On May 24, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that topline results from the Phase III study of Arzerra (ofatumumab) plus bendamustine did not meet the primary endpoint of improved progression-free survival (PFS) in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) who were unresponsive to rituximab or a rituximab-containing regimen, compared to those given bendamustine alone (Press release, Genmab, MAY 24, 2018, View Source [SID1234527081]). The safety profile observed in this study was consistent with that observed in other trials of ofatumumab and no new safety signals were observed.

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"We are disappointed that the ofatumumab treatment regimen did not meet the primary endpoint in this trial. The completion of this Phase III study, which began in 2010, would not have been possible without the generous participation of the patients and their families, and we are most grateful for this. The full data will be submitted for publication at a future medical conference and we hope that these will provide a better understanding of this result," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The results from this Phase III study do not impact any other ongoing studies with ofatumumab.

About the study (COMPLEMENT A+B)
The study is an open-label, two-arm, randomized, Phase III study that included 346 patients with indolent B-cell non-Hodgkin’s lymphoma who were unresponsive to rituximab or a rituximab-containing regimen. Patients in the study were randomized 1:1 to treatment with up to eight cycles of bendamustine given in combination with 12 doses of ofatumumab (1,000 mg) or up to eight cycles with bendamustine alone. The primary endpoint of the study was PFS.

Ofatumumab is not approved for the treatment of indolent non-Hodgkin’s Lymphoma.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes and on B cell malignancies (including chronic lymphocytic leukemia and non-Hodgkin’s lymphomas).

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate, in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy and in combination with fludarabine and cyclophosphamide for adult patients with relapsed CLL. In more than 60 countries worldwide, including the United States and EU member countries, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab. On January 22, 2018, it was announced that Novartis intends to transition Arzerra for the treatment of CLL indications from commercial availability to limited availability via compassionate use programs in non-U.S. markets.

Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).

Arzerra is marketed under a collaboration agreement between Genmab and Novartis. A subcutaneous formulation of ofatumumab is also being investigated in two Phase III clinical studies in relapsing multiple sclerosis.

On May 24, 2018 VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, reported that the final results from a Phase I study in recurrent glioblastoma with its lead product candidate, oral VXM01, are being presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1-5, 2018 in Chicago, IL, USA (Press release, Vaximm, MAY 24, 2018, View Source [SID1234526877]).

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Abstract #2017, Poster Board #175

A poster entitled, "VXM01 phase I study in patients with progressive glioblastoma: final results," will be presented during the Central Nervous System Tumors Session on Saturday, June 2nd, 1:15-4:45 PM CDT, as well as during a poster discussion session that day, 4:45 PM – 6:00 PM CDT. The abstract (#2017) is available on the ASCO (Free ASCO Whitepaper) website here.

The Phase I trial was designed to evaluate the safety and tolerability of VXM01, as well as clinical and immunogenic response, in patients with recurrent glioblastoma whose disease had progressed following treatment with radiochemotherapy including temozolomide, which is the standard of care. Fourteen patients were treated with VXM01, including three who were also treated with the anti-PD-1 checkpoint inhibitor, nivolumab. Patients were given VXM01 on days 1, 3, 5 and 7. Tumor resection was then performed on eight patients. During the follow-up period, patients could receive oral VXM01 every four weeks. Median dosage was eight vaccinations. VXM01 appeared to be well tolerated, both as monotherapy or in combination with nivolumab. ELISpot analysis showed detectable VEGFR-2-specific T-cell responses.

Of the fourteen patients treated, one patient experienced an objective response with VXM01 monotherapy and a durable response with the addition of nivolumab. During the observation period of up to 20 months, seven patients were still alive, all of them living for more than one year. Survival seemed to be correlated with a higher CD8/Treg ratio in the progressive and primary tumors. The ratio further increased after VXM01 treatment. In patients with prolonged survival, a decrease in intratumoral PD-L1 was observed, which supports the rationale for combining VXM01 with an anti-PD-L1 checkpoint inhibitor.

Prof. Wolfgang Wick, MD, Chairman, Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany, and principal investigator of the study, said: "The results of this trial are promising and support advancing the development of VXM01 for the treatment of glioblastoma, a deadly form of brain cancer, where there is an urgent need to find more effective treatments to help prevent recurrence. We are particularly excited about the early clinical signals we have seen with VXM01 and we look forward to the start of a planned trial combining VXM01 with a PD-L1 inhibitor."

In 2017, VAXIMM entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate VXM01 in combination with avelumab, a human anti-PD-L1 antibody. The clinical combination trial in glioblastoma is expected to be initiated this year.

About VXM01:

VXM01 is an oral T-cell immunotherapy that is designed to activate T-cells to attack the tumor vasculature, and, in several tumor types, attack cancer cells directly. It is based on a live attenuated, safe, orally available, bacterial vaccine strain, which is modified to carry vascular endothelial growth factor receptor-2 (VEGFR2) as the target gene. VXM01 stimulates the patient’s immune system to activate VEGFR2-specific, cytotoxic T-cells (so-called killer cells). These immune killer cells then actively destroy cells in the tumor vasculature, leading to an increased infiltration of various immune cells into the tumor. In several tumor types, including brain cancer, VEGFR2 is highly over-expressed on the cancer cells themselves. In preclinical studies, a murine analog VXM01 vaccine showed broad anti-tumor activity in different tumor types. This activity was linked to a VEGFR2-specific T-cell response and was accompanied by the destruction of the tumor vasculature and increased immune cell infiltration. In a Phase I double-blind, randomized, placebo-controlled study in 71 patients with advanced pancreatic cancer, VXM01 appeared to be safe and well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival.

