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This was a company struggling to keep their doors open before a recent influx of millions in bullish investment capital and recent debt pay-offs. One can see trading volume increasing as speculators have begun to move in now that the most recent filings with the SEC have confirmed that CEL-SCI has also been quietly positioning itself as a player in the H1N1 space with solutions that will get the attention of parties at the CDC, FDA and beyond (if they haven't already).  This possibility now ringing more true than ever given the warning bells sounded by the Obama administration's advisory group on Science and Technology, who said in a report released yesterday afternoon that the H1N1 flu virus could cause as many as 30,000 and 90,000 deaths in the United States and that it "poses a serious health threat" to young people and children- unlike past strains of the virus.

The widely published report predicts that at least 1.8 million people will be hospitalized during the epidemic, with up to 300,000 patients requiring intensive care units. These patients could occupy 50-100 percent of all ICU beds in affected regions at the peak of the epidemic and would place "enormous stress" on ICU units.

Keep in mind that these are U.S. numbers alone and that this is one of the few countries with the financial resources to begin "hording" vaccine suuplies.  Imagine what the impact might be in coutries with far, far fewer resources.

From a trading standpoint, one need only look at the recent run ups by "small" companies like Novavax, Inc. (NasdaqGM:NVAX), BioCryst Pharmaceuticals Inc. (Nasdaq:BCRX), and Generex Biotechnology (Nasdaq:GNBT) to realize that speculative buyers have not only been turning the increasingly bad news into a Swine Flu Bonanza. Look at what those stocks were trading at back in March and realize that it only gets more interesting from here.

And so, day after day, we see press releases from companies attempting to position themselves as players in this space. Still, few have offered solutions that prove substantive after a close look under the microscope, both figuratively and literally.By contrast, CEL-SCI has become tantalizingly alluring because they have kept their head down, busily preparing both in the lab and via back channels in Washington- at least according to some sources at our nations capital, interestingly, not far from where CEL-SCI is headquartered.

When I first approached them for comments after stumbling across them while doing research for my investigative article about H1N1 they said only enough as was required. Now, more details have emerged about the rumored flu vaccine and treatment I first told our subscribers about over the weekend. Although the details were very sketchy when we interviewed the company CEO, Geert Kersten on Friday, we have now pieced together more information about their innovative, dare I say revolutionary, approach to dealing with the growing flu problem.The latest filing with the SEC confirms, that CEL-SCI has created one (and perhaps even several) potential peptide vaccine/treatments against H1N1 swine flu using their L.E.A.P.S.™ technology- a patented, T-cell modulation, peptide epitope delivery technology. The platform has enabled CEL-SCI to begin pre-clinical formulation, evaluation and testing of a new application of its H1N1 vaccine, which will allow the targeting of "mutated" versions of H1N1 swine and other influenza viruses. World health officials believe that the influenza virus may mutate and evolve between now and the winter flu season. According to the filing:"In conjunction with the testing, CEL-SCI has produced several L.E.A.P.S. flu vaccines that focus on the conserved, non changing epitopes of the different strains of Type A Influenza viruses (H1N1,H5N1, H3N1, etc.), including "swine", "avian or bird", and "Spanish Influenza", in order to minimize the change of viral "escape by mutations" from immune recognition. CEL-SCI's L.E.A.P.S. flu vaccine contains epitopes known to be associated with immune protection against  influenza in animal models."This is a developing story. As we mentioned earlier we have scheduled an interview with the company CEO, who was not available for immediate comment.It is known, however that administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated, peptide antigens and may provide a new method to treat and prevent certain diseases (the company has disclosed that they are also working on a potential rheumatoid arthritis vaccine)."The ability to generate a specific immune response is important because many diseases are often not combated effectively due to the body's selection of the 'inappropriate' immune response. The capability to specifically reprogram an immune response may offer a more effective approach than existing vaccines anddrugs in attacking an underlying disease."Also according to the filing, CEL-SCI also discovered a second peptide named CEL-2000."The data from animal studies of rheumatoid arthritis using the CEL-2000 treatment vaccine demonstrated that CEL-2000 is an effective treatment against arthritis with fewer administrations than those required by other anti-rheumatoid arthritis treatments, including Enbrel(R). CEL-2000 is also potentially a more disease type specific therapy, is calculated to be significantly less expensive and may be useful in patients unable to tolerate or who may not be responsive to existing anti-arthritis therapies."

