On October 12, 2021 Mayo Clinic reported an agreement on Tuesday, Oct. 12 that will allow it to offer clinical-grade comprehensive cancer genomic sequencing to cancer patients who choose to participate (Press release, Mayo Clinic, OCT 12, 2021, View Source [SID1234591118]). Test results will be available to patients and their treating health care providers to guide therapeutic decisions, advance cancer research, and support the development of new diagnostic tests and therapies for cancer treatment.

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Mayo Clinic Cancer Center, Mayo Clinic’s Department of Laboratory Medicine and Pathology, and Mayo Clinic’s Center for Individualized Medicine are collaborating with Personalis Inc. (Nasdaq: PSNL), a cancer genomics company whose clinical-grade, comprehensive cancer genomic test includes sequencing the entire coding genome through whole-exome and transcriptome sequencing. The test will provide a clinical report for each patient and comprehensive aggregated data that Mayo Clinic and Personalis will use to further develop this comprehensive diagnostic approach.

"Our goal for this relationship is to assure cancer patients from across the world get the most comprehensive genomic testing at Mayo Clinic," says William Morice II, M.D, Ph.D., chair of Mayo Clinic’s Department of Laboratory Medicine and Pathology. "We’re committed to making this test available to diverse patient populations who haven’t yet had access to this type of testing."

"We believe the use of aggregated and de-identified genomic sequencing data will improve both patient care and patient access to care," says Konstantinos Lazaridis, M.D., medical director of Mayo Clinic’s Center for Individualized Medicine. Dr. Lazaridis says the consortium will make it possible to offer individual patients a clinical benefit in their treatment and the ability to contribute data in the aggregate that may lead to the development of new and improved treatments and systems that will benefit all patients.

"Developing individualized treatment plans for each patient based on their unique spectrum of cancer-promoting mutations is critical to our mission to provide the most advanced cancer care," says Cheryl Willman, M.D., executive director of Mayo Clinic Cancer Programs and director of Mayo Clinic Cancer Center. "As we advance the Human Cancer Genome Project to more diverse and understudied populations, it is particularly important to use comprehensive sequencing methods to uncover all possible mutations."

Dr. Willman says that collaborations with groups such as Personalis provide health care providers with access to molecular data that may offer new insights into the causes of particular cancers and also may help researchers develop more effective, personalized treatments. "Our goal is to develop our capacity for ‘precision prevention’ that will help us detect and treat cancers earlier in all populations," says Dr. Willman.

"We are honored to work with Mayo Clinic to increase access to advanced cancer testing," says Richard Chen, M.D., chief medical officer of Personalis. "Rapid advances in our understanding of cancer and the development of new cancer therapies are driving the need for more comprehensive testing platforms."

On October 12, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported two research collaborations with Massachusetts General Hospital (MGH), the largest hospital-based research program in the U.S. that delivers care grounded in leading-edge research, advanced treatment offerings and the latest clinical trials (Press release, BostonGene, OCT 12, 2021, View Source [SID1234591117]). The collaborations are designed to explore the role of tumor genetics and the tumor microenvironment of patients with follicular lymphoma (FL) and to understand their impact on disease transformation and response to treatment.

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An indolent B-cell lymphoma, FL can transform into an aggressive lymphoma; however, the underlying causes of transformation remain unknown. To elucidate the molecular mechanisms and the role of the microenvironment in this process, Abner Louissaint MD, PhD, of the Department of Pathology at the MGH, developed a unique PDX mouse model of FL transformation. In support of this work, BostonGene performs large-scale analytics utilizing next generation sequencing (NGS data) and multiplex immunofluorescence (MxIF) imaging to provide insight into the cellular composition and spatial architecture of the reconstructed patient tumor and microenvironment in these PDX mouse models. BostonGene computational modeling of the molecular profiles of the primary patient FL tumors and the PDX tumors uncovers which patients may undergo transformation. This collaborative project drives the utilization of FL PDX mouse models in the personalization of therapy, the discovery of potential therapies for transformed FL, and the identification of biomarkers of transformation.

A second study focuses on the elucidation of the role of tumor microenvironment on FL patients’ response to treatments. Jacob Soumerai, MD, a clinical lymphoma investigator at the MGH Cancer Center, in collaboration with Dr. Louissaint are evaluating the influence of tumor genetics and tumor microenvironment composition on FL patient response and the development of resistance to the combinatorial therapy of rituximab and umbralisib, a PI3Kδ inhibitor. As part of this study, BostonGene provides integrated transcriptomic and genomic analysis of FL patients treated with this combination therapy such as the identification of somatic alterations, evaluation of gene expression, estimation of tumor heterogeneity, microenvironment classification and neoantigen prediction. This work will determine biomarkers of FL patient response to PI3Kδ inhibition, ultimately improving the clinical outcomes of this patient population.

"By using an analytical approach to further understand the cellular composition of patients with follicular lymphoma and identify biomarker response to therapy, we are hopeful that we can be better informed when making individual treatment decisions," said Dr. Louissaint, who is also an assistant professor of Pathology at Harvard Medical School.

