"maybe we can turn you from a non responder into a responder" Lol ! a classic line.
twizisatruthsayer - I enjoy your posts cause I know you are a 'closet oncs groupie' -
You broke the SBIR story before the co. , and now this thread listing significant presentations. The investigative journalism award is all yours : ) Thank you.
the (appreciative) weasl..
This article was written 15 months ago, dated 7/29/13 - from the Asco Post - conference next week could prove to be a real coming out party for Oncs. - The data might ink the partnership we need : )
Intratumoral injections of plasmid DNA encoding interleukin-12 (IL-12), facilitated in its delivery by electroporation, results in tumor regression in patients with both metastatic melanoma and Merkel cell carcinoma, according to findings reported at the 2013 World Cutaneous Malignancies Congress on Sunday, July 27, in San Diego.
“IL-12 is a very powerful immune-stimulating protein. There was excitement for IL-12 in the 1980s and 1990s, but systemic toxicity prevented further development of it. Since that time, investigators have been trying to deliver IL-12 in creative ways, and this is one example of such an approach,” said Shailender Bhatia, MD, of the Seattle Cancer Care Alliance in Seattle.
Electroporation can transduce, with high efficiency, plasmid DNA directly into melanoma and Merkel cell carcinoma cells. The IL-2 expression remains concentrated within the tumor microenvironment, with no systemic spillage. This stimulates innate and adaptive immune responses while avoiding toxicities associated with systemic IL-12 therapy, he explained to The ASCO Post.
Lesion Regression Observed in Melanoma
In a phase II multicenter study in 13 patients with metastatic melanoma reported as a poster at this meeting, patients were injected intratumorally with IL-12 (0.5 mg/mL) followed immediately by electroporation. Treatment was delivered to up to four lesions on days 1, 5, and 8 every 6 weeks, for a total of 37 treated lesions.
The study was led by Adil Daud, MD, of the University of San Francisco, and Dr. Bhatia was a coinvestigator.
At the day 90 assessment, 82% of target lesions demonstrated a response after only a single cycle of treatment, with 47% being complete responses. Target lesions demonstrated a 68% durable response rate (≥ 6 months) at 90 days.
Two patients have been assessed 180 days after the first cycle of treatment. One had a complete response and continues to remain disease-free past 1 year. The second had stable disease at day 180 but subsequently showed disease progression. The data are not yet analyzed for the remaining patients.
Blood samples taken at baseline and day 90 suggested that plasmid delivery of IL-12 can result in a decrease in “exhausted T cells,” the researchers reported.
Merkel Cell Carcinoma Responds Well
Because of the encouraging results seen for this approach in melanoma, a phase II study was begun in Merkel cell carcinoma, and results were similar, said Dr. Bhatia, who lectured on emerging therapies for Merkel cell carcinoma at the meeting.
He said complete responses were observed within weeks of injections, and noninjected lesions elsewhere on the body also regressed within weeks or months. Increased intratumoral CD8-positive infiltration was observed in 50% of patients.
“This suggests that we are getting a successful immune response,” Dr. Bhatia said. “The big advantage of this approach is its localized delivery without the production of systemic side effects.”
“The hope is we could combine this local therapy with a systemic therapy,” he added, perhaps a novel immunotherapeutic agent such as ipilimumab (Gleevec) or anti-PD-1. “It would be like starting a fire with local treatment, and using drugs to spread the fire throughout the forest.”
50% move gets us to .65, 100% sees .90 - We see a double from here, selling will keep a lid on upside share price. My guess, .80-.90 with milestones met. Partnership will impact price more than all 5 milestones combined. IF there is one.
Oct 7th, Punit said "in order for us to get off the ground we would have the cooperation of somebody"
The following day Oncs traded 2.4M shares (-10%). Largest 1 day volume in a month. A sell off. His comment opened the door to going alone, no partnership .......- "cooperation" is not a partnership. Interim data of the combo Ph2b trial will be needed to get the likes of MRK, BMS, etc. to sign up with a bio trading at .38 cents a share. The big companies are in no hurry, they have approved anti PD-1 drugs. The partnership talks will get serious when/if our combo trial shows an improvement in patients.
the (contrarian) weasl.
Merkel Cell - NCT01440816
- Primary Outcome Measures: •Proportion of patients who experience at least 2-fold increase in expression of IL-12 protein in the tumor tissue after IT pIL-12 injections and in vivo electroporation [ Time Frame: From baseline to 2-4 weeks after the first injection ] [ Designated as safety issue: No ]
Patients who experience at least 2-fold increase in the expression of IL-12 protein will be counted as having a successful outcome. . . . . . . .. .. . ....
- Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
This is an open label trial, recruitment began Nov., 11' - One would have to believe Oncs is updated on all 15 patients every few months. - "milestones (2014) . .. .. .of unprecedented significance."
