1stOncology™: Cancer Intelligence Service – Page 15752 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

OncoSec to Present Preclinical Data at the American Association for Cancer Research (AACR) Annual Meeting 2017

On March 28, 2017 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported it will present preclinical results from recent studies describing the latest developments of its gene delivery platform, at a poster session at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, in Washington, D.C., on April 1- 5, 2017 (Press release, OncoSec Medical, MAR 28, 2017, View Source [SID1234518300]).

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!

Details of the poster abstract are as follows:

Abstract Title: Intratumoral Delivery of a P2A-linked Bicistronic IL-12 Construct Leads to High Intratumoral Expression and Systemic Anti-tumor Response (Abstract ID #: 1614)
Session Title: Cytokines: The First Modern Immunotherapies
Date and Time: Monday, April 3, 2017 / 8:00 a.m. – 12:00 p.m. EDT
Location: Convention Center, Halls A – C, Poster Section 26
Further details on the poster presentation will be provided in upcoming Company communications. For more information about this conference, please visit: www.aacr.org.

Ignyta Announces Multiple Presentations at the 2017 AACR Annual Meeting

On March 28, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported three data presentations at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Washington, D.C (Press release, Ignyta, MAR 28, 2017, View Source [SID1234518298]).

Two poster presentations will include new preclinical data on the immuno-oncology therapeutic capabilities of RXDX-106, which represents a novel class of immunomodulatory agents that appears to restore innate immunity in preclinical models via potent inhibition of the TYRO3, AXL and MER (or TAM) family of receptors.

Additionally, the company will present its first ever data from molecularly targeting hematological malignancies with entrectinib – an orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions – in previously unexplored, molecularly defined acute myeloid leukemia (AML). Entrectinib is currently being studied in a registration-enabling Phase 2 clinical trial known as STARTRK-2.

"We are excited to participate in this year’s AACR (Free AACR Whitepaper) Annual Meeting and provide key program updates on multiple compounds from across our precision medicine pipeline," said Pratik Multani, M.D., Ignyta’s Chief Medical Officer. "In particular, we look forward to highlighting RXDX-106’s promising immuno-oncology potential and our first entrectinib data in hematological malignancies."

Details of the presentations are as follows:

Poster Presentations:

RXDX-106

Title:
Immuno-oncological efficacy of RXDX-106, a novel, selective and potent small molecule TAM (TYRO3, AXL, MER) inhibitor (Abstract number 4698)

Date/Time: Tuesday, April 4, 2017, 1:00 PM – 5:00 PM ET

Title:
RXDX-106, a novel, selective and potent small molecule TAM (TYRO3, AXL, MER) inhibitor, demonstrates efficacy in TAM-driven tumors (Abstract number 4191)

Date/Time: Tuesday, April 4, 2017, 1:00 PM – 5:00 PM ET

Entrectinib

Title:
Anti-tumor activity of entrectinib, a highly potent pan-TRK, ROS1 and ALK inhibitor, in molecularly defined acute myeloid leukemia (Abstract number 5158)

Date/Time: Wednesday, April 5, 2017, 8:00 AM – 12:00 PM ET
A copy of the posters will be made available during the sessions in the Scientific Presentations section of the company’s website at View Source, and will be archived and available at that site.

Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results

On March 28, 2017 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) (“Cyclacel” or the “Company”) a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the fourth quarter and full year ended December 31, 2016 (Press release, Cyclacel, MAR 28, 2017, View Source [SID1234518296]). The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2016 was $2.9 million and $12.0 million, respectively. As of December 31, 2016, cash and cash equivalents totaled $16.5 million.

“Following the outcome of the SEAMLESS study and a review of our clinical development pipeline we will concentrate our resources on our transcriptional regulation and DNA damage response clinical stage programs,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “While we will discuss the SEAMLESS data with regulators after completing ongoing analyses, we are looking ahead with a clear strategy. We are dedicating our efforts and resources to progressing our CYC065 CDK inhibitor program and the promise in our BRCA positive stratified, sapacitabine and CDK inhibitor study. We are encouraged by the support received from various stakeholders, the recent success of commercial stage CDK inhibitors and early clinical data from our own CDK inhibitor trials.”

