New Hope for Overlooked Diseases

May 2022

For Ritu Lal, Ph.D., it was a bigger risk not to pursue an entrepreneurial path.

As Dr. Lal followed the executive track with biopharma giants like Roche and Abbott Laboratories, her thoughts kept returning to a staggering statistic: Of the 7,000 known rare/orphan diseases, over 90% did not have a treatment.

Dr. Lal’s experience bringing novel drugs and therapies to market at prominent companies gave her unique insights into the intricacies of drug development. During her professional career, she oversaw the entire process of drug development – ranging from drug discovery to lead optimization, to candidate selection, to clinical trials to FDA approvals.

As her career advanced, she was brought back to a stronger calling: developing novel therapies for rare and inflammatory diseases that devastate families. Dr. Lal was acutely aware that the patients who survive many of these diseases have diminished quality of life and their wallets are often emptied due to health care costs.

GEn1E has created a rich pipeline of next generation immunomodulators in a time span of 2 years with $5 million spend – something that would have taken traditional companies about 7 years and over $100 million

For example, Acute Respiratory Distress Syndrome (ARDS) is an inflammatory lung disease that can arise from an injury caused by many factors, such as COVID, smoke inhalation, influenza or vaping. The condition has a 40% mortality rate and no FDA-approved therapies. The current care typically costs patients 4–5 times more than an average ICU patient, with first visits alone totaling more than $115,000. ARDS takes a $20 billion toll on society every year in the US alone.

Dr. Lal knew she could develop the technology to solve this disparity and drive novel drugs to market with unprecedented velocity and capital efficiency. Her startup, GEn1E Lifesciences (pronounced “genie” from the magical lamp), is a next-generation biotech company turbocharging cures for rare and inflammatory diseases. GEn1E uses sophisticated computational technology to target a new binding pocket in the p38 alpha enzyme to develop novel drugs. This enables them to develop selective immunomodulators which are highly differentiated compared to previous generations of immunosuppressive therapies.

The AI-based Machine Learning platform technology developed by GEn1E has also enabled it to hyper accelerate drug development where they have taken a lead compound from discovery stage to creating a rich pipeline of next generation selective immunomodulators in a time span of 2 years with $5 million spend – something that would have taken traditional biotech companies about 7 years and over $100 million.

While there is surely an opportunity cost and risk to entrepreneurship, Dr. Lal says that “ultimately, the inaction of not building GEn1E Lifesciences would have been the real risk because there are so many devastating diseases with no therapeutic treatment. And now, given all the latest developments in computational technologies and data science there is a way to bring these much-needed therapies to the patients faster, better, and more cost-effectively”

Dr. Lal understood that the best starting point for her platform was with a rare and“orphan disease,” so in mid-2018 she chose ARDS to be her first target indication. Two years later, the coronavirus pandemic catapulted ARDS to center stage, as 67% of critically ill patients developed the condition, making ARDS the leading cause of mortality from COVID-19.

The GEn1E story doesn’t end with ARDS. Today, GEn1E has developed more than 21 novel immunomodulators in its pipeline to tackle a variety of rare and inflammatory diseases. Looking forward, GEn1E will be accelerating more therapies for devastating diseases to the IND (Investigational New Drug) stage while further developing its AI platform.