On June 1, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that its Phase 3 registration trial of Vicinium in non-muscle invasive bladder cancer (NMIBC) has exceeded 50% enrollment and that the independent Data and Safety Monitoring Board (DSMB) for the trial has recommended that the trial continue as planned (Press release, Eleven Biotherapeutics, JUN 1, 2017, View Source [SID1234519355]). The DSMB reviewed available data to assess the risk/benefit to patients on drug and recommended that the trial continue without modification.

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"We are very pleased that the DSMB recommended we continue enrolling our Phase 3 trial after their review of available safety and efficacy data," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "Patients with Bacillus Calmette-Guérin (BCG) unresponsive NMIBC have limited therapeutic options and frequently require cystectomies to prevent disease progression. Bladder removal, however, is a serious and life-altering surgery associated with significant morbidity and mortality. Vicinium may offer patients a positive non-surgical risk/benefit profile versus the standard of care. We look forward to advancing our trial as we continue to gain important information about the activity of Vicinium in patients with NMIBC."

"Urologists are looking for new treatment options for their patients with NMIBC once they stop responding to BCG. Their patients want alternatives to cystectomy. However, the NMIBC treatment landscape has not seen meaningful advances in forty years," commented Arthur DeCillis, Chief Medical Officer of Eleven Biotherapeutics. "With this positive step behind us, we look forward to continuing our Phase 3 registration trial and to reporting topline 3-month data in the second quarter of next year."

Vicinium is a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) antibody fragment fused with Pseudomonas Exotoxin A (ETA) that is designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. The ongoing Phase 3 registration trial is a single-arm study evaluating Vicinium in patients with high-grade NMIBC, who have previously received two courses of BCG and whose disease is now BCG-unresponsive. Eleven Biotherapeutics plans to enroll 134 patients, at over 70 centers in the United States and Canada. The trial’s primary endpoint is the complete response rate in patients with carcinoma-in-situ (CIS). Secondary endpoints include time to disease recurrence and event free survival. The Company expects to complete patient enrollment in the second half of 2017 and to report 3-month data in the second quarter of 2018.

On June 1, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that the pivotal phase 3 part of the B-MIND clinical study of MOR208 has been opened for enrollment (Press release, MorphoSys, JUN 1, 2017, View Source [SID1234519341]).

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The randomized, multicenter phase 2/3 study is designed to investigate the efficacy of MOR208 plus bendamustine versus rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma (R/R DLBCL) who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). DLBCL is the most common form of non-Hodgkin’s lymphoma. MOR208 is an investigational, Fc-enhanced monoclonal antibody directed against CD19 and is being developed for the treatment of patients with B cell malignancies.

"We are delighted that MOR208, as the first antibody from MorphoSys’s proprietary pipeline, has started pivotal phase 3 development," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "For patients with relapsed or refractory DLBCL who are not eligible for HDC and ASCT, current treatment options are limited. In our pivotal B-MIND study, we are therefore exploring MOR208 in combination with bendamustine, as a potential treatment alternative for this difficult-to-treat patient group".

Based on the available data from the phase 2 safety evaluation part of the B-MIND trial, the Independent Data Monitoring Committee (IDMC) supported the continuation of the trial as per protocol and the transition of the study into its pivotal phase 3 part.

Patients must have been treated previously with at least one but not more than three prior lines of therapy, including one anti-CD20 targeted therapy. The study is expected to enroll a total of approximately 330 patients in about 180 centers in Europe, Asia Pacific (APAC) and the USA.

The dosing of the first patient in the phase 3 part will trigger an undisclosed milestone payment to Xencor, Inc., from whom MOR208 was in-licensed in 2010. MorphoSys has worldwide rights to MOR208.

Detailed information on the trial can be found at ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT02763319).

