At the much-awaited 46th Annual Meeting of the American Society of Clinical Oncology, or ASCO, clinical-stage biotechnology company, Nektar Therapeutics (NKTR) will be presenting supporting data from phase II results on NKTR-102 for ovarian cancer and preliminary phase I data on cancer compound NKTR-105. The company's shares have more than doubled in value from their 52-week low of $5.50 and trades around $12.83.
ASCO: A Quick Brief
The ASCO Annual Meeting allures the oncology community just as FIFA World Cup attracts soccer lovers. It throws open information about the latest in innovative treatments, practices, and approaches in cancer care (not cure yet). The research and education presented at ASCO enhance oncologists' knowledge, thereby enables advancement in high-quality cancer care.
The ASCO congregation also draws attention of investors across the globe primarily because cancer treatment means big bucks. Also, results published are significant stock movers. Often stocks rally well before the ASCO extravaganza even begins. Many companies including established bigwigs as well as those in clinical stage publish their oncology findings on the ASCO meet's rostrum.
The ASCO 2010 meet is slated to be held at Chicago, Illinois between June 4 and June 8. This year's theme is "advancing quality through innovation."
Why is Nektar Therapeutics Profiled?
Nektar is scheduled to present results from phase II trial of NKTR-102 for women with platinum-resistant/refractory ovarian cancer at the Oral Abstract Session of the Gynecologic Cancer Track on Sunday, June 6 at 11:15 am CT.
The San Carlos, California-based company, since inception in 1990, has grown to develop a proprietary advanced polymer conjugate chemistry technology platform, which enables customized conjugation of various molecular entities. Its oncology pipeline includes two investigative drug candidates: the lead candidate NKTR-102, under mid-stage study for platinum resistant ovarian cancer, metastatic breast, metastatic cervical cancer and colorectal cancer; and NKTR-105, under phase I trial for colorectal and non-small-cell lung cancer.
Ovarian cancer is indicated as the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Agents currently approved by the FDA to treat women with platinum-resistant ovarian cancer have modest overall response rates of 6.5% - 13.8%.
NKTR-102 is a formulation of polyethylene glycol or PEG-encapsulated irinotecan with antineoplastic activity. PEGylation is a water soluble, amphiphilic, non-toxic, non-immunogenic compound that is safely cleared from the body. Its primary use to date in currently approved drugs is to favorably alter the pharmacokinetic properties of biologics. By applying PEGylation technology to irinotecan, NKTR-102 provides improved drug penetration into tumors and decreases drug clearance, thereby increasing the duration of therapeutic effects while lowering the toxicity profile.
Irinotecan, also known as Camptosar; is a chemotherapeutic agent used for the treatment of solid tumors. NKTR-102 was invented by Nektar using its proprietary small molecule PEGylation technology platform, and is the first oncology product candidate to leverage its releasable polymer technology platform. The prodrug irinotecan is a semisynthetic derivative of camptothecin, which is converted to inhibit topoisomerase I activity by stabilizing the cleavable complex of topoisomerase I and DNA, resulting in DNA breaks that inhibit DNA replication and trigger apoptosis.
NKTR-102 phase II randomized open-label study enrolled 71 patients diagnosed with platinum-resistant/refractory ovarian cancer, wherein "refractory" was defined as disease progression within 3 weeks of last platinum. The primary endpoint for the study is overall response rate using Gynecologic Cancer InterGroup criteria, a combination of response by tumor imaging and ovarian cancer biomarker criteria. Secondary endpoints of the mid stage study were progression-free survival and safety.
Most recently, according to research abstract filed with ASCO last week, women treated with NKTR-102 once every two weeks reported a 47% response rate, while a 41% response rate was attained by women treated every three weeks. The reported response rate is superior to interim results from the same study published earlier. Consistently high treatment response rates were observed with NKTR-102 across all measures in both treatment arms along with a favorable safety profile were summarized in the ASCO abstract.
In March, the company published interim results of the phase II trial which showed women who received NKTR-102 once every 21 days had a median Progression-free survival of 21.0 weeks. In the second arm of the study, women who received NKTR-102 once every 14 days had a median PFS of 12.2 weeks. PFS is a measure of how long patients live without their disease advancing. Current agents approved by the FDA to treat women with platinum-resistant ovarian cancer have median PFS of between 9.1 and 13.6 weeks. The company noted that NKTR-102 demonstrated a progression-free survival time of nearly five months, which is "remarkable for a largely refractory population" that is expected to have a PFS of less than three months.