New details have begun to emerge about Cel-Sci Corporation's (Amex:CVM) new new, state-of-the-art "Cold-Fill" manufacturing facility which will not only be used to manufacture Multikine® the world's first immunotherapeutic agent (which is being developed as a first-line standard of care treatment for cancer) for both the Phase III trials and commercial sales, but CEL-SCI plans to offer the use of the facility as a service to pharmaceutical companies and others, particularly those that need to "fill and finish" their drugs in a cold environment (4 degrees Celsius, or approximately 39 degrees Fahrenheit).

This is a key process of filling injectable drugs in a sterile manner and is an important part of the manufacturing process for many medicines.

This lab, which many now consider a cornerstone to the future financial success of the company is located near Baltimore, MD. According to newly released documents filed with the SEC, it was designed over several years, and was built out to CEL-SCI's specifications during the past 18 months. One insider calls it "absolutely state-of-the art" and "extremely impressive down to the smallest screw."

An interview between CEL-SCI's CEO, Geert Kersten, has been scheduled and more details will follow in this space as soon as I can provide them, but CEL-SCI believes it will be able to charge approximately $150,000 for an eight hour fill and finish "run" at this extremely unique facility whose aseptic filling suites are maintained at FDA and EU ISO classifications of 5/6. CEL-SCI also has the capability to formulate,inspect, label and package biologic products at cold temperatures. Furthermore, the company discloses that they do not know of any other facility in the United States which is able to provide cold 4 degrees Celsius finish and fill services on a contract basis.

What this will mean for the financial security and future of the company is significant, particularly given the fact that the  fastest  area of growth in the  biopharmaceutical  and  pharmaceutical markets is biologics,  and most recently stem cell products. These compounds andtherapies are derived from or mimic human cells or proteins and other  molecules.  Nearly  all of the major  drugs  developed  for unmet medical  needs  (e.g.,   Avastin(R),   Erbitux(R),   Rituxan(R),   Herceptin(R), Copaxon(R), etc.) are biologics.  Biologics are usually very sensitive to such things as heat and humidty and are known to  quickly  lose their  biological  activity  if  exposed to room or elevated  temperatures (which may also affect the shelf-life of a biologic- with the  result being  that the  product  cannot be  stored  for as long as desired).  These products do not generally lose activity when kept at 4 degrees Celsius.

This story continues to develop and we will keep you posted.

Disclosure: No Positions

(IMUC.OB) is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells (CSCs), based on two distinct technology platforms - active (cancer vaccines) and passive (monoclonal antibodies or mAbs). This approach is in the early stages of development, but has the potential to become a disruptive, paradigm shifting therapeutic approach to the treatment of cancer. CSCs are resistant to standard treatments such as chemotherapy and radiation, but numerous bio-markers on these cells have been identified which can be used to develop targeted mAbs and CSC immunotherapy products.

Although CSCs account for a small proportion of the cells in a given tumor, a growing body of scientific literature suggests CSCs drive the process of tumor growth and recurrence (even after the disease is undetectable and thought to be eradicated). Current therapeutic options such as radiation therapy or chemo target the proliferating cells, which form the bulk of any tumor mass while the CSCs lie dormant and unaffected at the root of the disease. Click here for a link to several overview articles on CSCs at MIT's Technology Review website.

The Company is developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) stem cell cancer vaccine (ICT-121) which targets a protein marker called CD133 which is typically expressed only on cancer stem cells and not on normal cells. CSCs are responsible for the prolific growth of primary and metastatic tumors and these cells must be eliminated for the complete eradication of a tumor to prevent recurrence of the disease (which may occur after months or years of being free of cancer).

While glioblastoma (GBM, a deadly type of brain cancer) will be the initial target for ICT-121, CD133 is also over-expressed in a wide variety of cancers such as colon cancer, breast cancer, liver cancer, prostate cancer, multiple myeloma and melanoma. In late June, IMUC announced an agreement with Formatech, Inc. to manufacture the Company's CSC vaccine product candidate (ICT-121) for an upcoming Phase 1 clinical trial in early 2010 targeting GBM. The deal includes a provision for Formatech to prepare the cancer vaccine vials for the clinical trial in a FDA-compliant GMP (Good Manufacturing Practices) environment.

The Phase 1 study for ICT-121 will involve 20 patients with GBM receiving five treatments each with final data from the trial anticipated after about 18 months (e.g. 3Q11), since the median time to recurrence in GBM patients is only 6.9 months. The Company is focusing on the following deadly forms of cancer which represent unmet medical needs with the following incidence of new cases each year according to American Cancer Society statistics for 2008: brain (21,800), small-cell lung (215,020), and pancreatic cancer (37,680). These cancers represent an unmet medical need with a 15% five-year survival rate for this trio, compared to a five-year survival rate for  breast cancer that is nearly 6X higher. A major problem is the recurrence of disease after initial treatment which is IMUC's target by focusing on residual disease (CSCs) following surgery in combination with standard radiation/chemo treatments.

