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Celyad Announces Registration of the first patient in the Belgian THINK trial

On January 17, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, reported that the first patient of the Therapeutic Immunotherapy with NKR-2 (THINK) trial started cell processing in Belgium (Press release, Celyad, JAN 17, 2017, View Source [SID1234517421]). Blood was collected from this patient and first CAR-T NKR-2 dose level infusion (3×108 cells) is expected in January 2017.

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"We are pleased to announce that the first patient has been registered in our Belgian Phase Ib trial of CAR-T NKR-2. After witnessing evidence of activity in our initial safety studies, we are enthusiastic about reporting data from this trial in 2017,"said Christian Homsy, CEO of Celyad. "We look forward to expanding the trial to U.S.-based institutions and I would like to thank our clinical partners, and the Celyad team for enabling this milestone."

Dr. Frédéric Lehmann, VP Clinical Development & Medical Affairs at Celyad: "This is an important moment for Celyad. The THINK trial is aimed to demonstrate that CAR-T NKR-2 cells can deeply transform the way we treat cancer patients. The team keeps on showing its awe-inspiring ability to deliver in Research and Development, and the Company has now reached a cardinal inflection point to emerge as a key player in the CAR-T space."

About the THINK trial
THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous CAR-T NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).
The trial will test three dose levels adjusted to body weight: up to 3×108, 1×109 and 3×109 CAR-T NKR-2 cells. At each dose, the patients will receive three successive administrations, two weeks apart, of CAR-T NKR-2 cells. The dose escalation part of the study will enroll up to 24 patients while the extension phase would enroll 86 additional patients.

ONCURIOUS NV Announces European Commission Confirmed Orphan Medicinal Product Designation for TB-403 for Medulloblastoma

On January 17, 2017 ONCURIOUS NV, an emerging oncology company focused on the development of innovative orphan drugs for the treatment of pediatric tumors, reported that the European Commission has confirmed the orphan drug designation for TB-403 for medulloblastoma (Press release, Oncurious, JAN 17, 2017, View Source [SID1234517434]). Today’s decision by the EC follows the earlier positive opinion issued by the European Medicine Agency (EMA).

TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. In medulloblastoma patients, high expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall patient survival.

An orphan drug designation is for "medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious".

Today’s confirmation by the EC follows an earlier in-depth review and positive opinion on the drug candidate by the EMA Committee for Orphan Medicinal Products (COMP). The COMP gathers a group of experts chosen on the strength of their qualifications and a number of patient organization representatives. Altogether, the COMP assesses the potential incremental benefits of a drug candidate versus existing treatments.

TB-403 is currently being evaluated in a Phase I/IIa clinical trial for treatment of medulloblastoma, a rare, life-threatening pediatric cancer.

The clinical trial is being conducted in partnership with the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC). The Consortium is a collaboration of 25 US academic medical centers, teaching hospitals and other entities, with the purpose of facilitating and conducting collaborative research activities and investigations of new treatments for neuroblastoma, medulloblastoma and other pediatric cancers. NMTRC is headquartered in Grand Rapids, MI, USA.

ONCURIOUS nv is working with BioInvent International AB as a development partner for this project.

Patrik De Haes, MD, Executive Chairman of ONCURIOUS nv comments
"We are very happy with today’s news. Gaining this orphan-drug designation is an important validation of the TB-403’s scientific rationale

Xcovery Joins National Cancer Institute (NCI) Formulary to Help Expedite Cancer Clinical Trials

On January 17, 2017 Xcovery, a developer of targeted therapeutics for cancer, reported their participation in the NCI Formulary, a public-private partnership between the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and pharmaceutical and biotechnology companies to expedite the use of agents in clinical trials (Press release, Xcovery, JAN 17, 2017, View Source [SID1234517433]). The partnership, which launched last week with fifteen targeted agents from six pharmaceutical companies, will seek to alleviate the lengthy process to develop new therapies for patients, and respond to the call for greater collaboration within the industry made by Vice President Biden’s Cancer Moonshot Initiative.

"Collaboration among pharmaceutical companies with the NCI and the NIH will speed up the development of novel therapies and benefits for patients down the line," said Lieming Ding, M.D., Chairman of Xcovery. "Xcovery has focused on developing drugs with reduced toxicity, which allows for combination therapies. We’re excited to join the NCI Formulary by providing our ALK inhibitor, ensartinib, to the broad research community for additional development opportunities, particularly in combination therapy programs."

Research indicates that combination therapies, which include drugs with different mechanisms of action impacting cancer cells in multiple ways, provide an improved clinical benefit and can decrease the risk of relapse. The establishment of the NCI Formulary will enable the NCI to facilitate and streamline the arrangements for access to and use of pharmaceutical agents from multiple organizations, allowing for further research on various therapeutic opportunities. Following Xcovery’s approval, investigators will be able to obtain and test ensartinib in new preclinical or clinical studies, including combination studies with formulary agents from different companies.

