Paul Vincelli, extension professor and Provosts Distinguished Service Professor at the University of Kentucky| March 7, 2017

HIGHLIGHTS:

Biases, conflicts of interest come from many sources, including associations with industry, advocacy groups, other non-profits Industry funding of studies on GE crops does not appear to be important bias source Personal experience suggests corporations receptive to negative results, as they improve products, limit liability Limited resources for much agricultural research without industry support Dubious shill accusations against biotech scientists discourage public engagement, depress discourse

Agricultural scientists who interact with the public often feel under enormous scrutiny. One of the most common concerns is that professional ties with industryespecially obtaining funding from industrycompromise scientific credibility. This concern is particularly acute in the area of genetically engineered crops (GE crops, commonly known as GMOs).

Research into genetically engineered crops is not my specialtymy work is focused on plant pathologyand I have never solicited nor received private-sector funding on this issue. Over my career, my industry interactions have dealt with non-GMO products for plant disease control. My interest in GE crops arises from their potential to address genuine human needs and to reduce the environmental footprint of agriculture. And I am concerned that a dark shadow has been cast over many independent scientists because of their collaborative efforts with various stakeholders, including companies.

Biases From Many Sources

Across multiple disciplines, industry-funded projects may be more likely to report positive outcomes, or less likely to report negative outcomes [1-4]. However, industry funding is not always associated with biased outcomes [5, 6]. Furthermore, many sources of funding NGOs, non-profits, other civil and governmental organizationsmay engender conflicts of interest (COIs) and biases that influence reported research. Powerful biases may arise for non-monetary reasons [7] in both researchers and in non-researcherspossibly including you and me.

Regarding GE crops, I am aware of three journal articles on the topic of industry funding and bias. In the first [8], the authors found no evidence of bias due to financial COIs (studies sponsored by an industry source that may benefit from the outcome), but they did document bias associated with professional COIs (where at least one author was affiliated with a company that could benefit from the study outcome). In that study, among the 70 studies examined (see their Table 2), 61% had either a financial or a professional COI. Among the much larger sample size (698 studies) examined by Sanchez [9], the majority had no COI, and only one quarter had COIs related to author affiliation and/or declared funding source.

A recent study by Guillemaud et al [10] had similar findings: among 579 studies with definitive COI information (see their Figure 3), the majority did not report a COI. However, among those with COIs, there was a higher probability of reported outcomes favorable to the GE crop industry. In addition to these journal articles, another independent analysis [11] suggested that industry funding did not bias study outcomes for GE crops, but these data have not been analyzed statistically nor published in a peer-reviewed journal.

Thus, while evidence to date shows that the majority of studies on GE crops are not influenced by COIs, some fraction is so influenced. Therefore, there is value in remaining alert to the possibility of bias and in continuing to practice full disclosure. I believe it is important to remain alert to COIs and biases of all sortsnot only those associated with corporate influences, but also those of NGOs or other civil organizations that may have explicit or implicit agendas.

Some people simply do not trust corporations. This is understandable, given the indefensible behavior of some in business, such as the tobacco industry, the chemical industry, Exxon, and Volkswagen [12-15]. Consequently, some members of the public perfunctorily dismiss commercial-sector scientists who may have solid scientific skills and high personal integrity. I personally must admit to a measure of distrust of corporations, which may even express itself occasionally as an anti-industry bias. But I also believe it is unwise to categorically reject all industry-funded data, solely on the basis of their provenance. In fact, I would label such an attitude a bias itself. Thoughtful, evidence-based analysis must always trump bias and ideologyand does, for a good scientist.

Why do researchers accept industry funding? Public-sector and private-sector scientists may share common interests. Industry scientists and I share a common interest in knowing what works in the field and what doesnt. Consequently, industry sources provide funding for field tests of their products for plant disease control. Furthermore, public funding for science in the USA is insufficient to support even a fraction of the worthy research projects. Inadequate funding can quickly and thoroughly undercut a career in science at any stage. Since researchers are hired to do research on important topics and not to whine about the difficult state of public funding, some will welcome funding from commercial sources, if it allows them to continue to do research they believe is intellectually compelling, important to society, or both. Also, industry scientists may have knowledge, skills, and facilities that we public scientists may not.

