On March 14, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in cell-free, enzymatic DNA production, and Spindle Biotech Inc. ("Spindle Biotech"), a company focused on the development of a novel, high yield, and low-cost RNA production systems, reported that the two companies have executed a non-binding letter of intent ("LOI") that outlines the terms of a collaborative research agreement (the "Definitive Agreement") to investigate the feasibility of utilizing the Company’s LinearDNA platform to produce chemically modified DNA templates for use in Spindle Biotech’s proprietary, high yield RNA manufacturing system (Press release, Applied DNA Sciences, MAR 14, 2022, View Source [SID1234610030]). The companies believe the combination of their respective platforms provides for a simplified, high yield, and 100% cell-free workflow that is differentiated from current mRNA production that uses plasmid DNA (pDNA). In addition to increased speed and purity, the use of LinearDNA as an IVT template for mRNA production removes several complex manufacturing steps necessitated by pDNA.

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The companies believe that Spindle Biotech’s proprietary, high yield, and engineered RNA polymerase, which requires a chemically modified DNA template, is particularly well suited to leverage the unique advantages of Applied DNA’s PCR-based LinearDNA platform. Under the proposed Definitive Agreement terms, Applied DNA will produce specialized IVT DNA templates for RNA transcription using Spindle Biotech’s RNA polymerase. Following initial validation work, the companies intend to explore the commercialization of an mRNA production system that leverages the benefits of the companies’ respective platforms.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, "We believe that Spindle’s mRNA manufacturing approach is a very good fit for our LinearDNA platform, which excels at the efficient production of chemically modified DNA constructs. As demand for mRNA therapeutics grows, Spindle Biotech and we are pursuing a simplified and efficient method to produce mRNAs with potential advantages in terms of cost, complexity, and production time versus standard pDNA methods to produce mRNA."

Added Aaron Chung, CEO of Spindle Biotech, "Our preliminary studies suggest that a chemically modified LinearDNA-based IVT construct transcribed with our engineered RNA polymerase can offer at least five to ten-fold improvement in yield compared to conventional mRNA production methods using a wild-type T7 RNA polymerase. We believe that the increase in yield coupled with the speed and simplicity of the LinearDNA platform offers compelling advantages over legacy mRNA production methods. Combining Applied DNA’s LinearDNA production technology and Spindle’s proprietary RNA synthesis technology, the two companies can provide tremendous value to the mRNA community with a complete package of high-quality, scalable, and rapid mRNA manufacturing with minimal change to customers’ existing mRNA production pipeline."

Completion of the Definitive Agreement is subject to the negotiation and successful execution of the Agreement by both companies. Accordingly, there can be no assurance that the Definitive Agreement will be entered into by the parties.

On March 14, 2022 Elektrofi (ELEKTROFI, INC) & IPA (IMMUNOPRECISE ANTIBODIES LTD.) (NASDAQ: IPA) (TSXV: IPA) reported they are entering into a collaboration to explore a high-concentration formulation of IPA’s COVID-19 antibody cocktail, PolyTope TATX-03 (Press release, ImmunoPrecise Antibodies, MAR 14, 2022, View Source [SID1234610046]). This collaboration aims to generate an IND-enabling data package for the FDA for an alternatively formulated version of TATX-03, named TATX-03E, that could be easily self-administered in a non-healthcare setting. By joining forces, the parties anticipate formulating TATX-03E for stable and rapid distribution to the consumer, a drug product ideally suited to serve unmet needs for rapid deployment, field use, and higher frequency dosing for immunocompromised individuals requiring on-going access to therapies and prophylaxis.

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The collaboration between Elektrofi and IPA will be supported by Elektrofi’s contract with the DHA Small Business Innovation Research (SBIR) Program within the Department of Defense (DoD). The companies will begin by conducting formulation feasibility studies followed by IND-enabling, non-clinical studies to establish safety and efficacy with the novel formulation.

"We are impressed by the neutralizing activity demonstrated by ImmunoPrecise’s antibody cocktail against current variants of concern, including Omicron. Nearly all other programs we have looked into partnering with do not demonstrate the ability to neutralize so many variants," said Daniel Dadon, Director of Scientific Strategy at Elektrofi. "We look forward to working with IPA to develop a product that could potentially improve access to this class of life saving medicines and reduce the burden on healthcare systems."

