Author: [email protected]

OncoMed to Present Clinical Data for Anti-RSPO3 and Anti-DLL4/VEGF Bispecific Antibody at the 28th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium

On November 15, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) announced today it will present first-in-human data from its Phase 1 clinical trials of anti-RSPO3 (OMP-131R10) and anti-DLL4/VEGF bispecific antibody (OMP-305B83) at the upcoming 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium being held November 28 — December 2, 2016 in Munich, Germany. Abstracts for the presentations have been posted to www.ecco-org.eu/ENA.

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Data will be presented on Tuesday, November 29, 2016:

Poster #P039; Abstract #68: Initial results from a Phase 1a/b study of OMP-131R10, a first-in-class anti-RSPO3 antibody, in advanced solid tumors and previously treated metastatic colorectal cancer (CRC)
Session: Molecular targeted agents I
Presenting author: Johanna Bendell, M.D., Sarah Cannon Research Institute

Poster #P057; Abstract #87: A first-in-man Phase 1a study of the bispecific anti-DLL4/anti-VEGF antibody OMP-305B83 in patients with previously treated solid tumors
Session: Molecular targeted agents I
Presenting author: Kathleen Moore, M.D., University of Oklahoma Stephenson Cancer Center

The posters will be available on OncoMed’s website following the presentation at www.oncomed.com.

About Anti-RSPO3
OncoMed is currently enrolling patients in an ongoing Phase 1a/b clinical trial of anti-RSPO3 that was started in July 2015. The Phase 1a/b trial initially enrolled patients with advanced refractory solid tumors and includes an expansion arm for biomarker-selected patients to receive single-agent therapy. The Phase 1b portion, which began enrollment in January 2016, is testing anti-RSPO3 with FOLFIRI in patients with second-line metastatic colorectal cancer. Anti-RSPO3 is believed to be the first drug candidate in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.

About Anti-DLL4/VEGF
OncoMed initiated a single-agent study of its anti-DLL4/VEGF bispecific in January 2015 in patients with advanced refractory solid tumors. Dose escalation is completed in the Phase 1a trial and enrollment in an expansion cohort is ongoing. The anti-DLL4/VEGF bispecific antibody is designed to combine the anti-cancer stem cell, dysangiogenic and immunotherapy mechanisms of anti-DLL4 with the anti-angiogenic activity of an anti-VEGF agent. The bispecific antibody was discovered using OncoMed’s proprietary MAbTrap antibody display technology, which enables the rapid identification of monoclonal antibodies that bind targets with high affinity and specificity. The antibody is the first program based on OncoMed’s BiMAb bispecific platform technology to enter clinical testing.

Loxo Oncology to Present Preclinical Data for LOXO-292 and LOXO-195 at the 28th EORTC-NCI-AACR Symposium

On November 15, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that new preclinical data for the company’s LOXO-292 and LOXO-195 programs will be presented at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place November 29 – December 2, 2016 in Munich, Germany (Press release, Loxo Oncology, NOV 15, 2016, View Source [SID1234516601]).

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The details of the poster presentations are as follows:

LOXO-292

Date: December 1, 2016
Title: The development of a potent, KDR/VEGFR2-sparing RET kinase inhibitor for treating patients with RET-dependent cancers
Session: Molecular targeted agents II
Abstract Code: 441
Poster Number: 120
Location: Exhibition Hall

LOXO-195

Date: December 1, 2016
Title: The development of LOXO-195, a second generation TRK kinase inhibitor that overcomes acquired resistance to 1st generation inhibitors observed in patients with TRK-fusion cancers
Session: Molecular targeted agents II
Abstract Code: 442
Poster Number: 121
Location: Exhibition Hall

Atreca to Present at the Stifel 2016 Healthcare Conference

On November 15, 2016 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that Tito Serafini, Ph.D., President, Chief Executive Officer, and Co-Founder, will present at the Stifel 2016 Healthcare Conference on Wednesday, November 16, 2016 at 8:45 a.m. Eastern Time at the Lotte New York Palace Hotel. Dr. Serafini will provide an overview of Atreca and business update (Press release, Atreca, NOV 15, 2016, View Source [SID1234522961]).

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Kura Oncology to Present Preclinical Data on Pipeline Programs at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

On November 15, 2016 Kura Oncology, Inc. (Nasdaq:KURA), a clinical stage biopharmaceutical company developing precision medicines for cancer, reported it will be presenting two posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2016), taking place November 29 – December 2, 2016 in Munich (Press release, Kura Oncology, NOV 15, 2016, View Source [SID1234516638]). The presentations will feature preclinical data from Kura Oncology’s KO‒947 ERK inhibitor and menin-MLL inhibitor programs. Abstracts are currently available online at the European Cancer Organisation website (www.ecco-org.eu/Events/ENA2016).

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Posters
Date & Time: Nov. 30, 2016, 10:15 a.m. – 5:00 p.m. (CET)
Poster Title: Discovery of novel menin-MLL small molecule inhibitors that display high potency and selectivity in vitro and in vivo
Session: Epigenetic modulators
Abstract Number: 264
Poster Location: P090, ICM – Internationales Congress Center München

Date & Time: Dec. 1, 2016, 10:15 a.m. – 5:00 p.m. (CET)
Poster Title: KO-947, a potent and selective ERK inhibitor with slow dissociation kinetics
Session: Molecular targeted agents II
Abstract Number: 381
Poster Location: P060, ICM – Internationales Congress Center München

Boehringer Ingelheim bevacizumab biosimilar candidate demonstrates bioequivalence to Avastin®

On November 16, 2016 Boehringer Ingelheim reported new data from the Phase I INVICTAN-1 study, which show that BI 695502, its bevacizumab biosimilar candidate, is bioequivalent to U.S.-licensed and EU-approved Avastin (Press release, Boehringer Ingelheim, NOV 15, 2016, View Source [SID1234516656]).* Avastin is an angiogenesis inhibitor that is used to treat a variety of cancers.

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BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN-1 study. These data were presented in a poster at the American Association of Pharmaceutical Scientists Annual Meeting in Denver, CO, November 13 – 17.

"This study is an important milestone for Boehringer Ingelheim, and supports our commitment to improving the lives of patients with cancer by exploring innovative ways for biosimilars to contribute to the long-term sustainability of the U.S. healthcare system," said Martina Flammer, Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to evaluating BI 695502 in our ongoing Phase III study to establish its safety and efficacy as compared to Avastin."

About BI 695502 and INVICTAN
BI 695502, a bevacizumab biosimilar candidate to Avastin, is a monoclonal antibody that may slow or stop the growth of certain tumor types by preventing the growth of blood vessels that supply the tumor.

INVICTAN-1 (NCT01608087) is a randomized, blinded, single-dose, parallel-arm Phase I clinical study, evaluating bioequivalence (how a drug is absorbed, distributed, metabolized and excreted in the body) of BI 695502 to Avastin. The study enrolled 91 healthy male individuals who were randomized evenly across treatment groups. BI 695502 was well-tolerated in this study, with no clinically relevant differences in safety or immunogenicity evaluations between the BI 695502 and bevacizumab treatment groups.

INVICTAN-2 (NCT02272413) is a randomized, double-blind Phase III study, evaluating efficacy and safety of BI 695502 plus chemotherapy versus Avastin plus chemotherapy in patients with advanced non-squamous non-small cell lung cancer.