On January 27, 2020 Immunomic Therapeutics, Inc. reported that it will present data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses and inhibits tumor growth when used with its investigational vaccine, ITI-4000, in mice (Press release, Immunomic Therapeutics, JAN 27, 2020, View Source [SID1234553591]). In preclinical studies, ITI-4000, a DNA vaccine targeting EBNA1, demonstrated robust activation of anti-tumor CD4 and CD8 T cells in vivo and promoted tumor infiltration with activated TNFα-producing CD8 T cells. Intratumoral IL-12-producing dendritic cells and iNOS-producing macrophages were also induced by the vaccine. This data will be presented at the SITC (Free SITC Whitepaper)-ASCO Clinical Immuno-Oncology Symposium in Orlando, Florida.

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"ITI-4000 is an innovative and novel approach to an EBV-tumor vaccine," says Rich Ambinder, M.D., Ph.D., Director of the Division of Hematologic Malignancies and Professor of Oncology at Johns Hopkins, Immunomic’s Scientific Advisory Board member, and expert in viral-driven malignancies.

Current treatment strategies for nasopharyngeal carcinoma are limited to radiation and chemotherapy, demonstrating a need for new, targeted therapies. Most nasopharyngeal carcinomas express Epstein-Barr nuclear antigen 1 (EBNA1), a sequence-specific DNA-binding protein involved in maintenance of the episomal virus genome that is required for EBV latency and associated transformation. Targeting EBNA1 allows for an immunotherapeutic approach by exploiting the potential of the immune system to recognize tumor cells through their expression of this viral antigen. We designed a DNA vaccine encoding EBNA1 using the UNITE platform (ITI-4000). The UNITE platform is based in part on lysosomal targeting technology which results in enhanced antigen presentation and a balanced T cell response. We report that the ITI-4000 induced IFNγ- and TNFα-producing effector memory CD4 T and CD8 T cells, with complete rejection of EBNA1-expressing tumors observed in 50% of mice. Mice rejecting tumors were protected from rechallenge with CT26-EBNA1, demonstrating that antigen-specific memory was induced in these animals. These pre-clinical data suggest that ITI-4000 has the potential to be used as an immunotherapeutic agent against EBV-associated cancers.

Poster Session B

Poster Title: The Effect of Lysosomal-associated membrane protein-1-targeting of Epstein–Barr virus nuclear antigen 1 (EBNA1) elicits potent immune responses and inhibits tumor growth in preclinical studies

Date and Time: 02/07/2020, 11:30 AM – 1:00 PM; 02/07/2020, 6:00 PM – 7:00 PM

Abstract ID: #74

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release, and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy, and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On January 27, 2020 Stand Up To Cancer (SU2C) reported a groundbreaking initiative to increase minority representation in cancer clinical trials (Press release, SU2C, JAN 27, 2020, View Source [SID1234553611]). All future SU2C-supported research grant proposals will now be required to include and address crucial issues related to recruitment and retention of patients from ethnic groups to improve diverse participation in cancer clinical trials. The announcement was made at Stand Up To Cancer’s annual Scientific Summit, which is attended by SU2C’s leadership and 300+ prominent cancer researchers representing each of SU2C’s Dream Teams, Research Teams and individual grants.

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The lack of diverse participation in cancer clinical trials has been ongoing for decades, largely due to socio-economic, cultural, trust and other barriers.

"As one of the leading funders of cancer research, we believe it is our duty to ensure that minority representation in cancer clinical trials is addressed. Now, more than ever, better understanding of the role of biology in cancer treatment, advances in precision treatment, and development of new technologies demands that we also make significant improvements in diverse clinical trial participation," said SU2C CEO Sung Poblete, PhD, RN. "We are confident that this initiative will make a significant and meaningful impact to ensure all communities have equal access to potentially life-saving treatments."

Despite an overall decline in U.S. cancer deaths since 1991, not all patients have benefited equally from advances in prevention, early detection, precision medicine and targeted cancer treatments. According to the U.S. Food and Drug Administration, currently only four percent of clinical trial participants are black, and four percent are Hispanic, and 15 percent are Asian, despite minority groups overall in the U.S. having both the highest death rate and shortest survival rate for most cancers.

