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Andrew Goodwin holds a Ph.D. in the cellular and molecular basis of human disease, with research experience in infectious diseases and cancer. After 11 years as an academic scientist I now work on the regulatory side of drug development. Aside from my day job, I operate the websites... More
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  • Updates On Ariad's AP26113 ALK/EGFR Inhibitor

    Ariad Pharmaceuticals ARIA issued a corporate update press release today (4/4/2013). The main focused was CML drug ICLUSIG (ponatinib), but there were also more updates, discussion, and color regarding their ALK/EGFR inhibitor AP26113 than I expected (learn more about ALK inhibitors in development here). Therefore, I'll summarize these below along with any additional color from the conference call.

     

    • The Phase 1 portion of our Phase 1/2 clinical trial of AP26113 is ongoing, and we expect to transition into the four Phase 2 expansion cohorts [crizotinib-naive ALK+ NSCLC, crizotinib-resistant ALK+ NSCLC, EGFR-mutant NSCLC resistant to at least one EGFR inhibitor, and other ALK+ or ROS fusion tumors] in the second quarter of 2013.
    • A fifth Phase 2 cohort in ALK-positive NSCLC patients with brain metastases is also being planned [big problem - over 50% of NSCLC failures, including crizotinib failures. No comment on whether these patients will have had crizotinib already...Excited about CNS activity that has been seen with '113. Best way to characterize activity was to study separately in phase 2...not to say these patients won't be part of broader ALK registrational strategy...no comment on entry criteria for pivotal trial until it starts...no comment on if they are seeing brain met responses in the dose escalation phase].

    Continue reading this post on the BiotechDueDiligence blog.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Additional disclosure: Dr. Goodwin is prohibited from trading biopharma stocks by his employer.

    Apr 26 9:50 PM | Link | Comment!
  • 8 Possible Explanations For BioSante Pharma's 56% Pop

    Theory 1: BPAX is about to conduct a reverse split, in-license a spectacular specialty pharma portfolio, and generate meaningful shareholder value
    Ha. Had you going there didn't I. Moving on.

    Theory 2: Recent Ceregene data
    BPAX, via its acquisition of Cell Genesys, also inherited a stake in privately held drug developer Ceregene. Ceregene has never run a successful clinical trial, but that hasn't stopped them from reanalyzing and re-announcing data from the same trial repeatedly. Last week Ceregene issued another press release from their failed phase 2 trial of CERE-120 in Parkinson's disease.

    Theory 3: ELESTRIN is flourishing now that Jazz Pharma has acquired the drug
    Oops. BPAX makes zero dollars from ELESTRIN. The paltry couple hundred thousand per quarter flows directly to Antares Pharma $AIS.

    Theory 4: ASCO data
    As I posted earlier, BPAX will present yet more data from their phase 1/2 trial of GVAX prostate cancer vaccine plus YERVOY (ipilimumab). Abstracts were announced May 16th, and this is relatively meaningless data mining via lab experiments of samples from an old trial. Any pop from this event would have come last week, as ASCO abstract release date is well known and is pretty much a national holiday among biotech investors. There will be another chance for stock movement based on this data in early June once the actual presentation at ASCO 2012 has occurred.

    Theory 5: Big news regarding LibiGel has leaked
    True, BPAX will make an announcement in the second quarter with regards to the future of the LibiGel cardiovascular safety study. And they may even be crazy enough to start a new efficacy study that seeks to avoid such a dramatic placebo effect. But no one cares anymore.

