Opexa Expands Patent Portfolio -- Hints At New Indications

In April, I wrote an article on Opexa Therapeutics (NASDAQ: OPXA) with a thesis stating that ongoing clinical success of Opexa's lead drug candidate, Tcelna (imilecleucel-T), could translate to regulatory approval and potentially fill a significantly unmet medical need in patients with Secondary Progressive Multiple Sclerosis (SPMS). I also argued that Merck Serono, the biopharmaceutical division of Merck (NYSE: MRK), which has option and licensing rights to Tcelna, could acquire Opexa at a substantial discount before exercising its option in order to avoid hefty milestone and royalty payments if and when the product is commercialized. Opexa's announcement of allowance of its 98th T-cell Patent only strengthens my bull thesis, as it enables the company to expand its core T-cell technology platform for the development of patient-specific immunotherapies.

Some key highlights from Opexa's latest announcement are as follows:

  • Allowance for patent No. 2,459,969, entitled, "Autologous T-Cell Vaccines Materials and Methods," broadly protects Opexa's coveted T-cell technology platform for the development of patient-specific immunotherapies.
  • Opexa noted that it is expanding IP protection to cover B-cell mediated diseases in connection with OPX-212 for Neuromyelitis Optica NMO.
  • Other pending provisional applications are aimed at protecting Opexa's proprietary protocols for examining the potency of therapeutic T-cell vaccines and its proprietary screening assay.
  • Opexa's intellectual property portfolio now stands at 98 issued and validated patents worldwide.

I reaffirm my bull thesis for several reasons. First, the allowance of this patent should facilitate the expansion of Opexa's T-cell technology platform. This should translate to additional catalysts as Opexa could announce new indications in patient-specific immunotherapies. Second, as Opexa strengthens its portfolio of assets, it diversifies its risk profile. As a reminder, Opexa remains almost completely reliant on the success of Tcelna. The company has invested approximately $155 million in developing Tcelna with little tangible results, and any clinical mishap could cause catastrophic damage to shareholders. Hence, shareholders should welcome new indications since the risk of failure of one clinical program could be mitigated by the success of another. Lastly, Opexa's latest announcement hints at near-term allowance of OPX-212 for NMO, which could serve as a much-needed near-term catalyst. As Opexa remains on course to provide a topline readout for the Abili-T study in 1H 2016, preceded by catalysts related to OPX-212 and new indications, I see no reason to amend my bull thesis.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate a position over the next 72 hours. The information presented is for entertainment purposes ...

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Terrence Howard 10 years ago Member's comment

You've sold me... to be Opexa that is!