2020 11 11 Rastreador de Tratamientos y Vacunas contra el SARS-CoV-2 (COVID-19)

1. SARS-CoV-2 (COVID-19)
Treatments and Vaccines Tracker
Last update 07 November 2020
Fuente: https://Statnews.com

2. SARS-CoV-2 (COVID-19)
Treatments
Last update 07 November 2020

3. Gilead Sciences
Phase 3 (authorized foremergency usein the U.S.)
Gilead’s drug, remdesivir, is an intravenous treatment meant to block viruses from replica-
ting. Gilead developed it as an all-purpose antiviral, conducting preclinical tests in SARS,
MERS, and other infectious diseases. In 2015, as Ebola spread through West Africa, Gilead’s
treatment was part of a multi-drug clinical trial. In the final data, remdesivir was significantly
less effective than the other tested medicines. In 2020, as the novel coronavirus spread
across the world, Gilead began studying remdesivir again.
Feb. 6: Researchers begin two Phase 3 studies in China
Feb. 26: Gilead launches to Phase 3 studies of its own, planning to enroll about 4,000 pa-
tients
April 10: Gilead publishes data on 53 patients who received remdesivir under compassionate
use
April 15: Researchers suspend the two China studies over lack of eligible patients
April 29: Remdesivir leads to a 31% improvement in recovery time compared to placebo in an
800-patient trial
May 1: The FDA issues an emergency use authorization for remdesivir, allowing the drug to
be used in limited cases
May 7: Japan's health ministry approves remdesivir to treat Covid-19
May 22: The National Institutes of Health publishes full Phase 1 data in the New England
Journal of Medicine
Read More

4. Roivant Sciences
Phase 3
Roivant is studying whether its investigational anti-inflammatory can treat acute respira-
tory distress syndrome, or ARDS, which is a severe and potentially fatal consequence of the
novel coronavirus. The treatment, gimsilumab, is an intravenous antibody that targets GM-
CSF, a protein that drives inflammation. GM-CSF appears to be up-regulated in the blood of
Covid-19 patients admitted to the ICU, and blocking it might be a way to improve outcomes
in the most severe cases.
March 18: Roivant begins investigating gimsilumab as a treatment for Covid-19
April 15: Roivant doses first patient in a placebo-controled trial enrolling Covid-19 patients
with acute lung injury or ARDS. The primary goal is improving mortality after 43 days. The
trial will enroll up to 270 patients.

5. Regeneron Pharmaceuticals
Phase 3
Regeneron has grown into a $50 billion business based on its ability to craft human antibo-
dies out of genetically engineered mice. Now it’s tapping that technology in hopes of
treating coronavirus. The company immunized its proprietary antibody-generating mice
with a harmless analog of the novel coronavirus, generating potential treatments for the
infection. The last time Regeneron embarked on this process, during the Ebola outbreak of
2015, it came up with an antibody cocktail that roughly doubled survival rates for treated
patients.
March 17: Regeneron plans to select two of the most potent antibodies and enter clinical
trials by early summer
June 11: Regeneron begins Phase 1 studies of a two-antibody cocktail treatment, enrolling
patients with and without Covid-19 to see whether its therapy can both treat and prevent
the disease
July 6: Regeneron begins a Phase 3 study to determine whether its cocktail can prevent coro-
navirus infection in healthy volunteers, and two mid-stage studies involving hospitalized and
non-hospitalized Covid-19 patients
Oct. 28: Regeneron's treatment led to a significant reduction in viral load and need for medi-
cal visits in a study involving more than 500 Covid-19 patients who aren't hospitalized. The
company has filed for an FDA emergency use authorization
Read More

6. Eli Lilly
Phase 3
Eli Lilly has partnered with a Canadian firm called AbCellera to develop antibody treat-
ments for coronavirus infection. Using a blood sample from a coronavirus survivor, AbCe-
llera identified more than 500 antibodies that might protect against the virus, and it’s wor-
king with Lilly to identify which are most potent.
March 12: Lilly says it will have an antibody ready for human trials within four months
June 1: Lilly and AbCellera began a placebo-controlled Phase 1 study
Sept. 16: Lilly announced interim data in which one of three antibody doses met the primary
goal of speeding up viral clearance
Oct. 7: Lilly releases data in which a combination of two antibodies reduced levels of the vi-
rus and prevented hospitalization. The company plans to request an FDA emergency use
authorization next month
Read More

