On December 22, 2016 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it has entered into global license and supply agreements with Novartis for the development and commercialization of a Captisol-enabled oral liquid formulation of trametinib, a kinase inhibitor currently indicated as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation (Press release, Ligand, DEC 22, 2016, View Source [SID1234517166]). Under the terms of the license, Ligand will be eligible to receive a license fee, royalties on future net sales, and revenue from Captisol material sales. Novartis will be responsible for all costs related to the program. Schedule your 30 min Free 1stOncology Demo! "This represents an expansion of our relationship with Novartis as they develop an oral liquid formulation potential treatment option," commented John Higgins, Chief Executive Officer of Ligand. "This transaction continues to show the ability of Captisol to address unmet solubility and other formulation issues facing the industry."
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PRIMA BIOMED ANNOUNCES DATA FROM IMP321 AIPAC CLINICAL TRIAL IN BREAST CANCER
On December 22, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima" or the "Company") reported interim data from the AIPAC Phase IIb clinical trial for IMP321 in metastatic breast cancer (Active Immunotherapy PAClitaxel) (Filing, 6-K, Prima Biomed, DEC 22, 2016, View Source [SID1234517162]). The initial data confirms previous trial results showing IMP321 is safe and well tolerated. Schedule your 30 min Free 1stOncology Demo! In this Phase IIb study of IMP321 plus paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer, data from all 15 patients in the safety run-in phase demonstrated that IMP321 is safe and well tolerated at both the 6mg and 30mg dosage levels. Immune monitoring data has also confirmed that IMP321, as an Antigen Presenting Cell (APC) activator, is working to generate the desired immune responses. The data demonstrated activation and an increased level of blood monocytes, dendritic cells and CD8 T-cells.
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Prima’s Chief Medical Officer, Dr Frédéric Triebel, said: "Following the initial data released in June, we are now very pleased to confirm the safety, pharmacokinetics and pharmacodynamics of IMP321 across the initial patient cohorts at both dosage levels. This is another important step in de-risking our AIPAC trial as we look to commence the enlarged randomised and double-blind phase in the new year. We also look forward to providing further insights into efficacy of these safety run in patients by the middle of 2017."
Subject to the confirmation of the dose escalation committee on the 30th December, Prima will now commence the randomised phase of the trial in January 2017. Patients will receive paclitaxel treatment plus placebo or paclitaxel in conjunction with IMP321.
About IMP321
IMP321 is a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint LAG-3. IMP321 represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response.
IMP321 has been shown in an open-label Phase I study1, to be able to double the expected six-month response rate in HER-2 negative metastatic breast cancer patients receiving standard-of-care paclitaxel; from a 25% historic response rate2, to 50% when combined with IMP321.
Avastin® Received Orphan Drug Designation for the Treatment of Malignant Pleural Mesothelioma
On December 22, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Avastin received orphan drug designation by the Ministry of Health, Labour and Welfare for the treatment of malignant pleural mesothelioma (Press release, Chugai, DEC 22, 2016, View Source [SID1234517159]). Schedule your 30 min Free 1stOncology Demo! It is estimated that there are approximately 2,000 patients with malignant pleural mesothelioma in Japan. [Patient Survey 2014 (by classification of diseases), Statistic Bureau, Ministry of Internal Affairs and Communications]. Treatment options for malignant pleural mesothelioma, which is a refractory disease, include surgery, radiotherapy, chemotherapy and symptomatic therapy, and the treatment provided is determined based on the clinical stage of the cancer and general condition of the patient. Systemic chemotherapy can be chosen even for limited-stage malignant pleural mesothelioma without metastasis, due to its clinical characteristics.
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"There is high unmet medical need for patients with malignant pleural mesothelioma whose prognosis is poor," said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. "With the results of a study conducted in France and a Japanese phase II study, I have high hopes that Avastin will be newly added as a drug with an indication of malignant pleural mesothelioma in Japan. We are committed to deliver Avastin to patients as early as possible to contribute to the development of and access to better treatments."
In Japan, the phase II study (JO39183) to evaluate the tolerance and safety of triplet combination therapy (Avastin, cisplatin and pemetrexed) in chemotherapy-naïve patients with unresectable malignant pleural mesothelioma has been conducted.
About malignant pleural mesothelioma
The lungs, the heart, and abdominal organs such as the stomach, the intestines and the liver are covered by membranes called the pleura, pericardium and peritoneum, respectively. The surface of these membranes is wrapped around by the "mesothelium" and tumours developing from this layer are called mesothelioma. Therefore, mesothelioma can be divided into pleural mesothelioma, pericardial mesothelioma, and peritoneal mesothelioma, depending on the site of onset.
Pleural mesothelioma is a malignant cancer, commonly referred to as malignant pleural mesothelioma. Malignant pleural mesothelioma develops in a localized pattern (in which a mass is formed in one specific area) or in a diffuse pattern (in which a tumour widely spreads along the pleura). While this is a rare cancer, it is known to be triggered by asbestos.
