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.

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 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 Genosity Inc., and Olink Proteomics AB reported that they have entered into a strategic services and collaboration agreement within the United States (Press release, Genosity, SEP 29, 2020, View Source [SID1234567749]). This will allow Olink to further expand its innovative protein biomarker discovery services for the U.S. market, while enabling Genosity to add high throughput proteomics to its repertoire of available technologies.

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Genosity is a biotechnology company that currently offers many genomic assays based on DNA and RNA analysis to its pharmaceutical customers for both clinical research and clinical trials applications. Through the collaboration, Genosity will provide wider access to the Olink high-multiplex protein biomarker discovery portfolio by utilizing Genosity’s cutting edge CLIA/GCP/GLP laboratory. Beyond offering the Olink technology within the Genosity laboratory, Genosity will also provide Olink with a path towards further decentralization and commercialization through inclusion of the Olink technology inside the Genosity Integrated Genomics Toolkit (IGT) software solution. The Genosity comprehensive sample to result report system is operational at a number of institutions within the United States that are potential customers for the Olink technology and allows for easier adoption and implementation of innovative and new testing solutions.

"We are excited to introduce another cutting-edge omics platform into our Genomic ecosystem. As we continue to advance precision medicine, we are always looking for new technologies to add to our laboratory service offering. The ability to perform such highly multiplexed, proteomic profiling experiments with the same sequencers we use to sequence Genomes is revolutionary," said Robert Daber, CTO and cofounder of Genosity.

"We are delighted to enter into this strategic partnership with Genosity, which we are confident will broaden the access to our protein biomarker solutions for the wider scientific community in the U.S. We have been greatly impressed during our discussions with Genosity, from their well-established entrepreneurial history in the biotechnology arena, to their clear understanding of precision medicine and Olink’s contribution to this area. Our conversations with Genosity’s existing customers have only strengthened this impression, and they are clearly at the forefront of genomics, bioinformatics and precision oncology. We are genuinely excited about the opportunity to add proteomics to their offering in order to expand and accelerate precision medicine towards clinical applications and patient care," said Erik Pettersson, Head of Business Development, Olink Proteomics.

"Proteomics is becoming an area of increasing interest for research and clinical research applications. Olink’s unique approach has clearly made it the market leader in this innovative area of biomarker discovery. The key to any biomedical innovation is how it will eventually answer a relevant clinical question for patient care. Proteomics and especially Olink have only scratched the surface of their applications, we look forward to working with them as they expand their footprint across this country and beyond," says Marc Grodman MD, cofounder and CEO, Genosity Inc.

About the technology

Olink’s Proximity Extension Assay (PEA) technology utilizes pairs of antibodies linked to complementary oligonucleotides, which are brought into proximity when the antibody binds to the target protein. The proximity results in formation of PCR Target sequence which can be further amplified, detected, and quantified using standard methodologies. The Olink Explore platform currently enables 1536 proteins to measured using less than 3 µL of sample using Next Generation Sequencing (NGS) readout, producing up to 1.3 million protein data measurements per week per Illumina NovaSeq system. Olink’s technology is superior to other immunoassays because using specific DNA oligos prevents any cross-reactivity as a result of unspecific antibody binding, and enables sensitive, rapid, high throughput protein measurements at very high multiplexing levels, consuming minimal sample.

On September 29, 2020 Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid malignancies, reported the treatment of the first patients in its ANCHOR phase 1 study of KUR-502, an allogeneic CAR-NKT therapy (Press release, Kuur Therapeutics, SEP 29, 2020, View Source [SID1234567747]).

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"This is an important day, as the initiation and dosing of the first patients in the ANCHOR phase 1 clinical study marks the first time that patients have been treated with an allogeneic engineered CAR-NKT cell therapy," said Dr. Carlos Ramos, Principal Investigator of the ANCHOR study, Professor of Medicine in the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center. "CAR-NKT cells have the potential to offer a distinct set of advantages over other lymphocytes commonly used for cell therapy, such as T cells. We are pleased to be advancing this ground-breaking first-in-human clinical study and anticipate that CAR-NKT cells could be an important treatment option for patients with both hematological and solid tumors in the future."

"With the initiation of the ANCHOR study of KUR-502 in CD19 positive hematological malignancies, we are able to turn our focus to exploring the effects of off-the-shelf CAR-NKT cells," said Kevin S. Boyle, Sr., Kuur’s Chief Executive Officer. "This study will allow us to evaluate our platform technology with a validated target in CD19 and validated indications, generating critical data to advance our allogeneic efforts. Together with the results from our proof of concept GINAKIT2 study of KUR-501 in neuroblastoma, the forthcoming data from the ANCHOR study will guide future development of our next generation platform technology."

KUR-502 is built on Kuur’s next-generation CAR-NKT platform, with novel engineering capabilities that harness and enhance the unique tumor-homing properties of NKT cells. This NKT platform technology was developed in the CAGT Lab of Dr. Leonid Metelitsa, Professor of Pediatrics-Oncology at Baylor College of Medicine and Texas Children’s Hospital and member of the Dan L Duncan Comprehensive Cancer Center, and KUR-502 was produced by the CAGT cGMP facility. One of the challenges with allogeneic therapies is that infusing a patient with donor-derived lymphocytes can induce graft versus host disease (GvHD), a potentially life-threatening condition in which the infused cells recognize the patient’s tissues as foreign. The NKT cells used in Kuur’s CAR-NKT platform have an invariant T cell receptor that does not distinguish between self- and non-self tissues, making the cells unlikely to induce GvHD when given to another person. Preclinical data generated by Baylor College of Medicine indicate that while human CAR-T cells cause severe GvHD, CAR-NKT cells from the same donor do not.

The ANCHOR (NCT03774654) study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies, including B cell lymphomas, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). The single arm study will evaluate three dose levels, with patients receiving lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502.

Patients with R/R CD19 positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by delays to get treatment, a requirement for patient leukapheresis, and issues with inferior quality leukapheresis starting material due to prior treatment. Off-the-shelf KUR-502 is designed to overcome these limitations.

The ANCHOR study is being sponsored and conducted by Kuur’s collaborator, Baylor College of Medicine.

About KUR-502

KUR-502 is an innovative allogeneic (off-the-shelf) product in which natural killer T cells are engineered with a chimeric antigen receptor targeting CD19. KUR-502 is engineered with a CD19-specific CAR construct that is additionally designed to secrete the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. In addition, the CAR-NKT cells express short hairpin RNA (shRNA) designed to downregulate HLA class I and class II expression, which may minimize rejection by the patient’s immune system and further enhance persistence. The CAR, IL-15 and shRNAs are effectively expressed in NKT cells via a single gammaretroviral vector, allowing for one-hit generation of off-the-shelf CAR-NKT cells. In contrast to off-the-shelf CAR therapy with conventional alpha-beta T cells, gene editing to remove the TCR to prevent GvHD is not required for off-the-shelf CAR-NKT therapy. KUR-502 is manufactured from healthy donors, from whom cell therapy products can be prepared in large quantities from a single procedure and used to treat many different patients.