My Funding Choices: Scientific Rigor Coupled With Personal Integrity

Discussing my own practices should provide an idea of how many scientists work. Roughly half of my funding over the years has been from industry, primarily to support product testing for plant disease control. I have commonly tested synthetic fungicides, but I have also tested natural products of various sorts. In fact, commercial pesticide manufacturers can fairly accuse me of an anti-pesticide bias. I say this because I have tended to favor testing products that might be perceived as more consistent with sustainability (biocontrol products, for example) than applications of synthetic chemicals, often requesting limited, or no, funding for such tests. Besides industry funding, I have received federal funds for research and outreach on detection and management of plant diseases.

I publish all efficacy trials in Plant Disease Management Reports. We commonly publish data showing inadequate efficacy or phytotoxicity, and I never consider funding sources when the report is drafted. In fact, the reports are drafted by the Senior Research Analyst who conducts the field work, and he doesnt know who provided funding nor for what amount. Thus, our testing program does not suffer from publication bias. This approach is not exceptional [16, 17].

I accept no personal giftsmonetary or materialfrom private-sector sources.

I have no hesitation about challenging multinational corporations. For example, I provided a degree of national leadership in challenging a major pesticide manufacturer over certain uses of a commercial crop fungicide. I was one of the lead authors of a letter to the US Environmental Protection Agency raising questions about the paucity of public data to support plant health claims. I gave a similar talk in a major scientific conference, the 2009 American Phytopathological Society meeting.

Several factors may help me and other scientists to offset natural human tendencies towards bias:

A common concern is that providing funding buys access to researchers. This may sometimes be the case, but for me, this criticism doesnt fit. I am an Extension Specialist everybody has access to me and my expertise. I dont recall a single instance in my entire career when I failed to return a phone call or email from anyone. In fact, it is a federal requirement that Extension programming be grounded in engagement with diverse stake- holdersincluding,
but certainly not limited to, industry [18].

What Happens When Data Fall Short Of Company Expectations?

We regularly see poor product performance in our experiments. In a memorable instance, we observed visible injury to a creeping bentgrass putting green from a particular formulation of the widely used fungicide, chlorothalonil. On the day of application, the turfgrass was suffering exceptionally severe drought stress, due to an irrigation equipment failure, which probably was a predisposing factor.

I notified the company of my observations, which is my standard practice if a product provides unexpectedly poor performance or unexpected phytotoxicity. This is not to provide the company the opportunity to help me see the error of my ways. Rather, this is simply good scientific practice. I want industry scientists to collect their own samples, so that they may better understand the poor results obtained; and to offer hypotheses or insights that may account for the unexpected results, as they often know things about their product and its performance that I do not.

In the case of the turfgrass injury caused by chlorothalonil, a company representative and I visited the experiment together and shared observations. I listened to the representatives hypotheses and shared my own. After the meeting and additional lab work, I reported my findings in various outlets. In my research program, unfavorable results get reported no differently than favorable results.

I must state emphatically that, in my 34 years of product testing for plant disease control, I cannot recall a single instance where a company representative attempted to pressure me to report favorable results. Company representatives do not like to receive bad news, but in my experience, almost every company representative I have interacted with has been professional enough to recognize the importance of discovering the limitations of their products sooner rather than later. The consequences of introducing an inadequate product can be catastrophic for a corporation.

