-Agenus Inc. is a biotechnology company developing treatments for cancers and infectious diseases. The company has multiple immunotherapeutic products based on strong technology platforms that are advancing through the clinic. Agenus’ technology is further validated through partnerships with major pharmaceutical companies, with several product candidates in late-stage clinical trials with corporate partners. Through our own efforts and those of our partners, we remain committed to advancing our heat shock protein platform, our QS-21 Stimulon adjuvant platform and additional immunotherapy platform product candidates over the next several years. **** HerpV therapeutic genital herpes vaccine met its primary endpoint in a phase 2 trial. Genital herpes is among the most prevalent sexually trasmitted diseases in the US, affecting an estimated 16% of the US population ages 14-49, according to the CDC. Agenus is nowhere near the first to try to develop a successful genital gerpes vaccine, and all have failed in the past all the way back to the 1920's. HerpV is basically a combination of 32 distinct antigens, or markers. To destoy the disease AGEN uses a loading a gun approach with 32 bullets instead of 2 or 3, and shooting them all at the same time HSV-2 is very difficult to cure It's not that the immune system can't handle it. The body repeatedly fights off the symptoms and the disease is not fatal. Rather, it's the way the virus attacks that keeps infection perpetual. Researchers were stumped. The real blockbuster potential, however, comes if and when Agenus translates HerpV from therapeutic (treating only disease carriers) to prophylactic (preventive). Though this is just speculation, it is possible that weaponizing the immune system against HSV-2 before infection occurs may prevent the virus from hiding dormant in the body in the first place. **** Elsevier Business Intelligence- today announced that its Prophage Series (HSPPC-96) vaccine program for the treatment of brain cancer was selected as a 2013 Top Project to Watch in oncology. This selection was made through Elsevier Business Intelligence's panel of independent experts who screen hundreds of programs and weigh their potential as future products. A recent analysis from the Phase 2 trial in patients with newly diagnosed GBM treated with Prophage Series in combination with the current standard of care (radiation and temozolomide) showed an almost 18 month median progression free survival, which represents a 160% increase versus current standard of care alone. *** Agenus plans to hold an end of Phase 2 meeting with the US Food and Drug Administration to discuss a Phase 3 trial that, if initiated and successful, could potentially lead to marketing approval of the Prophage Series vaccine as a treatment for patients with newly diagnosed GBM. The study is being sponsored by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI. This trial is the largest brain tumor trial ever funded by the NCI and the largest vaccine study ever conducted with Avastin. About Prophage Series Vaccines
Derived from each individual’s tumor, Prophage Series therapeutic vaccines contain the ‘antigenic fingerprint’ of the patient’s particular cancer and are designed to direct the body’s immune system to specifically target and destroy cancer cells bearing this fingerprint. Prophage Series vaccines, based on Agenus’ heat shock protein platform technology, are intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy.
Each patient’s cancer is unique. Random mutations and tens of thousands of genes mean even within the same type of cancer, no two individuals’ cancers are biologically the same. Taking these factors into account, the Prophage Series vaccines are developed from the best biological representation of a patient’s cancer and created individually for each patient from their own tumor.
http://seekingalpha.com/article/152016-biotech-volatility-antigenics-biodelivery-sciences?source=article_lb_articles one of the following scenarios is taking place:
• The launch of Oncophage in Russia is imminent and the commercial launch will be accompanied by news of Russian government reimbursement,
• Rumors of a buyout or another significant partnership are circulating
HerpV news or Agenus’ heat shock protein platform technology
• Something big is brewing in the 'cancer vaccine' market that will positively effect associated companies. Shares of Dendreon (DNDN) (SQNM) and Oncothyreon (ONTY) have also traded with increased volatility lately.
Our cash and cash equivalents were $30.2 million as of September 30, 2013. Based on our current plans and activities we expect sufficient financial resources to fund operations through 2014. 2013 milestones.- First let me begin with GSK's Phase 3 program for the RTS,S for the prevention of malaria. During the quarter, new 18 month data for GSK's RTS,S malaria vaccine candidate, which contains our QS-21 Stimulon adjuvant were presented at a malaria conference in South Africa. GSK QS-21 Stimulon containing program has advanced. In October, GSK initiated a new Phase 3 study to evaluate the immunogenicity and safety of its herpes zoster vaccine candidate co-administered with GSK's seasonal influenza vaccine in adults, 50 years and older. Phase 3 programs of this vaccine candidate include nine active Phase 3 studies for the prevention of shingles. GSK MAGE-A3 cancer immunotherapeutic trial, which contains our QS-21 Stimulon was also reported. While the trial did not meet its first co-primary endpoint, GSK will continue the study until the second co-primary endpoint is assessed. I am also pleased to report that we continue to explore new licensing agreement for QS-21. During the quarter, we announced an agreement with VaxLogic for the use of QS-21 Stimulon adjuvant in the development of select addiction, allergy and respiratory disease indications.
