On September 28, 2020 Diaceutics PLC, (AIM: DXRX), reported three new partnerships on its DXRX platform, as it continues with its mission to get every patient the treatment they deserve (Press release, Diaceutics, SEP 28, 2020, View Source [SID1234567693]). The company has signed agreements with external quality assessment (EQA) organizations Canadian Pathology Quality Assurance – Assurance Qualité Canadienne en Pathologie (CPQA-AQCP), European Molecular Genetics Quality Network (EMQN CIC) and Nordic Immunohistochemical Quality Control (NordiQC). The partnerships will help to establish best-in-class global laboratory standards for diagnostic testing through in-lab quality assurance and will provide the transparency which pharmaceutical companies need to reach more patients with their precision medicines.

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"Establishing partners in quality within the industry is important for CPQA-AQCP and we are excited with this opportunity to evolve our relationship with Diaceutics and participate in the DXRX network. "

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By partnering with CPQA-AQCP, EMQN CIC and NordiQC on DXRX – the world’s first diagnostic network for precision medicine – Diaceutics will support the implementation of accurate and high-quality testing across its 2500+ laboratory relationships.

These collaborations facilitate a critical piece of the end-to-end solution which DXRX enables for the development and commercialization of precision medicine diagnostics. They are also part of multiple partnerships which Diaceutics is building with industry providers across the globe to help achieve their mission of getting every patient the treatment they deserve.

Currently focused on the Canadian market, CPQA-AQCP is dedicated to monitoring and improving the proficiency of immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) testing. DXRX is a global platform which will enable CPQA-AQCP to expand its services further worldwide. The organization is currently collaborating with Diaceutics on a project sponsoring the HER2 biomarker modules for gastric cancer. Using IHC and FISH, they are assessing the landscape and efficiency of HER2 gastric cancer testing, which has now been on the market for more than 10 years.

UK-based EMQN CIC provides molecular genetics, molecular pathology, and technique-specific EQA schemes for the global molecular testing market. It is currently collaborating with Diaceutics on a pilot study involving mutations in the EGFR, PIK3CA, KRAS, HRAS, NRAS, KIT, TP53 and BRAF genes, which will help laboratories using high throughput technologies – such as NGS – to accurately validate assay sensitivity and specificity. Data will be generated for a white paper to demonstrate a real-world review on NGS usage for clinical purposes: where we are today and the market readiness for additional biomarkers.

NordiQC is a global and scientific proficiency program for diagnostic Immunohistochemistry with more than 500 participants. NordiQC provides a broad range of relevant modules for immunohistochemical proficiency testing within diagnostic pathology and with special attention to predictive biomarkers. By joining the DXRX network, NordiQC strengthens its mission to bridge all stakeholders in diagnostic precision testing to optimize and standardize this field.

The addition of CPQA-AQCP, EMQN CIC and NordiQC on DXRX complements recent partnerships announced with HistoCyte Laboratories and Targos Molecular Pathology, which provide control slide materials and training for laboratories respectively.

John Garratt, Director, CPQA-AQCP, said: "Establishing partners in quality within the industry is important for CPQA-AQCP and we are excited with this opportunity to evolve our relationship with Diaceutics and participate in the DXRX network.

"Personalized medicine requires precision diagnostics to ensure the therapies are targeted accurately, thus providing optimum outcomes for patients. There is a greater demand on labs to provide prognostic biomarker testing of more esoteric targets and we, in EQA organizations, need to provide support for establishing the tests and for maintaining quality of the tests so that patients and their oncologists are confident that the most effective therapy is being used.

"Working with Diaceutics and its established partners is a great opportunity for CPQA-AQCP to assure accurate and sustainable pharma-diagnostic testing."

Simon Patton, Managing Director, EMQN CIC, said: "EMQN CIC and Diaceutics have a shared vision on improving the quality and accuracy of testing to ensure all patients get access, where possible, to the most effective treatments. We are delighted to be offering our ISO 17043 accredited Oncogene panel testing EQA scheme through the DXRX platform to support these goals."

Søren Nielsen, Director of NordiQC, said: "It’s with great expectations and excitement we enter the cooperation with Diaceutics. The partnership is driven by mutual interest and goal to raise and secure the global level of immunohistochemical precision testing and only by broad collaboration between laboratories, pharma, industry, regulatory bodies and EQA programs this can be accomplished."

Karina Hjort, Senior Director of Innovation, Diaceutics, said: "The precision medicine market is growing rapidly. Approximately 1,000 precision medicine drugs are currently in development and our research shows that by next year, the FDA will be approving more personalized oncology drugs than one-size-fits-all treatments. As they shift towards a personalized approach to treating patients, pharmaceutical companies must ensure that they are choosing the correct solutions and services to fulfil the promise of their precision medicines.

"We are delighted to have CPQA, EMQN CIC and NordiQC join the DXRX network to enable a critical piece of an end-to-end development and commercialization solution designed to get every patient the treatment they deserve."

On September 28, 2020 Accent Therapeutics reported that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Accent Therapeutics, SEP 28, 2020, View Source [SID1234567691]).

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Accent is a leader in the development of small molecule therapies that selectively inhibit RNA-modifying proteins (RMPs) that drive cancer. By targeting RMPs, the company is taking a novel approach to unlocking the potential of RNA biology by targeting enzymes responsible for post-transcriptional chemical modifications of RNA. Accent is developing a rich pipeline of oncology-focused therapies in a new class of medicines that target RMPs.

"We are honored to be recognized by Fierce Biotech as a leader in the biotech landscape, pursuing novel RMP-targeted therapies to bring new and potentially life-changing medicines to patients," said Shakti Narayan, Chief Executive Officer, Accent Therapeutics. "This recognition is a tribute to our team’s fierce commitment to giving patients living with cancer greater hope, fewer burdens and the promise of a life beyond disease."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 18th annual Fierce 15 selection.

