April 13, 2017 20:00 ET | Source: M3 Biotechnology

SEATTLE, April 13, 2017 (GLOBE NEWSWIRE) -- As the first investor in M3 Biotechnology, the Alzheimers Drug Discovery Foundation (ADDF) helped validate the therapeutic potential of M3s drug candidate for Alzheimers disease. With a second investment of $1.4 million, the ADDF is now providing key funds to support the launch of human trials this year.

While current drugs for Alzheimers disease only provide symptomatic relief, M3s small molecule therapeutics have the potential to be truly disease-modifying. By re-establishing lost connections between brain cells, these therapies may halt the course of the disease. M3 is now in the process of planning a first-in-humans Phase 1a clinical trial for its lead candidate, NDX-1017, to evaluate its safety and determine optimal dosing range.

ADDFs first investment spurred others, including many private investors and Washington state-based venture groups W Fund and WRF Capital. These investments evidenced the faith in our potential, which helped us make it past the valley of death for drug development and raise nearly $14 million in additional funding, said Leen Kawas, M3s CEO.

The most noteworthy new investor in M3 is Dolby Family Ventures, which invests in technology and life sciences. The fund makes early stage investments in the most promising Alzheimer's-specific therapeutics which require funding for the critical phase of translating successful animal therapies to human clinical trials. The fund honors the late inventor, Ray Dolby, who died in 2013 and who lived with Alzheimer's disease.

The relationship with the ADDF has been vital to our progress as they have fostered a dynamic, collaborative biotech ecosystem, Kawas said. By providing early funding and connecting us with potential partners and investors, the ADDF has helped us reach the clinic.

Howard Fillit, MD, Founding Executive Director and Chief Science Officer of the ADDF, says, We are excited by the promising therapeutic approach of Dr. Kawas and her team at M3 Biotechnology. By helping neurons survive, NDX-1017 may restore cognitive function for Alzheimers patients. The ADDF looks forward to the results from this first human trial.

Alzheimers Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, ADDF is dedicated to accelerating the discovery of drugs to prevent, treat and cure Alzheimers disease. The ADDF is a public charity solely focused on funding the development of drugs for Alzheimers, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, ADDF has awarded over $100 million to fund more than 500 Alzheimers programs in 18 countries.

M3 Biotechnology, Inc. M3 Biotechnology is a therapeutics company with a novel platform of disease-modifying regenerative small molecules, particularly relevant to neurodegenerative diseases like Alzheimers. M3s lead asset is being advanced as a first-in-class, disease-modifying treatment with the potential to restore lost connections between brain cells, turning degeneration into regeneration. Total financing of $14M to-date is used to prepare for and conduct Phase I clinical trials.

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Excerpt from:
Funding From Alzheimer's Drug Discovery Foundation Advances M3 Biotechnology Toward Human Trials - GlobeNewswire (press release)

WASHINGTON Overly cautious regulations that contravene decades of academic research and ignore the lessons from massive real-world experience are stifling innovation in plant and animal improvement, said the Information Technology and Innovation Foundation.

The Trump administration should roll back overly precautionary regulations to encourage much-needed innovations that produce safer and more sustainable crops and livestock while still preventing unreasonable risks to public and environmental welfare, argues the science- and tech-policy think tank in a recently released report.

"From reducing the need for pesticides to increasing crop yields, genetically modified crops have already made farming more safe and environmentally friendly," said L. Val Giddings, a senior fellow at ITIF and the report's author. "Researchers are discovering ever more precise, predictable, and easy-to-use techniques derived directly from nature. But despite decades of evidence on the safety of genetically improved crops, unfounded fears and politically driven opposition have led to regulations that chill innovation. It's time to rethink these policies and allow and enable a new generation of discoveries that can feed the world even more safely and sustainably."

