News

< Back to News

AACR17 Immunotherapy Presentations to Watch

Mar. 28, 2017

The annual meeting of the American Association for Cancer Research (AACR) takes place in Washington, DC on April 1-5. Investors follow meetings like this closely because they are where biotech companies often present their most important clinical data and pre-clinical research. We recommend keeping an eye on the news from AACR because this type of info has the ability to move stocks.

Given that AACR is devoted exclusively to cancer research, cancer immunotherapy advances will be a key theme. In fact, many component companies of the Cancer Immunotherapy ETF (Nasdaq: CNCR) will be attending and presenting new data at this year’s meeting. To help investors prepare, we are highlighting five data presentations to watch for.

text

KITE PHARMA (NASDAQ: KITE)

Full data from the ZUMA-1 pivotal trial of axicabtagene ciloleucel in patients with aggressive non-Hodgkin lymphoma (NHL).

Earlier this year, Kite Pharma announced the primary topline results for a pivotal study using their CAR-T approach to immunotherapy in patients with an aggressive form of NHL. In this study, the CAR-T therapy produced an objective response rate of 41% of patients at the six-month mark and a complete response rate of 36%. The National Cancer Institute defines an objective response as a measureable response and a complete response as the disappearance of all signs of cancer in response to treatment.  The study met its primary endpoint objective.

At AACR, Kite will present the full and thorough data from this ZUMA-1 study. The presentation will give investors and cancer researchers a better idea of how patients are responding to the therapy, what the safety and side effect profile is like, and how these results compare to more traditional treatments like chemotherapy. This data is important because Kite plans to use it as the basis for applying to FDA for commercial approval of axicabtagene ciloleucel in NHL. There are not yet any approved CAR-T therapies so this has the potential to be a landmark event for immunotherapy if everything goes well.

text

NEWLINK GENETICS (NASDAQ: NLNK)

Interim analysis of the Phase 2 clinical trial of the IDO pathway inhibitor indoximod in combination with pembrolizumab for patients with advanced melanoma.

In September of 2014, Merck’s immunotherapy drug pembrolizumab (Keytruda) became the first FDA-Approved anti-PD-1 checkpoint inhibitor therapy by winning approval for patients with an advanced form of melanoma. It was both a major event for advanced melanoma patients and the cancer immunotherapy field in general. This class of immunotherapy drugs has already gone on to be approved in six other unique types of cancer (lung cancer, kidney cancer, bladder cancer, Hodgkin lymphoma, head and neck cancer, and Merkel cell carcinoma).

However, as important as this news was, unfortunately only a portion of advanced melanoma patients (24 percent) had an overall response to the drug. The biotech industry is committed to seeing more patients helped by immunotherapy so companies are now taking a combination approach to treatment – adding two or more medicines together to try to boost the number of patients helped. One such promising combination uses another drug in the checkpoint inhibitor class of immunotherapy, called an IDO inhibitor, in combination with anti-PD-1.

At AACR, NewLink will present an interim analysis of a phase 2 study of their IDO inhibitor indoximod with Merck’s anti-PD-1 pembrolizumab. This data could be meaningful because researchers are in the early stages of understanding what drugs work best in combination. If IDO succeeds and becomes widely used in the combination approach, it could be considerable for the field given the number of cancers that checkpoint inhibitors have already been approved for on their own. NewLink has significant exposure to the IDO inhibitor space and has one other IDO candidate that is partnered with the Swiss pharmaceutical giant Roche.

text

BRISTOL-MYERS SQUIBB (NYSE: BMY)

BMS-986205, an optimized IDO1 inhibitor, is well tolerated with potent pharmacodynamics activity, alone and in combination with nivolumab in advanced cancer in a phase 1/2a trial.

Bristol-Myers Squibb has 21 oncology compounds in clinical development and is a leader in the immunotherapy space. You might have already heard of their core immunotherapy asset, the anti-PD-1 inhibitor nivolumab (Opdivo). Bristol will have many presentations at this year’s AACR annual meeting illustrating the use of immunotherapy drugs such as nivolumab as monotherapy and in combination with other assets.

Just as we have highlighted the combination of NewLink’s IDO inhibitor indoximod with Merck’s anti-PD-1 pembrolizumab above, we are also highly anticipating Bristol’s IDO presentation because it will be the first time we have seen data from its wholly owned IDO inhibitor BMS-986205. The presentation will include data from BMS-986205 by itself and in combination with the anti-PD-1 nivolumab. A lot is at stake with BMS-986205 because Bristol acquired it by purchasing Flexus in early 2015 for $800 million upfront and potentially another $450 million in milestones.