"The 2020 Fierce 15 comes at a time when the world is focused on a pandemic, but even as coronavirus remains a threat, patients with cancer, rare diseases and other disorders still need treatment," Fierce Biotech Senior Editor Ben Adams said. "This year, we’ve chosen from a diverse range of those fighting COVID, as well as those fighting longer term plagues against our biology," Adams said.

An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, Fierce Biotech provides subscribers with an authoritative analysis of the day’s top stories. Every year Fierce Biotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

On September 28, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for the third quarter 2020 following the close of market on Thursday, October 29, 2020 (Press release, Illumina, SEP 28, 2020, View Source [SID1234567688]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, President and Chief Executive Officer, and Sam Samad, Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, October 29, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both with Conference ID 9488740. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On September 28, 2020 ROME Therapeutics, a biotechnology company harnessing the power of the repeatome in drug development, reported that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Rome Therapeutics, SEP 28, 2020, View Source [SID1234567686]).

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ROME was founded to develop novel therapies for cancer and autoimmune diseases by harnessing the power of the repeatome – vast stretches of uncharted genetic material that have long been dismissed as "junk DNA." ROME was launched in April 2020 with $50M Series A funding led by GV and ARCH Venture Partners with participation from Partners Innovation Fund.

"We are honored to be selected as a Fierce 15 company, recognizing ROME’s mission to unlock the uncharted territory of the repeatome and discover a new class of therapies for patients with serious debilitating diseases," said Rosana Kapeller, M.D., Ph.D., CEO, President and Co-founder of ROME Therapeutics. "In a short amount of time, our growing team of ‘Romans’ has generated significant momentum for our lead programs and research platform. We are thankful for the continued support of our founders, collaborators, advisors and investors in pursuit of this mission."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 18th annual Fierce 15 selection.

On September 23, 2020 Sapreme, a biotechnology company focused on improving the delivery and efficacy of macromolecule therapeutics, reported positive preclinical data on its proprietary endosomal escape platform in two presentations at the 16th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS), held virtually from September 27th to 30th, 2020 (Press release, Sapreme Technologies, SEP 28, 2020, View Source [SID1234567684]).

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Sapreme is developing macromolecule delivery methods based on compounds that release therapeutic cargo from the endo-lysosome, improving access to intracellular targets and enhancing the therapeutic window for these therapeutics. Current macromolecular biologics rely on receptor-mediated endocytic uptake into the endosome and inefficient passive release from these vesicles into the cell to achieve therapeutic efficacy. The company’s presentations demonstrate that Sapreme’s SPT001 compound improves intracellular release of targeted antisense oligonucleotides (ASOs) and thereby also their therapeutic efficacy. In addition to ASOs, SPT001 has also been demonstrated to enhance delivery of other targeted payloads such as antibody-conjugated toxins.

"The data presented today underscore the broad potential of our platform to overcome endosomal entrapment and improve the therapeutic window of macromolecule therapeutics," stated Guy Hermans, Ph.D., Chief Executive Officer of Sapreme. "We are encouraged to see that conjugating SPT001 to liver or tumor targeted ASOs leads to significantly improved silencing, with positive implications for development of metabolic syndrome and oncology targeting drug developments. These results support the further development of SPT001 as the delivery mechanism of choice for future intracellularly active macromolecular drug candidates."

As described in the presentations, multiple in vitro preclinical studies were conducted demonstrating the broad potential of SPT001. Highlights from the data include:

In one experiment, an ASO targeting HSP27 was tested separately or conjugated to monoclonal antibody (mAb) Cetuximab, an epidermal growth factor receptor (EGFR) targeting antibody. While antibody targeting slightly improved HSP27 silencing, results from the study demonstrated that the additional conjugation of SPT001 to the ASO-mAb compound resulted in a highly improved and target-dependent reduction of HSP27 expression.
Further studies showed that combining Cetuximab-SPT001 with Cetuximab-ASO conjugates similarly improved ASO delivery efficacy – demonstrating SPT001 can also improve delivery of an ASO not directly linked to it. Also, combined treatment by Cetuximab-SPT001 and Trastuzumab-ASO of EGFR/Her2 double positive cells yields similar synergies. This dual targeting approach allows for the introduction of additional tumor cell selectivity. Furthermore, such combined Trastuzumab-ASO delivery was effective in double positive cells expressing only low levels of Her2, which are typically not sensitive to Trastuzumab-ASO in the absence of SPT001.
In a third study, Sapreme evaluated the effect of using SPT001 conjugates to improve oligonucleotide delivery to liver cells. N-Acetylgalactosamine (GalNAc) is used as a targeting ligand to drive liver uptake of many oligonucleotides in many late stage clinical trials. ApoB overexpression is known to result in lipid-induced endoplasmic reticulum stress and insulin resistance in the liver, and efficient silencing of ApoB is therefore of therapeutic interest. High doses of GalNAc-ApoB silencing ASOs were required to reduce ApoB expression, whereas combination treatment with GalNAc conjugated SPT001 allowed for complete gene silencing at considerably reduced doses. Similarly, combining SPT001 and ASO payloads with GalNAc into a single next generation compound, resulted in a molecule of superior potency as compared to the GalNAc-ApoB benchmark. Reduced ApoB protein production levels confirmed mRNA silencing results, demonstrating SPT001 conjugates can improve on existing compounds in combination therapy, or serve as building blocks for next generation drug candidates.
The presentations are available on demand at the 16th Annual Meeting of the OTS conference website through this link.