On September 8, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported that it has entered into a Master Services Agreement (the "MSA") with Flora Growth (NASDAQ: FLGC) (Flora) to deploy the Company’s CertainT platform as part of Flora’s global cannabis product validation and authentication platform for consumers, distributors, and government regulators (Press release, Applied DNA Sciences, SEP 8, 2021, View Source [SID1234587450]). Concurrently, the Company received a Statement of Work (SOW) under the MSA from Flora to implement its CertainT platform and supply related equipment and services for three locations (1 in Florida; 2 in the Republic of Colombia), where the Company’s molecular tags will be applied to quantities of Flora’s cannabis flower and derivatives, as well as select products in their portfolio. Financial terms of the SOW were not disclosed.

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The MSA is the result of the Company’s strategic alliance, referral, and technology integration agreement with TruTrace Technologies, Inc. (CSE: TTT; OTCQB: TTTSF) (TruTrace) under which TruTrace’s blockchain-based StrainSecure platform was integrated with CertainT to deliver a complete, end-to-end supply chain security solution to cannabis companies. Flora will employ the integrated CertainT-StrainSecure solution to support its product validation and authentication platform to be utilized to deliver on Flora’s previously announced commercial agreements to export cannabis products internationally to open markets like Australia.

Flora, a manufacturer and wholesaler of cannabis and cannabis derivative products and operator of one of the largest outdoor cannabis cultivation facilities, is differentiated by its use of natural ingredients and value-chain sustainability. Flora’s cannabis derivative products are used in premium cosmetics, hemp textiles, and food and beverage applications.

"Business imperatives centered on branding and supply chain mastery will be the defining characteristics of cannabis companies positioning to compete globally. To that end, CertainT’s value proposition delivers brand and product differentiation, IP protection, and supply chain security from inception to consumption that, we believe, will further catalyze interest and adoption of our platform," stated Dr. James A. Hayward, president and CEO of Applied DNA. "CertainT offers customers like Flora unmatched levels of transparency, traceability, and trust across their supply chains that are further improved through our integration with TruTrace. We are very pleased to undertake our first international commercial cannabis venture alongside Flora and, given its growing and diverse portfolio of cannabis and cannabis derivative products, we believe we are in the early stages of a mutually beneficial commercial relationship with Flora."

Robert Galarza, CEO of TruTrace, stated, "The first fruits of our partnership with Applied DNA have been realized and at a time when the cannabis industry’s globalization has accelerated the need for solutions to verify supply chains in defense of a brand’s intellectual property and brand equity. Companies like Flora, who recognize and address this need, will hold a competitive advantage in the market and offer compelling value to end-customers. The integration of our platform with CertainT is designed specifically to meet that need."

About the CertainT Platform

The CertainT platform has three technology pillars (Tag, Test, Track), which allows raw materials and products to be tagged with a unique molecular identifier. This identifier can then be tested for its presence as it travels throughout a global supply chain. All the data points associated to tagging and testing are tracked by uploading to a secure cloud database. The CertainT platform can be used across industries such as textiles, cannabis, military, leather, fertilizer, pharmaceuticals, personal care.

On September 8, 2021 Science 37 and Foundation Medicine reported a collaboration to enable decentralized clinical research in oncology that will optimize recruitment and enrollment, improve patient retention, and expand access to precision cancer care (Press release, Foundation Medicine, SEP 8, 2021, View Source [SID1234587449]).

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It is estimated that less than 1 in 20 patients with cancer participate in clinical trials.1 Further, more than 80 percent of clinical studies globally fail to enroll patients within the sponsor’s desired timeline.2 Lack of participation in clinical research may hinder a patient’s ability to access the latest therapeutic options and slow the pace of treatment discovery.

As part of this novel offering, Foundation Medicine’s FoundationSmartTrials patient identification solution will be used to identify patients who may be eligible for a trial based on results from its tissue and blood-based comprehensive genomic profiling (CGP) tests. Science 37 will then enroll the appropriate patients and provide ongoing support via its operating system—underpinned by its technology platform and specialized networks of mobile nurses, telemedicine investigators, remote coordinators and connected devices.

"Many advanced cancer patients are unable to travel to or visit in-person clinical trials sites, so it’s critical that we work across the ecosystem towards new and innovative solutions to improve access to clinical trials regardless of a patient’s location," said Jonathan Cotliar, M.D., Chief Medical Officer at Science 37. "Combining our operating system with Foundation Medicine’s precision oncology expertise sets us on an exciting path with the goal of accelerating treatment discovery while bringing the research directly to patients."