7. Vir Biotechnology
Phase 3
Vir Biotechnology, a company focused on infectious disease, has isolated antibodies from
people who survived SARS, a viral relative of the novel coronavirus. In addition, the com-
pany has aligned with Alnylam Pharmaceuticals to work on treatments that might halt viral
replication by interfering with RNA signaling. Vir’s CEO, Biogen veteran George Scangos, is
also coordinating the trade group BIO’s response to the coronavirus outbreak.
March 25: Vir plans to get its antibodies into clinical trials within three to five months
Sept. 1: Vir and its partner GSK begins Phase 1/2 trial of its Covid-19 antibody treatment
Oct. 6: Companies say results of Phase 1/2 were positive but withhold results. Phase 3 of the
trial, called COMET-ICE, is started.
Read More

8. Merck and Ridgeback Biotherapeutics
Phase 2
Ridgeback Biotherapeutics, a privately held biotech company, has an exclusive license to
develop an antiviral invented at Emory University. Called EIDD-2801, the drug is designed
to interrupt the process by which viruses replicate. The mechanism is similar to that of Gi-
lead Sciences’ intravenous remdesivir, but EIDD-2801 is an oral medicine. In animal studies,
the drug has demonstrated promise against SARS and MERS, which are related to the novel
coronavirus
March 19: Ridgeback licenses EIDD-2801 from Emory
April 6: FDA permits Ridgeback to begin human trials in the U.S.
April 10: Ridgeback begins Phase 1 study in the U.K.
May 26: Merck licenses EIDD-2801
June 19: Ridgeback advances the drug, now called MK-4482, into two Phase 2 studies, enro-
lling Covid-19 patients in and out of the hospital

9. Athersys
Phase 2
Athersys has a stem-cell therapy it believes could be helpful in treating acute respiratory
distress syndrome, or ARDS, which is a severe and potentially fatal consequence of the no-
vel coronavirus. The treatment, called MultiStem, is made from a type of stem cell harves-
ted from adult bone marrow. MultiStem was demonstrated to be safe in an earlier ARDS
study, but the efficacy results were inconclusive
April 13: Athersys plans to start a Phase 2/3 study in Covid-19 patients with ARDS by July
Read More

10. Ascletis Pharma
Phase 1
Chinese drug maker Ascletis Pharma is testing a combination of antivirals, one approved
for HIV and one approved for hepatitis C, that might treat coronavirus infection. Danopre-
vir, marketed in China as Ganovo, targets an enzyme hepatitis C uses to replicate. Ritonavir,
sold as Norvir, acts on a different viral enzyme found in HIV.
Feb. 17: Doctors in China treat first patients with the combination
March 25: Ascletis reports that 11 patients with moderate Covid-19 were discharged from
the hospital after four to 12 days of treatment with the combination

11. Celularity
Phase 1
Celularity is developing a treatment that would use immune cells to treat Covid-19. The
company uses stem cells to generate so-called natural killer cells, which the innate immune
system uses to fight foreign infections. The company’s investigational treatment, CYNK-
001, is also being developed as a cancer treatment.
April 2: Celularity got the FDA's permission to begin a Phase 1 trial

12. I– Mab
Phase 1
I-Mab, headquartered in Shanghai, is developing a treatment for one of Covid-19’s dange-
rous side effects. Patients with severe infections sometimes develop cytokine release syn-
drome, in which the immune system overreacts by producing proteins that lead to inflam-
mation. I-Mab’s therapy is an antibody against the protein GM-CSF, a key inflammatory cy-
tokine.
April 3: The FDA signed off on I-Mab's plan for a placebo-controlled trial, which the company
said it would begin "as soon as possible"