IMUC uses peptides (the building blocks of proteins comprised of amino acid chains) in combination with another compound called an adjuvant to elicit a targeted immune response by T cells to destroy CSCs. This T cell response targets CSCs with a specific bio-marker (CD133 positive CSCs) that has been identified in a number of cancer types such as those outlined earlier. The goal of the Company's cancer vaccine approach is to combine conventional treatment(s) such as chemo or radiation with a product such as ICT-121 to target the residual CSCs to eliminate or delay the recurrence of cancer following treatment. The current treatment for brain cancer (GBM) typically involves a combination of surgery, radiation treatment, and chemotherapy which may lead to tumor cell DNA mutations or other changes leading to treatment-resistance and/or tumor recurrence.

At ASCO 2009, IMUC presented promising Phase 1 clinical data for ICT-107, which is the Company's dendritic cell-based cancer vaccine product candidate for the treatment of GBM (the most common and malignant type of brain cancer). The data presented at ASCO supplement the preliminary data from the completed study that IMUC initially reported in December 2008. The study enrolled 19 patients, including 16 with newly-diagnosed and three with recurrent disease. IMUC will seek a partnership to fund the future clinical development of ICT-107 as it focuses its resources on ICT-121 and cancer mAbs.

ICT-107 is the Company's patient-specific therapeutic cancer vaccine (in contrast to ICT-121 as an off-the-shelf vaccine) product candidate that consists of dendritic cells (immune system cells also referred to as antigen presenting cells or APCs that present molecules to the immune system to elicit a reaction) which are obtained from the patient's blood and programmed with tumor antigens which in turn provide a target for the immune system. Patients in the Phase I trial received three intradermal injections of ICT-107 at two-week intervals.

Seven of the 16 newly-diagnosed patients demonstrated stable disease with median progression-free survival of 64 weeks, and three of these seven patients have progression-free survival (PFS) exceeding two years, compared to the historical median PFS time of newly-diagnosed glioblastoma of just 30 weeks. ICT-107 was well tolerated with no significant adverse events (with no grade 3/4 adverse events and only mild side effects) reported in the study. Nine of the 16 newly-diagnosed patients had progressive disease with a median PFS of 39 weeks and median survival of 56 weeks. The three patients enrolled with recurrent disease exhibited disease progression, but still exhibited extended survival times of 34, 47, and 59 weeks.

Surasak Phuphanich, M.D., the principal investigator of the trial and a senior author of the ASCO presentation, stated that, "With a historical median PFS time of 6.9 months in GBM, we are encouraged to see a median PFS time of 14.2 months (57.5 weeks) in this newly-diagnosed glioblastoma (16 patients) population, and furthermore, it is exciting to see the correlation between immune response and survival given that the goal of ICT-107 is to elicit a cancer-specific immune response." A total of 15 patients in the trial were evaluated for immune responses, and six of them had a significant immune response to at least one tumor-associated antigen.

In early 2008, IMUC acquired a technology platform from Molecular Discoveries, LLC which referred to as DIAAD (Differential Immunization for Antigen and Antibody Discovery) for the rapid discovery of antigen targets to develop mAbs for the diagnosis and treatment of a wide variety of conditions with a focus on the detection and treatment of multiple myeloma, small cell lung cancer, pancreatic cancer, and ovarian cancer. The mAbs that IMUC acquired from Molecular Discoveries have been created to recognize certain bio-markers (antigens) which are highly specific to cancer cells and not expressed on normal cells to allow for the targeted treatment and detection of cancer cells.

The Company's mAb pipeline includes the following: (1) ICT-109 is a humanized mAb in development for the diagnosis of SCLC and pancreatic cancers; (2) ICT-037 is in preclinical development for therapeutic and diagnostic applications for colon cancer, ovarian cancer, and multiple myeloma; and (3) ICT-69 is in preclinical development for multiple myeloma and ovarian cancer.

The BioMedReports.com stock research section has recently been updated to include a research report for IMUC published by Griffin Securities on 4/27/09 with a buy rating and $2.50 price target (12-month) in addition to the most recent corporate presentation for the Company. The report presents both a discounted cash flow and transactions analysis models, which value IMUC shares at $2.50 and $3.10, respectively. On 8/18/09, IMUC's President and CEO, Manish Singh, Ph.D., presented an overview of the Company's business and strategy at the Southern California Investor Conference which I have uploaded in PDF format to provide a single file with all of the slides and images along with a link to the audio transcript from the event. Click here to visit IMUC's page on Facebook.

