OxThera AB, a Stockholm-based privately-held biopharmaceutical company with a product in late stage clinical development focusing on Primary hyperoxaluria (PH), announces the randomization of the first patient into its phase III study, EPHEX, with Oxabact.
Study OC5-DB-02 (EPHEX) is a randomized, placebo-controlled, 52-week study with the goal to investigate the efficacy and safety of Oxabact in patients with PH. The purpose of the study is to show that Oxabact can halt or delay the disease progression and preserve kidney function.
“This is an important step for OxThera in developing a promising treatment approach for patients suffering from Primary hyperoxaluria, a devastating disease with high unmet medical need. With Oxabact, we are attempting to reduce the systemic oxalate crystal burden and hope to demonstrate that chronic treatment with Oxabact can preserve kidney function for these patients.” said Matthew Gantz, CEO of OxThera.
Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing tumor-directed immunotherapies, today announced that the company is scheduled to present at the 10th Annual Biotech Showcase conference held 8-10 January, 2018 in San Francisco, US.
Chief Executive Officer Per Norlén will give an update on the company’s clinical stage project ADC-1013, out-licensed to Janssen Biotech Inc., as well as the near-clinical bispecific antibody ATOR-1015 and the preclinical projects ALG.APV-527 and ATOR-1017.
The presentation will take place on 8 January, at 10:30 a.m. PST /8 Jan 7:30 p.m. CET. The audio and slide presentation will be webcasted live and can be accessed via the Alligator web site. To access the presentation, live and replay, please go to https://event.webcasts.com/starthere.jsp?ei=1175723&tp_key=101995f0f8.
Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, announced today that a development milestone payment of USD 6 million has been triggered under the partnership agreement for ADC-1013 (JNJ-64457107) with Janssen Biotech, Inc.
The milestone payment is for the partnership agreement to initiate a clinical combination study of ADC-1013 with one of Janssen’s proprietary PD-1 inhibitors. This is the first out of a number of pre-defined milestones, related to the start of combination or phase II studies as part of the ADC-1013 clinical program, which all together have an aggregated potential value of 35 MUSD.
The licensing agreement with Janssen Biotech Inc. encompasses milestone payments up to a potential total value of USD 695 million. Alligator is also eligible to receive tiered royalties on worldwide net sales upon successful launch and commercialization of ADC-1013.
“We are pleased that our collaboration with Janssen is continuing to progress according to plan”, said Per Norlén, CEO at Alligator Bioscience. “The upcoming combination is a very important step in the continued clinical development. Synergy between ADC-1013 and PD-1 blocking antibodies is supported by pre-clinical data. If this translates to the clinic, it could create new treatment opportunities for many cancer patients”.
Alligator’s partner Janssen Biotech, Inc. is performing a phase I dose-escalation clinical study (ClinicalTrials: NCT02829099) with intravenous administration of JNJ-64457107 (ADC-1013). This study is ongoing with approximately 50 patients recruited to date.
On Thursday November 16th, Orphazyme A/S (Orphazyme) initiated its first trading day on Nasdaq Copenhagen, Denmark. The IPO was several time oversubscribed at an initial price of DKK 80 per share raising 80M€. This gives Orphazyme a market capitalisation of DKK 1,594 million after completion of the Offering (excluding a 15% overallotment option).
Orphazyme is a Danish biotech company with a late stage orphan drug pipeline, developing new treatment options for orphan protein misfolding diseases. The Company was founded in 2009 based on early scientific discovery in heat shock proteins (“HSPs”). Since inception, the Company has translated scientific discovery into a late stage clinical development programme. The Company is headquartered in Copenhagen and currently has 30 employees. The Company focuses on severe and mostly fatal diseases with a high unmet need, and with a particularly strong commitment to neuromuscular diseases and a group of severe genetic diseases called lysosomal storage diseases. The Company plans to pursue development of its lead candidate through to registration in the EU and the United States after which launch and commercialization is expected to be undertaken by the Company. The lead candidate arimoclomol is in development as a potential treatment for four orphan diseases; two neuromuscular diseases, sporadic Inclusion Body Myositis (“sIBM”) and Amyotrophic Lateral Sclerosis (“ALS”), and two lysosomal storage diseases, Niemann Pick type C (“NPC”) and Gaucher disease.
Sunstone Capital acted as co-lead investor of Orphazyme series A financing in February 2011 through an investment from its Sunstone Life Science Fund II, and has participated in all subsequent financing rounds. Since the first investment, Sunstone has been represented on the Board by Sten Verland, senior partner, supporting the company in strategic and operational matters since then. Sten Verland will continue on the Board after the IPO. This transaction represents one of the more significant recent European biotechnology IPOs, and is a validation of Sunstone’s investment strategy as well as yet another example of an increasingly active and competitive European biotech industry.
Sunstone Life Science Fund II portfolio company Orpahzyme, publishes an offering circular and the indicative price range in connection with its intended initial public offering (“IPO” or the “Offering”) and subsequent admission to trading and official listing of its shares on Nasdaq Copenhagen.
For a further description of the Offering, please refer to www.orphazyme.com.