On July 20, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, reported that it will host a key opinion leader webinar on Tuesday, July 27, 2021, at 8 am Eastern Time (Press release, Infinity Pharmaceuticals, JUL 20, 2021, View Source [SID1234584965]).

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The webinar will provide updates on the MARIO-3 TNBC and MARIO-275 UC clinical studies, both of which add eganelisib to approved standard of care regimens. MARIO-3 is a Phase 2 triplet combination study evaluating the addition of eganelisib to the approved standard of care combination of Tecentriq and Abraxane in the front-line setting in TNBC. MARIO-275 is a randomized, controlled Phase 2 combination study evaluating the addition of eganelisib to the approved standard of care Opdivo monotherapy in the second line setting for immune-oncology naïve UC patients who have progressed on a platinum therapy.

The webinar will feature a presentation by Erika P. Hamilton, M.D. of Sarah Cannon Research Institute at Tennessee Oncolgy, of updated data from MARIO-3 in the context of the current standard of care. Dr. Hamilton presented initial MARIO-3 TNBC data at the 2020 San Antonio Breast Cancer Symposium in December 2020 and will be available to answer questions following the formal presentation.

Brian Schwartz, M.D., Consulting Chief Physician of Infinity, will present a status update on eganelisib in UC that builds upon the initial data from MARIO-275 Phase 2 study in second line patients with UC, which he presented at the 2021 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February 2021 and will be available to answer questions following the formal presentation.

To register for the webinar, please click here.

Dr. Hamilton joined Sarah Cannon as investigator, drug development and women’s cancer in 2013. Her responsibilities include overseeing the breast cancer research program as well as caring for patients with breast and gynecologic cancers in the clinic. After receiving an undergraduate degree from Washington and Lee University in Virginia, Dr. Hamilton completed her medical degree and residency from University of North Carolina in Chapel Hill. She received her fellowship training in hematology and oncology from Duke University in Durham, North Carolina, where she was recognized as a Top 5 Finalist for Duke’s Annual House staff Fellow Teaching Award. Dr. Hamilton is board certified in internal medicine and oncology.

Dr. Brian Schwartz has more than a decade of experience as a drug development expert in pharmaceutical and biotechnology industries, spanning several therapeutic areas including oncology, dermatology, neurology and rare diseases. In senior leadership roles at ArQule, Ziopharm, Bayer and Leo Labs, Dr. Schwartz has accumulated a number of successful New Drug Applications (NDA), numerous Investigational New Drug (IND) applications, preclinical and clinical drug development programs. During his time in biotech, Dr. Schwartz acquired knowledge of investors relations, partnering and capital raising. Currently, Dr. Schwartz is an advisor for California Institute of Regenerative Medicine, numerous biotech companies and board member of LifeSci Acquisition Corp. Dr. Schwartz qualified as a medical doctor in South Africa followed by additional fellowship training in Canada.

On July 20, 2021 ChromaDex Corp. (NASDAQ:CDXC) reported that it will hold a conference call on Tues., August 3, 2021 at 4:30 p.m. ET to discuss its financial results for the second quarter ended June 30, 2021 (Press release, ChromaDex, JUL 20, 2021, View Source [SID1234584964]). The financial results will be reported in a press release after the close of regular stock market trading hours on the same day as the conference call.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investor Conference Call:

ChromaDex management will host an investor conference call to discuss the second quarter results and provide a general business update on Tues., August 3, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at www.chromadex.com.

On July 20, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that its 64Cu SAR-bisPSMA clinical trial in patients with confirmed prostate cancer is open for recruitment at two sites, GenesisCare CTA Medical Clinic, Perth and Nepean Hospital, Sydney (Press release, Clarity Pharmaceuticals, JUL 20, 2021, View Source [SID1234584961]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to open this trial for patients with newly diagnosed prostate cancer using our optimised PSMA agent, 64Cu SAR-bisPSMA, that has the novel combination of two targeting agents attached to our SAR Technology. The preclinical data to date is compelling, with both higher tumour uptake and greater tumour retention compared to the single targeted products utilised by other radiopharmaceutical products on the market, and we look forward to recruiting our first patient for this trial shortly."

The PROPELLER trial is a Phase I Positron Emission Tomography (PET) imaging trial of participants with confirmed prostate cancer using 64Cu SAR-bisPSMA. It is a 30-patient clinical trial conducted across three sites in Australia (NCT04839367)1. PROPELLER is a multi-centre, blinded review, dose ranging, non-randomised study of 64Cu-SAR-bisPSMA administered to patients with confirmed prostate cancer prior to radical prostatectomy. The primary endpoints of the trial are safety, tolerability and efficacy in the detection of primary prostate cancer compared to histopathology.

