AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures

Host-directed antiviral drugs have the potential to enhance the immune response to viruses from a range of viral families

Tonix was awarded a contract with the U.S. Department of Defense for up to $34 million for the accelerated development of its host-directed broad-spectrum antiviral program TNX-4200

CHATHAM, N.J., October 8, 2024 (GLOBE NEWSWIRE) – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it has entered into an AI and ML research collaboration with X-Chem, Inc. (X-Chem), a leader in small molecule drug discovery, to accelerate development of Tonix’s oral broad-spectrum antivirals.

Tonix’s TNX-4200 antiviral program focuses on the development of oral CD45 phosphatase inhibitors, with broad-spectrum activity against a range of viral families. As previously disclosed, Tonix entered into a contract with the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) for up to $34 million to advance the development of Tonix’s TNX-4200 broad-spectrum oral antiviral program for medical countermeasures, including an Investigational New Drug (IND) submission and a first-in-human Phase 1 clinical study.

“We are excited to enter into this research collaboration with X-Chem, which we believe will expand our capabilities, and deepen our understanding of host-targeted small molecule therapeutics for a variety of targets,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “With the support of X-Chem’s drug discovery AI/ML technology, we expect to optimize the physicochemical properties, pharmacokinetics, and safety attributes of our drug candidates.”

“We are excited to partner with Tonix in their pursuit of such important programs in human health, at the intersection of laboratory and in silico technology. This collaboration highlights how integrative work continues to leverage the creation of target-specific high-quality data to drive AI drug discovery.” said Erin Davis, Ph.D., Chief Technology Officer of X-Chem.

The DTRA contract awarded to Tonix to help fund and accelerate the development of the Company’s lead oral host-directed TNX-4200 broad-spectrum antiviral program. The TNX-4200 program aims to reduce viral load and to allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors to optimize lead compounds for therapeutic intervention of biothreat agents.

For the oral broad-spectrum antiviral programs, including TNX-4200, Tonix is utilizing its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center (RDC) located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community.

About X-Chem, Inc.
X-Chem, Inc. is a leader in small molecule drug discovery services for pharmaceutical and biotech companies. As pioneers of DNA-encoded chemical library (DEL) technology and its integration with proprietary AI technology and computational sciences, X-Chem can accelerate all steps in the discovery process. The company leverages its unique AI/ML approach, market-leading DEL platform, and computationally-driven medicinal chemistry expertise to discover novel small molecule leads against challenging, high-value therapeutic targets. Integrated with X-Chem’s extensive chemistry and computational technologies, project teams can deliver clinical candidates with unmatched speed. X-Chem also provides libraries, reagents, and informatic tools to allow DEL operators to get the most of their DEL platform. X-Chem empowers its partners to effectively build drug pipelines from target to clinical candidate, enhanced with AI and extensive data packages.

Further information about X-Chem can be found at www.x-chemrx.com.

Tonix Pharmaceuticals Holding Corp.^*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in October of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL was generally well tolerated in the Phase 3 program. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years to develop TNX-4200 small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

WALTHAM, Mass.; Sept. 17, 2024 (Business Wire) – X-Chem, a global leader in innovative drug discovery services, announces the achievement of a drug discovery milestone, under its collaboration agreement with AstraZeneca. Working together, the companies utilized X-Chem’s DNA-encoded chemical library (DEL) screening platform to identify hits for a target of interest to AstraZeneca. The resulting hits led to a candidate compound poised for clinical study, representing a milestone under the companies’ collaboration agreement.

“We are very pleased that our colleagues at AstraZeneca have attained this important achievement,” said X-Chem CSO Matt Clark. “The fact that AstraZeneca was able to move so quickly from the hit discovered at X-Chem to a candidate molecule is a testament to their hard work and dedication, and to the quality of the hit our DEL platform yielded. Compounds with good efficiency metrics make great starting points for medicinal chemistry campaigns.”

About X-Chem
X-Chem, Inc. is a leader in small molecule drug discovery services for pharmaceutical and biotech companies. As pioneers of DNA-encoded chemical library (DEL) technology, the company leverages its market-leading DEL platform and medicinal chemistry expertise to discover novel small molecule leads against challenging, high-value therapeutic targets. Integrated with X-Chem’s extensive chemistry and computational technologies, project teams can deliver clinical candidates with unmatched speed. X-Chem’s advanced proprietary artificial intelligence (AI) technology and computational sciences accelerate all steps in the process. X-Chem also provides libraries, reagents, and informatic tools to allow DEL operators to get the most of their DEL platform. X-Chem empowers its partners to effectively build drug pipelines from target to clinical candidate, enhanced with AI and extensive data packages.

WALTHAM, Mass.; Sept. 5, 2024 – Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and X-Chem, leader in DNA-encoded library (DEL) technology, today announced a collaboration agreement focused on accelerating early-stage drug discovery.

X-Chem’s DEL technology streamlines hit finding by simultaneously screening up to billions of DNA-tagged compounds, identifying potential start points with high efficiency and precision.

In partnership with Evotec’s screening platforms and capabilities, X-Chem is providing access to its DEL technology, including DELflex, a traditional experimental DEL solution, and HITMiner, a machine learning solution, leveraging high quality experimental DEL data to deliver optimal drug intervention starting points for innovative biological targets.

“Partnerships to access best-in-class platforms are the way forward to address the complexity in drug discovery,” said Karen Lackey, CEO of X-Chem. “This collaboration highlights our commitment to partner with leading research organizations, like Evotec, to make DEL screening services more accessible.”

“We are pleased to collaborate with X-Chem and to leverage their leading DEL platform and capabilities,” said Craig Johnstone, Chief Operating Officer of Evotec. “X-Chem’s expertise in DEL, combined with their advanced data-mining solutions, provides us with access to an additional tool to tackle innovative and difficult biological targets.”

About X-Chem
X-Chem, Inc. is a leader in small molecule discovery science, providing pharmaceutical and biotechnology companies with a complete, seamless solution for screening, hit validation and lead optimization. As pioneers of DNA-encoded chemical library (DEL) technology, the company leverages its market-leading DEL platform to rapidly screen billions of diverse drug-like molecules to discover novel small molecule leads against challenging, high-value therapeutic targets. In house hit-to-lead and lead optimization services driven by AI and physics-based modeling enable clients to progress their compounds directly in-house from hit all the way through to candidate nomination. Our well-proven expertise in medicinal chemistry, custom synthesis and scale-up process chemistry enables us to support all aspects of drug discovery in a deeply integrated technology-driven platform.

About Evotec SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec provides high value pipeline co-creating partnerships and solutions to all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s sites in Europe and the USA offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com.

• Carlos Garcia-Echeverria, Katharina Kreymborg and Karen Lackey become members of the board
• Christoph Lengauer, co-founder and CSO of Curie.Bio, is chair of the board
• New strategy to realign resources to accelerate the translation of promising assets into benefits for people with cancer

LONDON, UK, 22 August 2024 – Cancer Research Horizons, the innovation arm of Cancer Research UK, has appointed Carlos Garcia-Echeverria, Katharina Kreymborg and Karen Lackey as the first members of its Therapeutic Innovation board to steer its drug discovery strategy.

Therapeutic Innovation is Cancer Research Horizons’ drug discovery division. From target identification to candidate drug nomination, Therapeutic Innovation’s scientists collaborate with academic and industrial partners to progress promising ideas, de-risk assets and bring projects to their next value inflection point.

The new board members’ experience across academia and the biopharma industry brings a fresh perspective to reshape Cancer Research Horizons’ drug discovery strategy

Carlos Garcia-Echeverria has led drug discovery and development teams across the biopharma industry, including at EQRx, Sanofi and Novartis.

Carlos Garcia-Echeverria says: “After three decades of working in drug discovery and development in pharma, it is an honour to join the board of Therapeutic Innovation, support its mission and bring real hope to cancer patients and their families by advancing effective, safe and affordable new medicines.”

Katharina Kreymborg, SVP at Curie.Bio, brings perspectives on drug development from big pharma, biotech and venture capital.

Katharina Kreymborg says: “Drug development is the successful fusion of many different disciplines. I am excited to support the purposeful orchestration of scientific innovation, technical rigour and commercial potential at Cancer Research Horizons for the benefit of patients.”

Karen Lackey, CEO of X-Chem, brings over 30 years of leadership in drug discovery with previous roles at Roche, GSK, and Evotec.

