Biotech Bay Companies Fighting Against COVID-19

May 22, 2020 |

11 min read |

Biotech Bay, the bustling biotech industry around San Francisco in California, is home to many biopharma companies developing diagnostics, therapies, and vaccines to fight against coronavirus disease 2019 (COVID-19) and the virus that causes it, called SARS-CoV-2.

The rush to develop treatments and vaccines for the novel coronavirus is on.

The breakneck pace of research and development can be hard to keep up with. To keep tabs on the research hustle, BioSpace looked at what each Hotbed was up to.

Biotech Bay, the bustling biotech industry around San Francisco in California, is home to many biopharma companies developing diagnostics, therapies, and vaccines to fight against coronavirus disease 2019 (COVID-19) and the virus that causes it, called SARS-CoV-2.

Check out the table below to find out how the companies in Biotech Bay are joining the fight against COVID-19 and what they are developing.

The information below was up to date as of May 18, 2020.

Biotech Bay’s Fight Against COVID-19

AbbVie

Drug/Vaccine Type: Protease inhibitor

Drug (Name Brand): Lopinavir/ritonavir (Kaletra, Aluvia)

FDA Approved? (Indication): Yes (HIV)

Mechanism of Action: Prevents the protease enzyme from working (protease forms the structural proteins and enzymes that new copies of HIV need to replicate) – causes formation of defective viruses that cannot infect new cells

Clinical Trials, Testing & Partnerships:

WHO Solidarity Phase 3 trial
Inserm DisCoVeRy Phase 3 trial – a multicenter European trial
CATCO Phase 2 trial
Partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to “support in-vitro testing of lopinavir/ritonavir among other protease and polymerase inhibitors in the U.S.”
Joined the “Innovative Medicines Initiative to support research and discovery of targeted medicines against COVID-19”

Clinical Trial Results: ChiCTR2000029308 (Wuhan, China) – NEJM (3-18-20) – open-label RCT (199 patients) – No benefit observed compared to standard of care (no sig. dif. in mortality, detectable viral load, or hospital stay length)

Company Press Releases:

ABBVIE

Drug/Vaccine Type: Bruton’s tyrosine kinase (BTK) inhibitor

Drug (Name Brand): Imbruvica (ibrutinib)

FDA Approved? (Indication): Yes (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), chronic graft versus host disease (cGVHD))

Mechanism of Action: Small molecule that inhibits BTK, an enzyme important in B-cell development

Clinical Trials, Testing & Partnerships: Phase 2 study to “determine whether IMBRUVICA is able to improve patient outcomes by diminishing the immune response known as the cytokine storm that contributes to the morbidity and mortality in COVID-19”

Company Press Releases: AbbVie’s update on COVID-19

Amgen

Drug/Vaccine Type: Phosphodiesterase 4 (PDE4) inhibitor

Drug (Name Brand): Apremilast (Otezla)

FDA Approved? (Indication): Yes (plaque psoriasis, psoriatic arthritis, oral ulcers caused by Behçet’s Disease)

Mechanism of Action:

Decreases pro-inflammatory cytokines (TNF-α, IL-17A, IL-23)
Increases anti-inflammatory cytokines (IL-10)

Clinical Trials, Testing & Partnerships:

“‘Amgen expects to begin clinical trials of Otezla for COVID-19 in the coming weeks,’ said research chief David Reese.” (4-30-20)
Amgen partnered with Adaptive Biotechnologies to “discover and develop fully-human neutralizing antibodies to potentially prevent or treat COVID-19.” – Adaptive will use its high-throughput platform to screen B-cell receptors from people who have recovered from COVID-19 to identify antibodies. Amgen will select, develop & manufacture the antibodies.

Clinical Trial Results: deCODE Study of SARS-CoV-2 Genetics & Prevalence in Iceland (Reykjavik, Iceland) – NEJM (4-14-20) – 9,199 high risk individuals: 13.3% tested positive, women (11% positive) & children under 10 (6.7% positive) were less likely to test positive than men (16.7% positive) – 0.8% of 10,797 volunteers & 0.6% of 2,283 people tested positive – 43 of the 100 positive tests were from asymptomatic people at the time of testing

Company Press Releases:

Boehringer Ingelheim Fremont (all press releases are from Boehringer Ingelheim, not specifically the Fremont, CA location)

Drug/Vaccine Type: (No specific drug indicated)

Drug (Name Brand):

Identify novel antibodies against the SARS-CoV-2 spike protein
Computationally screen their entire compound library (over one million compounds) for “novel small molecules with activity against 2 priority viral targets: SARS-CoV-2 main protease and SARS-CoV-2 papain-like protease.”
Investigate compounds from their pipeline as treatment for COVID-19 lung symptoms
Investigate past antiviral molecules against HIV and Hep C for activity against SARS-CoV-2

Clinical Trials, Testing & Partnerships:

Joined the COVID-19 Therapeutics Accelerator (Bill and Melinda Gates Foundation, Wellcome & Mastercard)
Joined a “fast track call initiated by the Innovative Medicines Initiative (IMI) of the European Union”
“We do our utmost to ensure that the supply of the study drug as well as the study related assessments are not interrupted. … We have decided to pause patient recruitment for a certain trial or refrain from initiating new clinical trials or sites for a short period of time.” – Company press release

Company Press Releases:

Bristol Myers Squibb

Drug/Vaccine Type: (No specific drug indicated)

Drug (Name Brand):

