Biodefense therapeutics developer PharmAthene, Inc. and Theraclone Sciences, Inc., a privately-held monoclonal antibody (mAb) discovery and development company, last week announced the signing of a definitive agreement for the merger of PharmAthene and Theraclone in an all-stock transaction.
The combined company will be a fully-integrated and diversified biologics company with four clinical-stage product candidates targeting high-value commercial and government markets. The merged company will combine vaccine and human monoclonal antibody expertise with a focus on infectious diseases and oncology, and will feature a discovery pipeline with four pre-clinical programs and multiple discovery candidates, along with three partnered products.
Under the terms of the merger agreement, a wholly-owned subsidiary of PharmAthene will merge into Theraclone in an all-stock transaction. PharmAthene will issue shares of PharmAthene common stock to Theraclone stockholders such that Theraclone stockholders will own 50% of the combined company.
“A merger with Theraclone will significantly advance PharmAthene’s goal of achieving broader portfolio diversification,” said Eric I. Richman, President and Chief Executive Officer of PharmAthene. “The combined company also expects to be able to leverage non-dilutive government funding sources to support ongoing and future product development efforts, with the possibility to receive a share of revenues from sales of SIGA Technologies’ smallpox antiviral, Arestvyr.
Clifford J. Stocks, Chief Executive Officer of Theraclone, who will head the new company, commented, “By combining PharmAthene’s strong vaccine and biologics development capabilities and government contracting experience, with our clinical antibody candidates and novel discovery platform we are establishing a premier biologics organization with multiple product candidates possessing significant near- and longer-term revenue potential in high-value commercial markets.”
The combined company’s clinical stage product candidates following the merger will include:
- TCN-202 CMV Antibody – a broadly-neutralizing mAb that is being developed for the prevention and treatment of human cytomegalovirus (CMV) infections, common in immunocompromised populations, including patients with HIV, cancer and those undergoing organ transplant surgery. TCN-202 has completed a Phase 1 clinical trial, with a Phase 2 study in solid organ transplant scheduled to begin later this year. The combined company will explore other indications for this program.
- TCN-032 Influenza Antibody – a broadly-protective mAb being developed for the treatment of pandemic and severe seasonal influenza. TCN-032 has completed a Phase 2a clinical trial, with results expected to be announced later this year.
- SparVax Anthrax Vaccine – a recombinant protective antigen (rPA), next-generation anthrax vaccine being developed for pre and post-exposure prophylaxis of anthrax infection. One Phase 1 and two Phase 2 clinical trials involving 770 subjects have been completed. Additional Phase 2 clinical trial testing is planned to begin this year.
- Valortim Anthrax Anti-Toxin – a fully human mAb intended for the prevention and treatment of anthrax infection that has completed two Phase 1 clinical trials.
In addition to four clinical-stage product candidates, the merged company will feature a robust pre-clinical pipeline driven by the proprietary I-STAR memory B-cell interrogation platform, which facilitates the discovery of human antibodies against novel targets. Presently, Theraclone has an established collaboration with Pfizer for specific infectious disease and oncology indications for which they have received upfront payments and research funding and may receive development and commercialization milestones and royalties on product sales in the future based on successful advancement. Theraclone also has collaboration with Zenyaku Kogyo who licensed the rights of the flu antibody program for Japan.
Source: Adapted from PharmAthene press release