The BioMedReports.com stock research download section has been updated today to reflect my new 22-page PDF report and overview of Mentor Capital (MNTR.PK), Quantum Immunologics (QI) (privately held), and clinical / regulatory updates for several other companies in the cancer vaccine that are outlined below and summarized in the report.
Mentor Capital is a public-traded, private equity firm that specializes in acquisitions. The Company provides passive equity funding and liquidity to smaller companies and owners by investing in select shelf IPOs, public, and private companies to provide public market access to owners of small private companies. In early July 2009, as the first of four steps leading to a potential merger and name change, MNTR.PK acquired a 20% ownership stake in the privately-held cancer vaccine company, QI.
In mid-December, Mentor Capital announced plans to launch an actively managed Cancer Immunotherapy (CI) Index fund shortly after New Year's Day that will be based on the underlying Mentor Capital CI Index, which has gained 45% on an equal-weight basis since its inception on 7/10/09. MNTR.PK intends to invest a significant portion of the cash proceeds from the exercise of warrants which are currently outstanding on a stepped-price basis at $1, $3, $5, and $7 per share.
The Company also announced that $1.2 million each in initial seed funding for the CI Index will be provided in approximately equal parts by Mentor Capital management, WellCap Partners (fund administrator) , and MNTR.PK Series C (previously at $5) warrant holders. Mentor Capital currently has about 900,000 shares outstanding and the Series C warrants were called last week at $0.65 (for a period of 45 days) to provide approximately one-third of the initial seed funding for the CI Index fund.
QI's approach to cancer immunotherapy involves sensitizing the dendritic cells (which present foreign antigens to the immune system) from a patient's blood to educate and direct the immune system to attack malignant tumor cells in a targeted effort to eradicate or stabilize the disease. This integrated approach to the treatment, diagnosis, and monitoring of cancer is being developed to create novel, individualized products and services that offer a high rate of efficacy and minimal side effects by harnessing the innate power of the immune system in a targeted manner against the disease.
QI expects to complete enrollment of all 27 patients in the ongoing Phase I/II trial for metastatic breast cancer by the end of 1Q10, at which time preliminary data is expected from the initial cohort of patients that will be discussed with the FDA to design a pivotal, Phase IIb/III clinical trial that could begin in late 2010.
QI is the exclusive licensee of various patent rights in the U.S., Europe, and other countries for the use of OFA to diagnose, monitor, and treat multiple types of cancer. The OFA-iLRP patents are the by-product of 20 years and $30 million of research primarily funded by the National Institute of Health / National Cancer Institute. In addition, QI has filed two provisional patents related to OFA peptides, further expanding QI’s patent estate.
Dendreon (NASDAQ: DNDN) follows a similar approach to QI, except that Dendreon is initially focused on the treatment of prostate cancer as it prepares to become a commercial-stage company with the possible early to mid 2010 launch of Provenge (sipuleucel-T). 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 also referred to as therapeutic cancer vaccines.
In November 2009, Dendreon announced that it completed the submission of an amended Biologics License Application (BLA) for Provenge, seeking FDA approval for men with metastatic castrate-resistant prostate cancer (CRPC). The amended BLA includes data from the IMPACT trial, which was conducted under a Special Protocol Assessment (SPA) with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. Provenge is currently available through several ongoing clinical trials, including OpenACT (an open label trial enrolling men with metastatic CRPC), ProACT, and NeoACT.
In late April 2009, Dendreon announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011. On 11/20/09, the FDA accepted Dendreon’s amended BLA as a complete response and set a PDUFA action date of 5/1/10 for an expected FDA decision for Provenge.
In mid-November, Oncothyreon (NASDAQ: ONTY) reported its quarterly results and provided a development pipeline update. Stimuvax (BLP25 liposome vaccine, L-BLP25) is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, which is a glycoprotein antigen widely expressed on common cancers, including lung cancer, breast cancer, prostate cancer and colorectal cancer. ONTY’s partner for the development of Stimuvax, Merck KGaA / Serono (MKGAY.PK), is actively enrolling patients in two global Phase 3 trials.
Initiated in February 2007, START is a randomized, double-blind, placebo-controlled study in patients with documented unresectable stage III non-small cell lung cancer who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. NCT00409188 is the ClinicalTrials.gov identifier for this study, which currently has an estimated date of December 2010 for final data collection of the primary outcome measure with an estimated enrollment of 1,322 patients.
STRIDE is a randomized, double-blind, placebo-controlled study in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer, initiated in June 2009 with a primary endpoint of progression-free survival (PFS). NCT00925548 is the ClinicalTrials.gov identifier for this study, which currently has an estimated date of September 2012 for final data collection of the primary outcome measure with an estimated enrollment of 909 patients.
