On paper, Oncothyreon Inc. (NASDAQ:ONTY) doesn't look like a particularly compelling investment. The pre-revenue biotech company is poised to keep booking sizable losses as it continues to work on its lung cancer drug tecemotide (formerly Stimuvax), which has rejected by the FDA last year but is still being reworked for a slightly different illness than was being targeted initially. And, with no other Phase 3 drug in its pipeline, traders may be rightfully wondering if there's any real catalyst for ONTY in the foreseeable future.
The doubts nagging ONTY even make sense... basically. As is the case with so may other biotech stocks though, Oncothyreon is a case where we need to pat close attention to what the market is telling us about the stock rather than the headlines. After all, it's the collective of traders that determine a stock's price - via the bidding process - and not the company's fiscal performance itself. If the market sees enough upside in ONTY, then technically speaking, it IS at least a good trade.
Top 5 Retail Companies To Watch For 2015: ImmunoCellular Therapeutics Ltd (IMUC)
ImmunoCellular Therapeutics, Ltd., incorporated on March 20, 1987, is a clinical-stage biotechnology company. The Company is engaged in developing immune-based therapies for the treatment of cancers, such as brain, ovarian and other solid tumors. Immunotherapy is an approach to treat cancer in which a patient�� own immune system is stimulated to target tumor antigens, which are molecular signals that the immune system uses to identify foreign bodies. The Company�� products include ICT-107, ICT-140, ICT-120, ICT-109 and DIAAD. ICT-107, the pipeline product, is a Phase II therapeutic dendritic cell (DC) vaccine for the treatment of glioblastoma multiforme (GBM), the common and lethal type of brain cancer. ICT-107 is designed to activate a patient�� immune system to target six different tumor-associated antigens. In February 2012, it acquired a world-wide license from the University of Pennsylvania and The John Hopkins University (JHU).
The Company in addition to ICT-107, is also developing other therapeutic DC vaccines: ICT-140 for ovarian cancer and ICT-121 for recurrent GBM. ICT-140 targets seven tumor-associated antigens expressed on ovarian cancer cells. ICT-107 is a DC vaccine that targets six different tumor-associated antigens that are found on patients��tumor cells; four of the six antigens are expressed on CSCs. The therapeutic vaccine is used subsequent to conventional therapy or concomitantly with chemotherapy in patients with newly diagnosed GBM. ICT-140 is a DC vaccine that targets seven different ovarian cancer antigens. ICT-121 is a DC vaccine that targets CD133 antigens; it has the potential to be a universal cancer vaccine because CD133 is widely expressed on CSCs from a majority of cancers. Data from this small study demonstrated that ICT-109 had a statistically ability to discriminate between cancerous and non-cancerous samples, suggesting the potential to detect pancreatic and lung cancer in plasma and serum study sets. The DIAAD (differential immunization for an! tigen and antibody discovery) platform it acquired from Molecular Discoveries utilizes immunological tolerization to accelerate the discovery of the molecular differences between diseased cells and their normal counterparts. The monoclonal antibodies produced by DIAAD provide the basis for the discovery and development of its potential diagnostic and therapeutic products.
The Company competes with Dendreon, Oncothyreon, Galena, Bavarian Nordic and Immunovaccine, Northwest Biotherapeutics, Prima Biomed, DCPrime, Roche/Genentech, Seattle Genetics, Bristol-Myers Squibb and Immunogen.
Advisors' Opinion:- [By Lauren Pollock]
ImmunoCellular Therapeutics Ltd.(IMUC) said its leading product candidate, a dendritic cell-based vaccine for brain cancer, didn’t show a statistically significant advantage in overall survival in a Phase II study. In a research note, Maxim Group said it is pushing its EU approval date target to 2019 and lowered its estimate on the stock to $12 a share from $18 a share. The stock plunged 62% to $1.04 premarket.
