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OncoSec Medical closes sale of 31,000,000 shares of common stock in registered public offering
Published on March 29, 2012 at 5:41 AM
OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumor cancers, announced today the closing of the sale to institutional investors of an aggregate of 31,000,000 shares of its common stock at $0.25 per share in a registered public offering. Additionally, investors received Warrants to purchase up to 31,000,000 shares of common stock at an exercise price of $0.35 per share for a term of five years.
The gross proceeds of the offering were $7.75 million and net proceeds, after deducting the placement agent's fee and estimated offering expenses payable by OncoSec, were approximately $7.2 million.
OncoSec intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM), acted as the exclusive placement agent for the transaction. Roth Capital Partners, LLC served as financial advisors to the Company in the offering.
A bad day for this stock is when Pro Basher Salty shows up
New Broad Steps Forward in Cancer Drugs
Small cap network put this out today by alpha vn.
2013 has been a year in which a number of novel new cancer therapies have made significant advancements at the clinical trial level, involving both conjugation of existing drug treatments and all new treatment techniques.
These developments have the potential to overhaul our view of how various cancers will be treated in the coming decade. From immunotherapies to targeted gene therapy, the industry is poised to take a distinct turn with leadership coming from the top players as well as the smallest startups.
These key developments are especially apt for investors looking for long term opportunities in this fast growing, high yield sector.
Roche (RHHBY) recently released the results of its Phase III TH3RESA study, which showed that their new drug, Kadcyla (trastuzumab emtansine), almost doubled the amount of time that patients with HER-2 positive breast cancer survived without their cancer worsening. This was in comparison with ‘doctor’s choice’ treatments such as Roche’s own Herceptin and GlaxoSmithKline’s (GSK) Tykerb.
Finding New Tricks for an Old Dog
Kadcyla is an antibody-drug conjugate, consisting of Herceptin, one of the first home-run oncology drugs with annual sales in excess of $5 billion, and the chemotherapy drug DM1, developed by and licensed from ImmunoGen Inc (IMGN). Kadcyla works by directly attaching to HER-2 positive cells and blocking out growth signals to the cancer cells, giving the body’s immune system and DM1 the opportunity to destroy them.
Broadening the use of Herceptin through conjugation with another drug is something that Roche has been exploring in advance of the expiration of its US patent in 2019.The firm recently let its patent protection in India expire after running into interference from Indian regulators.
Along with Kadcyla, Roche is working with Galena Biopharma (GALE) in a Phase II clinical trial of a treatment involving Galena’s Neuvax and Herceptin. Neuvax, in effect, complements Herceptin in killing off micro-clusters of HER-2 expressing cells in patients that can no longer be treated with Herceptin alone. Early results have shown a 0% reoccurrence rate 2 years post treatment.
Neuvax on its own is a very promising gene therapy which is targeted at the 75% of breast cancer patients that Herceptin cannot treat. Neuvax is just beginning an FDA Special Assessment Protocol Stage III clinical trial which should have preliminary data in Q1 of 2014.
So, while Herceptin’s future post-2019 looks murky in emerging markets, Roche is working diligently with new technologies to keep its hero drug relevant post patent expiration.
Delivery is the Key
Investors looking for entry into this fast growing market would do well to keep an eye out for OncoSec Medical Inc $ONCS, a biotech company focused on developing treatments for advanced stage skin cancer. The primary reason why OncoSec is interesting to me is not its specific treatment but rather how it delivers that treatment and the options it opens up for new delivery systems for a broader range of treatments.
Immunopulse is OncoSec’s main product and it is the combination of powerful immune-support therapies and a delivery system, electroporation, that targets the tumor, in this case skin cell melanomas, directly.This allows new treatment options for high mortality skin cancers.
These treatments are extremely toxic and cannot be introduced orally or intravenously. Electroporation opens temporary holes in the cancer cell walls which allows the drug to be delivered and sealed up in the cancer cell once the treatment ends.
ImmunoPulse is currently in the midst of a Phase II ‘safety and efficacy’ clinical trial focused on the treatment of Merkel Cell Carcinoma, one of the deadliest forms of skin cancer. ImmunoPulse introduces pro-inflammatory cytokine proteins into the body which trigger the immune system into targeting and eliminating local and metastasized cancer cells.
OncoSec recently announced positive preliminary animal data in a study of combining ImmunoPulse with anti-CTLA4 and anti-PD1 antibodies to treat solid tumors, with encouraging results.
The latest study, the result of a Sponsored Research Agreement with Old Dominion University and the Frank Reidy Research Center for Bioelectrics, was conducted using a single tumor model where forty mice in eight treatment groups were treated with either ImmunoPulse alone, or a combination of ImmunoPulse with anti-CTLA4, anti-PD1 or both at varying concentrations.
Results indicated that treatment led to 100% regression of treated lesions in all mice, with no fatality as a result of toxicity from treatment. These results are a positive indicator for the growing significance of gene therapy’s role in treating cancer. As well, it speaks to the potential for developing electroporation as a more generalized delivery system for other treatments.
Medical device manufacturers like Thermo Fisher Scientific (TMO) have to be watching the development of these trials closely. Thermo has been on an acquisition spree in the past year, buying or partnering with a number of start-ups, such as Perfinity and Proteome, looking to insert itself into the nanotech drug supply chain. Its purchase of Life Technologies Corp (LIFE) earlier in the year strongly supports that claim.
The Larger Bowl
With personalized medicine growing at a rate of 7.5% in 2013 and the nanotech drug market expected to grow at 74% CAGR through 2016, gene therapy represents a major growth prospect for investors over the next generation, and small to mid-cap companies such as OncoSec that are in the midst of developing game changing new products can prove particularly enticing for investors looking to make an entry into this field.
