Press Releases and News

Landos Biopharma Raises $10 Million in Series A Financing

September 21 2017

Landos Biopharma Raises $10 Million in Series A Financing

First company Launched Under Xontogeny Accelerator Model; Chris Garabedian Joins Landos Board to Provide Strategic and Operating Expertise

Perceptive Advisors Will Serve as Exclusive Investor

BOSTON, MA and BLACKSBURG, VA, September 21, 2017 – Landos Biopharma, Inc., an emerging biopharmaceutical company focused on developing improved treatments for autoimmune diseases, announced today it has raised $10 million in a Series A financing led by life sciences investment management firm Perceptive Advisors, LLC, which will serve as its exclusive investor for the Series A round.

Landos, founded by serial entrepreneur and innovator Dr. Josep Bassaganya-Riera, is advancing a robust pharmaceutical pipeline for autoimmune diseases toward commercialization and will partner operational efforts with Xontogeny, LLC, a life sciences accelerator operating company led by industry veteran Chris Garabedian. Xontogeny’s model works in synergy with partner companies to support management teams and provide expertise and strategic direction in the early stages of pharmaceutical and biotechnology development.

Current therapies for autoimmune diseases, a $100 billion market, have limited efficacy and significant side effects. Landos’ mission is to accelerate the development of safer, more effective therapeutics for painful and debilitating autoimmune diseases including Crohn’s disease and ulcerative colitis.

“I’m thrilled to have Xontogeny and Chris Garabedian as a strategic and operating partner along with Perceptive Advisors as Landos’ exclusive financier in the Series A, to bring our lead product, BT-11, through initial clinical studies in 2018,” said Landos Chairman and CEO, Dr. Josep Bassaganya-Riera “We have a committed leadership team with industry experience focused on developing oral treatments that address an unmet clinical need of patients, can disrupt the $9.2 billion per year inflammatory bowel disease (IBD) therapeutics market, and most importantly improve the lives of millions of patients living with these diseases.”

Landos will focus its development efforts in a novel target pathway called Lanthionine Synthetase C-Like 2 (LANCL2), which has shown promise for the treatment of autoimmune diseases by engaging a unique mechanism of action that exerts potent anti-inflammatory effects. Landos’ lead product candidate BT-11 is a first-in-class, orally active, locally-acting therapeutic for treatment of Crohn’s disease and ulcerative colitis that has shown a benign safety profile in animal models and that is advancing toward an Investigational New Drug (IND) filing. BT-11 intercepts IBD by decreasing the production of inflammatory mediators and increasing anti-inflammatory molecules within the gastrointestinal tract. IBD impacts approximately 1.6 million Americans and 4 million people worldwide.

“Landos is an exciting company for Xontogeny to partner with as Josep and his team have produced very compelling data in animal models of IBD and have brought their lead compound, BT-11, to the cusp of clinical trials,” said Mr. Garabedian, who will serve as a Landos Board member and senior business advisor. “The properties of BT-11 are unique and well differentiated from current IBD products and we believe it has the potential to represent an advance in the treatment of both Crohn’s disease and ulcerative colitis.”

“We are extremely excited to partner with both Josep and Chris to build Landos into a global biopharmaceutical company focused on autoimmune diseases, and are convinced that the team will provide an accelerated path to compelling clinical proof-of concept for IBD,” said Joe Edelman, CEO of Perceptive Advisors. “As the first investment in a Xontogeny portfolio company since partnering with Chris earlier this year, we believe that Landos exemplifies the company profile we aim to support – an outstanding leadership team, a lead product with a novel mechanism, strong IP, and a compelling preclinical and translational dataset that is close to the clinic for the treatment of an important disease with an unmet need for safer and more effective drugs.”

With the Series A investment, Landos plans to complete remaining IND-enabling studies, file an IND for BT-11 in 2018 and expects to complete Phase 1 clinical testing by early 2019.

For more information about Landos Biopharma, visit www.landosbiopharma.com. For more information about Xontogeny, visit www.xontogeny.com. For more information about Perceptive Advisors, visit www.perceptivelife.com.

