VBI Vaccines Inc. (VBIV:NASDAQ), which is focused on the development of novel infectious disease and immuno-oncology vaccines, yesterday announced "data from three preclinical mouse studies conducted to enable selection of optimized clinical candidates for the company's coronavirus program, VBI-2900."
The firm advised that after reviewing the data from these three studies, it has selected two vaccine candidates that it believes have the potential to become one-dose vaccines that can be examined in an adaptive Phase 1/2 human clinical trial. The company anticipates that subject to regulatory approval, it will be able to start the study around the end of 2020. The company identified the first vaccine candidate as "VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins, and the second candidate as VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 (COVID-19) spike protein."
VBI explained that the goals of the preclinical studies were "to assess the impact of VBI's proprietary enveloped virus-like particle (eVLP) platform technology vs. recombinant vaccine candidates, differences in the conformation of the spike protein, and a variety of adjuvants." The company noted that the data from the preclinical studies showed positive results in neutralizing antibody (nAb) and antibody binding (Ab) activity, impact of adjuvants and additional benefit of trivalent construct.
The company's President and CEO Jeff Baxter commented, "We are excited to announce these impressive pre-clinical data, which we believe clearly support the advancement of the two vaccine candidates, VBI-2901 and VBI-2902, into human clinical studies around the end of the year...An effective solution to the ongoing COVID-19 pandemic will require a vaccine that is capable of providing robust protection, quickly. Based on the data seen to-date, we believe the VBI-2900 program has the potential to be administered as a one-dose vaccine regimen at human doses ranging from 2-5mcg, and, further, VBI-2901 may offer increased breadth of reactivity across a broader range of coronaviruses. We are very encouraged by these results and remain deeply committed to addressing this devastating public health crisis."
The firm stated that as part of these studies it collected and analyzed convalescent sera from 20 people who had previously contracted COVID-19 and recovered. The samples were grouped based upon those participants who mounted a high-titer, robust response to the infection and those with a low-titer, weaker response.
VBI indicated that earlier this month to prepare for the commencement of clinical studies by year-end 2020, it entered into a collaboration agreement with Therapure Biomanufacturing. Therapure is a contract development and manufacturing organization that will be instrumental in assisting in the production of its coronavirus vaccine candidates and will manufacture bulk vaccine for use through Phase 2 clinical studies.
VBI Vaccines is a commercial-stage biopharmaceutical company headquartered in Cambridge, Mass., with research operations in Canada and research and manufacturing facilities in Israel. The firm concentrates its efforts on developing next generation vaccines that meet unmet medical needs in infectious disease and immuno-oncology. VBI stated that it is currently advancing several vaccines in order to prevent and treat hepatitis B along with a vaccine immunotherapeutic candidate targeting glioblastoma, a prophylactic cytomegalovirus vaccine candidate, and a prophylactic pan-coronavirus vaccine candidate.
VBI Vaccines started the day with a market capitalization of around $742.1 million with approximately 231.2 million shares outstanding and a short interest of about 5.5%. VBIV shares opened 29% higher today at $4.15 (+$0.94, +29.28%) over yesterday's $3.21 closing price. The stock has traded today between $4.05 and $5.20 per share and is presently trading at $4.30 (+1.09, +33.96%).[NLINSERT]
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