- [By Monica Gerson]
ImmunoCellular Therapeutics (NYSE: IMUC) dropped 11.05% to $1.3699. ImmunoCellular's trailing-twelve-month ROE is -59.80%.
Posted-In: market losersNews Movers & Shakers Intraday Update Markets
- [By Smith On Stocks]
Using my assumptions, the common of Agenus might be worth about $7.00 per share in early 2014 based on the royalties from the Glaxo vaccines and the net operating loss carry forward even if every other asset in the company were valued at zero. However, there may be substantial value in Agenus' internal vaccine programs in recurrent and newly diagnosed glioblastoma and the genital herpes vaccine. Based on a comparison to peer companies like Northwest Biotherapeutics (NWBO) and ImmunoCellular Therapeutics (IMUC), I believe that the internal programs at Agenus currently may be worth $150 million or $4.45 per share. Adding this to the value of the MAGE A-3 vaccine could produce a stock price of $11.00 in early 2014.
Hot Biotech Companies To Invest In 2014: Bellicum Pharmaceuticals Inc (BLCM)
Bellicum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on discovering and developing cellular immunotherapies for various forms of cancer, including hematological cancers and solid tumors, as well as orphan inherited blood disorders. The Company�� product pipeline includes clinical product candidates, such as BPX-501, which is an adjunct T-cell therapy administered after allogeneic hematopoietic stem cell transplantation; BPX-201, which is a dendritic cell cancer vaccine; and Preclinical product candidates, including BPX-701, which is a T cell receptor (TCR) product candidate for solid tumors; BPX-401, which is a CAR-T product candidate for hematological cancers that express the CD19 antigen, and BPX-601, which is a TCR product candidate for solid tumors expressing the preferentially-expressed antigen in melanoma (PRAME). The Company�� Chemical Induction of Dimerization (CID) technology platform engineers and controls components of the immune system in real time.
CaspaCIDe
CaspaCIDe is the Company�� Chemical Induction of Dimerization (CID) safety switch technology. The CaspaCIDe eliminates cells in the event of toxicity. The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9 (iCasp9), an enzyme that is part of the apoptotic pathway. The infusion of rimiducid triggers activation of this domain of caspase-9, which in turn leads to selective apoptosis of the CaspaCIDe-containing cells. The CaspaCIDe technology is applied to its lead clinical product candidate, BPX-501 and to its TCR product candidate, BPX-701.
The CaspaCIDe technology has demonstrated clinical efficacy in human patients beginning as soon as 30 minutes after administration of the activating drug, rimiducid. In the preclinical studies, rimiducid reduced or eliminated CaspaCIDe-containing cells in a dosage dependent manner. The National Cancer Institute is conducting a Phase I/II clinical trial for sarcoma! and other solid tumors with a chimeric antigen receptor (CAR) construct targeting a solid tumor antigen combined with CaspaCIDe.
CIDeCAR
CIDeCAR Technology consists of a CAR T cell that incorporates its co-stimulatory domain, MC, for improved T-cell activation and proliferation, and the CaspaCIDe safety switch. CAR interaction with cancer cell antigens leads to MC signaling, which then leads to activation of T cells. In the event of serious toxicity, rimiducid activation of caspase-9 eliminates the CIDeCAR T cells.
The Company has conducted proof-of-principle preclinical studies for CIDeCAR technology, CIDeCAR candidate BPX-401 and CIDeCAR solid tumor CAR targeting Her2, in which, both were evaluated in vitro. These preclinical studies demonstrated that CIDeCAR technology results in enhanced activation, proliferation and tumor cell killing; and the elimination of these CIDeCAR T cells after exposure to rimiducid.
