On February 23, 2021 GenesisCare, a leading provider of integrated cancer care globally, and Prelude Corporation (PreludeDxTM), a leader in molecular diagnostics and precision medicine, reported a new strategic partnership aimed at increasing access to personalized breast cancer treatment and improved patient outcomes (Press release, GenesisCare, FEB 23, 2021, View Source [SID1234575478]).

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DCISionRT is a precision medicine test for women diagnosed with DCIS (Ductal Carcinoma in situ) or Stage 0 breast cancer who are treated with breast-conserving surgery. The DCISionRT test, developed by PreludeDx, assesses a woman’s 10-year risk of recurrence of DCIS or development of invasive breast cancer. The test provides predictive information regarding recurrence risk, allowing physicians to better select those patients who will benefit from radiation therapy in addition to surgery.

Patients with DCIS have abnormal cells lining the milk ducts of the breast that have not spread into surrounding breast tissue. According to a March 2020 report from the National Center for Biotechnology Information in the United States, 20 percent of all breast carcinomas are DCIS.1 In Australia, women who are diagnosed with DCIS are, on average, 3.9 times more likely to develop invasive breast cancer than Australian women of a similar age without DCIS.2 With the help of DCISionRT, doctors are able to better identify patients with elevated scores and provide patients with information on whether receiving radiation therapy, in addition to surgery, will reduce the risk of DCIS recurrence or invasive disease.3

The new partnership between GenesisCare and PreludeDx will make DCISionRT testing available in Australia, where the test is currently not offered, as well as increase patient access in the United States through GenesisCare’s network of integrated cancer treatment centers. Australian-headquartered GenesisCare is one of the largest networks of integrated oncology care in the world, with more than 440 treatment centers and clinics across the US, Australia, the UK, and Spain.

Through the partnership GenesisCare and Prelude will also investigate the clinical development of precision medicine tests, for breast or other cancers, with global real-world evidence. GenesisCare will draw on its global network of physicians and clinical research expertise through its Contract Research Organization to extend Prelude’s existing US based registry to Australia to advance and further evaluate DCISionRT’s impact on treatment decision-making for women with DCIS.

GenesisCare’s Founder and Global Chief Executive Officer, Dan Collins, said: "GenesisCare is delighted to be bringing this much-needed test to early-stage breast cancer patients in Australia and the United States."

"Over the last decade, we have witnessed the profound positive impact of precision medicine on the quality of life of cancer patients, through personalizing the therapeutic journey to an individual’s tumor and risk factors."

"The innovative DCISionRT test heralds a new era in the delivery of precision cancer care, and we are thrilled to be at the forefront of bringing this latest evolution in personalized medicine to early-stage breast cancer patients around the globe."

"Our new global partnership with PreludeDxTM will empower thousands of women with information about their own biological risk factors, enabling doctors and patients to make better-informed decisions about their treatment options," said Mr. Collins.

PreludeDx’s President and Chief Executive Officer, Daniel Forche, said: "We share GenesisCare’s mission to treat every cancer patient as an individual and we are thrilled to be partnering with GenesisCare to increase patient access to DCISionRT."

"This partnership is an important milestone as it means that for the first time, DCIS patients in Australia will have access to personalized information to better inform decisions about whether surgery alone or surgery with radiation therapy is appropriate."

"This partnership will also leverage GenesisCare’s international network outside of the US to rapidly expand our real-world data registry and we are excited about the clinical evidence we will be able to provide to patients, physicians, governments and payers," said Mr. Forche.

GenesisCare’s Global Chief Medical Officer, Dr. Wally Curran, said: "Historically, physicians have relied on clinical information and pathology to determine treatment plans for women with DCIS, but we can now employ molecular information from each patient’s cancer to personalize treatment plans with unrivaled confidence. We know that globally there are significant variations in the management of DCIS patients with radiotherapy in conjunction with surgery."

"This test levels the diagnostic playing field for DCIS patients and will empower physicians and patients to make better-informed decisions about treatment options based on a patient’s individual biological risk profile," said Dr. Curran.

On February 23, 2021 The Lung Cancer Research Foundation (LCRF) reported a collaboration with AstraZeneca to fund over $900,000 in research grants focused on understanding resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) and immune checkpoint inhibitors (ICIs), including therapeutic approaches to overcome these mechanisms, as well as biomarkers of immune-mediated adverse events (Press release, AstraZeneca, FEB 23, 2021, View Source [SID1234575494]).

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Lung cancer is currently the number one cause of cancer death both in the U.S. and globally among both men and women. An estimated 625 new cases are diagnosed in the U.S. every day. As research funding grows, new treatments become available and survival rates improve. Promising new treatment options exist including targeted therapies and immunotherapies. Certain patients with non-small cell lung cancer (NSCLC) may benefit from targeted therapies which interfere with specific molecules involved in the growth and progression of cancer. For example, patients with EGFR mutation positive NSCLC can frequently benefit from treatment with EGFR tyrosine kinase inhibitors (TKIs). Despite clinical improvement with these therapies, acquired resistance invariably develops and insights into the mechanisms of resistance are needed as well as approaches to overcome and/or prevent resistance.

Over $900,000 in Research Grants Focused on Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs) and Immunotherapies

ICIs, which function by enhancing the body’s immune response against cancer, have also led to profound improvements in the treatment of both locally advanced and metastatic NSCLC. Sustained clinical benefit of ICIs is not uniformly observed, however, and biological insights and biomarkers are needed to better guide patient selection to maximize their therapeutic benefit.

This collaboration seeks to support research studies that focus on understanding mechanisms of primary and acquired resistance to 3rd generation EGFR TKIs, and to identify more effective approaches to predict response and recurrence in patients treated with ICIs in locally advanced NSCLC. This collaboration will also promote advancing scientific knowledge in early stage and resectable NSCLC, including identification of predictive biomarkers of disease recurrence.

