On July 5, 2017 Oxis International, Inc. (OTCQB: OXIS and Euronext Paris OXI.PA), parent of Oxis Biotech, reported that the U.S. Patent and Trademark Office has approved and issued Patent No. 9,580,382 for its drug candidate OXIS-4235 for the treatment of myeloma (Press release, OXIS International, JUL 5, 2017, View Source [SID1234539562]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The USPTO also requires that products made or sold under the patent be marked with the statement "Patent No. 9,580,382."

The patent clears the way for Oxis Biotech to begin the process of pursuing clinical trials for OXIS-4235. The drug is a P62-ZZ chemical inhibitor intended for use as a treatment for multiple myeloma. According to the American Cancer Society, more than 30,000 people are expected to be diagnosed with the disease this year and more than 12,000 are expected to die from it.

Dr. Sean Xie of Pittsburgh, Pa., developed the drug. The drug is intended to stop the growth of multiple myeloma cells without harming healthy cells. In addition to shrinking the tumors, the dual purpose drug is also intended to increase bone density, a second benefit of the technology.

Oxis Biotech, through its licensing agreement with Dr. Xie, holds the exclusive worldwide rights to commercialize this technology.

CEO, Anthony Cataldo, said, "Patents are one of the major build blocks of market cap appreciation. Oxis continues to show progress with it’s oncology product pipeline. The issuance of patents that support the products in our portfolio, allows us to move these assets into commercially driven clinical trials with the market protections that issued patents provide." With the most recent announcement of the Oxis merger with Georgetown Translational Pharmaceuticals, Inc. (GTP), GTP brings in highly successful Executive Management, CEO, Kathleen Clarence-Smith, MD, Ph.D., and her team, are able to advance Oxis’ patented portfolio in oncology.

On June 20, 2017 Biocad reported that the Central Drugs Standard Control Organization (CDSCO) has recommended Acellbia, the first rituximab biosimilar made in Russia, for approval in India (Press release, Biocad, JUL 4, 2017, View Source [SID1234527808]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In August 2017, BIOCAD will receive permanent market authorization in India, which represents a strategic milestone for BIOCAD’s international expansion.

Today, the Indian market for rituximab exceeds $40 m, with an annual growth of 8%. According to experts, this volume may reach $58 million in the next five years.

Meanwhile, India experiences low rituximab availability. Therefore, the Russian biosimilar marketed here will not only boost competition among the existing players, but will make this product available for larger numbers of patients with certain types of lymphomas and autoimmune disorders.

"We are happy to see Acellbia, our first biosimilar drug product to receive MA in India, but our efforts to register more products there will continue. In the first quarter of 2018 we plan to obtain MA for Herticad, BIOCAD’s trastuzumab biosimilar which is used to treat certain types of breast cancer, and is already supplied to Syria, Sri Lanka and other countries," says Mr. Dmitry Morozov, BIOCAD’s CEO.

The quality of Acellbia manufactured by BIOCAD, including the API, was clearly demonstrated in sizeable international clinical trials, parts of which were conducted in India. The trials were conducted in accordance with the EMA’s guidelines for the non-clinical and clinical development of biosimilar monoclonal antibodies. They demonstrated similar efficacy and safety of Acellbia in a head-to-head comparison with the original drug product by F. Hoffmann-La Roche, Ltd.

BIOCAD’s rituximab has already been authorized in seven countries, including Bolivia and Honduras, with the registration pending in 27 countries.

Since 2014, over twenty-six thousand patients in Russia and other countries were treated with rituximab produced by BIOCAD.

The first shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

On July 3, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer, infectious diseases and autoimmune diseases, reported that GlaxoSmithKline (GSK) has selected a third target as part of their ongoing oncology discovery collaboration for multiple novel targets not addressable with antibody-based technologies. Immunocore will generate a novel ImmTAC molecule against the selected target which is relevant in multiple cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This is the third programme to be initiated as part of the discovery collaboration with GSK, announced in 2013. Immunocore is currently working on two other ImmTAC programmes under the agreement. The lead programme is on track for an Investigational New Drug (IND) this year with potential application in Non-Small Cell Lung Cancer (NSCLC), bladder cancer, synovial sarcoma, melanoma and ovarian cancer.