GoCAR-T
The Company�� GoCAR-T technology incorporates a switch that activates CAR T cells when triggered by both rimiducid and the targeted antigen expressed on the surface of the cancer cells. The GoCAR-T technology separates the CIDeCAR dual co-stimulatory domain, MC, from the antigen recognition domain and moves it onto a separate molecular switch that can be controlled by rimiducid. GoCAR-T cells can only be fully activated when exposed to both the cancer cells and rimiducid. This separation controls the degree of activation of the CAR T cells through adjustments to the amount of rimiducid administered, but still in a tumor-dependent manner.
The Company conducted a proof-of-principle in vitro study for GoCAR-T technology, in which it demonstrated that the GoCAR-T cells targeting the PSCA antigen can only be fully activated, as evidenced by production of IL-2 (left panel) and T-cell proliferation (right panel) when the GoCAR-T cells are exposed to both their target PSCA-expressing human pancreatic cancer cells ! and rimid! ucid. In further in vivo studies of GoCAR-T technology, target antigen PSCA-expressing Capan-1 human pancreatic tumors were established in immune-deficient, or NSG, mice. After seven days, five mice received control T cells modified only with firefly luciferase, an imaging protein, and 10 mice received T cells modified with MC in the form of a molecular switch or iMC, plus a PSCA. CAR (together, BPX-601) and firefly luciferase. Five mice in this second group also received 5 mg/kg rimiducid weekly. T-cell imaging clearly demonstrated that GoCAR-T cells can be stimulated to proliferate in vivo when exposed to target antigen-expressing cancer cells by rimiducid administration.
DeCIDe
The DeCIDe technology is used to control the activation of dendritic cells. The DeCIDe technology couples the signaling domains of CD40 and MyD88 to its CID binding domain, to create inducible MC switch, which is then insert into dendritic cells along with the PSMA antigen to take control of the activation of the dendritic cells and the resulting immune response to cancer. Upon exposure to rimiducid, DeCIDe-containing dendritic cells become highly activated. The DeCIDe technology activates dendritic cells with rimiducid after the patient has been vaccinated and the dendritic cells have migrated to the draining lymph nodes.
The cultured BPX-201 cells transduced with DeCIDe switch technology produce supra-normal levels of IL-12 in response to rimiducid. These data demonstrates that, in addition to the temporal control of dendritic cell activation that DeCIDe technology affords, once exposed to rimiducid, DeCIDe-containing dendritic cells become highly activated, which may lead to more potent anti-cancer activity in patients.
BPX-501
The Company�� CaspaCIDe product candidate BPX-501, is under development for the treatment of hematological diseases. BPX-501 is an adjunct T-cell therapy administered after allogeneic hematopoietic stem cell transplantation (HSCT), us! ing donor! stem cells. The BPX-501 eliminates donor T cells through the triggering of the CaspaCIDe safety switch upon emergence of Graft-versus-host disease (GvHD). The BPX-501 improves stem cell engraftment and accelerates immune system recovery, while providing for resolution of GvHD. The BPX-501 has a range of applications: an add-back of donor T cells administered to accelerate immune system recovery after allogeneic haplo-HSCT in which the T cells in the transplanted stem cells were depleted, and a donor T-cell infusion administered to prevent or treat relapse of underlying disease after allogeneic HSCT independent of donor match.
The product has undergone a 10-patient Phase I clinical trial with CaspaCIDe modified T cells. Four patients developed GvHD after donor T-cell infusion. A single dosage of rimiducid eliminated around 90% of the modified T cells and resolved GvHD in all four patients without recurrence of GvHD. In the second clinical trial of CaspaCIDe-modified T cells, these demonstrations have been replicated in preliminary data from three patients. BPX-501 is being evaluated in multiple Phase I/II clinical trials in the United States, which includes BP-001, a clinical trial in adults and and BP-003, a clinical trial in children. During the BP-001 clinical trial, BPX-501 is administered after initial allogeneic HSCT for hematological cancers. The BP-003 clinical trial in children with orphan inherited blood disorders includes the administration of BPX-501 after initial allogeneic HSCT. The Company also initiated an additional Phase I/II clinical trial, BPX-004 in children with hematological cancers or orphan inherited blood disorders.
