On May 14, 2015 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis technology platform, reported financial results for the first quarter ended March 31, 2015 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, MAY 14, 2015, View Source [SID:1234504337]).
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"We continue to make strong progress in our clinical programs," said Jeff Abbey, president and chief executive officer. "Data from the previously conducted phase 2 clinical trial of AGS-003 in metastatic renal cell carcinoma (mRCC) were recently published in the Journal for ImmunoTherapy of Cancer and showed that an increase in memory T-cells after five doses of AGS-003 was associated with prolonged survival. In addition, patients with intermediate risk mRCC experienced a median survival in excess of 5 years. Expected median survival for these patients treated with sunitinib as their first line targeted therapy is approximately 20.5 months. These and the other findings of the trial are being further evaluated in the ongoing phase 3 ADAPT trial. We look forward to an interim data analysis for this trial by the Independent Data Monitoring Committee, or IDMC, at approximately 25% of events which we expect will occur during the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting."
Mr. Abbey continued, "We are also pleased to have recently entered into an agreement with Lummy HK, under which they licensed from us the rights to manufacture, develop and commercialize AGS-003 for the treatment of cancer in China, Hong Kong, Taiwan and Macau. We believe this agreement provides further validation of AGS-003 to treat not only mRCC, but potentially others cancers as well, and look forward to the development of this promising product candidate to treat a new population of patients with high unmet medical needs."
Recent Highlights and Anticipated Milestones
Data from the previously conducted phase 2 clinical trial of AGS-003 published in the Journal for ImmunoTherapy of Cancer
The data from the trial show that treatment with AGS-003 in combination with sunitinib was safe, well tolerated and associated with immunologic responses and extended survival
Median overall survival for all patients was 30.2 months and median overall survival for intermediate risk patients was over 5 years
Observations from the trial indicate that an increase in memory T-cells after five doses of AGS-003 was associated with prolonged survival
Entered into a license agreement with Lummy HK for the development of personalized immunotherapies to treat cancer in China
Lummy HK licensed the rights to manufacture, develop and commercialize AGS-003 for the treatment of cancer in China, Hong Kong, Taiwan and Macau
Lummy HK has agreed to pay Argos a royalty on net sales of AGS-003 at a rate in the teens and up to an aggregate of $20 million for regulatory and commercial milestones
Argos sold $10 million of its common stock to an affiliate of Lummy and the China BioPharma Capital I Fund
NIH Division of Aids (DAIDS) approved $6.6 million in funding for the investigator-initiated phase 2 adult eradication study of AGS-004, the company’s investigational fully personalized immunotherapy for HIV
Allows stage two of the adult eradication trial to move forward; the trial has already been cleared for initiation by the FDA
Received the Economic Development Award at the 17th annual Triangle Commercial Real Estate Women (Triangle CREW)
Champion Awards
Argos recognized for its plans to expand into a new 100,000 square foot manufacturing facility currently under construction and create nearly 250 jobs in Durham, NC
Initiation of an investigator-initiated phase 2 pediatric trial of AGS-004 planned for second half of 2015
Continue the build-out and equipping of Argos’ automated commercial manufacturing facility
Full enrollment of the phase 3 ADAPT trial for AGS-003 in mRCC expected by the end of second quarter 2015
Interim data analysis from the ADAPT trial by the IDMC at approximately 25% of events expected during the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Dr. Robert Figlin, Principal Investigator, will present an update from the ADAPT trial at ASCO (Free ASCO Whitepaper) during the Genitourinary (Nonprostate) Cancer poster session on Monday, June 1st from 1:15-4:45pm CT
Poster titled "Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience" (abstract TPS4582)
Selected First Quarter 2015 Financial Results
Revenue for the three months ended March 31, 2015 totaled $0.2 million compared to $0.8 million for the same period in 2014. Net loss attributable to common stockholders for the three months ended March 31, 2015 was $17.5 million, or $0.89 per share, compared to a net loss attributable to common stockholders of $10.9 million, or $1.05 per share, for the same period in 2014. Research and development expense for the three months ended March 31, 2015 totaled $14.8 million compared to $8.5 million for the same period in 2014. General and administrative expense for the three months ended March 31, 2015 totaled $2.4 million compared to $1.9 million for the same period in 2014.
As of March 31, 2015, Argos’ cash, cash equivalents and short-term investments totaled $39.2 million compared to $56.2 million as of December 31, 2014.