A combination of the Merck & Co immunotherapy Keytruda and a different type of drug (IDO inhibitor) that also helps the immune system fight cancer from Incyte Corp (Epacadostat) led to a high rate of durable responses in a small, ongoing study of patients with advanced lung cancer, according to data released on Wednesday.
Epacadostat belongs to a new class of experimental drugs called IDO1 inhibitors which block an enzyme that protects tumors from the immune system. Keytruda is one of five approved drugs known as PD-1 or PD-L1 inhibitors that block a different mechanism tumors use to evade detection.
Merck, Incyte immunotherapy combination effective in lung cancer study
A combination of the Merck & Co immunotherapy Keytruda and a different type of drug that also helps the immune system fight cancer from Incyte Corp led to a high rate of durable responses in a small, ongoing study of patients with advanced lung cance
Oncolytics Biotech was granted FDA Fast Track designation in the process of approval of Reoysin in metastatic breast cancer (mBC).
European Medical Agency (EMA) - Conditional marketing authorisation
The European Medicines Agency (EMA) supports the development of medicines that address unmet medical needs of patients. In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required, based on the scope and criteria defined in legislation and guidelines.
Influenza Vaccination Increases Toxicity in PD-1/PD-L1 Immunotherapy Blockade for Lung Cancer
For some lung cancer patients, seasonal influenza vaccination was associated with increased rates of immunologic toxicity.
Fast track has to be good news. Nice
2022 launch date, lol. 5 more years! I am so glad I never bought this.
On May 8th, Oncolytics Biotech, Inc. (ONCYF) announced that the FDA had granted Fast Track status to REOLYSIN for the treatment of metastatic breast cancer. Fast Track is granted when there is promise that a therapy can treat a serious or life-threatening disease and address an unmet medical need. The status is awarded to pharmaceutical products that treat diseases with limited therapeutic options. The designation provides several incentives with regards to approval and interaction with the FDA. Closer collaboration, frequent meetings regarding trial design and rolling review all come together to streamline the approval process. Accelerated approval and priority review are other potential benefits as well, and we anticipate the company will aggressively pursue these options which will have the dual benefit of reducing costs and advancing the launch date of REOLYSIN. We believe that the granting of Fast Track by itself, with closer collaboration with the FDA, will increase the likelihood of approval and provides stronger support for our 2022 launch estimate.
Another CAR-T death --- which further emphasizes the importance of Reolysin's safety
Investors spooked by Kite CAR-T death, but biotech remains confident | FierceBiotech
Kite Pharma was off by 15% in morning trading after it announced the death of a patient in late April of cerebral edema—the very same fatal outcome that beset rival Juno’s Rocket trial, killing five people and its CAR-T program for JCAR015.
Colorectal cancer (CRC) is one of the most common malignancies with high prevalence and low 5-year survival. CRC is a heterogeneous disease with a complex, genetic and biochemical background. It is now generally accepted that a few important intracellular signaling pathways, including Wnt/β-catenin signaling, Ras signaling, and p53 signaling are frequently dysregulated in CRC. Patients with mutant p53 gene are often resistant to current therapies, conferring poor prognosis.
The recent advancements in the treatment of p53 metastatic Breast Cancer patients using the I/O combination of Reolysin + chemotherapy (pacitaxel) resulting in a more than doubling of overall survival (OS) in this patient cohort, merges well with the results that Oncolytics Biotech found in the treatment of colorectal cancer patients (CRC) in a randomized Phase II clinical trial of its lead product, REOLYSIN, in combination with FOLFOX-6 and bevacizumab (Avastin®) in patients with advanced or metastatic colorectal cancer (IND 210).
When the results were examined and stratified by gender the Overall Response Rates demonstrated that hte female patients in the test arm had an objective response rate of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054). A tripling of response rates versus the control group.
The results of the CRC study involving an I/O combination using Reolysin along with the recently announced p53 metastatic breast cancer results using an I/O combination of Reolysin + chemotherapy is beginning to form an understanding of the effectiveness of Reolysin particularly in those patients that are gender stratified(female versus male) and who present with KRAS, BRAF and p53 cancers, for example.
Metastatic Breast Cancer (mBC) Survival - Stage IV cancer - based on 2012 data
Stage IV metastasis ... 5 year Survival Rate % =10% ... 10 year Survival Rate % = 2%
So will the financing be announced today or next week?
Mark and Neal, sitting in a tree..... kissing and throwing dung from a tree, 1st comes Bloom, then comes Fasttrack, then comes asco in the baby carriage. Laughable chimps up in the tree, both of 'e,
Just listened to Matts presentation. ASCO coming up and finally serious straight talk about partnering to further the program in a non dilutive way. Somebody pinch me.
"Lifting the tail" of the overall survival (OS) curve in the treatment of cancer
"Now that immunotherapy looks like the future, how far can it go? As I stood with Allison and Sharma in the MD Anderson parking lot, saying our good-byes, they seemed hopeful. Allison grabbed a piece of paper and sketched a graph. Start with everyone who has cancer, he said. Then, going out to the right, trace the survivors: how many are left after two months, six months, a year. It’s a line that, for most advanced cancers, drops relentlessly to the dust. But immunotherapy is lifting the curve. In melanoma, there are more and more long-term survivors. Allison calls it “raising the tail.”
“Ultimately, the goal is to try to get the survival rate as high as we can in as many different kinds of cancers as we can,” he says.
Just sold all my shares, after I lost half my profits the past two weeks. Hoping it falls some more so I can scoop up some shares again.
So I imagine this can not be good!
As at May 4, 2017 , the Company had an unlimited number of authorized common shares with 121,836,722 common shares issued and outstanding, and 8,032,827 options outstanding (with exercise prices ranging between $0.26 and $6.72 and expiry dates ranging from 2017 to 2027).
Anyone know when the FDA breakthrough designation application was made for REOLYSIN in advanced breast cancer? Could we sell an announcement this month that REOLYSIN on track for approval by FDA by early 2018?
.67... been here since .43... and sold a lot .72...
any truth to the rumor of dilution? if it does happen im getting back in after it tanks