On October 9, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported that the first patient has been dosed with TP-1454, an investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, administered alone and in combination with ipilimumab and nivolumab, in a Phase 1/1b study in patients with advanced metastatic or progressive solid tumors (Press release, Sumitomo Dainippon Pharma, OCT 9, 2020, View Source [SID1234568273]).

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"Dosing the first patient in this study marks an important milestone, as TP-1454 is the first PKM2 activator to be evaluated in patients with cancer," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "The novel mechanism of action for TP-1454 aims to target the underlying drivers of tumor growth and tumor-driven immune suppression. We look forward to further understanding the safety and efficacy of TP-1454 alone and in combination in patients with solid tumors and applying these learnings to advance the compound."

The primary objectives of the first-in-human, open-label study are to assess the safety of oral TP-1454 administered once daily as monotherapy in patients with advanced metastatic or progressive solid tumors and as combination therapy with ipilimumab and nivolumab. The study will also establish the dose of TP-1454 alone and in combination with ipilimumab and nivolumab for future studies in select advanced solid tumors. Secondary objectives include assessing the pharmacokinetic (PK) profile and preliminary antitumor activity of TP-1454 alone and in combination with ipilimumab and nivolumab and evaluating pharmacodynamics of TP-1454.

The trial is being conducted in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04328740).

About TP-1454

TP-1454 is an investigational oral pyruvate kinase M2 isoform (PKM2) activator, that is currently being evaluated in a Phase 1/1b study in patients with advanced metastatic or progressive solid tumors (NCT04328740). TP-1454 is the first PKM2 activator to be evaluated in cancer patients. Pyruvate kinase is the enzyme responsible for catalyzing the last step of glycolysis. PKM2 plays a critical role in the metabolic changes observed in cancer and immune cells and establishes a metabolic advantage for tumor cells over the tumor immune microenvironment.1

On October 9, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its third quarter 2020 financial results after the close of the U.S. financial markets on October 29, 2020 (Press release, Exact Sciences, OCT 9, 2020, View Source [SID1234568257]). Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

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An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 2379459. The webcast, conference call and replay are open to all interested parties.

On October 9, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that the Company’s European manufacturer, BSP Pharmaceuticals S.p.A. ("BSP"), has begun the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable (Press release, CNS Pharmaceuticals, OCT 9, 2020, View Source [SID1234568274]).

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"Our preparations for filing an IND for Berubicin require continued execution in both our clinical and manufacturing initiatives," stated John Climaco, CEO of CNS Pharmaceuticals. "With the manufacturing of our Berubicin Drug Product in Europe, we continue to advance closer toward an IND filing for Berubicin, which we expect to submit later this quarter. We have also made significant progress on the clinical front and recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group ("IAG") as the imaging partner, and Berry Consultants as a biostatistical advisor for our Phase 2 trial design. We have also added Dr. Patrick Wen, a renowned neuro-oncologist, to our Scientific Advisory Board. Our laser focus remains on initiating a U.S. Phase 2 trial for Berubicin in Q1 of 2021 and we continue to demonstrate our ability to execute our operational and clinical plans toward that goal."

As part of the Company’s plan to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin, the Company implemented a dual-track drug product manufacturing strategy. Under this dual-track strategy, it engaged two separate manufacturers for Berubicin on different continents, both U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP. As previously announced, CNS completed synthesis of Berubicin active pharmaceutical ingredient (API) and shipped API to both Pii and BSP to prepare an injectable form of Berubicin for clinical use. BSP and Pii have now begun manufacturing of Berubicin and the Company expects to complete manufacturing at both locations early in the fourth quarter.

The FDA recently granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product’s development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug’s approval for that use.

On October 9, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported a poster presentation and oral discussion at the upcoming 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held virtually October 24 – 25, 2020 (Press release, ORIC Pharmaceuticals, OCT 9, 2020, View Source [SID1234568258]). The presentation will highlight preclinical data in prostate cancer cell lines that demonstrate the company’s glucocorticoid receptor (GR) antagonist, ORIC-101, reversing GR-mediated resistance to an androgen receptor (AR) degrader.

