Daily Archives: November 26, 2019

The acceptance of the microbiome diet as a means of achieving gut health among consumers could pave a path for a shift in attitude towards GM food, according to Michael Miille CEO at Joyn Bio.

Proponents of GM food contend that genetic engineering can help us find sustainable ways to feed people. One proponent is the US start-up Joyn Bio, a joint ag-tech venture between synthetic biology company Ginkgo Bioworks and pharma giant Bayer, which was formed in 2017 with a $100 million Series A round coming from its two parent companies.

Joyn Bio is attempting to engineer microbes that can provide plants with biological nitrogen fertilizer, thus decreasing the environmental impact of agriculture.

By engineering microbes it can eliminate the need for synthetic fertilizers, which have boosted crop yields over the past century but in the process have harmed soil health and caused environmental ills. Runoff from excess nitrogen fertilizer into rivers and oceans has created a dead zone of toxic algae in the Gulf of Mexico the size of New Jersey, for example.

Joyn Bio is headquarted in Boston. Its testing facility in California focuses on the genetic modification of the colonies of bacteria that make up crops microbiomes. It can then engineer those microbes to produce specific proteins as possible alternative to chemical fertilizers and other chemicals.

Any product is unlikely to be ready for market before 2020. Neither will any product be offered in Europe, where regulations do not currently permit engineered microbial products as produced by Joyn Bio (its current focus is on offering its solution to growers in the US, Brazil and India).

It believes nevertheless that it offers a potential global solution to the challenges facing the food industry. Its goal is to engineer microbes to reduce the amount of industrial nitrogen fertilizer needed to grow crops like corn, wheat, or rice, to dramatically decrease the water pollution, fossil fuel used and greenhouse gases produced by agriculture today.

"What we were really launched around was nitrogen fixation and recognising the environmental impact both in production and in application of the synthetic nitrogen fertilisers, which is not sustainable, then at the same time trying to come up with a solution,explained Miille.

Growers, he believes, are in desperate need of innovation and additional solutions given all the things they are confronting.Joyn Bio claims it can help farmers increase yield by promoting stronger plants and better nutrient uptake, ultimately contributing to the transformation of agriculture towards a more sustainable future.

How exactly does it all work? Our product would be a microbe that associates with the plant and is delivered as a seed treatment, said Miille.

Image the microbe as a trillion little FedEx trucks running all over the plant delivering cargo, he says. That cargo then takes nitrogen from the air, converts it into the nitrogen that the plant needs, and then gives it to the plant.

Its very similar to what happens in a soy bean plant naturally via evolution, but the soy and wheat plants never did that.

All this can allow a grower to reduce their fertilizer input by 30-40%, thus saving the grower money and allowing them to benefit from an environmental standpoint.

The process could potentially be used to make food more nutritious too. "You could use the microbes to signal the plant to potentially produce more of its nutritious part - there are number of nutrition enhancements that you can engineer. It's not our initial focus because it's a little more challenging but [improved nutrition] is certainly something people are looking at across the whole food spectrum today.

GM foods have something of a toxic legacy with European consumers, however, of which Miille is well aware. His solution to this challenge is simply to be straight with people. The problems of the past came about because companies such as Monsanto failed to be, he said. "Were trying to learn from that. I think its really critical to be transparent with consumers. Well want them to know we have these engineered microbes and here's what they did.

If crops produced via engineered microbes are used to grow something viable then people will accept it, he believes. Take the papaya industry in Hawaii, he noted, which was saved by GMO technology. "The same thing is going to happen with the US chestnut industry. There are going to be more examples of a pest or diseases that will threaten to wipe something out and the solution is biotechnology. And when you can save something when its that dramatic a benefit and you can communicate that to consumers, they get it.

He continued: For those of us on the science, technology and innovation side, the important thing is to understand how critical it is to engage with consumers and be transparent with them. The other side of the equation is to be able to articulate the benefit. If the benefit is that you either have strawberries or you don't, people will get that.

"Another thing in our favour is that peoples opinions and concerns about chemicals are probably at an all-time high.

The growth in popularity of the microbiome diet among consumers is another potential factor in Joyn Bios favour. If consumers now accept that the microbes in our gut play a critical role in overall health, whats not to stop them accepting the importance microbes could potentially have in agriculture?

