As the world scrambles to monitor and contain the COVID-19 outbreak,
drug companies are racing to develop or repurpose treatments to combat
the potential pandemic. The death toll continues to climb. The first
U.S. death associated with the SARS-CoV-2 virus was reported in
Washington state February 29. As of March 2, according to the
Center for Systems Science and Engineering (CSSE) at Johns Hopkins University, 3,048 people in 11 countries had died worldwide, nearly all of them (96% or 2,914) in China.
CSSE also reported 89,198 confirmed cases in 67 countries, including
80,026 (90%) in China and 86 in the U.S. Of those confirmed cases, just
over half (45,175) have recovered.
A new survey by Genetic Engineering & Biotechnology News (
GEN)
reveals 35 active drug development programs in North America, Europe,
and China. Those 35 include treatments that have received the greatest
public attention in recent days, being developed by companies that range
from pharma giants like GlaxoSmithKline and Sanofi, to small and large
biotechs such as Moderna and Gilead Sciences. Gilead
has begun clinical trials in China after peer-reviewed journals showed its antiviral candidate, remdesivir, having positive results in
a case involving an American patient and
Chinese in vitro tests.
China’s status as the center of the SARS-CoV-2 outbreak is reinforced by a statistic tucked at the bottom of a
report
published February 28 by the state-run Xinhua news agency: Of 234
clinical trials registered with the Chinese Clinical Trial Registry,
nearly half (105) focus on treatments for COVID-19.
Many of those trials are included in the 60 studies listed in
ClinicalTrials.gov whose descriptions include the term COVID-19, as well
as the seven studies whose descriptions include SARS-CoV-2. The U.S.
website lists 331,715 trials in 209 countries.
In the Xinhua report, Wu Yuanbin, director-general of Science and
Technology for social Development with China’s Ministry of Science and
Technology (MOST), announced the publication of guidelines for clinical
studies of drugs and vaccines intended to combat the deadly viral
outbreak. The guideline gives priority to drugs that are already
marketed, and whose efficacy has been proven in animal and in vitro
studies.
Yet repurposing existing drugs is just one proverbial arrow in the
quiver of drug developers and health agencies worldwide, as seen in
GEN’s
A-List of top 35 treatments under development and/or clinical study for
COVID-19, as disclosed by drug developers and/or authorities in recent
weeks. Because some of the experimental treatments have yet to be named,
or identified, each prospective treatment is listed by its developer,
followed by the treatment name or description, the type of treatment
including its mechanism, and a brief status update summarizing recent
developments.
Where applicable, the status updates include links to recent news reports in
GEN, as well as to clinical trials pages maintained by U.S. authorities via
ClinicalTrials.gov, and by Chinese authorities as the
Chinese Clinical Trial Registry.
In many cases, Chinese authorities, hospitals, and companies are
studying potential treatments outside the auspices of their original
developers. The First Hospital of Changsha and the Second Xiangya
Hospital of Central South University are primary sponsors partnering
with Hu’nan Haiyao hongxingtang Pharmaceutical Co. on a clinical trial
assessing the combination of Beijing Genova Biotech’s Novaferon, a
recombinant interferon alpha (IFN-α) like viral protein
launched in 2018 to treat hepatitis B, and AbbVie’s Kaletra
®
(See above) in eliminating SARS-CoV-2 in patients with COVID-19. The
trial has been prospectively registered with Chinese authorities. (
ChiCTR2000029496).
Another example: Pirfenidone—an idiopathic pulmonary fibrosis drug marketed by Roche and its Genentech subsidiary as Esbriet
®—will
be studied in patients with severe and critical COVID-19, under a
planned randomized, open-label clinical trial that has been
prospectively registered by Tongji Hospital of Tongji Medical College,
part of Huazhong Science and Technology University (
ChiCTR2000030333).
