Six Biotechs to Watch in 2021

2020 was an interesting year for the biotech industry and the BioHealth Capital Region as we adjusted to continue moving forward during the COVID-19 Pandemic. While the biggest stories in terms of dollars were related to the Coronavirus and funding to create a vaccine in record time, that didn’t stop other biotech companies from working hard to develop their research, science, and/or devices. 

As we begin 2021, we ask the same question this time every year:
Who’s the next big success story that could emerge in the new year?

To answer that question, we looked back at our stories from 2020 to review the companies in our ecosystem poised for transformative funding transactions or collaborations in 2021.

Here are the six life science companies to keep an eye on in 2021 and beyond.

Immunomic Therapeutics, Rockville, MD

Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies, and animal health.

By investing over $77M, HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs, ITI is well-positioned to accelerate its immuno-oncology platform, in particular glioblastoma multiforme, and rapidly advance other key candidates in our pipeline, including the most recent initiative into infectious diseases with development of its vaccine candidate for COVID-19. ITI’s UNITE™ platform drives all program areas.

Looking back on their 2020, ITI formed collaborations with EpiVax and PharmaJet to develop a vaccine candidate against COVID-19. They closed over $61M of Financing in May to support their Phase II Clinical Trial for treatment of glioblastoma multiforme (GBM), entered into an agreement with Ichor to Use Electroporation (EP) Delivery Technology in Phase I Study of DNA Vaccine Therapy, and expanded to South Korea.  All signs point to an active year ahead for ITI that many will be watching for.

NexImmune, Gaithersburg, MD

NexImmune was one of our biotechs to watch in 2020, and they return to this list in 2021. They’re 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.

NexImmune added to their leadership throughout the year by adding John Trainer, MBA, as Chief Financial Officer. More recently, they added  Jerome Zeldis as EVP R&D, Jeffrey Weber as Chief Scientific Advisor, and Immunotherapy Veteran Robert Knight, MD, as Chief Medical Officer

Last September, NexImmune completed doing of their first cohort in Phase 1/2 Clinical Trial of NEXI-001 in Relapsed Acute Myelogenous Leukemia (AML) and followed that in October with the first patient dosed in their Phase 1/2 Clinical Trial of NEXI-002 in Multiple Myeloma.

A few months later in December, they present preliminary results from Phase 1/2 Trial of NEXI-001 with data representing safety and tolerability results from the first five patients treated and reflect a median of four months of follow-up infusion doses ranging from 50-200 million total T cells.

NexImmune entered 2021 at full speed with a filing for their initial public offering to raise $86.25M.

NeoImmuneTech, Rockville, MD

NeoImmuneTech, Inc. (NIT) is a biotech company developing T cell-centered novel immunotherapeutics. Founded in 2014 as a spin-off company from Genexine, NIT is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. 

NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at leading companies. NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7. It is being studied in multiple clinical trials in solid tumors and infectious diseases (such as COVID-19), including two-phase 2 programs and four-phase 1/2 programs. Several of these studies are being conducted under clinical collaboration agreements with global industry leaders in immuno-oncology, including Roche, Bristol Myers Squibb, and Merck.

On December 30, 2020, NIT received notice of approval from the Korea Exchange for an Initial Public Offering (IPO) on the KOSDAQ and is planning to complete the IPO process in early 2021. “This IPO opportunity would allow us to further enhance our competitiveness by expanding our already robust clinical program for NT-I7,” said Se Hwan Yang, Ph.D., President, and Chief Executive Officer of NeoImmuneTech. 

Arcellx, Gaithersburg, MD

Making our list for the 2nd year in a row, Arcellx is a clinical-stage biopharmaceutical company developing novel, adaptive, and controllable cell therapies to treat patients with cancer and autoimmune diseases. Arcellx’s vision is to bring ARC-sparX platform cell therapies to millions of patients who can self-administer prescribed sparX proteins under the care of academic and community practices with greater safety and control than currently available therapeutics.

Arcellx began 2020 by announcing the first patient treated with T Cell therapy using their novel binding domain. They followed that up by announcing FDA Orphan Drug Designation for CART-ddBCMA for the treatment of Multiple Myeloma. In August, they announced the award of an EvansMDS Discovery Research Grant to Johns Hopkins University to support the development of an Arcellx ARC-sparX therapy to treat high-risk myelodysplastic syndromes (MDS). They wrapped up 2020 with initial results in a first-in-human trial utilizing a novel synthetic binding domain demonstrating “Deep and Durable Deep and Durable Responses in the Treatment of Relapsed and Refractory Multiple Myeloma.” 

The immuno-oncology segment of the market is among the most active among investors and public markets, with analysts projecting it to reach $135 Billion by 2024. As a platform technology company that addresses several significant challenges that exist with current therapeutics, and the momentum behind their clinical programs, Arcellx is in the right position to have another breakout year.  

American Gene Technologies, Rockville, MD

American Gene Technologies International Inc. (AGT) is a private biotechnology company pursuing cures and treatments for Infectious diseases, cancers, and monogenic disorders. They have developed a rapid drug development platform for cell and gene therapies to pursue clinical “cures” in large and orphan indications and complex diseases. Last August, the FDA Approved American Gene Technologies (AGT) Phase 1 Clinical Trial of their HIV Cure Program, and the company is expected to begin infusing the first patients this Spring.  

The company wrapped up 2020 completing an undisclosed raise, and is starting 2021 off with significant momentum, and was recognized as a Breakthrough Company of the Year.  Aside from the Phase 1 HIV Cure program, their PKU program is entering the IND Enabling phase and has been granted Orphan Drug Designation by the FDA.  They also have a promising immuno-oncology program in preclinical validation.  The success of their phase 1 program this year would open up the doors for a tremendous amount of interest in AGT’s platform technology and may signify several transactions and/or funding events in the company’s future.

Sensei Biotherapeutics, Gaithersburg, MD

Sensei Biotherapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and delivery of next-generation immunotherapies to treat cancer and infectious diseases. The company has developed a proprietary phage-based platform, ImmunoPhage™, that enables the rapid generation of immune-activating agents that fully engage the immune system. Using its proprietary ImmunoPhage™ platform, Sensei is developing a library of ImmunoPhage called Phortress™ targeting multiple tumor-associated antigens to treat patients using a personalized yet off the shelf cocktail approach.

In May of last year, Sensei completed the acquisition of Alvaxa Biosciences, Inc., a camelid antibody therapeutics company with technology licensed from Fred Hutchinson Cancer Research Center. They followed that news in September with early data reporting from their Phase ½ Clinical trial of SNS-301 in Combination with Pembrolizumab in Advanced Head and Neck Cancer Patients. The report stated that SNS-301 demonstrated early signals of anti-tumor activity correlated with immune response and tumor infiltration.

In October, Sensei announced the completion of $28.5M financing co-led by Cambrian Biopharma and H&S Ventures to advance their clinical pipeline and Immunophage™ platform targeting multiple cancers. To kick off 2021, they announced the completion of $30M financing, which was also financed co-led by Cambrian Biopharma and H&S Ventures.

We will continue to track these companies to share their updates throughout 2021.