On October 13, 2021 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported that Brian Roberts, President and Chief Executive Officer, will present virtually at the Solebury Trout/BMO Fall 2021 Private Company Showcase on Thursday, October 14 (Press release, Tarveda Therapeutics, OCT 13, 2021, View Source [SID1234591192]).

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The presentation details are as follows:

Solebury Trout/BMO Fall 2021 Private Company Showcase
Date: Thursday, October 14
Time: 9:40am Eastern Time
Location: Virtual – register to attend

On October 13, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported an agreement with the Broad Institute for the distribution of a customized next-generation sequencing (NGS) target enrichment exome panel designed for the identification and research of a wide range of cancer, rare and inherited disease genes from patient samples (Press release, Twist Bioscience, OCT 13, 2021, View Source [SID1234591190]). Twist will market this expert-developed exome panel as the Twist Alliance Clinical Research Exome.

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The Twist Alliance Clinical Research Exome helps support the Broad Institute Genomics Platform and was designed using validated data from clinical patient samples. The panel leverages Twist’s flexible NGS platform to easily and quickly customize content, resulting in a comprehensive survey of the exome with supplemental enrichment of clinically relevant areas of the genome related to cancer as well as rare and inherited diseases. By leveraging the best-in-class uniformity of Twist NGS probes, the assay enables a per sample cost and throughput efficiency that Broad has already leveraged to process more than 250,000 samples to date, keeping it on the leading edge of exome sequencing.

"Exome sequencing has long been a key part of our sequencing efforts for large cancer and germline research studies. Our development with Twist has leveraged many of our learnings on the technical side and pulls in knowledge from collaborating investigators to provide an enhanced exome that will increasingly span both research and clinical applications in which results are returned to patients" said Stacey Gabriel, senior director of the Broad Institute Genomics Platform.

The Twist Alliance Clinical Research Exome will be available for customers in mid-October. The full design of this panel includes the Twist Core exome, the mitochondrial genome, and additional validated coding and non-exonic regions of interest such as the ACMG73 genes, supplemental coverage of regions from OMIM and COSMIC, and specific Broad-defined targets. To see Broad’s Director of Genomics Research and Development Brendan Blumenstiel presenting data on the panel, visit: View Source

"Typically, in cancer research studies, there is a great need to focus sequencing efforts on particular genes or mutations but often with a small number of samples available. Leveraging the Broad’s vast expertise, together we have developed a specialized custom panel that enables deeper sequencing, producing validated genetic variants that could be used for therapeutic intervention," said Emily M. Leproust, PhD, chief executive officer and co-founder of Twist Bioscience. "We are thrilled to bring this important tool to our customers to drive deep insights into research and potentially therapeutic development."

About Twist Alliance Panels

In partnership with leading research institutions from around the world, Twist has curated a collection of high-quality target enrichment panels for applications ranging from carrier screening to cancer diagnostics and whole exome sequencing. The Twist Alliance Panels combine the strengths of precise, highly uniform oligonucleotide synthesis with the specialty expertise of leading scientific research partners.

Well designed, custom target enrichment panels enable increased sequencing depth on target genes while reducing overall

On October 13, 2021 Susan G. Komen, the world’s leading breast cancer organization, reported the awarding of $1.5 million for three new research projects that examine three unique areas focused on metastatic breast cancer (MBC) (Press release, Susan G Komen, OCT 13, 2021, View Source [SID1234591189]). The grants are part of the Susan G. Komen Metastatic Breast Cancer Collaborative Research Initiative, an innovative, first-of-its-kind collaboration between Komen, Duke Cancer Institute and the University of North Carolina Lineberger Comprehensive Cancer Center. The initiative is an effort to pair researchers from each of the organizations to work together to address significant gaps in our knowledge about MBC to advance patient care and improve patient outcomes.

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"We know that finding the cures for breast cancer will only be accomplished by working together through innovative research," said Paula Schneider, Komen’s president and CEO. "It’s this strong belief in the power of collaboration to advance discovery that led to this novel partnership between some of the leading researchers at two institutions that are known for their rivalry."

These three grants fall under Komen’s two primary research priorities, which are to find new ways to prevent, detect, and treat metastatic and aggressive breast cancers, as well as to understand and overcome the inequities that lead certain people and communities to have higher rates of mortality from breast cancer.

"This bold investment by Komen and its supporters is aimed at changing our fundamental understanding of metastatic breast cancer," said UNC Lineberger Director Shelley Earp, M.D. "Combining the creative minds of two of the country’s premier cancer centers is the way to probe the longstanding problem of breast cancer spread. Each of these approaches will yield groundbreaking knowledge to develop better, more effective treatments by harnessing a patient’s own immune system and will identify the biological and societal drivers that contribute to disparities in breast cancer outcomes among Black and white women."