IMUC is also one of 10 components in the Mentor Capital Cancer Immunotherapy (CI) Index, which has posted a gain of about 23% since its inception six weeks ago. The equal-weight CI Index tracks the following stocks: Mentor Capital (MNTR.PK) (as a public-traded proxy for tracking Quantum Immunologics), Dendreon (NASDAQ:DNDN), ImmunoCellular Therapeutics, Antigenics (NASDAQ:AGEN), Biovest (BVTI.PK), Celldex Therapeutics (NASDAQ:CLDX), Oncothyreon (NASDAQ:ONTY), Northwest Biotherapeutics (NWBO.OB), CEL-SCI Corp. (AMEX:CVM), and Generex Biotechnology (NASDAQ:GNBT) ( as a proxy for its wholly-owned immunotherapeutic subsidiary, Antigen Express).

The CI Index is primarily a subset of my actively managed Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index, which reflects a cross-section of emerging cancer companies with market caps below $250 million at the time of index inclusion. In addition, Mentor Capital expects to update the CI Index on a weekly basis at its website.

As of the Company's most recent SEC 10Q filing on 8/14/09, IMUC had 14.65 million (M) shares of common stock outstanding, 9.7M options outstanding (at weighted average exercise price of $1/share or about 2X the current stock price of $0.55 as of 8/25/09), a market cap of $8M, zero debt, $2.3M in cash + investments, and a current cash burn rate of just $0.5M per quarter. In addition, IMUC has a strong intellectual property (IP) position, including seven issued patents and 17 pending applications that cover composition of matter, therapeutic treatments, and diagnostics related to CSC mAbs. Early next year (1Q10), IMUC expects to make an IND filing with the FDA for permission to begin human clinical trials for a Phase 1 study of its off-the-shelf cancer stem cell vaccine candidate (ICT-121).

The Company plans to raise $4-5M (sufficient to fund operations for 2.5 years) through a PIPE transaction with warrant coverage to fund Phase 1 trials of ICT-121 in GBM, pancreatic, and lung cancer; in addition to developing mAbs and additional vaccine candidates targeting CSCs. Any pending catalysts in the form of preclinical/clinical data, IND clearance to begin the Phase 1 trial for ICT-121, and development partnerships will have a major impact on IMUC given its low share count (less than 15M shares outstanding) and conservative valuation (market cap of about $8M) which ignores the Company's strong IP position as a pioneer in the emerging field of both active (vaccines) and passive (mAbs) immunotherapy product candidates focused on the root cause of cancer and its recurrence (CSCs).

Because of the very low cash burn rate of about $0.5M/quarter and $2.3M in cash + investments (sufficient to fund operations through at least mid-2010), IMUC has the luxury of waiting for higher stock prices before raising additional capital as the market becomes aware of the Company's prospects following expected catalysts before year-end that include partnership(s) for its CSC-targeting mAbs and feasibility data for ICT-109 in the detection of SCLC.  Beyond 2009, value-enhancing catalysts include preliminary clinical data for ICT-121 (e.g. immune response data), a potential partnership to fund further clinical development of ICT-107, the generation of additional CSC mAbs and vaccine product candidates, and additional partnerships for mAbs beyond the deal expected to occur before year-end.

Disclosure: Long IMUC.OB

(QI). QI is a privately held company with a goal of initially marketing its active immunotherapy for the treatment of breast cancer in the U.S., in addition to planning for new studies in other types of cancer and a new cancer screening tool. Mentor Capital is providing funding for QI to complete its ongoing, FDA-authorized Phase I/II trials for its experimental metastatic breast cancer treatment, in addition to possible acquisitions and additional clinical trials.

Currently, the 1,386 shareholders on Mentor Capital stock hold $145 million in stepped warrants that will provide a continual flow of equity to fund QI and other projects. Mentor Capital has $13.5 million in assets under management through its lead hedge fund's S&P 500 investment portfolio, which has generated a 31.4% annualized rate of return on MNTR.PK invested funds since inception last year compared to a flat 0% return for the Dow Jones Industrial Average in the same time frame, as previously announced on 5/27/09.

In addition to providing $2.2 million in funding to help support the FDA Phase I/II trial through approximately February 2010, Mentor Capital has agreed to assist QI in funding future strategic stock or cash acquisitions. The Company will also serve as a preferred funding source for QI during later stage or additional trials. In exchange for this funding support, Mentor Capital has received common stock in QI reflecting a carried interest of 20%. At the current private placement price for the QI shares, this 20% stake in QI increases the assets of Mentor Capital by $3.74 per share.