Fourth Quarter and Full Year Highlights

Transcriptional Regulation Program – Cyclin Dependent Kinase (CDK) inhibitors

Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors. Expanded sixth dose escalation level with the objective of determining maximum tolerated dose and recommended dosing for Phase 2.
Data presented at the 2016 Annual Meeting of the American Association of Cancer Research demonstrated that CYC065 can induce cell death and combine beneficially with anti-cancer drugs from the Bcl-2 and BET (Bromodomain and Extra-Terminal) inhibitor classes, in in vitro models of B-cell lymphoma, including double-hit lymphomas. Combinations of CYC065 with the Bcl-2 inhibitor venetoclax (ABT-199) or BET inhibitors were both synergistic.
Preclinical data published in the Journal of the National Cancer Institute demonstrated that CYC065 had promising antitumor activity against certain lung cancer cells through anaphase catastrophe, a novel, cancer-specific mechanism of action.
DNA Damage Response (DDR) program

The extension of the Phase 1 study evaluating a sequential regimen of sapacitabine and the CDK inhibitor seliciclib is continuing enrollment in an enriched population of BRCA positive patients with advanced breast cancer.
A part 3 of this study has been initiated to include BRCA positive patients with pancreatic and ovarian cancer.
SEAMLESS Study in Elderly Patients with Acute Myeloid Leukemia (AML)

In February 2017, the Company reported that the SEAMLESS study did not reach statistically significant superiority in overall survival (OS), although an improvement in complete remission rate was observed. In the stratified subgroup of patients with low baseline peripheral white blood cell count, comprising approximately two-thirds of the study’s population, an improvement in OS was observed for the experimental arm.
The Company is currently analyzing stratified and exploratory subgroups to identify patients who are most likely to benefit from treatment with the experimental arm. Depending on this analysis the Company may initiate discussions with European and U.S. regulators to determine a potential regulatory pathway.
Poster Presentation on the PLK Inhibitor CYC140 at the AACR (Free AACR Whitepaper) Annual Meeting

Today, Cyclacel also announced a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting to be held April 1-5 in Washington, D.C. The poster is titled “The novel PLK1 inhibitor, CYC140: Identification of pharmacodynamic markers, sensitive target indications and potential combinations” (Poster Board 1, Abstract number 4178, Convention Center, Halls A-C, Poster Section 7). The poster details Cyclacel’s preclinical study to identify target indications including acute leukemia and esophageal cancer. The results will be presented in a session titled “Targeting Protein Kinases and DNA Repair” on Tuesday Apr 4, 2017 1:00 PM – 5:00 PM Eastern Time.

Data presented in December 2016 at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, demonstrated anti-tumor activity of CYC140 in preclinical xenograft models of acute leukemia and solid tumors, including esophageal cancer, with tumor growth delay, tumor regression and cures being observed. Several pharmacodynamic markers were identified and activity was demonstrated in a majority of malignant cell lines derived from AML, acute lymphoblastic leukemia (ALL) and esophageal cancer.

Financial Highlights

As of December 31, 2016, cash and cash equivalents totaled $16.5 million, compared to $20.4 million as of December 31, 2015. The decrease of $3.9 million was primarily due to $10.1 million of net cash used in operating activities, partially offset by net proceeds of $6.8 million from the sale of common stock through the ATM sales agreement with FBR Capital Markets & Co.

Revenue for the three months and year ended December 31, 2016 were $0.3 million and $0.8 million respectively, compared to $0.4 million and $1.9 million for the same periods of the previous year. The revenue is primarily related to previously awarded grants from the UK government being recognized over the period to progress CYC065 to IND, which was completed in 2015, and IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor, completed in November 2016.