"We are very grateful to Susan G. Komen for their long-term dedication to improving approaches to the prevention, diagnosis and treatment of breast cancer," said Michael B. Kastan, M.D., Ph.D., executive director of the Duke Cancer Institute. "Metastatic breast cancer remains a major challenge and this visionary funding mechanism brings together outstanding investigators and physicians from two neighboring institutions in collaborative projects that will make a difference for women in the state of North Carolina and around the country."

Thanks to a $500,000 lead gift by Blue Cross and Blue Shield of North Carolina (Blue Cross NC), we are able to award the Susan G. Komen and Blue Cross NC Metastatic Breast Cancer Disparities Collaborative Research Grant to:

A research team led by Drs. Jennifer Freedman and Steven Paterno of Duke Cancer Institute, and Dr. Katie Hoadley of the University of North Carolina Lineberger Comprehensive Cancer Center, who were awarded a grant to investigate how the ancestry of different populations impacts the immune response to metastatic breast cancer. The study leaders identified biological differences in certain genetic events (called RNA splicing) in tumors between those with African versus European ancestry. The team seeks to determine if these differences cause breast cancer cells to grow and spread more quickly in patients of African descent and contribute to higher metastasis and death rates among Black women. Improved understanding of these underlying molecular mechanisms may lead the way to better treatments and outcomes.
"We know that the health of our state depends on the health of all our communities – and to improve health equity, we must take a closer look at the factors that drive the disparities between Black women and metastatic breast cancer," said Dr. Kia Williams, associate medical director at Blue Cross NC. "We are excited to support Komen and researchers at UNC and Duke and eagerly await the invaluable scientific contributions to come from this collaborative effort."

Thanks to a $500,000 gift by Gilead Sciences, Inc., we are able to award the Susan G. Komen and Gilead Sciences, Inc. for North Carolina’s Metastatic Breast Cancer Collaborative Research Grant to:

A research team led by Dr. Melissa Troester of the University of North Carolina Lineberger Comprehensive Cancer Center and Dr. Terry Hyslop of Duke Cancer Institute for their project that will seek to use information on tumor biology and social factors in UNC’s long-standing Carolina Breast Cancer Study (CBCS) to understand racial differences in breast cancer metastasis and death. Researchers will also evaluate how life stress contributes to higher metastasis rates and worse breast cancer outcomes in Black women when compared to white women. They aim to develop specific interventions to reduce metastasis that consider multiple factors from basic biology to societal factors in order to improve outcomes for Black women.
"As metastatic breast cancer disproportionately impacts Black women, this innovative research to better understand evidence-based solutions to improve outcomes for Black women is crucial," said Bill Grossman, M.D., Ph.D., Senior Vice President, Oncology Therapeutics, Gilead Sciences. "Gilead is proud to support Susan G. Komen in these much-needed efforts."

Thanks to funds raised by individuals and organizations in North Carolina and across the country, Komen is able to award:

A research team led by Dr. Benjamin Vincent of the University of North Carolina Comprehensive Cancer Center and Dr. Zachary Hartman of Duke Cancer Institute with a $500,000 grant for their project to develop a personalized anti-tumor vaccine strategy for patients with advanced Triple Negative Breast Cancer that would mobilize the body’s immune system (T cells) to shut down tumor growth and metastasis.
Spearheaded by Komen Development Director Pam Kohl, who is living with MBC, the Komen Collaborative Metastatic Research Initiative seeks to raise funds with the hope of accelerating discovery by connecting leading researchers from these two leading institutions. These three grants are the initial awards from this initiative. Those interested in supporting additional collaborations can donate at www.komen.org/mbccollaborative.

"Currently, there is no cure for MBC and the treatments are difficult at best," said Kohl. "Research is HOPE for the far too many of us who are living with MBC. This disease is smart, and it is relentless, but I know that these brilliant researchers at UNC and Duke will work every day to help give us the gift of time."

On October 13, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that the first patient has been dosed in a Phase 1b study of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), following CAR-T cell therapy tisagenlecleucel (Kymriah) in patients with relapsed/refractory (r/r) Large B-Cell Lymphoma (LBCL) (Press release, NeoImmuneTech, OCT 13, 2021, View Source [SID1234591188]).

