Clinical-stage biotechnology company Moderna Inc. (MRNA:NASDAQ), which focuses on developing therapeutics and vaccines utilizing messenger RNA (mRNA), today announced "positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH)."
The company stated that "mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies."
The firm advised that "based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies." The company mentioned that it believes that it will establish a dosage of between 25 µg and 100 µg in its Phases 3 study, which it anticipates will commence in July, subject to finalization of the clinical trial protocol.
The company's Chief Medical Officer Tal Zaks, M.D., Ph.D., commented, "These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg...When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials."
Moderna's CEO Stéphane Bancel remarked, "With today's positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA...We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2."
The company explained that "mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the NIAID, a part of the NIH."
The firm noted that to date, greater than 1,400 individuals have participated in its infectious disease vaccine clinical studies in the Australia, Europe and the U.S. The company added that it now has nine development candidates in its prophylactic vaccines modality including vaccines against respiratory infections, vaccines against infections transmitted from mother to baby and vaccines against highly prevalent viral infections. The firm indicated that so far it has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines and highlighted that its CMV vaccine is currently in a Phase 2 dose-confirmation study and that its investigational Zika vaccine (mRNA-1893), which is currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
Moderna Inc. is a clinical stage biotechnology company headquartered in Cambridge, Mass., engaged in transformative medicines based on messenger ribonucleic acid (mRNA). The firm is pursuing mRNA science to minimize the undesirable activation of the immune system by mRNA and to maximize the potency of mRNA once in the target cells. The company has a diverse development pipeline of 24 programs with multiple clinical studies underway. Its therapeutics and vaccine development programs span infectious diseases, oncology, cardiovascular diseases and rare genetic diseases.
Moderna began the day with a market capitalization of around $24.8 billion with approximately 371.2 million shares outstanding and a short interest of about 6.00%. MRNA shares opened 29% higher today at $86.14 (+$19.45, +29.16%) over Friday's $66.69 closing price and reached a new 52-week high price this morning of $87.00. The stock has traded today between $75.66 and $87.00 per share and is currently trading at $84.28 (+$17.59, +26.38%).[NLINSERT]
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