Corporate Funding for Outreach

What about private-sector funding for outreach? To my knowledge, such funds are never provided with a quid pro quo that the scientist will make particular claims about a companys products. To the contrary, private-sector representatives take note of speakers whose scientific understanding is consistent with their own. They may approach those speakers to discuss possible support for outreach, but without specifying the content of such presentations. Although I refuse industry funding for all aspects of GE crops, I do not suspect undue industry influence when funds are provided for travel expenses or supplies of invited speakers. Even honoraria or stipends for speaking engagements dont particularly concern me. This is true for such funding across the full spectrum of possible funding sources, ranging from advocacy groups for organic agriculture to multinational pesticide manufacturers. I want to see the scientific methods and data, no matter who did the study.

Who Should Pay For Research?

Should publicly funded professors even do product testing? Yes: there is a public interest in independent assessments of how products perform. The more public data on performance, the better.

If you agree that third-party testing is desirable, the question arises, Who pays for it? I believe that, usually, the manufacturer is responsible, not the taxpayer. Of course, this raises concern about funding bias. If a researcher wishes to avoid funding bias, can they tap into other sources? Not in my discipline. Pools of public funding for product testing are essentially non-existent.

What about studies of possible impacts of products to the environment? Who should pay for that? Again, in my opinion, such costs fall to the manufacturer, although in some cases, there is a compelling public interest that justifies the use of public funds for product testing.

Final thoughts: Does industry-researcher cooperation undermine the credibility of scientific research?

For me, the answer is, No. We should be cognizant of possible biases and COIs due to source of fundingwhether the source is industry, NGOs, advocacy organizations, or other sources. Disclosure is critical [7, 19]. However, industry scientists are often excellent scientists who take pride in their work, no differently than any industry critic. Yes, we should exercise a degree of caution when reviewing industry-funded research, but the same holds for research funded by advocacy organizations, since each has an agenda. Personally, in all cases, I will not reject either source out of hand; I will judge the work based on its scientific merit.

Sometimes the bias against industry-funded research on GE becomes hurtful, especially in the social media. Witnessing dedicated public servants being unfairly attacked as industry shills is demoralizing to public scientists, and it has the unintended consequence of discouraging public engagement by scientists who already have very busy professional and personal lives. Such unfounded charges are not only divisive and unproductive: they are unkind and can be abusive. (Sadly, unkind behavior can be found in all sides of the GMO debate.)

My freedom from industry funding on all aspects of GE protects me from similar accusations. Yet it doesnt surprise good scientists that, after years of studying the scientific literature, I independently arrived at an understanding very similar to that presented in the re- port of the National Academy of Sciences, Engineering and Medicine (NASEM) published earlier this year [20]. This isnt because industry has somehow influenced me or the members of the NASEM review committee. It is because there is a substantial body of credible science supporting the conclusions presented in the NASEM report. In reviewing the body of peer-reviewed scientific literature on GE crops, one is likely to arrive at similar conclusions. I had an identical experience with the scientific consensus on climate change [21].

Ultimately, with enough careful study of evidence from credible sources, fidelity to good scientific practice, and a degree of humility, it is hard not to arrive at findings rather similar to those of journal-published experts of a scientific discipline. They actually do know something about their subject after all.

Paul Vincelli is an Extension Professor and Provosts Distinguished Service Professor at the University of Kentucky. Over the 26 at UK, he has developed specializations in management of diseases of corn, forages, and turfgrasses, molecular diagnostics, and international agriculture. He also has provided Extension programming on climate change and on genetic engineering of crops. He currently is UKs Coordinator for the USDAs Sustainable Agriculture Research and Education program, and he serves as Councilor-At-Large for the American Phytopathological Society.

The Genetic Literacy Project is a 501(c)(3) non profit dedicated to helping the public, journalists, policy makers and scientists better communicate the advances and ethical and technological challenges ushered in by the biotechnology and genetics revolution, addressing both human genetics and food and farming. We are one of two websites overseen by the Science Literacy Project; our sister site, the Epigenetics Literacy Project, addresses the challenges surrounding emerging data-rich technologies.

Acknowledgements

Thanks are expressed to John R. Hartman and Jon Entine, for reviewing earlier drafts of the manuscript.