Two other recent coronavirus-related collaborations focus on
potential targets. The Israeli Institute for Biological Research, a
government research institute, said February 25 it will explore the
potential of Dyadic International’s C1 gene expression platform to
express gene sequences and targets developed by the Institute into an
rVaccine candidate and monoclonal antibodies for treating COVID-19. A
day earlier, Cocrystal Pharma agreed to license proprietary
broad-spectrum antiviral compounds for COVID-19 and norovirus from
Kansas State University Research Foundation. Cocrystal’s technology is
designed to generate a 3D structure of inhibitor complexes at
near-atomic resolution, enabling the company to identify novel binding
sites.
And at least one collaboration announced January 28 focuses on a
platform with the promise of future treatments: AbCellera said it and
partners will apply its pandemic response platform to develop
field-ready medical countermeasures within 60 days of isolation of an
unknown viral pathogen. Those partners include researchers at the
Vaccine Research Center at the NIH’s National Institute of Allergy and
Infectious Diseases (NIAID).
This list is certain to multiply in coming weeks as global health
agencies, governments, and drug developers step up efforts against the
SARS-CoV-2 virus.
AbbVie
Treatment: Kaletra
® (also marketed as Aluvia; lopinavir/ritonavir)
Type: HIV-1 protease inhibitor indicated in
combination with other antiretroviral agents for the treatment of HIV-1
infection in adults and children 14 days old and older.
Status: China’s National Health Commission
authorized Kaletra to treat pneumonia caused by SARS-CoV-2, AbbVie
announced on January 27. AbbVie has donated RMB 10 million ($1.4
million) of Kaletra to Chinese authorities “as an experimental option to
support this growing public health crisis.”
The Health Commission of Henan Province announced January 31 that
three confirmed cases of patients diagnosed with new coronavirus
infections recovered after taking Kaletra, a combination of ritonavir
and lopinavir. As of that date, nucleic acid testing of more than 20
confirmed cases of patients infected with new coronavirus, admitted to
hospitals in Zhejiang Province turned negative after taking Kaletra,
according to Ascletis Pharma, which is evaluating a combination therapy
of its own candidates ASC09 and ritonavir (See below).
AIM ImmunoTech
Treatment: Ampligen
® (rintatolimod)
Type: Immune modulator indicated for severe chronic fatigue syndrome
Status: AIM ImmunoTech said February 27 it is
partnering with ChinaGoAbroad, a matchmaking and advisory service for
cross-border deals involving China, to facilitate talks with China’s
government to allow entry of AIM’s drug candidate Ampligen into China
for use as a prophylactic/early-onset therapeutic against COVID-19. The
companies are pursuing approval for trials in China, and FDA
authorization under regulations allowing the export of investigational
drugs for use in a sudden and immediate national emergency. Through
those rules, AIM won FDA authorization to import Ampligen into Argentina
in 2019 as a treatment for severe chronic fatigue syndrome.
Altimmune
Treatment: Single-dose, intranasal vaccine designed to provide systemic immunity
Type: Vaccine based on Altimmune’s proprietary
platform vaccine technology, which the company applied in developing
NasoVAX, the company’s influenza vaccine candidate that showed positive
Phase IIa results.
Status: Altimmune said February 28 that it completed
the design and synthesis of the vaccine, and was advancing it toward
animal testing and manufacturing. Clinical testing of the vaccine could
start as early as August. The company also said it was “actively engaged
in discussions with a number of potential partners.”
APEIRON Biologics
Treatment: APN01
Type: Recombinant human angiotensin-converting
enzyme 2 (rhACE2) developed for the treatment of acute lung injury,
acute respiratory distress syndrome, and pulmonary arterial
hypertension.
Status: Vienna-based APEIRON on February 26 launched
a pilot investigator-initiated clinical trial in China designed to
assess APN01 as a treatment for patients with severe SARS-CoV-2
infection. The randomized, unblinded trial will treat 24 patients for
seven days to obtain preliminary data on the impact of rhACE2 on
biological, physiologic, and clinical outcomes, as well as safety.
Suzhou-based Angalpharma is coordinating the Chinese clinical trial,
with support from dMed Pharmaceutical, a CRO based in Shanghai.
