1stOncology™: Cancer Intelligence Service – Page 10054 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Exicure Announces Presentation at 2021 H.C. Wainwright Global Life Sciences Conference

On February 23, 2021 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that CEO David Giljohann will present at the 2021 H.C. Wainwright Global Life Sciences Conference, March 9-10, 2021 (Press release, Exicure, FEB 23, 2021, View Source [SID1234575480]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

The presentation will be available to registered conference attendees for on-demand viewing beginning March 9, 2021 at 7:00AM EST via the virtual conference link, and will be archived for 90 days.

Exicure will be taking 1×1 investor meetings with registered conference attendees.

Replays of the presentation will be available on Exicure’s website for 30 days following the presentation.

NeoImmuneTech Receives U.S. FDA IND Clearance for Pilot Study of NT-I7 (efineptakin alfa) in Progressive Multifocal Leukoencephalopathy

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).

"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.

GenesisCare and PreludeDx™ Partner to Provide Access to Ground-Breaking Precision Medicine Test for Women With Early-Stage Breast Cancer

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]).

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.

TG Therapeutics Announces Publication of Final Results from the Phase 3 GENUINE Trial Evaluating Ublituximab Plus Ibrutinib in Patients with Relapsed/Refractory High-Risk Chronic Lymphocytic Leukemia in The Lancet Haematology

On February 23, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of final results from the Phase 3 GENUINE trial evaluating ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib, in patients with relapsed or refractory high-risk chronic lymphocytic leukemia (CLL), in The Lancet Haematology (Press release, TG Therapeutics, FEB 23, 2021, View Source [SID1234575477]).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "The Phase 3 data published yesterday, and previously presented, demonstrated that the addition of ublituximab to ibrutinib significantly improved overall response rate, complete response rate as well as prolonged progression-free survival. Significant unmet need still exists within the CLL landscape, and patients with high-risk relapsed or refractory CLL progress more rapidly than those without high-risk cytogenetics. The outcome of the GENUINE study is therefore very encouraging, and we believe these data are supportive of pursuing combination strategies with ublituximab for high-risk CLL patients." Mr. Weiss continued, "We look forward to bringing ublituximab to market as soon as possible as we pursue completion of a BLA submission with the FDA in the first half of 2021 for the combination of ublituximab plus umbralisib for patients with CLL."

Jeff P. Sharman, MD, Director of Research at Willamette Valley Cancer Institute and Medical Director of Hematology Research for The US Oncology Network and Study Chair for the GENUINE trial stated, "The utility of adding anti-CD20 therapy in combination with BTK inhibitors, such as ibrutinib, has long been unclear with prior studies using rituximab having failed to demonstrate an improvement in long-term outcomes. These results published from the GENUINE study are encouraging and may suggest that next generation anti-CD20 antibodies could have value in combination approaches to treating CLL."

The manuscript includes data from 126 patients with relapsed or refractory high-risk CLL who were randomized on study, of which 117 received at least one dose of treatment and were included in safety analyses, with 59 receiving ublituximab plus ibrutinib and 58 receiving ibrutinib monotherapy. Ibrutinib was given orally daily at 420 mg for all cycles. Ublituximab was given intravenously in 28-day cycles with up to 150 mg on day 1, 750 mg on day 2, and 900 mg on days 8 and 15 of cycle 1, and continuing at 900 mg on day 1 of cycles 2 through 6. Beyond cycle 6, ublituximab was given at 900 mg every 3 months. Ublituximab and ibrutinib were continued until unacceptable toxicity, disease progression, or withdrawn consent. The primary endpoint was independent review committee (IRC) assessed overall response rate (ORR) per iwCLL 2008 criteria. Key highlights from this manuscript include:

The IRC-assessed ORR among treated patients was 90% (53 of 59) in the ublituximab-ibrutinib arm and 69% (40 of 58) in the ibrutinib arm (p=0.0060), with a CR/CRi rate of 20% (12 of 59) and 5% (3 of 58), respectively (p=0.024).
After a median follow-up of 41.6 months, median IRC-assessed progression-free survival (PFS) in all treated patients was not reached in the ublituximab-ibrutinib group (95% CI, not estimable [NE]) after 15 PFS events and 35.9 months (95% CI, 17·0-NE) in the ibrutinib group after 25 PFS events (hazard ratio [HR], 0.46; 95% CI, 0.24-0.87).
The most common grade 3/4 adverse events in the ublituximab-ibrutinib group and the ibrutinib group were neutropenia (19%; 12%), anaemia (8%; 9%), and diarrhea (10%; 5%).
These data are described further in the manuscript entitled, "A Phase 3, Randomized Trial of Ublituximab Plus Ibrutinib for Patients With Relapsed/Refractory High-Risk Chronic Lymphocytic Leukaemia," which was published [online yesterday] in The Lancet Haematology. The online version of the article can be accessed at https://www.thelancet.com/journals/lanhae/home.

Phio Pharmaceuticals to Participate in the H.C. Wainwright Global Life Sciences Conference on March 9th-10th

On February 23, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that its Chief Executive Officer, Dr. Gerrit Dispersyn, will present at the upcoming H.C. Wainwright Global Life Sciences Conference, which is being held virtually from March 9-10, 2021 (Press release, Phio Pharmaceuticals, FEB 23, 2021, View Source [SID1234575476]).

During the conference, a corporate presentation by Dr. Dispersyn will be made available on-demand via the H.C. Wainwright conference portal starting at 7 a.m. Eastern Time on March 9, 2021. Interested parties may also access the webcast through the "Investors – Events and Presentations" section of the Company’s website. The webcast will be archived and available on the Company’s website for 90 days.