Seeking Alpha

Michael Becker

 
View as an RSS Feed
View Michael Becker's Comments BY TICKER:
Latest  |  Highest rated
  • 2012 Preview: Cancer Immunotherapy Catalysts [View article]
    TripNines,

    We neither have an agenda nor have been lax in doing due diligence on Advaxis. The purpose of our article was to highlight the readouts from randomized Phase 2 or Phase 3 trials expected during the next 12-months, which could represent catalysts for the cancer immunotherapy sector. We solicited input from Advaxis and other immunotherapy companies as part of our research and Advaxis did not respond at all, which we assume meant that they did not have any Phase 2 or Phase 3 catalysts for 2012. Please note that initiating a trial doesn't qualify as a catalyst; rather only results from ongoing studies. Before you point fingers, please take time to observe the facts.
    Dec 21, 2011. 09:54 PM | Likes Like |Link to Comment
  • 2012 Preview: Cancer Immunotherapy Catalysts [View article]
    PEhrlich,

    The majority of the programs with data readouts in 2012 appear to be non-autologous. Based on the Dendreon experience with Provenge, autologous products may be viewed as a greater commercial challenge. However, it really depends on whether or not the procedure fits within existing treatment paradigms. For example, leukapheresis is not part of the normal treatment of prostate cancer. In contrast, surgical removal of tissue is a common part of treating brain cancer - and if such tissue could be used to create a vaccine, this might be better received from a commercial perspective.
    Dec 16, 2011. 11:40 PM | Likes Like |Link to Comment
  • Adjuvants May Hold Key To Unlocking Cancer Immunotherapy Revolution [View article]
    Thanks, Ted.
    Sep 22, 2011. 08:14 AM | Likes Like |Link to Comment
  • Cancer Immunotherapy: A Roundtable Discussion [View article]
    We do not comment on individual stocks.
    Jul 1, 2011. 02:20 PM | Likes Like |Link to Comment
  • Cancer Immunotherapy: A Roundtable Discussion [View article]
    No, as they are not a cancer immunotherapy company.
    Jul 1, 2011. 02:20 PM | Likes Like |Link to Comment
  • Companies Positioned for Treating Acute Radiation Syndrome [View article]
    Your article is a nice overview of acute radiation syndrome [ARS] as it relates to the early hematopoietic effects. However, according to peer-reviewed literature, even in a severe form of ARS, this initial period can be managed with growth factors, such as Amgen’s (AMGN) granulocyte colony-stimulating factor [G-CSF, pegfilgrastim] along with additional supportive care and may no longer be the direct cause of death from ARS. Because large doses of radiation affect multiple systems, bone marrow recovery does not necessarily ensure survival. As a result, more attention should be focused on those organ systems that currently lack available treatment options, such as the lungs. None of the companies referenced in your article are focusing on the lung aspect of ARS.

    To illustrate, the majority of ARS cases reported worldwide resulted from the April 1986 accident at the Chernobyl nuclear power station, which exposed about 200 people to large doses of total-body radiation. The diagnosis of ARS was confirmed in 134 persons from this accident, but there were no early fatalities among 91 [68%] patients with ARS grade II [2–4 Gy doses].

    Of the 28 early deaths from Chernobyl, the majority occurred with people with whole‑body doses in excess of 6.5 Gy. This was before the availability of G-CSF, which is now available in stockpiles that have been developed in the U.S. and by the World Health Organization. In fact, Amgen’s G-CSF has recently demonstrated benefits in animal models of radiation exposure, as evidenced by approximate 80% survival at 60-days in animals exposed to 7.5 gy total body irradiation.

    Because the lung is quite sensitive to the effects of radiation exposure, those people who survive early ARS through G-CSF and delivery of appropriate supportive care are potential candidates for the development of pulmonary complications. The radiation sensitivity of the lung is well established by the fact that it is a dose-limiting organ in cancer patients receiving total body irradiation [TBI] as part of a bone marrow transplantation regimen. This sensitivity was also evident after the Chernobyl accident, where a significant number of the early victims died from pneumonitis or as a direct result of their lung injuries [source: UNSCEAR. Sources, Effects and Risks of Ionizing Radiation. Report to the General Assembly,
    Annex J: Exposures and Effects of the Chernobyl Accident. United Nations; New York: 2000].