13. SAB Biotherapeutics and CSL Behring
Preclinical
In addition to its work in plasma treatment alliance, CSL Behring is working with SAB Biot-
herapeutics on an antibody treatment. Monoclonal antibodies, as the name suggests, bind
to a single point on the protein they target. But SAB’s potential treatment, SAB-185, is
polyclonal, a difference the company believes will make it more potent
April 8: SAB and CSL say they plan to begin trials in the summer

14. Allo Vir
Preclinical
AlloVir, working with the Baylor College of Medicine, is developing a cell therapy tuned to
attack the novel coronavirus. The company’s technology involves taking T cells from
healthy donors and then exposing them to a harmless fragment of the coronavirus, trigge-
ring an immune response. Once the T cells are activated, they’re cryopreserved and stored
for transplant into a patient.
March 23: AlloVir and Baylor began work on T cell therapy for coronavirus but did not disclo-
se a timeline to clinical study

15. Amgen
Preclinical
Amgen has partnered with Adaptive Biotechnologies to develop antibody treatments for
coronavirus infection. Adaptive will screen the blood of coronavirus survivors to isolate an-
tibodies that might protect against the virus, and then Amgen will select, develop, and ma-
nufacture potential medicines.
April 2: The two companies announced their alliance and plans to begin clinical trials "as qui-
ckly as possible"

16. AstraZeneca and Vanderbilt University Medical Center
Preclinical
Global drug maker AstraZeneca signed a deal with Vanderbilt University Medical Center to
develop antibodies identified at the school’s lab. Vanderbilt has been screening the blood
of Covid-19 survivors, isolating antibody-producing white blood cells, and using them to
clone potential treatments. Under the agreement, Vanderbilt is providing those antibodies
to AstraZeneca, which will choose the best candidates for clinical development. Vanderbi-
lt’s work has been funded by the Department of Defense, the National Institutes of Health,
and Dolly Parton.
March 23: Vanderbilt plans clinical trials by the summer
April 8: AstraZeneca partners to develop Covid-19 antibodies

17. Celltrion
Preclinical
South Korean drug maker Celltrion, which markets FDA-approved biosimilars, is developing
antibody treatments for Covid-19. Working with the Korea Centers for Disease Control, the
company has identified a library of protective antibodies from the blood of recovered pa-
tients, and it’s screening them to find the most effective. In addition, Celltrion is resear-
ching what it calls a super antibody, one that could protect against all viruses within the co-
ronavirus family.
March 23: Celltrion begins its research program and plans to enter clinical trials in the third
quarte

18. Grifols
Preclinical
Spanish drug maker Grifols is working with the U.S. government to collect blood plasma
from Covid-19 survivors and transform it into a treatment for the disease. The company
aligned with the Biomedical Advanced Research Authority and the FDA to recruit recovered
patients to one of its more than 250 plasma collection centers in the U.S. Grifols plans to
process the resulting plasma at its facility in North Carolina.
March 25: Grifols enters agreement with federal authorities
April 20: Grifols begins recruiting Covid-19 survivors

19. Neurimmune and Ethris
Preclinical
Neurimmune, the Swiss drug maker that discovered Biogen’s Alzheimer’s disease treat-
ment aducanumab, is working on an approach that would get anti-coronavirus antibodies
directly into the lungs of infected patients. Working with Ethris, a German company focu-
sed on mRNA, Neurimmune is working to identify neutralizing antibodies from the blood of
Covid-19 survivors. Once that’s done, Ethris will design mRNA that encodes for those anti-
bodies and package it in an inhalant. If it all works out, the companies will craft a direct-
acting drug that generates antibodies at the site of infection.
April 1: Neurimmune and Ethris begin development with plans to enter human trials in the
fourth quarter

20. Pfizer
Preclinical
Pfizer is developing an antiviral medicine that targets an enzyme viruses use to replicate.
The drug came from a series of compounds Pfizer had previously developed against the vi-
rus that causes severe acute respiratory syndrome, or SARS, which is related to the new co-
ronavirus.
April 9: Pfizer said its drug will be ready for human testing in August or September
Read More

