Two biotech companies, Argos Therapeutics Inc. and Eleven Biotherapeutics Inc., slid initial public offering (IPO) filings under the wire for 2013 to raise $60 million and $69 million, respectively. The filings cap a spectacular year for IPOs. Thirty-seven biotechs successfully completed IPOs in 2013, raising about $3 billion. Argos and Eleven will join 15 other companies filed and pending for 2014.
Argos, which filed confidentially on Nov. 12, 2013, will apply proceeds from the planned offering to the advancement of its Phase III cancer candidate, AGS-003. Eleven will use funds from its IPO to develop products from its AMP-Rx protein therapeutic platform, particularly EBI-005, a Phase II candidate for dry eye disease.
Argos is enrolling patients in a pivotal Phase III trial of AGS-003 in combination with sunitinib (Sutent, Pfizer Inc.) for metastatic renal cell carcinoma (mRCC) under a special protocol assessment with the FDA. The trial will enroll about 450 intermediate- and poor-risk patients with mRCC that have been classified as clear cell. The primary endpoint of the trial is overall survival. Argos expects to complete enrollment in the second half of 2014, with results available in the first half of 2016. An independent data monitoring committee will carry out an interim analysis for safety and futility at the 25 percent, 50 percent and 75 percent milestones of required events.
Argos found in a previous Phase II trial of AGS-003 with Sutent that median overall survival was 30.2 months. Data collected by the International Metastatic Renal Cell Carcinoma Database Consortium from 1189 mRCC patients treated with sunitinib or other targeted therapies was 14.7 months.
RCC is the most common form of kidney cancer, with about 65,000 new cases and about 14,000 deaths in 2013, according to the American Cancer Society. The Durham, N.C.-based company estimates the worldwide market for targeted therapies for RCC and mRCC is more than $2 billion.
A second product from Argos’s Arcelis platform, AGS-004, is in a Phase IIb trial for HIV funded by the National Institutes of Health.
The Arcelis technology uses components of a patient’s cancer cells or virus to create personalized immunotherapies that stimulate dendritic cells to activate an immune response to the disease. The platform is based on the work of 2011 Nobel prize winner Ralph Steinman.
In addition to its pivotal Phase III trial in clear cell mRCC, Argos is planning a Phase II trial in the first half of 2014 in non-clear cell mRCC. Two investigator-initiated Phase II trials of AGS-003 are scheduled to launch in the first half of 2014, and another Phase II trial in solid tumors is planned for 2014.
Argos also expects to launch another Phase II trial of AGS-004 in HIV in 2014.
Proceeds from the offering will fund the ongoing Phase III trial of AGS-003, Phase II trials of AGS-003, Phase II trials of AGS-004, and expenses related to a new commercial manufacturing facility.
Argos previously raised $42.5 million, including $30 million from the venture arm of Russian pharma firm Pharmastandard International SA from a Series E financing. That equity investment round was intended to support the company through the end of its Phase III trial of AGS-003. At the time, Argos said that it was not counting on participation of a partner to get the product through registration. (See BioWorld Today, Aug. 28, 2013.)
Eleven to target cytokines for eye disease
Eleven’s most advanced product candidate, EBI-005, is a topical treatment for dry eye disease and allergic conjunctivitis. The drug targets elevated levels of interleukin-1 (IL-1), an inflammatory cytokine thought to play a role in the disease.
A Phase Ib/IIa trial completed in 2013 showed statistically significant improvements in the signs and symptoms of dry eye compared to baseline. It also met other pre-defined efficacy criteria and demonstrated a differential effect between patients who received the drug and those who received vehicle control. EBI-005 was also found safe and well tolerated. (See BioWorld Today, June 28, 2013.)
The Phase III program will include two trials for safety and efficacy of EBI-005 and a separate trial for safety. Eleven expects to submit a biologics license application to the FDA by the end of 2016. The Cambridge, Mass.-based company also has plans to launch a Phase II trial of EBI-005 in allergic conjunctivitis in 2014.
In its S-1 filing, Eleven said that it believes the net proceeds of the offering combined with its existing cash of $3.9 million will fund all three of those trials.
Additionally, Eleven is developing several preclinical product candidates including EBI-029 for diabetic macular edema and EBI-028 for uveitis.
Both Argos and Eleven filed as emerging growth companies under the JOBS Act, which entitles them to reduced disclosure requirements.