On May 30, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported it has entered into a collaboration with Roche to develop immunohistochemistry (IHC) companion diagnostic assays for use with Five Prime’s first-in-class investigational drug candidates, bemarituzumab, an anti-FGFR2b antibody (also known as FPA144), and FPA150, a B7-H4 antibody (Press release, Five Prime Therapeutics, MAY 30, 2018, View Source [SID1234526960]).

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"We are pleased to collaborate with Roche, a world leader and innovator of tissue-based diagnostic solutions, to identify patients with advanced cancers who might be eligible for treatment with our targeted immuno-oncology agents," said Aron Knickerbocker, chief executive officer of Five Prime Therapeutics, Inc. "We believe targeted therapies, such as bemarituzumab and FPA150, could provide clinical benefit to patients. Roche’s tissue-based assays will be important tools to help us identify the patients who might benefit most from these treatments."

Five Prime and Roche are collaborating to develop, validate and commercialize a tissue-based IHC companion diagnostic (CDx) assay to help identify patients whose tumors overexpress FGFR2b and are eligible for treatment with bemarituzumab. The CDx assay will be used in Five Prime’s global registrational study of bemarituzumab in combination with 5-fluorouracil (5-FU), leucovorin, and oxaliplatin, a regimen known as mFOLFOX6, as front-line treatment in patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b or have FGFR2 gene amplification (the FIGHT trial) that Five Prime expects to start in the second half of 2018. Five Prime plans to use the Roche IHC assay along with a circulating tumor DNA (ctDNA) test in the FIGHT trial to identify the estimated 10 percent of patients with gastric and gastroesophageal junction cancer who would be eligible for treatment with bemarituzumab.

Five Prime and Roche will also collaborate to develop and validate a tissue-based IHC diagnostic assay for use as a laboratory developed test (LDT) to help identify patients whose tumors overexpress B7-H4. Five Prime plans to use this IHC assay in the expansion portion of the ongoing Phase 1 clinical trial of FPA150 to identify patients with advanced or metastatic breast, ovarian, endometrial and bladder cancers whose tumors overexpress B7-H4.

Financial terms of the agreement were not disclosed.

About Bemarituzumab

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family, or amplify the FGFR2 gene. Bemarituzumab has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.

Bemarituzumab is being evaluated in the FGF2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment (FIGHT) Phase 1/3 clinical trial, a global registrational study in patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b or have FGFR2 gene amplification. The Phase 3 portion of the trial is expected to begin in the second half of 2018. In December 2017, Five Prime and Zai Lab announced a collaboration for the development and commercialization of bemarituzumab in Greater China. Zai Lab will manage the Phase 3 portion of the FIGHT trial in China.

About FPA150

FPA150 is a first-in-class, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast, bladder and gynecologic cancers, and has been documented to correlate with poor prognosis. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering potent ADCC against tumor cells expressing B7-H4. B7-H4 is being studied in a Phase 1 trial of monotherapy FPA150 with a dose-escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and bladder cancers.

On May 30, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC), a biopharmaceutical company focused on discovering and developing novel small-molecule drug candidates to treat rare diseases, reported it had signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) (Press release, GlycoMimetics, MAY 30, 2018, View Source [SID1234526959]). Under the terms of the CRADA, GlycoMimetics will collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled clinical trial testing the addition of GMI-1271 to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated acute myelogenous leukemia (AML) who are suitable for intensive chemotherapy. This Phase 3 trial will be led by Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, and the primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study.

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"The NCI’s support of this clinical development program in AML reflects a high-level of interest from the U.S.’s leading clinical investigators and oncology thought leaders," noted Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice President, Clinical Development, and Chief Medical Officer. "Based on our Phase 2 data, we believe GMI-1271 has the ideal profile to become the possible foundation of treatment across the continuum of care in AML. This is an important collaboration for us as we seek to realize the full potential of this novel therapeutic."

Under the terms of the CRADA, the NCI may also fund additional research, including clinical trials involving pediatric patients with AML as well as preclinical experiments and clinical trials evaluating alternative chemotherapy regimens. GlycoMimetics will supply GMI-1271 as well as provide financial support to augment data analysis and monitoring for the Phase 3 program.

In addition, GlycoMimetics announced that the generic name for GMI-1271 will be uproleselan, and the drug candidate will be referred to by this name going forward.

About GMI-1271 (Uproleselan)

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell chemoresistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The FDA has granted GMI-1271 Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory disease.

On May 30, 2018 GeneCentric Therapeutics reported that it will present the first data on the application of its proprietary Cancer Subtyping Platform (CSP) to bladder cancer and its potential utility to provide drug response biomarkers for the disease (Press release, GeneCentric Therapeutics, MAY 30, 2018, View Source [SID1234526958]). The gene expression subtyping data will be presented in a poster session at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL on June 2, 2018.

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"Gene expression subtypes of bladder cancer have shown considerable potential as drug response biomarkers," said Dr. Myla Lai-Goldman, CEO/Founder of GeneCentric and senior author on the study. "However, to date subtype signatures have required data on several thousand genes, limiting their use to research settings. This research demonstrates that by applying our CSP platform, subtypes can be generated with a 60-gene signature Cancer Profiler, opening the door to broad use in drug development and ultimately, clinical practice." She noted that with an estimated 81,190 new bladder cancer cases in the US and 17,240 deaths, and the emergence of promising immuno and targeted therapies, there is a significant need for biomarkers predictive of drug response.

The studies, conducted by GeneCentric scientists in collaboration with researchers at the University of North Carolina Chapel Hill’s Lineberger Cancer Center, assigned four gene expression subtypes based on approximately 2700 genes from 408 bladder cancer patients in The Cancer Genome Atlas (TCGA). The researchers then developed a subtype signature based on 60 genes and tested the 60-gene set in two additional data sets.

Analysis of the gene signatures suggested additional study of their potential as therapeutic biomarkers independently as well as in combination with other molecular features. For example, subtypes showed differences in the expression profiles of genes that are promising therapeutic targets in bladder cancer, such as FGFR3 and ERBB2. The differences were consistent across multiple data sets. Bladder cancer subtypes also showed variability in immune profiles that is likely to inform the response to immunotherapy. Subtypes were also found to be significantly prognostic for Stage 2 and 3 bladder cancer.

Details of the presentation are as follows:

Title: "Bladder Cancer Gene Expression Subtypes (60 gene signature) Defines Prognosis, Differential Immune Response and Biomarker Associations."
Abstract Number: 4538

Date: June 2, 2018
Time: 8:30AM-11:30AM
Location: Hall A
Presenter: Greg Mayhew, PhD, Director, Bioinformatics, GeneCentric Therapeutics

On May 30, 2018 McKesson Specialty Health reported that oncologists from The US Oncology Network (The Network) and US Oncology Research will showcase detailed findings from 43 studies during the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), held June 1–5, 2018, in Chicago with more than 32,000 oncology professionals in attendance (Press release, McKesson, MAY 30, 2018, View Source [SID1234526957]). The study abstracts accepted for presentation represent substantial contributions made by community oncologists towards the understanding and advancement of cancer care.

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"Research conducted by community oncologists and presented at this year’s ASCO (Free ASCO Whitepaper) meeting demonstrates the dedication of these professionals in not only advancing investigational treatment options, but also offering cutting-edge research to their patients," said Michael Seiden, M.D., Ph.D., president and chief medical officer for The US Oncology Network and US Oncology Research. "There have been tremendous advancements in cancer care, and being selected for a clinical study is no longer seen as a last option, but rather as access to some of the latest investigational therapies for treating a wide range of cancers. Our community-based oncology network, made up of 1,400 independent physicians, allows access to resources and emerging treatments across the country. This meeting provides a time to focus on the unmet needs of patients through clinical trials that are leading the way in the fight against cancer."

Key study presentations will include topics such as genome sequencing in lung cancer, metastatic breast cancer, real-world evidence in bladder cancer and melanoma, and Phase 3 data from the PROTECT study in asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer.

"The ability for community oncologists to participate in groundbreaking cancer research must remain a high priority for all research organizations, including those programs supported by the National Cancer Institute," said Nicholas J. Vogelzang, M.D., FASCO, FACP, medical oncologist with Comprehensive Cancer Centers of Nevada, an affiliate of The US Oncology Network, and 2018 recipient of an OncLive Giants of Cancer Care award. "It is critically important for oncologists around the world, regardless of the type of center they are practicing in, to be able to find time to conduct research and make advancements in cancer care. I’m proud to be an active clinical investigator within The US Oncology Network, where several studies have been selected for presentation at this year’s ASCO (Free ASCO Whitepaper) annual meeting. This conference is a time for us to share knowledge and gain insights to better and more effectively treat patients, while contributing to our collective mission to eradicate cancer."

Key oral presentations will include:

Results of PROTECT: A randomized phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer
Abstract #: 5006
Date/Time: Monday, June 4, 3-6:00 p.m.
Location: Hall D1
Affiliated Author: Nicholas J. Vogelzang, M.D., FASCO, FACP, Comprehensive Cancer Centers of Nevada, US Oncology Research

Genome-wide sequencing for early stage lung cancer detection from plasma cell-free DNA (cfDNA): The Circulating Cancer Genome Atlas (CCGA) study
Abstract #: LBA8501
Date/Time: Monday, June 4, 8-11:00 a.m.
Location: Hall B1
Affiliated Author: Donald Richards, M.D., Ph.D., Texas Oncology, The US Oncology Network

Efficacy of sacituzumab govitecan (anti-Trop-2-SN-38 antibody-drug conjugate) for treatment-refractory hormone-receptor positive (HR+)/HER2- metastatic breast cancer (mBC)
Abstract #: 1004
Date/Time: Sunday, June 3, 8-11:00 a.m.
Location: Hall D2
Affiliated Author: Joyce O’Shaughnessy, M.D., Texas Oncology, The US Oncology Network, US Oncology Research

First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt)
Abstract #: 4503
Date/Time: Sunday, June 3, 8–-11:00 a.m.
Location: Arie Crown Theater
Affiliated Author: Mark T. Fleming, M.D., Virginia Oncology Associates, US Oncology Research

Prevalence of clonal hematopoiesis of indeterminate potential (CHIP) measured by an ultra-sensitive sequencing assay: Exploratory analysis of the Circulating Cancer Genome Atlas (CCGA) study
Abstract #: 12003
Date/Time: Tuesday, June 5, 8–11:00 a.m.
Location: S406
Affiliated Author: Michael Seiden, M.D., Ph.D., The US Oncology Network, US Oncology Research

An additional 29 poster presentations and nine published abstracts affiliated with US Oncology Research will be featured as part of the ASCO (Free ASCO Whitepaper) program. The full schedule of US Oncology Research–affiliated data presentations, including location information, can be found here.

For more information or to be put in touch with a trial investigator, please contact Edie DeVine at 209-814-9564 or [email protected]. Please visit Booth #5123 on the Main Floor at ASCO (Free ASCO Whitepaper).

On May 30, 2018 Triumvira Immunologics, a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack multiple types of cancers, reported that it will present a company overview at the 4th Annual Immuno-Oncology Business Development & Licensing and Investment Forum (IOBDLI), in Chicago on June 1, and attend the 2018 BIO International Convention in Boston on June 4-5 (Press release, Triumvira Immunologics, MAY 30, 2018, View Source [SID1234526956]).

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At the IOBDLI Forum, Triumvira Scientific Founder and Acting Chief Scientific Officer, Dr. Jonathan Bramson, will provide an overview of the company’s T Cell-Antigen Coupler (TAC) technology, as well as updates on Triumvira’s lead drug, CD19-TAC01, which is targeted to enter clinical development in H1 2019 for the treatment of patients with CD19 positive B-cell malignancies. Dr. Bramson will be presenting at 3:20 p.m. CT on June 1.

At BIO International, President and Chief Executive Officer, Dr. Paul Lammers will be available for private meetings during the day on June 4-5 to discuss potential collaboration and licensing opportunities for the Company’s novel immuno-oncology platform T Cell-Antigen Coupler (TAC).

About the IOBDLI Forum
The 4th Annual Immuno-Oncology BD&L and Investment Forum, a by-invitation-only event to be held at the Waldorf Astoria Chicago Hotel, is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering, funding and investment.

About the 2018 BIO International Convention
The BIO International Convention, to be held at the Boston Convention and Exhibition Center, is hosted by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.