Mentor Capital has nearly completed its second year of financial audits, clearing the way to start the process of moving the stock off the Pink Sheets to become a fully-reporting entity on the OTCBB and eventually graduating to the AMEX or Nasdaq. As of year-end 2008, Mentor Capital had 221,742 average weighted common shares of stock outstanding and posted the following full-year financial results: 1) revenue = $308,435; 2) expenses = $264,985; and 3) after-tax income = $43,450 or $0.20 per share.

The Mentor Capital website also features a Cancer Immunotherapy (CI) Index of 10 stocks, which has posted a gain of about 23% since its inception six weeks ago on 7/10/09 to reflect the start of the Company's initial 20% stake in QI. The index currently features the following 10 component companies, in addition to Mentor Capital as a public-traded proxy for tracking QI: Dendreon (NASDAQ:DNDN), ImmunoCellular Therapeutics (IMUC.OB), Antigenics (NASDAQ:AGEN), Biovest (BVTI.PK), Celldex Therapeutics (NASDAQ:CLDX), Oncothyreon (NASDAQ:ONTY), Northwest Biotherapeutics (NWBO.OB), CEL-SCI Corp. (AMEX:CVM), and Generex Biotechnology (NASDAQ:GNBT) ( as a proxy for its wholly-owned immunotherapeutic subsidiary, Antigen Express).

The CI Index is primarily a subset of my actively managed Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index, which reflects a cross-section of emerging cancer companies with market caps below $250 million at the time of index inclusion. In addition, Mentor Capital expects to update the CI Index on a weekly basis at its website.

Quantum's approach to cancer immunotherapy involves sensitizing the dendritic cells from a patient's own blood to recognize and direct the body's immune system to attack breast cancer sites in a targeted effort to eradicate or stabilize the disease. This approach does not involve breast surgery (e.g. complete or partial removal of breast tissue), chemotherapy, or radiation - with the goal of eliciting a targeted immune response directed at cancer cells which may prove to be more effective and safer (i.e. a few days of temporary flu-like symptoms following treatment as the immune system attacks the cancer cells) than existing treatments.

Dendreon follows a similar approach for prostate cancer and has a market cap of about $2.7 billion as it prepares to become a commercial-stage company with the possible 2010 launch of Provenge (sipuleucel-T), following positive Phase 3 results announced earlier this year which demonstrated an acceptable safety profile and survival benefit beyond chemo that is expected to result in FDA approval for the treatment of metastatic, androgen-independent prostate cancer. Provenge is derived from a patient's own immune system (dendritic cells, hence the name Dendreon) and is poised (upon FDA approval) to become the first of a new class of therapeutics called active cellular immunotherapies (ACI) which are sometimes referred to as cancer vaccines (even though treatments such as Provenge are not designed to prevent the disease like Gardasil or Cervarix, which are designed to prevent HPV infection that is associated with cervical cancer).

The dendritic cells are extracted from patients by a process called leukapheresis (a blood collection process which isolates white blood cells) and then attached to an antigen (a molecule or substance which elicits a reaction by the immune system) known as prostatic acid phosphatase (PAP), which is specific to prostate cancer cells and is not found elsewhere in the body. Dendritic cells are the primary antigen presenting cells (APCs) for the immune system which activate a T cell response against a given antigen. The patient's APCs are then transported to the Company's manufacturing facility where they are co-cultured with a recombinant fusion protein containing PAP. The activated, antigen-loaded APCs (which is Provenge) is then delivered to the physician's office for infusion into the patient  with the goal of stimulating a T cell response targeted toward prostate cancer cells. The process is performed three times over the course of a four-week period, upon which treatment is completed.

The FDA-authorized Phase I/II clinical trial for QI is described in full detail at the ClinicalTrials.gov website with the official title posted as, "Phase I/II Vaccine Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP (immature laminin receptor protein) in Patients With Metastatic Breast Cancer." The University of South Alabama serves as a collaborator while the trial is sponsored by QI with a ClinicalTrials.gov identifier of NCT00879489. The Phase I/II clinical trial is structured as an open label, single-arm, interventional treatment study designed to assess both efficacy and safety in a single, combined trial. Combining Phase I/II into a single study saves about six months and $1 million from the clinical development process for Mentor/QI and reflects optimism toward the prospects for the Company's experimental cancer immunotherapeutic.

The study will be accomplished by collecting dendritic cells (APCs) from the each patient's blood using a machine to which the patient is connected through two small cannula placed into arm. The APCs will be manipulated in the lab with human recombinant oncofetal antigen (OFA/iLRP) and then injected into the skin of patients (intradermal administration). There will be a series of three monthly skin injections, administered at four-week intervals. The Company hopes to induce a safe, targeted anti-cancer response by this method and the outcome measures for the study will include toxicity/safety, response, survival, immunological monitoring, and time to disease progression. The OFA/iLRP patents are the by-product of 20 years and $30 million of research at The University of South Alabama Medical & Science Foundation and were primarily funded by the National Institute of Health's (NIH) National Cancer Institute (NCI).