BPX-201
The Company�� product candidate under development, BPX-201 is a dendritic cell cancer vaccine intended to treat metastatic castrate-resistant prostate cancer (mCRPC). BPX-201 is an autologous therapy, in which the patient�� own white blood cells are extracted and modified ex vivo. The cells are matured and then gen! etically ! engineered to express the DeCIDe switch domains and the prostate-specific membrane antigen (PSMA) antigen. The modified cells are then washed, apportioned into individual dosages, and frozen for later administration to the patient. The incorporation of the DeCIDe switch in the presence of rimiducid activates the therapy.
The Company is evaluating BPX-201 in an 18-patient Phase I clinical trial for mCRPC. It is evaluating opportunities for BPX-201 in combination with other cancer immunotherapies, such as checkpoint inhibitors.
BPX-701
The Company�� CaspaCIDe T cell receptor (TCR) Product Candidate, BPX-701 is under development for the treatment of Solid Tumors. BPX-701 is a TCR-based therapy for the treatment of PRAME-expressing melanoma, sarcomas and neuroblastomas. BPX-701 is designed to target preferentially-expressed antigen in melanoma (PRAMEa gene) that is predominantly expressed in human melanomas but not in normal tissues.
The BPX-701 has demonstrated complete elimination in response to rimiducid. The Clinical Cancer Research 2011 has demonstrated that PRAME-specific clones showed high reactivity against a panel of PRAME positive tumor cell lines, metastatic melanoma, sarcomas and neuroblastoma tissues, and no reactivity against normal cell types, with the exception of low reactivity against kidney epithelial cells and intermediate reactivity against mature dendritic cells. The vitro studies demonstrated BPX-701�� affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells. In other in vitro studies, rimiducid administration has proved the ability to eliminate BPX-701 cells.
BPX-401
The Company�� CIDeCAR Product Candidate under development, BPX-401, is developed for the treatment of Hematological Cancers, such as acute lymphotcytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and certain types of non-Hodgkin�� lymphoma. The CIDeCAR consists of CAR T cells modified to! include ! its CaspaCIDe safety switch and in which the CAR incorporates the signaling domains of two proteins, MyD88 and CD40. These proteins form the Company�� dual co-stimulatory domain, MC, which is designed to activate T cells in the presence of cancer cells. The Company has generated preclinical proof-of-principle data in vitro signifying that BPX-401 has CAR T cell activation and proliferation potential, and may be effective in killing cancer cells.
BPX-601
The Company�� GoCAR-T Product Candidate, BPX-601, is proposed for the treatment of Solid Tumors. The BPX-601 is undergoing preclinical studies for the treatment of solid tumors overexpressing the prostate stem cell antigen (PSCA), such as some prostate, pancreatic, bladder, esophageal and gastric cancers. The Company�� GoCAR-T technology consists of CAR and T cells. GoCAR-T controls activation and proliferation of the CAR T cells through the scheduled administration of a course of rimiducid infusions.
BPX-601 is undergoing preclinical studies for the treatment of solid tumors overexpressing the PSCA antigen. The Company has demonstrated positive proof-of-principle data in an animal pancreatic tumor model.
The Company competes with Adaptimmune Limited, bluebird bio, Inc., Celgene Corporation, Cellectis SA, GlaxoSmithKline plc, Intrexon Corporation, Juno Therapeutics, Inc., Kite Pharma, Inc., Novartis AG and Pfizer Inc.
Advisors' Opinion:- [By John Udovich]
Small cap cancer drug stock Kite Pharma Inc (NASDAQ: KITE) has surged after announcing a�strategic research collaboration and license agreement with Amgen, Inc (NASDAQ: AMGN)�involving Chimeric Antigen Receptors (CAR) ��meaning its worth taking a closer look at the stock, which had an IPO last June,�along with potential peers�Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) and Juno Therapeutics (NASDAQ: JUNO) which are players in the CAR therapies space and had more recent IPOs.