Demographic shifts are occurring in Asian populations which are also exhibiting similar growth rates in the occurrence of diseases like cancer and type-II diabetes as a result of dietary changes and urbanization similar to what was seen in the U.S. and Europe. Demand for these types of treatments will likely increase dramatically, a point that should not be lost on investors looking for long term options in the biotech space.
In Vietnam, for example, estimates run as high as 12% for type-II diabetes.In China, with the mandated shift towards a consumer-based economy less dependent on exports we already see high rates of heart disease and type II diabetes which will increase as the country’s demographic ages. With the emergence of a robust consumer-based middle class in China, I see the market potential for these types of treatments increasing dramatically over the next decade or two.
With the trend evolving in China similar to what we have seen in the West, it stands to reason that this is where the growth will come from. For firms like Roche, developing ways to extend the demand for Herceptin is critical.
For smaller firms finding ways to work with the larger ones to help fund development costs is also key, like Galena’s work with Roche to extend the market potential for both drugs. Firms like OncoSec are creating value along two different vectors: the development of an effective treatment for a current killer disease and a delivery mechanism that has the potential to be used in a number of other applications.
For these reasons and the broadening market potential coming with demographic and lifestyle changes occurring in the most populous areas of the world I feel all of these firms have great potential to reward investors over the long run.
Why has there never been mention of Wainwright coverage
The major conference where Oncosec released new data on a Thursday and Friday, they released news the following Monday.
press release
Oct. 4, 2013, 6:05 a.m. EDT
OncoSec CEO Punit Dhillon to Present at INTERFACE 2013 Digital Health Summit
SAN DIEGO, Oct 04, 2013 (BUSINESS WIRE) -- OncoSec is pleased to announce that CEO and co-founder, Punit Dhillon, will be speaking at this year's INTERFACE 2013 Digital Health Summit at the Vancouver Convention Centre located in Vancouver, B.C. The international, three-day conference is a gathering of the minds among some of North America's leading influencers in health IT, digital health, and the future of medicine.
"I'm delighted to be in the company of such an esteemed group of thinkers," said Dhillon. "I look forward to sharing my thoughts on the future of cancer treatment as well as hearing from the other speakers about their innovative digital health solutions."
Dhillon will deliver his talk on Thursday, October 10 at 10:45 AM PT entitled, "Inside the Battle of Making Chemo Obsolete" and will also be participating in a panel discussion on trade and investment in the healthcare industry. Other conference speakers include Terry McBride of YYoga, Geof Auchinleck of Claris Technologies, and Dr. Steven Steinhubl of Scripps Translational Science Institute. To learn more about the event or to register, please visit: www.interfacesummit.com
While in Vancouver, Dhillon will also be speaking at the launch event for TiE Young Entrepreneurs, a unique program that helps high school students learn about the challenges and rewards of becoming an entrepreneur. The program provides the students with an opportunity to be mentored by seasoned entrepreneurs, while creating a network of like-minded aspiring entrepreneurs. The TiE Young Entrepreneurs Launch Event is slated for October 12 at SFU Segal Graduate School of Business.
About INTERFACE 2013 Digital Health Summit
INTERFACE 2013 is produced by SANOTRON, Canada's first technology accelerator focused entirely on digital health solutions that can dramatically reduce costs, significantly improve user experience and quality of life, create new jobs and opportunities, and build a sustainable healthcare system in Canada and worldwide. This is SANOTRON's second annual summit.
SOURCE: OncoSec
OncoSec CEO Punit Dhillon to Present at INTERFACE 2013 Digital Health Summit October 12.
Congrats' there Cm! Further up!
Oncosec posts their news on Tues. around 6AM
Oncosec verifies $1.50 coverage
Hi Crandell,
Hope all is well. You are correct, H.C. Wainwright initiated coverage for OncoSec today.
Amy
From: Crandell Bliss <m>
Date: Mon, 30 Sep 2013 09:00:20 -0500
To: <investors@OncoSec.com>
Subject: Analyst Coverage Announcement
Good Morning Amy,
This link posted on the Yahoo Message Board for ONCS says that H.C. Wainwright initiated coverage at $1.50...Can you verify if this is true?
Sorry funds, that link only shows Roth capital reiterated it's buy rating. It doesn't validate yet that H.C. Wainwright has picked up coverage.
Emailed Amy Chan at ONCS will post her reply.
My appologies, I should have verified the link. I have not been able to confirm what the link is stating.
This Coverage need verification: Link
http://www.theflyonthewall.com/permalinks/entry.php/ONCSid1893729/ONCS-OncoSec-initiated-with-a-Buy-at-HC-Wainwright
THATS "BUY" at $1.50
Oncosec iniciated with a By at H.C. Wainwright with a Price target of $1.50
Yep, but that's short term talk (next week or two). In the mid to long term the work going on behind the scenes like the PD-1 mouse research at ODU coming out,and MC and MM interim results due out in Oct. is going to dramatically impact ONCS valuation to the degree that these 5-8 cent fluctuations become trivial.
These two horses in the IL-12 Melanoma race...both presenting Oct. 3rd, at the Cancer Vaccines and Gene Therapy meeting in Malvern, PA. next weeks conf. See earlier posted Chemistfrog article.
OncoSec's And Ziopharm's IL-12 Targeted Delivery Systems: Which Will Succeed? Reprinting Chemistfrog from last June
Editors' Note: This article covers a micro-cap stock. Please be aware of the risks associated with these stocks.