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About Landos Biopharma, Inc.

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of first-in-class oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally-acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases. Landos is headquartered in Blacksburg, VA. For more information, please visit www.landosbiopharma.com or contact [email protected]

About Xontogeny, LLC

Based in Boston, MA, Xontogeny seeks to accelerate the development of life science technologies by providing entrepreneurs with the leadership, strategic guidance and operational support necessary to increase the probability of success in early drug and technology development. Through a differentiated approach, the Xontogeny team partners with the founding scientists and entrepreneurs of new ventures to support their vision while allowing a more efficient development model to benefit company founders and early equity holders. For more information, please visit www.xontogeny.com or contact Xontogeny by emailing [email protected].

About Perceptive Advisors

Founded in 1999 and based in New York, NY, Perceptive Advisors is an investment management firm focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare. For more information about Perceptive, visit www.perceptivelife.com.


Company Contacts:

Landos Biopharma:

Lee Sandstead

540.218.2232

[email protected]

Xontogeny:

Heather Petty

857-241-3704

[email protected]

For Media Requests:

Andrew Mastrangelo

LaVoieHealth Science

617.374.8800, ext. 108

[email protected]

Landos featured in BioWorld

September 20 2017

BioWorld Online is the news service of record for the biotechnology industry, and they recently prominently featured Landos’ $10M series A raise. To read the full article, please click here:

BT-11: Oral Therapeutic Treatment for Inflammatory Bowel Disease

August 15 2017

BLACKSBURG, VA. August 15, 2017—The oral, small-molecule therapeutic known as BT-11 is on the fast track to becoming the new drug for treating inflammatory bowel disease (IBD), a widespread and debilitating disease afflicting over 4 million people worldwide. From discovery to investigational new drug (IND) submission in less than 12 months, the latest findings on BT-11 will be published in this month’s issue of the Journal of Medicinal Chemistry.

Landos Biopharma’s seminal publication can be found: http://pubs.acs.org/doi/abs/10.1021/acs.jmedchem.6b00412

There is an unmet clinical need for safer, more effective medications for IBD variants such as Crohn’s disease and ulcerative colitis. This publication outlines the steps for lead selection, optimization, and validation in animal models of IBD. The findings also provide novel evidence that oral treatment with BT-11 reduces gut inflammation and inflammatory lesions in single-digit doses by 90% in mice with IBD.

BT-11 is based on a novel mechanism of action targeting the Lanthionine Synthetase C-like 2 (LANCL2) pathway in immune cells of the gut. LANCL2 activation by BT-11 intercepts IBD at two levels: by decreasing the production of inflammatory mediators and increasing anti-inflammatory molecules in the gut. The study demonstrates the selectivity of BT-11 for LANCL2; the protective effects of BT-11 in IBD were abrogated following the genetic ablation of the LANCL2 target in animal models.

“This is a seminal paper in a series of upcoming publications that validates BT-11 as a first-in-class oral therapeutic for IBD,” said Dr. Raquel Hontecillas, LANDOS Chief Scientific Officer. “We are very excited to see chief results of the BT-11 program published in such a reputable, peer-reviewed journal. The development of BT-11 as on oral medication for IBD is an excellent example of how computational modeling accelerates the path to cures in IBD.”

The Journal of Medicinal Chemistry is the top medicinal chemistry journal worldwide, publishing novel studies that contribute to an understanding of the relationship between molecular structure and biological activity or mode of action.

“This recent paper further substantiates LANCL2 technology as a therapeutic target for IBD and reports our initial, nonclinical findings on BT-11, a small-molecule therapeutic that outperforms current drugs and INDs in mouse models of IBD,” said Dr. Josep Bassaganya-Riera, LANDOS President and CEO. “Our safety studies in rats demonstrate a benign safety profile for BT-11 at doses that are 100 times higher than its effective dose. We anticipate completing the remaining IND-enabling studies in order to file an application for BT-11 by 2018. In addition, we are currently raising $10 million in Series-A financing to advance BT-11 to first in human studies.”