Disclosure Statement

The author declares no conflicts of interest in the topic of GE crops. Detailed disclosure documents may be found here. The author donated the full amount of his monetary honorarium for writing this article to Human Rights Watch.

Literature Cited

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8. Diels, J., Cunha, M., Manaia, C., Sabugosa-Madeira, B. and Silva, M., Association of financial or professional conflict of interest to research outcomes on health risks or nutritional assessment studies of genetically modified products. Food Policy, 2011, Vol. 36, p. 197-203, DOI: 10.1016/j.foodpol.2010.11.016. Available from: http://www.sciencedirect.com/science/article/pii/S0306919210001302

9. Sanchez, M. A., Conflict of interests and evidence base for GM crops food/feed safety research. Nat Biotechnol, 2015, Vol. 33, p. 135-7, DOI: 10.1038/nbt.3133. Available from:http://www.ncbi.nlm.nih.gov/pubmed/25658276

10. Guillemaud, T., Lombaert, E. and Bourguet, D., Conflicts of interest in GM Bt crop efficacy and durability studies. PLoS One, 2016, Vol. 11, p. e0167777, DOI: 10.1371/journal.pone.0167777. Available from:https://www.ncbi.nlm.nih.gov/pubmed/27977705

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Should University Agricultural Research Scientists Partner With Industry? - Genetic Literacy Project

Representative photos of cotton and brinjal: Wikimedia Commons, CC BY

India has a long and dubious record of regulating genetically altered crops for agriculture. While the nation began at the same time as many other countries with the same ambitious goals to deploy new genetic engineering tools to address agricultural vulnerabilities it has fallen behind. Only one crop, modified with molecular techniques pest-resistant cotton has been approved by regulators.

In an attempt to expand farmers access to genetically engineered crops, in March of this year, the Indian government exempted crops with certain kinds of genetic modifications introduced by genome editing (also known as gene editing) from the cumbersome and time-consuming regulations previously imposed on the commercialisation of all crops genetically modified with molecular techniques.

Specifically (and as explained in more detail below), the new policy exempts crops with simple tweaks to genes that are already natural to the plant but that have not had any foreign DNA added. This approach may be expedient but it is not scientifically sound.

Bt cotton and Bt brinjal

Genetically modified cotton came first to India because of its economic importance and environmental externalities. Specifically, Bt cotton was the first product in the country modified with modern molecular genetic techniques. However, it sparked fierce political debate instigated by internationally visible but misguided activists.

Bt is shorthand for Bacillus thuringiensis, a bacterium found mainly in the soil that produces proteins toxic to some insects, especially the cotton bollworm. The genes that express these proteins were introduced by recombinant DNA technology a.k.a. gene splicing into the genome of various crop plants to protect them from pests.

Bt cotton soon became ensnared in spurious societal battles around neo-colonialism, the purported evils of Monsanto, organic agriculture and farmers suicides. It was officially regulated and socially stigmatised as a GMO, short for genetically modified organism. After 10 years, it remains Indias only approved genetically engineered crop.

The Indian versions of insect-resistant Bt-cotton proved highly successful in controlling the bollworm that had ravaged cotton crops. They contained only one transgene, or a gene introduced from an unrelated organism, for one trait and for only a single species of bollworm. Yet, because of the presence of this single newly introduced gene, this first successful application of molecular genetic engineering in Indian agriculture was subjected to a long and costly development process.

Herbicide tolerance as a weed-control trait also proved popular, although it was never approved and therefore its cultivation was, and is, illegal.

At the same time, farmers demand in underground markets moved the transgenic frontier forward in a poorly regulated and awkward way. Farmers vote with their ploughs, and many officials lack the knowledge and/or the incentives to contest illegal plantings.

Also read: Does India Need Transgenic Mustard?

The biggest flaw in Indias cumbersome and poorly understood regulatory system emerged vividly with the introduction of a second genetically engineered crop candidate: Bt brinjal1, a staple of some of the worlds poorest rural populations.