SU2C’s Committee for Health Equity in Cancer Clinical Trials in collaboration with SU2C scientific leadership, has developed procurement language that will now be used to solicit proposals for SU2C Dream Teams, Research Teams and other grants in the SU2C research portfolio to increase diverse participation in cancer clinical trials. SU2C now requires applicants for funding to include three critical components related to health equity:

an indication of whether the research will address the populations expected to benefit from widespread use of newly developed treatments;
patient recruitment and retention plans for including historically underrepresented racial and ethnic populations – such as the need for additional trial sites or mechanisms to reduce barriers to access; and
a letter of support from the lead institution’s Chief Diversity Officer, or an equivalent position.
By requiring these to be included in all proposals submitted moving forward, these factors will also be considered both in SU2C’s rigorous selection process, and as part of grant performance evaluation conducted in SU2C’s formal semi-annual reviews.

In addition, Stand Up To Cancer announced plans to fund up to $6.4MM for the SU2C Health Equity Breakthroughs Research Team researching cancers affecting underrepresented populations, supported by a transformational grant from Genentech, a member of the Roche Group. SU2C is expected to issue the [Request for Applications seeking proposals later in the first quarter of 2020. Proposals may address cancers that have a higher prevalence in a specific racial or ethnic population; cancers that are more deadly among specific minority populations; or may address the need for more effective treatments for specific cancers for patients of diverse backgrounds.

"Genentech is committed to improving the health and well-being of all patients, which means ensuring that scientific research and innovative treatment options are developed for every individual," said Quita Highsmith, Chief Diversity Officer at Genentech. "We are honored to partner with SU2C to support groundbreaking research that promotes health equity while working to revolutionize cancer care."

The SU2C Health Equity Breakthroughs Research Team will be selected and launched in 2020. For information, or to receive the Call for Ideas when it is issued, please visit "Funding Opportunities." To learn more about Genentech’s efforts in this area, please visit "Advancing Inclusive Research."

At the Summit, Stand Up To Cancer also introduced the new international SU2C Gastric Cancer Interception Research Team, which includes investigators from Harvard Medical School and Massachusetts General Hospital Cancer Center; University of Pennsylvania’s Perelman School of Medicine; University of Chicago; City of Hope Comprehensive Cancer Center; Memorial Sloan Kettering Cancer Center and Samsung Medical Center (South Korea).

While gastric (stomach) cancer is the third-leading cause of cancer death worldwide, it is more common in black, Hispanic, and Asian people than in white populations. New ways are needed to detect these cancers early, when they can be successfully treated. This $3MM Research Team is conducting intensive studies to identify biomarkers, such as particular bits of DNA, and cells shed from the tumor that circulate in the blood system and indicate the presence of gastric cancer. Team members have developed a new detection technology, extending the use of a pill-sized camera that can be swallowed by the patient using a new marker to "light up" cancer cells, allowing the camera to capture images of stomach tissue at risk of developing cancer. If validated in a clinical trial, these methods will help doctors screen people in groups at risk of gastric cancer. To learn more about the SU2C Gastric Cancer Interception Research Team, visit View Source

"By having Research Teams dedicated to cancers that correlate to, or greatly affect, different racial and ethnic populations, we’ll be able to ensure that strides are being made in cancers that typically affect these populations," said Edith A. Perez, MD, chairperson of the SU2C Committee for Health Equity in Cancer Clinical Trials. "Support for these teams further demonstrates our commitment to bringing breakthrough therapies to historically underrepresented racial and ethnic groups and improving overall health equity in cancer research. We are proud and excited to play such a large role in serving this unmet need and look forward to setting the tone for scientific research to come."

Dr. Poblete also noted that SU2C will be collaborating with the Black Women’s Health Imperative (BWHI) and Friends of Cancer Research in Project TEACH: Trained Empowered Advocates for Community Health (Healing), funded by the Patient-Centered Outcomes Research Institute (PCORI). Through education and outreach, this nationwide project will empower black women to effectively engage with researchers and clinicians, and to increase participation of black women in cancer-focused clinical trials.

On January 27, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (Press release, Hoffmann-La Roche, JAN 27, 2020, View Source [SID1234553548]). The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In July 2018, the FDA granted Breakthrough Therapy Designation for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial.

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"Liver cancer is the most rapidly increasing cause of cancer-related death in the United States. In the IMbrave150 study, Tecentriq in combination with Avastin became the first treatment in more than a decade to improve overall survival compared with the current standard of care," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "We are pleased that these results are being reviewed under the FDA Real-Time Oncology Review pilot programme, and we are working closely with the agency to bring this potential new treatment option to people with unresectable hepatocellular carcinoma as quickly as possible."

