On May 30, 2019 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported the initiation of the Phase 1b expansion stage of its ongoing Phase 1 study evaluating the investigational agent TP-0903, an AXL receptor tyrosine kinase (RTK) inhibitor, in patients with advanced solid tumors (Press release, Tolero Pharmaceuticals, MAY 30, 2019, View Source [SID1234536710]). The maximum tolerated dose (MTD) of TP-0903 was established during the Phase 1a portion of the study, allowing the study to advance to the Phase 1b stage. AXL inhibition by TP-0903 has shown to have anti-tumor activity and to reverse mesenchymal phenotype, leading to immune surveillance inhibition in preclinical models resistant to targeted agents including immunotherapeutics.1

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The Phase 1b stage of the study will enroll additional patients with specific solid tumor types, including advanced solid tumors with progressive disease post immunotherapy, EGFR positive non-small cell lung cancer progressed following TKI therapies, colorectal carcinoma (BRAF-, KRAS-, or NRAS-mutated), platinum refractory or resistant recurrent ovarian carcinoma, and BRAF-mutated melanoma progressed following immunotherapy or combination BRAF/MEK inhibitor.

"This milestone marks an important step forward in the clinical development of TP-0903 as a potential treatment option for patients with advanced solid tumors," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals, Inc. "We believe this study may further our understanding of the anti-tumor activity of TP-0903 in these tumor types."

The primary outcome measures of the interventional, open-label, non-randomized, dose-escalation study is to assess the incidence of dose-limiting toxicities and treatment emergent adverse events of oral TP-0903 administered once daily in patients with advanced solid tumors. Secondary outcome measures include pharmacokinetics, activity on predictive biomarkers and objective response rate of TP-0903. The Phase 1b stage of the study is expected to enroll up to 20 patients in each of the five additional cohorts, for a total of up to 100 additional patients enrolled. Ten patients in each of the five expansion cohorts will undergo pre- and post-dose tumor biopsies.

The study 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 (NCT02729298).

About TP-0903
TP-0903 is an investigational oral AXL receptor tyrosine kinase (RTK) inhibitor under evaluation in a Phase 1/2 study in patients with CLL/SLL (NCT03572634) and a Phase 1b study in patients with advanced solid tumors (NCT02729298). Tolero is exploring parallel clinical development paths for TP-0903 in both solid and hematologic malignancies.

About AXL Kinase
AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers.1 It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.2

On May 30, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company, taking a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, reported that the Company will host a business update conference call on Friday, June 7, 2019 (Press release, Trovagene, MAY 30, 2019, View Source [SID1234536709]).

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During the call, Trovagene’s senior management will review the Company’s onvansertib clinical development program and upcoming milestones, and will provide a general business update. The conference call and live audio webcast will begin at 11:00 a.m. Eastern time.

Conference Call & Webcast Information
WHEN: Friday, June 7, 2019 at 11:00 a.m. Eastern Time
DOMESTIC DIAL-IN: (866) 792-4365
INTERNATIONAL DIAL-IN: (270) 215-9475
CONFERENCE ID: 8596214
WEBCAST: trovageneoncology.investorroom.com/events

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning two hours after the close of the conference call. To access the recording, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the operator with the conference ID: 8596214. In addition, an audio webcast will be archived on the Company’s website for a period of time at www.trovageneoncology.com.

About Onvansertib

Onvansertib is a first-in-class, 3rd generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple cancers, including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform, only (not PLK2 or PLK3), is orally administered, has a 24-hour drug half-life with only mild to moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK1 inhibitor, onvansertib, with other compounds has the potential to improve clinical efficacy in Acute Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate Cancer (mCRPC), Colorectal Cancer, Triple Negative Breast Cancer (TNBC), as well as other types of 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.

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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"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.

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.