Hot Biotech Companies To Invest In 2014: Tauriga Sciences Inc (TAUG)
Tauriga Sciences, Inc., formerly Immunovative, Inc., incorporated on April 18, 2001, is a development-stage company. The Company along with Constellation Diagnostics, Inc. (Constellation) focuses on establishing a joint venture partnership to develop and commercialize a imaging-based diagnostic technology for use in predictive and preventative oncology.
The Company has rights to commercialize AlloStim and AlloVax. As of March 31, 2013 the Company did not have any revenues.
Advisors' Opinion:- [By Peter Graham]
Small cap marijuana stocks IMD Companies Inc (OTCMKTS: ICBU), Tauriga Sciences Inc (OTCMKTS: TAUG), ML Capital Group Inc (OTCBB: MLCG) and Lexaria Corp (OTCMKTS: LXRP) are aiming to give investors a high with their latest news. However, only one of these small cap marijuana stocks appears to be the subject of minor paid promotion or investor relations type of activities. So will investors and traders alike get a high off of these small caps? Here is a quick reality check:
- [By Peter Graham]
Small cap health care or personal care stocks Axxess Pharma Inc (OTCMKTS: AXXE), Radiant Creations Group Inc (OTCBB: RCGP) and Tauriga Sciences Inc (OTCMKTS: TAUG) have recently been attracting attention in various investment newsletters or in investor alerts. Some of the attention may have to do with paid promotions that two of these small caps have been the subject of. So how healthy are these three small cap health care or personal care orientated stocks? Here is a checkup:
Hot Biotech Companies To Invest In 2014: Cubist Pharmaceuticals Inc.(CBST)
Cubist Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The company markets CUBICIN (daptomycin for injection), a once-daily, bactericidal, intravenous, antibiotic with activity against gram-positive organisms, including methicillin-resistant staphylococcus aureus. Its clinical development product pipeline consists of CXA-201, which is in the phase III clinical trial for patients with complicated urinary tract infections; and in phase II clinical trial for patients with complicated abdominal infections. The company is also developing CXA-201 for the treatment of hospital acquired pneumonia. In addition, its product under development comprises CB-183,315, an oral, bactericidal lipopeptide with in vitro bactericidal activity against C. difficile, for the treatment of clostridium difficile-associated diarrhea (CDAD). Further , the company?s pre-clinical programs include therapies to treat various bacterial infections and agents to treat acute pain. Additionally, it promotes MERREM I.V. (meropenem for injection), a carbapenem class intravenous antibiotic, in the United States under a commercial services agreement with AstraZeneca Pharmaceuticals, LP; and DIFICID as the treatment for CDAD in adults under the co-promotion agreement with Optimer Pharmaceuticals, Inc. The company also has collaborations with Forma Therapeutics, Inc. to discover and develop antibacterial compounds; an agreement with the Broad Institute to transform natural products discovery; a collaboration with Hydra Biosciences, Inc., to develop ion channel drugs; and a collaboration agreement with Alnylam Pharmaceuticals, Inc., for the development and commercialization of Alnylam's RNAi therapeutics as a therapy for the treatment of respiratory syncytial virus. The company was founded in 1992 and is headquartered in Lexington, Mas sachusetts.
Advisors' Opinion:- [By Rich Bieglmeier]
Cubist Pharmaceuticals Inc. (CBST) share price is the beneficiary of an upgrade yesterday. Leerink Swann analyst Marko Kozul believes the biotech is headed to $76.
- [By Jon C. Ogg]
Cubist Pharmaceuticals Inc. (NASDAQ: CBST) was raised to Outperform from Market Perform at Leerink Swann.
Diamondback Energy Inc. (NASDAQ: FANG) was downgraded to Hold from Buy at Canaccord Genuity.
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