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

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Landos Founder Named 2017 Innovator of the Year

July 15 2017

BLACKSBURG, VA. July 15, 2017 —The Roanoke-Blacksburg Technology Council (RBTC) recognized a talented group of companies and individuals at its annual TechNite awards banquet, which was held at the Hotel Roanoke & Conference Center on April 21, 2017. TechNite is an annual celebration of the Roanoke - Blacksburg region’s technology community.

“The Innovator Award recognizes an individual, a group of individuals, company, or other organization that sets the standard for thought leadership and innovation in their respective field,” says RBTC President Robert McAden. “By definition, they are doing something new or different, and they are doing it well. Their innovation represents a significant technological breakthrough.”

Landos Biopharma (LANDOS) founder, Josep Bassaganya-Riera, won the 2017 RBTC’s Innovator of the Year award during its 18th annual TechNite Awards Dinner April 21. Bassaganya-Riera is a serial entrepreneur who founded three biotech companies, including LANDOS. He has a demonstrated track record of successfully leveraging advanced informatics and computational modeling to accelerate the discovery, development, and commercialization of innovative technologies into marketable products.

“My resolve to transform healthcare is the driving force behind the success we achieve in LANDOS. By focusing on a unique iterative integration of large-scale clinical record mining, informatics analyses and computer modeling, we are making tangible progress toward the personalized treatment of diseases, such as the development of BT-11 as a safer, more effective oral therapeutic for inflammatory bowel disease. It is a distinct honor and a privilege to be in the company of so many influential leaders and innovators who strive for progress in their fields and dig to find the answers that improve our society as a whole,” says Bassaganya-Riera, LANDOS President and CEO. “Transformative innovation is only possible with the unwavering resolve, hard work, and dedication of an amazing group of individuals. I am proud that the Landos team shares a vision for the future of precision medicine and health.”

Bassaganya-Riera discusses his innovative vision for precision medicine during Virginia Tech’s most recent TEDx event. The team’s resolve to make groundbreaking contributions to health has brought them one step closer to the next generation of human clinical trials that capture human diversity and variation, enabling smarter, faster, more accurate and precise decisions for personalized, predictive medicine.

In one of its largest yearly gatherings to recognize the area’s technology community, the RBTC recognized influential leaders in business and innovation. Bassaganya-Riera was one of dozens of nominees announced for awards that include STEM education, leadership, entrepreneurship and innovation.

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

Related Press Releases:

TEDx

BT-11

TEDx: Accelerated Path to Cures

June 15 2017

BLACKSBURG, VA, June 15, 2017 – Last Friday more than 600 people heard a message of hope and inspiration from Dr. Josep Bassaganya-Riera, founder of Landos Biopharma, Inc. (LANDOS) who presented his TEDx talk about the sparks of inspiration that led to the discoveries of new pathways, including the lanthionine synthetase C-like 2 (LANCL2) pathway, to treatment for millions suffering from autoimmune diseases such as inflammatory bowel disease (IBD) throughout the world. Bassaganya-Riera spoke at the Moss Center for the Arts about the moment of inspiration that set him on a new life journey, in line with the theme of the evening, “Spark.”

“How many of us have shunned, rejected or ignored medication because, ‘the treatment is worse than the disease?’” asked Bassaganya-Riera. “How many of us have taken anti-inflammatory drugs only to experience side effects as bad as our disease symptoms?” He explained to the audience that things are about to change in the area of treatment for diseases of the gut. Breakthroughs in precision medicine and health now in development at LANDOS, the company Bassaganya-Riera founded in order to bring his discoveries to the public, will soon change the experiences of those of us suffering from inflammatory diseases. And, these changes will profoundly transform the global autoimmune disease drug development landscape forever.

Bassaganya-Riera’s TEDx talk, Accelerated Path to Cures, outlined the future of precision medicine and health for inflammatory diseases with unmet clinical needs such as IBD with its two clinical manifestations: Crohn’s disease and ulcerative colitis.