ONTY is also developing BGLP40 as a completely synthetic MUC1-based liposomal glycolipopeptide cancer vaccine for potential use in several cancer indications. The antigen incorporated in BGLP40 combines carbohydrate and peptide determinates in a multi-epitope vaccine that evokes both cell- and antibody-mediated immune responses against major cancer-associated targets expressed on adenocarcinomas. The vaccine also includes the fully synthetic PET-lipid A adjuvant which is proprietary to ONTY, which currently intends to substantially complete the pre-clinical development of BGLP40 in 2010, with the goal of initiating clinical development in 2011. Merck KGaA / Serono has a right of first negotiation with respect to the development or marketing of BGLP40.
Celldex Therapeutics (NASDAQ: CLDX) is developing CDX-110 (PF-04948568) along with Pfizer (NYSE: PFE) as a cancer immunotherapy product candidate targeting the tumor specific molecule called EGFRvIII, which is a functional variant (tumor-specific) of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy (i.e. Erbitux). CDX-110 is currently being evaluated in a Phase 2 study (ACT III) of CDX-110 in patients with newly diagnosed GBM. NCT00458601 is the ClinicalTrials.gov entry for this study (last updated on 11/20/09) and April 2010 is the estimated date for data collection for the primary outcome of progression-free survival status at 5.5 months from the date of first dose. The estimated study completion date is Nov 2010.
ImmunoCellular Therapeutics (IMUC.OB) is developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) peptide-based, therapeutic cancer stem cell vaccine (ICT-121) that targets a protein marker called CD133 that is over-expressed on cancer stem cells. The Phase 1 study for ICT-121 will involve 20 patients with glioblastoma (GBM is a deadly type of brain cancer) 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. ICT-121 may also be beneficial to patients with pancreatic, lung, colon, renal, melanoma, and breast cancers. IND Filings for ICT-121 are expected for brain tumors in during 1Q10 while IND Filings for ICT-121 for pancreatic cancer are expected during 3Q10.
In late October, IMUC presented new data for its therapeutic cancer vaccine product candidate ICT-107 as an update to preliminary data that was presented at ASCO 2009 in late May and included a median PFS survival time (defined as the time between surgical tumor removal and tumor recurrence) in the 16 newly diagnosed patients enrolled in the trial was 19 months, which is over 12 months longer than the historical PFS of just 6.9 months. In addition, seven of the 16 patients continue to show no signs of tumor recurrence while three of the patients have gone more than two years without disease progression. ICT-107 targets six glioma-specific peptides, including targets that are highly expressed on cancer stem cells and IMUC expects to sign a licensing deal to fund further clinical development of ICT-107 during 2010.
In early October, Inovio Biomedical (AMEX: INO) announced interim safety / immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation. The vaccine was found to be generally safe and well tolerated, and achieved significant cellular and humoral immune responses at the lowest dose administered. The vaccine is delivered using Inovio’s proprietary CELLECTRA intramuscular electroporation delivery device. Inovio expects to report interim data relating to safety and levels of immune responses (immunogenicity) from the second and third dose groups during 1H10 and plans to initiate a Phase 2 trial in late 2010.
This Phase I clinical trial is designed to test the safety and immunogenicity of VGX-3100 in women with a previous history of cervical intraepithelial neoplasia (CIN) 2/3, a precursor lesion prior to the development of cancer. This dose-escalation study is enrolling patients in three cohorts of six subjects each with DNA vaccine doses at 0.6 mg (0.3 mg each of two DNA plasmids), 2.0 mg, and 6.0 mg. The immunization regimen consists of each subject receiving three immunizations at the indicated dose.
Northwest Biotherapeutics (NWBO.OB) is developing DCVax-Brain as a personalized therapeutic cancer vaccine designed to stimulate a patient's own immune system to fight cancer. DCVax-Brain is comprised of a patient's own dendritic cells that have been activated to mobilize the whole immune system to recognize and destroy cancer cells bearing the biomarkers of the patient's own tumor. Each patient undergoes surgical removal of their tumor as part of the current standard of care, and also undergoes a blood draw to obtain their immune cells. The biomarkers from the patient's tumor tissue are exposed to the patient's immune cells in order to activate the patient's dendritic cells, which are subsequently injected back into the patient under the skin in the upper arm.
The 10-day manufacturing process produces several years of personalized vaccine for a patient, making DCVax-Brain an off-the-shelf product for that patient throughout the treatment period, following the initial collection, preparation, and manufacturing process. NCT00045968 is the ClinicalTrials.gov identifier for a Phase 2 study evaluating DCVax-Brain in GBM patients which currently has an estimated date of December 2011 for final data collection for the primary outcome measure. On 10/21/09, NWBO.OB reported that DCVax-Brain has begun a 240-patient Phase 2 clinical trial with 13 trial sites at medical centers across the U.S. and stated that the trial is not currently enrolling patients, but expects to resume doing so soon.
In late October, MannKind Corp. (NASDAQ: MNKD) announced that results of two Phase 1 studies demonstrate that the novel, investigational cancer vaccines MKC1106-MT and MKC1106-PP are well-tolerated and show encouraging immune response rates and objective tumor response in advanced melanoma, prostate cancer and other solid malignancies, setting the stage for Phase 2 studies.