Giddings explains that in the 1980s, the U.S. government decided to regulate biotech-improved crops using the same principles and methods it would for any other crops, because expert bodies repeatedly found no unique or novel hazards that made these crops and livestock any different than those derived from the classical plant and animal breeding that has occurred for millennia. But since then, Giddings says the disparity between the minimal risk associated with these innovations and the major regulatory hurdles they must clear has widened from a gap to a chasm.

This discordance between the degree of regulatory oversight and the actual hazards is posing economic and environmental costs, as innovative new products are delayed from reaching the market, Giddings said. To overcome these barriers and unleash a new generation of innovation in agricultural biotechnology, the report recommends that:

The Trump administration should enforce the mandate from the Office of Science and Technology Policy that agencies update their regulations and policies for innovative agricultural-biotechnology products, and that the revised regulations should be effective in preventing unreasonable risks while still encouraging and enabling innovation;

The Animal and Plant Health Inspection Service should set aside its proposal for process-based revisions to existing regulations;

The Food and Drug Administration should enforce the federal law prohibiting misleading food labels;

The FDA should revise its current proposal for regulating gene-edited animals, withdraw its proposal for gene-edited plants, and develop new proposals to exercise its discretion in preventing unreasonable risks;

The Environmental Protection Agency should not prematurely obstruct gene-silencing technologies;

The Fish and Wildlife Service should immediately withdraw the prohibition on planting biotech-improved seeds on national refuge lands; and

The Trump administration should pursue efforts through the World Trade Organization to hold China and the European Union accountable for continuing to discriminate against crops improved through biotechnology, despite being obligated otherwise.

"Biotechnology innovations have improved the lives of farmers around the world, enhanced their stewardship of the land, and benefitted consumers and the environment," Giddings said. "The principle obstacle to even greater and more widespread benefits is regulatory hurdles that aren't grounded in the facts. Setting these barriers aside will unshackle innovators to solve challenges impeding our ability to meet the food, feed and fiber needs of a growing population while reducing undesirable environmental impacts."

Read the full report at http://www2.itif.org/2017-unshackle-agricultural-innovation.pdf?_ga=1.155989245.717142650.1491235245.

More here:
Trump Administration should unshackle further innovation in ag biotechnology by rolling back undue regulations - Fence Post

When it comes to getting biotechnology innovations to market, with commercial protection, it can be tough. Around three quarters of patent applications normally fail to cut it. Although biotechnology is recognised as being important for the economy and society, it can also be highly controversial attracting public protests

The European Patent Office (EPO) has faced opposition in the past, for instance, over patents relating to processes for re-engineering genes, for use in medical research into cancer treatment. These processes could apply to various animals, including great apes and that became a magnet for criticism from animal rights campaigners.

The number of patent filings for biotechnology increased by 0.3 percent in 2016, to 5,744 making it the tenth largest sector in its field.

Youris.com spoke to Benoit Battistelli, President of the EPO, about the role of patent protection and how it can aid biotechnology innovation and the wider bioeconomy despite the obstacles faced by some.

How much of a focus is the bioeconomy for patents and what are some of the key developments?

Biosciences play an important role in patent applications at the EPO, given the growing convergence of technologies, which is widely responsible for technical progress in a wide number of sectors. Such inventions are mainly found in industrial biotechnology, for instance, in the development of novel products such as new detergents, functional food or even new eco-friendly material in construction, such as pollution-eating concrete and self-healing concrete.

The area of clean energy production is also very important. For example, when it comes to using biomass as an energy source [editors note: In 2011, a Danish inventor won a European Inventor Award organised by the EPO for developing a system which increases the types of biomass fuels that can be used. Typically, biomass materials have to be dried before they can be used as fuel, but Jens Dall Bentzens furnace design can also burn materials with a moisture content of up to 60 percent. Hes since reported to have attracted interest from Europe and the US, selling the furnace to an American manufacturer, as well as building two others for use in Denmark].

Is the bioeconomy an increasing sector?

Biotech is among our top ten technical fields and it has increased. At the end of the patent granting process, its about 50 percent on average that become a patent. Its only 26 or 27 percent in the case of biotech. Why? Because it is a very sensitive issue and we are applying the patentability criteria very rigorously. There are huge European capacities in biotech and we have seen that we must find a good balance between the regulatory constraints and the economic capacities that this sector represents.