Cytokines are signaling molecules comprised of proteins, peptides, or glycoproteins produced by immune cells to communicate with other cells to induce an immune response. Interleukin-12 (IL-12) is a promising cytokine being evaluated as a cancer treatment due to its ability to elicit an immune response via CD8+ killer T cells against cells having IL-12 in their microenvironments. Helping to add to a robust, longer-term response, IL-12 also helps to generate CD4+ T cells, also known as memory T cells. Growing evidence indicates that CD4+ T cells are even required for the generation and maintenance of effective CD8+ cytotoxic response, a phenomenon known as CD4+ T-cell help. This maintenance indicates a long-term (robust) activity necessary for the continued effectiveness of the cytokine.
While IL-12 has been shown to be an effective cancer tumor fighter, the cytokine's promising effectiveness is offset by an extremely cytotoxic profile that renders its safety profile unacceptable when injected directly into a tumor. Many targeted chemotherapy and targeted radiotherapy treatments have garnered regulatory approvals by maximizing the safety profile of the respective therapies by reducing systemic exposure to the cytotoxic agents. Likewise, promising trials are already underway evaluating different means of administering IL-12 in a targeted manner in order to maximize efficacy while improving the safety profile by reducing systemic exposure.
Two very promising biotech companies are currently evaluating their own novel IL-12 administration platforms via phase II clinical trials to fight various cancer tumors, most notably metastatic melanoma. I believe that the investment potential in these two companies involves a more in-depth investigation into their respective platforms and clinical data before long-term investment decisions should be made for either. With two very different market capitalizations but having similar pipeline progression, investors should probably begin asking themselves whether one is over-valued or the other under-valued based on the data and information I wish to present below. Armed with this knowledge and after performing additional due diligence, investors may feel a bit more confident not in predicting clinical trial outcomes, but in their choice of which likely has the greatest upside potential with greater probability of promising IL-12 treatment data coming.
ZIOPHARM Oncology, Inc. (ZIOP) was a highly diversified oncology-focused pharmaceutical at the beginning of 2013. It lead product candidate, Palifosfamide, was in phase III trials evaluating its effectiveness in treating extensive-stage small cell lung cancer (SCLC) and metastatic soft tissue sarcoma (STS). With a great deal of its valuation hinging on the late-stage candidate, the company reported on March 26th that it was terminating the development of the drug for metastatic STS due to failed progression free survival data (its primary endpoint) and focusing on its synthetic biology programs. The news sent shares plummeting, ending the day at $1.82, down 65% from the previous day's close. Tuesday's closing price of $2.27 gives the company a current market capitalization of $189.7 million.
While the company is continuing the investigation of Palifosfamide in a late stage adaptive phase III trial for SCLC with data expected in early 2014, enrollment was suspended for the trial prematurely with 188 subjects randomized. Data is expected in 1H 2014 with the patient set being followed for overall survival in order to ascertain the drug's actual effectiveness in that indication and its place in the company's pipeline, if relevant.
With hope for Palifosfamide rapidly waning, the company is progressing nicely with its IL-12 platform via phase II trials evaluating the therapy for the treatment of metastatic melanoma and in combination with Palifosfamide for non-resectable recurrent or metastatic breast cancer. ZIOPHARM's IL-12 candidate, Ad-RTS IL-12, employs the use of an adenoviral vector to deliver into patients' cells the IL-12 DNA plasmid instructing the cells to produce the IL-12 cytokine. Termed the RheoSwitch Therapeutic System™ (RTS™), ZIOPHARM gained rights to the technology via a January 2011 agreement with the therapy's developer, Intrexon Corporation. In order to control the IL-12 expression and keep its expression localized, an inducible promoter is utilized that is conditionally activated by the orally bioavailable small molecule activator ligand, INXN-1001.
This controlled IL-12 expression induces a strong immune response directly against the cells having this expression, while theoretically reducing systemic exposure to the cytokine. Via a balance of injection amount and activator ligand, most of the adenovirus-delivered IL-12 gene is at the tumor site where the immune response should occur at the tumor microenvironment. On October 25th, 2012, ZIOPHARM simultaneously announced preliminary phase I data for AD-RTS IL-12 in advanced melanoma treatment as well as phase II enrollment initiation for the therapy treating patients with unresectable stage III or IV melanoma. According to the press release, the phase II data for up to 15 patients should be available 1H 2013 - an imminent event with significant implications for the company's synthetic biologics platform, especially for the large indication metastatic melanoma.
While investors eagerly await the phase II AD-RTS IL-12 data unveiling in the coming days, ZIOPHARM released updated phase I data at the American Society for Clinical Oncology (ASCO) annual meeting held May 31 - June 4, 2013 at McCormick Place in Chicago, IL. Data from the 14 patient set were basically the same as reported on October 25th. Five of the seven patients who had received the highest doses, 100 and 160mg of INXN-1001, exhibited "compelling clinical activity" and had increased intratumoral IL-12 mRNA expression.
Likely due to the increased IL-12 levels, CD8+ and CD45RO+ (a CD4+ subset) levels were elevated in the tumor microenvironment as measured in tumor biopsy analyses. Indicating a true possible systemic immunotherapy response, clinical activity was noted not only in the injected tumors, but also in distant lesions in which the immune system had "learned" that the tumors, like the injected ones, should be targeted and attacked. The clinical responses noted included inflammation, shrinkage, flattening and depigmentation of lesions each indicating possible effectiveness, but upcoming phase II data will be the true test.
OncoSec Medical (ONCS.OB) is rapidly advancing its IL-12 immunotherapy pipeline for the treatment of cancer which is also in multiple phase II trials. The company utilizes a novel electroporation approach to administer its IL-12 DNA plasmid to also instruct the targeted cells to express IL-12. Obtained from Inovio Pharmaceuticals (INO) via a licensing agreement in March of 2011, the electroporation administration platform appears to be a great fit for the IL-12 compound. Termed its ImmunoPulse technology, the device employs a handheld device comprised of six needles which are inserted into the tumor site. The needles are connected to an electrical generator that sends an electrical pulse through the six inserted needles which dramatically increases the permeability of the targeted tumor cell membranes. This electrical current allows previously-injected IL-12 DNA plasmid construct to rapidly enter the cells where it is trapped once the current is removed and the cells' membranes return to their previous state.
