Filing for a phase 2 run-in study in CRC using the I/O drug combination of FOLFOX6 / Avastin / Reolysin / Keytruda (pembrolizumab) in women who have progressed with metastases to the liver. The company's intent to proceed to a registration study on the confirmation of ORR and metastases response rate. The study is uniquely targeting the underserved gender specific (female) population in a large segment of the oncology market.
"Adding a checkpoint blocker, after a single typical dose of radiation (20 Gray) and a vaccine tipped the balance, inhibiting tumour growth and extending survival of tumour-bearing mice.
"These results suggest that radiation stimulated the recruitment of vaccine-primed T cells while anti-PD-L1 therapy protected these T cells from local immune suppression," the authors wrote. "This may be a promising therapy."
"Our results suggest that radiation therapy could synergise with immunotherapy to convert cancers with an unfavourable cold phenotype to a more favorable hot phenotype," said Weichselbaum. "The radiation's effects may include release of cell fragments and other signals that stimulate the immune system, as well as elimination of some of the immunosuppressive factors."
"Our results provide a step-by-step strategy to break the immune barriers that protect aggressive tumours by converting so-called 'cold,' or non-T cell inflamed tumours, to a 'hot,' or T cell-inflamed phenotype," said study author Ralph Weichselbaum, MD, co-director of the University of Chicago Ludwig Center for Metastasis Research and chairman of Radiation and Cellular Oncology at the University. "By promoting T cell infiltration, radiation therapy improved the efficacy of tumour vaccines and checkpoint inhibitors."
May 10, 2016
Other I-O work is focused on exploiting so-called oncolytic viruses, which can be manipulated to preferentially infect and attack certain cancers, and then induce the patient’s immune system to attack the virus. Today, a variety of native and genetically modified viruses are being investigated for commercial development, with some in advanced trials already . In October 2015, FDA approved its first oncolytic virus therapy, Amgen’s Imlygic (talimogene laherparepvec), for the treatment of patients with melanoma lesions in the skin and lymph nodes. It is based on live, genetically modified herpes simplex I virus that is injected into the melanoma lesions.
2016-05-12 04:25 ET - News Release
SYDNEY, AUSTRALIA and SEATTLE, WA -- (Marketwired) -- 05/12/16
Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD)
Sydys Licenses Clinical-Stage Immuno-oncology Assets in 'spin out' transaction
Potential for over A$400M in milestones and royalties
Prima to receive 9.9% equity in Sydys
Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) ("Prima") and U.S.-based Sydys Corporation, Inc. (OTC: SYYC) ("Sydys"), today announced an agreement through which Sydys will license Prima's CVac immuno-oncology program and oversee its future development.
CVac therapy is a personalized immunocellular therapeutic that has been investigated for the treatment of epithelial cancers.
Greg Michael Delgoffe, PhD, University of Pittsburgh: Metabolic reprogramming using oncolytic viruses to improve immunotherapy;
"This week, Martin-Green -- who plays the character of Sasha Williams on "The Walking Dead" but who is a cancer advocate in real life -- attended the 2016 annual meeting of the American Association for Cancer Research at the Ernest N. Morial Convention Center in New Orleans. As the member of a family repeatedly afflicted by cancer, Martin-Green was the celebrity ambassador of the group Stand Up To Cancer -- or SU2C -- which announced $7.5 million in research grants to 10 up-and-coming scientists at the meeting."
"The grant announcement, made Monday (April 18), marks the third time SU2C has selected a class of Innovative Research Grant recipients, following previous awards in 2009 and 2011. With the new class of grants, the total number of recipients now stands at 36."
And Stemcentrx's only clinical trial experience in 5 clinical Phase 1 studies - which are still to be completed.
"Oncolytic Reovirus in Combination with Paclitaxel/Carboplatin in NSCLC Patients with Ras Activated Malignancies, Long Term Results," covers updated results, including longer-term survival data, from the Company's REO 016 Phase 2 study in Non-Small Cell Lung Cancer (NSCLC).
n comparison - Reolysin produced longer term survival data (2 Year) of 31% ORR by RECIST and 43% ORR by PET analysis.
"Our research collaborators are noting the two-year survival data from this study, which is high for later-stage patients with recurrent or metastatic disease," said Dr. Matt Coffey, COO of Oncolytics. "As with our REO 017 clinical study that treated pancreatic cancer patients with gemcitabine and REOLYSIN®, there was a clear overall survival benefit with apparent limited impact on progression free survival, which is generally characteristic of immune involvement in outcomes."
