Research Capital analyst André Uddin delivered an update to clients on Friday on HIV-specializing Theratechnologies (Theratechnologies Stock Quote, Charts, News, Analysts, Financials NASDAQ:THTX), saying investors are now waiting for TH to get the green light from the FDA to restart one of its clinical trials.
A combined specialty pharma and biotechnology company, Montreal-based Theratechnologies announced on Thursday preliminary efficacy data from a Phase 1 study of lead candidate TH1902, a peptide-drug conjugate (PDC) for patients with advanced solid tumours. The company said it will be presenting a poster session on the data at the June 3 annual meeting of the American Society of Clinical Oncology in Chicago.
Theratechnologies said it’s working with the US Food and Drug Administration to amend the protocol of the Phase 1 trial, which had been previously paused due to safety and dosing-related issues. Theratechnologies said in the new press release that the data on safety and anti-tumour activity have informed the changes to the protocol, with the aim of improving the drug’s risk/benefit profile.
“The early efficacy data for our lead peptide-drug conjugate, sudocetaxel zendusortide, confirm that it rapidly internalizes and hyper-targets delivery of cytotoxic payload directly into cancer cells,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies, in a press release. “We look forward to re-initiating our trial with a revised protocol that increases the likelihood of showing the full therapeutic potential of sudocetaxel zendusortide.”
Along with its clinical work, Theratechnologies has two launched products in the US in Trogarzo for multi-drug resistant HIV and Egrifta for HIV-related lipodystrophy.
Uddin said the preliminary data on TH1902 show that 36 per cent of patients experienced a clinical benefit, including two patients with a partial response and seven having achieved prolonged stable disease.
“These results were used by Theratechnologies’ scientific advisory committee to create the modified protocol that was submitted to the FDA in early May. The new protocol outlines changes made to dosing, administration frequency, and tumour selection criteria – we expect the FDA to provide a response to the reviewed protocol in the coming days,” Uddin wrote.
Uddin said the data point to three likely changes in the study: potentially a lower concentration of TH1902 to reduce dose-related toxicities, changes to dosing frequency and/or tumour type selection primarily focusing on enrolling specific tumour types that have shown the best efficacy, such as patients with ovarian cancer, for example.
“On June 3, the company is expected to highlight their TH1902 poster at the ASCO conference – this is non-optimized dosing. We expect the company to have an Investor Day after ASCO and after the company receives the FDA ‘s go ahead to initiate their new trial (optimized dosing) with TH1902,” Uddin wrote.
With the update, Uddin reiterated a “Buy” rating on TH and $4.50 target, which at press time represented a projected one-year return of 374 per cent.