Author Archives: Sammy Michie

• Company on track for first clinical data for oral, brain-penetrant ALS drug candidate, prosetin, later this year
• Phase 2/3 study initiation expected in 2023

NEW YORK, May 18, 2022 /PRNewswire/ — ProJenX Inc., a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, today announced the appointment of Stan E. Abel as Chief Executive Officer. Abel joins the company after its recent launch by Medical Excellence Capital in collaboration with Project ALS, a leading nonprofit organization committed to ALS research, and with renowned researchers at Columbia University.

Abel, who has more than 20 years of senior management and financial experience in the life sciences industry, has an extensive background in building and leading biopharmaceutical companies. Under his leadership, executive teams with emerging businesses have identified and in-licensed development-stage drug candidates, raised more than $100 million to fund operations, conducted large-scale clinical trials and implemented successful M&A strategies. Prior to joining ProJenX, Abel was CEO of SiteOne Therapeutics Inc., where he led a team developing new treatments for acute and chronic pain. Before this, he was CEO of Corthera Inc. through its sale to Novartis with a focus on a new treatment for heart failure. Earlier in his career, Abel was the CFO of Cerexa Inc. from its inception through its sale to Forest Laboratories. In addition, he was CFO of Peninsula Pharmaceuticals Inc. through its sale to Johnson & Johnson. Abel began his career in finance positions with Eli Lilly and Company and DowBrands Inc.

Abel earned a B.S. in business from Indiana University and an M.B.A., with honors, from the University of Chicago Booth School of Business. He is chairman of SiteOne Therapeutics and serves as an advisor to early-stage life science companies.

“We are extremely pleased that Stan has joined us and accepted the role of ProJenX CEO,” said Eric Heil, Interim CEO and Chairman of ProJenX. “Stan brings a proven track record in building successful biotech companies and a compelling vision for developing novel, brain-penetrant therapies for people living with ALS and other serious brain diseases in collaboration with advocates, researchers, and industry. He joins ProJenX at an important time as we build out the leadership team, raise additional capital, and continue to advance the clinical development of prosetin and our pipeline.”

“The visionary collaboration between Project ALS and Columbia University that led to ProJenX has resulted in significant breakthroughs in the understanding of ALS motor neuron pathology and has facilitated the synthesis of promising new drug candidates for ALS and other neurodegenerative diseases,” said Stan Abel, CEO. “I am thrilled to join the ProJenX team to build on the momentum in advancing new therapeutic options for these areas of critical need.”

Erin Fleming, Co-Founder and Vice President of Operations at ProJenX, said, “Stan’s deep experience in building and leading biotech companies, including those focused on serious, hard-to-treat diseases, will be integral to ProJenX as we continue to develop prosetin with the urgency that ALS demands. We are on track with a Phase 1 study for results later this year. Beyond this and with additional financing in place, we expect to initiate a Phase 2/3 study of prosetin in ALS next year. With Stan’s leadership, we are poised to effectively advance prosetin and hopeful for its potential to make a meaningful difference in the lives of people with ALS.”

ProJenX recently initiated a three-part Phase 1 clinical trial, PRO-101, investigating prosetin in healthy individuals and people living with ALS. Prosetin is a potent, oral, brain-penetrant, mitogen-activated protein kinase (MAP4K) inhibitor targeting endoplasmic reticulum (ER) stress. ER stress is a common feature across sporadic and familial forms of ALS, and MAP4Ks emerged as the critical regulators of ER stress-mediated motor neuron loss in a patient-specific, cell-based discovery platform developed by researchers at Columbia University. Prosetin is an investigational new drug and has not been approved by the FDA.

About ProJenX

ProJenX is a clinical-stage biotechnology company developing novel, brain-penetrant, targeted therapies to address debilitating brain diseases, with an initial focus on ALS. ProJenX was created out of a long-term research collaboration between Project ALS and researchers at Columbia University to rapidly develop and commercialize its lead therapy candidate, prosetin, for people living with ALS. At the heart of ProJenX’s approach is an innovative patient-specific cell-based drug discovery platform that can be leveraged for research and drug development for ALS and other debilitating brain diseases. For more information, visit projenx.com.

