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Agennix - Protein Therapeutics for Cancer and Diabetes
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A Biopharmaceutical Company Developing A Novel Dendritic Cell Recruiter and Activator (DCRA) for Cancer and other Unmet Medical Needs
Agennix is a private biotechnology company developing a first-in-class molecule with activity in several types of cancer and in other indications with unmet medical needs. Talactoferrin is a targeted dendritic cell recruiter and activator (DCRA) with a novel mechanism of action. The Company is developing an oral formulation of talactoferrin for cancer indications, and a topical gel formulation for the treatment of diabetic foot ulcers. The Company is also investigating the activity of the oral formulation of talactoferrin in patients with severe sepsis in an NIH-funded clinical trial.
Agennix has completed two randomized, double-blind, placebo-controlled Phase II studies evaluating talactoferrin for the treatment of non-small cell lung cancer (NSCLC), which is one of the most common types of cancer worldwide. Approximately 150,000 patients in the U.S. and 300,000 patients in Europe are diagnosed with NSCLC each year. The therapy with the highest probability of curing NSCLC is surgical resection of localized disease. Unfortunately, the disease has usually spread by the time it is discovered, and less than 20% of lung cancers are diagnosed at a stage where surgery with a curative intent may be considered. Radiation therapy may be considered in combination with chemotherapy for a subset of patients with locally advanced disease. However, the most common modality used in locally advanced or metastatic disease is combination chemotherapy.
A commonly used doublet chemotherapy regimen in the U.S. for patients with newly diagnosed locally advanced or metastatic NSCLC (approximately 75-80% of all patients with NSCLC) is the combination of two off-patent chemotherapeutic agents: paclitaxel and carboplatin. Genentech's anti-VEGF antibody, Avastin® (bevacizumab), was approved in the U.S. in October 2006 for use in combination with paclitaxel and carboplatin for the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC. While Avastin® represents an improvement in the treatment of NSCLC, Avastin® is associated with significant toxicities and is contra-indicated in approximately 50% of NSCLC patients, primarily due to an increased risk of bleeding. Eli Lilly's Alimta® (pemetrexed) was also recently approved in combination with cisplatin for the treatment of patients with locally advanced or metastatic non-squamous NSCLC. However, neither agent is approved for the treatment of patients with squamous cell NSCLC.
Agennix's first Phase II trial in NSCLC evaluated talactoferrin or placebo in combination with carboplatin and paclitaxel chemotherapy (C/P) as first-line treatment in patients with Stage IIIB/IV disease of all histologies. The trial met its primary endpoint (improvement in response rate with p=0.05), generated positive trends on secondary endpoints including progression-free survival and overall survival, and was well tolerated. The confirmed response rate in the prospectively defined evaluable patients (the pre-specified primary endpoint for the trial) increased from 29% in the C/P + placebo arm to 47% in the C/P + talactoferrin arm (18% absolute improvement and 62% relative improvement). The magnitude of the talactoferrin effect in this trial compares favorably to the effect seen in first-line NSCLC with Avastin® (or with Erbitux® [cetuximab], which is believed to be the leading drug in development for this indication). Based on these results, the Company met with the FDA to discuss the trial design for the pivotal Phase III study, resulting in Fast Track designation for this program by the FDA, and FDA approval of a Special Protocol Assessment (SPA) for a single Phase III trial in first-line NSCLC. The Company also obtained favorable Scientific Advice from the European Medicines Agency (EMEA) regarding the pivotal Phase III study.