MKC1106-MT is an active cancer immunotherapy product candidate consisting of three components, a DNA plasmid and two synthetic peptides, each of which is administered separately by the unique route of intranodal injection and together are designed to target two tumor-specific antigens that are commonly expressed by melanoma tumor cells. Findings reveal an immune response rate of greater than 40%, defined as the percentage of patients who showed elevated numbers of antigen specific T cells in the blood upon immunization, and preliminary evidence of clinical benefit. Of the 18 patients treated, 14 had visceral metastases and the remaining four had metastases confined to the lymphatic system.
MKC1106-PP is a similar agent being developed by MNKD that is designed to target two specific tumor antigens commonly expressed by various solid tumor cells. An immune response rate of 60% was observed and, of the 26 patients treated, seven patients achieved clinical responses defined as partial response (RECIST), change in PSA doubling time or stable disease for at least six months.
In late October, Antigenics (NASDAQ: AGEN) announced updated Phase 2 data for Oncophage (vitespen) for recurrent high grade glioma (brain cancer) for the first 20 patients treated, demonstrating a median survival of 10.1 months. Survival data continues to accrue on all patients in the study and thus far, six patients (30%) have survived at or beyond 12 months. The Phase 2 single-arm trial is designed to enroll about 50 patients with recurrent high-grade glioma.
Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines and then receive four weekly doses of Oncophage and then bi-weekly doses thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. The Brain Tumor Research Center at the University of California, San Francisco (UCSF), has initiated an additional Phase 2 clinical trial of Oncophage in combination with the standard of care (radiation + Temodar) for newly diagnosed glioma patients to evaluate median overall survival, progression-free survival and immune response.
CEL-SCI Corp. (AMEX: CVM) is awaiting validation of its cold fill contract manufacturing facility (which will also manufacture Multikine) before initiating a pivotal Phase 3 clinical trial of Multikine. The pivotal Phase 3 study is designed as an open-label, randomized, global multi-center trial to evaluate the effects of Multikine plus standard of care (SOC) therapy (surgery + radiation or surgery + concurrent chemo / radiation) in subjects with advanced primary squamous cell carcinoma of the oral cavity versus the SOC therapy only.
The primary objective is to determine the efficacy of peri-tumoral and peri-lymphatic injection of Multikine given prior to SOC as measured by overall survival with secondary objectives that include evaluating the effects of Multikine on the cumulative incidence of local / regional control, progression-free survival, tumor response, tumor histopathology, and quality of life, and confirming safety of the treatment. About 800 patients are expected to be enrolled in the study on a global basis that includes North / South America, Europe, and Asia.
In late May, Biovest (BVTI.PK) announced that an eight year pivotal, randomized, multi-center, double-blind, controlled Phase 3 clinical study has shown that BiovaxID (personalized therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular non-Hodgkin’s lymphoma. The study found that patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine – an increase of 47%.
In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. In late June, Biovest announced that BiovaxID is available on a named-patient (compassionate-use) basis in Europe and will be supplied by Idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin’s lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma.
Omnimmune [OTC: OMMH.OB] has licensed rights to platform monoclonal antibody (MAb) technologies and a multivalent cancer vaccine targeting two epitopes of HER-2 (Human Epidermal Growth Factor Receptor-2) (HER-2 is found in about 15-20% of breast cancers and is associated with increased disease recurrence and a worse prognosis). The cancer vaccine has completed a Phase 1 NCI-sponsored clinical trial. Omnimmune plans to sponsor Phase 2 and 3 trials and market the vaccine in collaboration with others. Omnimmune plans to develop prophylactic and therapeutic vaccines, monoclonal antibodies, and gene-based products, which target a hormone called human chorionic gonadotropin (hCG).
On 12/9/09, Immunovaccine [TVE: IMV.V] announced FDA clearance for its Investigational New Drug (IND) application to begin human studies of its therapeutic cancer vaccine (DPX-0907). DPX-0907 is the Company’s lead therapeutic cancer vaccine candidate which uses the DepoVax platform to deliver tumor specific antigens. DPX-0907 is designed to cause a depot effect that has the potential to stimulate the immune system to seek out and destroy cancer cells in patients with breast, ovarian and prostate cancer.
The Phase 1 clinical trial for DPX-0907 will be conducted at five sites in the US and is on track to begin enrolling patients with breast, ovarian, and prostate cancers by the end of 1Q10. The Phase 1 clinical trial will evaluate the safety and tolerability of the DepoVax delivery system and seven tumor-associated antigens. The activity of DPX-0907 has been demonstrated in preclinical models whereby the vaccine produced a specific cellular immune response that was superior to immune responses achieved with other oil depot vaccines. Preclinical research also reveals DPX-0907 does not induce regulatory T-cell immune suppression, therefore enabling a longer lasting anti-tumor immune response.
Disclosure: Long CLDX, IMUC.OB, MNTR.PK, QI
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