Of the 35 patients evaluable for clinical response in the REO 016 study, 11 patients (5 Kras mutant) had a partial response (PR), 20 had stable disease (SD) and four had progressive disease by RECIST for an objective response rate (ORR) of 31%. Four patients with SD had a 40% PET standardized update value reduction after two cycles, yielding an ORR considering PET of 43%.
Stemcentrx - a phase 1/2.cancer development company with a targeted PLATFORM technology that reported a 44% overall response rate (ORR) in a Phase 1/2 study of relapsed SCLC.
As FierceBiotech reported today... "Now it’s not at all uncommon to see companies jump from Phase I with early evidence of success straight into a registration study looking for a fast approval followed by a larger, confirmatory study."
Viruses. 2016 Jan; 8(1): 4.
Published online 2015 Dec 24.
Exploring Reovirus Plasticity for Improving Its Use as Oncolytic Virus
Vera Kemp, Rob C. Hoeben, and Diana J. M. van den Wollenberg*
E. Antonio Chiocca, Academic Editor and Martine L.M. Lamfers, Academic Editor
"Reoviruses have the advantage of not being connected to serious human disease and the number of clinical trials that involve the use of reovirotherapy for cancer is still growing. To date, the focus is shifting towards combination strategies,..... "
" .... a mutant was obtained that readily induces cell death in the infected cells ). Currently, the mutants are being characterized and evaluated. These mutants may be useful for obtaining more insight into the cell death pathways that are still functional in therapy-resistant cell lines. In this manner the reovirus demonstrates its plasticity and may have a dual use. On the one hand, reoviruses can be used as a potent anti-cancer agent, while, on the other hand, they may help us as probes to study cellular processes."
Now if only someone would step up and just buy us out. $2.50 maybe $3 ?
--Analysis Shows Statistically Significant Increase in 2-Year Survival--
CALGARY, April 14, 2016 /PRNewswire/ - Oncolytics Biotech® Inc. (ONC.TO) (ONCYF) (ONY.F) ("Oncolytics" or the "Company") today announced updated results for a randomized Phase 2 clinical trial of its lead product, REOLYSIN®, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601). The study is being sponsored by the U.S. National Cancer Institute ("NCI"). The update is based on data collected up to January 19, 2016 from the NCI and updates information from previous disclosures by the principal investigator.
Oncolytic virus such as Reolysin (reovirus) is important as its therapeutic efficacy can also produce a reduction in levels of liver enzymes to a normal levels from toxically high pre-treatment levels.
Ingelheim, Germany and Geneva, Switzerland March 30, 2016 – Amal Therapeutics (Amal) completes CHF 3 million (EUR 2.75 million) Series A financing round with Boehringer Ingelheim Venture Fund (BIVF) as cornerstone investors. VI Partners and High-Tech Gründerfonds also participated in the round which will help progress Amal’s cancer vaccines.
Amal Therapeutics is a Swiss biotech company developing and progressing therapeutic cancer vaccines. The company will use the funds to progress the preclinical development of its lead vaccine (ATP124) for colorectal cancer
Dr. Braguglia, VI Partners: “We believe that the KISIMA technology is superior to many other tumor vaccine technologies, both as a stand-alone treatment and in combination with other vaccines or immuno-oncology treatment modalities....."
Amal’s vaccines combine a Cell Penetrating Peptide (CPP) with a multi-antigenic chimeric cargo with various CD8+ and CD4+ epitopes and a constitutive activator of dendritic cells, enabling them to simultaneously stimulate multi-epitopic cytotoxic T cell-mediated immunity, induce helper T (Th) cells and promote immunological memory.
Mar 29, 2016
Johns Hopkins Launches $125M Immunotherapy Institute
Johns Hopkins Medicine said today it will use a $125 million gift from Michael R. Bloomberg, Jones Apparel Group founder Sidney Kimmel, and others to establish a new institute studying immunology.
The new Bloomberg–Kimmel Institute for Cancer Immunotherapy reflects the $50 million each in gifts from its two namesake benefactors—Bloomberg, the entrepreneur-philanthropist and former New York City mayor, and Kimmel, another entrepreneur-philanthropist for whom the existing Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is named.
“We are grateful for these tremendous gifts which will help us accelerate the already rapid pace of discoveries in immunotherapy,” Paul Rothman, M.D., dean and CEO of Johns Hopkins Medicine, said in a statement.
Research at the institute will focus particularly on melanoma and colon, pancreatic, urologic, lung, breast, and ovarian cancers.