NEWS & EVENTS

Biolexis Therapeutics launches subsidiary Metabolexis to develop novel oral medicines for Obesity and Type 2 Diabetes to improve human longevity

October 26, 2023

Biolexis Therapeutics, a clinical-stage AI-enabled drug discovery company, today announced the launch of Metabolexis, a new pipeline company developing three targeted oral small molecules for the treatment of Obesity and Type 2 Diabetes, with the potential to improve human Longevity.

The World Health Organization estimates 650 million obese and 537 million Type 2 Diabetic patients worldwide. The World Obesity Federation predicts that 51% of the world — more than 4 billion people — will be obese or overweight within the next 12 years. These rates are alarming, especially among youth and adolescents. In the United States alone, more than 100 million people (about four in 10) are obese, and 37 million are diabetic (about 1 in 10), 90-95% of whom are Type 2, according to the Centers for Disease Control and Prevention. While recently approved drugs for treating Type 2 diabetes have also been found effective for weight loss, significant toxicity and drug administration complications remain.

“We believe that our novel small molecule therapeutics delivered orally can address some of the toxicity and delivery complications associated with today’s treatments,” said Dr. David J. Bearss, CEO and co-founder of Biolexis Therapeutics. “With the launch of Metabolexis, we have an opportunity to address this immense need by providing clinically effective, easily administered, and economically viable treatments that improve the lives of these patients.”

The Metabolexis pipeline includes isoform-specific activators of AMPK, aGLP-1/GLP-1R agonists, and mTORC1 inhibitors with plans to file Investigational New Drug Applications (INDs) for all three agents by the end of Q4 2024 and to initiate First-In-Human Phase I safety clinical trials in Q1 2025. Utilizing Biolexis’ MolecuLern™ process, the company has identified lead candidates currently in pre-clinical development.

MolecuLern is an AI-enabled drug discovery process that leverages empirical/wet lab data-driven models trained on Biolexis’ curated and proprietary library, including physical and virtual synthesis-ready fragments and NCEs, to identify lead molecules targeting any class of protein.

 This innovative and expedited process results in candidates with drug-like characteristics, reducing development costs, increasing the potential for clinical trial effectiveness, and significantly accelerating the drug discovery time frame.

“Obesity-related conditions, including Type-2 Diabetes, Cardiometabolic, Stroke, and age-related diseases, continue to be crucial issues in our communities,” said Dr. Hariprasad Vankayalapati, CSO and co-founder of Biolexis Therapeutics. “As we continue to research, develop, and implement innovative methods to address critical unmet medical needs, we believe our work in activating AMPK, agonizing GLP-1, and inhibiting mTORC1 targets will expand treatment options for patients with these and other metabolic disorders.”

Metabolexis will focus on targeting these important conditions with the goal to eliminate the presence of the major chronic conditions associated with aging. Aging is linked to the gradual deterioration in biological functions occurring in most tissues. Aging in specific tissues leads to a variety of disorders, including neurodegeneration, obesity, diabetes, cardiovascular diseases and cancer. The work at Metabolexis will focus on targeting known regulators and pathways that control the aging process and will develop drugs intended to improve the health of the aging population.

For more information, please visit www.biolexistx.com.

About Biolexis
Biolexis Therapeutics is a privately held clinical-stage biopharmaceutical company dedicated to developing small molecules targeting cancers, immune-mediated, neurodegenerative, auto-immune, metabolic, and inflammatory diseases. Biolexis rapidly discovers and develops novel clinical candidates with unprecedented speed and accuracy through their proprietary MolecuLern AI-enabled drug discovery process.

