Category: Biosante Pharma

AACR Preview part 4: More Astex Pharma ASTX plus ArQule ARQL and BioSante Pharma BPAX

04/01/2013

BiotechDueDiligence and HSP90 Central will be covering the 2013 AACR Annual Meeting live from Washington DC. This post will focus on abstracts to be presented by Astex Pharmaceuticals ASTX (partnered pipeline - see Parts 1 and 3 for internal ASTX assets), ArQule Inc ARQL, and BioSante Pharma BPAX.

Full coverage:
Introduction
Preview Part 1 (SNTA, ASTX, NVS, INFI)
Preview Part 2
Preview Part 3 (ARRY, ASTX)

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BioSante Pharma $BPAX notes from 6/2012 call: new LibiGel clinical trials

12/15/2012

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For archival purposes, even though it seems less and less likely that these trials will happen. Full background on Biosante Pharma BPAX and Libigel here.

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BioSante Pharma $BPAX notes from Jefferies Conference - Summer 2012

12/06/2012

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Quick notes from Biosante Pharma $BPAX CEO Stephen Simes at Jefferies:

We still don't know teva-abt launch date agreement. $1.6b total market. royalty 7.5-10%
two new trial to initiate 1h2013 same co primary endpoints and key secondary, but some design changes with goal of decreasing placebo response
over 7000 patient-years in LibiGel safety trial now
this is first public disclosure of specific changes that they are seeking via SPA with FDA
daily diary was also used unsuccessfully by B-I for flibanserin
we will not proceed if FDA will not let us switch to less frequent diary
next safety report by the end of august (9th unblinded look) with top-line safety data 4q-2012
patent thru year-end 2028 (method of use) and 2022 (formulation)
sexual dysfunction is the #1 complaint in gynecologist's office
[rehash of old GVAX cancer vaccine data]
~$40m net cash 3/31/2012, report results in new few weeks.
We hope for SPA agreement in 4q-2012 with FDA
no Question and answer session on webcast

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BioSante Pharma $BPAX 2q-2012 earnings/10-Q notes

11/25/2012

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There was no conference call held by BioSante Pharma $BPAX in connection with the 2q-2012 earnings release, but a couple quick notes from their quarterly SEC filing:

cash until 3q-2013
new LibiGel phase 3 trials to start mid-2013. Combined spend of $30-36m over 18 months
now $8.3m notes out as of 7/31
phase 2 of gvax melanoma + revlimid is enrolling, target 15 pts
Libigel safety study next interim look 3q-2012, top-line unblinded data in 4q-2012

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BioSante Pharma $BPAX Update - why a 56% pop today?

05/21/2012

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Just when I think I can stop writing about BioSante Pharma $BPAX for awhile, the stock goes an pops 56% today with no apparent explanation. I'll run through a few of the spurious theories to explain the jump and discredit them.
EDIT: I decided to increase the number of theories from 4 to 8 due to inspiration from @AdamFeuerstein, @Gekkowire, and others. I'll address all eight - in reverse order of plausibility! Keep reading below for the full list.

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BioSante Pharma $BPAX ASCO 2012 Presentation

05/21/2012

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BioSante Pharma $BPAX will present biomarker analysis data from a phase 1/2 trial of GVAX cancer vaccine plus YERVOY (ipilimumab) in prostate cancer at #ASCO12 in June. The clinical data from this trial have been presented and published on several occasions in the past.

Abstract #2562
Lymphoid and myeloid biomarkers for clinical outcome of combined immunotherapy with granulocyte-macrophage colony-stimulating factor-tranduced allogeneic prostate cancer cells (GVAX) and ipilimumab in castration-resistant prostate cancer patients.
Alfons J. van den Eertwegh, MD, PhD

