Endocyte (ECYT) Focused On Two Lead Pipeline Candidates
Zacks Investment Research | May 18, 2017 05:10AM ET
We issued an updated report on Endocyte, Inc. (NASDAQ:ECYT) on May 17.
Endocyte’s share price has increased 10.2% year to date, while the Zacks classified Medical-Drugs industry gained 4.9%.
Currently, the company is focused on the development of two candidates, EC1456 and EC1169, both of which are in phase I.
Endocyte is focusing on the development of its second-generation folate targeted agent, EC1456, as second-line treatment for non-small cell lung cancer (NSCLC), identified by the companion imaging agent etarfolatide. It has already initiated the expansion phase of the study on EC1456 in select folate receptor-positive NSCLC cancer patients. A dose of 6.0 mg/m2 has been established as the maximum twice a week dose and is being used in the expansion phase of the study.
Patients included in this expansion phase of the trial are expected to receive first-line chemotherapy and may also be treated with anti-PD-1 therapy. Initially, anti-tumor response of the single agent will be evaluated. Notably, positive results would lead to its evaluation as combination therapies in indications such as triple-negative breast cancer, ovarian cancer and endometrial cancer.
Although several companies are aggressively working on bringing new cancer treatments to market, demand for improved and targeted therapies makes this a space with high commercial potential. In fact, Endocyte uses its proprietary technology platform to develop various new small-molecule drug conjugates (SMDCs) for a range of diseases. Each SMDC consists of three modules: a targeting ligand, a linker and a drug payload.
Also, the company is working on generating a pipeline of SMDC candidates though this modular approach, including EC1456 and EC1169 (advanced metastatic castration-resistant prostate cancer/mCRPC – phase I ongoing), among others. Moving ahead, successful development of targeted SMDCs that are able to penetrate deep into dense solid tumors and have a shorter half-life might help Endocyte gain an edge over existing therapies.
Apart from these candidates, Endocyte is working on the development of companion imaging agents. These agents utilize the same modular structure as the SMDCs to replace the drug payload with an imaging agent.
The companion imaging agents facilitate the identification of patients who are most likely to benefit from Endocyte’s SMDC treatment. This should help in expanding the market for SMDCs, thereby boosting growth at the company. Currently, the company is evaluating EC1169 in a phase I study for metastatic castration-resistant prostate cancer (mCRPC).
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Patients are being scanned with its companion imaging agent, EC0652 to identify the presence of prostate-specific membrane antigen. The first part of the phase I study has been completed, and the company has started the second part, confirming 6.5 mg/m2 once a week as the maximum clinical dose. In this expansion phase of the study, two cohorts of mCRPC patients be evaluated.
The company is also nearing completion of preclinical work required to file an Investigational New Drug (IND) application for EC2629, which is its first candidate to target disease cells and simultaneously impact the tumor micro environment by shutting down tumors associated with macrophages. Moving ahead, Endocyte expects to file an IND for EC2629 by mid-2017.
However, the company has very few candidates in its pipeline with all of them in the early or mid-stages of development. Unfavorable results from any of these studies may lead to their postponement or discontinuation, thereby impacting shares adversely.
Endocyte’s products are expected to face intense competition in the market from both large pharma companies and small and mid-sized companies. Several companies are either pursuing the development of or marketing drugs that target NSCLC, prostate cancer, ovarian cancer and endometrial cancer, or other oncology pathways on which Endocyte focuses.
Furthermore, the market for lung cancer therapies is already crowded with treatments like Pfizer Inc.’s (NYSE:PFE) Xalkori and Eli Lilly and Company’s (NYSE:LLY) Alimta and Cyramza, and AstraZeneca Plc’s (NYSE:AZN) Tagrisso among others.
Zacks Rank
Endocyte currently carries a Zacks Rank #3 (Hold). You can see .
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