Avid Bioservices Inc (CDMO)

[cjgaddy]

My God, Bavi is about to double (or more?) MOS in 2nd-Line NSCLC in an n=121 Ph.2B randomized, placebo-ctl’d trial ( http://clinicaltrials.gov/ct2/show/NCT01138163 ), and I’ve Googled my head off and am convinced these are the only currently-approved drugs for 2nd-Line NSCLC – look at their MOS’s. I have no doubt this will be taken to the FDA before the end of the year for AA consideration. My opinion. (if you see any errors here, let me know and I'll correct & repost.)

Per Cancer.gov (NCI) - last modified: 8/15/2012…
Std. treatment options for Recurrent NSCLC include the following:
Chemotherapy or kinase inhibitors alone, including the following for patients who have previously received platinum chemotherapy:
• Taxotere (docetaxel) => MOS=6.3mos (meta-analysis of 5 trials, 865 pts)
• Altima (pemetrexed )=> No diff. vs. Docetaxel (Ph.3 non-inferiority vs. Doce, 571 pts)
• Tarceva (erlotinib) => MOS=5.3mos (TITAN** Ph.III n=424 trial – see http://tinyurl.com/8w8lo93 )
• Iressa (gefitinib )=> “Iressa does not improve OS”
• Xalkori (crizotinib) => very limited, only for ALK-positive pts (2-7% of pop.)
http://www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/healthprofessional/page12
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NOTE 10-8-08: “2nd-Line NSCLC: Avastin/Tarceva Improves PFS but Not Overall Survival vs. Tarceva” ( http://cancergrace.org/lung/2008/10/08/beta-neg-for-os )

** "The TITAN (Tarceva) study (treatment 4/2006-2/2010) is the first prospective head-to-head study to specifically investigate Tarceva (erlotinib) vs. systemic chemotherapy in 2nd-Line NSCLC for patients who progressed during 1st-line platinum-doublet chemotherapy.”
http://www.egfr.roche.es/TITAN/TITAN_EMCTO_Poster.pdf = http://tinyurl.com/8lfbrrs

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Standard Treatments for Lung Cancer (updated 8-18-12)
RECURRENT NSCLC:
If your cancer has progressed after one type of chemotherapy, other chemotherapy and targeted therapy drugs may be recommended. These drugs include pemetrexed (Alimta) and docetaxel (Taxotere), which are chemotherapy drugs, and erlotinib (Tarceva), which is a targeted therapy drug.
http://www.nationallungcancerpartnership.org/lung-cancer-info/resources/booklet/standard-treatments-for-lung-cancer

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Dr. Robert Garnick (Head/Regulatory) 12-10-09/CC http://tinyurl.com/y9tr3q3
“As you know, I’ve actually done Accelerated Approvals in the past and certainly, as Steve said, we want to be positioned such that if the data is striking and very compelling that we would be in a position to apply for that and that as you know takes a lot of coordination in across the company, not just in the clinical & regulatory side, but in the manufacturing & quality operations. We are actually making sure that should such an opportunity occur, that we would be in an excellent position in order to take advantage of that. Nevertheless, the real goal though is to obtain definitive data and develop our programs based on having really good solid clinical data in which to continue to develop the product.”

7-16-12: Peregrine's Ambitious Goal for Bavi: Accelerated Approval after Phase II: http://tinyurl.com/c39428b

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Recall, we learned that the Docetaxel ctl-arm had triggered MOS at “< 6 mos.” (in line with historical Doce data) in the 5-21-12 PR ( http://tinyurl.com/73aeyxj ), while both Bavi arms (low & high dose) had not yet reached MOS.

Given n=121 trial enrollment completed 10-6-2011 and 8-15-12 clarification by CEO Steve King (SK) at Wedbush/NYC that ctl-arm MOS had been already “well-surpassed” by the time of the 4-30-12 data cutoff, that means both Bavi arms were at a conservative minimum MOS of 9 mos. at 5-21-12.

Then on 7-12-12/JMP, SK announced, “the majority of patients are still alive (today) in both Bavi arms, and we expect that to continue for some period of time still.” ( http://tinyurl.com/csdclwb )
=> that took Bavi MOS in both arms to min. 11 mos, and growing daily.

Then on 8-15-12/Wedbush, SK announced, “As we're sitting here today, we have still not reached the # of events for MOS in either of the Bavituximab arms - and, in fact, we still have patients that are on treatments… it's going to be a very positive MOS result, it's just a matter now of magnitude." ( http://tinyurl.com/8mhrtld )
=> that took Bavi MOS in both arms to min. 12 mos, and still growing daily.

SK finished his 8-15-12 talk with this: “Basically, the longer, the better, obviously – it’s not just great for the program, it’s great for the patients, because, again, we do have patients that are out and still even on treatments as we speak.”

All of the above strongly suggests Bavi is going to Double MOS in 2nd-line adv. NSCLC, at-a-minimum, because each day that goes by Bavi’s MOS continues to grow, 12 mos. and counting as of 8-15-12.