More people than ever are taking probiotics because it improves gut health, said Miille. The next step is to say to consumers that microbes are part of the solution and all we've really done is taken this microbe and selectively optimised it for its particular purpose. These kind of discussions, he said, will get people to accept that microbes are going to be an integral part of agriculture over the next 20-30 years.

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Microbes 'set to be an integral part of agriculture over the next 20-30 years': Joyn Bio - FoodNavigator.com

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Global and Regional CRISPR And CRISPR-Associated (Cas) Genes Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2025 - Daily...

Geneticist Kat Arney takes a look at the science of de-extinction, asking whether its feasible or even ethical to bring species back from the past.

In 2003, Spanish researchers used cloning techniques to bring back the recently extinct bucardo (a type of mountain goat), only for the first cloned animal to die within minutes of birth.Other scientists are using genetic engineering techniques to stitch together the genomes of extinct species like passenger pigeons and woolly mammoths with their modern-day relatives.

Could these tools ever be used to bring back the biggest animals of them all, the dinosaurs? And is all this effort really worth it, or should we be focusing on conserving the species we already have on Earth?

Arney also investigates the history of one of the most famous diagrams in biology the Tree Of Life which Charles Darwin famously drew in 1837 to illustrate the evolutionary relationships between species.

Todays trees much more complex, bushy thickets, informed by modern genomics. But all this data brings a new challenge: deciding what counts as a species in the first place.

Full transcript, credits and show notes are available here.

Genetics Unzipped is the podcast from the UK Genetics Society, presented by award-winning science communicator and biologist Kat Arneyand produced byFirst Create the Media.Follow Kat on Twitter@Kat_Arney,Genetics Unzipped@geneticsunzip,and the Genetics Society at@GenSocUK

Listen to Genetics Unzipped onApple Podcasts(iTunes)Google Play,Spotify,orwherever you get your podcasts

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Podcast: From Jurassic Park to woolly mammoths is it right to bring back extinct species? - Genetic Literacy Project

MIT Provost Martin A. Schmidt said sharing the risk among several institutions will not only make possible work that would be difficult for a single institution to tackle, it will also encourage collaboration that accelerates the process of moving discoveries from lab to patient.

MIT researchers are developing innovative approaches to cell and gene therapy, designing new concepts for such biopharmaceutical medicines as well as new processes to manufacture these products and qualify them for clinical use, Schmidt said. A shared facility to de-risk this innovation, including production, will facilitate even stronger collaborations among local universities, hospitals, and companies and ultimately, such a facility can help speed impact and access for patients. MIT appreciates Harvards lead in convening exploration of this opportunity for the Commonwealth.

Richard McCullough, Harvards vice provost for research and professor of materials science and engineering, who also helped lead the project, said although the centers activity will revolve around science and manufacturing, its true focus will be on patients.

The centers overarching goal will be improving patient care, McCullough said. This would occur both by speeding access to the essential, modified cells that patients in clinical trials await, and by fostering discoveries through collaborations within the centers innovation space. The aim is that discoveries result in whole new treatments or improved application of existing treatments to provide relief to a wider universe of patients.

Organized as a private nonprofit, the center will be supported by more than $50 million pledged by its partners. It will be staffed by a team of at least 40, experienced in the latest cell-manufacturing techniques and trained in the use of the latest equipment. Among its goals is disseminating badly needed skills into the Boston life-sciences workforce.

We have to be sure that we are constantly feeding the industry with talented people who know the right things, so personally, I am very excited about education programs, Ligner said. Initiatives like [this center] are essential to advancing the industry because they help organizations build on one anothers advances. For example, the full potential of cell and gene therapies will only be realized if we collaborate to address challenges, such as manufacturing, improving access, accelerating innovation, tackling cost issues, and then sharing our learnings.

The new center emerged from conversations with state officials, including Gov. Charlie Baker and Attorney General Maura Healey, and industry sector leaders about ways to bolster Massachusetts preeminence in life science research and medical innovation. Those conversations sparked a two-year consultation process at the invitation of Garber and Harvard Corporation Senior Fellow Bill Lee, that was coordinated with state officials and included representatives from industry, academia, venture capital, area hospitals, and government.

Cell and gene therapies have the potential to revolutionize the global health system. Recently, in Sweden, the first patient received cell therapy outside of a clinical trial. Its the start of an incredible time in the industry and in human health.

