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How COVID-19 is Affecting Clinical Trials and Drug Supplies from Biotech Bay Companies

Published: Jun 05, 2020 By Chelsea Weidman Burke, M.S.

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Much of the news has been focused on the novel coronavirus and the rush to develop vaccines and treatments for the disease it causes (called COVID-19). But what is happening with all the other companies not directly involved in COVID-19 research? And how is COVID-19 affecting their clinical trials and drug supplies?

To answer these questions, BioSpace looked at COVID-19’s impact on each of the Hotbeds.

Biotech Bay, the bustling biotech industry around San Francisco in California, is home to lots of biopharma companies, many of whom are trying to keep business as close to usual while adapting to these unique times.

Check out the table below for the impacts that Biotech Bay companies are experiencing due to COVID-19.

(For information about what Biotech Bay companies have joined the fight against COVID-19 and how they are working towards vaccines and treatments, check out this article.)

The information in this table was up to date as of May 18, 2020.

 

4D Molecular Therapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

Allakos, Inc.

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

Ambys Medicines

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • None reported
  • No recent press releases

Drug Supply Impacts of COVID-19:

  • None reported

 

Apollomics, Inc.

Disease Focus:

Clinical Trial Impacts of COVID-19: 

 

Arcus Biosciences

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “Despite the ongoing situation with COVID-19, we continue to see relatively robust enrollment across our ongoing Arcus-sponsored studies at this time. Similar to other biotech and pharmaceutical companies, we believe this pandemic may ultimately cause delays in some of our clinical programs as well as delays initiating new studies and/or new clinical sites. However, the timing of any delays and overall impact will be difficult to determine until we have more visibility on the length of the crisis and the potential institution of additional public health orders.” – Company press release
  • “We remain on track to generate preliminary Phase Ib expansion data in mid-2020 and randomized data starting in the fourth quarter of 2020, respectively, that will inform the advancement of our regulatory strategy.” – Terry Rosen, PhD, CEO

Drug Supply Impacts of COVID-19:

  • “With respect to manufacturing, we currently have sufficient drug supply for our ongoing clinical studies. At this time and subject to further COVID-19 implications, we do not anticipate any disruptions to our drug supply chain.” – Company press release

 

Assembly Biosciences

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “We have managed to achieve our key business objectives while keeping the health and safety of patients, study staff, and employees top of mind, and continuing to assess and adapt to this environment. Importantly, we have finalized the stopping criteria by which patients with chronic HBV infection in Study 211 will be transitioned off combination therapy with our core inhibitor candidate ABI-H0731 and a nucleos(t)ide therapy later this year. This is a critical next step in the development of hepatitis B therapies, as ours would be the first trial of a core inhibitor to stop therapy and monitor patients for potential sustained virologic response.” – John McHutchison, AO, MD, CEO and President

Drug Supply Impacts of COVID-19:

  • None reported

 

BioMarin Pharmaceutical Inc.

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

BridgeBio

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “We are doing our absolute best to minimize any delays, but we know that right now health care institutions and doctors around the world have shifted their focus to emergent COVID-19 cases. Many hospitals and physicians have postponed elective medical procedures and delayed the start of new clinical trials. … There will inevitably be delays and we don’t know what the future holds, but we will not stop working as fast as we possibly and safely can for patients.” – CEO Neil Kumar

Drug Supply Impacts of COVID-19:

  • None reported

 

DNA Script

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

Eurofins DiscoverX

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • None reported
  • Eurofins COVID-19 Response includes clinical PCR testing kits, serology antibodies testing kits, and PPE product testing.

Drug Supply Impacts of COVID-19:

  • None reported

 

Exelixis, Inc.

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “We have ongoing investigational studies at clinical trial sites across the globe. We are monitoring how COVID-19 may impact this research.” – Company statement

Drug Supply Impacts of COVID-19:

  • “We do not expect there to be an impact on the availability of either of our commercial products (CABOMETYX® and COMETRIQ®) as we maintain a substantial amount of stock throughout our broad and diverse supply chain.” – Company statement

 

FibroGen

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “We continue to be focused on our goals to ensure the regulatory and commercial success of roxadustat, a potentially transformational oral medicine in patients with anemia on chronic kidney disease; accelerate pamrevlumab in the indications of idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer, and Duchenne muscular dystrophy; and advance innovation of our hypoxia-inducible factor and connective tissue growth factor platforms.” – CEO Enrique Conterno

