On November 4, 2021 Akoya Biosciences Inc., (Nasdaq: AKYA) The Spatial Biology Company, reported that new data generated with its CODEX and Phenoptics platforms will be presented at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 10-14 virtually and at the Walter E. Washington Convention Center in Washington, DC (Press release, Akoya Biosciences, NOV 4, 2021, View Source [SID1234594572]).

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In recent years, immunotherapy, which utilizes the patient’s immune system to fight cancer, has significantly advanced the care of cancer patients. However, it has delivered durable benefits only to some subsets of people with advanced disease, creating an urgent need for accurate, predictive biomarkers to stratify responders and non-responders.

Recent studies have demonstrated that spatial phenotypic signatures offer higher predictive power than traditional immunohistochemistry and genomic biomarkers because they preserve the spatial context of tumor samples and measure cellular proximity and interactions in the tumor microenvironment. Akoya’s CODEX and Phenoptics Solutions for discovery, translational and clinical research can image multiple biomarkers across whole tumor sections at single-cell and sub-cellular resolution, allowing researchers to discover novel signatures to predict immunotherapy response.

A sponsored dinner symposium entitled "Leading and Managing Spatial Biomarker Innovations in Immuno-Oncology: Multistakeholder Perspectives," will feature experts from a pharmaceutical company, an academic medical center, and a clinical research organization (CRO), who will discuss how they are using spatial biomarkers to transform oncology drug development and testing. The speakers are: Qingyan (Sandy) Au, PhD, principal scientist, director of multiplexing operations, NeoGenomics; Michael Surace, PhD, associate director, AstraZeneca; and Houssein A. Sater, MD, Lead Physician Scientist, Hematology Oncology, Cleveland Clinic Martin Health. The dinner will take place on Thursday, November 11, at the Marriott Marquis (next to the Convention Center).

The company and its collaborators will also highlight novel applications and data through the following poster presentations:

P#49: Highly Multiplexed Detection of Critical Immune Checkpoints and Immune Cell Subtypes in Cancerous FFPE Tissues Using CODEX.
P#51: A Novel Cross-Site Analysis of Vectra Polaris Multiplex Fluorescence PD-1/PD-L1 Immunohistochemistry on Colorectal Cancer with High and Low Microsatellite Instability.
P#309: Visualizing the Immunotherapy-Induced Spatial Reorganization of the Tumor-Immune Microenvironment by CODEX Multiplex Imaging.
P#937: Advanced Understanding of the Tumor Microenvironment with Multiplex Analysis: An Automated 7-color Multiplex Assay Using Akoya’s Opal Technology.
In addition, conference attendees can get hands-on experience with the CODEX and Phenoptics systems by visiting the Akoya booth (#4). In-booth presentations will take place on Friday, November 12 and on Saturday, November 13 covering the following topics:

Visiopharm: Analysis of a Spatial Signature Data Set
Expanding into Multiplex Immunofluorescence: Complementing Your Research
Paving the Path for Spatial Biomarker Discovery
Brian McKelligon, Akoya’s Chief Executive Officer, commented: "We at Akoya look forward to SITC (Free SITC Whitepaper) 2021, where we will demonstrate how complete workflow solutions like CODEX and Phenoptics can simplify the discovery and translation of spatial biomarkers into advanced clinical tools, leading to more optimal cancer treatments that produce better outcomes for greater numbers of patients."

For more information about Akoya’s activities at SITC (Free SITC Whitepaper) 2021, please visit akoyabio.com/sitc2021.

On November 4, 2021 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, reported the clinical launch of its DetermaIOTM test (Press release, Oncocyte, NOV 4, 2021, View Source [SID1234594571]). DetermaIO is a proprietary gene expression test that assesses the tumor immune microenvironment (TIME) to predict response to immunotherapy. In multiple clinical studies evaluating hundreds of patients across multiple tumor types, including lung, breast, bladder and renal cancers, the test has demonstrated the ability to predict response to immune checkpoint inhibitors (ICI) which has the potential to help inform the optimal use of immunotherapy treatment for more than one million eligible patients annually in the United States alone.