Bristol could use some good clinical trial news because the company had a challenging year last year in the clinic. In August, their trial for nivolumab in first-line lung cancer failed to reach a positive outcome weeks after Merck’s immunotherapy trial in first-line lung cancer succeeded. A main reason for the different outcomes was that Bristol tested their drug in a more aggressive patient population, and perhaps something learned from the result is the importance of the combination approach for this population. By providing a glimpse of how competitive Bristol might be in one type of combination – IDO/PD-1, their presentation at AACR will be an important test of the company’s continued leadership role leadership in cancer immunotherapy.

text

ADURO BIOTECH (NASDAQ: ADRO)

Development of a first in class APRIL fully blocking antibody BION-1301 for the treatment of multiple myeloma.

Aduro Biotech has three different cancer immunotherapy platforms in house. The first, LADD, uses bacteria to prime the immune system to recognize cancer and is currently in clinical trials for cancers such as mesothelioma and gastric cancer. The second, STING, mimics a natural mediator of immunity and is partnered with Novartis in a clinical trial of multiple tumor types. Lastly, Aduro’s third cancer immunotherapy platform consists of B-select monoclonal antibodies that can regulate the immune system by either stimulating an immune response or stopping a mechanism that holds the immune system back.

This B-select platform is not yet in clinical trials but a first trial by Aduro is scheduled to begin in the second half of 2017. It will focus on a target that is present in multiple myeloma called APRIL. APRIL might be a key factor that increases the persistence of multiple myeloma, leading to the fact that current medicines eventually stop working over time. No other companies have tested drugs against APRIL so this might be a new pathway for treating the disease if it is ultimately successful.

The AACR presentation will more fully explain the rationale behind APRIL and describe how Aduro has gone about developing an antibody to block it. This is an important proof of concept for the company because it will be the first B-select antibody asset to enter clinical trials and will be a reflection on the entire platform. Also, since Aduro believes this is a first-in-class drug, it has the opportunity to set the company apart commercially if it shows clinical activity. For these reasons, researchers will keen to learn more about this new approach to fighting multiple myeloma that Aduro has come up with.

text

COMPUGEN (NASDAQ: CGEN)

Discovery and development of COM701, a therapeutic antibody targeting the novel immune checkpoint PVRIG.

Checkpoint inhibitors utilizing PD-1 and CTLA-4 have revolutionized the treatment of many types of cancers. These drugs work by blocking a mechanism that tumors use to prevent the immune system from attacking them. In layman’s terms, one could say that checkpoint inhibitors “take the brakes off” the immune system and allow it to do its natural job. However, while these drugs work well for some patients, they unfortunately only work for a period of time and also do not help everyone so a search is on for more checkpoint targets that can also be used in the fight against cancer.

As the company’s name implies, Compugen utilizes a computational approach to identifying new drug targets, including novel checkpoint inhibitors. Their algorithm first searches for checkpoints that are highly expressed and active in cancer, and then the company discovers antibodies to block them. Using this approach, Compugen has discovered a novel antibody called COM701 that targets an immune checkpoint called PVRIG. They believe PVRIG plays an important roll in immune cells within the tumor microenvironment. The AACR presentation will describe the mechanism of PVRIG and how Compugen believes blocking it with their antibody will have an anti-tumor effect.

While in the past Compugen has traditionally licensed assets like this to other companies to develop after discovering them, they are planning to take COM701 and other newly discovered checkpoint inhibitors into the clinic by themselves for the first time ever. This is a new business model for Compugen and might capture more value in the drug development process if successful. For that reason, investors and researchers will be watching this presentation to gauge how promising the PVRIG target might be and also Compugen’s ability to develop the right antibody to block it and produce robust anti-tumor activity.

 

To see how it all plays out, look for press releases from individual companies or you can watch the action in real time April 1-5 by following #AACR17 on Twitter.


  • Loncar Funds
  • P.O Box 15072
  • Lenexa, KS 66285
  • +1 800-617-0004
  • Contact Us

CNCR Prospectus CHNA Prospectus

A basis point is a common unit of measure for interest rates and other percentages in finance. One basis point is equal to 1/100th of 1%, or 0.01% (0.0001).

