On November 18, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conference and invited investors to participate via webcast (Press release, Illumina, NOV 18, 2020, View Source [SID1234571356]).

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Piper Sandler Annual Healthcare Conference
Thursday, December 3, 2020 at 1:30pm Eastern Time

The live webcast can be accessed in the Investor Info section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentation will be posted on Illumina’s website as soon as possible after the event and will be available for at least 30 days following.

On November 18, 2020 PTC Therapeutics, Inc. (NASDAQ: PTCT), reported that the United States (U.S.) Food and Drug Administration (FDA) has granted PTC596 both Orphan Drug Designation and Fast Track designation for the potential treatment of leiomyosarcoma (LMS), a rare type of cancer that affects smooth muscle tissue (Press release, PTC Therapeutics, NOV 18, 2020, ry-designations-for-ptc596-to-advance-treatment-of-two-rare-oncology-indications-301175743.html [SID1234571377]). Furthermore, the FDA has also granted PTC596 a Rare Pediatric Disease designation and Orphan Drug Designation for the potential treatment of Diffuse Intrinsic Pontine Glioma (DIPG), an ultra-rare childhood glioma. PTC596 is currently being studied in clinical trials in LMS and DIPG.

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"We are very pleased with the FDA’s decisions to grant PTC596 these designations," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. "This brings us one step closer to providing truly novel therapeutic approaches to patients with devastating rare cancers seen in children and adults that do not have good treatment options."

PTC596 is an orally bioavailable small molecule tubulin binding agent that arrests tumor cells in G2/M phase, including cancer stem cells, through the action of inhibiting tubulin polymerization. It is currently in a Phase 1b study for LMS, which accounts for approximately 10 to 28% of all soft tissue sarcomas.1 Approximately 4000 patients are diagnosed with LMS annually in the US, the risk of developing metastases is approximately 40%, and the 5-year survival rate is estimated to be 13.6% for metastatic LMS.2 PTC596 is also currently in a clinical study for DIPG, an ultra-rare glioma arising in the brainstem that makes up 10 to 15% of all brain tumors in children.3 Approximately 300 patients are diagnosed with DIPG annually in the US, and the median overall survival with the current standard of care of radiation therapy, is approximately 9 months with a two-year overall survival rate of less than 10%.4

On November 18, 2020 Umoja Biopharma, a biotechnology company pioneering an integrated in vivo immunotherapy platform, reported the completion of its $53 million Series A financing led by MPM Capital and Qiming Venture Partners USA (Press release, Umoja Biopharma, NOV 18, 2020, View Source [SID1234575244]). Umoja was founded by a team of leading scientists and researchers with the vision of creating an entirely new approach to engineered immunotherapies. Umoja’s suite of innovations will re-engineer a patient’s own immune system to attack and destroy both hematologic and solid organ-based tumors with a simplicity and cost that enables widespread implementation.

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"Umoja has already made significant progress on its goal of delivering technologies that will address the limitations of current engineered immunotherapies," said Andy Scharenberg, M.D., co-founder and CEO of Umoja. "Our in vivo-based approach is scalable while also providing control, safety, and highly effective anti-tumor activity; our goal is to improve both access and outcomes."

Umoja’s platform incorporates three core components: the VivoVec delivery platform, RACR/CAR payload architecture, and the TumorTag platform. The VivoVec delivery platform acts in vivo to generate a population of cancer fighting cells, VivoCAR T cells, which can be exquisitely controlled by the RACR/CAR control system using exogenously administered, FDA approved drugs. TumorTag molecules can be used in combination with the VivoCAR T cells to direct cancer-killing T cells to the tumor and the critical supporting cells of the tumor. 2

"This represents an important step forward in delivering on a shared vision to develop transformational therapies for patients who need them, including the most vulnerable population affected by debilitating diseases – children," said Michael Jensen, M.D., co-founder, Umoja Biopharma, vice president, Seattle Children’s Therapeutics and chief therapeutics officer, Seattle Children’s. "We now have the opportunity to combine forces and move at light speed, eclipsing what could have been accomplished singularly or in a normal academic manner."

Umoja Biopharma was founded through an initial seed investment by MPM Capital and DCVC Bio, and its scientific founders from Seattle Children’s Research Institute and Purdue University, based on pioneering work in the laboratory of Philip Low, the Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry. The Series A financing will enable Umoja to advance its platform and therapeutic programs to early clinical development, attract talent and invest in research. "Umoja is comprised of a highly skilled and passionate team that brings together a unique complement of expertise with in vivo gene transfer, drug development and oncology," said Luke Evnin, Ph.D., co-founder and Managing Director of MPM Capital.

"We believe that Umoja’s approach represents the future of cancer treatment." "Umoja is working to create an entirely new approach to engineered immunotherapies that can pave the way for cancer therapies that are more accessible and effective for patients around the world," said John Hamer, Managing Partner, DCVC Bio. "We look forward to continuing to work with the exceptionally skilled Umoja team to support the development of their integrated and scalable VivoVec and TumorTag technology." "We believe that the combination of deep technical experience and integrated technology platform will put Umoja at the forefront of in vivo T cell engineering," said Anna French, Partner at Qiming Venture Partners USA. "Umoja’s universal CAR approach supports multi-antigen targeting which will be required for the development of solid tumor therapeutics."

On November 18, 2020 Cernostics, Inc. the GI Precision Medicine company, reported two newly completed clinical studies confirming the ability of the TissueCypher Barrett’s Esophagus Assay to identify patients at high risk for progression to cancer (Press release, Cernostics, NOV 18, 2020, View Source [SID1234571324]). The two independent peer-reviewed studies, both authored by Prof. Jacques Bergman and Dr. Nicola Frei (University Medical Center, Amsterdam, the Netherlands), have further validated Cernostics’ TissueCypher Barrett’s Esophagus Assay to accurately and objectively predict which patients with Barrett’s esophagus will develop esophageal cancer. These studies confirm the accuracy of the assay in patients with NDBE and LGDBE, and support clinical adoption of the assay to help providers make better-informed clinical decisions. TissueCypher has the potential to improve patient care by identifying patients at high risk for development of esophageal cancer who will benefit from early intervention or increased surveillance, as well as identifying patients at low risk for progression who can avoid unnecessary procedures.

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• Independent Validation of TissueCypher to Predict Future Progression in Non-Dysplastic Barrett’s Esophagus: A Spatial-Temporal Analysis, published in Clinical and Translational Gastroenterology. This blinded independent validation study confirms the ability of TissueCypher to accurately predict incident/future progression to esophageal cancer in patients with NDBE. The study also demonstrated that sampling multiple endoscopic levels across the Barrett’s segment further increases the detection rate for NDBE patients at high-risk for incident progression to esophageal cancer. This study validated findings from previous studies that TissueCypher identifies a high-risk subset of patients with NDBE who progress at a rate that is higher than published estimates for expert pathologist-confirmed LGD. A TissueCypher high-risk score in patients with NDBE may support a management approach similar to the approach for confirmed LGD, which includes endoscopic eradication therapy or increased surveillance to prevent development of cancer. This is a crucial finding as these are the "at-risk" group who may be missed by the current standard of care. This is the fourth study to independently validate the TissueCypher assay, and provides a critical level of evidence to support clinical adoption of the assay to risk stratify patients with non-dysplastic BE.

• Tissue Systems Pathology Test Objectively Risk Stratifies Barrett’s Esophagus Patients with Low-Grade Dysplasia, accepted in American Journal of Gastroenterology This blinded cohort study evaluated the TissueCypher Barrett’s Esophagus Assay in the screening cohort of a randomized controlled trial of SUveillance versus RadioFrequency ablation (SURF) for BE patients with community-based diagnosis of LGD. This is the fifth study to independently validate the risk stratification of TissueCypher, and a key strength is the study design in which the cohort was prospectively enrolled and followed. The results independently validated the ability of TissueCypher to objectively risk-stratify patients with LGD. TissueCypher provided objective risk stratification, whereas there was significant variability between the expert pathologists whose diagnoses were concordant for only 51.7% of cases in this study. In addition to risk stratifying patients with expert pathologist-confirmed LGD, TissueCypher also identified approximately 50% of the progressors that were downstaged to NDBE by expert pathologists. These patients are a high-risk subset who may be missed by the current standard of care, but could be identified early by TissueCypher and undergo management similar to LGD to prevent progression to cancer.

"Key opinion leaders from around the world continue to validate the potential for TissueCypher to improve care for patients with Barrett’s esophagus," commented Cernostics CEO Mike Hoerres. "We appreciate Prof. Jacques Bergman’s continued commitment to evaluating our innovative technology, and we anticipate additional studies from thought-leading institutions in the coming months that further validate the unique ability of TissueCypher to predict progression in patients with BE. Our momentum in growing clinical evidence and adoption bodes well for patients afflicted with this disease state and their physicians."

About Barrett’s Esophagus and TissueCypher

Barrett’s esophagus, which affects more than three million Americans, occurs when chronic exposure to acid from the stomach causes the esophageal cell lining to deteriorate, creating an environment for cancer. Without treatment, BE can lead to esophageal adenocarcinoma, the fastest-rising cancer in the U.S. The current approach to managing BE is surveillance, involving regular endoscopic procedures with biopsies, monitoring for disease progression, and GERD-related drug therapy to control symptoms and prevent injury to the esophagus. Cernostics has developed and commercialized the world’s first precision medicine test that predicts risk of developing esophageal cancer in patients with Barrett’s esophagus. The patent-protected technology platform – TissueCypher Barrett’s Esophagus Assay – uniquely analyzes whole slide digital images with multiplexed fluorescence, providing greater information and accuracy than traditional subjective tissue diagnostics. TissueCypher provides actionable information to gastroenterologists, eliminating the uncertainty related to the management of Barrett’s esophagus patients.

On November 18, 2020 Foundation Medicine reported it has entered into a non-exclusive agreement to license two foundational patent families from TwinStrand Biosciences, a next-generation DNA sequencing technology company based in Seattle (Press release, Foundation Medicine, NOV 18, 2020, View Source [SID1234571357]).

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The patented TwinStrand Duplex Sequencing technology is a biochemistry- and software-based platform that enables researchers and clinicians to detect faint signals of ultra-low frequency DNA mutations often obscured by technical noise.

"Advancing and improving patient care is our highest priority and we’re pleased to work with partners like TwinStrand who share this same goal," said Cindy Perettie, Foundation Medicine’s chief executive officer. "We look forward to expanding this agreement with TwinStrand to explore additional areas for future collaboration."

"We are delighted to partner with Foundation Medicine, a company that shares our patient-centric mission of applying innovative science to advance cancer care globally," said Jesse Salk, MD, PhD, TwinStrand’s chief executive officer. "We are excited to help power Foundation Medicine’s commitment to delivering the highest quality data and genomic insights to physicians and their patients."