OncoSec currently has three phase II trials underway evaluating the effectiveness of ImmunoPulse to fight cancer, each launched in 2012. In February of 2012, the company launched its phase II trial addressing its largest targeted market group, metastatic melanoma. On November 15th, OncoSec reported interim data on the patient set. At the time of the interim analysis, 13 of 25 expected patients were enrolled and had been treated. 13 patients were evaluable at 39 days with 95% percent of treated lesions indicating response (14% stable disease (SD), 42% partial response (PR), 39% complete response (CR)). 9 patients were evaluable at 90 days with 100% of treated lesions indicating response (5% SD, 50% PR and 45% CR). Two patients were evaluable at day 180 with 100% of treated lesions indicating response (33% PR, 67% CR).
On March 25th of this year OncoSec reported its most recent trial update on the metastatic melanoma patient set. The data set analysis was on all lesions with partial or complete responses in order to ascertain durability of the treatment. Data indicated that 68% of the lesions had a durable response at three months with 45% of lesions having a durable response at six months - a seemingly robust response. According to the press release, OncoSec expects to complete enrollment in Q2 2013 with topline data expected in Q4 2013, a huge and significant event for the company's future.
On February 13th, 2012 OncoSec initiated enrollment in a phase II trial evaluating ImmunoPulse for Merkel cell carcinoma (MCC). The company expects to enroll up to 15 patients with local and distant (metastasized) Merkel cell carcinoma. Interim data were reported on October 23rd with all three patients who had received at least one cycle of the treatment demonstrating elevated IL-12 levels at three weeks relative to IL-12 levels recorded before treatment with at least one patient having increased levels of CD8+ t cells in the targeted tumors. One of the patients treated had a confirmed partial response (more than 70% regression) which persisted for about 8 months.
Of particular note about this patient was that he had progressive MCC despite previous treatment with systemic chemotherapy, surgery, radiotherapy and IT interferon - a very difficult patient to have treatment success with. On July 19th, 2012 OncoSec initiated enrollment in its third phase II trial, evaluating ImmunoPulse for the treatment of cutaneous t cell lymphoma. Although interim data has not yet been released from this patient set, the company does plan on doing such in 2013 according to its January 15th corporate update.
With interim data already presented and more significant data yet ahead, ZIOPHARM and OncoSec each have two very different platforms addressing targeted IL-12 DNA administration. Both platforms attempt to induce immune response via CD8+ against tumors externally instructed to express IL-12 in their microenvironments. With promising early data from each presented already, upcoming data will soon determine each platform's fate, at least for the IL-12 cytokine in the evaluated indications. Evaluating the information above, ZIOPHARM is a bit earlier in development with no data presented yet except for the phase I data indicating "compelling clinical activity" with increased IL-12 expression in the tumor microenvironments with elevated CD8+ and CD45RO+ levels in treated and distant tumors. Phase II interim data for AD-RTS IL-12 is imminent and could be a strong indication of the therapy's success moving forward. OncoSec has enough data from its phase II metastatic melanoma trial to indicate early success with responses in actual tumor size and progression in local and distant tumors.
If the therapy continues similar success moving forward with a robust response implied, OncoSec expects to begin enrollment in a phase IIb trial for the metastatic melanoma indication in 2013 and a pivotal trial (one in which success would lead to a regulatory filing) for MCC according to the January corporate update. OncoSec seems to have the advantage with a more advanced phase II trial underway for the melanoma indication with two other indications not far behind. ZIOPHARM has just two IL-12 trials underway. One of those trials is combining AD-RTS IL-12 with what could be an ill-fated Palifosfamide for non-resectable recurrent or metastatic breast cancer. Although still being evaluated, Palifosfamide's future should be construed as "highly questionable."
Based on the above information, it appears that OncoSec is a safer bet with regard to the IL-12 trials underway with more advanced phase II trials, more confirmatory early data and no dependency on a likely dying adjuvant drug. However, ZIOPHARM does have a chance to come roaring back with promising imminent interim data for AD-RTS IL-12 - or does it? If there was a solid side-by-side comparison of the two platforms, or something similar, a more well-defined conclusion could be ascertained by investors attempting to make an investment decision - and such a comparison has already been made. In June of 2010, Inovio announced findings of a preclinical study on Rhesus macaques comparing adenovirus serotype 5 (Ad5) vaccine, considered to be one of the most immunogenic among viral vectors administered via traditional injections to Inovio's SynCon™ synthetic vaccine.
Titled "Comparative Analysis of Immune Responses Induced by Vaccination With SIV Antigens by Recombinant Ad5 Vector or Plasmid DNA in Rhesus Macaques", the study was very revealing with regard to the direct comparisons. Most significantly was the observation that "Ad5 immunizations failed to boost immune responses following the first immunization whereas immune responses from DNA vaccination were continually boosted even after four immunizations." The failure of additional immune response after the initial treatment with the Ad5 vector, ironically, was due to the body's own natural immune response against the Ad5 adenovirus. Meanwhile, the electroporation administration of SynCon™, the same technology utilized by OncoSec for its ImmunoPulse platform, had a more robust response even after multiple treatments as responses "were long-lasting and maintained at high levels."
Additional research reveals a bit more detail on the Rhesus Macaques study. Actual data portrays the electroporation treatment in a highly positive light relative to the Ad5 administration on its own. With a great deal of data to read through, a summary of the data is bullish for electroporation versus the adenovirus. The document notes: "Enhanced IFN? production following plasmid DNA vaccination compared to Ad5 vaccination", "DNA vaccination induces CD4+ and CD8+ T-cell responses with greater proliferative capacity", "Polyfunctional profile of CD8+ T cells demonstrates greater magnitude and functionality of DNA vaccine-induced responses", "DNA vaccination induces CD4+ and CD8+ T-cell responses with greater proliferative capacity", "Polyfunctional profile of CD8+ T cells demonstrates greater magnitude and functionality of DNA vaccine-induced responses", and "Polyfunctional profile of SIV-specific CD4+ T-cell responses following vaccination." If these data translate into comparable data with regard to OncoSec's ongoing phase II ImmunoPulse trials relative to ZIOPHARM's Ad-RTS IL-12 approach, ImmunoPulse has a clear advantage. This is speculation only and is not an indication of failure or success for each of the platforms. However, it could be construed as a valid comparison of the upcoming data at the early stages.
Tuesday's closing share price of $0.28 gives OncoSec a current valuation of $33.0 million. ZIOPHARMA's $2.27 closing gives it a valuation of $189.7. OncoSec appears to have an advantage at this stage of development for its IL-12 administration platform. ZIOPHARM is attempting to salvage the Palifosfamide program somewhat, but certainly appears to have given up hope for much of it with the termination of the metastatic STS indication and the early enrollment termination of the phase III SCLC trial. ZIOPHARM does have two phase I candidates to help with its valuation - ZIO-301 for metastatic breast cancer and ZIO-101 a mitochondrial- and hedgehog-targeted agent in early development as a cancer treatment with partner Solasia Pharma K.K.
Meanwhile, OncoSec shows a little diversification as well with an October 2012 CE mark for its electroporation administration platform for use in the European Economic Area (EEA). Although the company hasn't yet announced a launch or a partnership in the region, this regulatory approval adds to its valuation with revenue likely coming in the form of a licensing agreement or its own sales.
I will not attempt to add any conjecture about valuation for each of the two company's programs as I believe the comparison gives a hands-down victory to OncoSec. With ZIOPHARM's 5.7 times greater market capitalization than OncoSec's, I firmly believe that a correction in market capitalization is likely overdue. This could mean significant upside from here for OncoSec or a plummet for ZIOPHARM. Imminent data from ZIOPHARM could catalyze the valuation balancing or upcoming data from OncoSec could do the same. With the added CE mark under its belt, speculation on what OncoSec will do in Europe only adds to the investment interest with news that could be considered imminent from it as well.
Although I hope for success for both companies, both oncology platforms and both groups of investors, I believe investor increase should only increase for OncoSec in the coming days and decrease for ZIOPHARM as already evident by their respective 3-month stock charts. Before making a final investment decision with regard to either candidate, I advise more due diligence to confirm or invalidate my findings, and to garner a better understanding of the companies' valuation, financials, overall pipeline and probability of regulatory success.
Presentation next week.....
ONCS presenting next week, Oct. 3rd, at the Cancer Vaccines and Gene Therapy meeting in Malvern, PA. Punit Dhillon presenting 10:30-11:00 EST and Dr. Richard Heller is presenting 3:30-4:00. This event is not listed on ONCS' website.
Four Alternative Cancer Picks (ONCS) is one of them.
By Dutch Trader | Stock Markets | Sep 26, 2013 03:39PM GMT
Sep 26, 2013 03:39PM GMT | Add a Comment
Dutch Trader Dutch Trader
Last year I wrote an article entitled, Alternative Cancer Therapies Currently Overlooked By Investors, covering OncoSec Medical (ONCS.OB), Inovio Pharmaceuticals (INO), Dendreon Corp (DNDN) and Celgene (CELG).
My main focus in that specific article were companies that are specialized in Electro Cancer Therapy ("ECT") and immunotherapy. The main question investors want to know is:
"What has been the company’s performance so far and what does the future bring?"
In this article I will give you an update on the four companies.
OncoSec Medical
OncoSec Medical is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers.
Since June 4, its stock has increased by approximately 50%. Prior to the company's public offering last week, OncoSec had almost doubled from June 4.
Some big news came out on July 22 for the company. OncoSec, announced, interim immune response data from the company's Phase II study of ImmunoPulse in patients with metastatic melanoma. Findings showed that OncoSec's ImmunoPulse demonstrated a significant change in tumor immunity following treatment with DNA IL-12 and electroporation. Blood samples taken at baseline (Day 1) and Day 90 from subjects treated with ImmunoPulse were analyzed. The results demonstrated that plasmid delivery of interleukin-12 (IL-12) can also result in a decrease in exhausted T-cells, which may lead to improvement in clinical outcomes for patients treated with the company's main therapy ImmunoPulse.
On September 16, the company announced a public offering of approximately $12 million of securities. OncoSec has agreed to sell to institutional investors an aggregate of 47,792,000 shares of its common stock at $0.25 per share. Additionally, investors will receive warrants to purchase up to 23,896,000 shares of common stock at an exercise price of $0.35 per share for a term of four years.
The company intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses.
Fortunately stock price is not the only measure of evaluating whether or not a company is doing the right thing. At the milestones page on the company's website, you will see that OncoSec has been quite active with laying the foundation for future successes.
Key milestones that OncoSec looks forward to accomplishing for 2013 include:
Present interim response data from OncoSec's Phase II melanoma trial along with long-term progression-free survival data from its previous Phase I melanoma program
Present final data from OncoSec's Phase II melanoma trial and Merkel cell carcinoma trial
Conduct an end-of-Phase II meeting with the FDA for OncoSec's melanoma and Merkel cell carcinoma program
Present interim data from OncoSec's Phase II cutaneous T-cell lymphoma program
Plan to launch a pivotal Merkel cell carcinoma program
Plan to launch a Phase IIB metastatic melanoma program
All these milestones could impact the share price in a positive way. This company will definitely stay on my watch list, especially with financing out of the way.
