Applied DNA reports positive preclinical results for COVID-19 vaccine

Applied DNA Sciences Inc. (APDN) announced that its COVID-19 vaccine candidate has yielded robust antibody and T-cell responses even at very low doses of linear DNA. The company is collaborating with Takis Biotech for developing this vaccine. Both the companies believe that no single vaccine may be able to offer a universal solution to the outbreak.

During the trial, BALB/c mice were given linear DNA at day 1 and a booster vaccination on day 21. All animals exhibited seroconversion to producing IgG against SARS-CoV-2 Spike Protein by day 14. There was also significant increase in response by Day 38. This data was in line with IgGs that in prior studies with plasmids were neutralizing. Five different candidates of linear synthetic genomic constructs of the S gene were assessed. These constructs were designed for optimal expression in muscle and maximal immunogenicity after vaccination.

Linear construct with the sequence corresponding to an abbreviated form of the Spike protein was found to have the strongest T-cell response to the linear vaccines. The T-cell response implicated both the CD4+ and CD8+ lineages, indicating that the response may be sustained for long term. Dr. James A. Hayward, president and CEO of Applied DNA, said, “We look forward to supporting further studies by Takis with a goal of entering human trials in early Autumn. We believe no single vaccine will provide the security we need as a global population, and that our LineaDNA vaccines will complement those already marching toward the market.”

Takesi CEO Dr. Luigi Aurisicchio stated that the companies need to move to toxicology studies and must undertake large animal studies. The companies are also looking to collaborate with third parties to help them in the marketing process.

As per the data retrieved from titration studies, antisera derived from mice vaccinated with linear DNA retained its binding activity even at dilutions of 1:50,000. Existence of IgGs against SARS-CoV-2 Spike in bronchoalveolar lavage shows that vaccination in mouse muscle may permit the consequent antibodies to combat the infection in the lower lung.

These vaccine candidates, in plasmid format, have shown to prompt neutralizing antibodies that blocked uptake of SARS-CoV-2 upon introducing functional virus to human cells in culture in the presence of the mouse antisera. Similar neutralization studies are planned to be undertaken shortly for the antisera produced by the linear DNA constructs.

Linear DNA vaccines have several advantages associated with them. These vaccines remain stable during storage and shipment. These are also amenable to mass production globally. There is also no risk of transferring antibiotic resistance genes. Further, these vaccines are highly efficient, are simple to produce and avoid bacterial vectors. Applied DNA stated that it is capable of manufacturing an improved LineaDNA vaccine in a short period of time of receiving the sequence of a mutant variant.

Applied DNA is a leading Polymerase Chain Reaction (PCR)-based DNA manufacturer, aiding in vitro diagnostic. The company also engages in development of pre-clinical nucleic acid-based therapeutic product candidates and supply chain security measures.

Berkeley Lights shows impressive debut on NASDAQ

Berkeley Lights (BLI) showed stunning performance on its first day of trading. The stock opened at $51.05, 132 percent above its offer price of $22.00 apiece. The company is based out of California and described itself as “leading digital-cell biology company focused on enabling and accelerating the rapid development and commercialization of biotherapeutics and other cell-based products.” Berkeley proved to be the frontrunner in a bunch of biotech companies such as Relay Therapeutics (RLAY) and ALX Oncology (ALXO) raising funds this week.

Berkeley Lights offered 8.1 million shares at $22 per share. The company had raised both the quantity and price upward as earlier its offering was limited to 7.4 million shares. The estimated price range of $19 to $20 per share was also higher than its previous price target range of $16 and $18 per share.

The IPO market is currently in the boom stage in general, but the impact is particularly palpable in the biotech sector. Another biotech company, Relay Therapeutics, saw its stock shooting up 75 percent on the first of day of trading. ALX Oncology's stock climbed 58 percent, closing at $30 in comparison to its offer price of $19 per share. So far this year, 13 biotech companies have raised more than $200 million.

Berkeley does not produce any drug on its own, but its digital cell biology platform can be used to analyze living cells in a variety of ways. This feature is conducive to fast drug development and production processes. The platform captures deep phenotypic, functional and genotypic data for thousands of single cells in parallel. Digital cell biology platform mainly consists of proprietary consumables such as regent kits and OptoSelect chips.

The company is currently collaborating with Pfizer (NYSE:PFE) and Sanofi (NASDAQ:SNY) for antibody discovery processes. Berkeley Lights’ Beacon and Lightning systems and Culture Station instrument are designed for research use only and are not meant for use in diagnostic procedures.

Amicus Therapeutics raises $400 million through non-dilutive debt

Amicus Therapeutics (FOLD) reported that it has executed a definitive agreement with Hayfin Capital. The agreement will allow the company to avail up to $400 million in credit facility. Amicus plans to use the funds for financing various operational and strategic activities. The applicable interest rate for the debt is 6.5% above LIBOR, subject to a 100-basis-point floor.

Amicus stated that, subject to closing conditions, the new loan is likely to be funded before August 4, 2020. Daphne Quimi, Amicus Chief Financial Officer, said, “Securing this financing with market setting terms gives us a strong financial platform to advance both patient and Amicus shareholder interests. Defining now a clear path to profitability, without the need for any future dilutive financing, reflects the global profile of Amicus today and our future.” Hayfin Capital Management is a European alternative asset management firm with nearly €15 billion of assets under management.

Amicus Therapeutics is mainly engaged in the development of novel high-quality medicines for treating rare metabolic diseases. The company has robust development pipeline with well-formed focus on Fabry disease, Pompe disease and Batten disease. Amicus also has several plans in pre-clinical stage. Currently, it has Galafold monotherapy for Fabry in the market. The company expects the revenue to be in the range of $250 million to $260 million for this year.

Amicus has strong suite of platform technologies as well. Its pharmacological chaperone technology aims to deal with LDs that are characterized by mutated proteins. These pharmacological chaperones are small molecules and work by binding themselves to a target enzyme for potentially improving its stability factor. The company uses its proprietary Chaperone-Advanced Replacement Therapy (‘CHART’) technology for developing chaperone or ERT combinations.

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