Karen Lackey says: “Therapeutic Innovation has an enormous scientific pool of opportunities to impact cancer treatments. We are here to help shape the drug discovery efforts into a high-quality pipeline of drug candidate molecules.”

The new members join the inaugural chair of the board, Curie.Bio co-founder and CSO Christoph Lengauer, who was appointed in 2023.

Christoph Lengauer says: “Having worked across academia, biotech, big pharma and venture capital, our new board members have the experience and contacts needed to help Cancer Research Horizons accelerate the discovery, development, and commercialisation of new therapeutics.”

Cancer Research Horizons’ strategy focuses on generating a portfolio of projects, through engagement with our world-class network of academic science, to yield a steady flow of small molecule and antibody-based candidates for further drug development.  The new approach will align priorities,resources and partnerships to accelerate the translation of the most promising approaches into new therapies for people with cancer.

Hamish Ryder, CEO of Therapeutic Innovation at Cancer Research Horizons, says: “Karen, Katharina and Carlos have fantastic experience and will be vital to building on Therapeutic Innovation’s track record by helping reshape and drive our drug discovery strategy. Our aim is to progress promising approaches to candidates faster, because patient benefit is a function of speed as well as quality of the underlying science.”

WALTHAM, Mass.; June 20, 2024 (Business Wire) – Small molecule drug discovery acceleration experts and DNA-encoded library (DEL) technology pioneers X-Chem, Inc. welcomes Paul Davie as Chief Business Officer. He will lead global business development, focusing on the creation of new market opportunities for the company’s innovative technology platform and shaping new business ventures, collaborations and strategic partnerships to maximize the value of X-Chem’s digital drug discovery technology platform.

Davie, who joins X-Chem from Schrödinger, has an established record of building and growing successful business operations through innovative strategic partnerships that provide unique, data driven solutions and significant year-on-year growth.

“To deliver on our strategy of using our market-leading digital and experimental drug discovery platforms, the right strategic partnerships are essential,” said Karen Lackey, Chief Executive Officer of X-Chem. “I’m excited that Paul — with his deep expertise and strong global network — joins us as our platforms continue evolving with new capabilities that enable our partners to achieve discovery program success.”

“I am thrilled to join the X-Chem team and help deliver on its ambitious plans,” Davie added. “The combination of the world’s leading DEL hit-finding platform, hugely skilled medicinal chemistry teams and powerful AI-driven informatics capabilities singularly positions X-Chem as an outstanding partner for cost-effective drug discovery acceleration.”

X-Chem’s mission is to leverage its leading drug discovery platform — which combines DEL screening with AI-supported computational analysis and world class medicinal chemistry — to accelerate molecules through the discovery process. Its application of digital modalities enables scientists to make faster, smarter decisions, reducing time to clinic based on comprehensive arrays of data.

About X-Chem 
X-Chem is the leader in small molecule discovery, providing pharmaceutical and biotech companies a complete, seamless solution for screening, hit validation and lead optimization. As a pioneer of DNA-encoded chemical library (DEL) technology, the company leverages its market-leading DEL platform and proprietary artificial intelligence platform, ArtemisAI, to discover novel small molecule leads for challenging, high-value therapeutic targets. The company’s expertise in medicinal chemistry, custom synthesis and scale-up process chemistry supports all aspects of small-molecule drug discovery through candidate identification.

WALTHAM, Mass.; April 2, 2024 (Business Wire) – X-Chem, the leading provider of innovative solutions in early-stage drug discovery, today announced the addition of Dr. Erin Davis as chief technology officer. Dr. Davis brings extensive experience in the areas of data strategy, informatics, computational chemistry and software solutions in drug discovery. The addition of Dr. Davis to X-Chem’s executive team bolsters X-Chem’s strategy of leveraging its data generation platforms and deploying digitized drug discovery solutions to its clients. As a leader in DNA-encoded library technology, discovery and synthetic chemistry, and machine learning powered by its proprietary ArtemisAI platform, X-Chem is well positioned to uniquely marry real-world data generation and advanced machine learning approaches to transform and accelerate drug discovery. Dr. Davis’ unique expertise in knitting computational platforms with robust data strategies will make her a key leader as X-Chem continues its development into the leading provider of innovative services in small molecule drug discovery.