This application is based on the results of the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% (HR=0.59; 95% CI: 0.47–0.76; p<0.0001), compared with sorafenib. Safety for Tecentriq and Avastin was consistent with the known safety profiles of the individual medicines. The results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress in November 2019.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMbrave150 study
IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable HCC who had not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1–21 of each 21-day cycle. People received the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

The two primary endpoints were OS and PFS by independent review facility (IRF) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). Additional study endpoints included overall response rate (ORR) and duration of response (DoR), as measured by RECIST v1.1 (investigator-assessed [INV] and IRF) and HCC mRECIST (IRF), as well as patient-reported outcomes (including time to deterioration of patient-reported quality of life), safety and pharmacokinetics.

About hepatocellular carcinoma
HCC, the most common form of liver cancer, is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide.1 Every year, more than 750,000 people worldwide are diagnosed with HCC,1,2 with the majority of cases in Asia and almost half of all cases in China.2,3 In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise.4–6 HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage.1 The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.7

About the Tecentriq and Avastin combination
There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration, and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

On January 27, 2020 OncoImmune, Inc. reported that clinical data from its Phase IIa clinical trial of CD24Fc are being presented at the 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Meeting, taking place in Orlando, Florida in February (Press release, ONCOIMMUNE, JAN 27, 2020, View Source [SID1234553592]). The Phase IIa data will be presented by the study’s Principle Investigator, Dr. John Magenau of the University of Michigan’s Department of Medicine, at 11:15 am on February 21. Dr. Pan Zheng, the Chief Medical Officer of OncoImmune, Inc., will present Phase III clinical trial design in a poster session on February 19-20th.

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CD24Fc is OncoImmune’s first-in class fusion protein that selectively represses inflammation induced by tissue injury while preserving innate immune response to pathogens. The Phase IIa study is a randomized, double blind, placebo controlled, multi-center study to investigate adding CD24Fc to standard of care tacrolimus and methotrexate in acute graft-versus host disease (GVHD) prophylaxis for allogeneic hematopoietic stem cell transplantation (HCT) with matched unrelated donors in treatment of leukemia and myelodysplastic syndrome. The trial included three CD24Fc dose cohorts: 240 mg at day -1, 480 mg at day -1, and the multi-dose cohort of 480-240-240 mg at day -1, day 14 and day 28. CD24Fc has received orphan drug designation from both the US FDA and European Medical Agency (EMA) for GVHD prophylaxis.

The presentation, entitled, "Mitigating Damage Response with CD24 Fusion Protein for Prevention of Acute Graft-Versus Host Disease," compares safety and efficacy data of CD24Fc when used in combination with standard of care GVHD prophylaxis compared to placebo and historical controls. The results demonstrate that CD24Fc was safe and well tolerated in the patient population. More importantly, patients receiving CD24Fc performed significantly better than placebo and historical controls in 180 day grade III-IV GVHD-free survival, the planned primary endpoint for the Phase III trial. These data thus provided strong support for the primary endpoint and dosing regimen of the upcoming phase III clinical trial. Moreover, significantly better relapse free survival (RFS) was observed over placebo control and historical controls. Overall survival (OS) was also significantly improved when compared with a matched historical control. Furthermore, a significant, dose-dependent reduction of mucositis was observed.

"We are very excited by the data observed in the Phase IIa clinical trial. In addition, we have completed enrollment of an open label Phase II expansion study where the drug continues to perform very well with clear signs of clinical efficacy," said Dr. Pan Zheng. "HCT is a curative therapy for refractory leukemia patients but hampered by GVHD, leukemia relapse and conditioning toxicity. As suggested by our preliminary data, CD24Fc shows significant promise in all three of these outcomes and would likely be transformative for the HCT field," she continued.

On January 27, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its fourth-quarter and full-year 2019 financial results after the close of the U.S. financial markets on Feb. 11, 2020 (Press release, Exact Sciences, JAN 27, 2020, View Source [SID1234553551]). 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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Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)
Fourth-Quarter and Full-Year 2019 Webcast & Conference Call Details

Date:

Tuesday, Feb. 11, 2020

Time:

5 p.m. ET, 4 p.m. CT

Webcast:

The live webcast can be accessed at www.exactsciences.com

Telephone:

Domestic callers, dial 833-235-7650

International callers, dial +1 647-689-4171

Access code for both domestic and international callers: 3280195

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 3280195. The webcast, conference call and replay are open to all interested parties.