COVID-19 roundup: Grifols partners with BARDA, FDA on convalescent plasma; plus Vir, Sorrento, Ascletis, BMS and Ipsen
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On the heels of FDA guidance for compassionate use of convalescent plasma for COVID-19, Grifols announced on Wednesday a partnership with the U.S. government to develop the therapy. Meanwhile, Vir and Sorrento are advancing their COVID-19 countermeasures.
Grifols S.A. (Madrid:GRF; NASDAQ:GRFS) will collaborate with the Biomedical Advanced Research Development Authority, FDA and other U.S. public health agencies to generate a COVID-19 therapy derived from convalescent plasma collected from COVID-19 patients. The company will process the plasma into hyperimmune globulin and support preclinical and clinical studies evaluating the therapy’s efficacy.
Grifols said it is also making available its methylene blue-based viral inactivation technology to enable COVID-19 treatment with plasma. It is planning a clinical trial in Spain to test inactivated plasma.
FDA released guidance Tuesday to help physicians provide convalescent plasma to COVID-19 patients on a compassionate use basis while acknowledging that the safety and efficacy of the approach has not been established in clinical trials (see “FDA Facilitating Compassionate Use”).
Vir advances mAbs
Vir Biotechnology Inc. (NASDAQ:VIR) said it has chosen its first two mAbs against SARS-CoV-2 for clinical development, and expects to begin Phase I/II testing in three to five months, keeping pace with AbCellera Biologics Inc., which has floated a June Phase I start for its COVID-19 antibodies.
Both Vir and AbCellera have R&D collaborations with NIH for COVID-19 antibodies, and both have partnered with larger companies to boost manufacturing capacity -- Vir with WuXi Biologics Inc. (HKEX:2269) and Biogen Inc. (NASDAQ:BIIB) and AbCellera with Eli Lilly and Co. (NYSE:LLY). Vir said it had transferred its candidates “several weeks ago” to WuXi and Biogen to accelerate its development timeline (see “AbCellera, Vir Find Partners”).
Vir’s mAbs both hit the same target and have Fc domains that were engineered using Xtend Fc technology from Xencor Inc. (NASDAQ:XNCR) to extend half-life, and one of the mAbs include a “vaccinal” mutation designed to elicit CD8+ T cells for long-term immunity.
Xencor announced Wednesday it had granted Vir a non-exclusive license to Xtend for COVID-19 mAbs. Financial terms were undisclosed.
Sorrento’s COVID-19 vaccine
Sorrento Therapeutics Inc. (NASDAQ:SRNE) unveiled STI-6991, its preclinical COVID-19 vaccine, and said it discussing with FDA the IND-enabling studies, CMC and clinical protocol and endpoints it will need to obtain accelerated approval. The company aims to have STI-6991 in clinical trials mid-year.
STI-6991 comprises replication-deficient human erythroleukemia cells that express and present on the cell membrane viral S1, the portion of the SARS-CoV-2 spike that contains the receptor-binding domain. The company believes the vaccine from its I-Cell platform can elicit T and B cell responses.
The vaccine complements CMAB020 (STI-4920), a bispecific fusion protein comprising an antibody against the SARS-CoV-2 spike and truncated angiotensin-converting enzyme 2 (ACE2), the host protein that the spike binds to mediate viral cell invasion.
Sorrento gained exclusive rights from Mabpharm Ltd. (HKEX:2181) on Tuesday to develop and commercialize the bispecific in North America and Europe.
Latest Ascletis data
In a preprint posted to medRxiv, Ascletis Pharma Inc. (HKEX:1672) unveiled clinical data from 11 COVID-19 patients receiving Ganovo danoprevir plus ritonavir in an open-label Chinese Phase IV trial. In early March, the company said all 11 patients in the trial’s Ganovo/ritonavir cohort had been discharged from the hospital after satisfying discharge criteria under “Diagnosis and Treatment Program for Novel Coronavirus Infection (Trial Version 6),” issued by China’s National Health Commission.
Discharge criteria were normal body temperature for at least three days; significantly improved respiratory symptoms; lung CT scans indicating pneumonia resolution and two consecutive negative RT-PCR tests for SARS-CoV-2.
Six patients -- two who were naïve to antiviral therapy and four who were on lopinavir/ritonavir plus interferon -- had been hospitalized for five days or fewer prior to receiving Ganovo plus ritonavir and interferon. The patients, who had their first negative PCR tests 3-5 days after beginning Ganovo/ritonavir treatment, were discharged 4-12 days later.
The remaining five patients had been hospitalized and on lopinavir/ritonavir plus interferon for 10-13 days before treatment with Ganovo plus ritonavir without interferon; and were discharged 5-9 days later. In these patients, the first negative PCR readouts occurred on days 3-9 after beginning Ganovo/ritonavir therapy.
BMS, Ipsen updates
Bristol Myers Squibb Co. (NYSE:BMY) is suspending site activations for new studies and new site activations for ongoing trials in patients and healthy volunteers until April 13. The pharma disclosed the suspensions in a March 20 letter, which was included in an SEC filing Wednesday.
For studies that have already passed “first patient first visit,” enrollment may continue if trial sites are able to recruit and manage new patients and comply with the study protocol and BMS is able to conduct data monitoring on site or via established processes granting direct access to electronic medical records.
BMS advised investigators to weigh the public health consequences, including the impact of travel to trial sites, of enrolling new patients
Also on Wednesday, Ipsen Group (Euronext:IPN; Pink:IPSEY) said it predicts only limited financial impact from COVID-19, but suspended its 2020 financial guidance. It cited the “general economic slowdown, its performance year-to-date in China, reduced interactions with healthcare professionals and the uncertainty” about how long the pandemic would last.
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