Brinjal in India is attacked by a boring insect larva (Leucinodes orbonalis) that is susceptible to the same protein as the cotton bollworm. But as with cotton, there is no naturally occurring gene in the brinjal family tree that conventional breeding could utilise. This is why researchers introduced the Bt gene into a brinjal variety, thus rendering it a transgenic organism.

Brinjal is not extensively traded internationally but is very important for small farmers income and both local and national consumption. There is also no environmentally acceptable, effective alternative for farmers to use as insecticides against brinjal pests.

Field trials of the transgenic brinjal cultivars were extremely promising, even compared to the successes of Bt cotton. The fact that the transgene and the cultivars were both indigenous also suggested that the variety would be nationally acceptable in a way that Bt cotton couldnt be.

The Genetic Engineering Approval Committee of India approved Bt brinjal but it was vetoed in 2010 by the then-environment-minister, Jairam Ramesh. It has since been stuck in regulatory limbo in India. During this time, India donated the genetic event EE12 to Bangladesh and the Philippines.

After EE1 was introduced into Bangladeshi varieties of eggplant and tested, the government approved them and they have been extremely successful. Interestingly, some of the altered brinjal has spread to India, and is found growing happily in India but on an unknown scale and unapproved by bureaucrats.

Regulatory discrimination

Both Bt cotton and Bt brinjal in India tell the same story: that advances for farmers unavailable through conventional, pre-molecular plant-breeding techniques have proved useful not panaceas but incrementally beneficial, trait by trait, with more in the pipeline. However, the regulatory system is slow, unscientific, inconsistent and obstructionist. Its concerns often reflect more urban politics and the blandishments of activists than farmers interests.

Nonetheless, there is hope that the most recent advances in the seamless continuum of genetic modification of plants represented by genome editing will fare better. These techniques allow genetic material to be added, removed or altered at specific locations in the genome.

The best known of these techniques is CRISPR-Cas9. This system is faster, cheaper, more precise and more efficient than earlier genome editing methods. It is also more democratic, by being less dependent on the political heft and huge resources of the multinational plant science corporations. Innovation is thus often centred in universities and individual research teams.

This said, if genome editing is to live up its potential, its regulation will need to be scientifically defensible and risk-based.

This is why the UK has reconsidered its highly prohibitive stance on molecular genetic engineering. Even the generally anti-genetic engineering EU is discussing a revised legal framework that incorporates genome editing. Consistent with this global trend, in March 2022, India announced that it would exempt certain categories of genome-edited crops from regulatory oversight.

As part of this, it has categorised genome-edited alterations as SDN-1, SDN-2 and SDN-3 (SDN stands for site-directed nuclease3). Variants made using SDN-1 and SDN-2 involve simply tweaking particular traits that already exist in a genome whereas SDN-3 involves the insertion of genes from external, or foreign, sources. So making brinjal resistant to insect predators by introducing genes from B. thuringiensis would put it in the SDN-3 category.

India has announced that SDN-1 and SDN-2 will be regulated as non-genetically engineered organisms, as there are no distinguishable sequence changes made between them and those resulting from conventional crop breeding. SDN-3, however, which involves the incorporation of a foreign DNA sequence, will continue to be heavily regulated.

This approach to regulation is unscientific and short-sighted. It has no demonstrated connection to enhanced risk. Instead, the SDN categories are based simply on considerations of how close to nature the new constructions are. Bt cotton, which was introduced to India over 20 years ago and has transformed Indias economy, will be classified as an SDN-3 crop as will Bt brinjal. So as such, the latter looks set to remain stuck in the regulatory quagmire it has been in since the beginning of its development.

There is no scientific rationale for a regulatory policy that distinguishes SDN-3 crops from SDN-1 and -2 crops. The difference between these categories is determined by the presence or absence of a foreign
gene, but the term foreign has many connotations, none of which is meaningful for regulation in the current context.

