Companies continue to report promising data for vaccines and therapies against COVID-19. Here’s a look.
Companies continue to report promising data for vaccines and therapies against COVID-19. Here’s a look.
CureVac Expecting COVID-19 Vaccine Approval in Europe by June
Germany-based CureVac expecting its mRNA COVID-19 vaccine to be authorized in Europe in June at the latest. Meanwhile, it is expanding its production capacity.
The company’s first-quarter financial report noted it is working with its partner Bayer and expects a data readout from the pivotal Phase IIb/III trial in the second quarter, which will allow it to finalize its rolling submission with the European Medicines Agency (EMA). Its second-generation vaccine candidate, CV2CoV, which is developing with GlaxoSmithKline, is expected to begin clinical trials in the third quarter.
“The COVID-19 reality has changed dramatically since the beginning of this year and is today characterized by the rapid spread of Variants of Concern as well as the emergence of new strains, which together have now all but supplanted the original virus strain that we fought throughout 2020,” said Franz-Werner Haas, chief executive officer of CureVac.
“In this variant rich environment, we are convinced that our first-generation COVID-19 vaccine candidate, CVnCoV, will make an important contribution to the pandemic vaccination programs, for which availability of potent vaccines is now more important than ever to stop the virus from evolving further. CVnCoV is in the final stage of clinical development in what we believe is one of the most diverse efficacy trials in terms of the range of virus variants.”
Altimmune’s Intranasal AdCOVID Effective Against South African Variant
Altimmune reported data from a preclinical study of its AdCOVID vaccine candidate against the South African COVID-19 variant, B.1.351. In collaboration with Saint Louis University School, the study demonstrated a neutralizing titer against the original or wildtype Wuhan isolate, but against B.1.351 was only 4.4-fold lower. In mice that received a booster of AdCOVID, the decreased titer against B.1.351 was only 1.8-fold lower at seven weeks after vaccination.
“These data are impressive considering the B.1.351 variant has been consistently difficult to neutralize following vaccination with the original prototype vaccines,” said James Brien, assistant professor, Molecular Microbiology and Immunology at Saint Louis University.
“If the simple addition of an AdCOVID booster dose is able to provide effective coverage against variants of concern it would greatly simplify our response to the challenge presented by this virus by eliminating the need to develop new variant adapted vaccines.”
RedHill Biopharma Receives 2 Patents for COVID-19 Treatments
RedHill Biopharma, based in Tel Aviv, Israel and Raleigh, NC, announced receiving two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) for opaganib and RHB-107 (upamostat) for the treatment of COVID-19. Both are novel COVID-19 drug candidates, both pills are taken orally, with a dual mechanism of action. They are also expected to be effective against emerging variants.
Opaganib is currently in a Phase II/III trial in hospitalized patients with severe COVID-19. Upamostat is in a Phase II/III trial in non-hospitalized patients with symptomatic COVID-19 who do not require supplemental oxygen.
Danielle T. Abramson, vice president of Intellectual Property & Research at RedHill, said, “We are very pleased with the new intellectual property protection which extends until at least 2041. The Company has also filed for protection under the Patent Cooperation Treaty (PCT) and has the option of applying in the member countries thereof.”
Inhalon Wins $7 Million Contract from US Army for Inhaled Antibody Treatment
Durham, NC-based Inhalon Biopharma won a $7 million contract from the U.S. Army Medical Research & Development Command (USAMRDC) to run a Phase I/IIa trial of IN-006 in COVID-19 outpatients. IN-006 is a potent, neutralizing monoclonal antibody being developed for treatment of COVID-19.
The product uses the company’s muco-trapping antibody platform that “directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminating the virus from the lungs through the body’s natural ability to clear mucus.”
“The USAMRDC assessed the merits of Inhalon’s novel technology and planned study as outstanding,” said William Howell, president, Medical Technology Enterprise Consortium. “We believe that Inhalon’s inhaled therapy offers many attractive benefits for patients and the healthcare system that are not available with intravenous or other systemically-dosed treatments.”
PharmaMar’s Aplidin Shows Promising Results for Hospitalized COVID-19 Patients
Spain’s PharmaMar reported that the first clinical trials of its Aplidin demonstrated clinical effects and a good safety profile in hospitalized patients with moderate COVID-19. The data allowed the company to gain Spanish regulatory approval for a Phase III study last month.
In a statement, the company said, “The company has decided to share this data, which demonstrates the therapeutic potential of this drug, with the entire scientific and medical communities, along with patients.” The trials have already been authorized in the UK. The drug was originally developed for cancer but has an antiviral effect.