For Bassaganya-Riera, there have been many sparks in his long scientific career, but the two he discussed during his talk are the application of nutritional immunology to help address unmet clinical needs for safer and more effective treatments, and the application of transdisciplinary computational modeling methods to dissect and comprehend complex massively interacting biological systems such as the immune system and the gut.

Bassaganya-Riera’s team used modeling approaches to identify a new therapeutic target for IBD—LANCL2. Next, Landos developed a new drug, known as BT-11 to pharmacologically engage the receptor and elicit anti-inflammatory responses in the gut. LANCL2 activation by BT-11 intercepts IBD at two levels: by decreasing the production of inflammatory mediators and increasing anti-inflammatory molecules in the gut.

Dr. Bassaganya-Riera explained how artificial intelligence approaches are taking his team one step closer to the next generation of human clinical trials, enabling smarter, faster, more accurate and precise decisions. Using avatars of Crohn’s disease patients, modeling large-scale clinical information on the electronic health records with 32 PB for a 4-year patient, demographic information and immunological data, they have tested new drugs through computer simulations before the drug is tested in humans.

“With LANDOS, we have embarked on a journey to cure not only the disease and discomfort caused by IBD but to cure the inefficiency of the drug development process in the autoimmune disease space,” said Bassaganya-Riera. “In the next few months we will finalize investigational new drug-enabling studies and initiate human clinical testing of BT-11, Landos’ lead clinical asset for IBD.”

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

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BT-11

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Landos Recruits New Scientific Director

May 15 2017

BLACKSBURG, VA. May 15, 2017 —Landos Biopharma, Inc. (LANDOS) announced today that Dr. Andrew Leber has joined the company to lead efforts aimed at broadening Landos’ therapeutic pipeline and advancing its first-in-class oral therapeutic asset for IBD, known as BT-11 (Lancelot), toward an open investigational new drug (IND) within a year.

Dr. Leber, a graduate of Virginia Tech, joins LANDOS as Scientific Director to build on the Company’s recent successes in the gastrointestinal (GI) space with BT-11, their lead oral first-in-class therapeutic asset for inflammatory bowel disease (IBD).

“I am very excited to participate in the development of an extensive therapeutic pipeline,” says Dr. Leber, LANDOS Scientific Director. He added: “I am familiar with the LANCL2 technology as a therapeutic target for IBD. My first priority will be to complete the remaining IND-enabling studies in order to submit an IND for BT-11, our lead asset for IBD by the first half of 2018.”

“Dr. Leber provides a wealth of experience and knowledge in drug development, modeling, and informatics,” says Dr. Josep Bassaganya-Riera, LANDOS President and CEO. “Dr. Leber’s hard work and dedication, plus his ability to leverage computational methods to accelerate drug development, exemplifies the unwavering commitment of LANDOS to accelerating the path to cures.”

Dr. Leber is a graduate of Penn State University and Virginia Tech. He has degrees in Bioengineering and Genetics, Bioinformatics and Computational Biology. His expertise spans immunology, computational modeling, data analytics, infectious disease, drug development and metabolism with a focus on the integration of these disciplines.

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

Related Press Releases:

TEDx

Toxicology studies

BT-11

Toxicology Experiments Demonstrate that BT-11 has a Benign Safety Profile

April 15 2017

BLACKSBURG, VA, April 15, 2017 – Landos Biopharma, Inc. (LANDOS) lead oral therapeutic for inflammatory bowel disease (IBD)—BT-11—has demonstrated an outstanding therapeutic efficacy in 4 validated mouse models of IBD at doses as low as 8 mg/kg/day in addition to a benign safety profile at doses of 80 to 500 mg/kg and up to the limit dose of 1,000 mg/kg. These safety results, which were recently published in the International Journal of Toxicology, demonstrate that BT-11 is well tolerated in rats and holds great promise as an orally active, anti-inflammatory therapeutic for IBD.