The study utilizes an antigen that is found only on cancer cells and is not detected on normal tissue. The molecule is known as oncofetal antigen or OFA because it is only found on cancer cells and early-stage fetal cells/embryos in the womb. Because OFA is unique to cancer, the Company believes OFA could be used to train the patients' own immune system to mount a targeted attack of cancer cells which express this antigen. Although OFA has been found in large concentrations on all cancer types, it was found to be especially abundant in breast cancers. A study published in a medical journal (Blood. 2003;102:4416-4423) stated that it has been documented in previous rodent and human studies that OFA-iLRP is an immunogenic protein that can specifically activate both T and B lymphocytes, making it an ideal antigen for immunotherapeutic strategies directed against all types of human cancer.

The Phase I/II clinical trial is designed to examine the inherent immune response in breast cancer patients directed towards OFA/iLRP and whether this immune response could be amplified and modified through actively vaccinating using autologous (patient-derived) OFA/iLRP-pulsed dendritic cells which are re-injected into cancer patients. OFA/iLRP is the chosen target for this immunotherapy product candidate because it has been found to be expressed in all human cancers examined so far, including myeloid + lymphoid leukemias, lymphomas, renal cell (kidney) carcinomas, prostate cancer, breast cancer, lung cancer, melanoma, squamous cell carcinoma, and ovarian cancer.

Furthermore, OFA/iLRP is not found in normal human tissue after mid-gestation during early fetal development. OFA/iLRP is not only a highly-specific tumor marker, but it is also immunogenic in humans (i.e. eliciting a response by the immune system) based on studies outlined at QI's website. By producing dendritic cells which are personalized from each breast cancer patient's blood monocytes, loading them with OFA/iLRP, and inducing their maturation with cytokines, QI produces an OFA/iLRP-specific autologous cellular therapy for the treatment of metastatic breast carcinoma.

The mechanism of action of this active cancer immunotherapy product candidate is to generate a targeted and personalized immune T cell response that will fight the patient's cancer.  The OFA/iLRP-loaded mature, moDCs (monocyte-derived dendritic cells) do not have a direct cytotoxic effect as with traditional treatments such as radiation therapy or chemo. Rather, the anti-cancer effect is generated by the presentation of OFA/iLRP to activate each patient's T cells for a targeted immune response to OFA/iLRP, which is specific to the patient's cancer cells which express this marker.

This mode of action is distinct from chemotherapy, which kills not only tumor cells, but also affects normal cells such as those which divide rapidly (e.g. hair, GI tract, etc.). This approach is also different from immune-therapies that generically stimulate the immune system (e.g. cytokines such as Interleukin-2 or IL-2) or specifically target the tumor via an anti-tumor antibody (Herceptin- trastuzumab).  Because the product requires the development of an immune response after administration, there is some delay in the potential effect of the product with the generation of each patient's immune response and a clinical effect of that may take several weeks to develop, and is typically characterized by transient, flu-like symptoms rather than the harsh side effects of radiation and/or chemotherapy.

On 7/15/09, Mentor Capital announced that QI met a significant milestone which marked the beginning of its Phase I/II breast cancer trial upon the completion of the first clinical treatment injection. The Phase I/II clinical trial is testing the safety and efficacy of QI's immunotherapy on 27 Stage IV breast cancer patients who have failed conventional therapy, and the Company expects to provide updates on the study as it progresses. Mentor Capital's CEO, Chet Billingsley, stated that, "The successful initiation of concurrent Phase I/II trials represents an important step in the value equation for QI. Comparing the cost to acquire 20% of other dendritic immunotherapy companies, like Dendreon, with Mentor Capital, which holds 20% of QI, will reveal attractive buying opportunities for biotechnology investors, now that QI is at the clinical stage."

With expected updates and news flow from the ongoing Phase I/II clinical trial, Mentor Capital offers investors an under-the-radar opportunity for a promising new cancer immunotherapy approach which could apply to all types of cancer since OFA is only expressed on cancer cells and in early-stage fetal/embryonic development. At the current private placement price for the QI shares, Mentor Capital's 20% stake in QI increases the assets of the Company by $3.74/share, which is more than 2X the current stock price of $1.80/share. The prospects for this study and Mentor Capital are excellent since QI was given the okay for a combined Phase I/II trial, the study targets a cancer-specific marker (OFA/iLRP), the patents represent the by-product of two decades + $30 million of research that was primarily funded by NIH/NCI, and the previously announced positive Phase 3 results + potential 2010 launch of Provenge by Dendreon heightens investor awareness of the entire cancer immunotherapy space.