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NEW YORK, March 1, 2022 /PRNewswire/ — ProJenX, a clinical stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, today announced initiation of dosing for PRO-101, a Phase 1 clinical study of prosetin in healthy volunteers and people with ALS.

“We are excited to advance prosetin, a potential first-in-class treatment for ALS and related neurodegenerative diseases, into the clinic,” said Erin Fleming, Co-Founder and Senior Director of Operations at ProJenX. “PRO-101 will provide essential safety, pharmacokinetic, and biomarker data about prosetin to inform our decisions on future clinical testing, including potential registrational studies.”

PRO-101, the first-in-human study of prosetin, is a three-part, hybrid Phase 1 trial. Parts 1a and 1b will evaluate safety, tolerability, and pharmacokinetics of prosetin in healthy volunteers, and Part 1c is planned to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin in people with ALS. Designed after consulting the Food and Drug Administration (FDA), leading ALS clinicians, and ALS community advisors, PRO-101 aims to efficiently establish the safety and biomarker data necessary for rational dose selection and late-phase study design. Prosetin Community Advisory Board member Michele Stellato said, “Soon after my ALS diagnosis, I learned about prosetin, and was energized by the promising results of this new drug candidate. I admire the transparency and urgency with which prosetin has been developed. Going to clinical trial is an exciting milestone for prosetin and a true beacon of hope for the ALS community.”

Prosetin is a potent, oral, brain-penetrant, mitogen-activated protein kinase kinase kinase kinase (MAP4K) inhibitor targeting endoplasmic reticulum (ER) stress. ER stress is a common feature across sporadic and familial forms of ALS, and MAP4Ks emerged as the critical regulators of ER stress-mediated motor neuron loss in a patient-specific, cell-based discovery platform developed by researchers at Columbia University. Prosetin is an investigational new drug and has not been approved by the FDA.

Preclinical development of prosetin was funded by the nonprofit organization Project ALS. Valerie Estess, Project ALS Co-Founder and Director of Research, and ProJenX Co-Founder and Board Director, commented, “Today marks an important first for the Project ALS family. We are confident that the ProJenX team will take prosetin to the next level clinically with the determination, spirit, and scientific rigor that marks Project ALS research.”

About PRO-101

PRO-101 is a three-part Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin in healthy volunteers and patients with ALS. Parts 1a and 1b consist of a randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, and pharmacokinetics of single ascending and multiple doses of prosetin in healthy volunteers. Following analysis of data from these parts, Part 1c is planned to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin in ALS patients.

For more information, contact trials@projenx.com.

About ProJenX

ProJenX is a clinical-stage biotechnology company with novel, brain-penetrant, targeted therapies to address debilitating brain diseases, with an initial focus on ALS. ProJenX was created out of a long-term research collaboration between Project ALS and researchers at Columbia University to rapidly develop and commercialize its lead therapy candidate, prosetin, for people with ALS. At the heart of ProJenX’s approach is an innovative patient-specific cell-based drug discovery platform that can be leveraged for research and drug development for ALS and other debilitating brain diseases. For more information, visit projenx.com.

NEW YORK, Feb. 16, 2022 /PRNewswire/ — ProJenX, a New York City-based, clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, launched today. A $5.1M seed financing was led by Medical Excellence Capital, which created ProJenX in collaboration with Project ALS, a leading nonprofit organization committed to ALS research, and with renowned researchers at Columbia University.

ProJenX will use proceeds from the financing to fund early clinical development of its lead asset, prosetin, for the treatment of ALS, expand its leadership team, and advance additional preclinical programs in its pipeline. Prosetin, an oral, brain-penetrant, MAP4 kinase (MAP4K) inhibitor targeting endoplasmic reticulum stress, is the first investigational drug developed in a collaboration between researchers at the Project ALS Therapeutics Core—a drug discovery and development program led by researchers at Columbia’s Center for Motor Neuron Biology and Disease and its Eleanor and Lou Gehrig ALS Center—and researchers from the Departments of Pathology & Cell Biology, Biological Sciences, and Chemistry at Columbia University.