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"For my patients with lung cancer, there are myriad treatment options including mono immunotherapy, combination immunotherapy with chemotherapy, and even a combination of two immunotherapies, each with their benefits and risks in terms of toxicity and side effects," said Dr. Nagdala Abdel-Karim, Director of the Thoracic Oncology Multidisciplinary Clinic and Medical Director of the Georgia Cancer Centers Clinical Trials Program. "Therefore, selecting the right immunotherapy regimen for the patient is a very complex decision. We use PD-L1 and occasionally tumor mutational burden (TMB), but neither biomarker is completely accurate or takes into account both the tumor and its microenvironment, which is important as both determine response to immunotherapy. I am impressed with the DetermaIO data, especially the superior progression free survival relative to legacy biomarkers and feel confident it will enable us to better navigate the immunotherapy decision."

In studies in multiple solid tumors presented at oncology congresses around the world, including at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and American Association of Cancer Research (AACR) (Free AACR Whitepaper), and in a peer-reviewed publication with authors from MD Anderson and Yale, DetermaIO has demonstrated superior utility in identifying patients who may respond to immunotherapy compared to alternative biomarkers in development. DetermaIO has also demonstrated superior utility in identifying patients who are unlikely to benefit from these immune therapies which can cause serious, long-lasting side effects. In a study presented at the recent ESMO (Free ESMO Whitepaper) congress, triple negative breast cancer patients randomized to receive either neoadjuvant chemotherapy alone or chemotherapy combined with an immune checkpoint inhibitor, DetermaIO positive patients had a 20% higher pathologic complete response only when an ICI was added to standard of care chemotherapy (71% response compared to 51%), while those patients who were DetermaIO negative showed no additional benefit from the addition of immunotherapy to a standard of care regimen. This study confirmed findings in a previously published study where ICI given in combination with standard neoadjuvant chemotherapy showed far superior benefit in DetermaIO positive patients compared to DetermaIO negative.

Padma Sundar, Chief Commercial Officer of Oncocyte, said, "Given the data presented to date, there is strong interest among physicians to access this test and incorporate it into their practice to aid in the complex decision making for immunotherapy treatment. We are launching the test initially as part of an early access program to optimize sample processing and logistics, targeting sites that have successfully partnered with Oncocyte on prior tests. Recruitment for the early access program is ahead of schedule and clinical samples are expected to begin coming in before the end of the year. Demonstrating test adoption is an important step towards pursuing Medicare reimbursement, along with peer reviewed publications which are in progress, and we remain committed to deliver our reimbursement dossier in the first half of 2022."

Ms. Sundar continued, "The next step in our menu roll out is to combine DetermaIO with DetermaTx, a DNA/RNA based comprehensive genomic profiling test, which already has established Medicare reimbursement rates. With both tests performed on a single sample, we will deliver the most complete and differentiated biomarker information needed to make both immunotherapy and targeted therapy decisions to treating physicians, while conserving precious sample and minimizing turnaround time. This, combined with DetermaCNI, our blood-only test for treatment resistance monitoring currently in clinical trials, builds on our ‘one-lab’ offering, and will differentiate us with oncologists. Our one lab and sample sparing approach strengthens our position as an emerging leader in precision oncology testing."

The launch of DetermaIO is built on the growing body of evidence on the clinical applications of the test, suggesting a potential pan-cancer and pan-immunotherapy utility in both primary and metastatic settings. In combination with the Company’s robust pipeline of diagnostic and monitoring tools, as well as its recently-launched real world cancer registry in early stage NSCLC for DetermaRx, this launch underscores Oncocyte’s commitment to driving rigorous science in order to empower surgeons, physicians, and their patients to better manage the oncology patient journey.

About DetermaIO

DetermaIO is a 27-target multivariate gene expression test performed on FFPE biopsy specimens that measures the presence of subtypes of infiltrating inflammatory cells, and the presence or absence of a differentiated stromal microenvironment. DetermaIO’s proprietary algorithm combines mRNA gene expression data to interpret the physiology of both the tumor and its surrounding micro-environment in order to predict the response to immuno-oncology therapies. For more information, visit www.oncocyte.com/products/determa-io.

On November 4, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported its participation at these upcoming investor conferences (Press release, Nkarta, NOV 4, 2021, View Source [SID1234594570]):

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Cowen 5TH Annual IO Next Summit
November 15, 2021
11:15 a.m. ET – fireside chat presentation

Stifel 2021 Virtual Healthcare Conference
November 17, 2021
2:00 p.m. ET – fireside chat presentation

Evercore ISI 4TH Annual HealthCONx Conference
December 1, 2021
4:20 p.m. ET – fireside chat presentation

A simultaneous webcast of the presentations will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.

