This week's 6th annual World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers held in conjunction with the 8th annual EADO Congress in Barcelona, Spain provided investors, healthcare providers and patients with a wealth of information on the current advances in melanoma research. In a recent article that I wrote earlier this week, I delved into some companies that were presenting data or mentioned in the conference's program along with some closely associated companies that might be affected by promising trial data. Following are some of the data presented and their implications for the companies developing those therapies. For additional information on the data, please view the conference website and associated press releases from the companies presenting the data.
OncoSec Medical (ONCS.OB) presented two sets of data at the conference. Wednesday, the company announced Phase IV data for its NeoPulse therapy for the treatment of squamous cell carcinoma and basal cell carcinoma. NeoPulse utilizes an electroporation device to apply an electrical current across targeted tumors, increasing the cellular membranes' permeability by 4,000 - 10,000-fold. This allows the pre-injected chemotherapy agent, bleomycin in this case, to effectively penetrate the cancer cells where it is trapped once the current is removed. The premise behind the regimen is to more accurately place the bleomycin where it can be most effective and leave less circulating in the body to have undesired side effects. Data from the 88-patient trial yielded a complete response of greater than 92.8% in basal cell carcinoma patients and 70% in squamous cell carcinoma patients at six months (of 69 evaluable patients). The conclusion on the poster noted "Electrochemotherapy appears to provide local control with the potential advantage of preserving normal tissue and therefore warrants further exploration as an alternative or even adjuvant treatment in cutaneous skin cancers."
Yesterday, the company followed up its NeoPulse presentation with interim data from a promising phase 2 therapy of its ImmunoPulse platform in metastatic melanoma. OncoSec's ImmunoPulse program, like the NeoPulse, utilizes electroporation to more effectively administer a cancer treatment agent, but for this program the agent is DNA IL-12, a plasmid DNA construct with instructions for the cells to produce the IL-12 cytokine. Once inside the cells, the agent causes the targeted them to produce the IL-12 cytokine. Once ignored by the immune system, the newly expressed IL-12 triggers the patient's immunity system into action via circulating macrophages and cytotoxic T-cells. In other words, cancer cells once ignored by the immune system are now targeted and attacked. The most exciting part of the regimen is that, unlike the NeoPulse treatment, ImmunoPulse's response extends beyond the targeted tissue/tumors. Cancer tumors throughout the body are targeted by the immune system, potentially leading to a system-wide immune response against the tumors.
Leading into the data, the readership should first be familiarized with some medical terms. All definitions are from the National Cancer Institute website. Stable disease (SD) is defined as "Cancer that is neither decreasing nor increasing in extent or severity." Partial response (PR) is defined as "A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission." Complete response (CR) is defined as "The disappearance of all cancer in response to treatment. Also called complete remission." Data presented on Friday and released in Monday's press release noted eleven (of thirteen total enrolled) subjects were evaluable at 39 days, six at 90 days and two at 180 days. All treated lesions demonstrated response at 39 days (10% SD, 50% PR, 40% CR), at 90 days results were (44% PR, 56% CR) and at 180 days (43% PR and 57% CR). At 180 days, two subjects were evaluable for ORR (by trial design, ORR is to be measured at 180 days, so more updates here in the coming months will be critical). Of the two evaluable patients, one had a confirmed stable disease. The second patient had a near complete response of all treated and untreated lesions.
With a recent CE mark authorization to its credit on October 17th for its OMS gene and drug delivery system, promising data for its phase 2 ImmunoPulse Merkel cell carcinoma trial on October 23rd, the positive data for its NeoPulse melanoma trial reported on November 14 and promising data yesterday for its Phase II ImmunoPulse metastatic melanoma trial behind it, OncoSec should have plenty of positive catalysts ahead in 2013. The company should still be considered a development-phase company as it has not yet begun generating revenue with its platform and is still operating at a loss. Investors should perform a careful risk assessment on the company while taking into consideration its pipeline, its targeted indications, the company's financials and its OTCBB status.
Vical Incorporated's (VICL) Allovectin was mentioned on the program for the conference. However, I am unable to find any presentations or press releases indicating that data was presented. Investors are advised to continue watching for Allovectin's Phase III data updates of which topline data should be presented in mid 2013. An immunotherapy agent, Allovectin induces the expression of the two genes, HLA-B7 and β2 microglobulin, that together form an MHC class 1 complex. The therapy is injected intratumorally where it initiates an immune response, locally and systemically against that tumor type. Vical gave an update on its ongoing Phase III trial November 7th, and that resource may be a good starting point for interested investors. Efficacy and safety information on the trial should both be considered as well as the remainder of the company's pipeline and targeted market group.
Vical Incorporated is now trading just above its 52-week low of 2.77. Investors should watch to see if the downtrend continues while awaiting Phase III data in mid 2013. With markets trading in some turmoil for the small pharma sector, a small capitalization company such as Vical may see more downside with the next major catalyst several months away. This should provide for ample opportunities for new investors to make educated, wise and low entries into the company's depressed shares.
Amgen, Inc's (AMGN) T-VEC (formerly OncoVEX) was listed on the program on November 14th in a plenary session with Axel Hauschild, MD listed as the speaker (Dr. Hauschild is listed elsewhere as the president of the president of the Interdisciplinary Global Conference on Developing New Treatments for Melanoma). As of the date of this publication, no poster presentation or announcement on the data has been released. Although not likely a large share price mover for the company, investors in Amgen should consider the data to be significant as it will help to validate or debunk the company's decision to purchase privately-held BioVex Group on March of 2011 for $1 billion (including milestone payments for the late-phase OncoVEX cancer therapy). With the overall markets trading lower in recently, negative data for the phase 3 trial could cause an over-exaggerated selloff for Amgen's stock, which is trading near its 52-week high. Investors who firmly believe in Amgen's long-term possibilities, even without T-VEC in its pipeline, could use such a sell-off to open a long position in the company's shares if it should happen.