“As a toxicologist with over 30 years of experience, I am confident that orally administered BT-11 is safe,” says Virginia-Maryland Regional College of Veterinary Medicine’s toxicologist Marion Ehrich, a former president of the Society of Toxicology, who led the Virginia Tech team in these safety studies and is the corresponding author on the paper. “Our data suggest that BT-11’s chemical properties allow limited systemic exposure after oral administration and that most of the compound reaches the lower gastrointestinal tract where it exerts its efficacy in IBD.”

LANDOS is advancing BT-11—an orally active, locally acting small molecule therapeutic that binds to Lanthionine Synthetase C-like 2 (LANCL2) and exerts potent anti-inflammatory effects in gut—towards investigational new drug (IND) filing plus Phase I and IIa human clinical testing in 2018.

“IBD, a widespread and debilitating disease, afflicts 4 million people worldwide and occurs when the immune system mistakenly destroys healthy gut tissue,” says LANDOS President and CEO Josep-Bassaganya-Riera. “LANDOS is working to fill an unmet clinical need for safer, more effective oral therapeutics for autoimmune diseases. Our program lead for IBD, BT-11, has the potential to become a first-in-class oral therapeutic that outperforms current IBD medications and INDs without the increased risk for infection, cancer, and death of standard-of-care medications.”

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

For More Information:

BT-11

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NLRX1: A New Therapeutic Target for Inflammatory Bowel Disease

March 15 2017

BLACKSBURG, VA. March, 2017 – The Landos Biopharma, Inc. (LANDOS) team recently characterized a new mechanism of action underlying the regulation of immunity and metabolism by nucleotide oligomerization domain like receptor X1 (NLRX1), an immunoregulatory target implicated in antiviral immune responses. We provide evidence that the new NLRX1 mechanism synchronizes immunity and metabolism.

The findings were published in a recent paper in the Journal of Immunology.

The loss of NLRX1 results in an increase in inflammatory T cells in the gut of mouse models of inflammatory bowel disease (IBD) coinciding with a shift in metabolic function. Specifically, NLRX1 deficiency diverts resources from the citric acid cycle and allocates them toward the production of lactate. Interestingly, when this shift is prevented, NLRX1-deficient T cells behave no differently than a wild type cell.

Due to an incomplete understanding of the conditions surrounding NLRX1, targeting this molecule as a potential therapy had previously stalled. The results in the Journal of Immunology paper by the LANDOS team shed new mechanistic insights on the role of NLRX1 in mucosal immunity and metabolism.

The discovery of NLRX1 on the immunometabolic interface lends support that nutrition and cellular metabolism are intimately linked with immune function. As such, immunoregulatory molecules like NLRX1, PPARs, or lanthionine synthetase C-like 2 (LANCL2) are new therapeutic targets applicable to a spectrum of immune-mediated diseases.

The need to produce energy is inherent to all cells within the body. However, as research delves into the field of immunometabolism, it has become clear that inflammatory, regulatory and memory cells have distinct patterns of metabolic preferences across not only T cells, but also macrophages and dendritic cells as well epithelial cells and their functional subsets. Whether fulfilling a need to proliferate, produce cytokines, or sustain a long lifespan, the targeting of cellular metabolism offers new therapeutic possibilities beyond traditional immunological targets in immune-mediated disease.

“For decades, immunologists have applied reductionist approaches to studying the smallest details of the immune response without considering crucial system-wide interactions with nutrition and metabolism,” said Josep Bassaganya-Riera, LANDOS President and CEO, and the corresponding author of the paper. “Landos has built computational and mathematical models capable of analyzing complex massively interacting systems, including interactions between immunity and metabolism. This study not only elucidates novel mechanisms of immunoregulation in IBD, but it also validates transcriptomic and computational modeling studies that predicted the importance of NLRX1 in regulating gastrointestinal inflammation and its potential as a therapeutic target for infectious and autoimmune diseases.”