Ascletis Pharma
Treatments: Ganovo
® (danoprevir) plus ritonavir; ASC09 and ritonavir; ASC09 and oseltamivir; ritonavir and oseltamivir;
Types: HIV protease inhibitors
Status: Ascletis stated February 26 that three COVID-19 patients treated with its combination therapy Ganovo
®
(danoprevir) plus ritonavir were discharged from the Ninth Hospital
of Nanchang following treatment. On February 2, Ascletis said it is
actively assisting “relevant medical institutions and medical
researchers” in clinical trials assessing the combination of Ascletis’
ASC09 and ritonavir for COVID-19, following a request they made to the
company. On January 25, Ascletis applied to the National Medical
Products Administration and its Drug Evaluation Center to include
ritonavir and ASC09 fixed-dose combination into the national emergency
channel.
China’s Tongji Hospital is also testing combinations of ASC09 and
Tamiflu (oseltamivir), ritonavir and Tamiflu (oseltamivir), and Tamiflu
alone in one trial listed on ClinicalTrials.gov (
NCT04261270).
Tamiflu is distributed in the U.S. by Genentech, a member of the Roche
Group, under license from Gilead Sciences. Also, a trial prospectively
registered by The First Affiliated Hospital of Zhejiang University
School of Medicine is assessing combinations of ASC09 and ritonavir, and
lopinavir and ritonavir (
ChiCTR2000029603).
Bayer and numerous Chinese manufacturers
Treatment: Chloroquine phosphate (marketed by Bayer as Resochin
®)
Type: Phosphate salt of chloroquine, a quinoline
compound with antimalarial and anti-inflammatory properties. Resochin
was discovered by Bayer and introduced into clinical practice in 1947 to
treat malaria.
Status: Evaluated in clinical trials in over 10
hospitals in Beijing, as well as in south China’s Guangdong Province and
central China’s Hunan Province, where it has “
shown fairly good efficacy”
according to Sun Yanrong, deputy head of the China National Center for
Biotechnology Development under the Ministry of Science and Technology
(MOST), the state-owned Xinhua news agency reported on February 17.
Chloroquine and remdesivir were “
highly effective in the control of 2019-nCoV infection in vitro,” a team of Chinese researchers reported in a study published February 4 in
Cell Research.
After China’s National Health Commission included chloroquine phosphate
in its latest treatment guidelines for COVID-19 pneumonia, eight
Chinese companies sped up manufacturing and supply of the drug, Shanghai
Daily
reported February 20.
Beijing Staidson Biopharma and InflaRx
Treatment: IFX-1
Type: Anti-C5a monoclonal antibody in development for COVID-19 as well as hidradenitis suppurativa
Status: Chinese authorities approved clinical trials of IFX-1 as a COVID-19 treatment in February.
Biocryst
Treatment: Galidesivir (BCX4430)
Type: Nucleoside RNA polymerase inhibitor designed to disrupt the viral replication process
Status: Shown broad-spectrum activity in vitro
against more than 20 RNA viruses in coronaviruses and viral disease
families that include filoviruses, togaviruses, bunyaviruses,
arenaviruses, paramyxoviruses, and flaviviruses.
BioXyTran
Treatment: BXT-25
Type: Anti-necrosis drug whose glyco-polymer
structure consists of hybrid molecules integrating the Hemoglobin
molecule and a proprietary polymer chemical structure. BXT-25 is
company’s lead product candidate, designed to carry oxygen to tissues
when the flow of blood is blocked.
Status: Boston-based Bioxytran said February 5 that
it is exploring partnering with “international drug companies” to
develop BXT-25 as a treatment for Acute Respiratory Distress Syndrome
(ARDS) in end-stage patients with SARS-CoV-2. Since BXT-25 is 5,000
times smaller than red blood cells, the company will use MDX Life
Sciences’ MDX Viewer to assess the safety and efficacy of the drug.