This partnership builds on a collaboration between Foundation Medicine and Science 37 to provide decentralized trial services for Roche’s ALPHA-T trial. The ALPHA-T trial seeks to assess the efficacy and safety of alectinib for patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic solid tumors excluding lung cancer. This type of tumor-agnostic approach represents a ground-breaking advance in cancer treatment and demonstrates further progress towards achieving personalized healthcare for patients with these types of cancers.

"Beyond providing high quality genomic profiling to support informed decision making, we’re committed to empowering practitioners to act on those decisions by identifying personalized treatment options, including clinical trials. Through this partnership with Science 37, leveraging our combined assets and expertise, our goal is to improve access to clinical trials for patients who aren’t frequently able to participate," said Brian Alexander, M.D., M.P.H., Chief Executive Officer at Foundation Medicine. "As we explore this decentralized approach to research, we hope to continue innovating on this model for other clinical programs in the future. Ideally, we’ll create a learning system where physicians and patients have more options, and their experiences help inform treatment for patients in the future."

On September 8, 2021 Huadong Medicine (SZ.000963) and Insilico Medicine ("Insilico"), an end-to-end artificial intelligence (AI)-driven drug discovery company, reported that the companies have entered into a co-development partnership to accelerate the discovery of breakthrough small-molecule therapeutics by leveraging an innovative approach to oncology (Press release, Huadong Medicine, SEP 8, 2021, View Source [SID1234587448]).

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Pursuant to the collaboration agreement, Insilico and Huadong Medicine will launch a new drug discovery project involving the research and development (R&D) teams of both parties. The collaboration will leverage Huadong Medicine’s advanced innovative drug discovery and screening characterization platform, in combination with Insilico’s end-to-end AI-driven drug discovery platform, particularly the small molecule generation platform Chemistry42, in order to design and screen out potential first-in-class ("FIC") drug molecules with superior activity that may increase the druggability of targets. The project team will interfere with protein-protein interactions to hit undruggable targets that regulate tumor growth.

Insilico’s self-developed small molecule generation platform Chemistry42 combines AI technology with computational and medicinal chemistry methods to efficiently generate novel molecular structures with desired properties for specific targets. This platform helps to screen and obtain potential therapeutic molecules, which are verified in vitro and in vivo, and delivers rapid comprehensive solutions from hits to preclinical candidates ("PCC").

Huadong Medicine, a publicly-traded pharmaceutical company with fully integrated R&D, manufacturing, distribution, sales and marketing capabilities, has more than 10,000 employees and a sales force covering thousands of hospitals in China. In addition, Huadong Medicine’s R&D organization currently has more than 1000 FTEs involved in drug discovery, preclinical research, clinical research, CMC, and RA. Huadong Medicine focuses on innovation and transformation strategies and is committed to concentrating its advantages and R&D resources to build prospective products R&D pipeline in the fields of oncology, endocrine/metabolic, and autoimmune disease with the help of advanced technology and methods from its partners.

"Complementary advantages and cooperative innovation have increasingly become the trends of novel drug discovery and development. Insilico is honored to form a partnership with Huadong Medicine. By leveraging the strength of Insilico’s advanced small molecule generation platform Chemistry42 and Huadong Medicine’s powerful target verification and screening platform, we will hit previously undruggable targets by inhibiting protein-protein interactions, in order to meet unmet medicinal needs efficiently," said Feng Ren, Ph.D., Chief Scientific Officer and Head of Drug R&D at Insilico.

"The combination of AI and novel drug R&D can greatly improve the efficiency of drug R&D, and has the potential to significantly shorten timelines and reduce the cost of drug design, discovery, pre-clinical R&D, and clinical development. We look forward to collaborating with the leading international AI company Insilico, by leveraging respective advantages of both companies, in advancing the development of potential FIC drug molecules to meet increasing clinical medical needs, in addition to providing patients with more, better and ground-breaking treatment options," said Dongzhou Liu, Ph.D., Chief Scientific Officer and President of Global Research and Development at Huadong Medicine.

On September 8, 2021 Mission Bio, the pioneer in high-throughput single-cell DNA and multi-omics analysis, reported two key improvements to the core capabilities of its Tapestri Platform intended to expand its accessibility and utility in the area of hematologic oncology (heme-onc) research (Press release, Mission Bio, SEP 8, 2021, View Source [SID1234587447]). These new additions to Tapestri will enable researchers to apply single-cell analysis in a wider range of projects than previously possible through the introduction of new ready-to-use panels and a lowered input threshold.

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With Tapestri’s expanded capabilities, heme-onc researchers can now access single-cell insights from as few as 20,000 cells while conserving precious samples. Mission Bio is also launching Tapestri Single-cell DNA Published Panels, a new set of pre-designed gene panels sourced from leading investigators in the field covering various indications. These newly available gene panels have powered discoveries across hematological malignancies including acute lymphoblastic leukemia (ALL), and have been featured and verified in peer-reviewed publications like Blood.