 SOCIETY OF NEUROSCIENCE ANNUAL MEETING TO BE HELD 

November 11-15, 2023

Biolexis Therapeutics Scientific Team participates and present their pre-clinical stage small molecule HDAC6 inhibitor program for ALS indication at the “SfN” (Society of Neuroscience) Annual Meeting to be held on Nov 11-15, 2023 – Walter E. Washington Convention Center in Washington, D.C.

https://www.sfn.org/meetings/neuroscience-2023

Abstract Title: Development of a Novel, Orally Active, Brain Penetrable HDAC6 Inhibitors Shows a Therapeutic Potential for Amyotrophic Lateral Sclerosis (ALS)

Session Title: ALS: Non-Human Models

Session Type: Poster | Abstract Control Number: 2773
Session Number: PSTR200 | Presentation Number: PSTR200.26
Session Date and Time: 11/13/2023 8:00:00 AM – 11/13/2023 12:00:00 PM
Location/Room: WCC Halls A-C | Presentation Time: Mon. Nov. 13, 2023, 9:00 AM – 10:00 AM

INTERNATIONAL CONFERENCE ON MOLECULAR TARGETS AND CANCER THERAPEUTICS

October 11-15, 2023

Biolexis Therapeutics Scientific Team participates and present their IND stage small molecule CDK9 inhibitor program for Pancreatic Cancers indications at The “AACR-NCI-EORTC” International Conference on Molecular Targets and Cancer Therapeutics to be held on Oct 11-15, 2023 – Haynes Convention Center, Boston, Massachusetts

Abstract title: Development of BLX-3030, A Potent, Selective, Orally Available CDK9i shows promise in Pancreatic Ductal Adenocarcinoma (PDAC) Models

Poster number:LB_C13 | Session: Poster Session C     

Session location: Level 2, Exhibit Hall D        

Session date and time: Saturday, October 14 | 12:30 pm-4:00 pm

14th Annual World Cancer Congress

July 22-24, 2023

Biolexis Therapeutics CSO invited to Chair Cancer Immunology & Immunotherapy session and present MolecuLern technology at 14th Annual World Cancer Congress – WCC 11: Cancer Immunology & Immunotherapy on July 22-24, 2023, at Barcelona, Spain.

WCC-2022 (bitcongress.com)

AACR (American Association of Cancer Research) Annual Meeting

April 8-13, 2023

Biolexis management participated and presented pre-clinical data on CDK9 inhibitor at the AACR (American Association of Cancer Research) Annual Meeting on April 8-13, 2022, Ernest N. Morial Convention Center New Orleans, Louisiana.

B137 / 13 – Orally available, CDK9 selective, small molecule inhibitors shows promise in n-Myc-driven neuroendocrine prostate cancers (NEPC)

Session LBPO.MCB02 – Late-Breaking Research: Molecular/Cellular Biology and Genetics 2.

Next Generation Kinase Inhibitors Summit

February 22-23, 2023

Biolexis Therapeutics Business Development team participated 2nd Next Generation Kinase Inhibitors Summit was held on February 22-23, 2023, in Boston.

Precision in Drug Discovery & Preclinical Summit 2022

November 14-15, 2022

Biolexis Therapeutics Management participates and presents their MolecuLern technology at Precision in Drug Discovery & Preclinical Summit 2022 on Nov 14-15, 2022, San Francisco CA, US.

10th Annual Drug Discovery Strategic Summit

Oct 27-28, 2023

Biolexis Therapeutics Management participates and presents their MolecuLern technology at 10th Drug Discovery Strategic Summit, Oct 27th – 28th 2022, San Francisco CA, US

AACR 2022 Annual Meeting

April 8-13, 2022

BioLexis is pleased to announce the acceptance of a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting, taking place at the Ernest N. Morial Convention Center in New Orleans from April 8-13, 2022. Representing BioLexis, Co-Founder and Chief Scientific Officer, Dr. Hariprasad Vankayalapati will present data highlighting an orally available, CDK9 selective small molecule inhibitor demonstrating early proof of concept in n-Myc-driven neuroendocrine prostate cancers (NEPC). Dr. Vankayalapati noted “Development of CDK9 selective drugs for cancer applications have been pursued globally for several decades. This is the first reported data demonstrating this level of selectivity.”

Headquartered in American Fork, Utah, BioLexis has created an AI-driven drug discovery platform they dubbed MolecuLern. Based on more than two decades of pioneering research by Dr. Vankayalapati and his co-founder, Dr. David Bearss, MolecuLern leverages a vast proprietary compound library coupled with AI software developed by BioLexis. The combination of unique tools allows BioLexis to reduce the typical time to identify a potential drug from several years to just four weeks.

“This is another in a series of impressive discoveries using the MolecuLern platform” stated Dr. David Bearss, CEO of BioLexis. “While we are focused on bringing a select number of assets to the clinic, we see MolecuLern as a tremendous opportunity to partner assets we’ve discovered as well as provide unique discovery and development services to the pharmaceutical industry.”

To date, MolecuLern has established an 80% success rate in identifying drug candidates. BioLexis will begin partnering with the MolecuLern platform in 2023, following completion of validation studies.

About BioLexis
Biolexis Therapeutics is a privately held biopharmaceutical company dedicated to developing small molecules targeting complex disease processes. Biolexis rapidly discovers and develops novel clinical candidates with unprecedented speed and accuracy through their proprietary MolecuLern AI-enabled drug discovery process.

About AACR
The American Association for Cancer Research (AACR) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer. Founded in 1907, by a few scientists gathering to share information to the multifaceted organization that exists today, the growth of the AACR reflects the increasing complexity of our understanding of the collection of devastating diseases we now know as cancer.

https://www.pr.com/press-release/859029

PRESS RELEASES

Biolexis Secures $10 Million in Series A Funding to Advance Metabolic Drug Development 

Led by Clarke Capital, the new funding round will accelerate the company’s drug discovery pipeline

American Fork, UT – November 29, 2023— Biolexis Therapeutics, Inc., a clinical stage AI-driven drug discovery company, announced today the successful closure of a $10 million Series A funding round. The investment was led by Clarke Capital, a prominent institutional investor and alternative investment firm. 

The new funding will advance Biolexis’ development pipeline which includes a range of promising metabolic drug candidates. These drugs have the potential to tackle various metabolic disorders that affect millions of people worldwide and are linked to significant health complications such as obesity and diabetes. 

“This financial backing from Clarke Capital is a testament to the potential of our metabolic drug portfolio,” said David Bearss, CEO of Biolexis. “Our science is on point and our team is ready to tackle the unmet needs within the metabolic disorder spectrum. With Clarke Capital’s support, we’re in a strong position to accelerate our drug development pipeline and move closer to bringing our solutions to patients.” 

The Series A funding marks a significant milestone for Biolexis but also marks Clarke’s return to partner with Drs. Bearss and Vankayalapati, having been a major investor in their first company, Montigen Pharmaceuticals, a decade and a half ago before it was sold to a publicly traded company. The reteaming will allow the company to expand its operations and accelerate the clinical development of its key drug candidates. With the prevalence of metabolic diseases on the rise and current treatments in limited supply, the need for new and effective treatment options is more urgent than ever. 

“At Clarke Capital, we’re committed to investing in companies poised to make a significant impact on healthcare,” said James Clarke, CEO of Clarke Capital. “Biolexis’ impressive approach to addressing metabolic disorders and other treatment-resistant conditions has the potential to change lives. We are overjoyed to support their mission and look forward to seeing the results of their groundbreaking work.” 

To date, Drs. Bearss and Vankayalapati have filed more than 20 Investigational New Drugs (INDs) and have secured more than 100 patents. Using its unique AI-driven MolecuLern™ process, Biolexis has 40 active programs in discovery and 10 pipeline programs in the IND-enabling stages of development. The process, which targets any class of protein to identify novel chemical entities (NCEs) with drug-like characteristics and real wet-lab data validation, reduces the discovery and development timeline from years to months.  

To learn more about Biolexis visit www.biolexistx.com. 

### 

About Biolexis 

Biolexis Therapeutics is a privately held clinical-stage biopharmaceutical company dedicated to developing small molecules targeting cancers, immune-mediated, neurodegenerative, auto-immune, metabolic, and inflammatory diseases. Biolexis rapidly discovers and develops novel clinical candidates with unprecedented speed and accuracy through their proprietary MolecuLern AI-enabled drug discovery process. 

