On September 29, 2020 Sema4, a patient-centered health intelligence company, reported that it has entered into a research agreement with Janssen Research & Development, LLC (Janssen) to optimize oncology clinical trials (Press release, Sema4, SEP 29, 2020, View Source [SID1234567751]). Together, Sema4 and Janssen will utilize genomic testing and advanced data analytics to more efficiently and accurately identify patients diagnosed with cancer who may be candidates for oncology clinical trials.

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Approximately 1.8 million people are expected to be diagnosed with cancer in the US in 2020, yet only a small percentage of adult patients participate in oncology clinical trials each year, despite clinical trials evaluating promising investigational therapies. Suboptimal patient recruitment is a significant rate-limiting factor in clinical trials that can lead to studies using excessive resources and time, and being underpowered or even abandoned.

To address this problem, Sema4 will provide Janssen access to two of the company’s key assets: industry-leading genomic testing and its proprietary Centrellis health intelligence platform. Centrellis utilizes automated natural language processing capabilities, complemented by PhD oncology curators, to extract critical information regarding patient characteristics from electronic medical record (EMR) data.

Sema4 will deploy its advanced analytics capabilities to apply Janssen’s clinical trial recruitment criteria to Sema4’s large pool of deidentified clinical and genomic patient data to evaluate if a patient may benefit from one of Janssen’s clinical trials.

"Sema4 is passionate about improving patient care through its work with patients, providers, and biopharmaceutical companies," said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. "We are delighted to collaborate with Janssen to utilize our technology and digital expertise and market-leading science experience to potentially accelerate trial recruitment times, with the goal of more treatment options becoming available to patients more quickly."

The collaboration with Janssen follows several other significant developments for Sema4 since the beginning of 2020. Earlier in the year, Sema4 released several software solutions to enable biopharmaceutical partners to rapidly find patients matching clinical trial recruitment criteria and effectively and efficiently design new clinical trials. The company also announced an alliance with artificial intelligence informatics company VieCure, provider of an oncology EMR and point-of-care decision support system, to further enable its national clinical trial support capabilities.

Additionally, Sema4 this year launched its Sema4 Signal Whole Exome/Transcriptome Sequencing (WES/WTS) offering, which is available to biopharmaceutical companies, and became the first commercial laboratory to be approved by the New York State Department of Health (NYSDOH) for WES/WTS for solid and hematologic malignancies utilizing tumor-normal analysis. NYSDOH review represents one of the most rigorous levels of validation nationally for such testing.

On September 29, 2020 Immunomic Therapeutics, Inc. reported that it will participate in a panel at the MD Life Sciences Bio Innovation virtual conference in Maryland (Press release, Immunomic Therapeutics, SEP 29, 2020, View Source [SID1234567725]). On Monday, October 5, Chief Executive Officer at Immunomic, Dr. Bill Hearl, will participate in a panel titled, "Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency" alongside Novavax’s President and CEO, Stanley Erck, and Emmes’ President, Anne Lindblad.

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The Bio Innovation Conference is presented by Maryland Life Sciences, a division of the Maryland Tech Council that is driving the future of life sciences in Maryland. This conference provides a forum for professionals from industry, academia and government to discuss trends and insight into Maryland’s burgeoning life sciences industry and topics related to funding, structuring, commercialization and government relations.

Panel details are as follows:

Title: Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency

Panel Category: Life Science Track

Moderators:
Linda Segal, Principal, The McCormick Group
Gayatri Varma, Director, Transactions, Business Development & Licensing, AstraZeneca

Speakers:
Stanley Erck, President and CEO, Novavax
Bill Hearl, Ph.D., CEO, Immunomic Therapeutics
Anne Lindblad, Ph.D., President, Emmes

Panel Date and Time: Monday, October 5, 2020 10:25 AM

Location: MD Life Science Bio Innovation Virtual Event

On September 29, 2020 US Oncology Research, one of the largest community-based oncology research site management organizations in the U.S., reported that it is celebrating the significant milestone of contributing to the FDA approval of over 100 cancer therapies (Press release, US Oncology, SEP 29, 2020, View Source [SID1234567753]). This achievement is a result of the hard work and dedication to research from more than 165 research locations conducting over 1,600 clinical trials for cancer therapy. More than 80,000 participants have enrolled in clinical trials since 1999.

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"US Oncology Research’s core mission is to bring potentially life-saving and life-improving treatments to the community where patients seek care," said Robert L. Coleman, MD, FACOG, FACS, chief scientific officer, US Oncology Research. "These new interventions come from expert stewardship and execution of clinical research protocols positioned to better understand cancer biology and challenge the status quo. We are, therefore, incredibly proud of this milestone, which reflects the dedication and collective spirit of investigators across The US Oncology Network, committed to defining the next treatment standard. Research is a team sport dedicated to the individual patient."

