of 61% and 41%, respectively, as well as an estimated 1- and 2-year OS of 80% and 53%, respectively. Additionally, the CML-LBP arm had 60% estimated EFS rate at 1 and 2 years, respectively, as well as a 100% estimated 1- and 2-year rate.

Notably, there were no grade 4 or higher adverse effects (AEs) reported on the study. Common grade 3 AEs related to ponatinib in patients with ALL included elevated lipase (6%), alanine aminotransferase increase (ALT; 3%), cerebrovascular ischemia (3%), hypertension (3%) pancreatitis (3%), and deep vein thrombosis (3%). Grade 2 AEs included rash (11%), ALT increase (3%), and cerebrovascular ischemia (3%) and grade 1 AEs included rash (11%) and ALT increase (3%).

Although most AEs related to blinatumomab were grade 1 or 2 in patients with ALL, 1 patient developed grade 3 encephalopathy that was resolved by corticosteroids and treatment interruption, according to Short. Common grade 2 AEs included cytokine release syndrome (6%) and tremors (3%), as well as 1 patient who developed grade 1 tremors.

References

1. Short NJ, Kantarjian H, Konopleva MY, et al. Combination of ponatinib and blinatumomab in Philadelphia chromosome-positive acute lymphoblastic leukemia: Early results from a phase II study. Presented at: 2021 ASCO Annual Meeting; June 4-8, 2021; Virtual. Abstract 7001.

2. Daver N, Thomas D, Ravandi F, et al. Final report of a phase II study of imatinib mesylate with hyper-CVAD for the front-line treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Haematologica. 2015;100(5):653-651. doi:10.3324/haematol.2014.118588

3. Ravandi F, OBrien S, Cortes J, et al. Long-term follow-up of phase II study of chemotherapy plus dasatinib for the initial treatment of patients with Philadelphia-chromosome positive acute lymphoblastic leukemia. Cancer. 2015;121(23):4158-4164. doi:10.1002/cncr.29646

4. Rousselot P, Coud MM, Gokbuget N, et al. Dasatinib and low-intensity chemotherapy in elderly patients with Philadelphia chromosomepositive ALL. Blood. 2016;126(6):774-782. doi:10.1182/blood-2016-02-700153

5. Jabbour E, Short NJ, Ravandi F, et al. Combination of hyper-CVAD with ponatinib as first-line therapy for patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia: long-term follow-up of a single-centre, phase 2 study. Lancet Haematol. 2018;5(12):e618-e627. doi:10.1016/S2352-3026(18)30176-5

6. Martinelli G, Boissel N, Chevallier P, et al. Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: results from a phase II, single-arm, multicenter study. J Clin Oncol. 2017;35(16):1795-1802. doi:10.1200/JCO.2016.69.3531

7. Fo R, Bassan R, Vitale A, et al. Dasatinibblinatumomab for Ph-positive acute lymphoblastic leukemia in adults. N Engl J Med. 2020;383:1613-1623. doi:10.1056/NEJMoa2016272

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HSCT-Sparing, Chemotherapy-Free Treatment of Ph+ ALL With Ponatinib/Blinatumomab Leads to 100% CR Rate - Cancer Network

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Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market : Industry Perspective, COVID-1 – PharmiWeb.com

Posted: June 6, 2021 at 1:58 am

Global Autologous Stem Cell and Non-Stem Cell Based Therapies Marketresearch report has set a bench-marking example for such a vibrant market that explores several recommendations and practical growth strategies in relation to the market. The chapter on the competitive landscape is presented well in the research report and is analyzed based on the tools such as Porters five forces analysis. This market research document produced covers numerous growth prospects in recent times with linkage in the coming decades. The assumptions are made here by the panels and key vendors. The business research report on a serious note focuses on the several analysis viewpoints, market rankings, industry key points, and business profiles that integrate together and form a platform. The research provides benefits to identify market opportunities and the latest trends. This market report covers a wide spectrum across geography coupled with key segments of the industry that assist the competitors to get a glimpse of the trends of the market.This general market measure is used as a part of the top-down procedure to assess the sizes of other individual markets through percentage parts from auxiliary sources catalogs, databases, and primary research.

Autologous stem cell and non-stem cell based therapies market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 121.68 billion by 2027 growing at a CAGR of 3.75 % in the above-mentioned forecast period. The introduction of novelautologousstem cell based therapies inregenerativemedicine will help in driving the growth of the autologous stem cell and non-stem cell based therapies market.

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Reduction in transplant subjected risks and prevalence ofcancerand diabetes in all age groups will likely to accelerate the growth of the autologous stem cell and non-stem cell based therapies market in the forecast period of 2020-2027. On the other hand, growing geriatric population will further boost various opportunities that will lead to the growth of the autologous stem cell and non-stem cell based therapies market in the above mentioned forecast period.