"LCRF is honored to continue its fifteen-year legacy of identifying and supporting outstanding lung cancer research projects over the years. We are excited to partner with AstraZeneca, who continues to be a generous supporter of our mission," said Katerina Politi, PhD, Chair, LCRF Scientific Advisory Board. "The specific focus of this grant program is to study treatment resistance and how that resistance may be overcome or prevented, addressing this very important issue that affects many lung cancer patients undergoing treatment."

On February 23, 2021, Odonate Therapeutics, Inc. (the "Company") reported that entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC (the "Agent"), pursuant to which the Company may offer and sell shares of the Company’s common stock having an aggregate offering price of up to $100,000,000, from time to time, in "at the market" offerings through the Agent (Filing, 8-K, Odonate Therapeutics, FEB 23, 2021, View Source [SID1234575447]). Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from the Company of 3.0% of the gross proceeds of any shares of common stock sold under the Sale Agreement.

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The Company is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sale Agreement. No assurance can be given that the Company will sell any shares of common stock under the Sale Agreement, or, if it does, as to the price or amount of shares of common stock that it sells or the dates when such sales will take place.

In the Sale Agreement, the Company agreed to indemnify the Agent against certain liabilities, including under the Securities Act of 1933, as amended, or to contribute payments that the Agent may be required to make because of such liabilities.

The shares of common stock sold pursuant to the Sale Agreement will be offered pursuant to a shelf registration statement on Form S-3 (File No. 333‑233990), which became effective on October 18, 2019. The Company filed a prospectus supplement with the U.S. Securities and Exchange Commission on February 23, 2021 in connection with the offer and sale of shares of the Company’s common stock pursuant to the Sale Agreement.

A copy of the Sale Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the Sale Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sale Agreement.

On February 23, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, reported its results for the quarter- and year-ended December 31, 2020 (Press release, Corcept Therapeutics, FEB 23, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2020 [SID1234575463]).

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Corcept’s 2020 revenue was $353.9 million, compared to $306.5 million in 2019. Fourth quarter revenue was $85.7 million, compared to $87.9 million in the fourth quarter of 2019. The company reiterated its 2021 revenue guidance of $375 – 405 million.

GAAP net income was $106.0 million for the year and $26.0 million in the fourth quarter of 2020, compared to $94.2 million for the year and $29.4 million in the fourth quarter of 2019.

Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income was $34.7 million in the fourth quarter, compared to $40.3 million in the fourth quarter of 2019. For the full-year, non-GAAP net income was $145.6 million, compared to $133.3 million in 2019. A reconciliation of GAAP to non-GAAP net income is included below.

Cash and investments increased by $32.7 million in the fourth quarter, to $476.9 million at December 31, 2020. At December 31, 2019, the balance of cash and investments was 315.3 million.

The company spent $9.7 million in the fourth quarter repurchasing 458,769 shares of common stock pursuant to its stock repurchase program. Under the currently authorized terms of that program, $190.3 million remains available for the repurchase of shares.

"Corcept’s financial and clinical accomplishments in 2020 lay the foundation for significant progress this year," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "As the COVID-19 pandemic is brought under control, the easing of public health restrictions and greater willingness of patients to visit their doctors will allow more physicians to diagnose and optimally treat patients with Cushing’s syndrome. We expect revenue next year of $375 – 405 million.

"Improving conditions should also permit more rapid progress in our clinical development programs, many of which have been significantly slowed by the pandemic," he added. We are currently evaluating our proprietary, selective cortisol modulators as potential treatments for patients with metastatic ovarian and pancreatic cancer, castration-resistant prostate cancer, adrenal cancer, Cushing’s syndrome, antipsychotic-induced weight gain and non-alcoholic steatohepatitis. We will have topline data from our ovarian and pancreatic cancer trials in the second quarter. In the fourth quarter, we plan to initiate a Phase 2 trial in patients with amyotrophic lateral sclerosis (ALS)."

On February 23, 2021 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for a pilot study evaluating the company’s lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in progressive multifocal leukoencephalopathy (PML) (Press release, NeoImmuneTech, FEB 23, 2021, View Source [SID1234575479]). PML is a rare, aggressive, opportunistic brain infection caused by the reactivation of John Cunningham virus (JCV) in immunocompromised individuals. The investigator-initiated study will be led by Irene Cortese, M.D., of the National Institute of Neurological Disorders and Stroke (NINDS)/National Institute of Health (NIH).

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"With no anti-viral therapies available to treat PML, the only possibility for survival is to restore the antiviral immune response," said Dr. Cortese. "Unfortunately for many people who develop PML this is not easily achieved – and this is why we have strong interest in strategies that can facilitate and effectively speed up immune reconstitution, such as NT-I7."

PML is characterized by progressive damage of the white matter of the brain at multiple locations resulting from lytic infection of glia cells, leading to permanent damage of the affected nervous system, and in some cases can be fatal. Common conditions predisposing PML are hematologic and solid malignancies, rheumatologic disorders, primary immune deficiencies, and HIV infection. Currently, there is no specific prophylaxis for PML and no effective anti-JCV treatment.

"Following NT-I7’s FDA Orphan Drug Designation for the treatment of PML in June 2020, this IND clearance is an important step in developing a new treatment option for PML, a serious and potentially fatal infection of the brain," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. "PML chiefly affects immunocompromised individuals. We believe that NT-I7’s ability to amplify T cells as well as increase their functionality could enhance the recovery of the immune system, bolster the immune response in PML patients, and thereby provide assistance to patients in fighting this devastating disease."

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.