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Approval for Clinical Trial for New Drug Goserelin Acetate Extended-release Microspheres for Injection (LY01005) in China

On August 9, 2018 The Board of Directors (the ‘‘Board’’) of Luye Pharma Group Ltd. (the ‘‘Company’’, together with itssubsidiaries, the ‘‘Group’’) reported that the Group’s product candidate, Goserelin Acetate Extended Release Microspheres for Injection (LY01005), has obtained the approval from the China Food and Drug Administration (the ‘‘CFDA’’) to initiate clinical trials for the treatment ofcarcinoma of the prostate (Press release, Luye Pharma, AUG 9, 2016, View Source;id=663103 [SID1234525075]). This product has also obtained the approval from the United States Food and Drug Administration (the ‘‘FDA’’) to initiate clinical trials for the treatment of carcinoma of theprostate in March this year.

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LY01005 is the Group ’s monthly extended release microspheres for intramuscular formulation ofgoserelin acetate, a gonadotropin -releasing hormone agonist, applying our microspheres injection technology. It is an oncology product candidate for the treatment of certain cancers and other indications, including prostate cancer, breast cancer and endometriosis. LY01005 is now being registered via a 505(b)(2) pathway of the United States Federal Food, Drug and Comestic Act in the United States ( ‘‘U.S.’’). The Company believes its extended-release microspheres formulation ofgoserelin acetate may have similar bioavailability as compared to another marketed product (goserelin implant), with better patient compliance and more stable efficacy.

The Company had filed a Patent Cooperation Treaty application for its goserelin microsphere pharmaceutical composition in 2014 and such PCT application entered into the U.S., Europe, Japan and certain other countries in 2015.

According to IMS Health Incorporated, the market size for gonadotropin -releasing hormone agonist products in China in 2015 was approximately RMB2.79 billion, and grew at a compound annual growth rate of 21.6% from 2013 to 2015. The Company believes that LY01005 has a good marketing potential – 1 – and will provide an impetus to the Group ’s development in the oncology therapeutic area. In addition toChina and the U.S., the Company is also targeting to obtain clinical trial approval for this potential new drug in Europe and Japan.

Apart from LY01005, the Company is currently developing several new pharmaceutical products both in China and the U.S., including Risperidone Extended Release Microspheres for Injection (LY03004 ), which had been confirmed by the FDA for New Drug Application for submission in the U.S. without additional clinical trials, Rotigotine Extended Release Microspheres for Injection (LY03003 ), which had completed phase I trials in the U.S. and Ansofaxine Hydrochloride Extended Release Tablets (LY03005 ) which had also completed phase I trials in the U.S.

CRT and Alta Innovations join forces to commercialise world-leading research

On August 9, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the commercial arm of Cancer Research UK – the University of Birmingham and its commercial arm, Alta Innovations (Alta), reported an agreement to work together to develop and commercialise the university’s cancer research (Press release, Cancer Research Technology, SEP 9, 2016, View Source [SID1234523183]).

The two-year agreement draws on the strengths of each organisation to accelerate commercialisation of the University’s world-leading research in cancer into diagnostics, treatments and technologies that could one day benefit patients.

Alta will use its expertise in working closely with world-leading scientists at the University to identify the most promising cancer research opportunities and CRT will use its expertise in commercialising cancer research and its vast network across the pharmaceutical and biotechnology industry to identify and translate promising research at the university.

CRT will work together with Alta and the University of Birmingham’s academics to identify promising cancer opportunities, including the significant clinical expertise available and the university’s leading research in areas such as immunology and genomics.

Financial benefits that come from the work will be shared between CRT and the University of Birmingham. All financial returns for CRT are invested into Cancer Research UK’s life-saving research and all returns to the University are for the benefit of the educational charity.

Professor David Adams, head of the college of medical and dental sciences at the University of Birmingham, said: "Bringing Alta and CRT together in this way means we are giving our world-class cancer researchers access to a team of people with the right skills to give their ideas the fastest route to having an impact on patients’ lives."

Dr James Wilkie, CEO of Alta Innovations, said: "This agreement is built on a long standing working relationship. Our job is to ensure that the world-leading cancer research done here gets translated into better patient outcomes as fast as possible.

"Combining the skills that Alta and CRT have built up over many years will allow our researchers to accelerate the development of their world-leading ideas and patients will benefit from these being brought to market more quickly."

Dr Phil L’Huillier, CRT’s director of business management, said: "We’ve already seen some great successes from our work with Alta Innovations, such as the formation of Revitope Oncology in 2014, an exciting new immunotherapy company. So we’re delighted to be working with the University of Birmingham and Alta Innovations to help develop and commercialise pioneering research that could lead to new treatments to patients faster.

"Developing relationships of this kind draws on the strengths and expertise of both organisations. We hope to develop more relationships like this with other top UK universities in the future to accelerate research and bring new hope to patients."

Actinium Pharmaceuticals Granted SME Status by the European Medicines Agency; Reiterates Focus on EU Market

On August 9, 2016 Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or the "Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, reported that the Company has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA) (Press release, Actinium Pharmaceuticals, AUG 9, 2016, View Source [SID:1234514454]).

Dr. Roland Turck, Advisor to the Board of Directors of Actinium Pharmaceuticals said, "SME status is an integral step in the Company’s approach to the EU market and will serve the company well going forward. Based on our initial assessment of the EU market we believe there is a compelling commercial opportunity for Iomab-B and I look forward to continuing to work with Actinium in the pursuit of Orphan designation in the EU as well as progressing Actinium’s exciting radioimmunotherapy candidates."

SME status was established by the EMA to promote innovation and development of new medicines. Companies granted SME status receive administrative and regulatory support including scientific advice, scientific services, pre-authorization inspection and post-authorization procedures. In addition, financial support is provided with fee reductions up to 100% in certain instances. Based on Actinium’s SME status the Company expects to receive fee reductions up to 90%.

"We are excited and grateful to have been granted this important SME status by the EMA," said Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals. "The assistance and financial support we will receive as a result of this status will be beneficial as we drive towards bringing our Iomab-B and Actimab-A drug candidates to patients located in the EU."

About Iomab-B

Iomab-B is a radioimmunotherapy consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by the Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues. Iomab-B is being studied in the pivotal Phase 3 SIERRA trial and is designed to be used, upon approval, in preparing relapsed or refractory AML patients over the age of 55 patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant.

Cellectar Biosciences Announces $2 Million NCI SBIR Contract for a Phase 2 Clinical Study

On August 3, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) ("the company"), an oncology-focused biotechnology company, reported that it has received the second phase of a National Cancer Institute ("NCI") Fast-Track Small Business Innovation Research ("SBIR") contract award in the amount of $2 million to support funding of a Phase 2 clinical study of the company’s lead product candidate, CLR 131, for the potential treatment of hematologic malignancies, including multiple myeloma (Filing, 8-K, Cellectar Biosciences, AUG 9, 2016, View Source [SID:1234514436]).

"The NCI SBIR contract is important to Cellectar in a variety of ways, ranging from the opportunity to receive non-dilutive funding that will significantly support a Phase 2 clinical study of our lead product candidate, CLR 131, to further advance our understanding of the potential clinical utility of CLR 131 in additional hematologic malignancies with high unmet medical needs, as well as providing further validation of the benefits of our Phospholipid Drug Conjugate (PDC) development program, " said Jim Caruso, president and CEO of Cellectar Biosciences. "Previous studies have demonstrated that hematologic malignancies are highly sensitive to radiotherapeutics. We anticipate observing the unique clinical benefits iodine–131, a cytotoxic radioisotope, may provide in combination with our cancer-selective delivery vehicle. We are also extremely pleased to be continuing our collaboration with the NCI’s SBIR program, which plays a vital role in the development of novel therapeutics."

The first phase of the NCI SBIR contract was focused on the pre-clinical development of CLR 125. However, following a comprehensive data review and product development and commercialization analysis, the company determined that the superior strategic approach would be to redeploy the contract to CLR 131, its lead product candidate. Following a review of all the data, both the NCI and the company determined that the second phase of the contract would be optimized through a multi-center, open label, study of CLR 131 in patients with hematologic malignancies.

Celsion Corporation and Zhejiang Hisun Pharmaceutical Company Sign Technology Transfer, Manufacturing and Commercial Supply Agreement for the Development of its GEN-1 Immuno-Oncology Therapy

On August 9, 2016 Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, reported that it has signed a long-term Technology Transfer, Manufacturing and Commercial Supply Agreement (the "Agreement") with Zhejiang Hisun Pharmaceutical Co. Ltd. (SSE Code:600267), a leading pharmaceutical company in China, to pursue an expanded partnership for the technology transfer relating to the clinical and commercial manufacture and supply of GEN-1, Celsion’s proprietary gene mediated, IL-12 immunotherapy, for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect (Press release, Celsion, AUG 9, 2016, View Source [SID:1234514409]). GEN-1 is currently being evaluated by Celsion in first line ovarian cancer patients.

The Agreement will help to support supply for both ongoing and planned clinical studies in the United States, and for potential future studies of GEN-1 in China. Hisun is one of the largest manufacturers of oncology agents globally, including ThermoDox, Celsion’s heated activated liposomal dosage form of doxorubicin, and is also a leading manufacturer for multinational pharmaceutical companies.

"Hisun has already proven itself to be an exceptional partner through our existing ThermoDox collaboration, and has been the source of high quality, cost-effective manufacturing. We are delighted to have the opportunity to expand our relationship, and to further harness their state-of-the-art manufacturing expertise and facilities through this newly established GEN-1 Agreement," said Michael H. Tardugno, Celsion’s Chairman, President and Chief Executive Officer. "Our partnership with Hisun serves multiple strategic purposes towards successful GEN-1 approval and eventual product launch both in China and internationally. Hisun’s expertise may provide an advantage when seeking China Food and Drug Administration (CFDA) approval, as well as securing a long-term supply for one of the largest markets for ThermoDox in the world."

Key provisions of the partnership are as follows:

The Agreement has targeted unit costs for clinical supplies of GEN-1 that are substantially competitive with the Company’s current suppliers;
Once approved, the cost structure for GEN-1 will support rapid market adoption and significant gross margins across global markets;
Celsion will provide Hisun a percentage certain of China’s commercial unit demand, and separately of global commercial unit demand, subject to regulatory approval;
Hisun and Celsion will commence technology transfer activities relating to the manufacture of GEN-1, including all studies required by CFDA for site approval; and
Hisun will collaborate with Celsion around the regulatory approval activities for GEN-1 with the CFDA. A local China partner affords Celsion access to accelerated CFDA review and potential regulatory exclusivity for the approved indication.
Mr. Hua Bai, CEO and Chairman of Hisun, stated "It is a pleasure to continue our relationship with Celsion, and we are delighted to be their partner of choice as they continue forward with the development of GEN-1, which may hold the potential to address a significant public health issue not only in China, but globally. We look forward to formalizing this long-term commercial supply agreement, and to continuing our transition from a traditional generics business to a branded global oncology franchise. With the wide prevalence of cancers in China, Hisun is well-positioned to aid in Celsion’s global effort to develop this important immuno-oncology therapeutic for this vast territory."

In June 2012, Celsion and Hisun signed a long-term commercial supply agreement for the production of ThermoDox, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin. Hisun is one the largest manufacturers of chemotherapy agents globally, including doxorubicin. In July 2013, the ThermoDox collaboration was expanded to focus on next generation liposomal formulation development with the goal of creating safer, more efficacious versions of marketed cancer chemotherapeutics. During 2015, Hisun successfully completed the manufacture of three registration batches for ThermoDox and has obtained regulatory approvals to supply ThermoDox to participating clinical trial sites in all of the countries of Southeast Asia, Europe and North America, as well as to the European Union countries allowing for early access to ThermoDox. The future manufacturing of clinical and commercial supplies by Hisun will result in a cost structure allowing Celsion to profitably access all global markets, including third world countries, and help accelerate the Company’s product development program in China for ThermoDox in primary liver cancer and other indications.

About GEN-1 Immunotherapy

GEN-1 is a development stage immunotherapeutic. It is currently being evaluated as a first line treatment in combination with chemotherapy in a Phase I study of newly diagnosed ovarian cancer patients. GEN-1 is designed using the TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results in previous trials of GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer and in combination with PEGylated doxorubicin in patients with platinum resistant ovarian cancer. The application of GEN-1 in ovarian cancer provides for a unique approach using immunotherapy for this indication.