Wednesday, July 03, 2013 8:46:47 AM
H. 1st Investigator-Sponsored (IST) Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label)
...Note: Sorafenib = Onyx/Bayer's Nexavar - see http://www.nexavar.com
Protocol: http://clinicaltrials.gov/ct2/show/NCT01264705 UTSW: http://tinyurl.com/2che4us (4 sites: 3/UTSW, 1/Parkland-Hosp.)
...4-4-12 AACR'12: Dr. Adam Yopp, "promising safety profile to-date" http://tinyurl.com/7yrwqm7 (see #5591)
...Feb-Mar’13 ~8 times: CEO Steve King hints of future ex-US partner-driven Bavi+Sorafenib/LIVER trial in Asia: http://tinyurl.com/czhopfo
......Articles & Data describe Liver Cancer challenges in Asian populations: http://tinyurl.com/7z7o8j9 & http://tinyurl.com/7z99cy4
...12-1-10: PPHM's 1st IST (Liver Cancer) initiated at UTSW, ~56 patients - http://tinyurl.com/3xd3e6c
…Per S.King, 5-18-10/R&R, "We've had a lot of interest in running clinical trials with the compound from investigators who have either had prior experience with the drug or would like to study the drug in various settings. Potential IST indications include all the major solid tumor types. Of particular interest is Liver Cancer, in which we have a natural tie-in with our HCV program, Ovarian Cancer and Pancreatic Cancer, also very nicely supported by the prior data."
= = = = = = = = = = = = = = = = = = = = = = = =
Backwards in time…
3-18-13: CEO STEVE KING AT ROTH/DANAPT http://tinyurl.com/cebtwen
Slide[ISTs]: • “Another study that’s ongoing is Liver Cancer in combo with Sorafenib, where, unlike other treatments, we’ve been able to successfully combine with Sorafenib, in which normally things such as anti-angenesis agents cannot be given with Sorafenib, and we’ve generated a good safety profile in that combination. Again, we expect data coming this year. This can be a very important study from a partnering standpoint; one of our goals in partnering is to primarily do Ex-US partnering and maintain as much of the U.S. rights as we can. Liver Cancer is a very large indication throughout the Asia, so it would be a very attractive from a partnering standing for a regional partnership that area.”
3-12-13 QTLY. CONF. CALL http://tinyurl.com/c48osut
Q&A/Jaffray/Duncan: “Re: ISTs, are there any settings that you're particularly intrigued with and would look forward to reading out at, at say, ASCO or something like that?”
Joe Shan: “…I think we are really interested in the one with Sorafenib with HCC [Liver Cancer]. That's a fairly large study at the end of the day; it's enrolling well.”
3-5-13: CEO STEVE KING AT COWEN HC CONF. (BOSTON) http://tinyurl.com/bczyfb3
SK/15 [IST’s]: “…We expect addl. data points coming this year from the other (IST) studies that have been ongoing. In particular, we’re interested in the results from the Liver Cancer study in combo with Sorafenib. Here again, we’ve had a good safety profile. This can be a very important combination & indication as we move forward with partnering discussions – Liver Cancer, a major indication throughout the Asian-Pacific region…”
9-5-12: CEO STEVE KING AT STIFEL-NICOLAUS/BOSTON http://tinyurl.com/cr65pug
• OTHER STUDIES (Slide19): “…a Liver Cancer study [IST, UTSW http://tinyurl.com/3xd3e6c & http://tinyurl.com/8cuxjdn ] in combination with Sorafenib – that study could be particularly important as we think about ex-US partnering, because Liver Cancer, while a relatively small indication in the U.S. is a huge indication throughout Asia, so again, really adding value to the ex-US program…”
8-15-12 WEDBUSH/NYC, STEVE KING (Slide18/IST’s): http://wsw.com/webcast/Wedbush18/pphm
S18/IST’s: “Bavi+Sorafenib in Liver Cancer, which can be a very important indication as we start to think about the future as we partner the drug, and certainly Liver Cancer is a major market opportunity throughout Asia.”
