BioNTech reports positive COVID-19 vaccine data with Pfizer, receives $2 billion order from US Govt

BioNTech SE (BNTX) reported positive early data for its COVID-19 vaccine candidate, BNT162b1. The company is collaborating with Pfizer (PFE) for developing this vaccine candidate. BNT162b1 is a lipid nanoparticle formulated, nucleoside-modified messenger RNA encoding a SARS-CoV-2 receptor binding domain (RBD) antigen.

Phase I/II of the study is an open-label, non-randomized, non-placebo-controlled, dose-escalation trial. It is being conducted in Germany and involves 60 healthy participants aged between 18 and 55 years. Out of these, 12 participants were given 1g, 10g, 30g or 50g of BNT162b1 each on day one and day 22. The remaining 12 participants were administered with a single injection of 60g.

The data showed that the drug candidate induced high, dose-dependent SARS-CoV-2 neutralizing titers and RBD-binding IgG concentrations. These results were found after the administration of second dose. It showed a concurrent stimulation of high level CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD as well. Overall BNT162b1 was found to have a manageable tolerability profile as no serious adverse events were reported.

The data did not show any clear dose level dependency of the T cell response between 1g to 50g, suggesting that low mRNA dose levels may have induced and expanded T cells. zlem Treci, CEO of BioNTech said, "The preliminary data indicate that our mRNA-based vaccine was able to stimulate antibody, as well as T-cell responses at remarkably low dose levels. We believe both may play an important role in achieving effective clearance of a pathogen, such as SARS-CoV-2." He added that the data from German study is in line with the data obtained from US study cohort.

The company plans to use the data collected from these studies to determine a dose level. BioNTech will also use the data from other preclinical and clinical studies. Further, the data will also be used for selecting vaccine candidates for a Phase IIb/III safety and efficacy trial, which may enroll up to 30,000 healthy volunteers.

The company's successful trial is followed up by a mass order for the vaccine candidate placed by the United States government. According to the reports, the US government has ordered up to 100 million dosage for $1.95 billion. The payment will be made once the vaccine is delivered, post regulatory approval. The US government may decide to opt for up to additional 500 million doses.

Further, European Union is also believed to be in fray for the vaccine candidate. However, European Union declined to individually identify the firms it is currently in talks with. The United States government has entered the deal through its Department of Health and Human Services and the Department of Defense. The government's Operation Warp Speed aims to begin delivering 300 million doses of a vaccine for COVID-19 in 2021.

The BNT162 program is based on BioNTech's proprietary mRNA technology. Pfizer is supporting the program through its global vaccine development and manufacturing capabilities. BioNTech will hold all trademarks for the potential product and has the global market authorization. The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each with a unique blend of messenger RNA (mRNA) format and target antigen.

AxoGen Inc. (AXGN) reported the conclusion of its enrollment for Phase 3 pivotal RECON clinical study. The company has enrolled 220 participants in the trial. The protocol for the trial comprises one year follow up assessment as well as three-month visit window. The last patient enrolled is expected to finish the study no later than October 2021.

RECON clinical study or Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair is a multicenter, evaluator blinded and randomized clinical study of nerve cuffs and Avance Nerve Graft evaluating recovery outcomes for the repair of nerve discontinuities. The study aims to test non-inferiority between the static two-point discrimination outcomes for nerve cuffs and Avance Nerve Graft.

AxoGen expects the preliminary data to be available during the second quarter of 2022. Karen Zaderej, chairman, CEO, and president of AxoGen, "Completing enrollment for the RECON Study is a critical step in transitioning our Avance Nerve Graft from classification as a section 361 HCT/P tissue product to a section 351 biological product." The company will likely file the BLA for the drug candidate in 2023.

Avance Nerve Graft is a biologically active off-the-shelf processed human nerve allograft. It is mainly used for bridging the gap between severed peripheral nerves without the comorbidities associated with a second surgical site. The product is available in wide range of lengths and diameters. Avance Nerve Graft received a Regenerative Medicine Advance Therapy tag from the FDA in September 2018. The designation allows the candidate to go through a streamlined approval process for regenerative medicine technologies. It also provides for frequent informal meetings with the FDA.

InflaRx (IFRX) announced its plan to continue development of IFX-1 for treating severe COVID-19 induced pneumonia. The company is looking to start a randomized, placebo-controlled, double-blinded Phase III trial spread across multiple sites in the US, Europe, South America and potentially other regions. The plans are subject to regulatory approvals.

The Phase III study is expected to enroll nearly 360 patients who are early intubated and are critically ill. An interim analysis is planned to be carried out once 180 patients are enrolled. There is also provision for an early stop of efficacy or futility. The primary endpoint for the trial is 28 day all cause mortality. Other proposed key endpoints include evaluation of organ support and analysis of disease improvement on the ordinal scale.

The Phase II part of the study assessed IFX-1 treatment plus best supportive care compared to best supportive care alone for up to 28 days. That phase enrolled 30 patients and was randomized. Dr. Korinna Pilz of InflaRx noted, "Data from the initial exploratory Phase II part of the study in patients with severe COVID-19 induced pneumonia suggested a positive impact of IFX-1 treatment on the all-cause mortality rate and other endpoints." The IFX-1 treatment arm had shown 13 percent 28-day all-cause mortality rate.

IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody. It works by blocking the activity of C5a. It also shows high selectivity towards its target in human blood. The drug candidate is currently being assessed for a wide range of indications including Pyoderma Gangraenosum, Hidradenitis Suppurativa and ANCA-associated vasculitis among others.

InflaRx is a clinical-stage biopharmaceutical company. It is mainly engaged in discovering and developing specific and potent inhibitors of C5a using its proprietary anti-C5a technology.

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BioNTech COVID-19 Progress, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha