BioLife Solutions Inc. (NASDAQ: BLFS) was up solidly in Monday’s trading session on positive results from a Phase 3 study. The company announced that its customer TiGenix NV recently disclosed that its lead compound, Cx601, met the primary endpoint in the Phase 3 ADMIRE-CD trial of complex perianal fistula in Crohn’s Disease patients.
For some background: TiGenix is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells.
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra-lesionally. A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs.
Major highlights from the Phase 3 study include:
- A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24 of complex perianal fistulas in Crohn’s disease patients with inadequate response to previous therapies, including anti-TNFs.
- More than 50% of patients treated with Cx601 achieved combined remission at week 24.
- A higher number of Cx601-treated patients had their fistulas closed by week 6.
- The results confirm the favorable safety and tolerability profile of Cx601.
Mike Rice, BioLife’s president and CEO, commented on the results:
We congratulate the entire TiGenix team on this outstanding accomplishment. All of us at BioLife are pleased to be a critical biopreservation tools supplier to TiGenix and are proud to know that our clinical grade HypoThermosol cell storage and shipping media is helping to commercialize another novel cellular therapy.
Previously BioLife stock jumped about 60% in early June, but the company could not hold on to these gains. The move originally happened when BioLife reported several new customer disclosures on the use of its CryoStor and HypoThermosol biopreservation media products in pre-clinical validation projects and clinical trials. These disclosures took place at the recent International Society for Cellular Therapy (ISCT) conference.
Shares of BioLife were up over 45% at $2.95 on Monday afternoon. The stock has a consensus analyst price target of $4.50 and a 52-week trading range of $1.50 to $4.50.
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