“I am so excited to see Erin join the amazing team we have here at X-Chem,” said Karen Lackey, chief executive officer. “Erin brings enormous creativity and a track record of innovation to a company full of innovation and cutting-edge technology. I believe that this team will transform the way that small molecule drugs are discovered.”

About X-Chem
X-Chem is the leader in small molecule discovery, providing pharmaceutical and biotech companies a complete, seamless solution for screening, hit validation and lead optimization. As a pioneer of DNA-encoded chemical library (DEL) technology, the company leverages its market-leading DEL platform and proprietary artificial intelligence platform, ArtemisAI, to discover novel small molecule leads for challenging, high-value therapeutic targets. The company’s expertise in medicinal chemistry, custom synthesis and scale-up process chemistry supports all aspects of small-molecule drug discovery through candidate identification.

FCF is pleased to announce the establishment of a research collaboration with X-Chem, a global leader in DNA-encoded library (DEL) technology. Through the effort, X-Chem will leverage its powerful DEL platform to support drug discovery efforts against fibrolamellar’s difficult-to-drug fusion protein. The hope is that this powerful screening technology can be used to identify potential small molecule “hits” that could eventually lead to the identification of drug candidates for FLC.

About X-Chem
X-Chem, Inc. is the leader in small molecule discovery science, providing pharmaceutical and biotech companies a complete, seamless solution for screening, hit validation and lead optimization. As pioneers of DNA-encoded chemical library (DEL) technology, the company leverages its market-leading DEL platform to discover novel small molecule leads against challenging, high-value therapeutic targets. In-house lead optimization services enable clients to progress their compounds directly for even higher quality outputs. X-Chem’s expertise in medicinal chemistry, custom synthesis and scale-up process chemistry enables the company to support all aspects of drug discovery, supporting lead optimization through candidate identification.

WALTHAM, Mass.; Jan. 4, 2024 (Business Wire) – X-Chem, the leading provider of innovative solutions in early-stage drug discovery, today announced executive management team changes aimed at expanding its position as a premium provider of integrated services to drug hunters.

Karen Lackey, currently Chief Scientific Officer, will transition to the role of Chief Executive Officer. Karen’s extensive drug discovery experience in both pharma and service organizations makes her the ideal leader to guide X-Chem into the next phase of its evolution. Under Karen’s leadership, X-Chem will continue innovating in data-accelerated drug discovery utilizing a unique combination of computational science and experimental data generation to catalyze a small molecule drug discovery revolution.

Current X-Chem Chief Executive Officer Matthew Clark will transition to the role of President and Chief Scientific Officer. In this role, Matt will focus on maintaining X-Chem’s edge in novel drug discovery technologies, ensuring X-Chem’s clients access a full range of innovative services to advance their pipelines. A drug discovery technology thought leader, Matt will continue to have a crucial role aligning X-Chem’s scientific capabilities to its corporate mission and clients’ needs.

“I’m very proud of what the team has accomplished over the past four years, transitioning X-Chem from a boutique DNA-encoded library (DEL) shop to a global, integrated service provider,” said newly appointed X-Chem President and CSO Matt Clark. “Now, under Karen’s visionary leadership, I am incredibly excited to participate in the next stage of our journey. X-Chem has the potential to transform the way small molecule drugs are discovered.”

“I am so excited about the future of small molecule drug discovery and X-Chem’s role in that future,” said incoming CEO Karen Lackey. “In my first six months at X-Chem, I have seen top-tier science and met many amazingly talented scientists. Together, we can continue to bring incredible innovation to drug discovery, unlocking the biological problems of the future to the benefit of patients.”

About X-Chem
X-Chem is the leader in small molecule discovery science, providing pharmaceutical and biotech companies a complete, seamless solution for screening, hit validation and lead optimization. As pioneers of DNA-encoded chemical library (DEL) technology, the company leverages its market-leading DEL platform to discover novel small molecule leads against challenging, high-value therapeutic targets. In-house lead optimization services enable clients to progress their compounds directly for even higher quality outputs. Our expertise in medicinal chemistry, custom synthesis and scale-up process chemistry enables us to support all aspects of drug discovery, supporting lead optimization through candidate identification.