"We are excited to include our ALL panel with the initial launch of Tapestri Single-cell DNA Published Panels," said Jan Cools, PhD, Group Leader at VIB, Center for Cancer Biology. "We developed this panel as a sensitive assay to detect clonal architecture and evolution in T-cell ALL, the basis for our study on T-cell ALL published in Blood. We hope the availability of these panels can accelerate single-cell studies for those new to Tapestri."

Another key addition to Tapestri for simultaneous single-cell DNA and protein analysis is BioLegend’s expanded TotalSeq-D antibodies catalog. Taking these advances together, researchers can now start with a pre-designed heme-oncology panel or customize one to fit the needs of a specific project, connect genomic data to a broader array of phenotypes, and do it all in a smaller sample.

"Researchers have been using the Tapestri Platform to make strides in hematologic oncology research, with breakthrough applications in therapy resistance and measurable residual disease," said Yan Zhang, CEO of Mission Bio. "We are thrilled to lower the barrier to entry with a lower input threshold and expanded menu of ready-to-use panels and antibodies that will more easily enable single-cell multi-omics insights and advance critical research."

In addition to customers presenting Tapestri data this week at the Society of Hematologic Oncology (SOHO) 2021 Annual Meeting, Mission Bio will be hosting a virtual launch event on Tuesday, Sept. 21 at 8 a.m. PT/11 a.m. ET. To register for the event, please visit the registration page.

On September 8, 2021 ATP, a leader in life sciences venture capital, reported the launch of Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer, and treat autoimmune and inflammatory disorders and other diseases, using self-replicating RNA (srRNA) (Press release, Replicate Bioscience, SEP 8, 2021, View Source [SID1234587380]). Replicate will use $40 million in committed Series A funding from ATP to advance multiple novel srRNA programs into clinical development.

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"Next-generation srRNA agents are taking RNA therapeutics into many more areas of disease treatment, and what Replicate is doing to define and expand this field is completely new and exciting," said Michael Ehlers, M.D., Ph.D., Chief Scientific Officer of ATP and a venture partner at the firm. "ATP is investing in Replicate because we see the company’s technology as a quantum leap in RNA therapeutics."

Self-replicating RNAs, or srRNAs, work by copying themselves inside cells of the body and instructing the cells to make, and keep making, therapeutic proteins. Replicate uses synthetic biology, original molecular design principles, and a diverse, proprietary repertoire of virally derived vectors to engineer custom srRNAs that offer unique advantages compared to other RNA or srRNA therapeutic approaches. These advantages include lower dosing levels by several orders of magnitude; increased duration of therapeutic effect; and selectively programmed ability to either activate or evade the immune system.

Nathaniel Wang, Ph.D., Replicate Bioscience Chief Executive Officer, said: "We started Replicate to build a best-in-class srRNA platform from scratch—to pursue our vision of a better way to make srRNAs that we are convinced can solve life-threatening medical problems, from drug resistance in cancer to autoimmune and inflammatory disorders and more. We are thrilled to partner with ATP, to accelerate our progress towards realizing that vision for patients."

Dr. Wang and Andrew Geall, Ph.D., Replicate Chief Development Officer, previously collaborated on srRNA technologies at Synthetic Genomics and at Novartis Vaccines and Diagnostics. They joined with a former colleague, Herbert Kim Lyerly, M.D., and Zachary Hartman, Ph.D., both professors of cancer research and immunology at Duke University, to develop an srRNA application capable of preventing or removing drug-resistant cancer mutations—a tactic they dubbed "synthetic immune lethality." Replicate Bioscience is developing synthetic immune lethality srRNAs for concurrent administration with targeted therapies in solid tumors. Beyond cancer, Replicate is developing different types of srRNAs for autoimmune and inflammatory disorders, and the company’s versatile technology platform also lends itself to deployment in other disease areas.

The Replicate Bioscience Board of Directors is chaired by Dr. Ehlers and includes as members Dr. Wang; Seth Harrison, M.D., founder and managing partner of ATP; and Joseph A. Yanchik III, a venture partner at ATP. The company’s Scientific Advisory Board includes Drs. Lyerly and Hartman; Philip Santangelo, Ph.D., a spatial biologist and professor of biomedical engineering at Georgia Institute of Technology and Emory University; and Jeffrey Ulmer, Ph.D., former head of preclinical R&D at GlaxoSmithKline and former global head of external research at Novartis. The company is headquartered in San Diego, California.