Pharma COVID Roundup: News from Novartis, Amgen, Pfizer, and GSKBy
The latest from pharma companies on developments of potential COVID-19 treatments with news from Novartis, Amgen, Pfizer, GSK, CSL, Takeda, Biotest, Inovio Pharmaceuticals, and Hope Biosciences.
In this roundup:
- Novartis Initiates Clinical Study of Jakavi in COVID-19 Patients
- Amgen, Adaptive Biotechnologies Form Pact for COVID-19 Therapy
- Pfizer, BioNTech Sign $748-M Pact for COVID-19 Vaccine Candidates
- Pfizer Provides Update on R&D Projects for COVID-19 Treatments
- GSK, Vir Biotechnology Form Pact for COVID-19 Drug Development
- CSL, Takeda, Others Form Pact for COVID-19 Hyperimmune Therapy
- Inovio Readies COVID-19 Vaccine Candidate for Phase I Trial
- Fujifilm Initiates Clinical Trials of Possible COVID-19 Antiviral
- FDA Approves Stem-Cell COVID Clinical Trial from Hope Biosciences
Novartis Initates Clinical Study of Jakavi in COVID-19 Patients
Novartis has announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi (ruxolitinib), a drug for treating myelofibrosis, a form of bone-marrow cancer, and adult patients with polycythemia vera, a form of bone-marrow cancer. The proposed trial will assess Jakavi in combination with standard of care (SoC) therapy, compared to SoC therapy alone, in patients with severe COVID-19 pneumonia as a result of SARS-CoV-2 infection.
Given the rapid spread of the pandemic, and as plans for the study are finalized, Novartis also has set up an international compassionate-use program for eligible patients, subject to local regulations. Novartis says it is taking steps to manage the anticipated increase in COVID-19- related requests for Jakavi without interrupting access for patients taking the drug for its licensed indications. In the US, ruxolitinib access requests are coordinated by Incyte.
Amgen, Adaptive Biotechnologies Form Pact for COVID-19 Therapy
Amgen and Adaptive Biotechnologies, a Seattle, Washington-based biotechnology company, are partnering to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19) to potentially prevent or treat COVID-19.
The collaboration will use Adaptive’s immune-medicine platform for the identification of virus-neutralizing antibodies with Amgen’s immunology and antibody therapy development. As reported on April 2, 2020, the companies will begin work immediately and finalize financial details and terms in the coming weeks.
Neutralizing antibodies defends healthy cells by interfering with the biological function of an invading virus, according to information from the companies. These antibodies may be used therapeutically to treat someone currently fighting the disease and can be given to people who have heightened risk of exposure to SARS-CoV-2, such as healthcare workers.
Adaptive will extend its platform to screen the genetic diversity of the B cell receptors from individuals that have recovered from COVID-19. This enables the identification of tens of thousands of naturally occurring antibodies from survivors of COVID-19 to select those that neutralize SARS-CoV-2. Amgen will then use antibody engineering and drug-development capabilities to select, develop and manufacture antibodies designed to bind and neutralize SARS-CoV-2. deCODE Genetics, a subsidiary of Amgen located in Iceland, will provide genetic insights from patients who were previously infected with COVID-19.
The two companies have signed a memorandum of understanding to enable the parties to start work and are planning to execute a collaboration and license agreement. Terms of the agreement are not being disclosed.
Pfizer, BioNTech Sign $748-M Pact for COVID-19 Vaccine Candidates
Pfizer and BioNTech, a Mainz, Germany-based biopharmaceutical company, have provided further updates on their collaboration for the co-development and distribution (excluding China) of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection.
The collaboration seeks to advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring worldwide access to the vaccine, if approved. The collaboration will use Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.
The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the US and Europe across multiple sites. BioNTech and Pfizer say they intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance.
During the clinical-development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale up manufacturing capacity to provide worldwide supply in response to the pandemic. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China, which is already covered by BioNTech’s collaboration with Fosun Pharma, a Shanghai-based biopharmaceutical company), upon regulatory approval.
Under the agreement, Pfizer will pay BioNTech $185 million in upfront payments, including a cash payment of $72 million and an equity investment of $113 million. BioNTech is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. Pfizer and BioNTech will share development costs equally. Initially, Pfizer will fund 100% of the development costs, and BioNTech will repay Pfizer its 50% share of these costs during the commercialization of the vaccine.