Celularity and Sorrento Therapeutics
Treatment: CYNK-001
Type: Allogeneic, off-the-shelf, placental-derived Natural Killer (NK) cell therapy
Status: The companies on January 30 launched a
clinical and manufacturing collaboration designed to expand the
therapeutic use of Celularity’s CYNK-001 to COVID-19. Sorrento and
Celularity agreed to assess CYNK-001 as a potential novel therapy for
coronaviruses, specifically SARS-CoV-2. Sorrento—which owns 25% of
Celularity—agreed to use current existing capacity in its cGMP cell
therapy manufacturing facilities in San Diego to supplement Celularity’s
new cGMP facility in Florham Park, NJ. Sorrento said it is already in
contact with “leading” scientists and local Chinese experts to discuss
clinical validation and logistics requirements for fast-tracking
CYNK-001 in China.
Chugai Pharmaceutical and Zhejiang Hisun Pharmaceutical
Treatment: Tocilizumab
Type: Humanized mAb targeting interleukin-6
Status: A 94-patient trial assessing Tocilizumab has
been registered with Chinese authorities by The First Affiliated
Hospital of University of science and technology of China (Anhui
Provincial Hospital) (
ChiCTR2000029765).
CSL and The University of Queensland
Treatment: Vaccine
Type: Unspecified vaccine based on subsidiary Seqirus’ proprietary adjuvant technology, MF59
®
Status: On February 12, CSL said it will provide
technical expertise and a donation of MF59 to the University of
Queensland’s preclinical development program. The University will use
the adjuvant to test the viral protein it is developing with its
molecular clamp technology, CSL said. The company also committed a
donation of RMB 1 million ($143,000) to the China Red Cross toward
efforts to combat the epidemic.
CureVac
Treatment: mRNA-based vaccine
Type: Vaccine applying CureVac’s mRNA vaccine development platform
Status: CureVac and the public-private Coalition for
Epidemic Preparedness Innovations (CEPI) are collaborating to develop a
vaccine against SARS-CoV-2, the partners said January 31, extending
their existing partnership to develop a rapid-response vaccine platform.
CEPI has committed up to $8.3 million in additional funding for
accelerated development, manufacturing, and clinical tests. CEPI CEO
Richard Hatchett said the Coalition and CureVac aspire to bring the
pathogen’s gene sequence to a vaccine candidate for clinical testing
“within a few months.”
CytoDyn
Treatment: Leronlimab (PRO 140)
Type: Humanized IgG4 monoclonal antibody. Leronlimab
is CytoDyn’s lead candidate, and is a CCR5 antagonist with potential
for multiple therapeutic indications.
Status: CytoDyn plans to offer an update during a
March 5 conference call with analysts about its planned filing of an IND
and its Phase II clinical trial protocol with the FDA, as the company
seeks to evaluate the leronlimab as a coronavirus treatment. CytoDyn and
Longen China Group said February 12 they will begin exploring
leronlimab as a potential treatment for coronavirus as well as cancer.
Leronlimab has successfully completed nine clinical trials in over
800 people, according to CytoDyn, including meeting its primary
endpoints in a pivotal Phase III trial in combination with standard
antiretroviral therapies in HIV-infected treatment-experienced patients.
CytoDyn has said it plans to file a BLA with the FDA in HIV during Q1
2020. Leronlimab has the FDA’s Fast Track designation as a combination
therapy with highly active antiretroviral therapy (HAART) for
HIV-infected patients, and for metastatic triple-negative breast cancer.
Fujifilm Holdings and Zhejiang Hisun Pharmaceutical
Treatment: Favipiravir (marketed by Fujifilm as Avigan and by Hisun in China as Favilavir)
Type: Broad spectrum anti-viral agent that is
designed to selectively and potently inhibit the RNA-dependent RNA
polymerase (RdRp) of RNA viruses. Japan has approved Avigan for novel or
re-emergent influenza and was previously used to treat Ebola patients
in Guinea.
