COVID-19 Vaccine Progress from 14 BioHealth Capital Region Organizations

Editor’s Note: This post was originally published on April 7, 2020. As updates are discovered and advancements are announced regarding the work below, details will be published for accuracy.

As the U.S. continues to find its way through a tough fight against this global pandemic, a number of BioHealth Capital Region (BHCR) biotech companies are making significant contributions to stem the COVID-19 pandemic. With people across the U.S. and the world making sacrifices to flatten the curve — along with nurses, doctors and first responders who stand heroically at the front lines — life science companies in our region are doing everything in their power to make COVID-19 vaccine progress with celerity, safety and efficacy top-of-mind.

In addition to the region’s medical diagnostics companies working to bolster testing capabilities, BHCR companies like Altimmune, Novavax, Emergent BioSolutions, Sanaria, GlaxoSmithKline, Cel-Sci and Integrated Biotherapeutics are racing to develop a COVID-19 vaccine. Here’s a roundup of 14 BHCR organizations striving to develop or assist in the development of COVID-19 vaccines.

Altimmune

Altimmune, based in Gaithersburg, Maryland is actively developing a new COVID-19 vaccine using the same technology that was deployed to create NasoVAX™, Altimmune’s recombinant intranasal vaccine for influenza.

NasoVAX, according to Altimmune’s recent press release, has shown “…the ability of intranasal vaccine delivery to stimulate a durable and broad immune response against the influenza virus.” The company believes that a COVID-19 vaccine delivered intranasally provides a more direct immune response to the likely point of the initial viral attack. COVID-19 and influenza share some similar traits that make Altimmune’s intranasal approach a strong match to potentially treat the novel coronavirus.

In a recent BioBuzz featured story, Altimmune’s Chief Science Officer Dr. Scot Roberts stated, ““This trial showed that NasoVAX was very well-tolerated and activated a broad immune response, including antibody, cellular immunity and mucosal immunity. We believe that mucosal immunity may be particularly important against respiratory viruses as it is a first line of defense with the potential to neutralize the virus at the point of entry. Mucosal immunity in the nasal cavity is strongly stimulated by our intranasal vaccine.”

What makes Altimmune’s novel coronavirus vaccine unique among other COVID-19 vaccine candidates is that it is designed to stimulate immunity after a single dose. The Altimmune team expect to have the necessary material to start animal testing of their potential COVID-19 vaccine by the end of March with the target of executing a Phase I study in August.

You can read a more in-depth story about Altimmune’s vaccine here.

*July 13 – Altimmune making headway with Covid-19 programs
*July 22 – Altimmune Announces Manufacturing Agreement with Vigene Biosciences for AdCOVID™, its Single Dose Intranasal Vaccine Candidate for COVID-19

Novavax & Emergent BioSolutions

Novavax is a late-stage biotech company located in Gaithersburg, Maryland. In late February 2020, the company announcedthat its vaccine candidate, which was created  “…using its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the Coronavirus spike (S) protein” had made progress. The company expects to use “…its proprietary Matrix-M™ adjuvant with its COVID-19 vaccine candidate to enhance immune responses.”

The COVID-19 development program is being led by Nina Patel, Director of Vaccine Development and Antibody Discovery. Her all-female team that is working to develop a viable vaccine for COVID-19 has been hard at work, almost non-stop since January 10th.

Novavax is currently testing the vaccine in animal models and expects to move into human trials in the Spring of this year.  According to Gregory Glenn, M.D., Novavax’s President of Research and Development, they hope to have a deployable vaccine in 18 months.

Novavax has also partnered with Emergent BioSolutions to help bring its vaccine candidate to the clinic. The companies have structured their collaboration anticipating the start of Phase I clinical vaccine trials to start in the late spring of 2020. Under the terms of the partnership, Emergent will produce the experimental COVID-19 vaccine candidate for Novavax with funding support via the Coalition for Epidemic Preparedness Innovations (CEPI). This funding brings CEPI’s total investment to $23.7M for Coronavirus/COVID-19 research for a vaccine.

Emergent BioSolutions and Novavax will combine forces, utilizing Emergent’s molecule-to-market contract development and manufacturing (CDMO) services to advance Novavax’s vaccine candidate. To advance the potential coronavirus vaccine into the clinic, Emergent is rapidly deploying its robust and integrated clinical, commercial and manufacturing network, which includes the company’s Gaithersburg location as well as two facilities located in Baltimore, Maryland.

Emergent BioSolutions is also providing services to Vaxart, a San Francisco-based late-stage biotechnology company developing an orally administered, recombinant COVID-19 vaccine. Emergent announced on April 2, 2020 their partnership with the U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19.

