On March 15, 2019 KIYATEC, Inc. reported that the company has opened Inova Health System (Inova) and Roswell Park Comprehensive Care Center as sites for its U.S. clinical study, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies in ovarian, glioblastoma (GBM) and rare cancer patients (Press release, KIYATEC, MAR 15, 2019, View Source [SID1234534402]).

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"The addition of Inova Health System and Roswell Park Comprehensive Cancer Center to our clinical study is an important milestone as we continue on the path to determine the best drug option for cancer patients before they begin their treatment journey," said Matthew Gevaert, CEO of KIYATEC. "Both hospitals are known for their excellence in clinical research and patient care, most notably in ovarian cancer. Not only will this be significant for our trial, it underscores their commitment to finding the best, personalized care for their patients."

The 3D-PREDICT clinical study analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically-relevant 3D microenvironment, to determine whether those cells respond to guideline-recommended cancer drugs. Evidence from the company’s earlier pilot study established a correlation between patient-specific predicted tumor response and actual patient clinical response to cancer therapy. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors. The 3D-PREDICT study is anticipated to continue through 2022. Details on the trial can be found on Clinicaltrials.gov.

"Roswell Park has the unique distinction of being the first clinical center in the world to focus exclusively on cancer, and we are continuously seeking new and improved methods to provide the best care for our patients," said Kunle Odunsi, MD, PhD, FRCOG, FACOG, deputy director, chair of gynecologic oncology and executive director of the Center for Immunotherapy, Roswell Park Comprehensive Cancer Center, and lead investigator. "The 3D-PREDICT trial presents an opportunity to utilize an emerging technology for identifying biomarkers of response in our ovarian cancer immunotherapy research."

Inova has already accrued patients into the trial and G. Larry Maxwell, MD, Chairman of Obstetrics and Gynecology and co-director of Inova’s Women’s Health Integrated Research Center (WHIRC) is the lead investigator. Inova Strategic Investments, the strategic investing division of the Inova Health System, is an investor in KIYATEC. The division invests in companies that align with Inova’s strategic priorities of delivering personalized health and healthcare services.

KIYATEC will be exhibiting at the Society for Gynecologic Oncology (SGO) 50th Annual Meeting on Women’s Cancer, which is being held March 16-19, 2019 at the Hawaii Convention Center in Honolulu, Hawaii.

On March 15, 2019 MorphoSys AG presented the corporate presentation (Press release, MorphoSys, MAR 15, 2019, View Source [SID1234534390]).

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On March 15, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or "the Company") reported that it will present a corporate overview at the Oppenheimer & Co. 29th Annual Healthcare Conference, being held March 19-20 at the Westin Grand Central Hotel in New York City (Press release, Actinium Pharmaceuticals, MAR 15, 2019, View Source [SID1234534391]).

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Presentation Details:

Date:

Wednesday, March 20

Time:

1:35 pm Eastern Time

Room:

Consulate

Venue:

Westin Grand Central Hotel

212 East 42nd St, New York City

(PRNewsfoto/Actinium Pharmaceuticals, Inc.)

Management will be conducting 1-on-1 meetings with conference attendees. Meetings with Actinium can be scheduled by emailing Steve O’Loughlin, Principal Financial Officer: [email protected].

On March 15, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO) reported that it has dosed the first patient in a Phase I study of STRO-002, an anti-folate receptor alpha (FoIRα) antibody-drug conjugate (ADC), in patients with ovarian and endometrial cancers (Press release, Sutro Biopharma, MAR 15, 2019, View Source [SID1234534392]). This is the second product candidate to be evaluated in clinical trials resulting from Sutro’s XpressCF+ technology platform.

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The study is a multi-center, open-label, dose-escalation with dose expansion Phase I trial evaluating the safety, tolerability and preliminary anti-tumor activity of STRO-002. The study plans to enroll up to 160 women with advanced relapsed and/or progressive ovarian, fallopian, primary peritoneal or endometrial cancer.

