Bind Therapeutics announces Phase 2 Data from iNSITE 1 and iNSITE 2 trials

7th April 2016 (Last Updated April 7th, 2016 18:30)

Bind Therapeutics has announced preliminary top-line results from the BIND-014 Phase 2 iNSITE 1 trial in advanced non-small cell lung cancer (NSCLC) of squamous histology and the iNSITE 2 trial in cervical and head and neck cancers.

Bind Therapeutics has announced preliminary top-line results from the BIND-014 Phase 2 iNSITE 1 trial in advanced non-small cell lung cancer (NSCLC) of squamous histology and the iNSITE 2 trial in cervical and head and neck cancers.

Bind is a biotechnology company developing targeted and programmable therapeutics called Accurins. BIND-014 is a PSMA-targeted docetaxel nanoparticles.

Data received from these trials show that BIND-014 continues to provide improvements in safety and tolerability or similar efficacy when administered at a 20% lower dose in comparison with past studies with docetaxel.

The company expects to further validate the potential of its Accurins platform, a type of nanomedicine being developed by Bind to treat various types of cancer, on the basis of the recently found data.

"We believe this data justifies further development of BIND-014 in clinical settings where improved safety and tolerability may be valuable to patients."

In the iNSITE 1 trial primary endpoint, BIND-014 showed a 52.5% six-week disease control rate (6wDCR) for the intent-to-treat population (n=40) and a 70.0% 6wDCR in the per protocol population (n=30), which surpassed the protocol defined criteria for success of 65%.

Bind expects to seek licensing or collaboration opportunities to further develop the BIND-014 in NSCLC.

During the first stage of the iNSITE 2 trial, for the primary endpoint, BIND-014 showed an objective response rate of 10% in the head and neck cancer cohort (n=20); there were no objective responses in the cervical cancer cohort (n=23).

Based on these results, Bind has decided to stop further enrolment in the iNSITE 2 trial in advanced cervical and head and neck cancers.

Bind Therapeutics chief medical officer Hagop Youssoufian said: "While the single-arm design of these trials precludes definitive conclusions, we remain especially intrigued by the iNSITE 1 data in squamous histology non-small cell lung cancer patients.

"We believe these data provide additional clinical validation that Accurins successfully widen the therapeutic window of conventional docetaxel.

"Taken together, we believe this data justifies further development of BIND-014 in clinical settings where improved safety and tolerability may be valuable to patients."

The company recently announced a shift in its research and development efforts to focus on developing new medicines that include a mix of tumour-directed targeting ligands and new sets of payloads, such as oligonucleotides and molecularly targeted therapies.