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[PDF]Kyowa Hakko Kirin Announces FDA Notification of PDUFA Action Date Extension for Mogamulizumab

On May 30, 2018 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151 President and COO: Masashi Miyamoto, "Kyowa Hakko Kirin") reported that it has been notified that the U.S. Food and Drug Administration (FDA) is extending its review of the Biologics License Application (BLA) for mogamulizumab for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy (Press release, Kyowa Hakko Kirin, MAY 30, 2018, View Source [SID1234526937]). In a notice received from the FDA, the Prescription Drug User FeeAct (PDUFA) target action date has been extended to September 4, 2018.

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During the review, Kyowa Hakko Kirin submitted additional documentation related to the manufacturing section of the BLA, and FDA subsequently decided that it constituted a major amendment that requiring a 3 month extension to the original target action date, to provide time to complete review of the submission.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About Mogamulizumab
Mogamulizumab is an investigational humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including CTCL (cutaneous T-cell lymphoma). Mogamulizumab was produced using Kyowa Hakko Kirin’s proprietary POTELLIGENT platform, which is associated with enhanced antibody-dependent cellular cytotoxicity (ADCC).

In August 2017, the FDA announced that mogamulizumab has been granted Breakthrough Therapy designation status for the treatment of MF and SS in adult patients who have received at least one prior systemic therapy. In late November 2017, the FDA accepted the BLA for filing and granted mogamulizumab Priority Review.

About Mycosis Fungoides (MF) and Sézary Syndrome (SS)
MF and SS are the two most common subtypes of CTCL, a rare type of non-Hodgkin’s lymphoma, which is characterized by localization of malignant T lymphocytes to the skin, and depending on the stage, the disease may involve skin, blood, lymph nodes, and viscera.

Laminar Pharma announces IND approval by the FDA to proceed with a PhI paediatric trial assessing 2OHOA in children with advanced brain and other solid tumours

On May 29, 2018 Laminar Pharma, a pioneering clinical stage biopharmaceutical company developing a new generation of products modulating metabolism of membrane lipids based on the groundbreaking MLT platform, reported that the FDA has approved an IND for a paediatric trial entitled "a phase I study of 2-hydroxyoleic acid (2OHOA) in pediatric patients with malignant glioma and other advanced solid tumors (Press release, Laminar Pharma, MAY 29, 2018, View Source [SID1234562094])"

This will be the first clinical study with 2OHOA in children with advanced malignant cancer and will be conducted in collaboration with two leading US paediatric clinical research institutions: Hackensack University Medical Center, in New Jersey and Dana-Farber Cancer Institute in Boston. The main objectives of this study are to determine the safety and tolerability of 2OHOA in paediatric population (under 18 years), to characterize the pharmacokinetic profiles in this population and to assess the preliminary anti-tumour efficacy of the product. The trial follows a standard 3+3 design in the dose escalation phase, where 9 to 18 patients will be recruited in three cohorts, and that will be followed by an expansion cohort with 10 additional patients.

High-grade gliomas (HGG) are relatively rare forms of paediatric brain tumours, constituting only 8–12% of primary central nervous system (CNS) tumours in children. The management of these tumours involves surgical resection to the extent feasible, as well as adjuvant radiation and chemotherapy. Even with these interventions, the prognosis for patients with these tumours is poor, with most patients succumbing to their disease within 12–18 months. The incidence rate of primary malignant and non-malignant brain and CNS tumours in the US in paediatric and adolescent population (0-19 years) is 5.42 cases per 100,000 for a total count of around 23,000 incident tumours per year, of which over 2.500 cases correspond to HGG.

Laminar Pharma is committed to advance the clinical development of this promising product and is excited about the prospect of providing a potential therapeutic alternative for children and adult patients with brain and other aggressive cancers.

The approval by the FDA of the Investigational New Drug (IND) application for this paediatric trial in the US is a significant regulatory milestone for 2OHOA, (re)validating the extensive preclinical and clinical development that Laminar Pharma is carrying out with this innovative product.

A PIIb trial in adult patients with newly-diagnosed glioblastoma (CLINGLIO) with 2OHOA added to the current chemoradiation standard of care for this type of tumours is also planned to open within this year in leading Hospitals in Europe and Israel, following the award of an important H2020 grant by the European Commission to an international consortium lead by Laminar Pharma.

Oncoceutics Abstracts at ASCO Highlight Efficacy of ONC201 in High-Grade Gliomas

On May 29, 2018 Oncoceutics, Inc. reported that two abstracts will be presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that will highlight clinical success of the company’s lead compound in treating high-grade gliomas (HGG), including those that harbor the H3 K27M mutation (Press release, Oncoceutics, MAY 29, 2018, View Source [SID1234558368]).

The first abstract, entitled "Integrated clinical experience with ONC201 in H3 K27M glioma," describes preliminary clinical data indicating ONC201 induces durable radiographic regressions and clinical benefit in patients with HGG that harbor the H3 K27M mutation. This mutation is prevalent among certain types of brain tumors that develop in children and young adults and is known to confer one of the most dismal and uniformly lethal prognoses amongst HGG. There is no proven medical therapy for these patients. The integrated cohort of H3 K27M-mutant glioma patients who have received ONC201 that will be reported at the meeting include children and adults with different tumor locations. The durability of regressions and clinical benefit will be reported, which is an important measure of efficacy in this disease that is consistent with the immunostimulatory activity of ONC201 that was recently reported in the Journal of Clinical Investigation. ONC201 is currently being evaluated in pediatric and adult H3 K27M-mutant gliomas in three ongoing clinical trials at several institutions around the United States: NCT03416530, NCT03295396, NCT02525692.

The second abstract, entitled "Intratumoral activity of ONC201 in adult recurrent glioblastoma patients" describes the concentrations, targeted signaling pathways, and apoptosis associated with ONC201 directly within tumors that have been surgically removed from adult recurrent glioblastoma patients who have received two doses ONC201. These results serve as an important complement to macroscopic clinical imaging by enabling microscopic studies that demonstrate the drug is inducing the intended therapeutic impact that causes tumor cells to undergo cell death.

In addition to the two abstracts focused on HGG, there is another abstract that reports the safety and pharmacodynamics of ONC201 in advanced solid tumor patients. Additional results support the conclusion that weekly, oral ONC201 is well-tolerated and results in prolonged stable disease, intratumoral apoptotic signaling and immunomodulatory activity.

The abstracts are listed below.

2059. Integrated clinical experience with ONC201 in H3 K27M glioma. Presented Saturday, June 2, 2018.

E14034. Intratumoral activity of ONC201 in adult recurrent glioblastoma patients.

2595. Safety and pharmacodynamics of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration. Presented Monday, June 4, 2018,

Nordic Nanovector Announces PARADIGME Trial Approved to Start in Norway

On May 29, 2018 Nordic Nanovector ASA (OSE: NANO) reported that its pivotal PARADIGME Phase 2b trial with Betalutin (177Lu-satetraxetan-lilotomab) in third-line (3L) follicular lymphoma (FL) patients has been approved by the Regional Committees for Medical and Health Research Ethics (REK) in Norway (Press release, Nordic Nanovector, MAY 29, 2018, View Source [SID1234553503]). Nordic Nanovector has now received all necessary approvals to begin PARADIGME in Norway and will commence start-up activities with the selected clinical sites immediately with the intention of recruiting patients into the study as soon as possible.

PARADIGME is a global, randomised Phase 2b clinical trial comparing two promising Betalutin dosing regimens in patients with third-line follicular lymphoma who are refractory to anti-CD20 immunotherapy (including rituximab), a population with a high unmet medical need. The trial will enrol 130 patients at 80-85 sites in approximately 20 countries. The first patient is expected to be dosed in the first half of 2018 and the data read-out is targeted to the first half of 2020.

10-Q – Quarterly report [Sections 13 or 15(d)]

Surface Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Surface Oncology, 2018, MAY 29, 2018, View Source [SID1234527480]).