LANDOS is at the forefront of developing oral therapies for immune-mediated diseases, most prominently IBD. Additional exploration into immunometabolism may hold the reasons as to why dietary compounds and microbiota components can provide critical immunological feedback that ameliorates disease and pathology.

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

For More Information:


Solving Immunology

TEDx

Landos Vision for Personalized Medicine and Health

February 15 2017

BLACKSBURG, VA. February 15, 2017 – Studying the human immune system is like trying to work a vast, multidimensional jigsaw puzzle with pieces that are constantly changing shape. Billions of microbes dynamically interact with the host, shaping the processes that keep us healthy and protect from disease.

Sometimes, however, these interactions do not occur as one would hope, sending the immune system out of synch, causing chronic inflammation which can lead to diseases like Inflammatory Bowel Disease (IBD), diabetes, arthritis, psoriasis, or multiple sclerosis.

Millions of Americans suffer from such diseases, and incidences are on the rise. It has been very difficult up until recently to understand what occurs during these interactions and how they might trigger chronic inflammation.

More importantly, efforts to stop such inflammation have produced drugs and treatments that have modest efficacy and significant side effects nearly as difficult to deal with as the disease itself.

Landos Biopharma, Inc. (LANDOS) is looking to understand how inflammation occurs at the systems level and what might best recalibrate an immune system that has been pushed wildly off-course into chronic inflammation. A recent paper in Trends in Immunology explores how the field of immunology can apply modeling approaches to solve the puzzle of immunity.

“By combining computational modeling and immunology experimentation,” noted Josep Bassaganya-Riera, LANDOS President and CEO, “we can ensure that we continue to make strides toward precision medicine that help streamline the process of clinical trials and move safer, more effective personalized, individual therapies to patients more quickly.”

The LANDOS team has integrated this approach with other forms of modeling and experimentation, allowing them to simulate inflammatory processes at an unprecedented scale. By applying this approach, researchers were able to model clinical responses to new IBD treatments with a high degree of accuracy for simulated patients using advanced machine-learning algorithms.

In a recent National Institute of Allergy and Infectious Disease workshop, Bassaganya-Riera presented about how solving immunity is a complex process requiring transdisciplinary solutions. The workshop led to a white paper that sets the vision for precision medicine in infectious and immune-mediated diseases. A white paper derived from that NIAID summit can be found here

Bassaganya-Riera spoke about the advances precision medicine offers us during Virginia Tech’s most recent TEDx event. In his discussion, he explained how modeling and simulation of immunological systems helps capture human variation and diversity, and offers clinicians and patients a more rapid pipeline between clinical trials and personalized, individual treatments for human diseases.

It also offers a chance for researchers to engage in “the art of the possible”: modeling that can demonstrate the promise of new therapies in human avatars even before they are tested in a living system. Building on these early successes, it is clear that collaboration between modelers and experimentalists will be key to ushering in an era of precision medicine.

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

For More Information:

Solving Immunology

Precision Medicine

BT-11

NLRX1

Landos is Solving Immunology to Accelerate Drug Development

January 15 2017

BLACKSBURG, VA. January 15, 2017 — “Solving Immunology?” is the culmination of the “Complex Systems Science, Modeling and Immunity” workshop convened by the National Institute of Allergy and Infectious Diseases (NIAID).

The white paper, a collaboration by 14 prominent immunologists and computational biologists, aims to define the need for systems immunology approaches, mechanistic modeling and data-driven modeling and the value these approaches can add when used in combination with traditional experimentation. This white paper serves as “a roadmap for bridging the immunologist-modeler divide in order to accelerate insight into newly discovered mechanisms of immune system function and the translation of data into individualized treatment for infectious and immune-mediated diseases.”

The balance between health and disease is exquisitely controlled by complex massively and dynamically interacting gene networks, immune signaling pathways, dietary choices, the microbiome with its trillions of gut bacteria, our body’s metabolism, the immune system and nutrition-microbiota-host interplay. When interactions among genes, the environment and the immune system become out of sync, disease follows. Dysregulation of immune and inflammatory pathways is at the core of many diseases facing mankind in the twenty first century. These diseases are multi-factorial, exhibit great patient-to-patient variability, and often are intractable to both traditional “one-size-fits-all” therapy and reductionist insight.