Status: Japan’s Health Minister Katsunobu Kato said
February 22 that his ministry would recommend Avigan, developed by
Fujifilm-owned Toyama Chemical, for use as a coronavirus treatment after
test dosages appeared effective in mild and asymptomatic cases at least
two medical institutions. In China, the National Health Commission on
February 17 approved Hisun’s version of the drug as an investigational
treatment for SARS-CoV-2 in an upcoming clinical trial being conducted
in Shenzhen.
Generex Biotechnology
Treatment: Ii-Key peptide vaccine
Type: Vaccine based on Generex’s Ii-Key immune system activation technology platform
Status: Generex said February 27 it has received a
contract from the China Technology Exchange, Beijing Zhonghua Investment
Fund Management Co. Ltd., Biology Institute of Shandong Academy of
Sciences, and Sinotek-Advocates International Industry Development
(Shenzhen) Co. Ltd. to develop a Ii-key vaccine. Generex said it would
receive $1 million upfront to initiate project work in the U.S., a $5
million licensing fee for the Ii-Key technology, payment by the Chinese
consortium for all costs and expenses related to the development of a
COVID-19 vaccine, and a 20% royalty on each dose of vaccine produced.
Gilead Sciences
Treatment: Remdesivir (GS-5734)
Type: Nucleotide prodrug
Status: The NIH
announced
February 25 it will run the first U.S. clinical trial evaluating an
experimental treatment for COVID-19, by assessing remdesivir in patients
at the University of Nebraska Medical Center in Omaha, where some
Americans with the disease are being cared for or are under quarantine.
Remdesivir showed “no adverse events” when administered to the first
American confirmed to be infected with SARS-CoV-2, members of the
Washington State 2019-nCoV Case Investigation Team reported in a
case study published January 31 in
The New England Journal of Medicine.
In China,
clinical trials of Gilead Sciences’ remdesivir have begun
after China’s National Medical Products Administration approved
applications by the China-Japan Friendship Hospital and the Chinese
Academy of Medical Sciences to conduct the studies. Remdesivir and
chloroquine phosphate were “
highly effective in the control of 2019-nCoV infection in vitro,” a team of Chinese researchers reported in a study published February 4 in
Cell Research.
GlaxoSmithKline and Clover Biopharmaceuticals
Treatment: COVID-19 S-Trimer
Type: Protein-based coronavirus vaccine
Status: GSK agreed to provide Clover with its
pandemic adjuvant system for further evaluation of S-Trimer in
preclinical studies, the companies said February 24, under a research
collaboration whose value was not disclosed. GSK reasons that Clover
could rapidly scale-up and produce large-quantities of a new coronavirus
vaccine since it has one of the largest in-house, commercial-scale cGMP
biomanufacturing capabilities in China.
“GSK is the world leader in vaccines, and partnering with them
significantly boosts our hopes of both the timely development of a
vaccine, and the capability to produce it in large enough quantities
necessary to curb the coronavirus outbreak,” said Michael Breen,
director, Infectious Diseases, Pharma at GlobalData.
iBio and Beijing CC-Pharming
Treatment: Vaccine
Type: Plant-derived vaccine to be manufactured using iBio’s FastPharming
System™
Status: The companies on February 3 disclosed plans
to develop and test a COVID-19 vaccine, combining the vaccine R&D
experience—including work on the MERS-coronavirus—by CC-Pharming
Chairman and chief scientific officer Kevin Wang, PhD, and iBio VP
Upstream Bioprocessing Sylvain Marcel, PhD, in rapid design of
manufacturing processes for biopharmaceutical production in plant-based
expression systems. If successful, the research will deliver product
candidates for production at iBio’s
FastPharming Manufacturing
Facility, built in 2010 with funding from the Defense Advanced Research
Projects Agency (DARPA), to establish facilities capable of rapid
delivery of medical countermeasures in response to a disease pandemic.
ImmunoPrecise Antibodies
Treatments: Vaccines and coronavirus-neutralizing antibodies
Types: Prophylactic and therapeutic compounds using
ImmunoPrecise’s proprietary discovery platforms (including B Cell
Select™ and DeepDisplay™) and ImmunoPrecise subsidiary Talem
Therapeutics’ access to the transgenic animal platform OmniAb
® for direct generation of human antibodies.
Status: ImmunoPrecise announced its commitment to
finding COVID-19 treatments on February 20, saying it had designated
Ilse Roodink, PhD, chairwoman of Talem’s scientific committee, as its
Coronavirus Global Project Leader.
Incyte, Shanghai Hengrui Pharmaceutical
Treatment: Camrelizumab and thymosin
Types: Humanized monoclonal antibody targeting PD-1 (Camrelizumab); 5-Da polypeptide hormone secreted by the thymus gland (thymosin)
Status: Chinese clinical trials assessing the
combination treatment have been registered by Wuhan Jinyintan Hospital
(Wuhan Infectious Diseases Hospital) (
ChiCTR2000029806) and Southeast University (
NCT04268537).
Innovation Pharmaceuticals
Treatment: Brilacidin
Type: Defensin mimetic in Phase II development in oral muscositis in Head and Neck Cancer patients
Status: Innovation said February 24 that it
submitted a Material Transfer Agreement with an unidentified “leading
U.S.-based virology laboratory” to study Brilacidin as a potential novel
treatment for SARS-CoV-2. If lab tests prove successful, Innovation
said, it will expedite research and clinical development of Brilacidin
“via pharmaceutical partnerships, academic collaborations and government
grants.” Innovation has also submitted a preliminary summary of
Brilacidin’s potential for treating coronavirus to the Biomedical
Advanced Research and Development Authority (BARDA).
Inovio Pharmaceuticals and Beijing Advaccine Biotechnology
Treatment: INO-4800
Type: Vaccine
Status: Inovio said January 30 it will leverage
Beijing Advaccine Biotechnology’s expertise to run a Phase I trial in
China in parallel with the company’s clinical development efforts in the
U.S. to develop INO-4800 as a coronavirus treatment. The company has
said it will develop INO-4800 through Phase I testing in the U.S., and
has launched preclinical testing for clinical product manufacturing.
Development of INO-4800 is supported by $9 million grant from the
Coalition for Epidemic Preparedness Innovations (CEPI).
Janssen Pharmaceutical Cos. (Johnson & Johnson)
Treatments: Prezcobix™ (darunavir and cobicistat); Vaccine to be developed with BARDA
Types: HIV protease inhibitors (Prezcobix); vaccine type to be developed
Status: Janssen said January 29 it has donated 300
boxes of Prezcobix to the Shanghai Public Health Clinical Center and
Zhongnan Hospital of Wuhan University for use in research to support
efforts in finding a solution against SARS-CoV-2. Another 50 boxes have
been provided to the Chinese Center for Disease Control and Prevention
for laboratory-based investigations. Prezcobix is under study in a trial
sponsored by Shanghai Public Health Clinical Center (
NCT04252274), while a Chinese trial is assessing Precobix or the lopinavir-ritonavir combination combined with thymosin a1 (
ChiCTR2000029541).
Separately, Janssen said February 11 it has expanded an existing
collaboration with the Biomedical Advanced Research and Development
Authority (BARDA) to develop a vaccine candidate for SARS-CoV-2. The
partners agreed to share R&D costs and expertise to help accelerate
Janssen’s investigational COVID-19 vaccine into clinical trials. Janssen
said it is also working closely with global partners to screen its
library of antiviral molecules to accelerate discovery of potential
COVID-19 treatments.
LineaRx (Applied DNA Sciences) and Takis Biotech
Treatment: Linear DNA vaccine
Type: To be based on PCR-produced linear DNA designed to induce antibodies that can neutralize SARS-CoV-2
Status: LineaRx, a majority-owned subsidiary of
Applied DNA Sciences of Stony Brook, NY, and Rome-based Takis Biotech
said February 7 they have formed a joint venture to develop the
preclinical vaccine using PCR-based DNA manufacturing technology. No
commercial partner to take the coronavirus vaccine to market has been
identified, the companies said.