Research and development expenses were $1.9 million and $9.5 million for the three months and year ended December 31, 2016 respectively, compared to $2.6 million and $12.4 million for the same periods of the previous year. The decrease was primarily due to reduced study and clinical supply costs associated with the completion of the SEAMLESS study.

General and administrative expenses for the three months and year ended December 31, 2016 were $1.5 million and $5.5 million respectively, compared to $1.7 million and $5.7 million for the same periods of the previous year.

Other income (expense), net for the three months and year ended December 31, 2016 were $(0.1) million and $0.4 million, compared to nil and $(0.3) million for the same period of the previous year. The increase in other income (expense) is primarily related to foreign exchange movements.

United Kingdom research & tax credits were $0.4 million and $2.0 million for the three months and year ended December 31, 2016 respectively, compared to $0.5 million and $2.1 million for the same periods of the previous year. The cash receipt for the 2016 tax credit of $2.0 million is expected to be received in the second quarter of 2017, which results in proforma cash and cash equivalents of $18.5 million as of December 31, 2016.

Net loss for the three months and year ended December 31, 2016 was $2.8 million and $11.8 million respectively, compared to $3.4 million and $14.3 million for the same periods of the previous year.

Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb and the Cancer Research Institute Announce Collaboration to Accelerate Immuno-Oncology Research

On March 28, 2017 The Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb Company (NYSE: BMY) and the Cancer Research Institute (CRI) reported a multi-year clinical research collaboration to coordinate and rapidly initiate clinical Immuno-Oncology (I-O) studies across the Parker Institute and CRI networks (Press release, Bristol-Myers Squibb, MAR 28, 2017, View Source [SID1234518295]). Bristol-Myers Squibb will work closely with leading Parker Institute and CRI scientists and researchers, soliciting clinical research proposals from their networks and coordinating multi-site collaboration clinical studies to pursue some of the most difficult questions in cancer research. It will provide scientists with an ecosystem of advanced translational tools, precision immunotherapy and cutting-edge bioanalytical expertise to maximize learning and ensure the generation of high quality data to inform future development.

The Parker Institute is a novel collaboration model which includes industry, academic and philanthropic participants, focused on the shared goal of accelerating immunotherapy research to develop and deliver new treatment options for patients. CRI is a nonprofit organization dedicated to advancing laboratory and clinical research through its global network of academic, industry, and nonprofit partners with the goal of developing lifesaving immunotherapies for all forms of cancer.

The collaboration will build on the Parker Institute model that brings together the nation’s top research institutions to share resources, data and technology to accelerate research through unifying and managing clinical trial design and conducting clinical studies across multi-centers. The Parker Institute currently funds projects across its network of more than 60 laboratories and 300 researchers who work together to advance research and potentially develop new therapies. The Cancer Research Institute will support the collaboration with investment from its Clinical Accelerator venture philanthropy program and access to its global network of leading investigators from around the world.

"Bristol-Myers Squibb is initiating this unique collaboration with a goal of accelerating the identification and development of new treatment options for patients who are facing very serious disease," said Fouad Namouni, M.D., head of Oncology Development, Bristol-Myers Squibb. "We are excited to partner with the Parker Institute and the Cancer Research Institute to leverage the unique translational capabilities of their networks and explore novel mechanisms of action in the field of I-O."

This is the Parker Institute’s first major agreement with a biopharma partner. The institute will continue to build key industry relationships critical for the success of its unique model.

"One of our goals is to help facilitate collaborations between academia and industry to help advance cancer research," said Jeffrey Bluestone, Ph.D., CEO and president of the Parker Institute for Cancer Immunotherapy. "Partnering with Bristol-Myers Squibb, a renowned leader in the field of immuno-oncology development, is a major leap forward for us. We could not be more enthusiastic to start this collaboration, which we believe will accelerate the process of turning important lab discoveries by our investigators into the potential for much needed treatments for patients."

