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 markegt called Sutent to treat renal cell a form of kidney canceer that forms in the lining of very smalk tubes in the kidney that filter the blood and removrwaste products. Agennix is working to get its talactoferrijn alfa agent approved as a treatmen for renal cell carcinoma in combinationwith Sutent. Agennisx plans to initiate a Phase 2b Trial later this year or early next according to CEORick Barsky. The fast-track designation awarded by the U.S. Food and Drug Administrationj — comes just three months after Agennis announced plans to merge withGPC Biotech, a publicly tradedc German biotech firm that is focused on oncology.
The new which will be based in is gettinga $20 million cash infusio from Dievini Hopp BioTech Holding. Dievin i Hopp is the investment compang managing the life science activities and investments ofDietmar Hopp, a co-founder of German softwarre giant SAP. Agennix was founded in 1993 with the helpof Houston’e BCM Technologies Inc., when technology developed at Baylor Collegwe of Medicine enabled the productionm of human lactoferrin in commercialp quantities. Since its founding, Agennix has raisedd more than $108 million in equity investment, plus some grang funding.
Agennix’s board chairman is Frank Young, a formee Food and Drug Administration commissionef with more than 200 published paperes in the field of Laurie Doyle, a spokeswoman for GPC says she is “pleased” that Agennix has received fast-track statux for talactoferrin for the treatment of renal cell carcinoma. “It’s a very helpfu l designation to have,” she says, “and has the potential to speed up the process and potentiallg get a fasterreview time.
” The FDA’s fast-track program is designes to expedite the review of investigationa drugs for the treatment of patients with serious or life-threateningf diseases where there is an unmef medical need. Barsky says that since most of the canceddrugs available, with rare exceptions, do not cure the diseass in a substantial percentage of other potential cancer drugs can be considered for fast-traclk status even when there are treatmentx already out on the market. “Eveb with Sutent and several other recentlyapproved drugs, median survival for patients with advanced or metastati renal cell carcinoma is only about two so there is still a clear unmet medical need,” he says.
Some 13,00p people die of renalo cell carcinoma annually in the UnitedStates alone. Barsk believes Pfizer’s Sutent is the most effectived drug for renal cancer currently onthe market, which makezs partnering with the industryy giant extremely significant. “It makes sense to combind (talactoferrin alfa) with that drug,” he says. “We hope that we wouls increase its effectiveness without increasingthe toxicity.” Dr. Eric a medical oncologist at The University ofTexaz M.D. Anderson Cancer Center who served as the lead investigator in the talactoferrin Phase2 clinical, describe the drug as a “promising, relativelyu nontoxic agent.
” “Although it was a small study, we did see a few patients with some strikint shrinkage of the disease,” he says. The 44 patientas who participated in the trial hadmediamn progression-free survival of 6.4 months and mediahn overall survival of 21 months, according to “Those types of numbers for kidney cancer are fairlyt interesting for those with pre-treatments,” he “What’s needed now is a randomized trial moving forward to treat one group with talactoferrin and Sutent, and (one grou with) Sutent alone to see if it reallhy strengthens the effectiveness of Sutent.
” Agennix is also currentlhy in two Phase 3 trials for the use of the same talactoferrin alfa, for the treatment of non-small cell lung One of those trials is studying the applicationj of talactoferrin by itself, while the other is studying its use in combinationn with chemotherapy. Agennix chose not to pursue talactoferrin as a solo treatmeny in the case of renal cellcarcinoma because, despitew it showing promise, “there are so many renalp cell carcinoma drugs approved or in late-stage Barsky says. “Because it is such a crowded we think it is more attractive to pursudethe first-line combination treatment ...,” he says.