March 11, 2016 (Last Updated: March 16 at 10:20am PT)
By Alex Keown, BioSpace.com Breaking News Staff
CHICAGO – Investors are anticipating pivotal clinical trial data for cancer therapies from Novartis and Aduro Biotech later this year, the Motley Fool reported this morning.
Sometime this summer, Berkeley, Calif.-based Aduro Biotech is expected to release data from its Phase IIb study of CRS-207, a combination treatment for pancreatic cancer. The treatment is a combination of GVAX pancreas and CRS-207, an immunotherapy using and engineered listeria bacteria to target cancerous cells and induce an immune response. The drug has been awarded both orphan drug status as well as breakthrough therapy status from regulatory bodies.
In November, Aduro stock took a hit following the company reported a trial patient taking CRS-207 developed a serious infection related to the medication. The company noted that the combination treatment can cause some adverse side effects, including the development of lymphopenia. Some patients in a Phase IIa clinical trial did come down with the illness, but the company also noted one patient developed a more serious infection. Buried on page 31 of a filing to the U.S. Securities and Exchange Commission is a one-paragraph report of the patient being diagnosed with Listeria monocytogenes. The company said the event was diagnosed by the treating investigator as a case of listeriosis.
It appears that the study treatment instructions were violated when the patient’s central line port was accessed during infusion of CRS-207 being given through a separate line. Several weeks after the CRS-207 infusion, the patient developed symptoms that were suggestive of an infection. The blood culture from the port site was positive for Listeria monocytogenes, and was determined subsequently to be CRS-207 while all other cultures, including from the peripheral vein, were negative. The patient was administered IV antibiotic treatment and all follow-up tests were negative for Listeria. At that point, the patient had been in the study for approximately three years. The patient continues to receive CRS-207 and GVAX at his/her request and that of the investigator, the company said.
Aduro’s CRS-207 does have developmental competition from Advaxis Inc. However, last summer the U.S. Food and Drug Administration placed a hold on experimental cancer treatment axalimogene filolisbac following the death of a patient. Like Aduro’s combination treatment, Advaxis’ therapy uses listeria to help trigger the body’s immune system to fight the cancerous cells. The Advaxis’ trial patient was hospitalized and treated for Listeria monocytogenes two years after taking axalimogene filolisbac as part of an investigator-initiated trial in 2013.
Aduro’s stock is down about 4 percent this morning, trading at $13.77 per share. The stock has been in decline since mid-December, when it was trading at $33.63 per share.
Novartis is anticipating results from its Phase II/III Bimagrumab trial for the treatment of cachexia in cancer patients, cachexia in COPD patients, sarcopenia and muscle atrophy after hip fracture surgery, Motley Fool reported. It is also being studied for its efficacy in sporadic inclusion body myositis, a progressive wasting of the muscles in the legs. If Bimagrumab, an intravenous drug, is approved, it could generate annual sales of $261 million by 2020, with about $60 million coming from sporadic inclusion body myositis patients, the Motley Fool reported. Analysts at Edison Investment Research have given Bimagrumab a 60 percent chance of success, the Motley Fool noted.
There are other treatments for sporadic inclusion body myositis under development by companies like GlaxoSmithKline , but despite being in late stages of development (Phase III for GSK’s Benlysta) there have not been any sales forecasts made, the Fool added.
Bimagrumab was developed by MorphoSys and licensed by Novartis . Novartis’s stock is up this morning, trading at $74.32 per share, although it too has been in decline since December, when it was trading at $88.05 per share.