On November 4, 2021 Grey Wolf Therapeutics, a biotechnology company spearheading a new therapeutic approach to immuno-oncology driven by targeted neoantigen generation, reported that preclinical in vivo data on the company’s first-in-class inhibitors of ERAP1 will be presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Grey Wolf Therapeutics, NOV 4, 2021, View Source [SID1234594569]). Presented findings will highlight the ability of the company’s novel ERAP1 inhibitors to significantly increase the diversity of T cell receptors in the tumor, drive synergistic upregulation of translationally relevant immune markers that have been shown to correlate with patient response to checkpoint inhibition, and trigger significantly greater T cell infiltration into tumors in preclinical models. Additionally, the presentation will showcase significant tumor growth inhibition in syngeneic mouse tumor models following combination of ERAP1 inhibition with an anti-PD-1 antibody. The SITC (Free SITC Whitepaper) conference is being held November 10-14, 2021 in Washington, D.C., as well as virtually.

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Grey Wolf Therapeutics’ first-of-its-kind immuno-oncology approach is centered on dramatically increasing the visibility of tumors to allow for their identification and destruction by the body’s immune system. This is achieved through targeted inhibition of the endoplasmic reticulum aminopeptidases (ERAP1 and ERAP2), causing the generation and presentation of novel and potent neoantigens to the surface of tumor cells. The appearance of these neoantigens uncloaks the tumor cells, illuminating them for the immune system and setting in motion powerful, differentiated T cell responses against the tumor. Importantly, this unique approach is orthogonal to a broad range of other cancer therapy modalities, including, but not limited to, immunotherapy. The company is developing a portfolio of ERAP inhibitors that it believes represents the first ever application of direct neoantigen generation to the treatment of cancer. GRWD5769, the company’s lead ERAP1 inhibitor development candidate, is expected to enter the clinic in the second half of 2022.

Details of the company’s presentation at the 2021 SITC (Free SITC Whitepaper) conference are as follows:

Poster Presentation #553:

Title: First-in-Class Inhibitors of ERAP1 Alter the Immunopeptidome of Cancer, Driving a Differentiated T Cell Response Leading to Tumor Growth Inhibition
Presenting Author: Peter Joyce, Ph.D., Chief Executive Officer of Grey Wolf Therapeutics
Date/Time: Friday, November 12, 2021, 7:00 a.m. – 8:30 p.m. Eastern
Location: Poster Hall – Hall E
The poster will be available for download (upon request) here following the annual meeting.

On November 4, 2021 Primmune Therapeutics reported that it has received $8.4 million in a second tranche of the Company’s Series A financing. The total proceeds for the equity raised in the Series A was $31.4 million (Press release, Primmune Therapeutics, NOV 4, 2021, View Source [SID1234594568]). These funds will be used to support the further clinical development of PRTX007 as a TherAjuvant for acute viral diseases, pre-cancerous lesions, and advanced cancer. PRTX007 is a novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonist that has both therapeutic and adjuvant properties.

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"Given the initial results from our Phase 1 study in healthy volunteers, we achieved our target clinical milestone that triggered a second tranche of $8.4 million from our existing investors. These funds will be used to set the stage for Primmune’s expansion into multiple definitive efficacy studies," said Charlie McDermott, Chairman and Chief Executive Officer of Primmune Therapeutics. "In 2022, we intend to study PRTX007 in ambulatory respiratory syncytial virus (RSV), outpatient SARS-CoV-2, human papilloma virus (HPV) driven high-grade squamous intraepithelial lesions (HSIL) of the cervix, and in the neo-adjuvant setting in combination with checkpoint inhibitors in advanced cancer."

About TherAjuvants
Primmune Therapeutics coined the term TherAjuvants to reference its lead candidate PRTX007, a toll-like receptor 7 (TLR7) agonist with a combination of therapeutic and adjuvant mechanisms of action. PRTX007 is designed to provide immediate benefit to patients through controlled stimulation of the innate immune response while also potentiating long-term effective innate and adaptive immune responses. PRTX007 uniquely engages TLR7 and targeted immune cells without exacerbating inflammation, a critical feature in treating respiratory viral infections. TherAjuvants differ from therapeutic vaccines in that the source of the antigens presented to the patient’s immune system come from the treated pathology. Additionally, TherAjuvants differ from most small molecule approaches in that they target the patient’s immune system and not tumor cells or virally encoded targets.