UroGen Pharma to Present at June 2019 Investor Conferences

On May 30, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), reported that management will present at three investor conferences in June (Press release, UroGen Pharma, MAY 30, 2019, View Source [SID1234536705]):

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Jefferies 2019 Global Healthcare Conference
Tuesday, June 4th
9:00AM Eastern Time
New York, NY
Goldman Sachs 40th Annual Global Healthcare Conference
Wednesday, June 12th
1:20PM Pacific Time
Rancho Palos Verdes, CA
Raymond James Life Sciences and MedTech Conference
Wednesday, June 19th
8:35AM Eastern Time
New York, NY
A live audio webcast of each event will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of each webcast will be available on the website for approximately two weeks.

Immunomic Therapeutics to Present at China Focus @BIO Philadelphia

On My 30, 2019 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company, reported that the company will present at the China Focus @BIO being held in Philadelphia, Pennsylvania, June 2, 2019 (Press release, Immunomic Therapeutics, MAY 30, 2019, View Source [SID1234536690]). Yan Su, Ph.D., Immunomic’s advisor for China and Corporate Development, will present a company overview and will discuss ITI’s recently expanded, investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). ITI’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

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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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Presentation details are as follows:

Title: Investigational Cell and Nucleic Based Vaccine Immunotherapies for China and SEA
Panel Date and Time: Sunday, June 2, 2019 2:10 PM
Location: Commonwealth Hall CD (Track 1)
Place: Loews Philadelphia Hotel, Philadelphia, PA

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.

Investigators From The US Oncology Network, US Oncology Research and McKesson Present More Than 60 Research Abstracts During the 2019 American Society of Clinical Oncology Annual Meeting

On May 30, 2019 McKesson, The US Oncology Network (The Network) and US Oncology Research reported that it will showcase detailed findings from more than 60 studies during the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, McKesson, MAY 30, 2019, View Source [SID1234536706]). The meeting, being held in Chicago from May 31 to June 4, 2019, will bring together more than 32,000 oncology professionals from around the globe.

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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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"ASCO continues to serve as a meaningful platform for community oncologists to share learnings and real-world evidence that advance therapies and care practices to foster the utmost care for oncology patients," said Michael Seiden, MD, PhD, president, The US Oncology Network. "As therapies continue to improve and become more personalized to the individual’s particular cancer, staying engaged in cutting-edge clinical trials and sharing our findings with forward-thinking colleagues in the oncology community help oncologists and researchers in The Network contribute in meaningful ways in the fight against cancer."

Key study presentations during this year’s conference will include research on sarcoma, non-small cell metastatic lung cancer, hematologic malignancies (such as leukemia, myelodysplastic syndromes and allotransplant), developmental immunotherapy and tumor immunobiology, non-Hodgkin lymphoma, developmental therapeutics and tumor biology and genitourinary (non-prostate) cancer. Some of these studies utilized high-quality real-world data captured from iKnowMed℠, McKesson’s oncology practice electronic health record (EHR) system that was named the top-ranked EHR platform for oncologists and hematologists for the eighth year in a row by Black Book Research. Through McKesson’s Data, Evidence and Insights business, this rich, regulatory-grade data is leveraged to support biopharmaceutical real-world evidence needs.

"The increased role of real-world evidence is ever important in improving patient outcomes for individuals battling cancer," said Nicholas Robert, MD, medical director of Data, Evidence & Insights, McKesson Life Sciences. "Furthermore, regulatory agencies now consider these data sets as a part of a bigger picture when evaluating a therapeutic filing, especially in areas with unmet needs."

Additionally, at the event, Debra Patt, MD, MPH, MBA, of Texas Oncology, a practice in The US Oncology Network, will officially be recognized with her designation of Fellow of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (FASCO). The designation honors the most active ASCO (Free ASCO Whitepaper) volunteers. Dr. Patt is a long-standing member of the community oncologist community with more than 20 years of experience. She also serves as editor-in-chief of JCO Clinical Cancer Informatics and is a member of ASCO (Free ASCO Whitepaper)’s Nominating Committee, White and Brown Bagging Committee, Clinical Practice Committee (CPC) Physician Compensation Workgroup, MACRA Speakers Group and CPC Payment Reform Implementation Workgroup.

"From harnessing data- and evidence-driven insights to breakthrough genetics-based scientific research, the pace of advancement in cancer treatment is more robust now than at any time in my career," said Dr. Patt. "New, more personalized treatments are revolutionizing oncology and delivering profound benefits to patients. We have witnessed the first cancer therapies approved by the FDA that have included real-world evidence. ASCO (Free ASCO Whitepaper) provides us with a glimpse of the future and the promise it holds for our patients. I’m honored to be named a recognized Fellow and to be able to bring real-world perspectives from community-based oncology to this outstanding organization."

The full schedule of affiliated data presentations, including location information, can be found here. For more information or to be put in touch with a trial investigator, contact Claire Crye at 281.825.9927 or Edie DeVine at 209.814.9564. Please visit Booth #4089 in the ASCO (Free ASCO Whitepaper) Exhibit Hall.

About US Oncology Research

US Oncology Research draws from a network of more than 1,000 experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves approximately 60 research sites and more than 155 locations, managing about 300 active trials at any given time. For the past 20 years, physicians in the research network have enrolled more than 77,000 patients in over 1,600 trials and have played a role in more than 85 FDA-approved cancer therapies, approximately one-third of all cancer therapies approved by the FDA to date. US Oncology Research is supported by McKesson Corporation.

About The US Oncology Network

Every day, The US Oncology Network (The Network) helps more than 1,200 independent physicians deliver value-based, integrated care to patients — close to home. Through The Network, these independent doctors come together to form a community of shared expertise and resources dedicated to advancing local cancer care and to delivering better patient outcomes. The Network provides practices with access to coordinated resources, best business practices, and the experience, infrastructure and support of McKesson Corporation. This collaboration allows the providers in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. The Network is committed to the success of independent practices, everywhere.

Intellia Therapeutics to Participate at June Healthcare Investor Conferences

On May 30, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that will participate in the following upcoming healthcare conferences in June (Press release, Intellia Therapeutics, MAY 30, 2019, View Source [SID1234536691]):

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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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Tuesday, June 4, 2019
Jefferies Healthcare Conference
Location: New York, NY

Tuesday, June 18, 2019
Raymond James Life Sciences and MedTech Conference
Location: New York, NY
Time: 1:15 p.m. ET

A live webcast of Intellia’s presentation at the Raymond James Conference will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.intelliatx.com. To access the webcast, please log on to the Intellia website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Intellia’s website for approximately 14 days following the conference.

Innovent Provides Update on Phase Ib Study of Sintilimab in Combination with Chemotherapy for First-line Advanced or Metastatic Non-small Cell Lung Cancer

On May 30, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the preliminary results of sintilimab, the anti-PD-1 antibody that co-developed with Eli Lilly and Company, in combination with chemotherapy for 1L advanced or metastatic non-small cell lung cancer (NSCLC) (NCT02937116, cohort D and cohort E) were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) [Abstract #e20546] (Press release, Innovent Biologics, MAY 30, 2019, View Source [SID1234536708]).

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As the top and most influential international oncology conference, ASCO (Free ASCO Whitepaper) Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient, Learning from Every Patient", 2019 ASCO (Free ASCO Whitepaper) Annual Meeting has attracted numerous top oncologists, scholars, staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology, with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO (Free ASCO Whitepaper), showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company, Innovent will provide key result update of several clinical studies at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session, and key data from six other clinical studies will be presented by posters and other sessions.

Lung cancer is one of the malignant tumors with the highest morbidity and mortality, and non-small cell lung cancer (NSCLC) accounts for approximately 80%-85% of all lung cancer cases. Cohort D and E of NCT02937116, Phase Ib study in China, evaluating the efficacy and safety of sintilimab monotherapy or in combination with chemotherapy for patients with advanced NSCLC. Cohort D and E of NCT02937116 are designed to evaluate the efficacy and safety of sintilimab in combination with chemotherapy for 1L unresectable locally advanced or metastatic non-squamous (nsq-) and squamous (sq-) NSCLC patients. Patients with EGFR mutations or ALK rearrangements were excluded from these cohorts. Cohort D enrolled non-squamous NSCLC patients who received sintilimab in combination with pemetrexed platinum doublet. Cohort E enrolled squamous NSCLC patients who received sintilimab in combination with gemcitabine and cisplatin.

At data cutoff on 15 Jan 2019, 21 and 20 patients had been enrolled in cohort D and E, respectively. Objective response rate (ORR) in nsq- and sq-NSCLC was 68.4% (95% CI, 43.4 ~ 87.4) and 64.7% (95% CI, 38.3 ~ 85.8) respectively based on data from 19 and 17 patients with at least one radiologic efficacy assessment. Median progression free survival (mPFS) was 11.4 months (95% CI, 3.1 ~ NA) and 6.5 months (95% CI, 5.3 ~ 8.0), respectively.

Cohort D

Cohort E

ORR (%, 95%CI)

68.4(43.4~87.4)

64.7(38.3~85.8)

mPFS (months, 95%CI)

11.4 (3.1 – NA)

6.5 (5.3 – 8.0)

mOS (months, 95%CI)

18.9 (5.3 – 18.9) *

Not reached (10.3 – NA) *

12mon OS (%, 95%CI)

68 (42 – 84)

64 (35 – 82)

Follow up (months), median (range)

11.4 (0.3 – 18.9)

10.3 (0.2 – 14.6)

* The data was immature at the time of data cut off.

The combination of sintilimab and chemotherapy showed clinical activity with an acceptable safety profile in 1L nsq- and sq-NSCLC.

Based on the results of the Phase Ib studies, Innovent and Eli Lilly have initiated two Phase III clinical trials evaluating sintilimab in combination with chemotherapy in 1L nsq- (NCT03607539) and sq-NSCLC (NCT03629925) in patients without EGFR mutations or ALK rearrangements to further investigate the efficacy of sintilimab in combination with chemotherapy for patients with advanced or metastatic NSCLC in China.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.