Five Biotechs to Watch in 2020

2019 was a banner year for the biotech industry which is brimming with innovation and growth, especially within the BioHealth Capital Region (BHCR). From Kite Pharma’s announcement of its new state-of-the-art cell manufacturing facility in Frederick County, Maryland, and the opening of the 32,000 square foot JLABS @ Washington, D.C. to Viela Bio’s $150M IPO and Paragon Bioservices $1.2B acquisition by Catalent, 2019 was an exciting year for so many companies and people in the region.

As the New Year begins, it’s time to turn the spotlight on 2020 and ask: Who will be the next big success story that could emerge in the new year?

To answer that question we dug into our databases, analyzed the news stories of the past year and asked around to get feedback from some of the region’s industry leaders.  There are many companies in this vibrant ecosystem that are advancing their pipelines and building momentum, but a few of them really stood out to be on the cusp of a break-out year. 

Here are the five life science companies to keep an eye on in 2020 and beyond.

American Gene Technologies (AGT), Rockville, Maryland

American Gene Technologies, led by serial entrepreneur Jeff Galvin, is a cell and gene therapy company that utilizes a proprietary viral vector platform to develop potential treatments for liver cancer, Phenylketonuria (PKU), HIV and inherited genetic disorders. AGT’s  — platform has enabled the company to develop, test and bank thousands of viral vectors, which can then be matched to develop treatments for new target diseases.

The company’s lead program is a potential cure for HIVAGT103-T. In October 2019, AGT announced the submission of their Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for AGT103-T, which potentially is a single-dose, lentiviral vector-based gene therapy developed for the purpose of eliminating HIV from people infected with the disease. AGT103-T is moving into the clinic, with recruitment expected to begin at the start of 2020.

AGT has a substantial patent portfolio and two additional lead programs in its pipeline, including Liver Cancer and PKU.  The company has received US FDA Orphan Drug Approval #DRU-2018-6572 for the treatment of PKU using proprietary, lentiviral vector-based technology and is progressing its PKU therapy toward the clinic.

After a year filled with key milestones, AGT is definitely a top biotech to keep an eye on in 2020.

Adaptive Phage Therapeutics, Gaithersburg, Maryland

Adaptive Phage Therapeutics (APT) is a clinical-stage biotechnology company in Gaithersburg founded to provide an effective therapeutic response to the global rise of multidrug-resistant (MDR) pathogenic bacteria. They were recognized on CB Insights 2019 Game-Changing Startups report as one of 36 startups that could change the world.  The company wrapped up 2019 with a $7M Series A funding and is already seeing success under the FDA emergency Investigational New Drug (eIND) allowance, through which PhageBank therapy has been used to treat 20 critically ill patients in which standard-of-care antibiotics have failed.

APT’s core asset is a large and continually expanding phage library (PhageBank®) deployed with a companion diagnostic to achieve rapid response and cost-effective therapy for otherwise recalcitrant bacterial infections. The technology was developed by the biodefense program of U.S. Dept of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under the FDA emergency Investigational New Drug (eIND) allowance, PhageBank therapy has been used to treat approximately 20 critically ill patients in which standard-of-care antibiotics have failed.

Proceeds from its $7M funding round will be deployed to support multi-center phase 2 clinical studies for its PhageBank® therapy for antibiotic-resistant bacterial infections. With seasoned, experienced backing from Alexandria Venture Investments, a large integrated healthcare delivery network currently exploring the option to implement PhageBank™ therapy within its network of more than 17 hospitals and an NYSE-listed specialty life sciences company, APT is poised for an exciting and promising 2020.

NexImmune, Rockville, Maryland

NexImmune is a clinical-stage biotech in Gaithersburg, MD developing novel immune-therapeutics based on the proprietary Artificial Immune Modulation (AIM) nanotechnology platform. The AIM platform enables the ability to expand multi-antigen specific T cells with enhanced anti-tumor properties without the need for genetic manipulation. NexImmune is using the AIM technology platform to develop a pipeline of products to treat cancer and auto-immune diseases. The AIM nanotechnology platform was licensed out of the Johns Hopkins University and was developed by Dr. Mathias Oelke and Dr. Schneck’s laboratory.

In April of this year the Multiple Myeloma Research Foundation (MMRF) Venture Philanthropy Fund Invested in NexImmune. Since then, NexImmune’s first two IND’s have cleared and are they are now preparing to enter their first clinical trials in 2020.  In addition to MMRF, NexImmune has attracted the attention of a highly notable investor group that includes several industry icons, Including Sol Barar, PhD, founder, and former Chairman, President, COO, and CEO of Celgene (NASDAQ: CELG), who was recently appointed as Chairman of the Board of Directors for NexImmune in December.

With two products moving into clinical trials, the continued support of MMRF Venture Philanthropy Fund and a growing, high profile investor base, 2020 will be a pivotal year for Neximmune and proof of concept for their platform of cell therapy. They are BioHealth Capital Region life science to keep a close eye on in 2020.

Arcellx, Gaithersburg, Maryland

A privately-held biopharmaceutical company, Arcellx recently raised $85M in oversubscribed Series B financing from a variety of partners in October 2019. Proceeds will be used to advance the Company’s ARC-T + sparX programs, including clinical development of bivalent BCMA-targeted cell therapy in multiple myeloma, and a CD123-targeted therapy in acute myeloid leukemia. The Series B will also fund earlier stage ARC-T + sparX programs for patients with solid tumors and diseases outside oncology.

Their proprietary Antigen- Receptor Complex T cell (ARC-T) platform technology is initially targeting cancer therapies, but has application across a broad spectrum of human disease.  With a unique platform technology that is designed to enhance the safety and efficacy of conventional CAR-T therapies, Arcellx is well-positioned for collaboration and licensing opportunities that can provide them with substantial funding to help advance their technology and pipeline.

Their vision is to provide cancer patients with adaptive gene cell therapies that are readily silenced, activated, and reprogrammed in order to combat the complexity of human disease. Their technology platform aims to achieve improved efficacy through the reprogramming of the immune system’s tumor-targeting receptors to address both newly diagnosed and relapsed cancers.

Arcellx’s technology will extend to solid tumors as well as autoimmune indications.

Arcellx was recently featured as one of Five Companies That Are Changing the Landscape for Cell and Gene Therapy and is led by founder David Hilbert, Ph.D. and a veteran team of top-caliber scientists and executives. With strong backing from well-established investors, the company is poised for an exciting New Year.

Sirnaomics, Gaithersburg, Maryland

Over the past two years, Sirnaomics has raised approximately $58M in financing and is now valued at approximately $200M. The Gaithersburg biotech company is a clinical-stage organization developing RNA interference (RNAi) technology for the development of therapeutics for human disorders with unmet medical needs.

What makes Sirnaomics approach different is its proprietary Polypeptide Nano-Particle (PNP) technology for small interfering RNA (siRNA) drug delivery, which can access the tumor microenvironment (TME) and various cell types in the liver. The company’s clinical development pipeline is focused on oncology and fibrosis indications. The company’s clinical development pipeline is focused on oncology and fibrosis indications and includes eight potential therapies. Its STP705 therapy for non-melanoma skin cancer is currently in Phase II trials. In addition. two of its potential therapies for liver cancer and liver fibrosis have Orphan Drug Status.

With a deep and variegated pipeline and strong backing from both U.S. and Chinese investors, Sirnaomics is well-positioned for the future.

Which of these companies will ultimately be successful is yet to be seen, but the foundation is laid for each of them to see tremendous progress in 2020.

We will be following these companies, and many others, closely this year so check back in to stay up to date on their progress and the important news that you won’t want to miss in 2020.

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