*April 8 – Vaccine Candidate Identified
*April 16 – Trial to start in Australia
*April 23 – Emergent BioSolutions Signs Agreement to be U.S. Manufacturing Partner for Johnson & Johnson’s Lead Vaccine Candidate for COVID-19
*May 13 – Gaithersburg’s Novavax Confident It Has Optimal Vaccine Candidate for Coronavirus
*May 14 – Novavax scores $384M deal, CEPI’s largest ever, to fund coronavirus vaccine work
*May 25 – Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine
*June 1 – Emergent BioSolutions, BARDA reach $628M deal to manufacture COVID-19 vaccine hopefuls
*June 11 – Emergent lands another partner for Covid-19 vaccine work

Cel-Sci

Cel-Sci Corporation, which has its headquarters in Vienna, Virginia recently announced a new research partnership with the University of Georgia’s Center for Vaccines and Immunology to develop a potential treatment for patients at high risk of death from COVID-19.

Cel-Sci’s immunotherapy technology called LEAPS (Ligand Epitope Antigen Presentation System) has shown effectiveness using peptides to prevent the Herpes simplex virus and has produced some promising preclinical data when used against H1N1. Cel-Sci and the Center of Vaccines and Immunology hope to build on this LEAPS’s data to create an immunotherapy against COVID-19.

According to late March Cel-Sci press release, “It is suggested, based on studies with H1N1, that a LEAPS coronavirus – SARS-CoV-2 immunotherapy may reduce or arrest the progression of the SARS-CoV-2 virus infection and prevent tissue damage from inflammation resulting from lung infection by the virus. By stimulating the correct immune responses to the COVID-19-causing virus without producing unwanted inflammatory responses associated with lung tissue damage, LEAPS immunotherapy may be particularly beneficial in those patients who are at highest risk of dying from COVID-19.”

The next step for Cel-Sci and the Center for Vaccines and Immunology is to commence pre-clinical studies with the ultimate goal of starting human trials as soon as the data and FDA allow.

GlaxoSmithKline

GlaxoSmithKline (GSK), which has an R&D center for vaccines in Rockville, Maryland has been providing its vaccine adjuvant with other life science organizations and research scientists developing COVID-19 vaccines.

By making their adjuvant available to fight the coronavirus pandemic, GSK is hoping to increase the amount of doses that will be available to patients in need. By making adjuvant available, GSK can contribute to reducing the amount of protein required per dose, thereby allowing more vaccines to be produced to cover more people. Adjuvants are added to some vaccines to boost immune responses, creating a longer, potentially more effective immunity.

GSK has current adjuvant partnerships with The University of Queensland, Clover Biopharmaceuticals and five other partners and research groups in the U.S. and China.

GSK’s adjuvant partnership with China’s Clover Biopharmaceuticals, which is developing its COVID-19 S-Trimer vaccine, could prove highly important. Clover Biopharmaceuticals has one of the largest, commercial-scale cGMP biomanufacturing capabilities in China and, if a vaccine gets approved, the company could scale up quickly and produce large amounts of the vaccine for distribution.

Initial feedback on GSK’s adjuvant clinical performance has been strong and the company expects more data to be produced and analyzed over the next few months, which will inform the next clinical steps for COVID-19 vaccine candidate development.

Additionally, GSK and AstraZeneca have forged a unique partnership with the University of Cambridge to combat shortages of Covid-19 tests.  Under this collaboration, the companies are setting up a laboratory at the university to develop “alternative chemical reagents for test kits in order to help overcome current supply shortages.”  Though neither company provides diagnostic testing as part of their core business, they are committed to contributing their resources where they are able to in order to make a difference.

*April 6 – GSK and Vir Biotech collaborate on research on COVID-19
*April 14 – GSK and Sanofi collaborate to find a Vaccine in Europe

Sanaria and Protein Potential

Sanaria and Protein Potential, which are co-located in Rockville, Maryland, are working on a number of initiatives to combat COVID-19. Dr. Stephen L. Hoffman is the CEO and Chief Scientific Officer at Sanaria, which is a leading global malaria vaccine biotechnology company. Dr. Kim Lee Sim is the President and Chief Scientific Officer at Protein Potential, an R&D group focused on vaccine development and innovative DNA and protein products. She is also the Executive Vice President of Process Development and Manufacturing at Sanaria.

Sanaria is a global organization with full R&D and robust translational science capabilities from early research through getting a product to cGMP manufacturing. Based on its innovative PfSPZ platform technology, the company has several malaria vaccine candidates in various stages of development and clinical evaluation. Sanaria’s lead malaria vaccine candidate is nearing Phase III trials.

Protein Potential produces intellectual property and recombinant bacteria, recombinant protein, and DNA products with a primary focus on the development of vaccines to protect against enteric diseases including shigellosis, diarrhea caused by ETEC, and typhoid fever and bioterrorism agents using its platform technology of recombinant, acid-stabilized Ty21a.

Dr. Hoffman and Dr. Sim are a dynamic husband and wife duo leading their respective teams as they pursue a range of COVID-19 initiatives in addition to advancing robust pipelines.

