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Athenex Announces Encouraging Results of the First Cohort of Phase I Clinical Trial of Oraxol and CYRAMZA® (Ramucirumab) Combination Treatment in Gastric Cancer

On January 22, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported the completion of the first cohort of patients in its Phase 1b clinical trial of Oraxol (oral paclitaxel) plus CYRAMZA (ramucirumab) in gastric cancer patients that failed previous chemotherapies. Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel P-gp inhibitor) (Press release, Athenex, JAN 22, 2018, View Source;p=RssLanding&cat=news&id=2327621 [SID1234523406]).

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A previously completed Phase II clinical trial of Oraxol in the second-line treatment of gastric cancer patients showed an encouraging overall median survival of 10.7 months. The expected overall survival for advanced gastric cancer patients who have failed previous chemotherapy and do not receive second-line therapy is approximately 4.0 months.

Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company. Athenex is evaluating the effect of Oraxol plus ramucirumab in gastric cancer in collaboration with Lilly.

Of the six patients in the first cohort, the Oraxol and ramucirumab combination treatment was well tolerated. Grade 4 neutropenia occurred in one patient who fully recovered and there were no patient deaths. There was no neuropathy. Two patients had partial responses (tumor shrinkage of 34-42%) and three patients had stable diseases (with tumor shrinkage of 27% in one patient). Only one patient had progressive disease. Although early, these results are regarded as encouraging compared with previous IV paclitaxel and ramucirumab combination therapy Phase III clinical trial results. Athenex is advancing to the second cohort with Oraxol dose escalation.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are heartened to see Oraxol and ramucirumab is well-tolerated with encouraging tumor response in our first cohort of patients with gastric cancer that failed previous chemotherapies in this Phase I clinical trial. We are proceeding to the second cohort of patients with an escalation dose of Oraxol to explore the possibility of even better clinical efficacy with a higher dose."

Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex.

PharmaEssentia Corp., licensed the Taiwan rights to Oraxol from Athenex and is a partner in the development of Oraxol in Taiwan.

Astellas Receives Orphan Designation from the European Commission for Gilteritinib for the Treatment of Acute Myeloid Leukaemia (pdf 377KB)

On January 22, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported that the European Commission (EC) has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia (AML) (Press release, Astellas, JAN 22, 2018, View Source [SID1234523405]). The decision follows a positive recommendation for Orphan Designation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). In Europe, an Orphan Designation is granted to a medicine that may be of significant benefit to patients with a rare condition, affecting no more than five in 10,000 people.1

The announcement follows the recent Orphan Drug Designation in the United States granted by the US Food and Drug Administration (FDA) to gilteritinib on July 13, 2017.2

"Around 13,000 people will be diagnosed with AML in Western Europe and, while AML patients constitute a small proportion of the overall population, they are faced with a life-threatening condition," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "We are grateful to the EMA for acknowledging the unique needs of patients with rare diseases, and for providing a potential path forward for gilteritinib in supporting these patients."

AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age.3 In Western Europe, there are around 13,000 new cases of AML every year.4 In Japan, approximately 4,500 patients are diagnosed with AML each year.5,6 The American Cancer Society estimates that in 2017 approximately 21,000 new patients will be diagnosed with AML in the United States and about 10,000 cases will result in death.7

About Gilteritinib
Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD),8 two common types of FLT3 mutations that are seen in approximately one-third of patients with AML.9 Further, gilteritinib has also demonstrated inhibition of the AXL receptor in AML cell lines.8 Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several Phase 3 trials.10,11 Visit www.clinicaltrials.gov to learn more about ongoing gilteritinib clinical trials.

Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and potentially commercialise gilteritinib. Gilteritinib has been granted

ONC/17/0046/APEL
Date of preparation: January 2018

Orphan Drug designation2 and Fast Track Designation12 by the U.S. FDA, and SAKIGAKE Designation by the Japan Ministry of Health, Labour and Welfare.13

The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated.

Genmab Announces Novartis’ Intention to Transition ArzerraÂ® (ofatumumab) from Commercial Availability to Limited Availability via Compassionate Use Programs for the Treatment of CLL in Non-US Markets

On January 22, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that Novartis (SIX Swiss Exchange: NOVN) intends to transition Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukemia (CLL) indications from commercial availability to limited availability via compassionate use programs in all markets around the world except the United States (Press release, Genmab, JAN 22, 2018, View Source [SID1234523372]). Novartis will work with regulatory authorities to establish compassionate use programs for patients outside the US currently being treated with Arzerra as an ongoing treatment, to ensure continuity of treatment for all patients who benefit from Arzerra. As a consequence, Novartis will pay Genmab a lump sum of USD 50 million as payment for lost potential milestones and royalties. This amount will be included in Genmab’s 2018 guidance which will be issued on February 21, 2018. Royalties will continue to be earned on net sales of Arzerra. Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

"Novartis’ intention to transition Arzerra to compassionate use programs in the non-US markets reflects the fact that many more drugs have become available for CLL over the last five years and that there is a low number of patients using Arzerra outside of the US market. The compassionate use programs will ensure that patients who benefit from Arzerra can remain on treatment. We welcome the continued commercial availability of Arzerra for US patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Patients accessing the compassionate use program will be offered continued treatment with Arzerra for as long as they benefit from it, free of charge.