About Ensartinib

Ensartinib (X-396) is a potent anaplastic lymphoma kinase (ALK) inhibitor currently in a global Phase 3 trial in ALK positive non-small cell lung cancer (NSCLC) patients. Besides ALK, ensartinib also potently inhibits TRKA fusions, TRKC, ROS1, EphA2, and c-MET.

The German National Center for Tumor Diseases (NCT) Heidelberg and Protagen AG Investigate Responsiveness to Checkpoint Inhibitors in Melanoma

On January 17, 2017 The German National Center for Tumor Diseases (NCT) Heidelberg and Protagen AG reported a collaboration to utilize Protagen’s SeroTag technology to identify biomarkers that predict therapy responsiveness and the detection of immune-related adverse events (irAEs) in melanoma patients treated with checkpoint inhibitors (Press release, Protagen, JAN 17, 2017, View Source [SID1234517430]).

Checkpoint inhibitors offer great potential for the treatment of many indications, including melanoma. Yet, only a subset of patients respond favorably to such treatment and it is not currently possible to predict who will benefit from the therapy in clinical routine. In addition, checkpoint inhibitors also trigger immune-related Adverse Events (irAEs) and even the onset of autoimmune diseases. Through this collaboration, Protagen and NCT will utilize Protagen‘s proprietary immune system profiling platform to predict response, monitor patients and detect immune related adverse events.

PD Dr. Jessica Hassel from the DermatoOncologic department of the Department of Dermatology and the NCT commented: "Checkpoint inhibitors offer exciting potential to cure cancer patients. However, at least half of the patients with a metastasized melanoma do not benefit long-term. Response rates can be increased via combination therapies such as a combination of ipilimumab and nivolumab, but such combinations also significantly increase the risk of suffering from sometimes serious irAEs, which have prevalence as high as 60% in these patients. To overcome the challenges posed by irAEs and to better select the appropriate therapy for each patient, we must learn more about the immune system status of these patients in general and their production of specific autoantibodies. Utilizing Protagen’s SeroTag platform enables this insight and we look forward to this collaboration."

Dr. Peter Schulz-Knappe, Protagen’s Chief Scientific Officer, added: "Our unique SeroTag technology has already proven that it can be used to define homogeneous patient subgroups in autoimmune diseases with the potential to predict treatment response. Based on the link between immuno-oncology and autoimmune disease, it is a natural extension to apply our profiling approach to checkpoint inhibitors to address some of the most challenging questions in this field. We feel privileged that Dr. Hassel and the NCT share this view and we are excited about our collaboration."

Agenus announces collaboration with the National Cancer Institute to evaluate the combination of Pembrolizumab (Keytruda®, Merck & Co., Inc.) with Prophage™ (Agenus Inc.) autologous vaccine

On January 17, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported a clinical trial collaboration with the National Cancer Institute (NCI) (Press release, Agenus, JAN 17, 2017, View Source [SID1234517428]). The double-blind, randomized controlled Phase 2 trial will evaluate the effect of Agenus’ personalized autologous vaccine candidate, Prophage (HSPPC-96), in conjunction with Merck’s pembrolizumab on the overall survival rate of patients with newly diagnosed glioblastoma (ndGBM). The trial will be conducted by the Brain Tumor Trials Collaborative (BTTC), a consortium of top academic centers led by Dr. Mark Gilbert, Chief of the Neuro-Oncology Branch at the NCI Center for Cancer Research.

The trial aims to assess the efficacy of PD-1 targeted checkpoint blockade in combination with a heat-shock protein based vaccine candidate in an indication in which this vaccine has shown improved progression-free survival, as presented at ASCO (Free ASCO Whitepaper) 2015. It is a two-arm trial with one arm receiving pembrolizumab as a monotherapy and a second arm receiving both Prophage and pembrolizumab in combination. Forty-five patients will be randomly assigned to each arm.

Under this collaboration, Agenus will supply Prophage, Merck will provide pembrolizumab (Keytruda) and NCI and BTTC member sites will recruit patients and conduct the trial.

About Prophage
Prophage is an individualized autologous vaccine candidate derived from proteins extracted from the patient’s tumor. The vaccine candidate consists of heat shock protein peptide complexes that include the chaperone gp-96 (HSPPC-96) naturally bound to tumor protein fragments. Administration of HSPPC-96 bearing the precise antigenic fingerprint of the patient’s particular cancer represents an effective immune education strategy that enhances recognition of a tumor as ‘non-self’ leading to a potent anti-tumor immune response.

In a Phase 2 study of Prophage monotherapy, patients with ndGBM exhibited an improved progression-free and overall survival as compared to historical control with standard of care.

About KEYTRUDA (pembrolizumab)
KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma; for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (TPS ≥50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations and upon disease progression on or after platinum-containing chemotherapy in patients with NSCLC whose tumors express PD- L1 (TPS ≥1); and for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. KEYTRUDA is administered as an intravenous infusion every three weeks for the approved indications.

For Safety and Prescribing Information for KEYTRUDA (pembrolizumab), please see View Source