    Theory 6: GVAX Pancreatic cancer randomized phase 2 trial
    This one sure seems tempting, doesn't it? As BPAX frequently reminds us, the prestigious medical research institution Johns Hopkins (full disclosure...JHU is also my current employer) is conducting many of the GVAX cancer immunotherapy clinical trials. Today, 5/21/2012, a listing of cancer trials ongoing at Johns Hopkins is updated and includes this phase 2 trial in pancreatic cancer entitled "A Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine (with Cyclophosphamide) Alone or Followed by CRS-207 in Adults with Metastatic Pancreatic Adenocarcinoma"
    Exciting right? A big boy randomized phase 2 trial of GVAX Pancreas. The only problem is that this trial has been ongoing and recruiting patients since September 2011, as you can see in theClinicalTrials.gov listing. If you are a reader of the BiotechDueDiligence blog, then you have no excuse for being fooled. This trial was discussed in some depth at an October 2011 Cancer Immunotherapy conference in presentations by both BPAX and partner Aduro Biotech (see my notes from the webcast here)

    Theory 7: Mine
    Sometimes things are simpler than they appear. BPAX has been a daytraders stock for months. Last Friday, as the world was apparently coming to an end thanks to Facebook, Greece, and JP Morgan, BPAX traded all the way down to $0.33, roughly equal to net cash levels (access real-time valuation calculations here). Today was a strong day for the broad markets and especially biotechs. The smaller, junkier names seemed to perform best. Some bottom feeders got BioSante stock moving, and momentum plus the above "reasons" kept the pop intact. The fact that BPAX has little or no fundamental value remains unchanged - but only sometimes reflected in the stock price.

    Theory 8: Today's deal in the male testosterone spaceOur good friend and leading bio-skeptic Gekkowire sends along the most plausible explanation for the pop in BPAX stock today. Notice I said explanation, not reason. In short, Auxillium $AUXM and GSK entered into a co-promote agreement for Testim. This might have had some relevance if the Teva-BioSante male testosterone gel (Bio-T-Gel) was going to hit the market anytime soon. Or if BPAX owned any rights with which to make a deal. They don't, so this deal is meaningless except for underscoring the growing overall testosterone market. However, I do think that this news is the most likely explanation for the rapid rise in BPAX share price today - just don't expect it to last too long.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Tags: ANIP
    May 22 5:20 AM | Link | Comment!
  • BioSante Pharma $BPAX 1q-2012 Updates

    The day-trading frenzy in shares of BioSante Pharma $BPAX may have settled down momentarily, but I don't expect that to last forever.

    Yet more data from the early stage combination trial of GVAX prostate cancer vaccine plus ipilimumab (YERVOY) will be presented at ASCO 2012 (abstract will be released May 16th). This is at least the third time this trial has been presented and each has involved a PR from the company and a brief stock price pop. We'll see whether that pattern remains. There are currently a total of 17 ongoing early stage clinical trials involving various BioSante-owned cancer vaccines.

    BioSante released 1q-2012 results and filed its 10-Q quarterly report on May 10th.

    Key stats include an outstanding share count that is now up to 120.86 million, cash balance of $49.5 million, and outstanding convertible debt of $11.8 million (due May 2013). Check out the resulting enterprise valuation calculation for BPAX and many other companies over on my Stocks page.

    Other notes:

    • Cash balance on hand sufficient through mid-2013
    • Cash burn $2.5 per month in 2012 (or $1.5m is LibiGel safety study is abandoned)
    • The company issued 2.1m stock options at $0.68 exercise price in first quarter 2012
    • Board of Directors is seeking reverse split somewhere in the range of 1:2 to 1:10, pending shareholder approval.
    • Still expect to make decision in 2q-2012 on whether or not to continue the LibiGel safety study (primary analysis of safety data would be on track for 2h-2012)
    • Royalty revenue for the quarter was $114,000 for ELESTRIN from Jazz Pharma $JAZZ via Azur Pharma acquisition. Note that 100% of these payments are passed along to Antares Pharma $AIS - BPAX does not retain any revenue from this drug.
    • No further disclosures have been made about Teva Pharma $TEVA male testosterone gel product. This has been FDA approved, but a patent litigation settlement is keeping the drug off the market for an undisclosed period. Therefore, BPAX does not currently royalties for this product either.
    • BPAX has until July 30, 2012 to regain compliance with NASDAQ $1.00 minimum bid requirement.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    May 12 4:53 PM | Link | Comment!
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