Emmanuel Ligner, president and chief executive of GE Healthcare Life Sciences

Called the Massachusetts Life Sciences Strategies Group, members reached out to regional experts beginning in 2017to discover what fields they considered most important and how best to support them. Cell and gene therapy rose to the top because of the considerable excitement generated by activity already going on, its potential to help patients, and its high potential for future growth and innovation. Also important were the opportunities to spread the high cost of these technologies across multiple institutions and, while so doing, capture the collaborative power of housing each player in the development chain within a single facility.

The centers board of directors will be comprised of Harvard, MIT, and industry partners Fujifilm, Alexandria Real Estate Equities, and GE Healthcare Life Sciences. Other members will include Harvard-affiliated teaching hospitals Massachusetts General Hospital, Brigham and Womens Hospital, Beth Israel Deaconess Medical Center, Boston Childrens Hospital, and the Dana-Farber Cancer Institute; as well as the Commonwealth of Massachusetts and life-sciences company MilliporeSigma.

When you look at the constellation of players coming together, you really have the best universities and the best teaching hospitals and the best corporate players all supporting it, McGuire said, which I think is a great opportunity.

The facility intends to provide researchers and emerging companies outside the consortium with access to excess material, though organizers said they expect it to be in high demand by center partners.

The centers boost to the areas cell and gene therapy endeavors comes early enough that it should help maintain leadership over places like California and China, which have made clear their interest in life-science research, McGuire said.

I think getting this early mover advantage is going to be huge [in] developing the technology and the know-how and, ultimately, the intellectual property around it, McGuire said.

For Sharpe, the ultimate payoff will come from using cancer immunotherapys checkpoint blockade and other cell and gene therapies to save and improve lives.

We are seeing long-term benefits in some patients whove received checkpoint blockade, Sharpe said. There are patients who are more than a decade out and are melanoma-free. I think that it really has transformed patient care, quality of life, and longevity. So Im optimistic that the more we learn, the more were going to be able to do to help patients.

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Partnership aims to accelerate cell and gene therapy - Harvard Gazette

Raphael Kim and Stefan Poslad from the Queen Mary University of London have pointed out that bacteria are similar to the internet of things (IoT) devices.

This is owing to the fact that they have an immaculate means of communication and in-built engines and sensors, processing architecture and effective information storage.

After pointing out the similarities between the two, they want to create a biological version of the internet using bacteria.

Escherichia Coli is a specific type of bacteria (amongst other types) that store information in ring-shaped structures similar to DNA. These structures are called plasmids and bacteria transfer these plasmids from one organism to another via a process called conjugation. The reason why scientists prefer using E.Coli is the fact that they are easy to program through genetic engineering.

Previously, Federico Tavella at the University of Padua in Italy along with his colleagues built a circuit in which a Hello World message was transmitted from a strain of immotile (not capable of motion) E.coli to motile strain.

This proof-of-principle experiment concluded that such information transfer in the world of bacteria can be used to create a complex network, therefore, a biological version of the internet.

One of the hurdles faced by scientists in creating a network using bacteria is the lack of a mechanism similar to GPS. This makes it difficult for researchers to track them and the information sent by them.

According to Kim and Poslad, Such challenges offer a rich area for discussion on the wider implication of bacteria driven Internet of Things systems.

While the project is far away from fruition, the idea and work being done to achieve is commendable. Nevertheless, a network created entirely by bacteria would be an interesting innovation in the world of science and tech, if at all possible.

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Researchers Want To Create Biological Version Of Internet Using Bacteria - Fossbytes

Certain provisions of both the draft seeds Bill as well as the Pesticide Management Bill need to be amended to prevent MNCs from swamping farmers

Farmers bodies are concerned that the proposed draft Seeds Bill, 2019, and the Pesticide Management Bill could weaken farmers rights and increase corporate control over seed, as the definition of farmer has been tweaked to include traders and corporations. The original definition of farmer excluded any individual, company, trader or dealer, who engages in procurement and sale on commercial basis (non-farmers); Bharatiya Krishak Samaj president Krishan Bir Chaudhary insists this should be retained.

The draft states, Farmer means any person who owns cultivable land or any other category of farmers who are doing the agricultural work as may be notified by the Central/State Governments. It identifies farmer as anyone owning cultivable land under Clause 11, which makes all corporations, who own land, eligible to be classified as farmer, while the new exemptions of Clause 47 spare multinationals from any regulation under the seed law.