Pfizer Provides Update on R&D Projects for COVID-19 Treatments
As part of a previously announced five-point plan to support the development of potential treatments against the novel coronavirus (COVID-19), Pfizer has provided an update on its drug-development efforts as outlined below.
Antiviral compound screening. Pfizer has confirmed (as reported on April 9, 2020) a lead compound and analogues are potent inhibitors of the SARS-CoV-2 3C-like (3CL) protease, based on the results of initial screening assays. In addition, the company reports that preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2, the virus that causes COVID-19. Consequently, Pfizer says it will perform preclinical confirmatory studies, including further antiviral profiling and assessment of the suitability of the lead molecule for intravenous administration clinically. In parallel, the company is also investing in materials that will accelerate the start of a potential clinical study of the lead molecule to the third quarter of 2020, three or more months in advance of earlier estimates, subject to positive completion of the preclinical confirmatory studies.
Azithromycin as an antiviral. In an effort to share information that could benefit COVID-19 mitigation efforts, Pfizer says its researchers will publish a review in the journal, Clinical Pharmacology and Therapeutics which assesses published in vitro and clinical data regarding azithromycin as an agent with antiviral properties. The company says that this open-access review may serve to facilitate the use of azithromycin in future research on COVID-19. Azithromycin is not approved for the treatment of viral infections.
Further evaluation of Pfizer’s existing medicines. Pfizer and the Liverpool School of Tropical Medicine’s Respiratory Infection Clinical Research Group are launching two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2, the virus that caused the novel coronavirus (COVID-19). Pfizer is expected to finalize in the coming days (as reported on April 9, 2020), a research collaboration agreement with Liverpool to provide funding and in-kind laboratory testing support for this research.
The studies will evaluate whether patients infected with COVID-19 have a higher risk of also developing pneumococcal pneumonia and if having both infections leads to more severe disease and poorer outcomes. One study, the SAFER study, will enroll 100 healthcare workers at the Royal Liverpool Hospital and examine rates of SARS-CoV-2 acquisition and dynamics of pneumococcal colonization. The other study, the FASTER study, will recruit 400 patients from the infectious disease ward at the Royal Liverpool Hospital suspected of having coronavirus. Enrollment has already begun, and data are expected over the next few months (as reported on April 9, 2020).
In addition, Pfizer is supporting an independent Phase II investigator-initiated study for the use of tofacitinib, an oral Janus Kinase (JAK) inhibitor, in patients with SARS-CoV-2 interstitial pneumonia, which is planned to be initiated in Italy later this week (as reported on April 9, 2020). The study is supported by a Pfizer grant.
Pfizer is also in discussions with other institutions about additional studies involving tofacitinib and potentially other immune modulators in the company’s portfolio. This research is based on the hypothesis that JAK inhibition could mitigate systemic and alveolar inflammation in patients with COVID-19-related pneumonia by inhibiting cytokine signaling involved in immune-mediated inflammatory response that could lead to damage of the lungs, resulting in acute respiratory distress syndrome in patients with COVID-19-related pneumonia. Tofacitinib is not currently approved for this use.
GSK, Vir Biotechnology Form Pact for COVID-19 Drug Development
GlaxoSmithKline (GSK) and Vir Biotechnology have signed a binding agreement to enter into a collaboration to research and develop for treatments for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.
The collaboration will use Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. The companies will use GSK’s experience in functional genomics and combine capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. The companies will also research SARS-CoV-2 and other coronavirus vaccines.
The initial focus of the collaboration will be to accelerate the development of specific antibody candidates identified by the Vir platform, VIR-7831 and VIR-7832, that have demonstrated for the SARS-CoV-2 spike protein and in neutralizing SARS-CoV-2 in live virus-cellular assays. Subject to regulatory review, the companies plan to proceed directly into a Phase II clinical trial within the next three to five months (as reported on April 6, 2020).
The collaboration will also use Vir’s CRISPR screening and machine-learning approach to identify cellular targets whose inhibition can prevent viral infection. Vir has identified potential targets against the flu and other respiratory pathogens, as well as the hepatitis B virus, and will now focus on SARS-CoV-2.
Additionally, the companies have agreed to conduct research into SARS-CoV-2 and other coronavirus vaccines by using GSK’s vaccines technologies with Vir’s ability to identify neutralizing epitopes that are present across entire viral families. These efforts will be additive to other initiatives GSK is advancing to develop a potential vaccine for COVID-19.
