Overview

Novellus is advancing a portfolio of engineered cell therapy programs to address multiple inflammatory, autoimmune, and neurologic indications.

Products

Novellus’s product candidates must proceed through several stages of preclinical and clinical development before receiving marketing authorization. Our pipeline includes several wholly controlled product candidates, as well as one product candidate under development as part of a strategic alliance. All of our therapeutic programs are designed for safety, availability, and cost-effectiveness for patients.

Candidate Indication(s) Target Selection Research Preclinical Ind-Enabling Clinical Partner
NV-001 Acute Respiratory Distress Syndrome (ARDS), including COVID-19 (Partnered)
NV-002 Multiple Sclerosis (MS)
NV-003 Ulcerative Colitis/Crohn’s Disease
NV-004 Undisclosed
NV-005 Multiple Undisclosed

NoveCellsTM Engineered Cell Therapies

NoveCells™ are “off-the-shelf” allogeneic cell therapy product candidates produced from perpetual master cell banks derived from a single donor. NoveCells™ are made using mRNA cell reprogramming and mRNA gene editing, enabling efficient, scalable manufacturing and consistent batch-to-batch product characteristics.

Technology

Novellus engineers cells using mRNA cell reprogramming and mRNA gene editing technologies. Messenger RNA (mRNA) is a molecule that, like DNA, encodes information that cells can translate into proteins, but unlike DNA, cannot create unwanted mutations in the cell’s genome. We use mRNA to induce somatic cells from a single donor to dedifferentiate into a pluripotent stem cell state. These pluripotent stem cells can be expanded and differentiated to create a near-unlimited supply of therapeutic cells with uniform characteristics that are tailored to patient needs.

Therapeutic Applications

Novellus is developing products for patients living with acute respiratory distress syndrome (ARDS), including as a result of COVID-19, ulcerative colitis and Crohn’s disease, and multiple sclerosis. Novellus is also developing product candidates to treat multiple undisclosed indications.

Acute Respiratory Distress Syndrome (ARDS)
Inflammatory Bowel Disease
Multiple Sclerosis (MS)

Acute Respiratory Distress Syndrome (ARDS) including as a result of COVID-19

Acute respiratory distress syndrome (ARDS) is a life-threatening condition that is often caused by acute lung infection. Patients with ARDS often require breathing support using a mechanical ventilator.

NV-001 (NoveCells™ iMSC) is a product candidate under development for the treatment of ARDS, including as a result of COVID-19.

NV-001 contains allogeneic cells produced from a single-donor perpetual master cell bank that are designed to home to inflamed lung tissue and secrete immunomodulatory proteins to reduce inflammation and promote recovery.

Ulcerative colitis (UC) and Crohn’s disease

Inflammatory bowel disease, which includes ulcerative colitis (UC) and Crohn’s disease, can cause various serious symptoms including severe pain, and can increase a patient’s risk of developing colorectal cancer.

NV-002 (NoveCells™-Stealth iMSC) is a product candidate under development for the treatment of UC and Crohn’s disease.

NV-002 contains allogeneic cells produced from a single-donor perpetual master cell bank that are designed to home to sites of active disease and regulate the patient’s immune system to reduce inflammation and promote healing. The allogeneic cells in NV-002 have been engineered using mRNA gene editing to inactivate certain proteins involved in immune recognition to create “stealth” cells with increased persistence for a more durable therapeutic effect.

Multiple Sclerosis (MS)

In patients living with multiple sclerosis (MS), the immune system attacks cells of the central nervous system, resulting in progressive loss of movement control. MS patients often develop problems with sensation and coordination, and can also develop psychiatric symptoms.

NV-003 (NoveCells™ iMSC) is a product candidate under development for the treatment of MS.

NV-003 contains allogeneic cells produced from a single-donor perpetual master cell bank that are designed to home to sites of active disease and regulate the patient’s immune system to inhibit immune-dysregulation-related demyelination.