"We’re proud to collaborate with MGH by providing next-generation multi-platform analytics to evaluate the molecular and immunologic profiles of follicular lymphoma patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our analysis will define genomic and transcriptional alterations that serve as predictive biomarkers of response and resistance to therapy, enabling doctors to personalize treatment plans."

On October 12, 2021 Transition Bio, Inc. (the Company) reported that named several critical additions to its leadership team, including naming Gregory Miller as Chief Executive Officer (CEO), Prof. Tuomas Knowles as Chief Technology Officer (CTO), and Martin Kulander as Chief Operating Officer (COO) (Press release, Transition Therapeutics, OCT 12, 2021, View Source [SID1234591116]).

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Mr. Miller is a Boston-based biotechnology executive with extensive experience in value creation and corporate development transactions. He was previously Chief Business Officer at Atalanta Therapeutics and brings a successful track record in leading significant liquidity events as well as establishing strategic industry partnerships and collaborations. Greg will also join the Board of Directors.

Prof. Knowles, a Scientific Co-Founder and Director, will assume the role of CTO. He takes on this critically important position in addition to his current academic responsibilities at the University of Cambridge. Tuomas will lead the Company’s technology and data platform strategy as well as the overall direction of the CondensomicsTM platform.

Martin Kulander has joined as Chief Operating Officer (COO) where he will oversee the Company’s business operations. Mr. Kulander joins from AstraZeneca, where he held a range of leadership roles in the oncology commercial and R&D organizations, working on product development strategy and business development. Prior to AstraZeneca, Martin was a member of the investment team at Malin plc, and before that a strategy consultant at Trinity Life Sciences.

Joseph Grosso joins the team as Vice President of Oncology Translation from Bristol Myers Squibb, where he held positions of increasing leadership responsibility. Most recently, he led the development of Breyanzi, an approved CD19 CAR T therapy, across hematological indications. Dr. Grosso brings significant scientific leadership and translational experience in immuno-oncology to the Company. He received his B.S. in Microbiology and Immunology at the University of Rochester and earned his Ph.D. in Microbiology and Immunology from the University of Miami. His post-doctoral training was at Johns Hopkins University School of Medicine where he focused on novel checkpoint molecules including LAG-3 and PD-1 in tumor tolerance models.

The Company also announced that Dr. Sarah Teichmann, who recently joined the Company as a Scientific Co-Founder, will join its Board of Directors.

Kelly Martin, Executive Chairman, commented, "Over the last 12 to 18 months, we have been precisely focused on building a technology and data platform within the world of condensates cell biology. Our advancement to-date – in terms of speed and capability – has exceeded all of our internal expectations." Martin commented further, "Given our accelerated progress, this is the right time to aggressively add unique talent at all levels of the Company. Greg, Martin, Tuomas, Sarah, and Joe are all superb additions to the team."

Mr. Miller added, "The Company’s goal is quite straight forward: To be the leading technology and data driven company in the condensates cell biology space. Our discovery engine generates and learns from proprietary data of unparalleled breadth and depth, down to the single condensate level. The opportunities resulting from our discovery and analytical expertise will be second to none." Miller continued, "The team I am joining is world class and the output of their collective effort, in a such a short period of time, has been incredible. It’s an honor to be part of this company at this stage of its journey."

On October 12, 2021 CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, reported that acceptance of an oral presentation and a poster presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, held virtually and in-person in Washington, DC, November 10-14, 2021 (Press release, CG Oncology, OCT 12, 2021, View Source [SID1234591115]).

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CG Oncology will present preliminary safety and efficacy data from CORE1, an ongoing Phase 2 clinical trial of CG0070 in combination with KEYTRUDA (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

Under a previously announced clinical collaboration with Merck relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus KEYTRUDA for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

Details of the oral presentation are as follows:

CORE1: Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Abstract Number: 955
Presenter: Roger Li, M.D., Moffitt Cancer Center
Session Date & Time: Saturday, November 13, 2021 from 12:15-12:30pm EST
Category: Late-Breaking Oral Abstract Session

In addition, CG Oncology will present an overview of trial design and methodology of BOND3, an ongoing global Phase 3 trial with CG0070 as a monotherapy for the treatment of patients with NMIBC unresponsive to BCG. The goal of BOND3, which will enroll 110 patients, is to evaluate the safety and efficacy of CG0070 as a monotherapy for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04452591).

Details of the poster presentation are as follows:

A phase 3, single-arm study of CG0070 in subjects with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG)
Abstract Number: 426
Presenter: Edward Uchio, M.D., UC Irvine Health, Department of Urology
Session Date & Time: Friday, November 12, 2021 and Saturday, November 13, 2021 from 7:00am-8:30pm EST
Category: Poster Abstract Session

Full abstracts of both presentations will be available on the SITC (Free SITC Whitepaper) website on November 10, 2021.

On October 12, 2021 4D pharma plc (AIM: DDDD, NASDAQ, LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that 4D management will present at the Jefferies Virtual Next Generation IBD Therapeutics Summit being held on October 19, 2021 (Press release, 4d Pharma, OCT 12, 2021, View Source [SID1234591114]).

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A webcast of the presentation will be available on the ‘Events’ section of the 4D pharma website at www.4dpharmaplc.com beginning Tuesday, October 19, 2021 at 8:00 a.m. ET (1:00 p.m. BST).