Novartis intends to start the transition process as soon as a carefully structured plan has been agreed with the various regulatory authorities.

The two Phase III studies of ofatumumab currently ongoing in Relapsing Multiple Sclerosis and the study of Arzerra in indolent non-Hodgkin lymphoma will continue.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate, for use in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL, and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is currently approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy and in combination with fludarabine and cyclophosphamide for adult patients with relapsed CLL. In more than 60 countries worldwide, including the United States and EU member countries, Arzerra is also currently indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Please consult the full European Summary of Product Characteristics and full US Prescribing information, including Boxed Warning, for all the labeled safety information for Arzerra.

Under the collaboration with Novartis, a subcutaneous formulation of ofatumumab is also being investigated in two Phase III clinical studies in relapsing multiple sclerosis.

Novartis has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.

Harbour BioMed Completes Series A+ Round Financing to Accelerate the Development of Clinical Programs and Company Growth

On January 22, 2018 Harbour BioMed reported that it has completed a Series A+ round financing to accelerate its growth, especially the development of multiple clinical programs (Press release, Harbour BioMed, JAN 22, 2018, View Source [SID1234523461]). The A+ round is financed by CDH Investments, a top PE firm in China, with A round investor Advantech Capital participating. Financial details were not disclosed.

"Within the first year of operation, Harbour BioMed has successfully acquired and integrated the antibody platform company Harbour Antibodies BV, and transformed into a biopharmaceutical company with multifaceted core business. We are building a top-notch antibody discovery and technology team specialized in Immuno-Oncology and Immunology, developing a robust internal pipeline targeting global market, in licensing innovative assets to address high unmet needs for the China market, and forging new partnerships based on internal technology platforms. This progress has been highly recognized by investors and the market," said Dr. Jingsong Wang, CEO of Harbour BioMed. "We are very pleased to collaborate with leading investors such as CDH Investments to accelerate the development of our clinical stage biologic assets, and to strengthen our partnering capabilities."

Dr. Wang noted that in September 2017, Harbour BioMed licensed in two innovative clinical stage biologics, and has assembled an experienced clinical development and regulatory science team. In 2018, Harbour BioMed plans to submit at least two IND targeting multiple indications in areas of high unmet medical needs for Chinese patients.

Harbour BioMed was established in 2016 with $50 million A round financing, and acquired Harbour Antibodies BV and its subsidiaries, one of the few companies that owns technologies for generating fully human monoclonal antibodies, of both conventional as well as heavy chain only form. Current investors of Harbour BioMed include Atlas Venture, Advantech Capital, Legend Capital, CDH Investments and founding team. Harbour BioMed is headquartered with R&D Centers in China. It also has a Business Operation and Innovation Center in Boston, and an Antibody Technology Innovation Center located in Rotterdam, The Netherlands.

VistaGen Therapeutics to Provide Update on Phase 2 Study for Major Depressive Disorder and Outline Key 2018 Initiatives at the 14th Annual Noble Capital Markets’ Investor Conference

On January 22, 2018 VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, reported that Shawn Singh, Chief Executive Officer of VistaGen, will provide an update on the Company’s Phase 2 study of AV-101 as an oral new generation adjunctive treatment for Major Depressive Disorder (MDD) and outline key 2018 initiatives at the 14th Annual Noble Capital Markets’ Investor Conference – NobleCon14 – to be held at the W Fort Lauderdale hotel in Fort Lauderdale, FL on Monday, January 29th at 4:30 p.m. ET (Press release, VistaGen Therapeutics, JAN 22, 2018, View Sourcenews/detail/80/vistagen-therapeutics-to-provide-update-on-phase-2-study-for-major-depressive-disorder-and-outline-key-2018-initiatives-at-the-14th-annual-noble-capital-markets-investor-conference" target="_blank" title="View Sourcenews/detail/80/vistagen-therapeutics-to-provide-update-on-phase-2-study-for-major-depressive-disorder-and-outline-key-2018-initiatives-at-the-14th-annual-noble-capital-markets-investor-conference" rel="nofollow">View Source [SID1234523421]).

The event will be available via video webcast on VistaGen’s investor relations website, View Source, the day following the live presentation.

For more information about NobleCon14, or to schedule a one-on-one meeting with VistaGen’s management, please contact your Noble Capital Markets representative directly, or visit the conference website here.