Drug Supply Impacts of COVID-19:

  • “As China comes back on line, we are continuing manufacturing operations and launch efforts. We have ample drug supply to support the roxadustat launches and clinical trials in additional indications, as well as the pamrevlumab trials.” – CEO Enrique Conterno

 

Global Blood Therapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • “GBT Source™, the company’s support program for those prescribed Oxbryta, is fully functional and remains available to assist with new enrollments, reimbursement, financial and copay support, and adherence and refill support. In addition, GBT believes it currently has sufficient supply of Oxbryta to sustain patient need through the remainder of the year and into 2021.” – Company press release

 

Horizon Therapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “Our trials are currently ongoing and patients who have any questions should reach out directly to their treating physician. For the safety of our patients, healthcare professionals and our employees, we will provide support to physicians, patients and partners virtually through at least May 30. We will continue to monitor and assess information to determine if virtual support will be necessary for a longer period.” – Company update

Drug Supply Impacts of COVID-19:

  • “At this time, we expect no impact on the supply of our medicines. We continue to closely monitor  our supply chain and will provide updates as necessary. We expect all of our patient services and financial support programs will continue to be available without interruption.” – Company update

 

Intabio

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

Iovance Biotherapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “While COVID-19 has impacted healthcare systems globally, we have been able to continue our key business operations due to dedication from our employees and through close collaboration with our clinical sites and other business partners.” – CEO Maria Fardis, Ph.D., MBA
  • “Enrollment in the cervical study C-145-04 continues and completion of enrollment in the pivotal program is on track for approximately mid-2020.” – Company press release

Drug Supply Impacts of COVID-19:

  • “Manufacturing at all manufacturing organizations continues as planned for ongoing clinical studies.” – Company press release

 

JOINN Biologics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • None reported

Drug Supply Impacts of COVID-19:

  • None reported

 

Maze Therapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

MyoKardia

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “All efforts will be made to allow patients to continue in ongoing mavacamten studies, including the MAVA-LTE long-term extension and the PIONEER open-label extension (OLE) studies. MyoKardia has temporarily suspended the rollover of patients from EXPLORER into the MAVA-LTE and plans to resume enrollment when conditions permit. The company has also paused the enrollment of healthy volunteers in the Phase I clinical trial evaluating MYK-224. Studies that were planned to initiate in the second quarter of 2020 will be delayed until conditions change, including the VALOR-HCM Phase III clinical study of mavacamten as an alternative to septal reduction therapy (SRT) procedures, the Phase II proof-of-concept study for mavacamten in subgroups of patients with heart failure with preserved ejection fraction (HFpEF), and the Phase II study of danicamtiv in patients with genetic dilated cardiomyopathy (DCM).” – Company press release
  • Recent press release: “MyoKardia Announces Primary and All Secondary Endpoints Met in Phase III EXPLORER Clinical Trial of Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy”

Drug Supply Impacts of COVID-19:

  • None reported

 

Nektar Therapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “For all ongoing clinical trials, we are working closely with clinical trial sites to understand their needs during this time. We are utilizing remote monitoring when possible to oversee study conduct. We have adopted processes to allow for telemedicine and closer access to patient care where and when appropriate so we can continue all data collection processes and support patient safety.
  • The majority of Nektar-run clinical studies in oncology have not experienced any significant delays. We caution that the evolving landscape could impact these statements and could still delay late-stage studies or enrollment of new patients into clinical trials in the future. We currently believe that we could experience delays of approximately three months with respect to previously-provided timelines for earlier stage Nektar-run studies, such as the PROPEL study, where the initiation of planned new investigator sites in Europe was delayed due to the COVID-19 pandemic.” – Howard Robin, President & CEO

Drug Supply Impacts of COVID-19:

  • “At this time, we do not anticipate any supply interruptions for manufacturing, including our preparations for scale-up of commercial supply of bempegaldesleukin, which are underway. The company has sufficient quantities of bempegaldesleukin, NKTR-262, NKTR-255 and NKTR-358 to supply the ongoing clinical programs for these investigational medicines. We and our manufacturing partners are continuing to regularly assess the situation.” – Howard Robin, President & CEO

 