Inovio Pharmaceuticals
Inovio Pharmaceuticals is focused on developing multiple DNA-based immunotherapies. The company develops applications of electroporation using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical.
Inovio has seen its price increase from $0.40 to $2.18 since June 4, 2012. An incredible stock performance.
On July 24 the company announced that in a preclinical study with two animal models, Inovio's hTERT (human telomerase reverse transcriptase) DNA cancer vaccine administered with Inovio's CELLECTRA® adaptive electroporation delivery technology generated robust and broad immune responses, broke the immune system's tolerance to its self-antigens, induced T-cells with a tumor-killing function, and increased the rate of survival. Because high levels of hTERT expression are found in 85% of human cancers, regardless of type, Inovio's cancer candidate holds the potential to perform as a "universal" cancer therapeutic based on these early but unprecedented results. Following this strong preclinical data, Inovio plans to advance its synthetic hTERT cancer vaccine, INO-1400, into clinical trials in 2014.
In the study, Inovio researchers confirmed that vaccination with Inovio's DNA vaccine delivered by adaptive electroporation induced hTERT-specific cellular immune responses with significantly greater T-cell magnitude compared to prior non-Inovio studies. Study results showed that mice vaccinated with Inovio's DNA cancer vaccine and then challenged with a cancerous tumor experienced delayed tumor growth and longer overall survival compared with non-vaccinated mice. Mice first challenged with a tumor and then treated with the hTERT DNA vaccine displayed killing activity of the targeted cancer cells expressing the hTERT antigen, with no killing of normal cells that did not express the hTERT antigen. The treated mice experienced significantly smaller tumors and also longer overall survival. Vaccinated animal results were compared to a control group of animals that did not receive Inovio's DNA cancer vaccine.
On September 10, Roche (RHHBY.OB) and Inovio announced that they entered into an exclusive worldwide license agreement to research, develop and commercialize Inovio's highly-optimized, multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B. The licensed compounds are currently in preclinical development and have generated robust T-cell responses in animal models.
Roche acquired an exclusive license for Inovio's DNA-based vaccines INO-5150 (targeting prostate cancer) and INO-1800 (targeting hepatitis B) as well as the use of Inovio's CELLECTRA® electroporation technology for delivery of the vaccines. Roche also obtained an option to license additional vaccine opportunities in connection with a collaborative research program in oncology. Roche and Inovio will collaborate to further develop INO-5150 and INO-1800.
Under the terms of the agreement, Roche will make an upfront payment of $10 million to Inovio. Roche will also provide preclinical R&D support and payments for near-term regulatory milestones as well as payments upon reaching certain development and commercial milestones potentially up to $412.5 million. Additional development milestone payments could also be made to Inovio if Roche pursues other indications with INO-5150 or INO-1800. In addition, Inovio is entitled to receive up to double-digit tiered royalties on product sales.
Great news always drives biotechnology stocks. So watch out for more!
Dendreon Corporation
Dendreon has seen its price decrease from $5.91 to $3.05 since June 4, 2012. A lousy performance.
Dendreon's novel technology platform gave rise to the world's first vaccine for the treatment of cancer. Provenge uses Dendreon's proprietary technology to essentially train a patient's immune system to recognize and fight cancer. The firm collects a patient's antigen-presenting cells (APCs or dendritic cells), exposes them to a tumor antigen combined with an immunomodulator in the lab, and infuses the primed APCs back into the patient to attack tumor cells. Provenge is approved for metastatic, castrate-resistant prostate cancer and has been shown to extend median survival by 4.1 months in clinical trials, putting it on par with some of the best-selling cancer drugs including Roche's Avastin.
Dendreon is facing new battles in its attempt to make the drug a commercial hit. Provenge's price tag of $93,000 has attracted reimbursement scrutiny. Dendreon's future is tied to Provenge's undetermined place in the evolving prostate cancer market.
More than a dozen new prostate cancer drugs are set to capture share in the market during the next decade, but Provenge represents a nontoxic treatment option for the underserved prostate cancer market, and it proved capable of extending overall survival and shortening treatment duration in clinical trials. The market for prostate cancer is expected to double during the next 10 years, because of an aging patient population and the arrival of new treatment options on the market. The firm is well-positioned to negotiate significant milestones and royalties from a potential marketing partner abroad.
On September 17 Dendreon announced that the European Commission has granted marketing authorization for PROVENGE®.
Celgene Corporation
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Articles (13)
Article
Last year I wrote an article entitled, Alternative Cancer Therapies Currently Overlooked By Investors, covering OncoSec Medical (ONCS.OB), Inovio Pharmaceuticals (INO), Dendreon Corp (DNDN) and Celgene (CELG).
My main focus in that specific article were companies that are specialized in Electro Cancer Therapy ("ECT") and immunotherapy. The main question investors want to know is:
"What has been the company’s performance so far and what does the future bring?"
In this article I will give you an update on the four companies.
OncoSec Medical
OncoSec Medical is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers.
Since June 4, its stock has increased by approximately 50%. Prior to the company's public offering last week, OncoSec had almost doubled from June 4.
Some big news came out on July 22 for the company. OncoSec, announced, interim immune response data from the company's Phase II study of ImmunoPulse in patients with metastatic melanoma. Findings showed that OncoSec's ImmunoPulse demonstrated a significant change in tumor immunity following treatment with DNA IL-12 and electroporation. Blood samples taken at baseline (Day 1) and Day 90 from subjects treated with ImmunoPulse were analyzed. The results demonstrated that plasmid delivery of interleukin-12 (IL-12) can also result in a decrease in exhausted T-cells, which may lead to improvement in clinical outcomes for patients treated with the company's main therapy ImmunoPulse.