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In the study, it was observed that upon treatment of prostate cancer cell lines with an AR degrader, GR mRNA and protein levels were significantly upregulated, similar to the GR upregulation seen after dosing with enzalutamide. This GR upregulation translated into GR activation that conferred resistance to the AR degrader, permitting prostate cancer cells to continue to grow. ORIC-101 was shown to completely reverse these effects and block tumor cell growth and androgen-regulated gene expression. These data demonstrate that GR may be a mechanism of resistance to AR degraders and that in vitro, ORIC-101 overcomes GR-driven resistance to AR degradation.

GR has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials of ORIC-101 in combination with Xtandi (enzalutamide) in metastatic prostate cancer and Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors. ORIC expects to report interim data from one of the trials in the first half of 2021 and from the other trial in the second half of 2021.

Details of the poster presentation are as follows:

Title: ORIC-101 Overcomes GR-driven Resistance to AR Degradation in Castration-Resistant Prostate Cancer Models
Date: October 25, 2020; 2:30 p.m. CEST
Session: Poster Discussion Session
Topic: Approaches to Overcoming Therapeutic Resistance
Abstract: PD-050

On October 9, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reported that Athenex Oncology, a U.S. based division of Athenex, launched Your Guide to Facing Metastatic Breast Cancer — a free, first-of-its-kind resource offering comprehensive lifestyle guidance to people living with metastatic breast cancer (MBC) (Press release, Athenex, OCT 9, 2020, View Source [SID1234568275]). The Guide provides evidence-based recommendations for increasing resilience, reducing stress, maintaining good dietary and sleep habits, managing inflammation, and other tips to improve quality of life while living with MBC. The Guide can be ordered at www.AthenexOncology.com/patient-resources.

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The launch of Your Guide to Facing Metastatic Breast Cancer is timed to coincide with MBC Awareness Day on October 13. The Guide, which is created by health and wellness company Viver Health, complements Facing MBC Together, a public education and patient support program that Athenex Oncology launched in June 2020 to provide practical and emotional support to people living with MBC.

"Introducing Your Guide to Facing Metastatic Breast Cancer during National Breast Cancer Awareness Month underscores Athenex Oncology’s commitment to meeting the needs of the metastatic breast cancer community," noted Timothy Cook, senior vice president, global oncology at Athenex. "Our continued provision of practical resources that promote health and wellness reflects our view of individuals as whole people, not as ‘patients.’ While the lifestyle tips in the Guide can be useful to anyone, they are designed to be especially helpful to those who are living with metastatic breast cancer."

The recommendations in the Guide are based on extensive research showing that a health-oriented lifestyle – one that encompasses a healthy diet and nutrition, exercise, stress reduction, inflammation management, and adopting coping mechanisms to become more physically and emotionally resilient – may improve overall survival and quality of life following a breast cancer diagnosis.1-6 The Guide has distilled and translated those research findings into simple and easily understandable information that people living with MBC can adopt and implement on their own.

"Living with metastatic breast cancer is about more than just taking your medicine and keeping all your doctor’s appointments," commented Beth Baughman DuPree, M.D., a board-certified general surgeon specializing in diseases of the breast, and a medical advisor to the development of the Guide. "It’s about being mindful and taking an active role in your own care, while also finding ways to bring meaning to your life, whether through connecting with friends, creating art, communing with nature, or relieving stress through yoga, tai chi, quigong, reiki, or just plain laughter. Your Guide to Facing Metastatic Breast Cancer is designed to help you find your own path to health, wellness, optimism, and inner strength."

Dr. DuPree, who is the medical director of the oncology service line at Northern Arizona Healthcare, vice president, health at Holy Redeemer Health System in Pennsylvania, as well as founder and president of the Healing Consciousness Foundation added, "While the Guide was created before the global COVID-19 pandemic struck, its recommendations can be particularly useful during these difficult times, when people with metastatic breast cancer feel even more isolated than usual."