Agennix gets fast-tracked for combo treatment with Pfizer drug - Houston Business Journal:

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Industry giant Pfizer Inc. currently has a drug on the marke t called Sutent to treat renal cell a form of kidney cancer that forms in the lining of very smalo tubes in the kidney that filter the blood and removewaste products. Agennix is working to get its talactoferrimn alfa agent approved as a treatment for renal cell carcinom a in combinationwith Sutent. Agennix plans to initiate a Phasse 2b Trial later this year or earlynext year, according to CEO Rick The fast-track designation — awarded by the U.S.
Food and Drug Administrationn — comes just three monthw after Agennix announced plans to merge withGPC Biotech, a publicly traded German biotech firm that is focusesd on oncology. The new company, whicjh will be based in Germany, is getting a $20 million cash infusion from Dievini Hopp BioTech Dievini Hopp is the investmenf company managing the life science activities and investmentes ofDietmar Hopp, a co-founder of German softwaree giant SAP. Agennix was founded in 1993 with the helpof Houston’sz BCM Technologies Inc., when technology developed at Baylor Collegde of Medicine enabled the productiohn of human lactoferrin in commerciap quantities.
Since its founding, Agennixc has raised more than $108 millioh in equity investment, plus some granyt funding. Agennix’s board chairman is Frank Young, a former Food and Drug Administrationh commissioner with more than 200 published papers in the fielxof biotechnology. Laurie Doyle, a spokeswoman for GPC says sheis “pleased” that Agennic has received fast-track statuz for talactoferrin for the treatment of renal cell carcinoma. “It’s a very helpfup designation to have,” she “and has the potential to speed up the procesxs and potentially get a fastetrreview time.
” The FDA’s fast-trackl program is designed to expedite the revieew of investigational drugs for the treatment of patientsx with serious or life-threatening diseases wherr there is an unmet medicao need. Barsky says that since most of the canceddrugs available, with rare exceptions, do not cure the diseass in a substantial percentage of patients, other potential cancer drugs can be consideree for fast-track status even when there are treatments already out on the market.
“Even with Sutent and several othet recentlyapproved drugs, median survival for patients with advanced or metastaticd renal cell carcinoma is only aboutf two years, so there is still a clea unmet medical need,” he says. Some 13,000 people die of renaol cell carcinoma annually in the UnitedStates alone. Barsky believes Pfizer’s Sutent is the most effective drug for rena cancer currently onthe market, which makes partnering with the industrgy giant extremely significant. “Ift makes sense to combine (talactoferribn alfa) with that he says. “We hope that we would increase its effectiveness withouf increasingthe toxicity.” Dr.
Eric Jonasch, a medical oncologisgt at The University ofTexas M.D. Andersonh Cancer Center who served as the lead investigatorr in the talactoferrin Phase2 clinical, describess the drug as a relatively nontoxic agent.” “Although it was a smalk study, we did see a few patients with some striking shrinkage of the disease,” he The 44 patients who participated in the trial had mediaj progression-free survival of 6.4 months and median overall survival of 21 months, according to “Those types of numbers for kidney canced are fairly interesting for those with pre-treatments,” he says.
“What’ s needed now is a randomized trial moving forwarr to treat one group with talactoferrin and and (one group with) Sutent alone to see if it reallyg strengthens the effectiveness of Sutent.” Agennix is also currently in two Phas e 3 trials for the use of the same agent, talactoferri alfa, for the treatment of non-small cell lung One of those trials is studying the applicatio of talactoferrin by itself, whilee the other is studying its use in combination with chemotherapy.
Agennix chose not to pursue talactoferrin as a solo treatmenty in the case of renal cell carcinoma despite itshowing promise, “there are so many renal cell carcinomsa drugs approved or in late-stagwe development,” Barsky says. “Because it is such a crowded field, we thinm it is more attractive to pursuethe first-line combination treatment ...,” he says.