On September 16, the company announced a public offering of approximately $12 million of securities. OncoSec has agreed to sell to institutional investors an aggregate of 47,792,000 shares of its common stock at $0.25 per share. Additionally, investors will receive warrants to purchase up to 23,896,000 shares of common stock at an exercise price of $0.35 per share for a term of four years.
The company intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses.
Fortunately stock price is not the only measure of evaluating whether or not a company is doing the right thing. At the milestones page on the company's website, you will see that OncoSec has been quite active with laying the foundation for future successes.
Key milestones that OncoSec looks forward to accomplishing for 2013 include:
Present interim response data from OncoSec's Phase II melanoma trial along with long-term progression-free survival data from its previous Phase I melanoma program
Present final data from OncoSec's Phase II melanoma trial and Merkel cell carcinoma trial
Conduct an end-of-Phase II meeting with the FDA for OncoSec's melanoma and Merkel cell carcinoma program
Present interim data from OncoSec's Phase II cutaneous T-cell lymphoma program
Plan to launch a pivotal Merkel cell carcinoma program
Plan to launch a Phase IIB metastatic melanoma program
All these milestones could impact the share price in a positive way. This company will definitely stay on my watch list, especially with financing out of the way.
Inovio Pharmaceuticals
Inovio Pharmaceuticals is focused on developing multiple DNA-based immunotherapies. The company develops applications of electroporation using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical.
Inovio has seen its price increase from $0.40 to $2.18 since June 4, 2012. An incredible stock performance.
On July 24 the company announced that in a preclinical study with two animal models, Inovio's hTERT (human telomerase reverse transcriptase) DNA cancer vaccine administered with Inovio's CELLECTRA® adaptive electroporation delivery technology generated robust and broad immune responses, broke the immune system's tolerance to its self-antigens, induced T-cells with a tumor-killing function, and increased the rate of survival. Because high levels of hTERT expression are found in 85% of human cancers, regardless of type, Inovio's cancer candidate holds the potential to perform as a "universal" cancer therapeutic based on these early but unprecedented results. Following this strong preclinical data, Inovio plans to advance its synthetic hTERT cancer vaccine, INO-1400, into clinical trials in 2014.
In the study, Inovio researchers confirmed that vaccination with Inovio's DNA vaccine delivered by adaptive electroporation induced hTERT-specific cellular immune responses with significantly greater T-cell magnitude compared to prior non-Inovio studies. Study results showed that mice vaccinated with Inovio's DNA cancer vaccine and then challenged with a cancerous tumor experienced delayed tumor growth and longer overall survival compared with non-vaccinated mice. Mice first challenged with a tumor and then treated with the hTERT DNA vaccine displayed killing activity of the targeted cancer cells expressing the hTERT antigen, with no killing of normal cells that did not express the hTERT antigen. The treated mice experienced significantly smaller tumors and also longer overall survival. Vaccinated animal results were compared to a control group of animals that did not receive Inovio's DNA cancer vaccine.
On September 10, Roche (RHHBY.OB) and Inovio announced that they entered into an exclusive worldwide license agreement to research, develop and commercialize Inovio's highly-optimized, multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B. The licensed compounds are currently in preclinical development and have generated robust T-cell responses in animal models.
Roche acquired an exclusive license for Inovio's DNA-based vaccines INO-5150 (targeting prostate cancer) and INO-1800 (targeting hepatitis B) as well as the use of Inovio's CELLECTRA® electroporation technology for delivery of the vaccines. Roche also obtained an option to license additional vaccine opportunities in connection with a collaborative research program in oncology. Roche and Inovio will collaborate to further develop INO-5150 and INO-1800.
Under the terms of the agreement, Roche will make an upfront payment of $10 million to Inovio. Roche will also provide preclinical R&D support and payments for near-term regulatory milestones as well as payments upon reaching certain development and commercial milestones potentially up to $412.5 million. Additional development milestone payments could also be made to Inovio if Roche pursues other indications with INO-5150 or INO-1800. In addition, Inovio is entitled to receive up to double-digit tiered royalties on product sales.
Great news always drives biotechnology stocks. So watch out for more!
Dendreon Corporation
Dendreon has seen its price decrease from $5.91 to $3.05 since June 4, 2012. A lousy performance.
Dendreon's novel technology platform gave rise to the world's first vaccine for the treatment of cancer. Provenge uses Dendreon's proprietary technology to essentially train a patient's immune system to recognize and fight cancer. The firm collects a patient's antigen-presenting cells (APCs or dendritic cells), exposes them to a tumor antigen combined with an immunomodulator in the lab, and infuses the primed APCs back into the patient to attack tumor cells. Provenge is approved for metastatic, castrate-resistant prostate cancer and has been shown to extend median survival by 4.1 months in clinical trials, putting it on par with some of the best-selling cancer drugs including Roche's Avastin.
Dendreon is facing new battles in its attempt to make the drug a commercial hit. Provenge's price tag of $93,000 has attracted reimbursement scrutiny. Dendreon's future is tied to Provenge's undetermined place in the evolving prostate cancer market.
More than a dozen new prostate cancer drugs are set to capture share in the market during the next decade, but Provenge represents a nontoxic treatment option for the underserved prostate cancer market, and it proved capable of extending overall survival and shortening treatment duration in clinical trials. The market for prostate cancer is expected to double during the next 10 years, because of an aging patient population and the arrival of new treatment options on the market. The firm is well-positioned to negotiate significant milestones and royalties from a potential marketing partner abroad.
On September 17 Dendreon announced that the European Commission has granted marketing authorization for PROVENGE®.
Celgene Corporation
Celgene's share price has done extremely well. From $64.89 in June to more than $149 right now.