The companies said advantages of their technology include the speed
of production, the absence of antibiotics and their resistance genes,
the purity of the DNA, the simplicity of design, the powerful
immunogenicity proved in a prior linear DNA vaccine, the absence of any
bacterial contaminants and the effectiveness of the vaccine gene without
insertion into the patient’s genome.
Moderna
Treatment: mRNA-1273
Type: Novel lipid nanoparticle (LNP)-encapsulated
mRNA vaccine against the COVID-19 encoding for a prefusion stabilized
form of the Spike (S) protein.
Status: Moderna said February 24 that it
shipped the first batch of mRNA-1273
to the NIH’s National Institute of Allergy and Infectious Diseases
(NIAID) for use in a planned Phase I study in the U.S. The primary aim
of the Phase I open-label, dose-ranging trial study (
NCT04283461),
which had yet to recruit patients at deadline, is to evaluate the
safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273,
given 28 days apart, across 3 dosages in healthy adults. Moderna
designed the vaccine in collaboration with investigators at the NIAID
Vaccine Research Center (VRC).
NanoViricides
Treatment: Antiviral therapy based on company’s novel nanomedicines platform.
Type: Broad-spectrum virus-binding ligand: “It is
like a ‘Venus-Fly-Trap’ for the virus,” says Anil R. Diwan, PhD,
President and Executive Chairman.
Status: NanoViricides confirmed January 30 that it
was developing a COVID-19 treatment, stating that it “already found some
lead candidate ligands in its chemical library” that can bind to the
SARS-CoV spike protein just as it binds to cognate receptor ACE2.
NanoViricides’ technology relies on copying the human cell-surface
receptor to which the virus binds, and making ligands that chemically
attach to a nanomicelle, to create a nanoviricide
®.
When a virus comes in contact with the nanoviricide, the nanomicelle
polymer is designed to fuse with the virus lipid envelope.
The company said it has started preparing for testing of potential
candidates in cell cultures against “low-threat” coronaviruses,
including ones that use the ACE2 receptor, in its own BSL-2 virology
laboratory at its Shelton, CT, campus. NanoViricides added that it is
working on developing collaborations to advance its COVID-19 program
should an effective drug candidate be identified.
Novavax
Treatment: Vaccine candidate to be selected
Types: Vaccines designed to apply company’s
proprietary recombinant protein nanoparticle technology platform to
generate antigens derived from the coronavirus spike (S) protein.
Novavax said it expects to utilize its proprietary saponin-based
Matrix-M™ adjuvant with COVID-19 vaccine candidates to enhance immune
responses.
Status: “We are now well-positioned to advance the
COVID-19 vaccine candidate to Phase I clinical testing in May or June,”
President and CEO Stanley C. Erck said February 26 in a statement.
Novavax cited progress in its development saying it has produced and is
currently assessing multiple nanoparticle vaccine candidates in animal
models prior to identifying an optimal candidate for human testing.
Pharmstandard
Treatment: Arbidol (umifenovir)
Type: Membrane fusion inhibitor developed as a treatment for influenza
Status: Pharmstandard is assessing Arbidol in
clinical trials as monotherapy and in combinations that include AbbVie’s
Kaletra (See above), Ascletis Pharma’s ASC09 (See above), lopinavir,
ritonavir, carrimycin, and Bromhexine Hydrochloride (enrolling by
invitation). Five trials including Arbidol were listed on
ClinicalTrials.gov. China’s Ruijin Hospital is conducting the
monotherapy trial (
NCT04260594), while various Chinese hospitals are investigating the combination therapies (
NCT04252885,
NCT04273763,
NCT04261907,
NCT04286503).