Below is a Q+A session that I conducted for BioMedReports.com (BMR) earlier this week with Mentor Capital's CEO, Chet Billingsley (CB), to provide an update on the Company's stock and the expected timeline for clinical data catalysts from QI's ongoing Phase I/II study. Click here to visit Mentor Capital's page on Facebook.

1.) BMR: What is your outlook for the Mentor Capital Cancer Immunotherapy (CI) Index?

CB: The market cap of the index is $3.3 billion, while the potential commercial opportunity is approximately $45 billion.  If one fair notion of total value is to set it equal to one times revenue, then that would suggest the 10 CI Index component companies will appreciate by a factor of 13x  (1,300%) much like Dendreon did this spring.  Or, if the full value for the sector won't be harvested for eight years, then the compound annual growth rate for the sector would be projected to appreciate at 33% annually, compounded for eight years.

2.) BMR: What is the estimated timeline for clinical data catalysts from the ongoing Phase I/II trial?

CB: The May 2010 timeline (as listed on the ClinicalTrials.gov website) for clinical data on the study's primary outcome is unchanged. We are targeting to have all 27 women started in the three-month procedure by the end of December 2009.  That puts them to be at the reportable stage by March 2010.  So, having clinical data available by May 2010 is still good (most of the data will be ready one or three months in advance of this). That being said, this assumes the availability of suitable trial test subjects and that is always a little dicey.  So far, it does look good, however.

3.) BMR: Since Mentor Capital ended 2008 with less than 250,000 shares of common stock outstanding, what is the current status of the Company's liquidity with regard to available shares of common stock?

CB: Mentor Capital is continually adding freely trading shares because its 1,400 shareholders are continually exercising registered warrants.  About 72,000 shares were added in the last three weeks.  Currently, there are 700,000 shares outstanding and another 28 million warrants total, in steps at $1, $3, $5, and $7 per share. The structure was designed to expand with increasing liquidity as the share price and market cap grows.  No shares have been issued for services, or to promoters, or in lieu of salary.  There are no 144 shares (a class of restricted stock), European shares, or blocks of owner shares waiting to be sold.

I believe, in 25 years, I have sold about 5,000 shares of stock. All but 15,000 of the current 700,000 shares of common stock were purchased by the exercise of $1 or $3 warrants during the last year.  It is unlikely that many sellers will be interested in selling for less than $2/share, however, I believe there would be an ample supply of shares that could be purchased in the $2.30 range from individuals that will hold out to get more than $2 per share before they exercise their warrants at $1 and sell above $2.  I expect no problems with having shares available for sale at any price less than $8.80/share.  At that point, the Company would have collected $145 million in fresh cash and have a market cap of $250 million.

Disclosure: Long MNTR.PK

The CI Index was developed by Mentor Capital as a peer group index against which investors could bench mark stock performance in the rapidly growing immunotherapy sector. In this first reporting, the strong six-week CI Index gain was paced by the 78% share price improvement of Mentor Capital, Inc. (Pink Sheets: MNTR - News).

On July 10, 2009, Mentor Capital announced it had acquired a significant interest in and was a new public market proxy for Quantum Immunologics, Inc., a private company in FDA breast cancer trials. Oncothyreon (NASDAQ:ONTY - News), with significant lung cancer involvement, followed in CI Index performance with a 71% gain in its stock. Dendreon (NASDAQ:DNDN - News), with $2.7 Billion market capitalization, is the largest company in the Cancer Immunotherapy Index, and experienced a 1,000% share price gain during the Spring of 2009.

In cancer immunotherapy, instead of chemotherapy, surgeries and radiation, the body's own immune system is triggered to attack cancer cells. Patients report only flu-like symptoms as their now activated natural defenses attempt to eradicate or stabilize the targeted cancers. The USA market addressed by the Cancer Immunotherapy Index companies is estimated at $45 Billion.

The current combined market cap of the index component companies is $3.4 Billion. In addition to Mentor Capital, Oncothyreon and Dendreon, the CI Index features ImmunoCellular Theraputics (IMUC.OB), Antigenics (NASDAQ:AGEN - News), Biovest International (BVTI.PK), Celldex Therapeutics (NASDAQ:CLDX - News), Northwest Biotherapeutics (NWBO.OB), CEL - SCI Corp. (AMEX:CVM - News) and Generex Biotechnology (NASDAQ:GNBT - News) as a proxy for its wholly-owned immunotherapeutic subsidiary, Antigen Express.