The position of the EPO is very clear and simple. There is an EU directive concerning biotech, which we respect and which we have integrated in our own legal framework, the European Patent Convention. Then you have the interpretations of the Directive by the European Court of Justice and we adapt our practice to these judgements.

Overall, how complicated is it to obtain a patent, and is it expensive?

I would not say that it is complicated, but it is a difficult process, because we always start from the basis that a patent is an exception to the principle of free trade, free industry, free competition. Globally, for around 20 to 25,000 euros, you can obtain a patent as the EPO. For this amount, 5,000 euros are the EPO fees and the rest is the fees of those who helped to draft a patent and then discuss it with the patent office.

So, with a patent, you are giving the holder the exclusive right of commercially exploiting his invention, for a certain period of time, a maximum 20 years.

By Damon Embling

Read this article:
Biotechnology: navigating a minefield - Cordis News

Dr Vinay Rale shares his thoughts with BioSpectrum on current biotech education and the academia-industry gap

Dr Vinay Rale, Director, Symbiosis School of Biomedical Sciences (SSBS)

Brief recapitulation of genesis of Biotechnology in India A quick recapitulation of the genesis of Biotechnology in India will not be out of place to apprise the lay public. We essentially (and blindly) followed the USA in 1985 in initiating Biotechnology programs at Master's level at six select universities across India. In the 1970s, the ability to modify DNA molecules and the realization of the power of genetic engineering led prominent universities in the US to convince their Government to allocate huge funds to start

Biotechnology' - a term newly coined by them. The Indian model, first at Masters level, to cater to the need for trained manpower for the anticipated boom in the Biotechnology industry was supported by the Department of Biotechnology (DBT). Very soon a large number of institutions both in private and public sector followed suit to attract students. The wildfire spread to undergraduate programs equally rapidly. However, this led to two major disadvantages - the relegation of basic courses in Life Sciences such as Microbiology, Biochemistry, Zoology and Botany and severely inadequate infrastructure and untrained faculty. As a matter of fact, the first Masters programs supported by DBT at six prominent institutions in the country were turned to the advantage of the then faculty expertise, e.g., developmental biology turning a blind eye to the basic essentials that the students have to be proficient in.

A rough estimate of the students enrolled in Biotechnology at undergraduate and postgraduate levels suggests a number exceeding 100,000 at any given time. Also, some institutions offer a bouquet of 8 to 9 allied courses in Biotechnology. Naturally the demand-supply ratio is skewed. The curricula in Biotechnology tries to accommodate' as many subsets as possible with little attention to the fundamentals - especially at the undergraduate levels. Moreover, to overcome the infrastructure deficiency, a good number of students (especially at postgraduate level) are encouraged to bank upon either research institutes or industries to undertake dissertations.

Unfortunately, both categories of organizations take little interest in the welfare of such dissertation research; more so due to the unavailability of mentors from either side. Therefore-, little research done at such levels goes unnoticed. As a consequence-, it is estimated that well over 70 percent of Biotechnology students are considered as unemployable by industries. This is the net result of a large number of factors contributing to the creation of unfit student mass. Reliable sources indicate that industries now prefer to hire students trained in conventional Life Sciences like Microbiology and Biochemistry (also Chemistry) to meet their stringent requirements. The general complaint is that the Biotechnology students lack fundamentals. This is also the observation of this author over the decades.

Considering the seriousness of the Government to increase funding for the DBT and the intiative of the Biotechnology Industry Research Assistance Council (BIRAC) coupled with those of SIDBI and MSME to strengthen research in academia and foster strategic alliances between academia and industry, one can only expect better things to happen. However, like Biotechnology, Microbiology and Biochemistry programs too need nourishment.

Read more from the original source:
Biotechnology Education vs Industry Requirements: Where - BSI bureau (press release)