7-12-12 JMP/NYC, STEVE KING (Slide18/IST’s): http://tinyurl.com/csdclwb
S18: “…Liver Cancer – of our IST’s, this is perhaps the most interesting, to me anyway. It’s bavi in combo with Sorafenib. This is one of the ways in which we can differentiate our drug with some of the other vascular-acting drugs, such as the Anti-VEGF therapies [ex: Avastin]. In the case of Liver Cancer with Sorafenib, the Anti-VEGF drugs have combined-toxicities with Sorafenib, which limits the ability to use those. In our study, we’ve been thru the Ph.1 portion of the study, had a good safety profile, and we’ve now moved to the Ph.2 portion of that study. We seeing some very interesting things in that study, and it gives us the opportunity to do, as well, is to start to look at some of the mechanistic parts of the story, in which we’re going to be collecting tumor biopsies, pre-treatment & post-treatment, and looking at signs of immune-activation, again, tying in with what we’ve seen in pre-clinical studies.
3-12-12 ROTH/OC, STEVE KING (Slide15/IST’s): http://tinyurl.com/7ao2epx
“Secondly, a Liver/Bavi+Sorafenib IST study; I think this is important for a couple of reasons – one being that Sorafenib is a drug that has not been able to be given along with anti-angiogenesis agents (ex: Avastin). Because we’re having an effect on vasculature, there are a lot of correlations and a lot of our earlier clinical data was very similar to drugs like Avastin. However this could be a real differentiator; we’ve already made it thru half, the Ph.I portion, of this trial, and it looks like we can give this [Bavi] safely with Sorafenib, which would be, again, a real way to delineate this from some of the other drugs that are on the market. It’s also very important from a partnering standpoint, because our strategy here is to seek ex-U.S. partners and allow us to move this pgm forward in the U.S. Liver cancer, while it’s a very small indication in the U.S., it’s a very large indication throughout Asia, so that could become a very important part of the thinking of potential partners. Again, we have an AACR presentation [on Liver IST] in a couple of weeks.”
3-9-12 CC, STEVE KING (Q&A): http://tinyurl.com/7t2xsks
“And now, before I turn over to Rob, one of the things that came up, for instance, is running an IST in combination with Sorafenib and in the partnering discussion they were particularly intrigued by the fact that we were able to significantly up to this point to be able safely give bavituximab with Sorafenib [1st IST Ph1/2, Bavi+Sorafenib vs. Liver Cancer, open-label, n=56, UTSW, note: Sorafenib=Bayer/Onxy's Nexavar http://www.nexavar.com , http://clinicaltrials.gov/ct2/show/NCT01264705 ] because that's a significant issue with the anti-angiogenesis drugs because of some overlapping toxicities. So, by running all these studies, you start to kind of tease apart where the differences are and where the similarities are, and I think that gives us a great opportunity for development.”
2-14-12 BIO-CEO, STEVE KING (Slide16/IST’s): http://tinyurl.com/86wque8
SK: “As I mentioned before, this is a broad-spectrum agent, so we have a number of exploratory studies (IST’s). . .
Secondly, a Liver study in combo with Sorafenib – this is an important study for a couple of reasons: #1, our goal is to use ex-US partnering to bring in money that would help us then fund Phase III and to be able to continue to advance the program. And #2, Liver cancer is a major indication throughout much of Asia. Interestingly, this is a Phase I/II study, we’ve now completed the Ph.1 component, and what you’re seeing is that you can safely combine Bavi with Sorafenib, which has been a significant problem anti-angiogenesis agents. So, also some data points to help us fully differentiate this from other antibodies that are on the marketplace in solid tumors.
= = = = = = = = = = = = = = =
iHub’er FIREFOX’s COMMENTARY ON SLIDE16/LIVER IST (2-14-12 #75257):
“SK gave another encouraging update this morning (2-14-12) on the prospects for a regional partnership in Asia for Bavi + Sorafenib in Liver cancer. This is the 2nd time he has talked about Liver cancer as a near term prospect for licensing. The Liver trial is open label so the pending Asian partner could have access to all the IST data as it develops depending on arrangements. I don't have time to listen again today, but maybe someone else out there could capture and report exactly what was said about partnering Bavi in Asia for Liver cancer. If I heard correctly, SK gave some details on why Sorafenib by itself is not working well on Asian patients???” http://investorshub.advfn.com/boards/read_msg.aspx?message_id=72099922
= = = = = = = = = = = = = = = = =
iHub’er FTM’s COMMENTARY ON BAVI+SORAFENIB LIVER CANCER IST:
8-17-12/#87330: “Another reason is that Sorafenib doesn't work all that well, but it is better than nothing, and the only approved therapy for HCC, and works even less in Asian patients. See my 3-25-12 post #77582. So the hope is that bavi + sorafenib will be a significant improvement. In addition, the rate of HCC is much, much higher in Asia, due to infection with HBV, than in North America and Europe.”
