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 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that it has filed its annual report, including its audited consolidated financial statements on Form 20-F, for the year ended December 31, 2021, with the U.S. Securities and Exchange Commission (Press release, Qiagen, MAR 14, 2022, View Source [SID1234610029]). The document can be accessed on QIAGEN’s website here.

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QIAGEN will provide printed copies of the 2021 Annual Report to shareholders free of charge upon request. To obtain a printed copy of the 2021 Annual Report please use our contact form or send an email to [email protected].

On March 14, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported it expects to release its fourth quarter 2021 financial results before markets open on Monday, March 28, 2022 (Press release, Nuvo Pharmaceuticals, MAR 14, 2022, View Source [SID1234610022]).

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The Company will subsequently hold a conference call the same day, Monday, March 28, 2022 at 11:00 a.m. ET, hosted by Jesse Ledger, Miravo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.

CONFERENCE CALL DETAILS

The audio webcast and webcast replay can be accessed at:

View Source

On March 14, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will present positive preclinical data on the in vitro efficacy of its drug candidate LP-184 in brain metastases (mets) at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, April 8-13th, 2022, held in New Orleans, Louisiana (Press release, Lantern Pharma, MAR 14, 2022, View Source [SID1234610021]).

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LP-184 is a small molecule drug candidate and next generation acylfulvene that preferentially damages DNA in cancer cells that overexpress certain biomarkers and is therefore lethal in tumors that harbor mutations or deficiencies in DNA repair pathways. LP-184 has already been demonstrated preclinically to have potent efficacy in several targeted central nervous system (CNS) cancer indications, including glioblastoma multiforme (GBM) and atypical teratoid rhomboid tumors (ATRT). The development promise for LP-184 in these indications is strengthened by LP-184’s favorable blood brain barrier (BBB) permeability. LP-184 has also demonstrated potent tumor cell killing capabilities in vitro and in animal xenografts of tumors such as lung, breast, melanoma and colon, many of which frequently metastasize to the brain. The tumor specificity of LP-184 is driven by expression levels of PTGR1, and Lantern’s RADR analysis indicates that such expression levels are retained in brain mets of these primary tumors.

The virtual poster will be presented by Lantern Pharma in collaboration with Johns Hopkins School of Medicine and the Kennedy Krieger Institute and will describe positive preclinical data demonstrating the effectiveness of LP-184 treatment in brain mets cell models derived from patient lung, skin, and breast cancers. The poster will also show that in an in vitro model of brain mets from lung cancer, LP-184 treatment was found to be 6 times more potent than EGFR tyrosine kinase inhibitors (a widely used type of therapy).

Brain mets are more common than primary brain tumors (cancer that starts in the brain), and studies suggest that brain mets occur in about 10%-30% of patients with cancer. In the U.S., brain mets (from all cancers combined) are estimated to account for over 100,000 diagnoses annually and generally have a very poor prognosis even after radiation therapy. There is an urgent and unmet clinical need for novel therapies for brain mets due to a current lack of novel agents that can cross the blood brain barrier. LP-184’s favorable BBB permeability paired with its observed preclinical efficacy in certain CNS cancers, underscore its potential to become a vital treatment option for patients relapsed from current standard of care treatment or for use in combination with other agents.

LP-184 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of malignant gliomas, pancreatic cancer, and ATRT, and was also granted a Rare Pediatric Disease Designation for ATRT. These designations and continued positive preclinical data will help to accelerate LP-184 towards IND submission and multiple Phase 1 clinical trials in 2022.

Details of the virtual poster presentation are listed below or can be found on the AACR (Free AACR Whitepaper) website:

Title: LP-184, a tumor site activated small molecule synthetic lethal therapeutic, is effective in central nervous system cancers
Permanent Abstract number: 5442
Date and Time: April 8, 2022, 12:00pm-1:00pm CST
Session Category: Experimental and Molecular Therapeutics
Session Title: Small Molecule Therapeutic Agents
Presenter: Aditya Kulkarni, Ph.D., Lantern Pharma

On March 14, 2022 Nutcracker Therapeutics, Inc., a biotech company developing RNA therapeutics using its proprietary biochip-based manufacturing platform, reported it has raised $167 million in Series C financing led by ARCH Venture Partners (Press release, Nutcracker Therapeutics, MAR 14, 2022, View Source [SID1234610020]). The funds will allow the company to expand and advance its pipeline of mRNA medicines for cancer, in addition to further refining its RNA manufacturing platform and the underlying technology.

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"The recent success of the mRNA vaccines for COVID-19 has brought newfound energy around the use of RNA as a therapeutic tool," said Igor Khandros, Ph.D., co-founder, and CEO of Nutcracker Therapeutics. "As a consequence, we have an unparalleled opportunity to bring this emerging class of medicines to treat patients suffering from very complex diseases. With this significant milestone and the support of our top-flight investors and partners, we are well-positioned to begin the next phase of Nutcracker’s evolution: accelerating RNA therapeutics development within the company and beyond using our unique ‘GMP-in-a-box’ platform, and meet the rising demand for RNA therapies and their efficient, scalable manufacturing."

Nutcracker Therapeutics’ RNA manufacturing platform is at the core of the company’s therapeutic effort. It combines RNA biochemistry with microfluidic engineering, semiconductor-like biochips, and a proprietary nanoparticle delivery technology to create a fully automated and isolated manufacturing pathway. The platform is capable of supporting RNA therapeutic development from discovery to the clinic and commercialization, scaling up appropriately at each stage. Using this platform, the company aims to increase the speed and scale at which therapeutics can be discovered, developed, and manufactured.

Concurrent to the financing, Nutcracker Therapeutics has added Michael F. Bigham, former CEO and current executive chairman of the board of Paratek Pharmaceuticals, to its board of directors. Bigham has more than 30 years of leadership experience in the biopharmaceutical and life science industries, including as a general partner at Abingworth LLP, President and Chief Executive Officer of Coulter Pharmaceuticals, and in various roles at Gilead Sciences, such as Chief Financial Officer and Executive Vice President Operations.

"RNA has unique qualities as a therapeutic modality and could prove to be a first-line tool for many diseases," commented Bigham. "Nutcracker Therapeutics is well-positioned to develop RNA therapeutics in a scalable and efficient manner with its innovative platform. I’m excited to be a part of the team and help further its goal of advancing its pipeline into the clinic and bringing RNA therapies to patients with the greatest need."