The draft Bill introduces new commercial definitions of seed, which facilitate easy market access to multinational corporations rather than conserve our rich biodiversity and guarantee farmers the freedom to save and exchange seeds they have evolved and, thus, ensure availability of high quality, reliable, affordable and ecologically adapted seed for their ecosystem and agro-climatic zone.

The Bill introduces unscientific definitions like national seed variety and state seed variety in Clauses 17 (national seed varieties means those varieties which are cultivated in more than one State) and 31 (State seed varieties mean those which are cultivated in one State only).

Seed is the expression of diversity of traits and agroclimatic zones, where varieties are bred by farmers and to which they are adapted. To describe seeds, not according to traits and agroclimatic zones but as national seed if grown in more than one state and state seed if grown in one state, has no scientific basis. This is a commercial description to facilitate the marketing and the spread of unreliable and costly seeds from MNCs.

Under the 1966 Seed Act, new seeds were evaluated in 22 agroclimatic zones to ensure farmers get quality inputs. Strangely, the 2019 Seed Bill makes evaluation optional: The Committee may, for conducting trials to assess the performance, accredit centres of the Indian Council of Agricultural Research, State Agricultural Universities and such other organisations fulfilling the eligibility requirements as may be prescribed to conduct trials to evaluate the performance of any kind or variety of seeds.

The seed Bill should ensure compensation to farmers in case of seed failure. Instead, it leaves farmers to seek compensation for seed failure under the Consumer Act. Liability clauses are meaningless if there is no liability for seed failure. The Consumer Protection Act, 1986, stated that the producer, distributor or vendor of seed of the registered kind or variety shall disclose the expected performance of such kind or variety to the farmer under given conditions and if such seed fails to perform as expected, the farmer could claim compensation from the producer, dealer, distributor or vendor.

The 2019 draft Bill is a Compulsory Seed Certification Bill under which seed producers and seed processing units must be registered [247, 22(1) and (2)]. Article 12 states that farmers shall not be required to register the farmers varieties of seeds in the said register but the deletion of farmers rights in exemption Clause 47 dilutes farmers rights.

Significantly, transgenic seeds are introduced. A new category of synthetic seeds enters the definition of seed in Article 24. Section 44 opens the door for introduction of transgenic varieties cleared by the Genetic Engineering Appraisal Committee (GEAC). Under special provision for registration of transgenic varieties, it states, notwithstanding anything contained in Section 14, no seed of any transgenic variety shall be registered unless the applicant has obtained a clearance in respect of the same as required by or under the provisions of the Environment (Protection) Act, 1986: (29 of 1986).

But the biosafety regulatory agency is a failure. It approved Bt cotton which is failing; it approved Bt brinjal which the Minister overruled; it approved GM mustard even though it has lower yields than indigenous public varieties and is tolerant to the prohibited herbicide, glufosinate. Only a case in the Supreme Court has prevented its commercialisation. Now, the new seed Bill could allow commercialisation of Bt brinjal and herbicide-tolerant mustard.

The Central Seed Committee under the 1966 Act included one person to be nominated by each State Government. The 2019 seed Bill has changed this provision to five representatives chosen by the Centre on a rotational basis. Meanwhile, the Seeds Division, Dept of Agriculture, has asked sellers for Expression of Interest (EOI) for bar-coding seed packets for a national seed traceability system. This must surely wait until Parliament passes the Bill.

Coming to the Pesticide Management Bill (PMB), it must provide for compulsory registration of Technical Grade Pesticides in India, prior to granting registrations for imports or indigenous manufacture of pesticides formulations, which is the prevailing practice in major agricultural nations such as the US, Europe, Brazil, China, Australia and Argentina.

The PMB should not include data protection for agrochemicals/pesticides as such provisions will effectively extend the monopoly enjoyed by multinational corporations, which already have 20-year patent protection under WTO (effective in India from 2005). Additional data protection would mean ever-greening of patents. Data exclusivity in agrochemicals sector will delay entry of generics and make agrochemicals/pesticides unaffordable for Indian farmers. Moreover, the PMB lacks a pesticide schedule. The insecticide schedule is an integral part of the Insecticide Act, 1968, and helps applicants and regulators to decide if registration is required or not.

The PMBs over regulation of exports will adversely affect exports of pesticides, which can earn foreign exchange and boost the indigenous agrochemicals industry. Export orders for pesticide formulations are time-bound, depending upon the agriculture season in different countries and timely delivery is critical else customers will go elsewhere. All importing countries have their own regulations and registration requirements for imports, which each exporter has to fulfill.

