Less than two months after merging with its one-time subsidiary Protiva Biotherapeutics, Tekmira Pharmaceuticals this week confirmed that it would move two RNAi-based drug candidates — one for hypercholesterolemia and one for cancer — into phase I trials next year.
In April, Tekmira and Protiva said terms of the merger would end all the litigation between them over ownership of Protiva’s core stable nucleic acid lipid particle, or SNALP, delivery technology (see RNAi News, 4/3/2008).
At the time, the companies said that the combined firm would advance the two investigational RNAi drugs into human testing in 2009.
According to Tekmira, the cholesterol drug, called SNALP ApoB, is slated to enter a phase I study in the first half of next year. The drug targets apolipoprotein B, a protein involved in cholesterol metabolism. The second drug, called SNALP PLK1, targets polo-like kinase 1, a gene linked to the growth of certain solid tumors, and is expected to enter phase I testing in the second half of 2009.
Tekmira’s partner Alnylam Pharmaceuticals holds an option to co-develop and co-market SNALP PLK1, although that option expires at the commencement of phase II trials.
"Following the close of the business combination between Tekmira and Protiva, we committed to taking a close look at the new company's combined product portfolio and future milestones,” Tekmira President and CEO Mark Murray said in a statement. “We are now moving forward with a clear two-part strategy [that includes focusing] on developing products exclusively in the RNA interference (RNAi) therapeutics field with our two lead product candidates, ApoB and PLK1, and [supporting] our partners as they advance products based on our leading delivery technology."
Currently, Merck, Alnylam, and Roche hold licenses to use Tekmira’s SNALP technology for certain RNAi drug programs.
Murray was not available for additional comment.
With the addition of SNALP ApoB and SNALP PLK1 to Tekmira’s formal drug-development pipeline, the number of investigational RNAi therapeutics has grown a little bigger. To provide a snapshot of the state of RNAi drug development, RNAi News has compiled a list of key RNAi drug programs.
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RNAi Therapeutics Pipelines
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| Company | Drug Name, Indication | Status |
| Allergan | AGN-745, wet age-related macular degeneration (licensed from Sirna Therapeutics) | Phase II |
| Alnylam Pharmaceuticals | ALN-RSV01, respiratory syncytial virus | Phase II in adult lung transplant patients infected with RSV; second phase II in pediatric populate slated for second half 2008 |
| Hypercholesterolemia | Preclinical, possible IND filing in 2008 | |
| ALN-VSP01, liver cancer | Preclinical, possible IND filing in 2008 | |
| ALN-HTT, Huntington's disease (in collaboration with Medtronic) | Preclinical | |
| Progressive multifocal leukoencephalopathy (in collaboration with Biogen Idec) | Preclinical | |
| Pandemic influenza (in collaboration with Novartis) | Preclinical, on hold | |
| Calando Pharmaceuticals | CALAA-01, solid tumors | Phase I |
| Cequent Pharmaceuticals | CEQ501, familial adenomatous polyposis | IND planned for 2009 |
| CEQ400, human papillomavirus | Preclinical, possible IND filing in 2009 | |
| CEQ600, inflammatory bowel disease (Novartis holds option on drug) | Preclinical, possible IND filing in 2009 | |
| Dicerna Pharmaceuticals | Hepatitis C | Preclinical |
| Solid tumors | Preclinical | |
| Type II diabetes | Preclinical | |
| Hyperlipidemia | Preclinical | |
| Intradigm | ICS-283, cancer | Possible IND in 2008 |
| Merck* | Unknown | Unknown |
| MDRNA (formerly Nastech Pharmaceutical) |
Rheumatoid arthritis | Preclinical |
| Influenza | Preclinical | |
| Opko Health | Bevasiranib, AMD | Phase III |
| Pfizer | RTP801i-14, AMD (licensed from Quark) | Phase I |
| RXi Pharmaceuticals | Amyotrophic lateral sclerosis | Preclinical |
| Obesity/type II diabetes | Preclinical | |
| Cancer | Preclinical | |
| Silence Therapeutics | Atu-027, gastrointestinal cancer (possibly lung cancer) | Possible phase I in 2008 |
| Atu111, prostate cancer | Preclinical | |
| Atu150, liver cancer | Preclinical | |
| Sirnaomics | STP-601, ocular neovascularization diseases including AMD | Phase I planned for 2008 |
| STP-705, wound healing | IND planned for late 2009 | |
| STP-503, solid tumors | IND planned for late 2009 | |
| STP-801, solid organ transplantation | Preclinical | |
| STP-702, pandemic influenza | Preclinical | |
| Tacere Therapeutics | TT-033, hepatitis C (in collaboration with Pfizer) | IND planned for 2009 |
| Tekmira Pharmaceuticals | ApoB SNALP, hypercholesterolemia | Phase I planned for first half of 2009 |
| PLK1 SNALP | Phase I planned for second half of 2009 | |
| Quark Pharmaceuticals | AKIi-5, acute kidney failure | Phase I |
| DGFi, delayed graft function | IND approved, phase I pending | |
| IGNi, glaucoma | Preclinical | |
| AHLi-11, acute hearing loss | Preclinical | |
| CTi-1, chronic obstructive pulmonary disease | Preclinical | |
| PAb-W4, chronic renal failure | Preclinical | |
* Editor's note: Following its acquisition of Sirna Therapeutics, Merck has not disclosed the status of any of Sirna's drug-development efforts, which had included ones in hepatitis C and cancer, as well as efforts in respiratory disease in collaboration with GlaxoSmithKline.
Merck did announce earlier this year that it had handed off the full rights to Sirna's preclinical Huntington's disease to partner Targeted Genetics Targeted Genetics (see RNAi News, 4/10/2008). As reported by RNAi News, Merck also quietly shut down Sirna's dermatology unit, which had been developing an RNAi-based drug for permanent hair removal (see RNAi News, 1/24/2008).