About Clarke Capital 

Clarke Capital is an alternative asset investment firm with a robust portfolio of successful companies. Clarke takes a “hands on” approach when partnering with visionary entrepreneurs with an aim to create and grow high-potential, industry transformative companies.

Biolexis Therapeutics launches subsidiary Metabolexis to develop novel oral medicines for Obesity and Type 2 Diabetes to improve human longevity

October 26, 2023

Biolexis Therapeutics, a clinical-stage AI-enabled drug discovery company, today announced the launch of Metabolexis, a new pipeline company developing three targeted oral small molecules for the treatment of Obesity and Type 2 Diabetes, with the potential to improve human Longevity.

The World Health Organization estimates 650 million obese and 537 million Type 2 Diabetic patients worldwide. The World Obesity Federation predicts that 51% of the world — more than 4 billion people — will be obese or overweight within the next 12 years. These rates are alarming, especially among youth and adolescents. In the United States alone, more than 100 million people (about four in 10) are obese, and 37 million are diabetic (about 1 in 10), 90-95% of whom are Type 2, according to the Centers for Disease Control and Prevention. While recently approved drugs for treating Type 2 diabetes have also been found effective for weight loss, significant toxicity and drug administration complications remain.

“We believe that our novel small molecule therapeutics delivered orally can address some of the toxicity and delivery complications associated with today’s treatments,” said Dr. David J. Bearss, CEO and co-founder of Biolexis Therapeutics. “With the launch of Metabolexis, we have an opportunity to address this immense need by providing clinically effective, easily administered, and economically viable treatments that improve the lives of these patients.”

The Metabolexis pipeline includes isoform-specific activators of AMPK, aGLP-1/GLP-1R agonists, and mTORC1 inhibitors with plans to file Investigational New Drug Applications (INDs) for all three agents by the end of Q4 2024 and to initiate First-In-Human Phase I safety clinical trials in Q1 2025. Utilizing Biolexis’ MolecuLern™ process, the company has identified lead candidates currently in pre-clinical development.

MolecuLern is an AI-enabled drug discovery process that leverages empirical/wet lab data-driven models trained on Biolexis’ curated and proprietary library, including physical and virtual synthesis-ready fragments and NCEs, to identify lead molecules targeting any class of protein.

 This innovative and expedited process results in candidates with drug-like characteristics, reducing development costs, increasing the potential for clinical trial effectiveness, and significantly accelerating the drug discovery time frame.

“Obesity-related conditions, including Type-2 Diabetes, Cardiometabolic, Stroke, and age-related diseases, continue to be crucial issues in our communities,” said Dr. Hariprasad Vankayalapati, CSO and co-founder of Biolexis Therapeutics. “As we continue to research, develop, and implement innovative methods to address critical unmet medical needs, we believe our work in activating AMPK, agonizing GLP-1, and inhibiting mTORC1 targets will expand treatment options for patients with these and other metabolic disorders.”

Metabolexis will focus on targeting these important conditions with the goal to eliminate the presence of the major chronic conditions associated with aging. Aging is linked to the gradual deterioration in biological functions occurring in most tissues. Aging in specific tissues leads to a variety of disorders, including neurodegeneration, obesity, diabetes, cardiovascular diseases and cancer. The work at Metabolexis will focus on targeting known regulators and pathways that control the aging process and will develop drugs intended to improve the health of the aging population.

For more information, please visit www.biolexistx.com.

About Biolexis
Biolexis Therapeutics is a privately held clinical-stage biopharmaceutical company dedicated to developing small molecules targeting cancers, immune-mediated, neurodegenerative, auto-immune, metabolic, and inflammatory diseases. Biolexis rapidly discovers and develops novel clinical candidates with unprecedented speed and accuracy through their proprietary MolecuLern AI-enabled drug discovery process.

Contact Us

CORPORATE HEADQUARTERS
858 S Auto Mall Dr. #102
American Fork, UT 84003
United States

Ph: 801-692-3655   info@biolexistx.com