"We are privileged that the ASCO Scientific Program Committee has accepted our Phase 2 data for NKTR-102 in ovarian cancer for presentation at the Gynecologic Cancer Oral Abstract Session. The notably high objective response rates seen with single-agent NKTR-102 in heavily pretreated patients with platinum-resistant/refractory disease indicate that NKTR-102 holds great potential as a new therapeutic option for even the most difficult-to-treat population within ovarian cancer. Further, the data demonstrate that Nektar's proprietary polymer technology can create greatly improved chemotherapeutic candidates with the potential to address significant unmet medical needs for patients with cancer," commented Lorianne Masuoka, M.D., Nektar Senior Vice President and Chief Medical Officer.
The other key candidate under development is NKTR-105. The phase 1 clinical trial results of NKTR-105 will be presented in the Trials In Progress Poster Session at the ASCO 2010, on Monday, June 7 between 8:00 AM - 12:00 PM CT. the poster discusses dose-escalation phase I study of NKTR-105, a novel pegylated form of docetaxel.
NKTR-105 is in a Phase 1 clinical trial in patients with certain types of solid tumors including hormone-refractory prostate cancer. Additionally, it is also explored as a therapy for breast, non-small cell lung, gastric, head and neck cancers. Each year, an estimated 3 million patients worldwide have been diagnosed with one of these types of cancer.
Docetaxel is the only chemotherapeutic agent approved for use in five different cancer indications. NKTR-105 is a novel form of the anti-mitotic agent, docetaxel, and was designed using Nektar's advanced polymer conjugate technology.
Nektar's pro-drug technology approach applied to docetaxel is expected to improve the pharmacokinetic profile of the drug, resulting in prolonged exposure of the tumor to docetaxel and an improved time-concentration profile.
Oncolytics such as docetaxel typically have sub-optimal half-lives which can limit their therapeutic efficacy, or have a safety and tolerability profile that limits their use. Nektar's advanced polymer conjugate technology platform has the potential to be used to optimize the bioactivity of these small molecule compounds and increase the sustained exposure of active drug to tumor cells in the body.
Nektar's product candidate, NKTR-118, an oral drug in phase II trial, is a peripheral opioid antagonist that is being evaluated for the treatment of opioid-induced constipation. In September 2009, the company entered into an exclusive worldwide license agreement for up to $1.5 billion in milestones in addition to significant double digit royalties with AstraZeneca plc (AZN) for its NKTR-118 and NKTR-119 programs.
Nektar claims that every PEGylated product approved over the last fourteen years has been enabled with its proprietary technology. To date, Nektar's technology and drug development expertise have enabled nine approved products for partners.
In oncology, the company partnered with Amgen, Inc. (AMGN) to develop Neulasta to treat neutropenia, a lack of certain white blood cells caused by cancer chemotherapy.
Nektar's research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. Studies in various stages are underway in a number of therapeutic areas including immunology, nephrology, ocular, pain, anti-infectives, anti-viral and surgical imaging.
In the financial front, the company has managed to narrow its first-quarter loss significantly to $6.13 million or $0.07 per share from $31.94 million or $0.34 per share, driven by a surge in revenue contributed by milestone payment received from license collaboration with AstraZeneca. Also during the quarter, net operating costs were down by 9% due to lower general and administrative expenses as well as cost of goods sold. Research and development expenses edged down. However, Barclays Capital downgraded Nektar to "Equal Weight" from "Overweight."
Howard Robin, Nektar's President and Chief Executive is upbeat about road ahead and stated, "We are excited about our product opportunities in pain and oncology generated by Nektar's advanced polymer conjugate technology platform. In particular, we are pleased with the recent recognition that NKTR-102 has received from the oncology community with the acceptance of our NKTR-102 Phase 2 ovarian data for oral presentation at the 2010 American Society of Clinical Oncology meeting in June."
Conclusion
Nektar's USP is its unparalleled technology that can reproducibly pegylate to small-molecule drugs. The results to be discussed at ASCO is the turnkey, as it may even translate into bait to fish out any potential suitor for licensed co-promotion or takeovers.
Related Reading Other ASCO plays.
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