To summarize the economics of these arrangements, we are entitled to receive milestone payments as GSK's QS-21 Stimulon containing programs advance as well as royalties on net sales for at least 10 years after commercial launch of the first prophylactic and the first therapeutic vaccine. These programs benefit our partner's financial development and sales and marketing resources. And QS-21 adjuvant is a unique proprietary asset, which represents a significant and unusually diversified value driver for our company.
In addition to newly diagnosed GBM study patients are being enrolled in NCI-Sponsored Randomized Study of Prophage G-200 vaccine, in combination with Avastin. We believe this trial represents a major milestone in efforts to develop affective vaccines for people living with brain tumors.
Company Overview from TRADER ON A BEACH-Alfa
NeuroMetrix (NURO) is a medical device company that develops and markets devices for the treatment and management of the neurological complications of diabetes. The company's newest product SENSUS Pain Management System came to market in the first quarter of 2013. The SENSUS system is used to treat chronic pain linked to diabetic neuropathy. For a good overview of diabetic neuropathy go here. The SENSUS system is the only transcutaneous electrical nerve stimulator that is designed to treat chronic pain associated to diabetes. Diabetic neuropathy is the main cause of this chronic pain with up to 50% of diabetics affected from it. The company estimates that the U.S. market for this type of pain management is over 300 million dollars. The company also has another product on the market which is the NC-stat DPN check. Its main focus going forward though is the SENSUS system.
The company also signed an agreement with Simplex Healthcare in September of this year for distribution of the SENSUS system. Simplex Healthcare runs Diabetes Care Club one of the biggest mail order suppliers of diabetes care products. The company also signed an agreement in October of this year. The agreement was with OsteoArthritis Centers of America, which is a subsidiary of Rehabilitation Management Group, Inc. This agreement paves the way to having the SENSUS system available in the clinics that operate in affiliation with RMG. These two agreements ( Simplex, OsteoArthritus) open up a good distribution network that was not there in the first three quarters of this year. The company also has a good focus on what it wants to accomplish in the rest of 2013. At the time of the company's CC it reported that over 1000 SENSUS systems had been shipped, while the original goal for 2013 was between 1000 and 2000 systems. The company stated that it is now looking to reach the higher end of this range by the end of 2013. The sales for the n
The stock is coiled again and ready to spring the second time. Phase I/II clinical trials of DCVax-Direct are underway, with initial results expected by the end of this year being that the primary endpoint is tumor regression, which happens either quickly or not at all. The news on this front is that a second site has opened in Orlando as of last week. When the coil breaks
Back to my original contention, the DCVax-Direct initial results, expected at the end of the year, will be the reason the coil will finally break, either up or down. While press releases from the company estimate initial results at the end of the year, due to a history of delays an announcement of initial results by January-February seems reasonable. NWBO will take off in one of two directions when those initial results are announced.
We are talking about a treatment for all solid tumor cancers after all. If there is any tumor regression, NWBO's price will find a new coiling range until final results are released, which are expected by midyear 2015 according to clinicaltrials.gov.
Disclosed Product Candidates currently in the pipeline are:
Generic Name Brand Indication Stage of Development Regulatory Pathway Rights
Dexmethylphenidate hydrochloride extended release capsules Focalin XR
Attention deficit hyperactivity disorder (ADHD)
ANDA application for commercialization under approval for 6 strengths under review by FDA ANDA Intellipharmaceutics and Par Pharmaceutical, Inc.