A successful outcome; EP/IL-12 administration working in two indications, Melanoma and Merkel Cell. Glta
The biotech blog of Ohad Hammer, a nice summary of ArQule written on Sept. 10, 2014.
"ArQule- An ultra rare opportunity emerges." His blog is an 'extreme science' discussion. GL
I listened to the conference. Important data on the way.- I listened to the first and only question about using PD-1. Replayed answer 10 times. I can't find " and there is no way for us to go to P-2b without a partner"
Punit does conclude answer by saying - " ah, yes, in order for us to get the trial off the ground we would have the cooperation of somebody"
In other words, if terms are not favorable for a partnership, " the cooperation of somebody" means Oncs will BUY the anti PD-1.
"If everyone is thinking alike, then somebody isn't thinking."
my call on the snss board, Oct. 1st --------------
"owned snss in 2010...maybe it was june 2010 (?) when sapacitabane failed a phase II --.I looked at the chemical makeup of vosaroxin and it was very similar. For that reason only, my guess is a miss"
Under section 902 of FDASIA, a breakthrough therapy must meet two general criteria: 1) It must be intended to treat a serious or life-threatening disease or condition; and 2) there must be early clinical evidence indicating "that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints." The manufacturer must present this clinical evidence when it applies for breakthrough designation, and the FDA must respond to the application within sixty days of receipt. The FDA may also rescind the designation if further evidence reveals that the drug no longer meets the qualifying criteria.
The results of the Ph2B trial, EP/IL-12 combined with an anti PD-1 drug, may show the clinical evidence needed to apply for BTD designation. Sept-Oct 2015 ?
In addition to filing annual reports on Form 10-K and quarterly reports on Form 10-Q, public companies must report certain material corporate events on a more current basis. Form 8-K is the “current report” companies must file with the SEC to announce major events that shareholders should know about.
Companies have 4 business days to file a Form 8-K . There will be a separate P.R. announcing the results. Two options, before market open, 8am, or a trading halt at 4pm, followed by VALOR results. Trading will resume about 1 hour after results, giving the MM's time needed to "reset" the opening price. The open will be 60-70% (?) higher or lower on the news. Been there, done that.
ESPR came out with a p value of 0.0001 on their ph II trial - ..new market cap of 400M. With 15 million shares outstanding =$30 a share. Oncs at $1.50, 400M market cap. 1 for 10 r/s during annual meeting next summer. We break $1 before then, I sell. All.
I owned snss in 2010.........maybe it was june 2010 (?) when sapacitabane failed a phase II --.I looked at the chemical makeup of vosaroxin and it was very similar. For that reason only, my guess is a miss.
I would like to see stat sig on primary, making money on the bio's is no cakewalk. With short interest over 20%, you long investors will be hootin and a hollering lol, maybe 100% upside with good news. GL
wow, 1 for 100 r/s .....investors lost everything. There seems to be a certain group of CEO'S, they've done quite well at issuing millions and millions of shares to keep the doors open. This co. is no different, put up by spring or we got scammed. End of story.
ps- Ambi has 5 million share float. Ph III results next fall. AML, a tough cookie. Quizartinub will succeed in combo with chemo. Hoping for Once success and big name partner. We need new wheels ! lol
Lion Biotechnologies, Inc., a development stage biotechnology company, develops T-cells and engineered T-cells for the treatment of various cancers. The companys lead product candidate includes a ready-to-infuse autologous T-cell therapy using tumor-infiltrating lymphocytes (TILs) for the treatment of patients with stage IV metastatic melanoma. It has a patent license agreement with the National Institutes of Health to develop and manufacture certain proprietary autologous TILs adoptive cell therapy products for the treatment of metastatic melanoma, ovarian cancer, breast cancer, and colorectal cancer; a cooperative research and development agreement with the National Institutes of Health and the National Cancer Institute to develop adoptive cell immunotherapies that destroy metastatic melanoma cells using a patients tumor infiltrating lymphocytes; and a process development and scale-up consulting agreement with Lonza Walkersville, Inc. to manufacture TILs
Dr. Manish Singh, Ph.D., MBA, CEO ......I owned Imuc when he resigned summer of 2013. His new venture , the science is similar, all about the administration of TIL'S. I have done no research on co. I did see this. . . .
Float ~ 10 million shares , we know Oncs float is TWO HUNDRED AND THIRTY MILLION SHARES.
The 1 for 10 r/s for Oncs will be at next summer's annual meeting. Will sell after asco, $1.50 ??
two days ago I asked , how many of the 20 mice received anti PD-1 .....LOL , they won't answer most of my questions, - (da weasl with his nosy nose under the big tent)