    ARS affects multiple organs beyond the hematopoietic system and bone marrow recovery does not necessarily ensure survival. Successful treatment of other organ failures, such as the lung, represents a large unmet medical need and deserves more attention.
    Apr 15, 2011. 03:58 PM | Likes Like |Link to Comment
  • Major FDA Approval Could Pave the Way for These 5 Biotechs [View article]
    Just curious, what is your source for "At least 50 cancer immunotherapy drugs are currently in clinical trials"?
    Mar 31, 2011. 11:20 AM | Likes Like |Link to Comment
  • Ipilimumab Approval Highlights Active Immunotherapy Renaissance [View article]
    The difference is that ipilimumab blocks a receptor with T-cell inhibitory activity and therefore increases T-cell activation across the board, while a bispecific antibody would only elicit a T-cell response when the target antigen (CD19) is bound to it. Ipilimumab acts directly on T-cells, whereas the bispecific antibody only engages T-cells in connection with the other end being bound to CD19. Both ipilimumab and bispecific antibodies are immunotherapies, but only ipilimumab is an "active" immunotherapy.
    Mar 29, 2011. 01:37 PM | Likes Like |Link to Comment
  • Ipilimumab Approval Highlights Active Immunotherapy Renaissance [View article]
    Immunotherapy can generally be divided into two segments - "passive" and "active" immunotherapy. The main focus of our article was active immunotherapy, not passive immunotherapy - which is how we classify Micromet's approach.

    Passive immunotherapy typically refers to a monoclonal antibody that is developed outside of a patient's body. They are designed to attack foreign substances directly and do not stimulate a person's immune system to play an active role in fighting the disease. Because most antibodies developed and marketed to date have these characteristics (Herceptin, Erbitux, etc.), some people mistakenly label Bristol-Myers' Yervoy (ipilimumab) as passive immunotherapy instead of calling it an active immunotherapy.

    However, an active immunotherapy (sometimes referenced as a "cancer vaccine") aids and/or stimulates the immune system to take an active role in attacking cancer cells. It is designed to trigger a response from a patient's immune system to fight tumor cells. In this regard, Bristol-Myers' Yervoy (ipilimumab) is really an active immunotherapy because of its direct effect on a patient's T cells.
    Mar 28, 2011. 03:34 PM | Likes Like |Link to Comment
  • Ipilimumab Approval Highlights Active Immunotherapy Renaissance [View article]
    It was not a mistake, as the article solely focused on "active immunotherapies" and Genta's product candidate (Genasense) does not qualify - as it inhibits production of a protein called Bcl-2. With regard to the "promising results" you mention, Genta's product failed to meet the co-primary endpoint of progression-free survival in a Phase 3 melanoma study. The drug also failed to meet secondary endpoints of overall response rate and disease control rate.
    Mar 28, 2011. 03:24 PM | 3 Likes Like |Link to Comment
  • Earthquake Highlights Opportunity for Treating Radiation Sickness [View article]
    A single therapy is not likely to work for ARS. As a potentially multi-organ failure, ARS requires global therapy, beyond the hematopoietic syndrome to include treating the gastrointestinal syndrome and also the lungs.

    Further, there is general agreement that Amgen’s (AMGN) granulocyte colony-stimulating factor (G-CSF, Neupogen) is an acceptable choice for treatment of hematopoietic or bone marrow syndrome in individuals receiving a whole-body radiation dose of 3 Gy or more. G-CSF is available in radiation stockpiles that have been developed in the U.S. and by the World Health Organization. Amgen’s Neupogen has also demonstrated superior survival data to Cleveland Biolabs’ CBLB502 in animal models, as evidenced by approximate 80% survival at 60-days in animals exposed to 7.5 gy total body irradiation (TBI) compared to approximate 70% survival at 40-days in animals exposed to lower TBI radiation (6.5 gy) in a similar CBLB502 study.
    Mar 15, 2011. 04:34 PM | Likes Like |Link to Comment
  • To Partner or Not to Partner: That Is the Question [View article]
    Agreed, a comprehensive analysis of the topic is beyond the scope of our brief article. However, I agree with your "cyclical" concept - as in addition to clinical stage preference, certain targets and diseases can be in vogue at one time, but out of favor at another. This can impact partnering. Also, the broader financial markets can impact whether capital is even available - and if so, at what price, which can impact a company's decision to go alone versus partner. On your last comment, I actually think that truly novel compounds or targets can sometimes attract the biggest partnerships or acquisitions, whereas "me too" product candidates may not.
    Mar 11, 2011. 03:09 PM | Likes Like |Link to Comment
  • To Partner or Not to Partner: That Is the Question [View article]
    Nice follow-up story titled "Copying Dendreon" by Brett Chase of Minyanville at link below:

    www.minyanville.com/bu...
    Mar 11, 2011. 03:01 PM | Likes Like |Link to Comment
  • To Partner or Not to Partner: That Is the Question [View article]
    If you read the article, you'd notice that I did not fail to mention the point, as evidenced by the following quote from the article: "Such a strategy requires that the company can access resources and capital to develop and launch its product globally."
    Mar 10, 2011. 08:12 PM | 2 Likes Like |Link to Comment
  • Spectrum Pharmaceuticals: Packed With Opportunities [View article]
    Agreed, moving along...
    Sep 16, 2010. 12:42 PM | 3 Likes Like |Link to Comment
COMMENTS STATS
54 Comments
54 Likes