Hence, imposing unnecessary data requirements and raising unqualified deficiencies for export-oriented products will only add to costs and delays. Data available in the public domain should be accepted by the registration authority as export orders are country-specific. The Ministry of Agriculture would do well to resolve these issues before proceeding with these legislations.

(The writer is Senior Fellow, Nehru Memorial Museum and Library; the views expressed are personal)

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Seeds of misfortune - Daily Pioneer

STRIKES, protests, petitions and demonstrations have been a staple of political life for many generations. Ahead of next month's General Election, we take a look back at a handful of causes that have had Dorset residents up in arms over the past few decades.

One of the more unusual topics that sparked fury amongst local people was the prospect of an ostrich farm taking up residence in West Stafford. In the late-1990s, campaigners positioned themselves outside the entrances of Tesco and Waitrose as well as the offices of the West Dorset District Council, urging both the public and authorities to reconsider the plans.

Local members of the vegetarian group VIVA - which now promotes a vegan lifestyle - also demonstrated to raise awareness of the growing trend among supermarkets to shop exotic meats. Neal Buckoke, spokesperson for the campaign group, was reported saying: "You can now buy ostrich, kangaroo and buffalo meat in superstores, and we want to stop the practice now. It is not natural for these animals to be farmed, and we have got to call a halt to the sale of exotic meat before it gets too big and too many animals suffer."

The protests were eventually successful and plans for the West Stafford ostrich farm were abandoned.

Although unparalleled in their scope, the aims of today's Extinction Rebellion are far from new. Friends of the Earth, an environmental campaign group that continues to work in 74 countries around the world, has certainly made its voice heard in Dorset throughout the decades.

A key protest of 1999 was against the production and sale of genetically modified food - or GMOs - a practice which involved altering the DNA of plant and animal products through genetic engineering. Photographs show members of the campaign group protesting outside Tesco in Dorchester, armed with placards reading "60% of Tesco's customers say NO!"

Acting chairman of South Dorset Friends of the Earth, Matt Pullman, was quoted saying: "It's time for Tesco to listen to public opinion and join the great majority of responsible food retailers in removing GM ingredients from their own products."

Members also gathered in Bridport's Bucky Doo Square, accompanied by a 'gene beast' which epitomised their fears of genetically modified food. Yet these protests ultimately failed: although public concerns about the practice remain, GM foods are continued to be produced and sold.

Recent decades have also seen South Dorset Friends of the Earth protesting against power stations, climate change, and even the use of cars.

Turning to more political qualms, members of the National and Local Government Officers' Association (NALGO) held a UK-wide strike in 1989. Workers were protesting against changes to their pay which would mean a rise not in line with inflation and the loss of negotiating rights. NALGO were instead calling for a 12% pay rise with no strings attached.

More than 90% of workers in England and Wales supported the strike action, which almost brought local government services to a complete standstill.

In 1993, NALGO was one of three unions which combined to become UNISON and went on to lead strike action in Dorset throughout the 1990s. In 1995, care workers gathered outside the County Hall in Dorchester, protesting against a proposed 12.5 per cent cut in their wages. Placards read: "Why target the lowest paid?" and "Who cares for the caring?"

Now the largest trade union in the UK - with almost 1.4 million members - UNISON was also established from the National Union of Public Employees (NUPE) and the Confederation of Health Service Employees (COHSE).

Young people have similarly been voicing their concerns over the decades, taking to the streets in 1997 to protest against the 100,000 cut in the county's budget for youth clubs. Teenagers from across Dorset equipped themselves with placards, whistles and megaphones, speaking out against the 13% cut which Dorset County Council said had been necessary to fund local government reorganisation.

A 16-year-old member of Sturminster Newton Youth Club, Sarah Sandall, was reported saying: "These cuts mean our youth clubs have to close for up to three months of the year." The youngsters also led a petition demanding that the budget be restored to its former level, and distributed badges emblazoned with "don't cut our future."

Ahead of the general election in 1997, petitions circulated areas of the county on issues both big and small. In Weymouth, residents campaigned to prevent a Conservative government adding VAT to food, as part of a nationwide petition. Labour Party agent for South Dorset, Gareth Thomas, was reported saying that the Tories had gone on record announcing they would extend indirect taxation, while Labour would strongly oppose any plans to introduce VAT on food.

