Applied DNA Biotherapeutics Subsidiary LineaRx to Present Data Showcasing Advantages of its Enzymatically Produced LinearDNA as Substitute for Plasmid DNA in IVT mRNA Production

On July 22, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in PCR-based technologies, reported that Dr. James A. Hayward, president and CEO of Applied DNA and its majority-owned biotherapeutics subsidiary, LineaRx Inc., will present data highlighting the advantages of its enzymatically produced linearDNA (linDNA) as an IVT template for mRNA production at the 2nd Annual mRNA-Based Therapeutics Summit on July 26-28, 2022, in Boston, Massachusetts (Press release, Applied DNA Sciences, JUL 22, 2022, View Source [SID1234616874]).

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Dr. Hayward’s presentation, titled ‘The Future of RNA Therapies Produced from LinearDNA Templates,’ is scheduled for Wednesday, July 27, at 4:30pm EST at Hilton Boston Logan Airport. A copy of the slide presentation will be made available to interested parties concurrent with the start of the presentation at View Source

LineaRx staff will be available at Booth 3 at the Summit. To schedule a meeting, contact: [email protected].

linDNA is an optimal IVT template for mRNA production as compared to plasmid DNA (pDNA). Produced by the LinearDNA platform, a cell-free enzymatic manufacturing platform for the large-scale production of high-fidelity DNA sequences for use in nucleic acid-based therapeutics, linDNA enables:

A simplified IVT workflow as compared to pDNA;
IVT from linDNA potentially requiring less DNA than IVT from pDNA to achieve equivalent RNA yields;
The production of difficult DNA sequences, such as precise poly(T) tails in IVT templates;
The removal of the problematic DNA sequences found in pDNA, such as antibiotic resistance genes; and,
Rapid scalability in a minimal footprint.
"Current IVT mRNA production methods must improve to move mRNA technology to broader commercialization to support therapeutic and vaccine development. As process yields and production scale have an impact on the manufacturing costs and consequentially on the cost per dose, we believe that linDNA’s numerous advantages over current pDNA as an IVT template can help solve many of the challenges currently experienced by mRNA developers and manufactures," stated Dr. Hayward.

Learn more about how linDNA can accelerate your DNA manufacturing through the clinic and towards commercialization: View Source

ITM Signs Clinical Supply Agreement with Y-mAbs for n.c.a. Lutetium-177

On July 21, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported the signing of a clinical supply agreement for its medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu / EndolucinBeta) with Y-mAbs Therapeutics, Inc. (Y-mAbs), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. Under the terms of the agreement, ITM will provide its n.c.a. 177Lu for the clinical development of Y-mAbs’ radiopharmaceutical candidate GD2-SADA: 177Lu-DOTA Complex.

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GD2-SADA is currently in the preclinical development for the treatment of GD2-positive solid tumors, with a phase I study planned for 2022. GD2 (Disialoganglioside 2) is a tumor-associated antigen overexpressed by various tumor types, such as malignant melanoma, sarcoma, and small cell lung cancer, and used as a target for Targeted Radionuclide Therapy, potentially a precise approach being developed to directly destroy tumor tissue with minimal impact to surrounding healthy tissue.

The radiopharmaceutical candidate GD2-SADA: 177Lu-DOTA Complex, is a two-step radioimmunotherapy, administered as an IV infusion. The 177Lu-DOTA Complex consists of a chelator (DOTA) and ITM’s medical radioisotope n.c.a. 177Lu and targets the previously administered tumor-binding antibody construct GD2-SADA enabling the delivery of the therapeutic radiation of n.c.a. 177Lu to the tumor-site in order to destroy the malignant cells.

"GD2-positive solid tumors include a wide range of tumor types, and we believe the Y-mAbs approach can potentially offer a promising treatment option for patients who are affected by these cancers. We are proud to contribute to the company’s candidate development with our highly pure n.c.a. 177Lu," comments Steffen Schuster, CEO of ITM. "We are committed to providing high-quality radioisotopes not only to our own radiopharmaceutical pipeline, but also to our partners to offer improved precision oncology treatments to healthcare professionals and their patients to the greatest extend possible."

N.c.a. 177Lu is a market-approved, highly pure form of the beta-emitting radioisotope lutetium-177 that can be linked to a variety of tumor-specific targeting molecules for the treatment of various cancers and has been successfully used in numerous clinical and commercial radiopharmaceutical cancer treatments.

The agreement was executed between Y-mAbs and ITM’s wholly owned subsidiary ITM Pharma Solutions GmbH.

About Targeted Radionuclide Therapy
Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue.

(Press release, ITM Isotopen Technologien Munchen, JUL 21, 2022, View Source [SID1234661149])

Roche achieves good results in the first six months of 2022

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Half-Year Results 2022

On July 21, 2022 Roche reported half-yearly results 2022 (Presentation, Hoffmann-La Roche, JUL 21, 2022, blob:View Source [SID1234618487]).

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Cytokinetics to Announce Second Quarter Results on August 4, 2022

On July 21, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report second quarter results on August 4, 2022 at 4:00 PM Eastern Time (Press release, Cytokinetics, JUL 21, 2022, View Source [SID1234616881]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics Q2 2022 Earnings Conference Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call. An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.