With each approved therapy, real patient stories reflect the hope and potential that new science brings. One such patient is Henry "Ray" Picagli, who consulted with his oncologist, James H. Essell, MD, at Cincinnati-based OHC (Oncology Hematology Care), after his lymphoma returned after chemotherapy. "Dr. Essell told us about the CAR-T clinical trial OHC was offering for patients in my exact situation and that he thought I would be a good candidate for the investigational treatment," said Picagli. "I was immediately all-in for two reasons. Obviously, I want to live, but I also want others to benefit from what I’m doing, even if it helps only one person."

Today, Ray’s scans are clear, and he is in remission. "I spoke with friends in the medical field," added Picagli. "Everyone said the same thing: ‘You have no idea how lucky you are to be able to get this investigational treatment and that it’s available at OHC. And they were right.’"i

OHC is one of 68 community-based practices in The US Oncology Network, including about 482 sites of care and more than 1,350 physicians, many of which offer their patients a chance to participate in advanced clinical trials. "Usually available only in major academic medical centers or hospital systems, these novel cancer trials are accessible to patients close to home, right in their own communities," said Michael Seiden, MD, PhD, president of The US Oncology Network. "With about 400 active trials at any given time, US Oncology Research is making a tangible difference in the lives of patients."

Having access to a state-of-the-art clinical trial has made all the difference for Laura Reith, who was diagnosed with stage IV triple negative breast cancer just months after delivering a baby. "I wanted to stay closer to home so I could continue with my life," said Reith, who enrolled in a trial under the guidance of her physicians at Illinois Cancer Specialists (ICS), a practice in The US Oncology Network. "I work full-time. I have small kids. It would be difficult to spend a full day in a hospital hours away." Now in her 39th round of treatment in the trial, which she started in 2018, she shows no signs of disease.ii

"It’s all about having the right advocate in your corner. I’m so thankful to have a team of physicians that cares about more than just the dollars – they care about not only my journey but about the future," said Reith. "Being on a clinical trial has provided me hope above all. Hope for more time with my kids. Hope for a future without cancer."

On September 29, 2020 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported that it has signed a license agreement with the National Cancer Institute (NCI) for the commercialization of mesothelin-targeting agents (Press release, Navrogen, SEP 29, 2020, View Source [SID1234567727]).

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Mesothelin is a cell surface protein that is over-expressed on a number of cancer types. Previous studies have found that certain therapeutic antibodies, which use humoral immune function for target cell killing, as well as antibody-drug conjugates (ADC) targeting mesothelin are negatively affected by factors produced in the tumor microenvironment. Navrogen has employed its proprietary Humoral Immuno Oncology (HIO) technology to screen for anti-mesothelin antibodies that are refractory to tumor-produced, immuno-suppressive factors from multiple sources and identified an anti-mesothelin antibody from the NCI collection. Navrogen has reformatted the antibody using next gen technologies and is advancing it into preclinical studies against a wide range of mesothelin-expressing cancers.

"We are pleased to obtain this commercial license from the NCI" said Dr. Nicholas Nicolaides, PhD, President and Chief Executive Officer of Navrogen. "Our team’s experience with this target will enable us to make key development decisions to maximize the opportunity for clinical success and offer patients with mesothelin-expressing cancers new therapeutic options."

Dr. Luigi Grasso, Chief Scientific Officer of Navrogen added, "We were delighted to identify an anti-mesothelin antibody that can naturally avoid the humoral immuno-suppressive effects caused by certain tumor-produced proteins. Our work with this antibody has shown positive activity across some of the more aggressive preclinical models tested. We look forward to expanding upon these preliminary findings and sharing our results with the oncology community in the near future."

On September 29, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the company’s participation at the Digital World CB & CDx meeting which will be held online, September 29-October 1, 2020 (Press release, Personalis, SEP 29, 2020, View Source [SID1234567755]).

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Personalis will present "Enabling the Expansive Interrogation of a Tumor & Its Microenvironment from a Single Sample for Translational Research and Precision Medicine," featuring the Personalis universal cancer immunogenomics platform, ImmunoID NeXT. Kedar Hastak, PhD, will present for Personalis.

Dr. Hastak will discuss challenges facing immuno-oncology translational and clinical researchers and review the importance of insights into the complex and dynamic interactions between the tumor and immune cells of the cancer microenvironment. He will present the company’s solution to these barriers, ImmunoID NeXT, that consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its microenvironment. He will also talk about the Personalis diagnostic initiatives, NeXT Dx, which supports patient management and biomarker-driven clinical trials, and NeXT CDx, a comprehensive companion diagnostic platform.