Currently, only certain items such as chocolate biscuits, crisps and fruit juice are subject to a 20% tax rate, while most others are tax-free.

These days, many petitions calling for political and social change are organised online and can attract widespread publicity. As of March 2019, the most popular petition - with 6.1 million signatures - called for the revocation of Article 50.

Under the Human Rights Law, everyone has the right to freedom of expression and therefore the right to protest peacefully. Peaceful protests, along with strikes and demonstrations, can be an effective campaigning tool, raising awareness of an issue and increasing visibility of a movement or organisation.

It is only if protests become violent, threatening national security or public safety, that they can be considered unlawful, and lead to police involvement and arrests.

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Ostrich farms and other causes that got residents up in arms - Dorset Echo

LOS ANGELES, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Enochian Biosciences, a company focused on gene-modified cellular therapy in infectious disease and cancer, announces the expansion of its infectious disease pipeline by entering into an agreement in principle to acquire an exclusive, license for a treatment under development aimed to treat the Hepatitis B Virus (HBV) infections from G-Tech Bio, LLC. An abstract accepted for presentation at the HepDART meeting featuring in vivo and in vitro data from preclinical studies conducted with this novel HBV treatment candidate will be presented by Dr. Serhat Gmrkc, MD, PhD on December 10, 2019. Approximately 5 percent of the worlds population is infected with HBV, and around 1 million people per year die from the disease.

The widely respected and well-published collaborating scientist, Dr. Philippe Gallay, PhD, of the Scripps Institute said, I have been working in the hepatitis field for three decades. The mechanism of action conceived of by the brilliant scientist, Dr. Gmrkc, is remarkably innovative. The data generated thus far have exceeded my expectations. I look forward to the presentation at HepDART, an important conference for the field, and to advancing the work with Dr. Gmrkc and Enochian Biosciences.

Building on a Broad and Deep Pipeline

Based on the determinations from independent valuation specialists as contained in our audited financial statements for our fiscal year ended June 30, 2019, our intangible assets related primarily to our HIV pipeline are approximately $154.8 million. The addition of a treatment that we believe could have the potential to cure HBV expands an already exciting pipeline for Enochian.

Enochian licenses are for intellectual property that include proprietary know-how and pending patent applications covering aspects of our pipeline therapeutics. Additionally, Enochian intends to protect the therapeutics that may be approved for marketing in the future with regulatory exclusivity that is available in many jurisdictions around the world. These exclusivity strategies, which are based on pending patent applications, patents, if issued, and regulatory exclusivity, are common among biotech companies as therapeutic candidates proceed through pre-clinical and clinical stages leading to commercialization.

HIV

The cure for HIV has been demonstrated to be more than a theoretical possibility. The so called Berlin and London patients have been cured by undergoing a bone marrow transplant for cancer with cells from another person who had a naturally occurring genetic mutation that makes cells resistant to HIV infection. Unfortunately, this procedure causes a death rate of approximately one-third and causes significant and in some cases, life-long side effects for those who survive. Therefore, it can only be done in people who require a transplant for a life-threatening disease such as lymphoma. Several researchers and companies have attempted to genetically modify the cells of HIV-infected persons and return (transplant) them back into the same person, hoping to reduce the significant side effects with the approach used in the Berlin and London patients. However, the chemotherapy used is still rather toxic, and more significantly, there has not been significant uptake (engraftment) of the genetically modified cells, so the patients have not been cured.

HV-01: a New Approach Toward a Potential Cure for HIV

HV-01 was the original impetus for the conception of Enochian Biosciences HIV focus. It is based on an insight by Dr. Gmrkc, drawn from a non-HIV field, that by adding an additional genetic modification to cells beyond those that protect cells from HIV infection could give a competitive advantage to the survival of the cells in HIV patients, leading to enhanced engraftment of the cells and increase the potential for a cure. This approach could also significantly reduce the therapies needed, potentially allowing the procedure to be done on an outpatient basis.

The results from in vitro and in vivo pre-clinical studies being conducted by Dr. Gallays laboratory and Scripps Institute and Enochians lab have thus far exceeded expectations. Therefore, an Initial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting package, which we expect will assist us in initiating the Investigational New Drug (IND) process with the FDA, is being prepared. We are seeking to potentially submit that package in December, meeting our original goal of submission before the end of 2019.