A fundamental challenge for therapeutic development in the post-genomic era is to ascertain what is the optimal way to leverage focused, hypothesis-driven and hypothesis-generating research to understand how immune system behavior in health and disease emerges from molecular, genetic, epigenetic, cellular and environmental modulatory elements.

“Even relatively simple mathematical models can improve insight from existing data. Better integration of mechanistic modeling approaches into immunology research can optimize the choice of what and when to measure, and sharpen the hypothesis generation process,” said Josep Bassaganya-Riera, President and CEO of Landos Biopharma, Inc. (LANDOS), and one of the leading authors of the paper. “We have successfully combined the power of computational modeling with immunology experimentation to characterize new immunoregulatory targets such as PPARs, LANCL2 and NLRX1 in infectious and immune-mediated diseases. Pharmaceutical companies spend billions of dollars every year in validating new therapeutic targets. We envision a role for modeling and informatics as the first step toward identifying and validating new targets for safer and more effective drugs and biologics. LANDOS is committed to leverage the power of high-performance computing, advanced informatics and data science to accelerating the development of therapies for autoimmune diseases.”

This work is a starting point to show traditional immunologists and modelers that collaborative efforts can greatly accelerate the generation of new knowledge about the immune system as well as facilitate discoveries that may not be possible independently.

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

For More Information:

BT-11

Toxicology

Precision Medicine

New Indications

New Indications: LANCL2 in Bacterial Infections

December 15 2016

BLACKSBURG, VA. December 15, 2016—Lanthionine synthetase C-like 2 (LANCL2) has been validated as a therapeutic target for inflammatory bowel disease (IBD). New research shows that LANCL2 might also be important in establishing regulatory macrophages in response to infection with Helicobacter pylori. The findings were published in a recent paper in PLOS ONE.

The study uses a combination of advanced computational and mathematical approaches, and experimental studies in mouse models of H. pylori infection and in vitro studies in macrophages to elucidate the mechanisms by which LANCL2 modulates immune tolerance at the gastrointestinal (GI) tract. To accomplish this, a multiscale modeling approach encompassed two spatiotemporal scales: first, the cell-cell interactions occurring at the tissue level, and the intracellular signaling pathways controlling macrophage behavior into inflammatory or regulatory phenotypes.

Sensitivity analysis and in silico simulations helped identify LANCL2 as a key contributor in the prevention of chronic gastric inflammation in response to H. pylori infection – the dominant member of the stomach microbiome in half of the world population. Its presence has been associated with beneficial health effects; however, an estimated 15% of individuals colonized by H. pylori could develop gastritis leading to abdominal pain, ulcers, or gastric cancer. As a result of these side effects, standard treatment involves eradication of the bacterium with antimicrobials, which have been linked to resistance and destruction of beneficial gut microbiota.

A potential alternative to indiscriminate antimicrobial usage is the activation of host immunoregulatory pathways, such as those controlled by LANCL2. Using mice deficient in LANCL2, experimental work validated the computational hypotheses and displayed that in the absence of LANCL2 regulatory responses characterized by the production of IL-10 were significantly lessened. This suggests that LANCL2 is required to initiate anti-inflammatory responses to this bacterium.

“Mathematical and computational models can optimize the choice of what and when to measure, and sharpen the hypothesis generation process. Our modeling work revealed that LANCL2 is a crucial immunoregulatory target that plays a crucial role in both infectious and immune-mediated diseases,” said Josep Bassaganya-Riera, President and CEO of Landos Biopharma (LANDOS). He added: “In this publication, we have successfully combined the power of computational modeling with immunology experimentation to characterize LANCL2 as a new immunoregulatory target during H. pylori infection. The LANCL2 pathway has also been validated as an important therapeutic target for IBD.”