Dr Bent Jakobsen, Chief Scientific Officer at Immunocore, commented: "The initiation of this new programme adds to a growing body of evidence that our ImmTAC technology has real potential to generate novel, potent drug candidates against disease targets which are difficult to address with other biologic platforms. ImmTAC molecules are relevant across a wide range of cancer types and have the ability to tackle solid ‘cold’, low mutation rate tumours – the majority of tumours which are difficult for other immuno-oncology drugs to address. We look forward to beginning work on this additional programme with GSK in oncology."

Dr Axel Hoos, Senior Vice President Therapeutic Area Head Oncology R&D Head, Immuno-Oncology at GSK, added: "We are pleased with the progress made in our ongoing collaboration with Immunocore and are excited to add a yet another target to the programme. ImmTAC molecules have great potential among the third generation of immuno-oncology agents and we look forward to seeing this promising program progress."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On June 30, 2017 Kyowa Hakko Kirin Co., Ltd. (Headquarters:Tokyo; President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announces that it has initiated a Phase 3 clinical study in Japan of mogamulizumab (code No. : KW-0761)*1 in patients with HTLV-1-associated myelopathy (Press release, Kyowa Hakko Kirin, JUN 30, 2017, View Source [SID1234519735]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HTLV-1-associated myelopathy (HAM) manifests as inflammation in the spinal cord caused by T-lymphocytes infected with human T-cell leukemia virus type 1 (HTLV-1). The disease progresses slowly and is accompanied by symptoms such as walking difficulties, numbness, difficulty passing urine, and constipation. A 2010 epidemiological survey estimated that approximately 3,000 patients in Japan have developed HAM, where it is a designated intractable disease*2. Mogamulizumab is a humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4).

Mogamulizumab utilizes its enhanced ADCC activity to eliminate CCR4-positive T-lymphocytes infected with HTLV-1, and therefore is expected to alleviate symptoms in patients with HAM. Kyowa Hakko Kirin started the Phase 3 study based on the results of the investigatorinitiated clinical trials (Phase 1/2a study (completed) and the long-term study (ongoing)) led by Dr. Yoshihisa Yamano, Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine. The purpose of the Phase 3 study is to evaluate the efficacy and safety of mogamulizumab in patients with HAM.

"HAM is a severe disease which causes long term myelopathic symptoms, such as lower limb paralysis, pain, dysuria, and constipation, and for which there are no currently effective treatments." said Mitsuo Satoh, Ph.D., Head of Research and Development Division of Kyowa Hakko Kirin. "We hope mogamulizumab will be a treatment option for patients with HAM."

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

News Release

Target Disease HTLV-1-associated myelopathy (HAM)
Design Randomized, double-blind, placebo-controlled study with an open label study
Target number of subjects 52
Primary endpoint Improvement in the Osame’s Motor Disability Score (OMDS)
Publicized information ClinicalTrial.gov: NCT03191526 *1

About mogamulizumab (KW-0761)
Mogamulizumab is a humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). CCR4 is frequently expressed in certain hematologic cancer cells, but also expressed in T-lymphocytes infected with HTLV-1. Mogamulizumab is manufactured using Kyowa Hakko Kirin’s POTELLIGENT technology that is related to increased ADCC activity. It was approved for sale for the first time globally in Japan, and since March 2012 has been sold as an approved drug (brand name: POTELIGEO) for relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL). Furthermore, mogamulizumab obtained approval for additional indications in Japan for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014 as well as for chemotherapy-naïve CCR4-positive ATL in December 2014. *2

About designated intractable diseases
Designated intractable diseases are diseases covered by medical subsidies as set forth in Article 5 of the Law for Medical Treatment of Patients with Intractable Diseases enacted in May 2014 in Japan. The designation is made by the Minister of Health, Labor, and Welfare when quality and appropriate medical treatment are judged to be imperative for patients with such a disease based on the opinion of the Health Science Council.