In addition, to gain access to Vir’s technology, GSK has made an equity investment in Vir of $250 million. The equity investment and collaboration agreement were completed at the same time and are conditional upon customary conditions, including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.
CSL, Takeda, Others Form Pact for COVID-19 Hyperimmune Therapy
Biotest, Bio Products Laboratory, LFB, and Octapharma have joined an alliance formed by CSL Behring and Takeda to develop a potential plasma-derived therapy for treating COVID-19. The alliance will begin immediately (as reported on April 6, 2020) with the investigational development of one, unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19.
The collaboration will use work that the companies already have underway. Experts from the pact will begin collaborating across aspects such as plasma collections, clinical trial development, and manufacturing. Further companies and institutions may join the pact as well.
Developing a hyperimmune will require plasma donation from many individuals who have fully recovered from COVID-19, and whose blood contains antibodies that can fight the novel coronavirus. Once collected, the convalescent plasma would then be transported to manufacturing facilities where it undergoes proprietary processing, including effective virus inactivation and removal processes, and then is purified into the product.
Source: CSL Behring
Inovio Readies COVID-19 Vaccine Candidate for Phase I Trial
Inovio Pharmaceuticals, a Plymouth Meeting, Pennsylvania-based pharmaceutical company, reports that the Food US and Drug Administration has accepted the company’s Investigational new drug (IND) application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection. The company was scheduled to begin Phase I clinical testing of INO-4 800 in healthy volunteers beginning April 6, 2020.
The Phase I study of INO-4800 will enroll up to 40 healthy adult volunteers in Philadelphia, Pennyslyvania (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, Missouri (at the Center for Pharmaceutical Research), where screening of potential participants has begun. Study supplies of INO-4800 arrived at the sites in early April (April 2020). Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer. Additional preclinical trials, including challenge studies, will continue in parallel with the Phase I clinical trial.
Source: Inovio Pharmaceuticals
Fujifilm Initiates Clinical Trials of Possible COVID-19 Antiviral
Fujifilm Toyama Chemicals, a provider of radiopharmaceuticals and small-molecule drugs, has initiated a Phase III clinical trial to evaluate the safety and efficacy of its influenza antiviral drug, Avigan (favipiravir),in Japan for patients of COVID-19, a respiratory infection caused by the novel coronavirus (SARS-CoV-2).
Avigan, approved for manufacture and sale as an influenza antiviral drug in Japan, has a mechanism of action for selectively inhibiting RNA polymerase involved in influenza viral replication. Due to this mechanism, it is expected that Avigan may potentially have an antiviral effect on the new coronavirus as it is classified into the same type of single-stranded RNA virus as influenza, and its clinical application to treat COVID-19 is now under study, according to information from the company
In early March (2020), Fujifilm began increased production of Avigan and now plan to accelerate the production of Avigan through cooperation with domestic and overseas partners in response to the needs of the Japanese government and other countries.
The company announced on April 9, 2020 that it will initiate a Phase II clinical study in the US to evaluate Avigan for treating COVID-19. The trial will enroll approximately 50 patients with COVID-19 in collaboration with Brigham and Women’s Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School.
FDA Approves Stem-Cell COVID Clinical Trial from Hope Biosciences
Hope Biosciences, a clinical-stage biopharmaceutical company focused on developing cell-based therapeutics for acute and chronic diseases, has received approval from the US Food and Drug Administration for a Phase II clinical trial of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19.
MSCs are known for their immunomodulatory and regenerative potential. In a recent Phase I/II clinical trial for rheumatoid arthritis, results appeared to show that HB-adMSCs were effective in attenuating systemic inflammation, according to information from the company. In COVID-19 patients, inflammation is a driving force behind disease progression.
This is the first of three new drug applications related to COVID-19 that Hope Biosciences has filed with the FDA. This initial protocol is specifically designed for patients who already have their own stem cells banked with Hope Biosciences. The next two protocols will utilize a donor-cell source that will aim in protecting against COVID-19 for those at high risk (patients and frontline workers) and treating hospitalized patients.
This study is funded by the Hope Biosciences Stem Cell Research Foundation, which is administered through the Greater Houston Community Foundation.
Source: Hope Biosciences