Identified ~1,000 compounds in their discovery library that they are “making available to collaborator for screening for potential treatments for COVID-19”
Evaluating drugs in their pipeline “that may have an impact on the inflammatory immune response associated with COVID-19” for “near-term clinical trials”

Clinical Trials, Testing & Partnerships:

Joined the COVID-19 Therapeutics Accelerator (Bill and Melinda Gates Foundation, Wellcome & Mastercard)
Joined the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a “public-private partnership formed by the NIH and the Foundation for the NIH (FNIH)”
“In some instances, we are continuing clinical studies as planned, while in others we are temporarily suspending or postponing trials as appropriate. For trials which were suspended or postponed, plans are underway to get them back up and running when circumstances on the ground permit.” -Company press release

Company Press Releases:

Dynavax

Drug/Vaccine Type: Toll-like receptor 9 (TLR9) agonist adjuvant

Drug (Name Brand): CpG 1018

FDA Approved? (Indication): Yes (adjuvant in HEPLISAV-B, the FDA-approved Hepatitis B Vaccine)

Mechanism of Action: Mimics bacterial/viral genetic material to increase immune response – it is a synthetic form of DNA (made of cytosine phosphoguanine (CpG) motifs)

Clinical Trials, Testing & Partnerships:

Dynavax provided CpG1018 to:

the University of Queensland as a part of a Coalition for Epidemic Preparedness (CEPI) initiative (3-2-20)
Clover Biopharmaceuticals – protein-based vaccine candidate COVID-19 S-Trimer (3-24-20)
Sinovac Biotech – chemically inactivated coronavirus vaccine candidate PiCoVacc (4-16-20)
Valneva (4-22-20)

Company Press Releases:

Emergent BioSolutions

Drug/Vaccine Type: Convalescent plasma COVID-19 vaccine production

Drug (Name Brand):

FDA Approved? (Indication): No

Mechanism of Action: Learn more about hyperimmune globulin with their fact sheet

Clinical Trials, Testing & Partnerships:

Partnered with U.S. government & received funding from the Biomedical Advanced Research and Development Authority (BARDA) to “expedite development of plasma-derived therapy for COVID-19”
Both hyperimmune globulin candidates (COVID-HIG and COVID-EIG) are “anticipated to be in Phase 2 studies over the summer”
Emergent will “provide contract development and manufacturing services” to “support bringing into the clinic Novavax’s novel experimental vaccine candidate for COVID-19,” “develop and manufacture Vaxart’s experimental oral vaccine for COVID-19,” and “support Johnson & Johnson’s commitment of 1 billion doses of vaccine for worldwide emergency pandemic use”

Company Press Releases: The fight against COVID-19

Gilead Sciences

Drug/Vaccine Type: Nucleotide analogue

Drug (Name Brand): Remdesivir (previously GS-5734)

FDA Approved? (Indication): No – granted Emergency Use Authorization (EUA) for COVID-19 by the FDA

Mechanism of Action: Inhibits SARS-CoV-2’s replication machinery (viral RNA-dependent RNA polymerase) – Journal of Biological Chemistry paper

Clinical Trials, Testing & Partnerships:

Gilead SIMPLE Phase 3 trials in moderate and severe COVID-19 patients
NIAID ACTT Phase 3 RCT
Inserm DisCoVeRy Phase 3 trial – a multicenter European trial
Gilead.com listings
ClinicalTrials.gov listings
Drugs.com listings

Clinical Trial Results:

NIAID ACTT Ph3 RCT – patients taking remdesivir recovered 31% faster & had lower mortality (8%) than those taking placebo (11.6% mortality)
Initial results from Gilead SIMPLE Ph3 trial in severe patients – “similar improvement in clinical status” with 5- and 10-day dosing
China-Japan Friendship Hospital Phase 3 trials in mild-moderate and severe COVID-19 patients – suspended because “no eligible patients can be enrolled at present” (didn’t meet enrollment goals) – patients taking remdesivir got better faster (but it wasn’t statistically sig.)

Company Press Releases:

Gladstone Institutes

Drug/Vaccine Type: (No specific drug indicated)

Drug (Name Brand):

FDA Approved? (Indication):

Mechanism of Action:

Clinical Trials, Testing & Partnerships:

Developing a “CRISPR-based method to rapidly measure COVID-19 RNA” and combining that with “iPhone technology” to create a “diagnostic that can deliver rapid results and be widely deployed”
Testing the “effects of the virus and drug candidates in human lung organoids and human heart cells developed from human stem cells”
Screen “a library of FDA-approved drugs to identify those that could be rapidly repurposed as a COVID-19 treatment”
Developing a vaccine alternative called “therapeutic interfering particles (TIPs)” that “transmit along the same paths as the virus itself”

Company Press Releases: Gladstone Institutes Response to COVID-19

Grifols

Drug/Vaccine Type: Convalescent plasma

Drug (Name Brand): Anti-SARS-CoV-2 hyperimmune globulin

FDA Approved? (Indication): No (not anti-SARS-CoV-2 hyperimmune globulin specifically) – the convalescent plasma is collected at FDA-approved plasma donor centers

Mechanism of Action: SARS-CoV-2 antibodies can be isolated from the blood of people who’ve recovered from COVID-19, then the antibodies can be given to people currently sick with COVID-19 – See Grifols’ video about how to get hyperimmune globulin from convalescent plasma

Clinical Trials, Testing & Partnerships: