1stOncology™: Cancer Intelligence Service – Page 14688 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Puma Biotechnology to Present at Jefferies Global Healthcare Conference

On May 30, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 11:00 a.m. EDT on Thursday, June 7, at the Jefferies 2018 Healthcare Conference (Press release, Puma Biotechnology, MAY 30, 2018, View Source [SID1234526963]).

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!

A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com . The presentation will be archived on the website and available for 30 days.

F-star Announces Early Exercise by Denali Therapeutics of
its Option to Acquire F-star Gamma

On May 30, 2018 F-star, a clinical-stage biopharmaceutical company developing novel bispecific antibodies, reported that its partner Denali Therapeutics (NASDAQ: DNLI) (Denali) has chosen to exercise early its option to acquire the asset-centric vehicle F-star Gamma Ltd (F-star Gamma) (Press release, f-star, MAY 30, 2018, View Source [SID1234526962]).

In the ongoing collaboration between F-star and Denali announced in August 2016, the partners are developing Fcabs (Fc-domains with antigen-binding) against up to three different transporters in the blood-brain barrier (BBB). These Fcabs enable delivery of biologic therapies into the central nervous system (CNS). In addition to the early acquisition of F-star Gamma, Denali has exercised its right to nominate the two remaining Fcab targets under the terms of the original agreement.

The acquisition of F-star Gamma provides Denali with exclusive rights to the Fcabs developed under the collaboration. The total consideration for the option exercise and expanded collaboration amounts to $24M, plus any net cash held by F-star Gamma at closing of the transaction. Further payments of up to $447M are contingent on achievement of future milestones.

John Haurum, CEO of F-star said "Denali’s early exercise of its option to acquire F-star Gamma is testimony to the progress of our collaboration. We are delighted that our Modular Antibody Technology is being applied to address significant unmet needs beyond F-star’s therapeutic focus in immuno-oncology."

Ryan Watts, CEO of Denali Therapeutics said "Our decision to exercise the option to buy F-star Gamma reflects the progress in our collaboration with F-star and the generation of data showing that our proprietary transport vehicle (TV) platform technology will enable us to deliver biologics across the BBB and into the brain. Furthermore, the expanded collaboration allows us to deepen and broaden our research efforts supporting our BBB platform technology."

F-star will invest its proceeds from the transaction in progressing its proprietary pipeline of first-in-class immuno-oncology bispecific antibodies through clinical development.

ImmunoGen Announces Webcast of Presentation at Jefferies 2018 Global Healthcare Conference

On May 30, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will present at the upcoming Jefferies 2018 Global Healthcare Conference (Press release, ImmunoGen, MAY 30, 2018, View Source [SID1234526961]). The presentation is scheduled for 1:30 p.m. ET on June 7, 2018.

A webcast of the presentation will be accessible live through the "Investors" section of the Company’s website, www.immunogen.com; a replay will be available in the same location for approximately two weeks.

Five Prime Therapeutics Announces Collaboration with Roche to Develop Companion Diagnostics for Targeted Immuno-Oncology Investigational Drug Candidates

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]).

"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.

GlycoMimetics Announces NCI-Sponsored Pivotal Trial of GMI-1271 in Older, Newly Diagnosed AML Patients Fit for Intensive Chemotherapy

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.

"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.