Innoviva (INVA) and GlaxoSmithKline plc (GSK) announced positive results from the pivotal Phase 3 FULFIL study of the Closed Triple combination of fluticasone furoate, umeclidinium, and vilanterol) for patients with chronic obstructive pulmonary disease (COPD).
The advancement in the treatment of COPD is obvious as the data demonstratedsuperiority for the Closed Triple combination as compared to the currently marketedSymbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients.
Adding the actions of three molecules with different mechanisms of action to be delivered only once a day through single delivery dry powder inhaler Ellipta® positions the new product as unique approach to COPD treatment.
Important to note that Theravance Biopharma (TBPH) has an economic interest in future payments of the new treatment, as per Inoviva and GSK agreement. When approved, Theravance Biopharma will be entitled to 85% of the royalties paid by GSK on worldwide net sales. Those royalties are upward-tiering from 6.5% to 10%.
GSK is responsible for all development costs related to the Closed Triple with no costs being borne by Theravance Biopharma.
For additional top-line FULFIL study results, most common adverse events and other details, read the press release or click here HERE
Or copy and paste: http://investor.theravance.com/releasedetail.cfm?ReleaseID=976432
In addition to the FULFIL study, a second Phase 3 trial, the IMPACT study, is evaluating the safety and efficacy of the combination compared to existing COPD therapies. Results of the IMPACT study are expected in 2017.
Superiority over the existing bestselling COPD inhalers and the uniqueness of the combination, in addition to being used once a day only make great news for Innoviva Theravance Biopharma, which will receive 85 % of the royalty.
Theravance biopharma does not have economic interests in the already approved inhalers for asthma and COPD. All the royalties on these drugs and others belong to Innoviva
In this news, we see an immune-oncology company, Argos Therapeutics (ARGS) an immuno-oncology firm focused on the development and commercialization of truly individualized immunotherapies for cancer based on the Arcelis® technology platform. This firm announced that it is partnering with Adaptive Biotechnologies Corporation to study precise response patterns to Argos’ investigational immunotherapies.
Adaptive will use its patented immune profiling immunoSEQ® Assay to enable a more in-depth characterization of the immune response induced by AGS-003, which is Argos’s lead product candidate being studied for metastatic renal cell carcinoma, non-small cell lung cancer, and bladder cancer.
Argos second Arcelis® product candidate, AGS-004 aims at treating and possiblyeradicating human immunodeficiency virus (HIV) in patients with HIV-infection or AIDS. Using Adaptive immune profiling technology expects to enable Argos to further characterize with greater precision the transfer of specific genetic signatures from each patient’s HIV, through AGS-004, to a specific immune response against each patient’s unique virus population.
Dr. Charles Nicolette, Argos’s chief scientific officer said, “Adaptive is our preferred partner because of their established expertise in offering high-throughput immune receptor repertoire characterization and advanced bioinformatics that are ideally suited to analyze precision of target-specific immune activation enabled by Arcelis administration with higher resolution.”
“Argos is on the cutting edge of precision immunotherapy with their advanced Phase 3 immuno-oncology agent, and platform extension into individualized HIV treatment,” said Chad Robins, Adaptive’s president, chief executive officer and co-founder. “As the leader in immunosequencing, Adaptive’s technology is well-suited to uncover the dynamics of the adaptive immune system response to Argos’ therapies.”
Adaptive Biotechnologies is a pioneer and in combining high-throughput sequencing and expert bioinformatics to profile T-cell and B-cell receptors. Adaptive is bringing the accuracy and sensitivity of its immune-sequencing platform into laboratories around the world to drive ground-breaking research in cancer and other immune-mediated diseases. Adaptive also translates immune-sequencing discoveries into clinical diagnostics and therapeutic development to improve patient care.
The immunoSEQ® Platform
Adaptive’s immunoSEQ Platform helps researchers make discoveries in oncology, autoimmune disorders, infectious diseases and basic immunology. The Assays can identify millions of T- and B-cell receptors from a single sample in exquisite detail. ImmunoSEQ Assays provide quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assays are for research use only.
For more information please visit adaptivebiotech.com.
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individual immunotherapies for the treatment of cancer using itsArcelis® technology platform. Argos’ most advanced product candidate, AGS-003, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of HIV, which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients.
Argos’ Arcelis® Technology Platform
Arcelis® is a precision immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies.
The Arcelis® process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection.
Prohost has never before brought this firm to its readers’ attention. Now that its lead immunotherapy products for cancer and AIDS have reached a critical advanced phases of trial we open our subscribers eye on this firm so they can follow up on its activities and consider it for investments in case it demonstrate further tangible successes. Argos collaboration with Adaptive Biotechnologies Corporation is great news as it points to Argos’ determination to understand the precise response patterns to its investigational immunotherapy products.
We have tendency to add Argos to our immunotherapy firms. It needs us to do a little bit of more homework towards confirming our belief and validating the firm’s technologies.
Read About the First CRISPR engineered immunotherapy product to reach clinical trials for cancer in “Le CompaGnon Part 2″ at www.prohostbiotech.com
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.