Through advances in genome sequencing, we now know that foreign genes i.e. genes that originated in an unrelated organism are present in many crop plants. They may be thought of as natural GMOs. From sweet potato to several species of grass, genes from unrelated organisms have found their way into the most unexpected places.

Also read: The Strange Case of Indias First Public-Sector Bt Cotton Variety

Failed tests

What matters from a risk and therefore regulatory perspective is not the source of a gene but its function and its effect on phenotype4. A construct that results from the addition of a foreign gene via molecular techniques should not be held to a different standard or subjected to a more stringent regulatory regime unless the modification could in some way increase risk.

Baseless regulatory discrimination against transgenic i.e. SDN-3 crops means that some new varieties that could drastically improve the fortunes of resource-poor people and environmentally vulnerable places will, for practical purposes, remain proscribed and unavailable except through the stealth practices of farmers.

The regulatory policies of the governments of India, the EU and many other countries fail this test of scientific logic. The regulation of molecular genetic engineering has been based more on political considerations than on sound science, and as such cripples progress.

Flawed regulation is not the only problem related to genetically engineered crops in India. Another is the chronic lack of transparency about agricultural technology generally and genetic engineering in particular. Data that supports government policies and specific regulatory decisions have been consistently and conspicuously lacking from government sources. That stokes public suspicion about incompetence or even corruption.

That is unfortunate and puzzling, because there is plenty of evidence they could cite. We have more than 20 years of data on commercialised genetically engineered crops worldwide. It is very clear that they are as safe as, or in some cases safer than, crops from other breeding methods. Put another way, there is no evidence that the use of molecular genetic engineering techniques confers unique or incremental risks.

The European Academies Science Advisory Council said in 2013, There is no valid evidence that [genetically engineered] crops have greater adverse impact on health and the environment than any other technology used in plant breeding. Even the WHO a component of the notoriously risk-averse UN agrees: it said in a 2014 report that

[genetically engineered] foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved.

Literally hundreds of other analyses by governmental and professional groups have echoed these findings.

Genome editing is both a continuation of plant modifications humans have depended on for millennia and a promising new frontier. Nevertheless, striking a balance between too little and much caution is not difficult, given the great precision and predictability of newer molecular techniques. Science shows the way, and politicians and regulators everywhere should follow it.

Henry I. Miller is a physician and molecular biologist and a senior fellow at the Pacific Research Institute. He was the founding director of the FDAs Office of Biotechnology and a consulting professor at Stanford Universitys Institute for International Studies. Kathleen L. Hefferon teaches microbiology at Cornell University. Ronald Herring is emeritus professor of government and International Professor of agriculture and rural development at Cornell University.

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India's GM Crops Regulation Should Be Based on a Gene's Effects, Not Its Source The Wire Science - The Wire Science

Facility to Provide Clinical Supply of Lead Gene Therapy Programs TN-201 and TN-401 for Planned First-in-Human Studies

94,000 sq. ft. Modular Facility has Initial Production Capacity at the 1000L Scale

SOUTH SAN FRANCISCO, Calif., June 16, 2022--(BUSINESS WIRE)--Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today announced that it has completed the build-out and operational launch of its Genetic Medicines Manufacturing Center in Union City, California. Tenaya is advancing a pipeline of therapeutic candidates, including several adeno-associated virus (AAV) gene therapies, for the potential treatment of both rare and prevalent forms of heart disease.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220616005336/en/

Tenayas Genetic Medicines Manufacturing Center located in Union City, CA (Photo: Business Wire)

"Tenaya made an early, strategic commitment to internalize several core capabilities to optimize the safety, efficacy, and supply of our product candidates on behalf of patients. With todays announcement we have made a big leap forward on that commitment by establishing end-to-end in-house manufacturing capabilities for our pipeline of AAV-based gene therapies," said Faraz Ali, Chief Executive Officer of Tenaya. "The operational launch of Tenayas Genetic Medicines Manufacturing Center represents an important milestone as we prepare to advance our robust pipeline of potentially first-in-class cardiovascular therapies into initial clinical studies."