Dr Taylor said: "Prostate cancer is one of the largest indications in oncology, and due to the logistical, manufacturing and imaging issues related to other radiopharmaceuticals, represents a lucrative opportunity for us to enter this space with our Targeted Copper Theranostics (TCT) platform. Clarity’s centralised manufacture and broad distribution model coupled with the flexibility of imaging at later time points, gives us confidence to believe that we can provide a large patient population with early, accurate and precise detection of prostate cancer and improve patient outcomes. We look forward to further progressing the development of our SAR-bisPSMA product and exploring the benefits of our TCT platform for patients with prostate cancer, including in our upcoming US based 64Cu/67Cu bis-PSMA theranostic trial (SECuRE trial (NCT04868604)2 which is due to commence shortly. The progress of these two trials will get us one step closer to our ultimate goal of developing better treatments for children and adults with cancer."

On July 19, 2021 Akoya Biosciences, Inc., (Nasdaq: AKYA) The Spatial Biology Company, reported that the Phenoptics mIF solution was used in a multi-site study to demonstrate and validate an automated end-to-end workflow that characterizes PD-1/PD-L1 immune checkpoint signaling in tumor tissue samples (Press release, Akoya Biosciences, JUL 19, 2021, View Source [SID1234590277]). The paper titled, "Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE Study)," was published in the Journal for ImmunoTherapy of Cancer (JITC) in July 2021. The MITRE results are an important step toward standardizing an automated mIF-based spatial biology workflow that provides the level of performance needed to support clinical trials and that can be applied to clinical testing in the future.

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Top immuno-oncology and pathology experts from five institutions collaborated with Akoya to conduct the MITRE study, including Johns Hopkins University School of Medicine, Yale University School of Medicine, Earle A. Chiles Research Institute, The University of Texas MD Anderson Cancer Center, and Bristol Myers Squibb.

"I am very excited by the results of this study because it is the first multi-institutional study of its kind involving mIF, representing an approach that should be part of every effort to develop a biomarker platform for trials and eventual clinical use," said Dr. David Rimm, Professor of Pathology at Yale University School of Medicine and one of the lead principal investigators on the study.

Immunotherapy utilizes the patient’s immune system to fight cancer and has delivered durable benefit to some subsets of patients with advanced disease, representing a significant step forward in the quest to conquer cancer. However, a majority of the patients still do not respond to treatment. There is a pressing need for accurate, predictive biomarkers to differentiate responders from non-responders. Recent studies have demonstrated that spatial biomarkers are able to predict immunotherapy response with greater accuracy than current methods1,2.

Spatial biology, a rapidly emerging field of science, allows researchers to map the interactions of tumor and immune cells across an entire tumor tissue section, without destroying the spatial context of the tissue, enabling a more accurate assessment of tumor-immune biology.

With the MITRE study, the authors sought to develop and validate a spatial biology workflow that is transferable among sites and delivers site-independent and reliable quantitative data for immunotherapy research.

Study details

The multi-institutional effort optimized an automated 6-plex biomarker assay focused on the PD-1/PD-L1 axis and assessed the inter- and intra-site reproducibility of the assay by measuring spatial biology parameters of tumor and immune cells within tissue samples. Among the parameters examined were tumor cell and immune cell subset densities, PD-L1 expression and location, and PD-1/PD-L1 spatial proximity.

Akoya’s Phenoptics workflow, which enables spatial phenotyping using mIF, demonstrated high concordance across multiple institutions. The study confirmed that quantitative measures of multiple biomarkers in a tissue section are reproducible at levels aligned with typical clinical testing standards. The authors also reported that quantitative mIF substantially outperforms challenging visual assessments, such as assessing PD-L1 positivity in immune cells, particularly in non-small cell lung cancer (NSCLC) samples.

"The foundational requirement for any platform including those delivering spatial phenotyping is the ability to fully demonstrate analytical robustness with a workflow that has the necessary throughput for large scale clinical studies. With the MITRE study and the robust end-to-end Phenoptics workflow, we believe Akoya is ideally positioned to support our customers’ translational and clinical research needs," said Brian McKelligon, CEO of Akoya. "Along with our recent announced partnerships with AstraZeneca and Johns Hopkins, the MITRE Study is another significant milestone in moving spatial biology into the realm of patient phenotyping and improving immunotherapy outcomes in the future."

For more information about Phenoptics, go to: akoyabio.com/Phenoptics

On July 19, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to COSELA (trilaciclib) investigation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC) (Press release, G1 Therapeutics, JUL 19, 2021, View Source [SID1234587574]). COSELA is currently being evaluated in PRESERVE 2, a pivotal Phase 3, randomized, double-blind, placebo-controlled study (NCT04799249) in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for TNBC.

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Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation may be eligible for more frequent engagements with the FDA to discuss the drug’s clinical development plan, eligibility for Accelerated Approval and Priority Review, and Rolling Review in which the Company can submit completed sections of its New Drug Application (NDA) for FDA review rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

"Fast Track designation underscores the urgent need for innovative drugs that can significantly improve TNBC patient outcomes," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "It provides an important pathway to help expedite the development and regulatory review of COSELA in this indication. We look forward to working closely with the FDA as we advance this pivotal program in TNBC and continue to work to unlock the broader potential of this pipeline-in-a-molecule compound that we hope will help patients across multiple tumor types."

About Triple Negative Breast Cancer (TNBC)
According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer makes up approximately 15% to 20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because TNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating TNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with TNBC compared to other forms of breast cancer, and TNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.