"Antibodies have been an essential asset for COVID-19 patients since their introduction earlier in the pandemic," said Dr. Jennifer Bath, CEO and President of IPA. "We are excited to be working with Elektrofi and applying their formulation technology to these critical therapies, as self-administration could significantly alleviate the burden associated with COVID-19 and future pandemics, as well as other diseases."

On March 14, 2022 NeoVirTech, a biotechnology company developing autofluorescent viruses for the discovery of antiviral molecules and the conception of oncolytic virotherapies, reported that joins one of the most advanced clinical research center in France to accelerate its development in the oncolytic field (Press release, Cancer Research Center of Toulouse, MAR 14, 2022, View Source [SID1234610064]). Oncolytic viruses are viruses that are specifically modified and armed to attack cancer cells and trigger a dual response by first inducing direct cancer cell killing and second by stimulating the patient immune system.

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Being located at the CRCT will allow NeoVirTech to combine its expertise in the tagging and visualization of DNA related mechanisms to advanced pilot preclinical research programs of the CRCT. NeoVirTech will share its expertise in high throughput phenotypic screening with CRCT researchers to validate candidate drugs or therapeutic targets. NeoVirTech will also develop new collaborative projects based on its ANCHORTM technology for real-time imaging of single genes in live cells.

The first iconic research program will be to develop novel oncolytic viruses with the Team 10 from CRCT led by Dr Pierre Cordelier. The goal is to provide a collection of ANCHORTM tagged oncolytic viruses to investigate their infection and replication capacities, in vitro and in vivo, and soon directly on patient derived samples. This will allow the measurement of oncolytic potential and help decision-making in terms of individualized cancer treatment by providing quantitative data on treatment efficiency and reduce time-to-decision.

Speeding oncolytic virotherapies development, from bench to bed
NeoVirTech SAS is a French biotechnology company focusing its activity on the development of autofluorescent viruses for the discovery of antiviral molecules, the development of oncolytic virotherapies and the measurement of virus disinfection processes. The company provides services to investigate the behavior of oncolytic viruses according to cell type, dose or the combination with pre-existing treatment. Combined with its ANCHORTM technology, that allows the visualization of the infection and replication of viruses in living cells using high content microscopy approaches, NeoVirTech oncolytic platform provides ultra-fast quantitative and qualitative results on the infection capacity of an oncolytic vector. The company already collaborates with major actors in the oncolytic field such as Transgene SA (Gallardo F et al. Fluorescent Tagged Vaccinia Virus Genome Allows Rapid and Efficient Measurement of Oncolytic Potential and Discovery of Oncolytic Modulators, Biomedicines. 2020 doi:10.3390/biomedicines8120543). The company also develops bespoke programs aiming at the visualization of other class of oncolytic viruses such as parvoviruses.

The Cancer Research Center of Toulouse is a center of excellence developing innovation for the understanding of cancer and the development of anticancer therapies. By combining more than 400 people in a multidisciplinary environment, the CRCT is one of the most advanced cancerology research center in France. Eighteen research teams are located in this center. Among them, Dr Pierre Cordelier’s team ImPact (therapeutic innovation for pancreatic cancer) investigates innovative strategies for patient diagnosed with pancreatic cancer. The team uses NeoVirTech’s proprietary technology to visualize new generation of oncolytic treatment, especially looking at the intrinsic resistance of pancreatic cancer cells to oncolytic viruses. The team also looks for means to sensitize resistant cells to oncolytic virotherapies. This long term collaboration already led to the publication of a scientific article (Quillien, L. et al. A Novel Imaging Approach for Single-Cell Real-Time Analysis of Oncolytic Virus Replication and Efficacy in Cancer Cells. Hum Gene Ther 32, 166–177 (2021). By combining their expertise, NeoVirTech and the Impact team within CRCT aim to develop a theragnostic platform for not only to interrogate the antitumoral efficacy of oncolytic virus in preclinical models, but also to identify combination to increase virotherapy therapeutic index.