Some of the Key Players/Manufacturers Involved in the Market are:

Market Segmentation:

Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market, By Product (Blood Pressure (BP) Monitoring Devices, Pulmonary Pressure Monitoring Devices, Intracranial Pressure (ICP) Monitoring Devices), Applications (neurodegenerative Disorders, Autoimmune Diseases, Cancer & Tumors, Cardiovascular Diseases), End User (Hospitals And Ambulatory Surgical Center), Country (U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa) Industry Trends and Forecast to 2027

Autologous stem cell and non-stem cell based therapies market is segmented on the basis of product, applications and end user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

According to Data Bridge Market Research the autologous stem cell and non-stem cell based therapies market in developing regions is witnessing a growth in terms of its adoption rate, due to rising ageing population, availability of novel autologous stem cell based therapies in regenerative medicine, growing popularity of cosmetic surgery and increasing R&D investment.

Now the question is which are the regions that autologous stem cell and non-stem cell based therapies market players should target? Data Bridge Market Research has estimated market leaders to target North America developing regions to help them in attaining better volume of revenue generation.

Autologous stem cell and non-stem cell based therapies market is becoming more competitive every year with cancer & tumors currently being the largest market application for the forecast period of 2018 to 2025. Data Bridge Market Researchs new report highlights the major growth factors and opportunities in the autologous stem cell and non-stem cell based therapies market.

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Autologous stem cell and non-stem cell based therapies market is analysed and market size insights and trends are provided by country, product, applications and end user as referenced above.

The countries covered in the autologous stem cell and non-stem cell based therapies market report are U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa.

North America dominates the autologous stem cell and non-stem cell based therapies market due to minimization of risks associated with the therapy, ability to treat a large number of infectious diseases while Asia-Pacific is expected to grow at the highest growth rate in the forecast period of 2020 to 2027 due to demand from China, Vietnam, Malaysia, and India. The demand is expected to be high as autologous stem cell and non-stem cell based therapies help in the effective treatment of cardiovascular diseases. Sophisticated healthcare infrastructure and favorable tax and reimbursement policies are some of the other factor which is driving the regions.

Autologous stem cell and non-stem cell based therapies market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to autologous stem cell and non-stem cell based therapies market.

Table Of Content::

Section 01: EXECUTIVE SUMMARY

Section 02: SCOPE OF THE REPORT

Section 03: RESEARCH METHODOLOGY

Section 04: MARKET LANDSCAPE

Market environment

Market attributes

Market division examination

Section 05: PIPELINE ANALYSIS

Pipeline examination

Section 06: MARKET SIZING

Market definition

Market estimating

Market size and conjecture

Section 07: FIVE FORCES ANALYSIS

Section 08: MARKET SEGMENTATION

Division

Correlation

Market opportunity

Section 09: CUSTOMER LANDSCAPE

Section 10: REGIONAL LANDSCAPE

Section 11: DECISION FRAMEWORK

Section 12: DRIVERS AND CHALLENGES

Market drivers

Market difficulties

Section 13: MARKET TRENDS

Section 14: VENDOR LANDSCAPE

Outline

Scene disturbance

Section 15: VENDOR ANALYSIS

Sellers covered

Seller arrangement

Market situating of sellers

Region & Countries (Customizable):

More Information Related to TOC, Tables, and Figures Can Be Provided

Coronavirus can influence the worldwide economy in three principal ways: by straightforwardly influencing creation and request, by making store network and market disturbance, and by its monetary effect on firms and monetary business sectors. The episode of COVID-19 has welcomed impacts on numerous viewpoints, similar to flight undoings travel boycotts and isolates cafs shut all indoor occasions confined more than forty nations highly sensitive situation proclaimed monstrous easing back of the Vaccine market unpredictability falling business certainty, developing frenzy among the populace, and vulnerability about future.

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Gaining Exposure to the BioRevolution Megatrend – ETF Trends

Posted: June 6, 2021 at 1:56 am

By Jeremy Schwartz, CFA, Global Head of Research;Kara Marciscano, CFA, Associate, Research

If the 19th century was the century of chemistry and the 20th the century of physics, the 21st will be the century of biology. Jamie Metzl

Revolutionary advances across multiple fields including computer science, artificial intelligence, big data analytics, automation, chemistry, biology and engineering are creating previously unimaginable new opportunities to reengineer biological systems in ways that will revolutionize health care, agriculture, manufacturing, energy production, consumer services and data storage.

The revolution in our ability to read, understand, write and hack DNA, the genetic code of all life, will touch most aspects of how we live.

All organisms have their own genome, a complete set of DNA that contains instructions to develop and direct the activities of life.

Researchers can sequence DNA (determine the order and information carried in DNA) more rapidly and cost-effectively than ever before, which is driving transformations in health care and many other sectors of our global economy.

The development of Modernas COVID-19 vaccine is just one poignant exampleit took the company only two days to design the sequence for its mRNA vaccine!1

We believe the biology revolution is creating a historic investment opportunity equivalent to the industrial and internet revolutions, and theWisdomTree BioRevolution Fund (WDNA)may be uniquely positioned to capture the companies at the intersection of science, technology and engineering.

WDNA seeks to track the price and yield performance, before fees and expenses, of theWisdomTree BioRevolution Index (WTDNA), which provides targeted exposure to companies that we believe lead the transformations and advancements in genetics and biotechnology.

To construct the WisdomTree BioRevolution Index, we leverage data from leading technology futurist2Dr. Jamie Metzl as a third-party consultant. Recognized as a thought leader on the biology revolution, Dr. Metzl authored Hacking Darwin: Genetic Engineering and the Future of Humanity, and he serves as a member of the World Health Organizations expert committee on human genome editing.

Considering proprietary data from Dr. Metzl, WTDNA identifies the key sectors and industry verticals that are expected to be most significantly transformed by advances in biological science and technology, as well as the companies that WisdomTree believes are most representative of this wave of innovation.

The technologies underpinning the biology revolution are connected and reinforce advancements across interdisciplinary fields. We have identified four key BioRevolution sectors, each including multiple subsectors of impact.

Human Health The genetics and biotechnology revolutions are most often associated with health care because many of the most high-profile preliminary applications are health care related. The quantity and quality of these applications will increase significantly as our health care systems transition from generalized medicine based on population averages to personalized, or precision, health care based on each persons individual biology. When the amount of data collected on the human genome reaches critical mass, our system will transition to a predictive and preventive health care system that will help us live healthier and longer lives.

Although health care is the most mature market to date, we expect other sectors to catch up.

Agriculture & Food Technologies will supercharge the selective breeding process to accomplish in months or a few years what previously might have taken centuries or millennia. Pest resistance, yield and variety can be enhanced significantly for staple crops, which can also be engineered to significantly increase photosynthesis to slow climate change. Domesticated animals can be engineered to increase disease resistance, productivity and product quality through marker-assisted selective breeding targeting specific desired outcomes.

Materials Chemicals & Energy The sourcing of industrial inputs for manufacturing is another area ripe for transformation. As the human population grows toward an estimated 10 billion people by mid-century, current resource extraction models will not be sustainable. The tools of the genetics and biotechnology revolutions, however, are making it possible to create materials at scale by manipulating genetic code rather than extracting them from nature. Instead of making plastic from petroleum and fragrances from flowers, for example, we can produce both through the genetic engineering of yeast and other microbes.

Biological Machines & Interfaces Connection and communication between the biology of humans and computers, including the use of DNA for computing and storage, is increasing the potential to extract, store and process data from individuals.

WTDNA currently holds approximately 80% of its weight within the Human Health sector. Over time, we expect the maturation of Agriculture & Food as well as Materials, Chemicals & Energy to drive their increased representation in WTDNA.

Although the general direction and accelerating pace of this revolution are nearly certain, the time horizons for how each specific application will play out will vary. Our approach targets dynamic companies deploying revolutionary technologies both in and outside of health care, and it invests in a wide range of 115 companies across the BioRevolution impact spectrum to reduce single-stock concentration risk.

We believe the diverse portfolio of companies captured in WDNA is the best way for investors to gain exposure to the biology revolution that we expect to fundamentally transform our world and lives over the coming years.

Originally published by WisdomTree, 6/3/21

1As of 5/25/21, WTDNA held 0.6% of its weight in Moderna.2An individual who studies or predicts the future based on current trends in technology

Important Risks Related to this Article

There are risks associated with investing, including possible loss of principal. The Fund invests in BioRevolution companies, which are companies significantly transformed by advancements in genetics and biotechnology. BioRevolution companies face intense competition and potentially rapid product obsolescence. These companies may be adversely affected by the loss or impairment of intellectual property rights and other proprietary information or changes in government regulations or policies. Additionally, BioRevolution companies may be subject to risks associated with genetic analysis. The Fund invests in the securities included in, or representative of, its Index regardless of their investment merit, and the Fund does not attempt to outperform its Index or take defensive positions in declining markets. The composition of the Index is governed by an Index Committee, and the Index may not perform as intended. Please read the Funds prospectus for specific details regarding the Funds risk profile.

U.S. investors only: Clickhereto obtain a WisdomTree ETF prospectus which contains investment objectives, risks, charges, expenses, and other information; read and consider carefully before investing.

There are risks involved with investing, including possible loss of principal. Foreign investing involves currency, political and economic risk. Funds focusing on a single country, sector and/or funds that emphasize investments in smaller companies may experience greater price volatility. Investments in emerging markets, currency, fixed income and alternative investments include additional risks. Please see prospectus for discussion of risks.

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Gaining Exposure to the BioRevolution Megatrend - ETF Trends

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Genetically modified mosquitoes and Africa – SciDev.Net

Posted: June 6, 2021 at 1:56 am

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Episode 44

In Sub-Saharan Africa, malaria is a leading cause of death for children under five and with an estimated 220 million cases worldwide every year, malaria remains a public health crisis.

For some, genetically modified mosquitoes could be a game-changing tool in the fight against malaria and other mosquito-borne diseases. But others say that genetic engineering threatens the delicate circle of life.

The World Health Organization has just released an updated version of its Guidance framework for testing of genetically modified mosquitoes. Our reporter Michael Kaloki finds out what genetically modified mosquitoes are, why guidance has been developed around this research, and what it all means for Africa.

Send us your questions from anywhere in the world text or voice message via WhatsApp to +254799042513.

Africa Science Focus, with Selly Amutabi.

This programme was funded by the European Journalism Centre, through the European Development Journalism Grants programme, with support from the Bill & Melinda Gates Foundation.

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Synthetic E. Coli Reprogrammed to Make Polymers from Artificial Monomers, and Resist Viral Infections – Genetic Engineering & Biotechnology News

Posted: June 6, 2021 at 1:56 am

Scientists have developed a synthetic strain of Escherichia coli that can construct artificial polymers from building blocks that are not found in nature, by following instructions that the researchers encoded in their genes. The scientists, led by a team at the Medical Research Council (MRC) Laboratory of Molecular Biology, engineered the genetic code of the E. coli strain to include several nonstandard amino acids, and found that this synthetic genome made the bacteria entirely resistant to infection by viruses.

The work is some of the first to design proteins that incorporate multiple non-canonical amino acids. The team suggests that their work, and achievement could lead to the development of new polymers such as proteins and plastics, and drugs including antibiotics, as well as making it easier to manufacture drugs reliably using bacteria.

The newly reported achievement builds on previous ground-breaking work by researchers who, in 2019, developed a new techniques to create the biggest ever synthetic genomeconstructing the entire E. coli genome from scratch. Commenting on the latest developments, study lead, Jason Chin, PhD, from the MRC Laboratory of Molecular Biology, said, These bacteria may be turned into renewable and programmable factories that produce a wide range of new molecules with novel properties, which could have benefits for biotechnology and medicine, including making new drugs, such as new antibiotics.

The investigators report on their latest development in Science, in a paper titled, Sense codon reassignment enables viral resistance and encoded polymer synthesis.

The genetic code instructs a cell how to make proteins, which are constructed by joining together strings of natural (canonical) amino acid building blocks. The genetic code in DNA is made up of four bases, represented by the letters: A, T, C and G. When a peptide or protein is being constructed, the four letters in DNA are read in groups of three letters, or codonsfor example TCG. Each codon tells the cell to add a specific amino acid to the peptide chain, which it does via molecules called transfer RNA (tRNA). Each codon is recognized by a specific tRNA, which then adds the corresponding amino acid. For example, the tRNA that recognizes the codon TCG, brings the amino acid serine.

With four letters in groups of three, there are 64 possible combinations of letters, but there are only 20 different canonical amino acids that cells commonly use. So, several different codons can be synonymousthey all code for the same amino acid for example, TCG, TCA, AGC and AGT all code for serine. There are also codons which tell a cell when to stop making a protein, such as TAG and TAA.

Its thought that removing certain codons and the transfer RNAs that read them from the genome and replacing them with noncanonical amino acids (ncAAs) may enable the creation of synthetic cells with properties not found in natural biology, including powerful viral resistances and enhanced biosynthesis of novel proteins. However, these hypotheses have not been experimentally tested, the authors wrote. And to date, the approach has been largely restricted to the incorporation of a single ncAA into a polypeptide chain. As the team noted, limitations preclude the synthesis of noncanonical heteropolymer sequences composed entirely of noncanonical monomers.

In 2019, the team at the MRC Laboratory of Molecular Biology created the first entire genome synthesized from scratch for the commonly studied bacteria, E. coli. They also took the opportunity to simplify its genome. In this engineered strain the scientists replaced some of the codons with their synonyms. So, they removed every instance of TCG and TCA and replaced them with the synonyms AGC and AGT. They also removed every instance of the stop codon TAG and replaced it with its synonym TAA. This meant that the modified bacteria no longer had the codons TCG, TCA and TAG in their genome, but they could still make normal proteins and live and grow.

The MRC scientists goal was to utilize their new technology to create the first cell that can assemble polymers entirely from building blocks that are not found in nature. For the newly reported studies, the scientists further modified the bacteria to remove the tRNA molecules that recognize the codons TCG and TCA. This means that, even if there are TCG or TCA codons in the genetic code, the cell no longer has the molecule that can read those codons.

This is fatal for any virus that tries to infect the cell, because viruses replicate by injecting their genome into a cell and hijacking the cells machinery. Virus genomes still contain lots of the TCG, TCA and TAG codons, but the modified bacteria are missing the tRNAs to read these codons. So when the machinery in the modified bacteria tries to read the virus genome, it fails every time it reaches a TCG, TCA or TAG codon.