Venlafaxine hydrochloride extended-release capsules Effexor XR
ANDA application for commercialization under approval for 3 strengths under review by FDA ANDA Intellipharmaceutics
Pantoprazole sodium delayed-release tablets Protonix
Conditions associated with gastroesophageal reflux disease
ANDA application for commercialization approval for 2 strengths under review by FDA ANDA Intellipharmaceutics
Metformin hydrochloride extended-release tablets Glucophage XR
Management of Type 2 diabetes
ANDA application for commercialization approval for 5 strengths under review by FDA ANDA Intellipharmaceutics
Quetiapine fumarate extended-release tablets Seroquel XR
Schizophrenia, bipolar disorder & major depressive disorder
ANDA application for commercialization for 5 strengths under review by FDA ANDA Intellipharmaceutics
Lamotrigine extended-release tablets Lamictal XR
Anti-convulsant for epilepsy ANDA application for commercialization for 2 strengths under review by FDA ANDA Intellipharmaceutics
Levetiracetam extended-release tablets Keppra XR
Partial onset seizures for epilepsy
ANDA application for commercialization approval for 2 strengths filed with FDA ANDA Intellipharmaceutics
Desvenlafaxine extended-release tablets Pristiq
Depression ANDA application for commercialization approval for 2 strengths filed with FDA ANDA Intellipharmaceutics
Carvedilol phosphate extended-release capsules Coreg CR
Heart failure, hypertension
Late-stage development ANDA Intellipharmaceutics
Pregabalin extended-release capsules Lyrica
Phase I clinical trial NDA 505(b) (2) Intellipharmaceutics
Oxycodone hydrochloride controlled-release capsules Oxycotin
Pain Phase I clinical trial NDA 505(b) (2) Intellipharmaceutics
IntelliOsmotics™ The IntelliOsmotics™ technology is based upon the inclusion of multiple populations of polymers with distinct chemical bonding characteristics that set up a complex matrix of hydrophilic and hydrophobic domains. When the tablet or bead is in an aqueous environment, like gastric contents, a mixture of water-soluble polymer and drug core is surrounded by gel layer(s) of water-insoluble polymer. Osmotic pressure drives the drug out when solvent passes through the gel layer while the polymer molecules remain which permits control of the rate of release of the drug active by the variation of polymer ratios. This is useful for drug molecules that require controlled pseudo-first-order release profiles, where the rate of release is proportional to the amount available for dissolution while being proportional to one other component; however the effect of the amount of drug is overriding, so that the rate appears first-order. This type of release control can be useful when attempting to match difficult profiles for generic formulation.
IntelliPaste™ The IntelliPaste™ technology consists of blends of multiple polymers, oils, excipients and drug active(s) which result in a paste-in-a-capsule dosage form. The physical attributes of the paste include that it is thixotropic, pseudoplastic and non-Newtonian. It is formulated for very low solubility in water or oil, and low solubility in alcohol. These characteristics enable the resulting drug product to have tamper-deterrent properties, and to resist dissolution in high concentrations of alcohol. IntelliPaste™ is Intellipharmaceutic’s preferred delivery technology for the controlled delivery of opiates, narcotics and other central nervous system drug products which are susceptible to unlawful diversion or abuse.
IntelliPellets™ The IntelliPellets™ technology consists of one or more type (population) of granule, bead, pellet, or tablet in a holding chamber or reservoir, such as a hard gelatin capsule. Each type (population) may be uniquely different from the other in the manner or rate it releases the drug. IntelliPellets™ technology is designed to control, prolong, delay or modify the release of drugs which is useful for the delivery of multiple drugs, for delayed, timed, pulsed or for chronotherapeutic drug delivery, designed to mimic the body’s internal clock for therapeutic optimization. This technology is most useful for the delivery of multiple-drug cocktails, or in situations where the timing of a single dose or the sequencing of multiple doses of the same drug is important.
IntelliShuttle™ The IntelliShuttle™ technology provides for drug release past the stomach, such as for drugs required for action beyond the stomach, for drugs which could be destroyed by the stomach environment, or for drugs which could harm the stomach itself. This technology shuttles the drug past the stomach to be released at predetermined times or sites where appropriate for optimum therapeutic effect. This technology is more useful for acid labile drug molecules (drugs that are destroyed in acid environment), such as the proton pump inhibitors, of which omeprazole (Prilosec) and lansoprazole (Prevacid) are examples, or for drug molecules which may harm the stomach, of which aspirin is an example.
Hypermatrix™ technologies are a multidimensional controlled-release drug delivery platform that are applied to the development of a range of existing and new pharmaceuticals. Intellipharmaceutics has a pipeline of product candidates in various stages of development, including eight Abbreviated New Drug Applications (ANDAs) filed with the FDA, seven of which are under review, in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
The Hypermatrix™ technologies are applied to the development of both existing and new pharmaceuticals across a range of therapeutic classes. The development activities are focused in two areas; difficult-to-develop controlled-release generic drugs, which follow an ANDA regulatory path; and improved current therapies through controlled release, which follow a New Drug Application (NDA) 505(b)(2) regulatory path.
IPCI currently has eight Abbreviated New Drug Applications (ANDA) awaiting FDA approval.