Background: In a phase-I dose escalation trial in patients with castration-resistant prostate cancer we showed that GVAX and ipilimumab had an acceptable safety profile. Moreover, we observed tumor responses and prolonged survival as compared to the Halabi predicted overall survival (OS). However, ipilimumab can also lead to severe immune-related adverse events. To avoid unnecessary exposure to this risk, it is essential to identify biomarkers that correlate with clinical activity.
Methods: Patients had castration-resistant prostate cancer and were chemotherapy-naïve. They received bi-weekly GVAX for a 24 week period combined with monthly intravenous administrations of ipilimumab. Each cohort of 3 patients received an escalating dose of ipilimumab at 0·3, 1·0, 3·0 or 5·0 mg/kg. In an expansion cohort 16 patients were treated with GVAX and 3·0 mg/kg ipilimumab. Flowcytometric monitoring of lymphoid and myeloid subsets in blood were performed.
Results: We observed a significantly prolonged OS for patients with high pre-treatment frequencies of CD4+CTLA-4+, CD4+PD-1+, or differentiated CD8+ T cells, or low pre-treatment frequencies of differentiated CD4+ T cells or CD4+CD25hiFoxP3+ regulatory T cells. In contrast, increased frequencies of granulocytic Myeloid-Derived Suppressor Cells (MDSC) and high pre-treatment frequencies of monocytic CD14+HLA-DRlo/- MDSC were associated with reduced OS. Treatment-induced CD4+ T cell differentiation and CD4+ and CD8+ T cell activation was associated with clinical benefit. Moreover, treatment-induced activation of CD1c+ conventional Dendritic Cells (cDC) and 6-sulfo LacNAc+ inflammatory DC were associated with significantly prolonged OS.
Conclusions: Together these data provide an immune profile to predict clinical outcome. Importantly, cluster analysis revealed pre-treatment, CRPC-associated expression of CTLA-4+ by CD4+ T cells to be a dominant predictor for OS after GVAX/ipilimumab. This potentially biomarker for patient selection should be validated in patients treated with ipilimumab.

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BioSante Pharma $BPAX 1q-2012 and ASCO updates

05/12/2012

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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.

Continue reading for a quick update from BPAX's 1q-2012 earnings announcement...

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BioSante Pharma $BPAX cancer vaccine data at AACR

04/01/2012

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BPAX goes to the well with the clinical trial once more at AACR - here is the full abstract:

#5381: "Activation and frequency of myeloid subsets in peripheral blood is associated with clinical outcome in prostate cancer patients treated with Prostate GVAX and anti-CTLA4"

Blockade of the CTLA-4 immune checkpoint can enhance anti-tumor responses and prolong survival, but it can also lead to the development of severe and potentially life-threatening immune-related adverse events (IRAE). To avoid unnecessary exposure to this risk, it is essential to identify biomarkers that correlate with clinical activity and can be used to recognize and select patients that will benefit from immune checkpoint blockade. We therefore performed extensive immune monitoring in a phase I/II dose escalation/expansion trial of combined Prostate GVAX (a GM-CSF-secreting allogeneic prostate cancer vaccine) and antiCTLA-4/ipilimumab immunotherapy in patients with Castration Resistant Prostate Cancer (CRPC). Here we report on the effects of the treatment on circulating myeloid cells and the identification of potential myeloid-related biomarkers. The GVAX/ipilimumab combination was clinically active with PSA declines of more than 50% in 5, and PSA stabilizations in 12 of 28 patients. Regressing bone and lymph node metastasis were observed in 2/5 PR patients. Flowcytometric monitoring of myeloid subsets in peripheral blood before and after Prostate GVAX/ipilimumab treatment revealed some striking differences between patients who benefited from therapy and patients who did not. Significant treatment-induced decreases of conventional and plasmacytoid Dendritic Cell subsets (cDC and pDC, respectively) were observed, which were paralleled by increased DC activation and recruitment to the vaccination sites. Treatment-induced activation of BDCA1/CD1c+ cDC and 6-sulfo LacNAc+ inflammatory DC was associated with significantly prolonged over-all survival (OS). In contrast, increased frequencies of CD11b+CD14-CD15+ granulocytic myeloid-derived suppressor cells (MDSC) and high pre-treatment levels of CD14+HLA-DRlo/- monocytic MDSC were associated with reduced OS. Together with similar analyses of T cell subsets, these studies have yielded an immune profile with predictive value for clinical outcome. The profile is characterized by pre- or on-treatment activation of immune effector subsets and low frequencies of regulatory/suppressive subsets. It may thus provide a potentially useful tool for patient selection and should be validated as such in other patient groups treated by antiCTLA-4 blockade.

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Recent news updates and comments $ALNY $AIS $BPAX $LGND $ONXX $INFI

11/29/2011

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I don’t typically do this, but there have been a flurry of press releases with news from companies I cover so below you will find quick comments on each:

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