When the researchers infected their bacteria with a cocktail of viruses, they confirmed that while unmodified, control bacteria were killed by these pathogens, the modified bacteria were resistant to infection and survived.

Many drugsfor example, protein drugs, such as insulin, and polysaccharide and protein subunit vaccinesare manufactured by growing bacteria that contain instructions to produce the drug. So making bacteria that are resistant to viruses could make manufacturing certain types of drugs more reliable and cheaper. Chin explained, If a virus gets into the vats of bacteria used to manufacture certain drugs then it can destroy the whole batch. Our modified bacterial cells could overcome this problem by being completely resistant to viruses. Because viruses use the full genetic code, the modified bacteria wont be able to read the viral genes. The team further wrote, We have synthetically uncoupled our strain from the ability to read the canonical code, and this advance provides a potential basis for bioproduction without the catastrophic risks associated with viral contamination and lysis.

By creating bacteria with synthetic genomes that do not use certain codons, the researchers also effectively freed up those codons to be used for other purposes, such as coding for synthetic building blocks (monomers). We reassigned these codons to enable the efficient synthesis of proteins containing three distinct noncanonical amino acids, the authors explained. For the studies detailed in Science, the team engineered the bacteria to produce tRNAs coupled with artificial monomers, which recognized the newly available codons (TCG and TAG).

They inserted genetic sequences with strings of TCG and TAG codons into the bacterias DNA. These were read by the altered tRNAs, which assembled chains of synthetic monomers in the sequence defined by the sequence of codons in the DNA. The cells were programmed to string together monomers in different orders by changing the order of TCG and TAG codons in the genetic sequence. Polymers composed of different monomers were also made by changing which monomers were coupled to the tRNAs. We incorporated three distinct ncAAs into ubiquitin, in response to TCG, TCA, and TAG, the team explained. We demonstrated the generality of our approach by synthesizing seven distinct versions of ubiquitin, each of which incorporated three distinct ncAAs.

Using their approach the scientists were able to create polymers made of up to eight monomers strung together. They joined the ends of these polymers together to make macrocyclesa type of molecule that forms the basis of some drugs, such as certain antibiotics and cancer drugs.

Chin said, This system allows us to write a gene that encodes the instructions to make polymers out of monomers that dont occur in nature. Wed like to use these bacteria to discover and build long synthetic polymers that fold up into structures and may form new classes of materials and medicines. We will also investigate applications of this technology to develop novel polymers, such as biodegradable plastics, which could contribute to a circular bioeconomy.

The synthetic monomers were linked together by the same chemical bonds that join together amino acids in proteins, but the researchers are in addition investigating how to expand the range of linkages that can be used in the new polymers. In their paper, they concluded, Future work will expand the principles we have exemplified herein to further compress and reassign the genetic code. We anticipate that, in combination with ongoing advances in engineering the translational machinery of cells, this work will enable the programmable and encoded cellular synthesis of an expanded set of noncanonical heteropolymers with emergent, and potentially useful, properties.

Commenting in an accompanying Perspective in the same issue of Science, D. Jewel, and A. Chatterjee, from Boston College in Chestnut Hill, acknowledged, The ability to generate designer proteins using multiple non-natural building blocks will unlock countless applications, from the development of new classes of biotherapeutics to biomaterials with innovative properties.

Megan Dowie, PhD, head of molecular and cellular medicine at the MRC, which funded the study, said, Dr. Chins pioneering work into genetic code expansion is a really exciting example of the value of our long-term commitment to discovery science. Research like this, in synthetic and engineering biology, clearly has huge potential for major impact in biopharma and other industrial settings.

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Synthetic E. Coli Reprogrammed to Make Polymers from Artificial Monomers, and Resist Viral Infections - Genetic Engineering & Biotechnology News

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Researchers Engineered a New Synthetic Fly Species Here’s Why – SciTechDaily

Posted: June 6, 2021 at 1:56 am

UC San Diego scientists have modified the genome of fruit flies using CRISPR-based technologies to create eight reproductively isolated species. In the future, this technique can be adapted to other organisms including plants, insects and vertebrates to provide new biocontrol opportunities. Credit: Akbari lab, UC San Diego

Researchers create novel CRISPR-based fly species as a new method of controlling gene drive spread.

CRISPR-based technologies offer enormous potential to benefit human health and safety, from disease eradication to fortified food supplies. As one example, CRISPR-based gene drives, which are engineered to spread specific traits through targeted populations, are being developed to stop the transmission of devastating diseases such as malaria and dengue fever.

But many scientists and ethicists have raised concerns over the unchecked spread of gene drives. Once deployed in the wild, how can scientists prevent gene drives from uncontrollably spreading across populations like wildfire?

Now, scientists at the University of California San Diego and their colleagues have developed a gene drive with a built-in genetic barrier that is designed to keep the drive under control. Led by molecular geneticist Omar Akbaris lab, the researchers engineered synthetic fly species that, upon release in sufficient numbers, act as gene drives that can spread locally and be reversed if desired.

The scientists describe their SPECIES (Synthetic Postzygotic barriers Exploiting CRISPR-based Incompatibilities for Engineering Species) development as a proof-of-concept innovation that could be portable to other species such as insect disease vectors. Spreading gene drives that limit pests that feast on valuable food crops is another example of a potential SPECIES application.

Gene drives can potentially spread beyond intended borders and be hard to control. SPECIES offers a way to control populations in a very safe and reversible manner, said Akbari, a UC San Diego Division of Biological Sciences associate professor and senior author of the paper, which is published in the journalNature Communications.

The idea behind the creation of SPECIES is reflective of the formation of new species in nature. As members of a single species separate over time, due to, for example, a new land formation, earthquake separation or other geological event, a new species eventually can evolve from the physical disconnection. If the new species eventually returns to mate with the original species, they could produce unviable offspring due to biological changes following the separation through a natural phenomenon known as reproductive isolation.

Working in the fly species Drosophila melanogaster, UC San Diego researchers and their colleagues at the California Institute of Technology, UC Berkeley and the Innovative Genomics Institute used CRISPR genetic-editing technologies to develop flies encoding SPECIES systems that are reproductively incompatible with wild versions of D. melanogaster.

Even though speciation happens consistently in nature, creating a new artificial species is actually a pretty big bioengineering challenge, said Anna Buchman, the lead author of the paper. The beauty of the SPECIES approach is that it simplifies the process, giving us a defined set of tools we need in any organism to elegantly bring about speciation.

Conceptually, when SPECIES are deployed in the wild in sufficient numbers, they can controllably drive through a population and replace all of their wild counterparts as they spread. Using malaria as an example, SPECIES mosquitoes could be developed with a genetic element that makes them incapable of transmitting malaria.

You can spread an anti-malaria SPECIES into a target population in a confinable and controllable way, said Akbari. Since SPECIES are incompatible with wild-type mosquitoes, their populations can be controlled and reversed by limiting their threshold population below 50 percent. This gives you the ability to confine and reverse its spread if desired.

As the SPECIES barrier completes its role in temporarily replacing wildtype populations, their numbers can be reduced with the reintroduction of wild type populations.

This essentially allows us to harness all of the power of gene driveslike disease elimination or crop protectionwithout the high risk of uncontrollable spread, said Akbari.

Reference: Engineered reproductively isolated species drive reversible population replacement by Anna Buchman, Isaiah Shriner, Ting Yang, Junru Liu, Igor Antoshechkin, John M. Marshall, Michael W. Perry and Omar S. Akbari, 2 June 2021, Nature Communications.DOI: 10.1038/s41467-021-23531-z

Coauthors of the paper include Anna Buchman, Isaiah Shriner (former UC San Diego undergraduate student), Ting Yang, Junru Liu (current Biological Sciences PhD student), Igor Antoshechkin, John Marshall, Michael Perry and Omar Akbari.

Funding: UC San Diego, DARPA Safe Genes Program

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Scientists Use DNA To Trace the Origins of Giant Viruses – SciTechDaily

Posted: June 6, 2021 at 1:56 am

Scientists investigate the evolution of Mimivirus, one of the worlds largest viruses, through how they replicate DNA. Credit: Indian Institute of Technology Bombay

Researchers from the Indian Institute of Technology Bombay shed light on the origins of Mimivirus and other giant viruses, helping us better understand a group of unique biological forms that shaped life on Earth. In their latest study published in Molecular Biology and Evolution, the researchers show that giant viruses may have come from a complex single-cell ancestor, keeping DNA replication machinery but shedding genes that code for other vital processes like metabolism.

2003 was a big year for virologists. The first giant virus was discovered in this year, which shook the virology scene, revising what was thought to be an established understanding of this elusive group and expanding the virus world from simple, small agents to forms that are as complex as some bacteria. Because of their link to disease and the difficulties in defining themthey are biological entities but do not fit comfortably in the existing tree of life viruses incite the curiosity of many people.

Scientists have long been interested in how viruses evolved, especially when it comes to giant viruses that can produce new viruses with very little help from the hostin contrast to most small viruses, which utilize the hosts machinery to replicate.

Even though giant viruses are not what most people would think of when it comes to viruses, they are actually very common in oceans and other water bodies. They infect single-celled aquatic organisms and have major effects on the latters population. In fact, Dr. Kiran Kondabagil, molecular virologist at the Indian Institute of Technology (IIT) Bombay, suggests, Because these single-celled organisms greatly influence the carbon turnover in the ocean, the viruses have an important role in our worlds ecology. So, it is just as important to study them and their evolution, as it is to study the disease-causing viruses.