ProJenX will build on the efforts initiated by Columbia and Project ALS to advance prosetin through ALS clinical trials with urgency, humanity, and scientific rigor. The company is named in honor of Project ALS founder Jenifer Estess, who was diagnosed with ALS at age 35. Valerie Estess, Project ALS Co-Founder and Director of Research, and ProJenX Co-Founder and Board Director, commented, “Since 1998, Project ALS has led aggressive, collaborative research to unlock the mysteries of ALS and the brain—the body’s most complex organ. We are immensely excited that ProJenX will take on the critical task of translating these hard-won discoveries to people with ALS—beginning with prosetin.”

Erin Fleming, Co-Founder and Senior Director of Operations at ProJenX, said, “Prosetin was developed out of a decades-long collaboration between the labs of Hynek Wichterle and Brent R. Stockwell at Columbia University and Project ALS to build more predictive models of ALS—and then use them to identify better treatments. We have seen promising effects of prosetin in a range of laboratory models and are hopeful for its potential to improve the lives of many people with ALS and other devastating neurological conditions.”

ProJenX’s seed financing was led by Medical Excellence Capital, LLC, an early-stage life sciences venture fund that combines a proprietary global network of leading physician-scientists with a team of experienced investment professionals, company builders, and operators. Eric Heil, ProJenX Interim CEO and Medical Excellence Capital Managing Partner, commented, “Medical Excellence is delighted to have played a central role in the formation of ProJenX. Patients with ALS desperately need new therapies. We believe that the patient-specific, cell-based discovery platform at the heart of ProJenX’s approach is an exciting opportunity for the creation of transformative neuroscience medicines.”

About Project ALS

Founded in 1998 by Jenifer Estess, her family and friends, Project ALS identifies and funds the most promising scientific and medical research that will lead to the first effective treatments and a cure for ALS. Project ALS recruits the world’s best scientists and doctors to work together—rationally and aggressively—to develop a better understanding of the ALS disease process and, in parallel, better therapeutic strategies. To learn more about Project ALS, visit projectals.org.

About Medical Excellence Capital, LLC

Medical Excellence Capital is an early-stage life-science venture capital firm that combines accomplished investment professionals and operators with a proprietary national medical network platform to create the most unique venture firm in life sciences. MEC deploys precision capital to nurture and advance the precision health innovations that solve the biggest, most complex medical problems. MEC has extensive experience investing in areas such as drug discovery, artificial intelligence, cell and gene therapy, synthetic biology, regenerative medicine, and precision medicine. Visit www.medexcelcap.com for further information.

About ProJenX

ProJenX is a clinical stage biotechnology company with novel, brain-penetrant, targeted therapies to address untreatable brain diseases, with an initial focus on ALS. ProJenX was created out of a long-term research collaboration between Project ALS and researchers at Columbia University to rapidly develop and commercialize its lead therapy candidate, prosetin, for people with ALS. At the heart of ProJenX’s approach is an innovative patient-specific cell-based drug discovery platform that can be leveraged for research and drug development for ALS and other untreatable brain diseases. For more information, visit projenx.com.

About The Project ALS Therapeutics Core at Columbia University

The Project ALS Therapeutics Core at Columbia aims to bring the first meaningful treatments for ALS from the lab bench to patients, rationally and efficiently. Under the scientific leadership of Drs. Serge Przedborski, Neil Shneider, and Hynek Wichterle, the Core integrates seven research groups—clinical research; lipidomics; gene therapy; antibody development; in vitro screening; in vivo evaluation; and in vivo electrophysiology—at Columbia’s Center for Motor Neuron Biology and Disease and Eleanor and Lou Gehrig ALS Center that engage in a world-class, patient-focused approach to ALS therapy development.