The CI Index was developed in consultation with Mike Havrilla, PhD, co-founder and Managing Editor of BioMed Reports. Dr. Havrilla actively manages 23 indexes. The Cancer Immunotherapy Index is primarily an immunotherapy subset of his Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index. Weekly detail updates of the Cancer Immunotherapy Index may be reviewed at Mentor Capital's website.

 Disclosure: Long IMUC.ob, MNTR.pk 

ImmunoCellular Therapeutics (OTC: IMUC.OB) is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells (CSCs), based on two distinct technology platforms - active (cancer vaccines) and passive (monoclonal antibodies or mAbs).

This approach is in the early stages of development, but has the potential to become a disruptive, paradigm-shifting therapeutic approach to the treatment of cancer. CSCs are resistant to standard treatments such as chemotherapy and radiation, but numerous bio-markers on these cells have been identified which can be used to develop targeted mAbs and CSC immunotherapy products.

IMUC’s President and CEO, Manish Singh, PhD, published an article in mid-June at Genetic Engineering & Biotechnology News (GEN) that outlined three distinct approaches targeting CSCs – including small molecules, mAbs, or vaccines. Small molecules act by disrupting the cell signal pathway of CSCs to halt the process of tumor formation. mAbs target bio-markers that are over-expressed on CSCs as compared to normal cells or stem cells in the body. Finally, active immunotherapy seeks to recruit the immune system to selectively target and destroy CSCs while sparing normal cells.

 

Although CSCs account for a small proportion of the cells in a given tumor, a growing body of scientific literature suggests CSCs drive the process of tumor growth and recurrence (even after the disease is undetectable and thought to be eradicated). Current therapeutic options such as radiation therapy or chemo target the proliferating cells, which form the bulk of any tumor mass while the CSCs lie dormant and unaffected at the root of the disease. Thus, a non-detectable number of CSCs may persist even after a patient is in remission, leading to the potential for recurrence of the disease.

 

In the article, Dr. Singh discusses CD133 (Prominin-1) as the most important target because it is over-expressed in a large variety of CSCs and recent studies have demonstrated a poor prognosis in brain tumor patients with high concentrations of this biomarker (Rebetz et al. 2008). IMUC’s cancer immunotherapy candidate, ICT-121, is expected to begin Phase I/II clinical testing in humans in early 2010 as an off-the-shelf product (i.e. does not require obtaining cells from the patient as part of the manufacturing process). ICT-121 works by eliciting a targeted T cell immune response specific to MHC class I molecules (which are highly specific to CSCs and cancer cells) and CD133+ cells, since CD133 also occurs on normal cells at reduced levels (e.g. 4,500 copies on a normal cell versus 30,000-180,000 copies on a CSC).

 

Blockbuster potential exists for ICT-121 targeting an unmet medical need (brain cancer initially, then pancreatic cancer) and is designed for use in combination with the current standard of care (i.e. surgery, chemo, and radiation therapy) to target residual disease as a paradigm-shifting treatment with the goal of completely eradicating the presence of cancer cells and their future recurrence or spread. IMUC is also developing CSC-targeting mAbs for both therapeutic and diagnostic applications in the treatment of cancer.

 

The BioMedReports.com stock research section includes a report for IMUC published by Griffin Securities in April with a buy rating and $2.50 price target (12-month) in addition to the most recent corporate presentation for the Company from mid-August. Click here to visit IMUC's page on Facebook. Click here to read my full overview article on IMUC at BioMedReports.com from late August, which includes a summary of the Company’s pipeline and expected catalysts before year-end into early 2010.

 

IMUC is also the top gainer (+200%) among 10 components in the Mentor Capital Cancer Immunotherapy (CI) Index, which has posted a gain of about 57% since its inception seven weeks ago. The equal-weight CI Index tracks the following stocks: Mentor Capital (MNTR.PK) (public-traded proxy for Quantum Immunologics), Dendreon (NASDAQ:DNDN), ImmunoCellular Therapeutics, Antigenics (NASDAQ:AGEN), Biovest (BVTI.PK), Celldex TherapeuticsOncothyreon (NASDAQ:ONTY), Northwest Biotherapeutics (NWBO.OB), CEL-SCI Corp. (AMEX:CVM), and Generex Biotechnology (NASDAQ:GNBT) (public-traded proxy for its wholly-owned subsidiary Antigen Express). (NASDAQ:CLDX),

 

Disclosure: Long IMUC.ob, MNTR.pk

 

Generex Biotechnology Corp (GNBT) Interview on MN1. Recorded Live on September 27, 2006.

Astea International, Generex Biotechnology, NYSE Group, Applied Materials, Intuitive Surgical, Baidu.com