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Diffuse Large B-Cell Lymphoma (DLBCL) is the most commonly occurring subtype of Non-Hodgkin Lymphoma (NHL), accounting for 25% to 30% of all NHL and >20,000 cases in the U.S. annually1. Despite improvement in therapeutic options, treatment is often not curative with as many as 50% of patients developing relapsed or refractory disease2.

"We have shown in multiple animal models that the addition of NT-I7 to CAR-T cells substantially increased CAR-T cell proliferation, persistence, and target-specific tumor killing, resulting in significantly prolonged survival of the treated animals," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech (NIT). "Now that we have begun dosing in this study, we look forward to evaluating the potential of NT-I7 therapy to prolong clinical response and survival for patients with r/r LBCL."

Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT added, "While CAR-T cell therapies have revolutionized the way we treat multiple hematologic malignancies, relapsed or refractory illness still impacts many patients with LBCL who are in need of additional treatment options. By advancing this Phase 1b study, we hope to pave the way for a new therapeutic solution that could enhance the clinical impact of Kymriah alone and ultimately improve patient outcomes."

This multicenter Phase 1b study will evaluate the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard-of-care tisagenlecleucel CAR-T cell therapy, and determine the recommended Phase 2 dose of the combination for further future clinical development.

More information on this trial can be found at www.clinicaltrials.gov, identifier: 05075603.

Kymriah is a registered trademark of Novartis AG.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On October 13, 2021 Veracyte, Inc., (Nasdaq: VCYT) reported the publication of new data demonstrating that the company’s Decipher Bladder genomic classifier accurately identifies bladder tumors that are most likely to respond to chemotherapy prior to radical cystectomy (Press release, Veracyte, OCT 13, 2021, View Source [SID1234591182]). These findings could ultimately help physicians optimize treatment planning for their patients with bladder cancer based on their tumor subtype biology. The peer-reviewed paper appears online today in The Journal of Urology.

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Patients diagnosed with non-metastatic muscle-invasive bladder cancer (MIBC) often undergo neoadjuvant chemotherapy (NAC) prior to standard-of-care radical cystectomy, even though the absolute survival benefit associated with the addition of NAC to radical cystectomy is 5-10%. Until recently, there was no reliable way to determine which MIBC tumors would – or would not – respond to chemotherapy. Molecular subtyping with the Decipher Bladder genomic classifier has shown that biological differences in MIBC are strongly associated with chemotherapy response.

"Our findings are among the first to show the clinical utility of implementing molecular subtyping in order to identify patients for whom NAC is most likely to confer significant benefit," said Yair Lotan, MD, professor of urology and chief of urologic oncology at UT Southwestern Medical Center, and the paper’s lead author. "This study represents meaningful progress in clinically validating biomarkers that are associated with chemotherapy response in patients with MIBC, and it offers hope that we will be able to better manage these patients in the future by accurately selecting those most likely to benefit from additional treatment."

In this multicenter retrospective study, scientists evaluated the use of the Decipher Bladder genomic classifier in a cohort of 601 patients. After three years, patients with classifier-identified luminal tumors (37% of the study population) experienced no additional benefit to overall survival (OS) from receiving NAC prior to radical cystectomy (63% OS with NAC and 65% OS without). However, those patients whose tumors were classified as non-luminal (63% of the study population) experienced a significant benefit from the addition of NAC, with 10% greater overall survival after three years as compared to patients who were treated with cystectomy alone (71% vs. 61%).

"We are pleased that our Decipher Bladder genomic classifier performed so well in this broad study," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of scientific and clinical operations, Urologic Cancers. "We look forward to further validating the test to encourage its routine clinical use for patients diagnosed with MIBC."

The Decipher Bladder test is supported by multiple peer-reviewed clinical studies demonstrating its ability to identify which patients have a higher risk of upstaging to non-organ confined disease at surgery and which patients may benefit the most from neoadjuvant therapy. The test also can be used to identify neuroendocrine-like and immune-infiltrated subtypes, which may have implications for future therapeutic strategies. In June 2021, Veracyte announced that Decipher Bladder had become the first molecular subtyping test to gain Medicare coverage to inform treatment for individuals with bladder cancer.

About Decipher Bladder

Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis from transurethral resected bladder tumor specimens. It was developed for bladder cancer patients with high-grade non-muscle-invasive disease who are being considered for treatment and patients with muscle-invasive disease who face the question of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy (NAC). Decipher Bladder reports the molecular subtype of the tumor specimen as Luminal or Non-Luminal (Luminal Infiltrated, Basal, Basal Claudin-Low or Neuroendocrine-like), with each subtype having distinct biological composition, clinical behavior and predicted benefit from NAC.