NeoVirTech brings to the alliance its know-how in high throughput imaging techniques and innovative models of virus visualization in living cells. NeoVirTech is equipped with high content screening microscope combined with pipetting robots in BSL2, BSL2+ environment. CRCT gives access to its technology platforms and to its scientific expertise in cancer biology and therapy, in close collaboration with clinicians from the University Institute of Cancer of Toulouse, Oncopole.

they testify

"By joining the CRCT, we are structuring our anticancer activities in a place at the forefront of cancer innovation. By being close to teams dedicated to cancer therapies, we will make our best effort to develop innovative virotherapies and optimized screening platform to ensure efficacy of oncolytics and other drugs in development. Our technology combined with state-of the art imaging platform gives a unique, robust and rapid way to measure how a specific tumor cell line, patient derived cell line or in the future patient biopsies respond to specific treatment. We aim at speeding up time-to-decision, maximizing the chance of patients to receive the correct and therefore efficient oncolytic vector, the sooner the better. "
Franck Gallardo, CEO NeoVirTech SAS

"While oncolytic viruses are quickly moving toward the forefront of modern medicines, much remains to be elucidated for creating highly effective treatments based on these biologics. This alliance represents a unique occasion to rationalize the use of oncolytic virus for cancer therapy. With NeoVirTech technology, we will not only have the opportunity to better understand the dialog between oncolytic virus and tumor cells, but also to accelerate personalized therapeutic profiling programs based on oncolytic virotherapy, especially for the management of patient with diseases with no cure such as pancreatic cancer"."
Pierre Cordelier PI, ImPact, CRCT

"One of the CRCT priorities is to foster public-private collaborations with highly dynamic start-ups such as NVT. This gives members of the center privileged access to innovation and supports very promising therapeutic strategies such as the use of oncolytic viruses for cancer therapy"

On March 14, 2022 Elektrofi (ELEKTROFI, INC) & IPA (IMMUNOPRECISE ANTIBODIES LTD.) (NASDAQ: IPA) (TSXV: IPA) reported they are entering into a collaboration to explore a high-concentration formulation of IPA’s COVID-19 antibody cocktail, PolyTope TATX-03 (Press release, ImmunoPrecise Antibodies, MAR 14, 2022, View Source [SID1234610031]). This collaboration aims to generate an IND-enabling data package for the FDA for an alternatively formulated version of TATX-03, named TATX-03E, that could be easily self-administered in a non-healthcare setting. By joining forces, the parties anticipate formulating TATX-03E for stable and rapid distribution to the consumer, a drug product ideally suited to serve unmet needs for rapid deployment, field use, and higher frequency dosing for immunocompromised individuals requiring on-going access to therapies and prophylaxis.

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The collaboration between Elektrofi and IPA will be supported by Elektrofi’s contract with the DHA Small Business Innovation Research (SBIR) Program within the Department of Defense (DoD). The companies will begin by conducting formulation feasibility studies followed by IND-enabling, non-clinical studies to establish safety and efficacy with the novel formulation.

"We are impressed by the neutralizing activity demonstrated by ImmunoPrecise’s antibody cocktail against current variants of concern, including Omicron. Nearly all other programs we have looked into partnering with do not demonstrate the ability to neutralize so many variants," said Daniel Dadon, Director of Scientific Strategy at Elektrofi. "We look forward to working with IPA to develop a product that could potentially improve access to this class of life saving medicines and reduce the burden on healthcare systems."

"Antibodies have been an essential asset for COVID-19 patients since their introduction earlier in the pandemic," said Dr. Jennifer Bath, CEO and President of IPA. "We are excited to be working with Elektrofi and applying their formulation technology to these critical therapies, as self-administration could significantly alleviate the burden associated with COVID-19 and future pandemics, as well as other diseases."

On March 14, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAR 14, 2022, View Source [SID1234610047]). This programme is part of the overall share repurchase programme of up to DKK 22 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 2 February 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 2 February 2022 to 2 May 2022.

Since the announcement 7 March 2022, the following transactions have been made:

Number of

B shares

Average

purchase price

Transaction

value, DKK

Accumulated, last announcement 2,494,151 1,672,029,156
7 March 2022 110,000 693.55 76,290,472
8 March 2022 110,000 699.04 76,894,538
9 March 2022 105,000 689.72 72,420,439
10 March 2022 110,000 704.36 77,479,852
11 March 2022 100,000 691.13 69,112,536
Accumulated under the programme 3,029,151 2,044,226,993

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 34,815,319 B shares of DKK 0.20 as treasury shares, corresponding to 1.5% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 22 billion during a 12- month period beginning 2 February 2022. As of 11 March 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 3,029,151 B shares at an average share price of DKK 674.85 per B share equal to a transaction value of DKK 2,044,226,993.