Scientists investigate the evolution of Mimivirus, one of the worlds largest viruses, through how they replicate DNA. Researchers from the Indian Institute of Technology Bombay shed light on the origins of Mimivirus and other giant viruses, helping us better understand a group of unique biological forms that shaped life on earth. Credit: Indian Institute of Technology Bombay

In a recent study, the findings of which have been published in Molecular Biology and Evolution, Dr. Kondabagil and co-researcher Dr. Supriya Patil performed a series of analyses on major genes and proteins involved in the DNA replication machinery of Mimivirus, the first group of giant viruses to be identified. They aimed to determine which of two major suggestions regarding Mimivirus evolutionthe reduction and the virus-first hypotheses were more supported by their results. The reduction hypothesis suggests that the giant viruses emerged from unicellular organisms and shed genes over time; the virus-first hypothesis suggests that they were around before single-celled organisms and gained genes, instead.

Dr. Kondabagil and Dr. Patil created phylogenetic trees with replication proteins and found that those from Mimivirus were more closely related to eukaryotes than to bacteria or small viruses. Additionally, they used a technique called multidimensional scaling to determine how similar the Mimiviral proteins are. A greater similarity would indicate that the proteins coevolved, which means that they are linked together in a larger protein complex with coordinated function. And indeed, their findings showed greater similarity. Finally, the researchers showed that genes related to DNA replication are similar to and fall under purifying selection, which is natural selection that removes harmful gene variants, constraining the genes and preventing their sequences from varying. Such a phenomenon typically occurs when the genes are involved in essential functions (like DNA replication) in an organism.

Taken together, these results imply that Mimiviral DNA replication machinery is ancient and evolved over a long period of time. This narrows us down to the reduction hypothesis, which suggests that the DNA replication machinery already existed in a unicellular ancestor, and the giant viruses were formed after getting rid of other structures in the ancestor, leaving only replication-related parts of the genome.

Our findings are very exciting because they inform how life on earth has evolved, Dr. Kondabagil says. Because these giant viruses probably predate the diversification of the unicellular ancestor into bacteria, archaea, and eukaryotes, they should have had major influence on the subsequent evolutionary trajectory of eukaryotes, which are their hosts.

In terms of applications beyond this contribution to basic scientific knowledge, Dr. Kondabagil feels that their work could lay the groundwork for translational research into technology like genetic engineering and nanotechnology. He says, An increased understanding of the mechanisms by which viruses copy themselves and self-assemble means we could potentially modify these viruses to replicate genes we want or create nanobots based on how the viruses function. The possibilities are far-reaching!

Reference: Coevolutionary and Phylogenetic Analysis of Mimiviral Replication Machinery Suggest the Cellular Origin of Mimiviruses by Supriya Patil and Kiran Kondabagil, 11 February 2021, Molecular Biology and Evolution.DOI: 10.1093/molbev/msab003

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Genomic Cold War? More nations joining the US in using biotechnology to enhance military capabilities – Genetic Literacy Project

Posted: June 6, 2021 at 1:56 am

The UK government recently announced an 800 million, taxpayer-funded Advanced Research and Invention Agency (Aria). The brainchild of the British prime ministers former chief adviser,Dominic Cummingsand modelled on the USDefense Advanced Research Projects Agency, Darpa, the organisation will focus partly on genomic research.

Genome technology is becoming an increasingly important part of military research. So given that the UK boasts some of the best genomic research centres in the world, how will its new agency affect the wider genome technology warfare race?

In 2019, Darpa announced that it wishes to explore genetically editing soldiers. It has also invested over US$65 million (45 million) to improve the safety and accuracy of genome-editing technologies. These include the famousNobel prize-winning Crispr-Cas molecular scissor a tool that can edit DNA by cutting and pasting sections of it.

But the ease of accessibility and low cost of Crispr-based technologies has caused concern around potential military genetic modification andweaponisation of viruses or bacteria. These include smallpox or tuberculosis, and could be extremely destructive.

The US is not alone in its military pursuit of genome technology. Russia and China have either stated or been accused of using genomic technology to enhance military capabilities.

Universal SoldierandCaptain Americaare just a few Hollywood movies that have explored the concept of the super soldier. Despite its sci-fi nature, several countries are looking to explore the potential of such prospects. Darpa intends to explore genetically editing soldiers toturn them into antibody factories, making them resistant to chemical or biological attacks.

In December 2020, the then US director of national intelligence,John Ratcliffe, said there was evidence that the Chinese militarywas conducting human experimentationin an attempt to biologically boost soldiers. This followed a report by theJamestown policy thinktankthat highlighted reports suggesting that Crisprwould form a keystone technologyin China to boost troops combat effectiveness. No further details were given, however.