HV-11 and HV-12: A Potential Preventive and Therapeutic Vaccine for HIV

Novel approaches to stimulate a persons immune response to more effectively respond to HIV could be used to prevent infection (preventive vaccine) or to allow an HIV-infected person to control HIV infection in the absence of any other treatment (therapeutic vaccine).

Enochian has partnered with one of the leading scientists and scientific institutions, Dr. Hans Peter Kiem, MD PhD, of the Fred Hutchinson Cancer Research Center, to test an innovative approach in non-human primates that we believe has the potential for development into a preventive and/or therapeutic/curative vaccine. Dr. Kiem said, We are very excited to be involved with this study. Dr. Gmrkcs scientific insight for the work is truly unique. I know of no similar approach being evaluated anywhere else in the world.

HIV 31 and 32: Potential new class of HIV treatment

Based on the innovative mechanism of action designed to be developed into a potential cure for HBV, Dr. Gmrkcs two novel approaches aimed at an alternative path to cure and/or treat HIV are in the discovery phase.

Oncology

Building on learning from peer-reviewed publications of Phase I/IIa trials, we are designing an innovative dendritic-cell based therapeutic vaccination platform that could potentially be developed into treatments to induce life-long remissions from some of the deadliest solid tumors. We plan to initially target pancreatic cancer, triple negative breast cancer, glioblastoma, and renal cell carcinoma with this platform. The platform might also allow for non-specific immune enhancement that could have the potential for impact against a broad array of solid tumors. As with HIV, our approach could potentially allow for outpatient therapy without ablating or significantly impairing the patients immune system, as many current approaches require.

Experimental designs have been created to develop our approach, including the procurement of vectors. We expect that the platform could move beyond the discovery phase in the coming months.

Building the Capital Foundation to Advance the Pipeline

Enochian has recently entered into agreements that upon satisfaction of certain closing conditions and closing will provide an additional $12 million in funding. Based on current projections, we believe these resources should be sufficient to advance the pipeline through pre-clinical phases into Phase I trials if IND approvals are secured.

The Inventor

After receiving his preclinical training at the Dokuz Eylul University in 2004, Dr. Serhat Gmrkc continued his training in various institutions and started working as a physician licensed by the Ministry of Health of Turkey in 2008. Later, after working under Dr. Suat Arusan in Turkey, Dr. Gmrkc decided to explore further studies in the field of cell and gene therapies. He is currently the director of Seraph Research Institute, a non-profit organization where he runs a research lab at the cutting edge of cell, gene and immunotherapy research. On agreeing to join the Institutes scientific board, one of the worlds leading experts and his mentor in immuno-oncology, Prof. Shimon Slavin said, Dr. Gmrkc was a young Turkish post-doc with interesting ideas when I first met him eight years ago. I am looking forward to our future collaboration in developing and implementing novel cancer treatments at Seraph Research Institute.

His interest in other fields of science, such as physics, has led him to pursue creating cross-disciplinary solutions to complex human diseases as a researcher. Based on his unique research training, Dr. Gmrkc has become a prolific inventor, submitting various patent/provisional patent applications, which include several approaches aimed to treat or potentially cure HIV/AIDS, Hepatitis B, major solid tumors, rare but deadly diseases, and for a novel vaccine for HIV among many others.

Dr. Gmrkc has licensed intellectual property related to HIV and several solid tumors to Enochian. Dr. Mark Dybul, MD, said, Dr. Gmrkc is one of those rare geniuses that is not bound by scientific discipline or dogma. He sees connections and opportunities often missed. His ideas are the purest kind: those that seem so obvious and simple once he has conceived of, and explained them.

About the Company

Enochian Biosciences is a pre-clinical stage biotechnology company committed to using its exclusive licenses for genetically modified cellular and immune-therapy technologies to seek to prevent or potentially cure HIV, to potentially provide life-long cancer remission of some of the deadliest cancers and to potentially cure HBV. We intend to do this by genetically modifying, or re-engineering, different types of cells, depending on the therapeutic area and then injecting or reinfusing the re-engineered cells back into the patient to provide treatment.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline or the sufficiency of our funding. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as believes, plans, expects, aims, intends or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Enochians most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Enochian undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Originally posted here:
Enochian Biosciences Expands its Infectious Disease Pipeline by Entering into an Agreement in Principle to Acquire an Exclusive License for a Novel...