Neurona Therapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

Nkarta

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

Nurix

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

Orchard Therapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

PACT Pharma

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

Pharmacyclics (an AbbVie Company)

Disease Focus:

  • “Small-molecule medicines for the treatment of cancers and immune-mediated diseases for which there is great unmet medical need”

Clinical Trial Impacts of COVID-19: 

  • “The safety and efficacy of BTK inhibitors, like IMBRUVICA, have not been established for the treatment of COVID-19. We remain open to collaborating with governments, academic institutions and healthcare professionals to support the collection of data and evidence generation that explores potential treatment options for people affected by COVID-19.” – Company press release

Drug Supply Impacts of COVID-19:

  • “Currently, there is no impact to the supply of IMBRUVICA® (ibrutinib).  We continue to closely manage manufacturing and supply chain resources within and outside the United States, which are subject to robust quality testing to help ensure patients continue to receive an uninterrupted supply of IMBRUVICA.” – Company press release

 

Portola Pharmaceuticals

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • “While the coronavirus pandemic has led to suspended activities and business around the world, it will not stop patients who take rivaroxaban or apixaban from experiencing life-threatening bleeds. It is important that we are able to continue to supply hospitals with Andexxa. We have adequate supply of this important medicine on-hand for the next couple of years in the United States and Europe. At this time, the global Andexxa supply chain and distribution structure is intact for customers to continue to use and re-order Andexxa.” – Company press release

 

Principia Biopharma

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “In considering the current impacts of the COVID-19 pandemic, Principia is not changing previously communicated guidance except in the case of its Phase II trial of rilzabrutinib in patients with IgG4-RD, which now will begin in the second half of 2020 rather than the first half as originally planned.” – Company press release

Drug Supply Impacts of COVID-19:

  • “We commenced our COVID-19 preparations at the end of January, and we continue to work with our clinical trial sites and third party manufacturers to maintain momentum of our trials and to provide study drug supply to our sites and patients.” – Company statement

 

Pulse Biosciences

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “Our operations in the first quarter of 2020 experienced minimal impacts as a result of the COVID-19 pandemic. Product development and regulatory timelines have not been materially affected at this point but due to the uncertain scope and duration of the pandemic, we cannot reasonably estimate the future impact to our operations and financial results.” – Company press release

Drug Supply Impacts of COVID-19:

  • None reported

 

Revance Therapeutics

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “JUNIPER Phase II trial for adult upper limb spasticity paused due to challenges in subject assessments during time of required social distancing.
  • Prescription Drug User Fee Act (PDUFA) target action date for DaxibotulinumtoxinA for Injection (DAXI) in glabellar lines of Nov 25, 2020.
  • ASPEN-1 Phase III trial in cervical dystonia and Phase II trial in plantar fasciitis remain on track to read out in 2H of 2020.” – Company press release

Drug Supply Impacts of COVID-19:

  • “As Revance is U.S. based and manufactures its drug substance and drug product in Newark, CA, the company does not anticipate any supply chain issues related to the production of DAXI and expects to have drug product on time for commercial launch, subject to product approval.
  • Launch of Resilient Hyaluronic Acid® (RHA®) fillers, and associated hiring of 100 field representatives, pushed back one quarter due to COVID-19 situation and temporary closure of Teoxane’s Swiss manufacturing facility.” – Company press release

 

Santen Pharmaceutical Co.

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported
  • “Our foremost priority is the continued delivery of treatments for visual conditions to our patients worldwide.” – Company website

 

Senti Biosciences

Disease Focus:

Clinical Trial Impacts of COVID-19: 

Drug Supply Impacts of COVID-19:

  • None reported

 

UNITY Biotechnology

Disease Focus:

Clinical Trial Impacts of COVID-19: 

  • “We completed enrollment of both our Phase II and Phase Ib studies in patients with osteoarthritis (OA) of the knee. This progress is particularly noteworthy given the impact of the COVID-19 pandemic on the clinical trial landscape.” – CEO Anirvan Ghosh
  • “UNITY’s clinical and regulatory teams remain active and are working closely with its investigators in its ongoing clinical studies of UBX0101 to adapt to the current environment and ensure the studies remain on-track.” – Company press release

Drug Supply Impacts of COVID-19:

  • “UNITY has sufficient supply of UBX0101 for all ongoing clinical studies.” – Company press release

 

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