21. Takeda, CSL Behring, Biotest, BPL, LFB, and Octapharma
Preclinical
Six companies are collaborating to develop a Covid-19 treatment derived from the blood of
people who have already been infected by the coronavirus. The approach involves drawing
blood from coronavirus survivors, harvesting the plasma, and then isolating the protective
antibodies that kept those patients alive. It’s not a new idea. Blood transfusions have been
used to combat viral outbreaks since at least the Spanish Flu pandemic of 1918. The com-
panies joined forces to make the development process more efficient.
April 6: The six companies announced their partnership but did not disclose a timeline for de-
velopment
May 13: Takeda said its plasma treatment, CoVIg-19, will begin human trials as early as July

22. Novartis and Molecular Partners
Preclinical
Global pharmaceutical giant Novartis is working with Swiss biotech firm Molecular part-
ners on a pair of antiviral therapies for Covid-19. The treatments, MP0420 and MP0423, are
designed to bind to multiple sites on the surface of the novel coronavirus, blocking it from
entering cells and replicating itself.
Oct. 28: Novartis agrees to co-develop Molecular Partners leading Covid-19 candidates, plan-
ning to begin a first human trial in November

23. SARS-CoV-2 (COVID-19)
Vaccines
Last update 07 November 2020

24. University of Oxford and AstraZeneca
Phase 3
University of Oxford researchers have developed a potential vaccine that uses a harmless
virus engineered to contain the genetic sequence that encodes for a protein on the surface
of the novel coronavirus. The researchers, from the University’s Jenner Institute and Ox-
ford Vaccine Group, are working at uncommon speed, starting a placebo-controlled clinical
trial while finalizing the manufacturing of their potential vaccine. British drug maker As-
traZeneca has partnered on the project.
March 27: Oxford begins recruiting patients for a placebo-controlled trial that will enroll up
to 510 healthy volunteers. The vaccine will not be ready for "some weeks," according to the
university.
April 30: AstraZeneca announces it will partner with Oxford to develop the vaccine.
July 20: Oxford publishes Phase 1/2 data demonstrating an immune response with mild to
moderate side effects.
Aug. 31: AstraZeneca begins enrollment in a U.S. Phase 3 trial that will involved 30,000 volun-
teers.
Sept. 8: AstraZeneca says a hold has been put on the trial following a suspected adverse reac-
tion in a participant. Sept. 12: AstraZeneca says trials in the U.K. have resumed.
Read More

25. Moderna Therapeutics
Phase 3
Moderna’s vaccine, mRNA-1273, is a synthetic messenger RNA that encodes for a protein
found on the surface of the novel coronavirus. By compelling cells to produce that protein,
the vaccine would spur an immune response, causing the body to generate antibodies that
would protect against infection. The company set a drug industry record with mRNA-1273,
identifying a vaccine candidate just 42 days after the novel coronavirus was sequenced.
March 16: First patient dosed in a Phase 1 trial
April 16: Moderna plans to begin a Phase 2 study by July
May 1: Moderna announces it will partner with Swiss firm Lonza on development
May 7: FDA clears Moderna to start a 600-patient Phase 2 study, which will begin "shortly"
May 18: Moderna discloses interim Phase 1 data, in which eight volunteers developed anti-
bodies to the coronavirus
May 29: Moderna doses the first volunteers in a Phase 2 study, planning to enroll about
600 people
July 14: Moderna publishes Phase 1 data showing a consistent antibody response and mild
to moderate side effects.
July 27: Moderna begins enrollment in a 30,000-subject Phase 3 trial
Read More

26. BioNTech and Pfizer
Phase 3
Germany’s BioNTech is working on a multitude of mRNA vaccines for the novel coronavi-
rus, planning to develop them in parallel. Like its competitors, the company uses strands of
mRNA to generate protective antibodies. Earlier this month, Shanghai’s Fosun Pharma sig-
ned a deal to market BioNTech’s vaccine in China if it’s eventually approved. Pfizer has
agreed to co-develop the vaccine in the rest of the world.
April 9: BioNTech says it will begin its first human trials "as early as the end of April"
April 29: BioNTech and Pfizer dose the first patients in a Phase 1 trial in Germany, planning to
enroll about 200 patients
May 5: BioNTech and Pfizer begin Phase 1 study in the U.S., recruiting up to 360 patients total
May 12: BioNTech says it expects preliminary data in June or July
July 1: In a Phase 1 trial, BioNTech's vaccine led to an increase coronavirus antibodies at three
doses, according to a preprint paper
July 27: Pfizer and BioNTech begin enrollment on a 30,000-volunteer study, expecting data as
early as October Sept. 12: Pfizer and BioNTech announce a plan to expand enrollment to
44,000 participants
Nov. 9: Pfizer and BioNTech's vaccine was found to be more than 90% effective in the first
analysis of Phase 3 data, the companies said.
Read More

27. Novavax
Phase 3
Novavax is at work on a coronavirus vaccine that begins in the ovaries of an insect. The
company’s vaccine platform involves genetically engineering a harmless virus and exposing
it to cells isolated from worms. Those cells then churn out the proteins needed to stimulate
antibodies, and those proteins become vaccines. For Covid-19, Novavax has isolated the
spike protein found on the surface of the novel coronavirus.
April 8: Novavax selects a vaccine candidate, planning to begin human trials in May with pre-
liminary data in July
May 26: Novavax begins Phase 1 trial, planning to enroll about 130 volunteers with data ex-
pected in July
Aug. 4: Novavax presents detailed data from its Phase 1 trial, demonstrating an immune res-
ponse with mostly mild side effects.
Aug. 24: Company launches Phase 2 portion of Phase 1/2
Sept. 25: Novavax initiates Phase 3 trial in U.K., with plans to initiate Phase 3 in the U.S. late
Read More

28. Sinovac
Phase 2
Sinovac, headquartered in Beijing, is developing a vaccine using an inactivated version of
the novel coronavirus. The company used the same technology to craft approved vaccines
for hepatitis A and B; swine flu; avian flu; and the virus that causes hand, foot, and mouth
disease.
April 17: Sinovac begins a placebo-controlled Phase 1/2 trial, planning to enroll 144 healthy
volunteers in China
May 6: Sinovac publishes results from a preclinical study in which its vaccine successfully
protected monkeys from contracting the novel coronavirus. The company plans to start a
second, larger human trial by mid-May
June 14: Sinovac released preliminary results from its Phase 2 trial, saying its vaccine indu-
ced neutralizing antibodies in “above 90%” of participants
Read More

29. CanSino Biologics
Phase 2
CanSino Biologics, headquartered in Tianjin, is developing a coronavirus vaccine using the
technology that led to a China-approved Ebola virus vaccine. CanSino’s approach involves
taking a snippet of coronavirus’ genetic code and entwining it with a harmless virus, the-
reby exposing healthy volunteers to the novel infection and spurring the production of an-
tibodies.
March 17: CanSino begins Phase 1 trial in China
April 10: Based on preliminary data, CanSino says it will move into Phase 2 "soon"
May 22: CanSino published data from a 108-subject trial, in which its vaccine generated a
immune response in volunteers
June 29: Chinese regulators provisionally approved CanSino's vaccine for military use
July 20: CanSino publishes interim Phase 2 data showing a consistent antibody response
but one that seemed to wane in older subjects
Read More

30. Inovio Pharmaceuticals
Phase 1
Inovio has spent the last four decades working to turn DNA into medicine, and the com-
pany believes its technology could quickly generate a vaccine for the novel coronavirus.
Inovio has come up with a DNA vaccine it believes can generate protective antibodies and
keep patients from infection. The company has partnered with a Chinese manufacturer,
Beijing Advaccine Biotechnology, to produce the vaccine.
April 6: Inovio doses first patient in Phase 1 trial
June 30: Inovio says its vaccine led to an immune response in 94% of patients but does not
provide data
Read More

31. Sanofi and GlaxoSmithKline
Phase 1
Sanofi is employing the same technology it employs for flu vaccines, which uses a geneti-
cally modified version of a virus to create proteins that train the immune system to react.
The company is combining its approach with GlaxoSmithKline's proprietary adjuvant, an
additive that makes vaccines more potent.
Feb. 18: Sanofi begins work on a coronavirus vaccine
April 14: Sanofi partners with GlaxoSmithKline and plans to begin human trials in the se-
cond half of 2020 and generate pivotal data in 2021
Sept. 3. Sanofi and GlaxoSmithKline begin a 400-volunteer, Phase 1/2 trial, expect data in
December
Read More