The first ANDA filed by the company, in May 2007, is for generic Focalin XR of 5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg strengths. Focalin XR, the company's lead product, is indicated for attention deficit hyperactivity disorder, or ADHD, in patients aged 6 years and older. According to Healthcare Analytics Data, Focalin XR branded sales of $625 million for the 12 months which ended in February 2013. IntelliPharmaCeutics partnered with Par Pharmaceutical Inc., a top ten U.S pharmaceutical company, for the commercialization of generic Focalin XR. IPCI has a ten-year profit sharing agreement with Par for the sale of a generic version of Focalin XR in the U.S., and plans to start marketing the generic versions of Focalin XR upon FDA approval.
The second ANDA filed is for generic Effexor XR, a drug prescribed for major depressive disorders. The first generic version of Effexor XR, manufactured by Teva, was approved in June 2010. Sales of branded and generic Effexor XR totalled $792 million for the 12 months ending in February 2013.
The next advanced product candidate in the company's generics pipeline is generic Protonix. Protonix is a drug approved for the treatment of gastroesophageal reflux disease, or GERD. Teva was the first to win FDA approval for the generic formulation of Protonix in 2007. Sales of branded and generic Protonix totaled $668 million for the 12 months ending in February 2013.
Rexista™ Technology Platform Rexista™ provides deterrence against intentional drug abuse and unintentional dose dumping.
Hypermatrix Technology Platform
"IntelliFoam™" The IntelliFoam™ technology is based on the drug active being embedded in, separately from a syntactic foam substrate, the properties of which are used to modulate the release of the drug active, that is embedded in a resin polymer matrix.
IntelliGITransporter™ The IntelliGITransporter™ consists of an active drug immobilized in a homogeneous matrix structure. A precise choice of mix ratios, polymers, and other ingredients imparts characteristics that protects the drug composition from mechanical degradation due to digestion, and/or from chemical degradation in the acidic stomach environment, and ensures that this technology allows control of release as well as releasing the medication at certain parts of the stomach or intestines without significant food effects or unintentional premature release of the entire drug dose. This is more useful for drug molecules with characteristics such as very low or very high potency, opiate analgesics, or susceptibility to acid degradation. It is also useful for products where a zero-order release profile is preferable.
IntelliMatrix™ The IntelliMatrix™ technology is a blend of several polymers; depending on the constituents of the blend and the manner in which these interact, the use of the blend with a drug allows the drug to be released at predetermined rates, while imparting protective characteristics to both the drug and the GIT. This is preferable for drugs which require precisely controlled first-order release profiles, where the amount released with time is dependent on one component like the amount of drug available for dissolution.
IntelliOsmotics™ The IntelliOsmotics™ technology is based upon the inclusion of multiple populations of polymers with distinct chemical bonding characteristics that set up a comp
NO WAY................... Fools are understanding the The conditioned ("educated") immune cells and what it could mean towards the potential life-extending treatment for all solid tumor cancers. Linda is the largest share holder and knows the game. She has the most to gain and I am around for the ride.
It is rare a to get somebody like this with out knowing the end game. She has been sold on the companies future. This alone is why I bought more. She is a trained survivor with more skills then given credit on this bourd of sharks talking the stock down. A manager is what the company needs going into the acceptance of the trials and negotiating the future success. This is a great plus the bashers are calling a weakness. I would put her up against a basket full of doctors in negotiating.
POWERS knows how to manage and is top caliber. Most l companies go through he transformation where a doctor is not suitable to run a expanding company. It take a business manager. The money will go towards the phase III and the news will put this company towards other solid tumor cancers. These guys want cheap shares and are to stupid to know this is the time to load with the funds. BY the end of the moth this should rocket. LOADING LOADING
ITS obvious funds want in with out driving this to ten dollars. By the end of next week the secondary will be done. ITS ONLY 1/5 the share out right now. ITS nothing compared to the Brain and prostrate Phase III trials and treatments. FUNDS will eat the shares up and we will have a stronger base. When people read about the double survival rate and the immune response from treatments we will sky rocket again. This is a great entry for people to by with the funds. Prostrate news will shock the industry in phase III. . Now they have the money.
DCVAX- The patient's immune cells are then harvested and exposed in the laboratory to the biomarkers taken from the patient's tumor. These conditioned immune cells are then injected back into the patient through a simple injection under the skin in the upper arm, similar to a flu shot. The conditioned ("educated") immune cells then mobilize the patient's immune system to now fight any tumor cells bearing the same biomarkers wherever such tumor cells are found in the body.
According to Dr. Siegel, some patients with Glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer, in preliminary trials have seen their survival times more than double from what would be expected under the current standard of care "Each cancer vaccine is personalized, and it takes just eight days to produce enough for three-to-five years' worth of treatment," remarks Dr. Siegel. "It's more cost-effective than older cancer vaccines, and the side effects are minimal versus standard treatments." "The prognosis for patients receiving standard of care treatment has not materially changed in decades. But DCVax now has the potential to significantly improve and extend the lives of cancer patients suffering from all types of solid tumor cancers, both operable and inoperable, without the toxic side effects associated with existing treatments."