About VAXIMM:

VAXIMM is a privately held, Swiss/German biotech company that is developing oral T-cell immunotherapies for patients suffering from cancer. VAXIMM’s product platform is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to stimulate patients’ cytotoxic T-cells to target specific structures of the tumor. VAXIMM’s lead product candidate, oral VXM01, activates killer cells targeting tumor-specific vasculature and certain immune-suppressive cells, thereby increasing immune cell infiltration in solid tumors. VXM01 is currently in clinical development for several tumor types, including pancreatic, colorectal and brain cancer. In addition to VXM01, VAXIMM has a pipeline of complementary development candidates targeting different tumor structures. VAXIMM’s investors include BB Biotech Ventures, Merck Ventures, Sunstone Capital and BioMed Partners. VAXIMM AG is headquartered in Basel, Switzerland. Its wholly owned subsidiary, VAXIMM GmbH, located in Mannheim, Germany, is responsible for the Company’s operations. For more information, please see www.vaximm.com.

On May 24, 2018 Merus N.V. (Nasdaq:MRUS), a clinicalstage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics), reported that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA158 in patients with solid tumors with an initial focus on metastatic colorectal cancer (Press release, Merus, MAY 24, 2018, View Source [SID1234532108]). The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States.

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MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G proteincoupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). MCLA-158 was identified from a large library of bispecific antibodies targeting molecules belonging to the Wnt and receptor tyrosine kinase signaling pathways as part of work performed by the suppresSTEM consortium, a project that was funded by the European Union. Functional evaluation of patient-derived colorectal tumors, including those harboring RAS and/or PI3K mutations, demonstrated that MCLA-158 was more effective at inhibiting tumor growth and promoting apoptosis than an approved targeted therapy comparator for metastatic colorectal cancer, cetuximab. In preclinical studies, Merus also observed that the growth inhibitory activity of MCLA-158 was greater for colon tumors compared to normal colon tissue, consistent with its good safety profile in non-human primates.

"The commencement of our Phase 1 clinical trial of MCLA-158 is an important milestone for the advancement of our pipeline of bispecific antibodies obtained from our Biclonics technology platform," said Ton Logtenberg, Ph.D., Chief Executive Officer. "We believe MCLA-158 has the potential to address features that limit currently approved colorectal cancer-targeted therapies, including issues with offtarget toxicity and inability to target tumor stem cells, and thus, potentially treat a broader population of patients more effectively."

The Phase 1, open-label, multicenter clinical trial of MCLA-158 consists of two parts, a dose escalation and a dose expansion. The dose escalation part is intended to determine the appropriate dose of MCLA158. The dose expansion part will evaluate the safety and tolerability of the defined dose of MCLA-158 in patients with solid tumors. The dose escalation and expansion parts of the trial will also examine the preliminary antitumor activity of single-agent MCLA-158.

On May 24, 2018 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that its Management Team will present an overview of the Company’s business at two investor conferences in June (Press release, West Pharmaceutical Services, MAY 24, 2018, View Source;p=RssLanding&cat=news&id=2350600 [SID1234526878]). Management will present at the Jefferies 2018 Global Healthcare Conference in New York, New York at 8:00 a.m. EDT on Tuesday, June 5, 2018; and at the Goldman Sachs 39th Annual Global Healthcare Conference in Rancho Palos Verdes, California at 10:00 a.m. PDT on Thursday, June 14, 2018.

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A live audio webcast of the presentation and a copy of the presentation will be accessible from the Company’s website at www.westpharma.com/en/investors.

On May 24, 2018 Cotinga Pharmaceuticals Inc. (TSX-V:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported the clearance of a protocol amendment for its ongoing clinical trial of COTI-2 (Press release, Cotinga, MAY 24, 2018, https://globenewswire.com/news-release/2018/05/24/1511485/0/en/Cotinga-Pharmaceuticals-Announces-FDA-Clearance-of-Significant-Protocol-Changes-for-COTI-2-Clinical-Program.html [SID1234533153]). The multi-part protocol amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers. The Company will initially evaluate COTI-2 combined with standard of care cisplatin in up to 30 patients with any of ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma.

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"Following extensive work with our academic collaborators and the FDA, we are pleased to expand the ongoing clinical trial of our lead asset, COTI-2, to evaluate its potential as a combination therapy in various cancers with severe unmet medical need," said Alison Silva, President and Chief Executive Officer. "We have already begun to roll-out the initial part of the protocol amendment for our sites at MD Anderson Cancer Center and Northwestern University, and we will continue to work closely with investigators to ensure the process runs smoothly. We look forward to announcing the first patient dosed with combination therapy and providing updates as we continue to advance the clinical development of COTI-2."

Phase 1b/2a Trial of COTI-2
The ongoing trial of COTI-2 will now focus on evaluating COTI-2 as a combination therapy for the potential treatment of a wide spectrum of cancers. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating monotherapy with COTI-2 was generally safe and well-tolerated. Monotherapy with COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

The current protocol amendment being implemented by the Company in May 2018 expands the ongoing trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers.

This protocol amendment evaluates COTI-2 combined with standard of care cisplatin in up to 30 patients with any of the following malignancies: ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma. Patients in this dose finding study will be given a 60 mg/m2 IV dose of cisplatin every three weeks in combination with an oral dose of COTI-2 five days per week. Up to five COTI-2 dose levels will be evaluated ranging from 0.5 mg/kg to 3.5 mg/kg and patient assessments will occur every eight weeks. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacokinetics and various signals of efficacy. Additional details on the protocol amendment are available on clinicaltrials.gov.