Tenayas Genetic Medicines Manufacturing Center is designed to meet regulatory requirements for production of AAV gene therapies from discovery through commercialization under Current Good Manufacturing Practice (cGMP) standards. Initial production efforts will support first-in-human studies of Tenayas lead gene therapy, TN-201. TN-201 is being developed for the treatment of genetic hypertrophic cardiomyopathy (HCM) due to MYBPC3 gene mutations. Tenaya plans to submit an Investigational New Drug (IND) application for TN-201 to the U.S. Food and Drug Administration (FDA) in the second half of this year. The facility will also support cGMP production for TN-401, Tenayas gene therapy program being developed for the treatment of genetic arrhythmogenic right ventricular cardiomyopathy (ARVC) due to PKP2 gene mutations, for which the company plans to submit an IND to the FDA in 2023.

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"The investment in our own world-class manufacturing facility provides Tenaya with greater control over product attributes, quality, production timelines and costs, which we believe will ultimately translate into better treatments for patients," said Kee-Hong Kim, Ph.D., Chief Technology Officer of Tenaya Therapeutics. "Tenayas Genetic Medicines Manufacturing Center complements our established internal genetic engineering and drug discovery capabilities and is designed to meet our near- and long-term needs such that we can readily scale and expand as our pipeline matures and evolves."

Tenaya completed customization of approximately half of the 94,000 square foot facility to incorporate manufacturing suites and labs, office space and storage. Utilizing a modular design, the state-of-the-art facility is now fully operational with initial capacity to produce AAV-based gene therapies at the 1000L scale, utilizing Tenayas proprietary baculovirus-based production platform and suspension Sf9 cell culture system. The excess space and modular design of the Genetic Medicines Manufacturing Center is intended to provide Tenaya with considerable flexibility to expand manufacturing capacity by increasing both the number and the scale of bioreactors to meet future clinical and commercial production needs.

The Union City location, approximately 30 miles from Tenayas South San Francisco headquarters, is expected to enable the seamless transition of Tenayas science from early research through commercial manufacturing. The selection of this location is intended to foster a culture of close collaboration across teams at all stages of developing and testing novel AAV capsids, de-risk the translation from research to process development and create opportunities for improvements in production processes. The Genetic Medicines Manufacturing Center is staffed by a growing in-house team with expertise in all aspects of gene therapy manufacture, including process development, analytical development, quality assurance and quality control.

About Tenaya Therapeutics

Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic cardiovascular disorders, as well as for more prevalent heart conditions, through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. For more information, visit http://www.tenayatherapeutics.com.

Forward Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as "potential," "will," "plans," "believe," "expected," and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements regarding the therapeutic potential of Tenayas pipeline of therapeutic candidates; Tenayas plan to use the cGMP manufacturing facility for the production of TN-201 and TN-401; Tenayas belief that its cGMP manufacturing facility will enable seamless transition from early research through commercial manufacturing and translate into better treatments for patients; the expected timing for submission of IND applications for TN-201 and TN-401; and statements by Tenayas chief executive officer and chief technology officer. The forward-looking statements contained herein are based upon Tenayas current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenayas ability to successfully manufacture product candidates in a timely and sufficient manner that is compliant with regulatory requirements; Tenayas ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; the timing, progress and results of preclinical studies for TN-201, TN-401 and Tenayas other programs; Tenayas ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenayas manufacturing and operations, including preclinical studies and planned clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Tenayas manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenayas reliance on third parties; Tenayas ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regardi
ng the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220616005336/en/

Contacts

Investors Michelle CorralVice President, Investor Relationship and Corporate CommunicationsTenaya TherapeuticsIR@tenayathera.com

Media Wendy RyanTen Bridge CommunicationsWendy@tenbridgecommunications.com

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Tenaya Therapeutics Launches Operations of New Genetic Medicines Manufacturing Center to Support the Development of Potentially First-In-Class...