“Across multiple diseases, the scientific community is discovering that macrophages have greater diversity and specialization than initially proposed,” said Raquel Hontecillas, LANDOS Chief Scientific Officer and lead author of the paper. She added: “Through this work we are dissecting the cellular and molecular mechanisms by which H. pylori modulates macrophage responses in the gastric mucosa.”

Aligned with recent developments in LANCL2 research in IBD and immunometabolism, this work continues to suggest that LANCL2 is a broad-based immunoregulatory target in the interface of immunity and metabolism and therefore capable of producing beneficial effects across a spectrum of infectious, metabolic and immune-mediated diseases.

LANDOS is leveraging this research to discover and develop safer and more effective therapies for infectious and immune-mediated diseases.

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

For more information:

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LANCL2: A Novel Therapeutic Target for Influenza

November 15 2016

BLACKSBURG, VA. November 15, 2016—The Landos Biopharma, Inc. (LANDOS) team has recently explored the potential of activating lanthionine synthetase C-like 2 (LANCL2) to treat infectious diseases, particularly influenza virus infection. Overall, seasonal flu is one of the most relevant infectious disease-related public health problems since it causes important economic losses up to $166 billion during a single influenza pandemic. The work, which characterizes the effects of model LANCL2 ligand NSC61610 in influenza A infection of mice, is published in Frontiers in Immunology.

LANCL2 is implicated in the induction of regulatory responses that act to prevent excessive inflammation, among other functions. In line with this, initial experiments identified that mice lacking LANCL2 struggled to recover after the peak of influenza virus infection and experienced higher mortality. Pharmacological activation of LANCL2 by NSC61610 resulted in significantly lower disease severity and a 2-fold increase in survival rates.

These beneficial effects of NSC61610 and LANCL2 were dependent on the production of IL-10 from macrophages and CD8+ T cells late in infection, which are able to drive resolution and repair responses within the lungs. The Landos team has also investigated the efficacy of abscisic acid (ABA), a proposed natural ligand of LANCL2, as a therapeutic for influenza infection in a 2013 publication in the Journal of Nutritional Biochemistry.

“While the mechanism by which LANCL2 ligands modulate immune responses in the gastrointestinal (GI) tract are well understood, less was known about what LANCL2 does in the respiratory tract. We have shown conclusively that not only does LANCL2 activation ameliorate disease activity and lung inflammatory pathology, but it does it through a mechanism involving upregulation of lung IL-10 in influenza-infected mice,” said Raquel Hontecillas, LANDOS Chief Scientific Officer and the corresponding author of the paper.

Vaccines have been valuable against the spread of infections. However, they often require more than 6 months from the emergence of a particular strain to become fully developed. In contrast, the current therapeutic option for those contracting disease, is anti-viral treatment such as Tamiflu. Unlike vaccines, numerous issues arise with anti-viral treatments, such as the need to early administration (before or immediately after first presentation of symptoms), the potential for emergence of resistant strains, and an inability to modulate host responses, which amount to only a 24-hour reduction in disease course on average.

When compared to Tamiflu, pharmacological activation of LANCL2 in the lungs results in increased survival and accelerated recovery from influenza. Further, a common concern of immunoregulatory treatment is that it will result in a greater viral or bacterial load. However, the viral titer from the lungs of NSC61610-treated mice did not significantly differ from untreated groups.

“Anti-virals used to treat influenza such as Tamiflu target the virus rather than the immune response to the virus,” said Josep Bassaganya-Riera, LANDOS President and CEO. “We provide novel evidence that modulating the host response to influenza virus by activating LANCL2 and favoring immune tolerance can dramatically ameliorate survival, disease and pathology during influenza and possibly outperform Tamiflu, the current standard of care for treating infections with influenza virus.”

Beyond treating influenza infection, the role of LANCL2 has previously been characterized in gastrointestinal and metabolic disease, showing potent capabilities in a variety of diseases and validating efforts to advance the LANCL2 as a therapeutic target for infectious and immune-mediated diseases.

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit www.landosbiopharma.com or contact [email protected].

For More Information:

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