The Loncar Cancer Immunotherapy Index is an index of 25 securities that have a strategic focus on the area of cancer immunotherapy, or harnessing the immune system to fight cancer. Quotes for the index can be found under the symbol “LCINDX” on the Bloomberg Professional service and other financial data providers. One may not directly invest in an index.

The Loncar China BioPharma Index is an index of 28 securities that have a strategic focus on advancing China’s biopharma industry. Quotes for the index can be found under the symbol “LCHINA” on the Bloomberg Professional service and other financial data providers. One may not directly invest in an index.

Holdings are subject to change.

The Hong Kong Stock Exchange (HKEX) is the primary stock exchange in the Hong Kong Special Administrative Region of China. Nasdaq is one of the primary stock exchanges in the United States.

Carefully consider the Fund’s investment objectives, risk factors, charges and expenses before investing. This and additional information can be found in the Fund’s prospectus, which may be obtained at www.loncarfunds.com. Read the prospectus carefully before investing.

Investing involves risk. Principal loss is possible. The fund may trade at a premium or discount to NAV. CNCR will invest in immunotherapy companies which are highly dependent on the development, procurement and marketing of drugs and the protection and exploitation of intellectual property rights. A company’s valuation can also be greatly affected if one of its products is proven or alleged to be unsafe, ineffective or unprofitable. The costs associated with developing new drugs can be significant, and the results are unpredictable. The process for obtaining regulatory approval by the U.S. Food and Drug Administration or other governmental regulatory authorities is long and costly and there can be no assurance that the necessary approvals with be obtained and maintained. The Fund may invest in foreign securities, which involve political, economic, currency risk, greater volatility, and differences in accounting methods. The Fund is non-diversified meaning it may concentrate its assets in fewer individual holdings than a diversified fund. Therefore, the Fund is more exposed to individual stock volatility than a diversified fund. The Fund invests in smaller companies, which may have more limited liquidity and greater volatility compared to larger companies. The Fund is not actively managed and may be affected by a general decline in market segments related to the index. The fund invests in securities included in, or representative of securities included in, the index, regardless of their investment merits. The performance of the fund may diverge from that of the Index and may experience tracking error to a greater extent than a fund that seeks to replicate an index. Shares are bought and sold at market price (not NAV) and are not individually redeemed from the Fund. Brokerage commissions will reduce returns.

RISK FOR THE CHNA ETF: The biopharmaceutical industry in China is strictly regulated and changes in such regulations, including banning or limiting certain products, may have a material adverse effect on the operations, revenues, and profitability of Biopharma Companies. The laws and regulations applicable to the process of administrative approval of medicine and its production in China require entities producing biopharma products to comply strictly with certain standards and specifications promulgated by the government. Changes in currency exchange rates and the relative value of non-U.S. currencies will affect the value of the investment. Currency exchange rates can be very volatile and can change quickly and unpredictably. Investments in non-U.S. securities involve certain risks that may not be present with investments in U.S. securities. For example, investments in non-U.S. securities may be subject to risk of loss due to foreign currency fluctuations or to political or economic instability. Investments in non-U.S. securities also may be subject to withholding or other taxes and may be subject to additional trading, settlement, custodial, and operational risks. These and other factors can make investments in the Fund more volatile and potentially less liquid than other types of investments. To the extent the Fund invests a significant portion of its assets in the securities of companies of a single country or region, such as China, it is more likely to be impacted by events or conditions affecting that country or region. The Fund is a recently organized, non-diversified management investment company with no operating history. As a result, prospective investors have no track record or history on which to base their investment decision. The Fund is considered to be non-diversified, which means that it may invest more of its assets in the securities of a single issuer or a smaller number of issuers than if it were a diversified fund. The Fund is not actively managed and the Fund's sub-adviser would not sell shares of an equity security due to current or projected underperformance of a security, industry or sector, unless that security is removed from the Index or the selling of shares of that security is otherwise required upon a reconstitution of the Index in accordance with the Index methodology. To the extent the Fund invests more heavily in particular sectors of the economy, its performance will be especially sensitive to developments that significantly affect those sectors."

Diversification may not protect against market risk.

Exchange Traded Concepts, LLC serves as the investment advisor, and Vident Investment Advisory, LLC serves as a sub advisor to the fund. The Funds are distributed by Quasar Distributors, LLC, which is not affiliated with Exchange Traded Concepts, LLC or any of its affiliates.