1)))) The Company's patented Hypermatrix(TM) technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. This is a novel and generic controlled-release and targeted-release oral solid dosage drugs delivery system 2))) FDA FDA Issues Final Approval of 15 mg, With 180 Days of Exclusivity, and 30 mg; and The company's strategy in the pharmaceutical space is to turn currently marketed drugs that are developed for immediate release into patentable extended release drugs. The company is also currently working on new drug delivery technologies which could attain a large value if successfully brought to market. (((BINGO)))))))
3)) -- Tentative Approvals for the Company's 5, 10, 20 and 40 mg Strengths 4)) Commercial sale of these strengths will be launched immediately by the Company's commercialization partner in the United States Par Pharmaceutical, Inc. ("Par"). 5) generic version of Focalin XR(R) is a major milestone for the Company in several respects. A) a strong validation of our core drug development B) partner with an established and well-regarded pharmaceutical company C) production through commercialization in the United States D) generate our first US revenues i) By virtue of being the first-filer in the 15mg dose, IPCI will have 180 days of exclusivity of generic sales.
6)) MORE TO COME ! Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of product candidates in various stages of development, including Abbreviated New Drug Applications ("ANDAs") filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
7) Pipeline- Intellipharmaceutics also has New Drug Application 505(b)(2) product candidates in its development pipeline. These include Rexista(TM) oxycodone, an abuse-deterrent oxycodone, based on its proprietary novel Point Of Divergence Drug Delivery System ("nPODDDS(TM)") and a pregabalin extended-release ("Regabatin(TM) XR").
• 8) Intellipharmaceutics approval should enhance cash position, says Brean Capital 9) UPGRADES! Maxim raised its price target for Intellipharmaceutics to $9 after the FDA approved the company’s generic version of Focalin. Brean's Jonathan Aschoff "believes the sales generated from generic Focalin XR should significantly enhance the company's financial position." Price target is $7. 10) cash and cash equivalents totaled $2.4 million In July 2013, Intellipharmaceutics announced an update on its Rexista(TM) oxycodone development program. The results from physico-chemical tests to assess abuse-deterrent properties of its Rexista(TM) oxycodone suggested that intact, pulverized or microwaved product with or without various solvents and temperatures, will be difficult to extract through inhalation, injection, chewing or licking. Results of a successful Phase I clinical trial suggested that the technology in the Company's formulation of Rexista(TM) oxycodone does not interfere with the bioavailability of oxycodone as compared to OxyContin(R).
• IPCI lead product (at this time), is a generic of Focalin XR, is partnered with Par Pharmaceutical Inc. Par Pharmaceutical Inc. markets generic drugs and innovative proprietary pharmaceuticals for specialty markets. Under the agreement, Par is to pay IntelliPharmaCeutics 15 million dollars upon approval, and royalties that are expected to be around 40 million per year. This will bring the company into profitability.
Northwest Biotherapeutics (NWBO) is a development stage oncology focused immunotherapy company currently in advanced and mid-stage clinical trials to treat several types of prevalent cancers as well as all solid tumor cancers. New news states, DCVax as a potential life-extending treatment for all solid tumor cancers. Dr. Lee Tessler participating in the Phase III trials for brain cancer at Long Island Brain Tumor Cancer described the process of the immune therapy. Further, Dr. Siegel added that some patients under treatment for Glioblastoma Multiforme (GBM) have experienced a double survival rate as compared to standard cancer therapies - removal of tumor, chemotherapy and radiation. Positive news was that the vaccine takes about eight days for producing enough vaccine for three to five years of treatment. The company is developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, Northwest Biotherapeutics's DCVax as a potential life-extending treatment for all solid tumor cancers by using biomarkers from the patient's own tumor cells to activate the patient's immune system to fight the cancer in the patient's body. According to Dr. Siegel, some patients with Glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer, in preliminary trials have seen their survival times more than double from what would be expected under the current standard of care "Each cancer vaccine is personalized, and it takes just eight days to produce enough for three-to-five years' worth of treatment," remarks Dr. Siegel. "It's more cost-effective than older cancer vaccines, and the side effects are minimal versus standard treatments." "The prognosis for patients receiving standard of care treatment has not materially changed in decades. But DCVax now has the potential to significantly improve and extend the lives of cancer patients suffering from all types of solid tumor cancers, both operable and inoperable, w