The success of its blood cancer drug Revlimid, and the acquisitions of Pharmion and Abraxis have led to investors' increased appetite in this company. The company's growing cancer and immunoinflammatory drug pipeline gives Celgene an interesting footprint going forward.
Revlimid sales increased to $3.8 billion in 2012, or 68% of Celgene's total sales. Some analysts believe Revlimid sales will surpass $6 billion in 2017.
Growth prospects in multiple myeloma are strong, so Celgene's Revlimid will contribute to future growth of the company. The strong pipeline of Celgene has more potential blockbusters such as Pomalyst, which is on track to receive U.S. and European approval in 2013 and could serve multiple myeloma patients who fail with therapies such as Velcade and Revlimid.
Outside of oncology, Celgene is on track to apply for approval of apremilast in psoriatic arthritis and psoriasis in 2013. Last Saturday Celgene announced that its experimental drug, apremilast, proved to be more effective than a dummy pill for psoriasis patients in a late-stage study, clearing the way for the company to file for U.S. regulatory approval in the second half of 2013.
Celgene said 59% of patients in the 844-patient trial achieved a 50% improvement in symptoms at 16 weeks, using a standard score of the severity and extent of psoriasis, compared with 17% of placebo patients. A 75% improvement in symptoms was seen in 33% of the treatment group and 5% of the placebo group.
Revlimid continues to generate impressive data in approved and potential new indications, and growth should be bolstered by expanded duration of use and geographic reach. Celgene has made two sizable purchases that contribute to its diversification. The acquisition of Pharmion further strengthened Celgene's strategic focus on blood- related cancer therapies, and the more recent Abraxis acquisition moves the firm into the broader oncology market.
The company had $3.9 billion in cash at the end of 2012 and with a free cash flow of more than $2 billion annually, the company has enough cash for share buy backs and acquisitions.
Final Note
Electrochemotherapy is a potential solution for challenging situations in melanoma, breast cancer, and head and neck cancer, and OncoSec has the platform to treat and cure these cancers going forward.
The advantages of electrochemotherapy are the repeatability, the preservation of normal tissue and organ function, the use in previously irradiated areas, palliation of painful, ulcerated or bleeding lesions, the possibility of concomitant use with other therapies, and improved quality of life.
Electroporation-based cancer treatment approaches are currently undergoing intensive investigation in the field of drug delivery and gene therapy. OncoSec and Inovio are both making progress in electroporation. Both companies will stay on my watch list for this year.
Dendreon will have to capitalize on its prostate cancer drug, Provenge, by finding the right partner, and Celgene has the cash to expand its reach into other cancer fields.
Big pharmaceuticals are always interested in finding first-in-class and best-in-class therapies that may become the next generation treatments for patients with different types of cancer. Roche partnership with Inovio is a good example how things can work out. gene's share price has done extremely well. From $64.89 in June to more than $149 right now.
The success of its blood cancer drug Revlimid, and the acquisitions of Pharmion and Abraxis have led to investors' increased appetite in this company. The company's growing cancer and immunoinflammatory drug pipeline gives Celgene an interesting footprint going forward.
Revlimid sales increased to $3.8 billion in 2012, or 68% of Celgene's total sales. Some analysts believe Revlimid sales will surpass $6 billion in 2017.
Growth prospects in multiple myeloma are strong, so Celgene's Revlimid will contribute to future growth of the company. The strong pipeline of Celgene has more potential blockbusters such as Pomalyst, which is on track to receive U.S. and European approval in 2013 and could serve multiple myeloma patients who fail with therapies such as Velcade and Revlimid.
Outside of oncology, Celgene is on track to apply for approval of apremilast in psoriatic arthritis and psoriasis in 2013. Last Saturday Celgene announced that its experimental drug, apremilast, proved to be more effective than a dummy pill for psoriasis patients in a late-stage study, clearing the way for the company to file for U.S. regulatory approval in the second half of 2013.
Celgene said 59% of patients in the 844-patient trial achieved a 50% improvement in symptoms at 16 weeks, using a standard score of the severity and extent of psoriasis, compared with 17% of placebo patients. A 75% improvement in symptoms was seen in 33% of the treatment group and 5% of the placebo group.
Revlimid continues to generate impressive data in approved and potential new indications, and growth should be bolstered by expanded duration of use and geographic reach. Celgene has made two sizable purchases that contribute to its diversification. The acquisition of Pharmion further strengthened Celgene's strategic focus on blood- related cancer therapies, and the more recent Abraxis acquisition moves the firm into the broader oncology market.
The company had $3.9 billion in cash at the end of 2012 and with a free cash flow of more than $2 billion annually, the company has enough cash for share buy backs and acquisitions.
Final Note
Electrochemotherapy is a potential solution for challenging situations in melanoma, breast cancer, and head and neck cancer, and OncoSec has the platform to treat and cure these cancers going forward.
The advantages of electrochemotherapy are the repeatability, the preservation of normal tissue and organ function, the use in previously irradiated areas, palliation of painful, ulcerated or bleeding lesions, the possibility of concomitant use with other therapies, and improved quality of life.
Electroporation-based cancer treatment approaches are currently undergoing intensive investigation in the field of drug delivery and gene therapy. OncoSec and Inovio are both making progress in electroporation. Both companies will stay on my watch list for this year.
Dendreon will have to capitalize on its prostate cancer drug, Provenge, by finding the right partner, and Celgene has the cash to expand its reach into other cancer fields.
Big pharmaceuticals are always interested in finding first-in-class and best-in-class therapies that may become the next generation treatments for patients with different types of cancer. Roche partnership with Inovio is a good example how things can work out.
Hey trade. This is waitforit52. I think it's only 12 million shares. It's two companies listed but one has power of attorney for the other so I'm pretty sure it's only 12 million shares