Q Biomed and Mannin Research
Treatment: Drug to treat vascular diseases in people with COVID-19
Type: Adjunct treatment for vascular leakage and
endothelial dysfunction seen in COVID-19 and other infectious diseases,
to be developed based on the lead platform of research partner Mannin
Research, which is designed to target the activation of the
Angiopoietin-Tie2 signaling pathway.
Status: Q Biomed and Mannin Research announced their
collaboration on February 4. In September 2019, the German state of
Saxony awarded Mannin approximately a US $7.7 million grant to advance
its novel therapeutics, including drugs and biologics that reduce
endothelial dysfunction and loss of endothelial barrier integrity.
Mannin recently submitted a funding application to the NIH’s Small
Business Technology Transfer Grant to investigate specific applications
of Mannin’s therapeutic platform.
Regeneron Pharmaceuticals
Treatments: REGN3048 and REGN 3051
Types: Combination of neutralizing monoclonal
antibodies leveraging Regeneron’s monoclonal antibody discovery platform
called VelocImmune
®, part of the company’s VelociSuite™ technologies.
Status: On February 4, The Biomedical Advanced
Research and Development Authority (BARDA) said it was expanding upon an
earlier partnership agreement with Regeneron to develop “multiple
monoclonal antibodies that, individually or in combination, could be
used to treat new treatments.” The combination completed a Phase I trial
in MERS-CoV last year (
NCT03301090).
Sanofi
Treatment: Unnamed vaccine
Type: Vaccine based on Sanofi’s recombinant DNA
platform, designed to produce an exact genetic match to proteins found
on the surface of the virus. Sanofi said the DNA sequence encoding the
antigen will be combined into the DNA of the baculovirus expression
platform and used for rapidly producing large quantities of the
coronavirus antigen, which will be formulated to stimulate the immune
system to protect against the virus.
Status: Sanofi said February 18 that its Sanofi
Pasteur vaccines global business unit will apply previous development
work for a SARS vaccine with the aim of accelerating development of a
COVID-19 vaccine through a collaboration with the Biomedical Advanced
Research and Development Authority (BARDA). In non-clinical studies, the
SARS vaccine candidate was immunogenic and afforded partial protection
as assessed in animal challenge models, Sanofi said. That earlier work
by Protein Sciences, acquired by Sanofi in 2017, “provides a head start
in expediting a COVID-19 vaccine,” Sanofi stated.
Tonix Pharmaceuticals Holding
Treatment: TNX-1800
Type: Live modified horsepox virus vaccine for percutaneous administration
Status: Tonix said February 26 it has partnered with
Southern Research to develop TNX-1800 as a vaccine treatment for
COVID-19. TNX-1800 is under development as a potential smallpox
preventing vaccine for the U.S. strategic national stockpile and as a
monkeypox preventing vaccine.
Vaxart
Treatment: Vaccine based on proprietary VAAST™ Platform
Type: Oral recombinant vaccine administered by tablet
Status: Vaxart said January 31 that it plans to
generate vaccine candidates based on the published genome of the 2019
COVID-19 (SARS-nCoV-2) and evaluate them in preclinical models based on
their ability to generate both mucosal and systemic immune responses.
Vir Biotechnology and WuXi Biologics
Treatment: As-yet undisclosed human monoclonal antibodies
Type: Human monoclonal antibodies shown to bind to
SARS-CoV-2, isolated from individuals who had survived a Severe Acute
Respiratory Syndrome (SARS) infection.
Status: Vir Biotechnology on February 25 announced a
development and manufacturing collaboration With WuXi Biologics to
advance and produce human monoclonal antibodies as potential treatments
for COVID-19. The antibodies were discovered through the company’s
antibody platform, which has been used to identify and develop
antibodies for pathogens that include Ebola (mAb114, currently in use in
the Democratic Republic of Congo), hepatitis B virus, influenza A,
malaria, and others. Should the antibodies receive regulatory approvals,
WuXi Biologics has rights to commercialize therapies in Greater China
and Vir, in all other markets worldwide.
How to Conquer Coronavirus: Top 35 Treatments in Development