3-25-12/#77582:
“Sorafenib in Asian HCC patients: I updated the data for Sorafenib with 2 trials done in Asia. For comparisons I also added the percentage of the patients with HCV or HBV infection. The Asian patients are almost all infected with HBV. This does make a difference in their survival.
From the paper, Cantarini et al, American Journal of Gastroenterology, 101, 91-98 (2006)
Effect of the Etiology of Viral Cirrhosis on the Survival of Patients with Hepatocellular Carcinoma.
"In the whole population, patients with hepatitis B tended to have a poor prognosis than those with hepatitis C (p = 0.160), and this difference became statistically significant among the patients with an advanced hepatocellular carcinoma (p = 0.025)."
This probably explains the differences between the non-Asian and the Asian trials below. If Bavi+Sorafenib shows an increase in survival then I would think the very large Asian market would be in play.”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=73658060
.
.
3-18-13 CEO Steve King, Roth/DanaPT [Slide15: ISTs]: http://tinyurl.com/cebtwen
• “Frontline NSCLC Bavi+Pemetrexed - a very important combination; PEM was orig. approved in 2nd-Line, and has subsequently been approved in Frontline, and is gaining mkt-share. So, as we think about the utility of Bavi in NSCLC, a combination with PEM could be quite powerful.”
• “Another study that’s ongoing is Liver Cancer in combo with Sorafenib, where, unlike other treatments, we’ve been able to successfully combine with Sorafenib, in which normally things such as anti-angenesis agents cannot be given with Sorafenib, and we’ve generated a good safety profile in that combination. Again, we expect data coming this year. This can be a very important study from a partnering standpoint; one of our goals in partnering is to primarily do Ex-US partnering and maintain as much of the U.S. rights as we can. Liver Cancer is a very large indication throughout the Asia, so it would be a very attractive from a partnering standing for a regional partnership that area.”
• “In addition, we’ve been running a Breast Cancer study in HER2- patients. It’s a frontline study in combo with Paclitaxel. We had some earlier Ph2 data in Breast Cancer that looked quite promising, with good OS results. Now we’re in the process of looking at one of the subsets of pts, namely HER2-, in which there’s still a very high un-met medical need and prognosis is poor. We expect data from this study coming this year.”
• “…Rectal Adenocarcinoma IST, in which we’re combining with Radiation, a very potent inducer of our molecule.”
Recent CDMO News
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:30:11 AM
- Avid Bioservices Announces Pricing of Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/07/2024 04:58:48 AM
- Avid Bioservices Announces Proposed Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/06/2024 09:32:07 PM
- Avid Bioservices Announces Certain Preliminary Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 03/06/2024 09:31:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:30:18 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:57:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2024 12:34:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:39:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:38:30 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:37:38 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:36:27 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:35:47 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/11/2024 12:56:02 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/08/2024 09:32:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:56:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:55:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:53:58 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:51:57 AM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 12/19/2023 09:05:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:34:08 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:33:03 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:32:11 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:31:12 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:30:26 AM
FEATURED Elevai Labs Launches E-commerce Portal to Support Rapid Growth as Stem Cell Exosome Disruptor in the $19.7 Billion Global Physician Dispensed Cosmeceutical Market • Mar 18, 2024 8:51 AM
FEATURED Prospera Energy Inc. Announces a 508% increase in the 2023 Proven Developed Producing (PDP) Reserve Valuation • Mar 18, 2024 8:09 AM
Greenlite Ventures Enters into Strategic Alliance with Woodway USA • GRNL • Mar 15, 2024 4:00 PM
HealthLynked Welcomes David Rosal as New Chief Financial Officer • HLYK • Mar 13, 2024 8:00 AM
ECGI Holdings, Inc. Announces Continued Efforts in Financial Optimization • ECGI • Mar 13, 2024 8:00 AM
PSYC Begins Business Overhaul Process with Consolidation of 10 Previously Issued Convertible Debentures • PSYC • Mar 13, 2024 7:13 AM