Versartis Announces Removal of FDA Partial Clinical Hold and Continuation of VRS-317 Phase 3 Clinical Trial

MENLO PARK, Calif., July 6, 2015 -- Versartis, Inc. (VSAR), an endocrine-focused biopharmaceutical company that is developing VRS-317, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the US Food and Drug Administration (FDA) has removed the partial clinical hold on the Company's Investigational New Drug Application for VRS-317. With this action, the Company will proceed with the Phase 3 registration trial, VELOCITY, of VRS-317 in children with GHD.

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Immunovaccine Publishes Clinical Results With DPX-Survivac in Combination With an Immune-Modulating Compound

Safety and immunogenicity data from Phase 1 trial with company's lead cancer immunotherapy candidate published in Oncoimmunology

HALIFAX, NOVA SCOTIA--(Jul 2, 2015) - Immunovaccine Inc. ("Immunovaccine" or the "Company") (IMV.TO)(IMMVF), a clinical stage vaccine and immunotherapy company, today announced that data from its completed Phase 1 clinical trial with lead cancer immunotherapy candidate, DPX-Survivac, was published in the peer reviewed journal Oncoimmunology. The manuscript "Survivin targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients," which was published in the Friday June 26, 2015 edition of the journal, outlines the safety and immunogenicity of DPX-Survivac when combined with a low dose of cyclophosphamide taken orally by patients.

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Biogen and AGTC Enter Collaboration to Develop Gene Therapies in Ophthalmology

Companies to advance a potentially transformative treatment approach for genetic diseases of the eye
AGTC to receive $124M upfront, with potential future milestone payments and royalties
AGTC to host conference call today at 8 a.m. EDT

CAMBRIDGE, Mass. & GAINESVILLE, Fla.-- Biogen (BIIB) and AGTC (AGTC) today announced a broad collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases. The collaboration will focus on the development of a portfolio of AGTC’s therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults. The agreement also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic condition, as well as an equity investment in AGTC by Biogen and a license agreement for manufacturing rights.

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Celgene and Juno Announce Ten-Year Collaboration to Advance Potentially Groundbreaking Immunotherapies for Patients with Cancer and Autoimmune Diseases

  • Broad strategic collaboration leveraging combined immunology expertise and assets to develop and commercialize novel immunotherapies for the treatment of cancer and autoimmune diseases
  • Celgene gains option to commercialize Juno programs outside North America and co-promote certain programs globally
  • Juno gains option to co-develop and co-promote select Celgene programs
  • Celgene to make initial payment of approximately $1 billion which includes the purchase of ~9.1 million shares of Juno stock at $93.00 per share, with potential to increase its stake over time
  • Joint conference call scheduled today at 5:00 p.m. ET, 2:00 p.m. PT
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Juno Announces FDA Acceptance of Investigational New Drug Application for JCAR017 in Relapsed/Refractory B Cell Non-Hodgkin Lymphoma

SEATTLE, June 29, 2015  -- Juno Therapeutics, Inc. (JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) accepted the Company's investigational new drug (IND) application for JCAR017 for patients with relapsed/refractory (r/r) B cell non-Hodgkin lymphoma, or NHL. JCAR017 is a chimeric antigen receptor (CAR) T cell product candidate targeting CD19, a protein expressed on the surface of most B cell leukemias and lymphomas.

The IND enables Juno to initiate a multi-center Phase I trial exploring JCAR017 for r/r NHL, scheduled to begin in 2015, with the potential to advance to a registration trial in 2016.

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