“We feel it’s our responsibility to do our part to fight COVID-19. We believe our experience working on SARS, malaria and other vaccines will be very helpful on multiple COVID-19 fronts,” stated Dr. Hoffman. “We have a unique perspective and approach — no one approach will be able to tackle the huge vaccination effort that’s coming. It will take contributions from many groups.”

Sanaria’s COVID-19 efforts began in earnest while working with its partners to establish the infrastructure needed to run its Phase I-III malaria vaccine trials in Equatorial Guinea. The consortium established for testing SanariaⓇ malaria vaccines found itself suddenly on the front lines of the country’s COVID-19 fight. After the COVID-19 sequence was released, the consortium developed the first PCR (Polymerase Chain Reaction) diagnostic test in Equatorial Guinea and Africa, ultimately leading to the first in-country diagnosis.

Sanaria and Protein Potential are planning the development and characterization of a COVID-19 antibody test in collaboration with the University of Maryland, Baltimore and the University of Tübingen in Germany to identify individuals who have built up protective immunity to the novel coronavirus. The antibody test could potentially roll out in the next few months.

In addition, Sanaria and Protein Potential are in the early stages of developing their own COVID-19 vaccine and have been working with SAb Biotherapeutics, Inc. to develop strategies for testing the efficacy against COVID-19 of SAbⓇ human antibodies against SARS-Cov-2. The potential COVID-19 therapeutic is called SAb-185. Sab-185 uses genetically modified cattle with human DNA — called transgenic animals —  to produce human antibodies in large quantities that are then purified for use as a therapy for COVID-19 patients.     

PepVax, Inc.

PepVax, Inc. and early stage biotech out of Bethesda, MD announced that it is temporarily pivoting from their breast cancer program to devote resources into applying their SMARTmid™ platform to address COVID-19. Their pre-clinical candidate, PVX-010, would be a first-in-class DNA immunotherapy to fight COVID-19. 

PepVax stands out among others with their novel cell therapy that would not only be a preventative vaccine but also a treatment for those already affected by the disease.  The company expects to have preclinical results this summer and is currently seeking funding to move the program forward.

Adaptive Phage Therapeutics

Adaptive Phage Therapeutics (APT) in Gaithersburg, MD is just recently got FDA approval on their IND for a clinical study for their PhageBank platform that should begin in Q2 this year.  PhageBank is essentially a database of hundreds of phages that target six of the highest priority multi-drug resistant (antibiotic-resistant) bacterial pathogens.

According to a recent WBJ article, “the company is in talks with a partner to help with rapid production of a COVID-19 vaccine candidate for a planned clinical study.”  APT co-founder and CEO Greg Merril expects that secondary infections will weigh into patient outcomes, which is something that APT’s technology is well-positioned to address.

Immunomic Therapeutics, Inc. (ITI)

Immunomic Therapeutics in Rockville, MD has also put its hat in the ring in the race for a COVID-19 Vaccine.  According to a WBJ article, ITI is “working to build a COVID-19 vaccine, evaluate it and seek grant funding to pay for the clinical study.”

*April 9 – ITI Forms Collaboration with EpiVax & PharmaJet to Develop Novel Vaccine Candidate Against COVID-19 Using Its Investigational UNITE Platform

University of Maryland, Baltimore

*April 21 – AIkido Pharma Executes Licensing Agreement with University of Maryland for Antiviral Compounds, Including COVID-19
*May 5 – University of Maryland begins testing COVID-19 vaccine on volunteers ages 18-85
*May 14 – University of Maryland, Baltimore’s (UMB) Center for Vaccine Development and Global Health (CVD), is at the center of the global effort to find a vaccine to prevent COVID-19
*July 15 – University Of Maryland School Of Medicine COVID-19 Vaccine Trials Will Advance To Phase 3

National Institutes of Health

*April 12 – Working on coronavirus vaccine trials, Kizzmekia Corbett is ‘not your average’ scientist

George Mason University

Dr Aarthi Narayanan, Associate Professor of Systems Biology in George Mason University’s College of Science, added, “My colleagues and I are looking forward to partnering with Emergex and we are especially pleased to be lending our expertise to efforts to create a vaccine during these challenging times. As members of the faculty of a premier research university, we work with other thought leaders to address global threats. This is how we make progress, and collaboration is the top priority for the College of Science, the Institute for Biohealth Innovation, and the University as a whole.“

*April 22 – Emergex Signs Agreement with George Mason University for Highly Pathogenic RNA Virus Studies

**May 4 – Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine

Stay tuned as BioBuzz continues to bring you coverage of the COVID-19 Vaccine progress from the BioHealth Capital Region.

And if you’re looking outside of the BHCR, here’s Every Vaccine and Treatment in Development for COVID-19, So Far.