"Moving our second product candidate into human clinical trials is another momentous milestone in Sutro’s evolution from a technology platform company to a clinical stage company," said Sutro CEO Bill Newell. "Our goal is to ultimately help fill the unmet need for more targeted therapies for patients with ovarian and endometrial cancer and advancing STRO-002 into the clinic brings us one step closer to achieving this."

STRO-002 is designed to target FoIRα, a cell-surface protein highly expressed in ovarian cancer. In preclinical studies, STRO-002 demonstrated potent in vitro cytotoxicity in ovarian cancer cell lines and significantly inhibited tumor growth in multiple ovarian cancer xenograft models. In safety studies conducted in non-human primates, STRO-002 was well tolerated at clinically relevant doses. "Based on observations from pre-clinical studies, STRO-002 has the potential to overcome traditional dose-limiting factors in the clinical setting, including ocular toxicity, which is a vexing problem with some ADCs," said Sutro Chief Medical Officer, Arturo Molina, M.D.

Denise Uyar, M.D., Associate Professor of Gynecology Oncology at Medical College of Wisconsin, an investigator in the STRO-002 study added, "Sutro’s unique ADC has the potential to be another important therapeutic option for oncologists in treating patients with ovarian and endometrial cancer. We look forward to evaluating the next-generation of ADCs in this study."

The Phase I study will consist of two parts: dose-escalation followed by dose-expansion. In both parts of the study, STRO-002 will be dosed as an intravenous infusion on Day 1 of 21-day cycles. Additional information can be found at View Source

STRO-002 was developed using Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platforms, which facilitates precision design and rapid empirical optimization of ADCs and other product candidates.

On March 15, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed a new drug application to the Ministry of Health, Labour and Welfare (MHLW) for a ROS1/TRK inhibitor entrectinib for the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC) (Press release, Chugai, MAR 15, 2019, View Source [SID1234534393]).

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"With the previous filing of NTRK fusion-positive solid tumors, which is a rare type of cancer, and ROS1 fusion-positive NSCLC, which accounts for one to two percent of NSCLC, Chugai wishes that entrectinib would become a new treatment option for these patients and we will continue working to contribute to the development of personalized medicine," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit.

This application for approval is based on an integrated analysis of an open-label, multicenter, global phase II study (the STARTRK-2 study) and three overseas phase I studies (the STARTRK-NG study, the STARTRK-1 study and the ALKA-372-001 study). Efficacy was evaluated in 53 patients with ROS1 fusion-positive NSCLC while safety assessment was conducted with 355 patients registered in the four trials.

As the top pharmaceutical company in the field of oncology in Japan, Chugai will work to obtain early approval in order to provide entrectinib as a new treatment option for patients and medical professionals.

[Reference information]

Media release issued by Roche on February 19, 2019
Title: FDA grants Priority Review to Roche’s personalised medicine entrectinib
View Source
Media release issued by Chugai on December 19, 2018
Title: Chugai Files a New Drug Application for a ROS1/TRK Inhibitor Entrectinib for the Treatment of NTRK Fusion-Positive Solid Tumors
View Source
Media release issued by Roche on September 24, 2018
Title: Roche’s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer
View Source
About entrectinib
Entrectinib is an oral medicine in filling for approval for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 or ROS1 gene fusions. It is a selective, CNS-active tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Entrectinib can block ROS1 and NTRK kinase activity and inhibit proliferation of cancer cells with ROS1 or NTRK gene fusions. FDA has granted priority review for entrectinib for the treatment of NTRK fusion-positive solid tumors and ROS1 fusion-positive NSCLC.

About ROS1 fusion-positive NSCLC
ROS1 fusion gene is an abnormal gene that can be formed by fusing the ROS1 gene and other genes (CD74, etc.) as a result of chromosomal translocation for some reason. The ROS1 fusion kinase made from ROS1 fusion gene is thought to promote cancer cell proliferation. ROS1 fusion gene is found in about one to two percent of non-small cell lung cancer, among which it is more expressed in adenocarcinoma.