May 6, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Malvern, Penn.-based TetraLogic Pharmaceuticals announced today that it has temporarily halted its Hepatitis B (HBV) clinical trial.
The company did not respond to a request for a statement by deadline.
The Phase Ib/IIa trial of birinapant for HBV was stopped because of cranial nerve palsies seen in the first cohort. Birinapant is an investigational SMAC-mimetic, being studied for treatment for HBV, myelodysplastic syndromes (MDS) and ovarian cancer. The compound, and SMAC-mimetics in general, are believed to disable certain pathways that allow cancer cells and some types of virally infected cells from growing.
The company is also studying birinapant in Phase I and Phase II trials for hematological malignancies and solid tumors.
The HBV clinical trial is being conducted in Australia. Cranial nerve palsy is a lack of function in the nerves that connect from the brainstem to the spinal cord and the brain.
This news comes only days after the company announced an initial public offering of 6.25 million shares of common stock at a public price of $4.00 per share. The IPO was expected to close today and generate gross proceeds of $23 million.
The stock didn’t exactly take off, dropping almost immediately from $4.00 per share to a low of $3.63 on the first day. Not surprisingly, given today’s news, the current price is $1.98.
The company announced on April 20 that it had entered into an oncology clinical study collaboration with Kenilworth, N.J.-based Merck & Co. . That study was to evaluate the safety and efficacy of birinapant in combination with Merck’s Keytruda (pembrolizumab). That study is expected to begin later this year.
In April 2014, TetraLogic acquired Shape Pharmaceuticals, acquiring the company’s clinical-stage product candidate, SHAPE. SHAPE is an HDAC inhibitor to be tested for the treatment of cutaneous T-cell lymphoma 9CTCL).
The company’s clinical trials in Australia are being performed with Marc Pellegrini and colleagues at the Walter and Eliza Hall Institute of Medical Research in Melbourne.
At the company’s 2014 earnings report in February, TetraLogic indicated it had cash, cash equivalents and marketable securities of $53.7 million at year-end. Its research and development expenses were $19.4 million and General and Administrative expenses were $8.5 million, minus $2.5 million in non-cash stock based compensation expense.
“The TetraLogic team achieved several significant milestones in 2014,” said J. Kevin Buchi, president and chief executive officer in a statement in response to the annual report. “We advanced birinapant into two randomized Phase II trials; we also acquired a second asset, SHAPE, and commenced a randomized Phase II trial with that molecule as well.”
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