32. Johnson & Johnson
Preclinical
Johnson & Johnson, which has in the past responded to outbreaks of the Ebola and Zika vi-
ruses, is using the same technology to develop a vaccine for the novel coronavirus. J&J’s
vaccine is made by grafting the coronavirus genes that confer immunity onto a harmless
virus, injecting it triggering an immune response without causing infection.
March 30: J&J expects to begin Phase 1 by September, with a vaccine available for emer-
gency use as soon as early 2021.
Sept. 23: J&J announces it is starting a Phase 3 trial that will recruit up to 60,000 partici-
pants

33. Arcturus Therapeutics
Preclinical
Arcturus Therapeutics is pressing forward with a vaccine that relies on engineering RNA.
The company plans to take an RNA virus that has been edited to encode for proteins that
will protect against infection and load it into a liquid nanoparticle. The resulting vaccine,
being developed in partnership with Duke University, promises a better immune response
at a lower dose than competing mRNA approaches, according to the company.
April 9: Arcturus plans to begin a Phase 1 trial in Singapore over the summer

34. Clover Biopharmaceuticals and GlaxoSmithKline
Preclinical
Clover Biopharmaceuticals, headquartered in Chengdu, is developing a vaccine that would
inject patients with a protein found on the surface of the novel coronavirus. GlaxoSmithKli-
ne is providing its proprietary adjuvant, an additive that makes vaccines more potent.
Feb. 10: Clover identifies its vaccine candidate
Feb. 24: GlaxoSmithKline provides its adjuvant

35. CureVac
Preclinical
CureVac uses man-made mRNA to spur the production of proteins and protective antibo-
dies. Like Moderna, the company got a grant from the nonprofit Coalition for Epidemic Pre-
paredness Innovations to apply its technology to coronavirus.
March 17: CureVac said it expects to have a candidate ready for animal testing by April, ai-
ming to start a clinical study in the summer

36. Imperial College London
Preclinical
Led by the immunologist Robin Shattock, Imperial College London is developing an RNA-
based vaccine for the novel coronavirus. The scientists have engineered a virus-derived
RNA strand that will get into cells, spur the production of the coronavirus’s signature pro-
tein, and then replicate itself. In animal studies, the vaccine has resulted in the generation
of protective antibodies.
April 17: With funding from the U.K. government, Imperial plans to complete preclinical
work and begin human trials in June

37. University of Queensland and GlaxoSmithKline
Preclinical
Australia’s University of Queensland, with funding from the Coalition for Epidemic Prepa-
redness Innovations, has been developing a coronavirus vaccine since January. Queensland
has a proprietary technology meant to make protein vaccines more effective at triggering
an immune response. Called a molecular clamp, the university’s approach keeps the coro-
navirus’s key protein in its natural shape before grafting it onto the vaccine.
April 9: Queensland plans to begin human trials in the third quarter

38. Merck
Preclinical
Merck purchased a Vienna-based company called Themis, which is developing an experi-
mental Covid-19 vaccine based on a measles vaccine. It also partnering with the nonprofit
IAVI on the development of a coronavirus vaccine related to the company's existing Ebola
vaccine.
May 26: Merck says the Themis vaccine will enter human trials in a matter of weeks while the
second candidate could reach the clinic by the end of the year
Read More

39. Sanofi and Translate Bio
Preclinical
Sanofi partnered with Translate Bio to develop potential vaccines using synthetic messen-
ger RNA, which would compel the body to produce antibodies against the novel coronavi-
rus. The two companies have worked together in the past on vaccines for infectuous disea-
se.
March 27: Sanofi and Translate Bio announce their collaboration but do not specify a develo-
pment timeline

40. SARS-CoV-2 (COVID-19)
Treatments and Vaccines Tracker
Last update 11 November 2017
Fuente: https://Statnews.com