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BIND Therapeutics Enrolls First Patient Expressing KRAS Mutation in Global BIND-014 Phase 2 Trial in NSCLC Patients

BIND Therapeutics, Inc., a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins™, today announced its 2015 strategic overview and enrollment of the first patient expressing a KRAS mutation in a global, multicenter two-tiered phase 2 trial with BIND-014 in non-small cell lung cancer (NSCLC) patients with KRAS mutant tumors (mutated Kirsten ras oncogene homolog) or squamous histology.

The trial was driven by positive results from the phase 2 trial in NSCLC presented at the EORTC-NCI-AACR Annual Symposium in Barcelona on November 19, 2014, with a confirmed objective response rate of 22 percent (n=9); one KRAS mutant NSCLC PR was also seen in the phase 1 trial with BIND-014, yielding a combined total response rate of 30 percent (n=10). Results from the phase 2 trial also suggested meaningful differentiation in NSCLC patients with squamous histology when compared to historical docetaxel results. BIND-014 results presented at EORTC-NCI-AACR also demonstrated a disease control rate of 66 percent and overall survival of 11.1 months (n=9) in NSCLC patients with squamous histology. BIND intends to begin accruing NSCLC patients with squamous cell histology in the two-tier phase 2 trial in 1Q 2015.

“We are pleased to see these phase 2 data for BIND-014 demonstrating that our Accurin technology is providing on-target anti-tumor activity with meaningful reductions in the incidence and severity of side-effects expected from conventional drugs,” said Hagop Youssoufian, M.D., chief medical officer at BIND Therapeutics. “Accordingly, we have devised a development plan in 2nd line NSCLC that we believe allows us to rapidly advance BIND-014 to phase 3. In addition, we are devoting significant resources to the advancement of BIND-014 in carefully selected tumor types with significant unmet need and a strong rationale for BIND-014 activity. Cytotoxic and anti-mitotic agents remain an integral part of therapy for most patients with cancer. We believe that these agents’ proven benefits can be significantly enhanced with our Accurin platform by achieving greater potency and less off-target toxicity. This is in addition to potential applications of the Accurin technology to other targets in cancer and non-cancer therapeutic areas, including many that are intractable with currently available approaches.”

The company also announced topline data from its ongoing phase 2 trial with BIND-014 in metastatic castration resistant prostate cancer (mCRPC). The primary endpoint of the study was to determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC. The trial enrolled 42 patients, 31 of whom had been treated with androgen inhibitors prior to enrolling in the study. As of December 15, 2014, BIND-014 demonstrated a median rPFS of 8.1 months with three patients currently on treatment and 60 percent of the patients enrolled attained a rPFS of 6 months or greater. Safety and tolerability were also promising, with notable reductions in adverse effects that often limit dosing of conventional docetaxel, including hematologic and non-hematologic toxicities. As of December 15, 2014, three patients continue on treatment and 24 patients continue to be followed for overall survival. Complete results of the mCPRC trial will be presented at an upcoming medical meeting.

“The efficacy and tolerability profile of BIND-014 in mCRPC, particularly in this later stage population with prior androgen inhibitor treatment, serve to reinforce the promise of the Accurin platform,” said Scott Minick, chief executive officer, BIND Therapeutics. “Given the rapidly evolving prostate cancer treatment landscape, we believe that there are more promising opportunities at this time for the Accurin platform within our development portfolio and are excited about the opportunities for BIND-014 in NSCLC and other difficult to treat areas.”

BIND’s 2015 key business priorities are aimed at supporting the ongoing development of BIND-014 in areas of high unmet need with the potential for high activity, with additional investment in key research, development and collaboration programs.

“We made substantial progress in 2014, including significant advances in our BIND-014 program and exciting new collaborations that further validate and advance our Accurin platform,” said Andrew Hirsch, BIND’s chief operating officer. “As we continue our evolution to a multi-product drug development platform company, we expect 2015 to be a particularly active period, with the initiation of additional BIND-014 clinical programs in six indications with data readouts that present multiple opportunities for expedited regulatory review. In addition, we are initiating manufacturing scale-up and investigational new drug-enabling studies for BIND-510, our PSMA-targeted vincristine Accurin, and expecting important collaboration milestones in areas of high unmet need that may benefit from our Accurin technology.”

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