(Reference: The Rare Cancer Center, National Cancer Center)
About orphan drug designation
Orphan drug designation is granted in conjunction with priority review status by the Minister of Health, Labour and Welfare according to the Pharmaceuticals and Medical Devices Law. Drugs satisfying the following criteria may be designated as orphan drugs: 1) the eligible number of patients should be less than 50,000 in Japan, 2) the drugs should be indicated for the treatment of serious diseases, and they must be drugs for which there are high medical needs where there is no appropriate alternative drug or treatment, or high efficacy or safety is expected compared with existing products, 3) there should be a theoretical rationale for the use of the product for the target disease, and the development plan should be appropriate.
PharmaMar and Chugai Pharmaceutical enter into a license and commercialization agreement for PM1183 in Japan
On December 22, 2016 PharmaMar (MSE:PHM) reported the signing of an exclusive license, development and commercialization agreement with Chugai Pharmaceutical Co. Ltd. (TSE:4519) for its third marine-derived anticancer drug PM1183 (lurbinectedin) in Japan (Press release, PharmaCyte Biotech, DEC 22, 2016, View Source [SID1234517158]). Under the terms of this agreement, PharmaMar will receive an upfront payment of €30 million, along with double-digit tiered royalties, and will also be eligible for receiving payments in line with the progress of the development and sales milestones; potentially worth over €100 million. Schedule your 30 min Free 1stOncology Demo! PharmaMar will continue to conduct the clinical development activities for the first two indications of PM1183 (platinum-resistant ovarian cancer and small cell lung cancer) in Japan, whereas Chugai will make milestone payments at study initiation and will be responsible for registration filing. In addition, Chugai will have the rights to conduct clinical development in Japan to pursue additional indications and may contribute to the global development. PharmaMar will retain the exclusive production rights of lurbinectedin and will supply the API to Chugai.
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PM1183 is PharmaMar´s third anticancer drug and is currently under development for the treatment of several types of solid tumors. The Company has recently completed the recruitment of patients in a Phase III study in platinum resistant ovarian cancer, and during the month of August, a pivotal Phase III trial in small cell lung cancer was initiated.
According to Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, "we are about to address our second strategic alliance with Chugai for the commercialization of a marine based anti-tumor compound. With this agreement, we will contribute to the sale of PM1183 in Japan. Meanwhile, we shall continue with the clinical development of the molecule and to advance in the upcoming regulatory steps to obtain its approval in the years to come".
"Both companies share the same value to bring PM1183 – an innovative marine based medicine to the Japanese patients so that we can contribute to the treatment," said Chugai’s Representative Director, President and Chief Operating Officer, Tatsuro Kosaka. "Chugai is committed to continuously provide innovative medicines to the patients. We hope to obtain approval based on the clinical results attained so far, and also from new results that will come in the future".
About PM1183 (lurbinectedin)
PM1183 is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III study for small cell lung cancer.
Circle Pharma announces Series A financing and appoints Walter H. Moos, Ph.D., to its board
On December 21, 2016 Circle Pharma, Inc. reported a Series A financing round in which it has issued over $4.5M of shares of Series A Preferred Stock (Press release, Circle Pharma, DEC 21, 2016, View Source [SID1234635669]). The financing was led by Mission Bay Capital, with Pfizer Inc. (NYSE:PFE), ShangPharma Investment Group, Ltd. and a syndicated group of individual investors joining the round. In connection with the financing, Walter H. Moos, Ph.D., representing ShangPharma, has joined the Circle Board of Directors.
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"We are delighted with the participation of such high caliber investors in our first equity round," said David J. Earp, J.D., Ph.D., Circle’s president and CEO. "With our seed funding, we established Circle’s computational design platform, advanced our synthetic chemistry capabilities in collaboration with ChemPartner, and engaged in a target-based collaboration with Pfizer. The Series A funds will be used to support Circle’s therapeutic pipeline, which is focused on intracellular protein-protein interactions that are key drivers in oncogenic pathways. We are also now building a physical library of cell- permeable macrocycles to augment our computational design tools, and this library will later be available to our collaboration partners. We are particularly excited to welcome Walter Moos to our Board of Directors. Dr. Moos brings a wealth of life sciences R&D experience, having served most recently as the president of SRI Biosciences and previously in senior executive roles at MitoKor, Chiron and Warner-Lambert/Parke-Davis. His teams have advanced numerous pharmaceutical products from discovery to commercialization, and we are fortunate to have him join Circle."
"I am very much looking forward to taking an active role on Circle’s board," said Walter Moos. "The combination of innovative technology and the great team at Circle could help unlock high value targets that have long been considered out of reach of drug developers."
Dr. Moos has served on about 20 business and scientific boards, including Amunix, Oncologic (Aduro), Onyx (Amgen), Rigel and the Biotechnology Industry Organization (BIO).
About Macrocyclic Peptides
Macrocyclic peptides have the potential to allow drug developers to address the large proportion of known therapeutic targets (estimated at up to 80%) that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited by the need for a greater understanding of how to develop macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Circle’s ability to design potent macrocycles with intrinsic cell permeability could unlock access to challenging, high value therapeutic targets that have been out of reach to other approaches.