About CD19 and MOR208
CD19 is broadly and homogeneously expressed across different B cell malignancies including DLBCL and CLL. CD19 has been reported to enhance B cell receptor (BCR) signaling, which is assumed important for B cell survival, making CD19 a potential target in B cell malignancies.
MOR208 (previously Xmab(R)5574) is an Fc-enhanced monoclonal antibody directed against CD19. Fc-modification of MOR208 is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. Furthermore, MOR208 has been observed in preclinical models to induce direct apoptosis by binding to CD19, which is assumed to be a crucial component for B cell receptor (BCR) signaling.
MorphoSys AG is clinically investigating MOR208 as a therapeutic option in B cell malignancies in a number of ongoing combination trials. A phase 2 combination trial (L-MIND study) started in March 2016 and is designed to investigate the safety and efficacy of MOR208 in combination with lenalidomide in approximately 80 patients with relapsed/refractory DLBCL. The phase 2/3 B-MIND study was started in August 2016 and transitioned into its phase 3 pivotal part in June 2017 following a recommendation of the IDMC based on the available data from the phase 2 initial safety evaluation. The B-MIND study is designed to investigate MOR208 in combination with the chemotherapeutic agent bendamustine in relapsed/refractory DLBCL patients who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) in comparison to the combination of the anti-CD20 antibody rituximab plus bendamustine. Furthermore, in December 2016, a third phase 2 combination trial (COSMOS study) was started with MOR208 evaluating the antibody in patients with relapsed/refractory CLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib). Currently MOR208 is being studied in combination with idelalisib; a second study arm of MOR208 plus venetoclax is currently in preparation.

On June 1, 2017 Ipsen reported that lanreotide (Somatuline Autogel Depot), cabozantinib (Cabometyx), irinotecan liposome injection (Onivyde) and the investigational compounds 177Lu-OPS201 and 68Ga-OPS201 are the subject of presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 conference (Press release, Ipsen, JUN 1, 2017, View Source [SID1234519340]). The meeting takes place in Chicago, Illinois, June 2-6, 2017.

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"Ipsen continues to build on the strength of its Oncology portfolio at ASCO (Free ASCO Whitepaper) this year with new data being presented to support our key products as well as our early-stage radiopharmaceutical compounds,", said David Meek, Chief Executive Officer, Ipsen. "We are establishing a leadership position in several specialty Oncology markets and will continue to collaborate with the research community to accelerate the discovery and development of therapeutic options with the goal of improving the lives of people living with cancer."

"These studies demonstrate Ipsen’s steadfast commitment to cancer patients for whom innovative options are urgently needed," said Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen. "Researchers are sharing deeper insights from Ipsen’s oncology’s portfolio to continue to improve treatment of gastroenteropancreatic neuroendocrine tumors, advanced pancreatic cancer and advanced renal cell carcinoma."

On June 1, 2017 BioLineRx Ltd. (NASDAQ: BLRX, TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that Genentech, a member of the Roche Group, has filed a total of three regulatory submissions required to commence Phase 1b trials for BL-8040 in combination with atezolizumab (Tecentriq), Genentech’s anti-PDL1 cancer immunotherapy, for the treatment of patients with solid tumors. The trials for pancreatic, gastric and non-small cell cancer are expected to commence during the second half of 2017, after receipt of regulatory approval.

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These clinical studies are part of a cancer immunotherapy collaboration between BioLineRx and Genentech to conduct several Phase 1b studies investigating BL-8040 in combination with atezolizumab in multiple cancer indications, announced in September 2016. The Phase 1b studies will evaluate the clinical response, safety and tolerability of the combination of these therapies, as well as multiple pharmacodynamic parameters.

BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in clinical trials to be a robust mobilizer of immune cells and to be effective in inducing direct tumor cell death. Additional findings in the field of immuno-oncology suggest that CXCR4 antagonists may be effective in inducing the migration of anti-tumor T cells into the tumor micro-environment, as well as improving the infiltration of T cells into solid tumors. Atezolizumab is a humanized monoclonal antibody designed to bind to PD-L1 in tumor cells and tumor infiltrating immune cells and blocks interactions with the PD-1 and B7.1 receptors. Through this interaction, atezolizumab may enable the activation of T cells, whose migration into the tumor may be enhanced by BL-8040.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "The completion of all three regulatory submissions by our partner, Genentech, for the combination studies of our CXCR4 inhibitor lead oncology platform and their anti-PD-L1 immune checkpoint inhibitor, is a testimony to the commitment on the part of both companies to advance our collaboration and establish new treatments for the potential benefit of cancer patients. This follows our recently announced regulatory filing of the same combination for the treatment of AML patients. Our clinical collaboration with Genentech is advancing on track, and we look forward to the initiation of these multiple clinical studies."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis). In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.