Bristol-Myers Squibb's (BMY) Yervoy (ipilumumab) was listed on the program for Barcelona, but no press release announcing data has been released. I had mentioned in my previous article on the conference that there was a possibility of Phase II data evaluating Yervoy to treat NY-ESO-1 expressed melanoma being presented. Although the monoclonal antibody does not directly target NY-ESO-1 antigens, it does target the cytotoxic T lymphocyte antigen 4 (CTLA-4), a negative regulator of T-cell activation. This deregulation enables the body's naturally occurring T-cells to attack cancer cells with certain expressions, in this case those with NY-ESO-1 antigens. Not only would Phase II data verify or deny ipilumumab for this specific indication, but positive data could indicate an advanced competitor for Celldex Therapeutics' (CLDX) early-stage CDX-1401, as it also targets the NY-ESO-1 antigens in its melanoma treatment approach. As of the date of this article, no data has been released by Bristol-Myers and there was no mention of the trial at the conference's poster sessions. There was a brief note on Thursday's guided poster tour on a posted titled "Ipilimumab Induced Simultaneous Regression of Melanocytic Nevi and Melanoma Metastases". On that poster was the statement "CTLA-4 antibodies generate immune responses to the melanoma-associated antigens Melan-A, NY-ESO-1, and gp100 in metastatic melanoma", giving more credibility to the possible success of Yervoy in this particular indication which would have a solid head start on Celldex's CDX-1401.
Data announced on October 29th for the Phase I trial of CDX-1401 to treat patients having solid tumors were promising in the trial in which the therapy was used in combination with the toll-like receptor (TLR) agonists resiquimod and/or Poly ICLC (Hiltonol). The patient set included 45 patients with advanced malignancies (21 melanoma, 6 ovarian, 5 sarcoma, 4 non-small cell lung cancer (NSCLC), 4 colorectal, 5 other). The data set as presented on the press release was a bit confusing due to the multiple indications targeted at once. However, pertinent to the subject at hand was the statement "Approximately 54% of patients with NY-ESO-1 positive tumors had anti-NY-ESO-1 titers at baseline and most increased after vaccination. Humoral responses were elicited in both NY-ESO-1 positive and negative patients. NY-ESO-1-specific T cell responses were absent or low at baseline, but increased post-vaccination in 53% (18/34) of evaluable patients, including both CD4 and/or CD8 T cell responses … Importantly, a well-tolerated and immunogenic regimen has been identified to take forward into the future study." Investors interested in Celldex should continue watching for Yervoy's Phase II trial for melanoma. Although not a significant source of the share price run up in 1H 2012 (that hype was due to Rindopepimut trials for glioblastoma and a CDX-011 trial for breast cancer), CDX-1401 does add diversification to the company's product portfolio. Even if unsuccessful for melanoma or if it has solid competition for the melanoma indication, the NY-ESO-1 target in solid tumors still has multiple other indications it can potentially address such as colorectal cancer, ovarian cancer, NSCLC, sarcomas and others if having the NY-ESO-1 over-expression.
Celldex shares, like many of those in the small pharmaceutical sector, are currently under pressure with a downtrend in place since its $6.55 close on October 4th. Shares are now trading at the $5.00 support with a market capitalization of $315 million. Interested investors should watch this support level closely to ascertain if it holds or breaks through. If a long position is opened at this level, a tight stop limit may be a wise decision to minimize loss. The company has a robust pipeline with multiple indications targeted, particular in its primary focus, cancer. This diversification also helps to protect against significant downside, as failure in one therapy for a particular indication would not necessarily be construed as a potential failure for another indication or with a different therapy.
Each of the presented companies has something to offer for varying types of investors. OncoSec's successes so far, a low market capitalization of $29 million and potential upcoming catalysts represent a high risk versus high reward type of investment in a company that is rapidly emerging with a novel approach to treating cancer. Vical should offer patient investors a more solid entry in the coming days as its major catalyst is still several months away, timing in entry at a bottom before interest returns in advance of the Phase III unveiling will be key. Celldex has many catalysts in its varied pipeline predominantly targeting cancer. With three trials in either Phase II or III clinicals, the company has multiple "make it or break it" catalysts upcoming. Positive data in either of these three trials could provide for solid upside, while the downside should be somewhat protected with the other trials' possibilities likely intact. Amgen and Bristol-Myers each offers investors the benefit of solid revenue, multiple marketed products and a much more protected downside than the three smaller market capitalization options noted. They also pay out quarterly dividends in the amounts of $0.36 and $0.34, respectively, adding to their investment quality.
Investors, healthcare providers and patients may view the posters at the conference themselves on its website through the program via this link, rather than through the abstracts link which does not appear to have any data as of yet. To view the multiple posters, please scroll to approximately 2/3 of the way down the PDF file. Much of the data in these posters have already been presented via earlier venues, but there may be additional pieces of information relevant in the posters that could clear up questions or concerns from the earlier presentations. For small pharma investors wanting to "stay ahead of the curve", the seemingly overlooked data could provide for a good starting point for new options, or could help to validate or debunk positions already taken. With the weekend ahead to perform research, perhaps there may be data in these posters that could be announced next week?