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5 CLINICAL NEWS 16 FINANCIAL NEWS Deals, Sales & Marketing, Other Regulatory, Clinical Results, Completed Offerings, Other News Clinical Status Financial News

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5 CLINICAL NEWS 16 FINANCIAL NEWS Deals, Sales & Marketing, Other Regulatory, Clinical Results, Completed Offerings, Other News Clinical Status Financial News WEEK OF SEPTEMBER 25, 2017 1 COMPANY NEWS 5 CLINICAL NEWS 16 FINANCIAL NEWS Deals, Sales & Marketing, Other Regulatory, Clinical Results, Completed Offerings, Other News Clinical Status Financial News COMPANY NEWS line data are expected in mid-2018 from Phase III trials to treat myelodysplastic syndromes (MDS) and beta-thalassemia (see DEALS BioCentury, Aug. 8, 2011). Luspatercept is a modifiedACVR2B fusion protein that inhibits Acceleron Pharma Inc. (NASDAQ:XLRN), Cambridge, Mass. several ligands in the transforming growth factor (TGF) beta (NASDAQ:CELG), Summit, N.J. Celgene Corp. superfamily. Business: Cancer, Hematology, Cardiovascular Acceleron Pharma Inc. (NASDAQ:XLRN) gained worldwide Arcus Biosciences, Hayward, Calif. rights to develop and commercialize sotatercept to treat pulmonary Taiho Pharmaceutical Co. Ltd., Tokyo, Japan hypertension, amending a deal with partner Celgene Corp. Business: Cancer (NASDAQ:CELG). Acceleron expects to begin a Phase II trial of Cancer company Arcus Biosciences (Hayward, Calif.) granted Taiho sotatercept to treat pulmonary arterial hypertension (PAH) in 1H18. Pharmaceutical Co. Ltd. (Tokyo, Japan) an option to develop and In 2008, Acceleron and Celgene partnered to co-develop and commercialize compounds in Japan and other Asian territories commercialize Acceleron's sotatercept for all indications, with an excluding China. Arcus said the deal includes anything listed on its initial focus on cancer, including breast and ovarian cancers, and pipeline chart. cancer-related bone loss. At the time, Acceleron received $50 million Arcus will receive $35 million over the first three years of the five- up front, including a $5 million equity investment by Celgene, and year agreement and is eligible to receive up to $275 million in was eligible for up to $510 million in milestones, plus tiered royalties milestones for each molecule, plus high-single to mid-double-digit (see BioCentury, Feb. 25, 2008). royalties. Arcus declined to disclose additional financial terms. Under the amended deal, Celgene is now eligible for low-twenty According to its website, Arcus expects to begin Phase I trials of percent royalties for pulmonary hypertension indications. Acceleron AB928 next quarter and AB154 in 2Q18. AB928 is a dual adenosine spokesperson Brad Miles told BioCentury that Celgene and other A2A receptor (ADORA2A) and ADORA2B antagonist, and AB154 investigators are evaluating sotatercept in multiple myeloma (MM) is a mAb that inhibits T cell immunoreceptor with Ig and ITIM and Diamond-Blackfan syndrome. According to ClinicalTrials.gov, domains (TIGIT). sotatercept completed a Phase II trial in MM and is in Phase I/II testing for Diamond-Blackfan syndrome. CritiTech Inc., Lawrence, Kan. Sotatercept is a soluble fusion protein consisting of the extracellular DFB Pharmaceuticals LLC, Fort Worth, Texas domain of activin receptor type 2A (ACVR2A) linked to the Fc NanOlogy LLC, Fort Worth, Texas protein of human IgGI. U.S. Biotest Inc., San Luis Obispo, Calif. Acceleron and Celgene are also partnered under a 2011 deal to Business: Cancer, Drug delivery co-develop and commercialize luspatercept (ACE-536). Top- COMPANY CLINICAL FINANCIAL NEWS NEWS NEWS WEEK IN REVIEW POWERED BY BCIQ DFB Pharmaceuticals LLC (Fort Worth, Texas), CritiTech Inc. Dimension's most advanced gene therapy product, DTX301, is (Lawrence, Kan.) and U.S. Biotest Inc. (San Luis Obispo, Calif.) in Phase I/II testing to treat ornithine transcarbamylase (OTC; formed NanOlogy LLC (Fort Worth, Texas) to develop nanoparticle OTCD) deficiency. DTX301 is an adeno-associated virus 8 (AAV8) drug-delivery technology to treat cancer. vector that delivers the OTC gene to liver cells. Dimension plans to The newco's pipeline includes NanoPac, a nanoparticle form of submit an IND early next year for its next lead candidate DTX401, paclitaxel, in Phase II testing to treat ovarian, prostate and pancreatic an AAV vector that delivers glucose-6-phosphatase catalytic subunit- cancer as well as mucinous cystic pancreatic neoplasms. Data from related protein (G6PC; G6Pase), to treat glycogen storage disease the prostate and two pancreatic trials are expected next year. Data type Ia (GSDIa). Both products have Orphan Drug designation in are also expected early next year from a Phase II trial of SOR007, a the U.S. and EU. topical ointment of uncoated nanoparticle paclitaxel, to treat actinic Dimension developed all of its candidates using RegenxBio's NAV keratosis lesions. A Phase II study of SOR007 to treat cutaneous technology, to which Dimension has a license. metastases from non-melanoma cancer is expected to begin next Ultragenyx's recombinant human glucuronidase beta (rhGUS) is quarter. DFB's affiliate DFB Soria LLC granted NanOlogy rights to under FDA and EMA review to treat mucopolysaccharidosis VII SOR007 for cancer indications. (MPS VII; Sly syndrome). The BLA's PDUFA date is Nov. 16. In NanOlogy's pipeline is being developed under section 505(b)(2) August, the company submitted a BLA to FDA for burosumab of the Food, Drug and Cosmetic Act, which allows sponsors to (KRN23, UX023) to treat X-linked hypophosphatemia (XLH). reference data on safety and efficacy from the scientific literature or An MAA for burosumab to treat XLH is under EMA review from previously approved products. with a CHMP opinion expected around year end Burosumab is a recombinant human IgG1 mAb against fibroblast growth factor 23 Dimension Therapeutics Inc. (NASDAQ:DMTX), Cambridge, Mass. (FGF23). Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), Novato, Calif. RegenxBio Inc. (NASDAQ:RGNX), Rockville, Md. Fred Hutchinson Cancer Research Center, Seattle, Wash. Business: Gene/cell therapy, Endocrine/Metabolic Fortress Biotech Inc. (NASDAQ:FBIO), New York, N.Y. On Sept. 18, Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) Business: Gene/Cell therapy, Cancer, Hematology offered to acquire gene therapy play Dimension Therapeutics Inc. Fred Hutchinson Cancer Research Center (Seattle, Wash.) granted (NASDAQ:DMTX) for $5.50 per share in cash, or about $138 the Mustang Bio Inc. (NASDAQ:MBIO) subsidiary of Fortress million. In August, RegenxBio Inc. (NASDAQ:RGNX) agreed to Biotech Inc. (NASDAQ:FBIO) exclusive, worldwide rights to a acquire Dimension in a stock deal with an implied value of $3.41 per third-generation CD20-specific chimeric antigen receptor (CAR) Dimension share. T therapy that incorporates tumor necrosis factor (TNF) receptor Dimension said its board will review and consider Ultragenyx's superfamily member 9 (4-1BB; TNFRSF9; CD137) and CD28 co- unsolicited offer, which is a 358% premium to Dimension's close of stimulatory domains. Mustang will partially fund a Phase I/II trial to $1.20 on Aug. 24, the day before it announced the RegenxBio deal. evaluate the candidate in patients with relapsed or refractory B cell On Sept. 19, Dimension said Ultragenyx's offer could reasonably be non-Hodgkin’s lymphoma (NHL). The trial is expected to begin at expected to lead to a "Superior Proposal" as defined in Dimension’s the center next quarter. merger agreement with RegenxBio, which would legally allow The center and Mustang declined to provide further details. Dimension to sit down at the table with Ultragenyx. Immunocore Ltd., Abingdon, U.K. Ultragenyx is developing biologics and small molecules to treat Bill & Melinda Gates Foundation, Seattle, Wash. rare genetic diseases. The company believes it can offer its "clinical and regulatory expertise" and "growing rare metabolic disease Business: Infectious commercial infrastructure to advance Dimension’s rare disease T cell receptor (TCR) company Immunocore Ltd. (Abingdon, U.K.) focused gene therapies through the clinic and to maximize their received a $40 million equity investment from the Bill & Melinda reach with patients." Ultragenyx said it would maintain a gene Gates Foundation (Seattle, Wash.) as part of a collaboration to therapy development unit at Dimension's Massachusetts facilities. develop new therapies to treat infectious diseases. Under the terms of RegenxBio's deal, Dimension would become Immunocore said the new capital will be used to accelerate the a RegenxBio subsidiary and Dimension shareholders would own development of the biotech's two infectious disease platforms: about 10.9% of the combined company. In August, the companies immune mobilizing monoclonal TCRs against virus (ImmTAV) and said they expect the deal to close by year end. Dimension would have immune mobilizing monoclonal TCRs against bacteria (ImmTAB). to pay RegenxBio a $2.9 million fee to terminate the deal, according The ImmTAV and ImmTAB technologies are similar in design and to an SEC filing. RegenxBio declined to comment. function to Immunocore's ImmTAC platform for cancer. Each is a bispecific biologic that combines an affinity-enhanced T cell 2 WEEK OF SEPTEMBER 25, 2017 COMPANY CLINICAL FINANCIAL NEWS NEWS NEWS WEEK IN REVIEW POWERED BY BCIQ receptor with an anti-CD3 single chain variable fragment (scFv) In 1H18, Provention plans to begin a Phase IIa proof-of-concept effector function to activate a T cell response against the target cell. study of PRV-6527 to treat Crohn's disease and a Phase I/II study of Under the collaboration, Immunocore's first infectious disease PRV-300 to treat ulcerative colitis. programs will target tuberculosis and HIV. J&J spokesperson Brian Kenney said Janssen out-licensed PRV- Most of Immunocore's pipeline is focused on cancer, with the lead 6527 and PRV-300 to Provention after "considering the depth of program, IMCgp100, in a pivotal Phase II trial to treat advanced our portfolio" and said Provention has the "translational and clinical uveal melanoma. expertise" needed to progress the assets. In 2015, Immunocore raised $320 million in a series A round, which Provention also has exclusive, worldwide rights to a preclinical at the time was the largest ever venture round for a European biotech enterovirus vaccine against coxsackievirus B (CVB) infection from (see BioCentury, July 20, 2015). Vactech Oy (Tampere, Finland), which it is developing to prevent or delay the onset of Type I diabetes. Inovalon Holdings Inc. (NASDAQ:INOV), Bowie, Md. The terms of the deals with Janssen and Vactech are undisclosed. Daiichi Sankyo Co.
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