Not all countries are prepared to use gene editing or even genomic technology to enhance soldiers, however. The French military ethics committee has recentlyapprovedresearch on soldier augmentation, such implants that could improve cerebral capacity. However, the committee warned that certain red lines could not be crossed, including genome editing or eugenics. In the morecandid words of the French minister of the armed forces,Florence Parly, this amounted to A yes to Ironman, but a no to Spiderman (Ironman gets his superpowers from a suit whereas Spiderman is bitten by a radioactive spider).

In Russia, the military is looking toimplement genetic passportsfor its personnel, allowing it to assess genetic predispositions and biomarkers, for example, for stress tolerance. This could help place soldiers in suitable military lines, such as navy, air force and so forth. The genetic project also aims to understand how soldiers respond to stressful situations both physically and mentally.

There are signs that the UK will be bolder and less accountable in its genetic defence research than many other countries. For example, Aria wont besubject to freedom of information requests, in contrasts with Darpa.

The UK has also been at the forefront in enabling controversial, pioneering non-military genome technology, such asthree-parent babies. And there has been no shortage of government reports that have stressed the importance of genome technology in the domain of defence and security.

In 2015,a UK national defence reviewhighlighted the influence that advances in genetic engineering can have for security and prosperity. In the recent 2021Security, Defence, Development and Foreign Policy reviewthe UK government once again stressed its significance for defence and national security.

The proposed lack of accountability of Aria, combined with the governments general mission for genome technology to be expanded into security and defence applications, will create a hotpot of debate and discussion. In recent years, British scientists have received Darpa fundingfor controversial genomic research, such as genetic extinction of invasive species such as mosquitoes or rodents. Despite its promise, this could have disastrous potential to damage food security and threaten the wider ecosystems of nations.

Genome technology deployment needs to be managed in a universally, ethically and scientifically robust manner. If it isnt, the potential for a new arms race for advances in this research will only lead to more radical and potentially dangerous solutions. There are many unanswered questions about how Aria will help genome research within the military sphere. The pathway the UK chooses will have lasting consequences on how we perceive genome tech in the public space.

Yusef Paolo Rabiah is a PhD Candidate at STEaPP UCL. Yusefs PhD is focused on developing public policy frameworks for the introduction of germline genome editing technologies into the UK. Find Yusef on Twitter @PaoloYusef

A version of this article was originally posted at the Conversation and has been reposted here with permission. The Conversation can be found on Twitter @ConversationUS

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Banned in Uganda: While the Irish potato faces disease and climate change, politics stymie farmers eager to adopt still unapproved GM seeds – Genetic…

Posted: June 6, 2021 at 1:56 am

Its a fivehour drive into the western part of Uganda to Kachwekano Zonal Agricultural Research and Development Institute (KaZARDI), where GM Irish potatoes are being bred. Visitors are welcomed by healthy looking plants, the centerpiece of the countrys ongoingpotato field trial.

The group of farmers engaged in potato farming and seed production came for a tour at the institute. KaZARDI director Alex Barekye explained to the farmers that the plants are still being researched and are likely to be released next year, but only if the government gives it a green light.

Some of the visiting farmers interrupted him, at times demanding more immediate availability of the genetically-engineered potato seed.Charles Byarugaba, a commercial potato farmer and leader of potato seed multiplication famers in Kabale, Uganda, challenged the scientists.

We want the GMO potato seed right away, he said. You can go ahead to follow those legal procedures but it must not affect us farmers because we are in need of varieties resistant to potato blight. His fellow farmers said that ifthey are not given the resistant seeds, there will be no option but to acquire them illegally.

Unfortunately, the politics of farming in Uganda, particularly when it comes to advanced biotechnology, has all but scuttled the implementation of cutting edge technologies. The countrys farmers face daunting challenges.

Our crops are facing extinction and there are no known ways of effectively dealing with the new pests and diseases other than the use of biotechnology, Dr Wilberforce Tushemeirwe, a prominent scientist, has said. Food crops such as cassava, bananas and sweet potatoes face extinction due to incurable crop diseases. Maize is under attack by the fall army worm. Cotton which is a cash crop has proven difficult to grow in Uganda because of the cotton bollworm pest infestation, which GM technology contains in many other countries.

The Genetic Engineering Regulatory law, formerly referred to as the National Biotechnology and Biosafety billhas twice come close to being signed into law. It would allow for regulated production and use of genetically modified crops in the country,and would pave the way to biotech solutions in use in dozens of other countries, including in other African countries.

However, anti GM groups have been working to ensure the GERA law is not passed. Speaker of Parliament Rebbeca Kadaga supported the law and has on two occasions tried to form a quorum of members of Parliament but to date no action has been taken.

The latest crop under siege is theIrish potato, a food security crop and is grown in the highland areas of southwestern Uganda in Kabale and Kisoro.For communities in this part of the country, it is considered staple food and a primarysource of income.

The country relies on supplies of potato from farmers in the southwest,who contribute 60% of supply, and those in the Eastern highlands of Uganda, who contribute the other 40%.As a result of increased demand from urban areas, production has intensified andis spreading into other areas of Uganda.

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