"Unlocking the full potential of next-generation precision cancer immunotherapy requires the kind of coordination, resources, and logistical support that the Parker Institute and the Cancer Research Institute can offer our research partners, and collaboration with industry leaders like Bristol-Myers Squibb will be essential to hastening the development of new cancer immunotherapies," said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at CRI.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents and our differentiated clinical development program, which is studying broad patient populations across more than 35 types of cancers with 13 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

Clovis Oncology Announces Data Presentations at AACR Annual Meeting 2017

On March 28, 2017 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that rucaparib preclinical data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 (Press release, Clovis Oncology, MAR 28, 2017, View Source [SID1234518292]). AACR (Free AACR Whitepaper) will take place April 1-5, 2017 in Washington, DC. The data being presented provide greater insight into the mechanism of action and function of rucaparib in multiple disease and therapy settings.

"These data demonstrate Clovis Oncology’s commitment to fully understanding rucaparib’s mechanism of action as well as the therapeutic settings in which it may offer the most benefit to patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology.

Rucaparib is the Company’s oral, potent, small molecule inhibitor of PARP1, PARP2 and PARP3. The FDA approved rucaparib (Rubraca) tablets in December 2016 for the monotherapy treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutations treated with two or more chemotherapies. Rucaparib is also being developed for other oncology indications in which patients may possess mutant BRCA tumors and other DNA repair deficiencies beyond BRCA – commonly referred to as homologous recombination deficiencies, or HRD.

Data from preclinical rucaparib studies are the subject of four poster presentations at the AACR (Free AACR Whitepaper) meeting:

Abstract 2475 – In vitro and in vivo assessment of the mechanism of action of the PARP inhibitor rucaparib

Presenter: Andrew J. Simmons, Ph.D., Translational Medicine, Clovis Oncology
Date/Time: Monday, April 3, 1:00-5:00 p.m. ET
Location: Halls A-C
Abstract 2476 – Preclinical assessment of the PARP inhibitor rucaparib in homologous recombination deficient prostate cancer models

Presenter: Minh Nguyen, Translational Medicine, Clovis Oncology
Date/Time: Monday, April 3, 1:00-5:00 p.m. ET
Location: Halls A-C
Abstract 3650 – Preclinical evaluation of the PARP inhibitor rucaparib in combination with PD-1 and PD-L1 inhibition in a syngeneic BRCA1 mutant ovarian cancer model

Presenter: Liliane Robillard, Translational Medicine, Clovis Oncology
Date/Time: Tuesday, April 4, 8:00 a.m.–12:00 p.m. ET
Location: Halls A-C
Abstract 4676 – DNA repair protein expression and response of homologous recombination deficient ovarian cancer to the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib in the ARIEL2 Part 1 study

Presenter: Andrea E. Wahner Hendrickson, M.D., Assistant Professor of Oncology, Medical Oncology, Mayo Clinic, Rochester, Minnesota
Date/Time: Tuesday, April 4, 1:00-5:00 p.m. ET
Location: Halls A-C
Each presentation will be available online at View Source as of the time of presentation at the meeting.

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. The MAA submission in Europe for an ovarian cancer treatment indication was submitted and accepted during the fourth quarter of 2016. Additionally, rucaparib is being developed as maintenance therapy for ovarian cancer in the ARIEL3 trial for patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, as well as biomarker negative patients. Data from ARIEL3 are expected in mid-2017, which, pending positive data, is expected to be followed by the submission of a supplemental NDA for a second line or later maintenance indication. Rucaparib is also being developed in patients with mutant BRCA tumors and other DNA repair deficiencies beyond BRCA – commonly referred to as homologous recombination deficiencies, or HRD. Studies open for enrollment or under consideration include prostate, breast, pancreatic, gastroesophageal, bladder and lung cancers. Clovis holds worldwide rights for rucaparib.