On March 14, 2022 SIWA Therapeutics, Inc. ("SIWA"), a Chicago-based biopharmaceutical company reported that SIWA’s proprietary humanized monoclonal antibody, SIWA318H, is efficacious in an immune competent humanized mouse xenograft model for pancreatic cancer (Press release, SIWA Therapeutics, MAR 14, 2022, View Source [SID1234610033]). The study was conducted by the Translational Genomics research Institute ("TGEN"), pursuant to a SIWA-sponsored research agreement.

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Results of the pancreatic cancer study in humanized mice treated with SIWA318H included:

Both the SIWA318H high dose and low dose treatment groups showed significant anti-tumor activity in a PSN1 human pancreatic cancer mouse xenograft tumor model by significantly reducing tumor growth (P-Value < 0.0001);
There was a significantly higher number of complete remission cases in the treated groups compared to the isotype-treated control group.
37.5% (6 out of 16 mice) treated with SIWA318H high dose had a complete remission response; (P-value = 0.0325)
43.8% (7 out of 16 mice) treated with SIWA318H low dose had a complete remission response; (P-value = 0.0143)
SIWA318H treated mice had a favorable overall survival of more than 45 days compared to only 26 days of median overall survival for control animals, strongly suggesting potential clinical benefit for the treatment of pancreatic cancer in humans.
There were no significant differences in body weight changes between the control and treatment groups, indicating SIWA318H at the doses used were well-tolerated.
"We are very pleased with the findings of SIWA318H in this study and what this means in the fight against cancer," said Lewis Gruber, CEO and Chief Scientific Officer of SIWA. "SIWA has developed a two-pronged attack on cancer by using SIWA318H to clear cancer cells as well as the senescent cells in the tumor micro-environment that support them. We believe this ability to target both cancer cells and senescent cells makes SIWA318H a comprehensive immunotherapy for virtually all cancers as well as for stopping cancer progression, metastasis, and relapse."

SIWA indicated that based upon its results with pancreatic cancer and metastasis, and based upon results showing statistically significant reduction in lung metastases in a 4T1 mouse model of triple negative breast cancer using a mouth homolog of SIWA318H (P-value ≤ 0.001), it expects to file its first IND with the FDA in 2023 for pancreatic cancer. It also expects to request that the FDA grant a FastTrack designation.

On March 14, 2022 SOPHiA GENETICS (Nasdaq: SOPH) and REALM IDx reported that they signed a letter of intent to collaborate in the co-development of novel genomic applications and commercialization of multi-modal applications (Press release, Sophia Genetics, MAR 14, 2022, View Source [SID1234610032]). Together, the companies aim to expand next-generation sequencing (NGS) research for cancer care and develop new multi-modal data streams to improve patient outcomes. The companies expect to enter into a definitive collaboration agreement following further discussion.

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NGS is becoming the new standard of care in cancer diagnostics, particularly as novel therapies require genomic information to be prescribed in a personalized way. With the intended collaboration, SOPHiA GENETICS and REALM IDx’s endeavor is to enrich and scale the analysis of NGS assays, including Homologous Recombination Deficiency (HRD). Assessments can leverage TumorNEXT-HRD, a product of Ambry Genetics, a subsidiary of REALM IDx. SOPHiA GENETICS and REALM IDx also expect to explore the potential for increasing diagnostic insights by combining Ambry Genetics’ Variant Assessment database (AVA) with SOPHiA GENETICS’ SOPHiA DDM (Data-Driven Medicine) platform for HRD detection.

"SOPHiA GENETICS’ mission is to advance data-driven medicine to improve health outcomes worldwide. We want to bring together our global SOPHiA DDM platform, powered by AI and machine learning, with REALM IDx’s cancer screening capabilities and early detection diagnostics. Our goal is to enable health care professionals to leverage insights across multiple data sources with the aim to provide better diagnosis and treatments for the benefit of patients around the world," said Jurgi Camblong, co-founder and CEO, SOPHiA GENETICS.

SOPHiA GENETICS and REALM IDx also share an interest in bringing together genomics, radiology, and pathology data, combined with artificial intelligence, to generate actionable insights. While REALM IDx’s subsidiary Ambry Genetics has focused on screening and early detection diagnostics in pancreatic and breast cancers, SOPHiA GENETICS’ focus has been on prediction response models in advanced stage cancers, such as lung cancer. The companies hope that synergies between SOPHiA GENETICS and REALM IDx may provide opportunities to explore combining data sources and capabilities in the multimodal space, potentially creating a roadmap for comprehensive oncology applications.

As part of the intended collaboration, SOPHiA GENETICS may use Ambry Genetics’ lab for their sequencing needs. The companies believe that the combination of Ambry Genetics’ decades of leadership in clinical next-generation sequencing and translational analysis and the SOPHiA DDM cloud-based analytics platform, can support improved clinical research decisions by pharmaceutical companies.

"The heart of our work is the ability to combine patient data from multiple sources to improve treatment decisions and discover new medicines," said Jonathan Usuka, Ph.D., chief strategy and informatics officer of REALM IDx. "With the synergies we hope to realize from collaborating with SOPHiA GENETICS, we will continue to enhance our ability to address some of health care’s most challenging diseases."

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 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].