Johnson & Johnson loves to make ambitious pronouncements for itself. Its latest was a commitment to submit to the FDA applications for 10 potential blockbusters within five years by the end of 2019. It fleshed out where it is on those 2015 plans on an Oct. 18 conference call.
In the longer term, the pharma is also making some overtures in immuno-oncology, an area that hasn’t explicitly been a major part of its strategy. J&J has been investing in “four critical areas including vaccines, T cell checkpoint inhibitors, T cell redirection and myeloid mechanisms of action,” said the company’s global head of pharmaceutical R&D, Dr. William Hait, during the call.
He said the pharma has 15 immuno-oncology assets in development, including eight that are already in the clinic.
“While we did not explicitly address immuno-oncology during our 2015 Pharmaceutical Business Review, we continue to make significant progress in this area,” said Hait. “We currently have 15 immuno-oncology assets in development, including eight that are in the clinic. Recently, we uncovered an important additional mechanism of action of Darzalex to the immune-mediated through the depletion of immunosuppressive myeloid and lymphoid populations including a previously unrecognized supersuppressor CD38 positive T-reg population as well as activation of CD8 and CD4 positive effector T cells. These results provide the impetus for exploring Darzalex in indications beyond key malignancies in solid tumors.”
Darzalex is the first of the 10 new potential blockbuster molecular entities J&J committed to filing; the CD38 monoclonal antibody to treat double refractory multiple myeloma was approved by the FDA last year. Up next is sirukumab to treat rheumatoid arthritis, for which it has already filed, and guselkumab for psoriasis for which it plans to file before year end.
On the immuno-oncology front, J&J partnered earlier this year to take its early stage antigen-presentation treatment into Phase II testing in combination with Opdivo (nivolumab) from Bristol-Myers Squibb.
Last year, Swedish startup Alligator Biosciences also did an immuno-oncology deal with J&J worth up to $700 million in milestones and royalties. It has a CD40-targeting ADC-1013, an antibody designed to spur a T-cell attack on cancer.
J&J also partnered with another startup in that time frame–San Diego,CA-based Poseida Therapeutics–to discover and develop new CARs, T cells and natural killer cells adapted with chimeric antigen receptors and targeted at cancer cells.
Slow growth in hepatitis C and the promise from Pfizer that a biosimilar Remicade is coming to market later this year were both downplayed by J&J. Remicade is by far J&J’s biggest drug with $5.3 billion in sales during the first three quarters of this year.
By Stacy Lawrence
Source: Fierce Biotech
Novartis will acquire Mariana’s lead candidate MC-339, a radioligand therapy (RLT) designed to target small-cell lung cancer. Last year, Mariana had raised $175m in a Series B round from several funds and pharma giant Eli Lilly.
The company’s aspiration to expand the use of its obesity products to cardiovascular indications has been successful. In March, its blockbuster drug Wegovy was approved by the US Food and Drug Administration (FDA) for reducing the risk of cardiovascular diseases in obese or overweight adults.
Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space.