In a second randomized, double-blind, placebo-controlled Phase II trial in NSCLC, talactoferrin monotherapy was evaluated in patients with refractory (second and third-line) Stage IIIB/IV disease of all histologies. The trial met its prospectively defined primary endpoint of improvement in overall survival with talactoferrin (p=0.04; Hazard Ratio=0.68). Patients in the talactoferrin arm had a 2.4 month (65%) increase in median survival relative to the patients who received placebo (6.1 vs 3.7 months). The results generated by talactoferrin in this trial compare favorably to the results with Tarceva® (erlotinib) monotherapy in patients with refractory NSCLC. Based on the Phase II results, and the positive feedback obtained from key opinion leaders, the Company will be conducting a pivotal Phase III trial with talactoferrin monotherapy in NSCLC patients who have failed two or more prior treatment regimens. The Company has received Fast Track designation from the FDA for this indication and obtained FDA's guidance on the protocol through the Fast Track process. In addition, the Company obtained favorable Scientific Advice on the Phase III monotherapy trial from EMEA. The Company has also received Orphan Drug designation from FDA for NSCLC, which applies to both the first-line and the refractory indications.
Due to the attractive safety profile of talactoferrin, and to its mechanism of action, which is complementary to the mechanism of action of traditional chemotherapy regimens and of new agents such as Avastin® and Tarceva®, talactoferrin could be expected to increase activity when added to existing or new therapeutic regimens without increasing toxicity. As a result, the Company believes that talactoferrin has the potential to be an important new treatment option for first-line and refractory NSCLC.
Oral talactoferrin has also demonstrated apparent activity as monotherapy in various other tumor types in clinical trials (including renal cell carcinoma [RCC], breast, ovarian, prostate and melanoma), and in combination with approved chemotherapeutic agents in animal studies.
In advanced RCC, talactoferrin monotherapy was tested in a Phase II open label trial to evaluate its effects in patients whose disease had progressed after receiving at least one prior regimen of systemic therapy. Indications of anti-cancer activity included partial responses, median progression-free survival (PFS) of 6.4 months, median overall survival (OS) of 21.1 months, and a 1-year survival rate of 77%. This compares favorably to outcomes expected in this patient population based on published results (2.4 to 2.8 months median PFS, 12.7 months median OS and a 1-year survival rate of 52% for untreated patients or patients who received placebo). Results from the RCC trial were submitted to the FDA and the EMEA as part of applications for Orphan Drug designation, which were awarded. The Company expects to conduct a Phase IIb trial in RCC and Phase II trials in other cancer indications.
In wound healing, the Company evaluated topical talactoferrin gel in a blinded, placebo-controlled Phase II trial in patients with diabetic foot ulcers. The trial met its primary endpoint. The proportion of patients achieving at least 75% wound closure at the end of the 12-week treatment period, which was the primary endpoint, was twice as high in the talactoferrin group (50%) as in the placebo group (25%).
Additionally, based on promising preclinical data in sepsis, the Company is conducting an NIH-funded, randomized, double-blind, placebo-controlled, multi-center Phase II trial in 190 patients with severe sepsis.
Both oral and topical formulations of talactoferrin have been well tolerated. Over 600 patients have been dosed with talactoferrin, including patients who had exposure to talactoferrin lasting over two years. No dose limiting toxicities have been reported and a maximum tolerated dose could not be defined.
The Company's talactoferrin development program is described below.
Candidate
Indication
Current Phase
Next ClinicalTrial Initiation
Oral Talactoferrin
NSCLC (Refractory)
II (Completed)
Phase III in H2 2008
NSCLC (First-Line)
II (Completed)
Phase III in H1 2009
Renal Cell Carcinoma
II (Results)
Phase IIb in 2009
Sepsis
II (Ongoing)
Initiated in H1 2008
Other Cancer Types
I (Completed)
Phase II in 2009
Topical Talactoferrin
Diabetic Foot Ulcers
II (Results)
Agennix has successfully scaled up the talactoferrin manufacturing process to a 35,000 liter fermentation scale according to current Good Manufacturing Practice (cGMP) standards, which is an economically attractive production scale with cost of goods sold (COGS) that are appropriate for commercial launch.
Agennix was founded in 1993 based on technology developed at the Baylor College of Medicine, and currently holds > 100 issued patents and > 40 pending patents broadly protecting talactoferrin composition of matter, use, and manufacturing methods. Agennix's rights to talactoferrin are unencumbered. Agennix currently retains worldwide rights for all territories and indications.
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