Merck & Co. expanded its reach into the HIV arena by signing two licensing agreements for investigational drug candidates. One deal is with Chimerix, based in Research Triangle Park, NC, and the other is with Yamasa of Choshi, Japan. Merck is also planning to advance an internally developed HIV candidate, MK-1439, into a Phase IIb trial.
“Despite the tremendous advances made over the past 20 years, there remains considerable unmet need in the treatment of HIV infection,” said Robin D. Isaacs, M.D., vice president, infectious disease clinical research, Merck Research Laboratories. “Merck remains committed to improving on the standard of care for HIV therapy.”
Chimerix is granting Merck exclusive worldwide rights to its HIV treatment candidate CMX157. Chimerix will receive $17.5 million up-front and be eligible for up to $151 million in milestone payments plus royalties on future sales, while Merck will have responsibility for developing and commercializing the compound, an investigational oral nucleoside reverse transcriptase inhibitor.
“This is what we hope will be part of the next generation of anti-HIV therapies,” Kenneth I. Moch, president and CEO of Chimerix, told GEN. “We’d been seeking a partner with financial resources and the will to develop a compound that will be part of a combination therapy, and certainly Merck is that type of partner.”
Moch said the agreement “is an important validation of our proprietary lipid technology,” which underpins both CMX157 and CMX001, Chimerix’ lead antiviral compound.
Merck also agreed to develop Yamasa’s EFdA (4’-ethynyl-2-fluoro-2’-deoxyadenosine), a novel nucleoside reverse transcriptase inhibitor candidate that is in preclinical studies and has shown antiviral activity toward highly resistant HIV strains. As part of the agreement, Merck will pay an up-front fee and future milestone payments in return for exclusive worldwide license rights. This candidate was discovered in collaboration with a group led by HIV research scientist Dr. Hiroaki Mitsuya of Kumamoto University’s Center for AIDS Research in Japan.
Speaking about what this collaboration means for Chimerix, Moch said license agreement funds will help the firm fund further clinical trials of the company’s lead antiviral compound, CMX001, a broad spectrum lipid acyclic nucleoside phosphonate that inhibits double-stranded DNA viruses including cytomegalovirus (CMV), adenovirus, BK virus (BKV), herpes simplex virus, and variola (smallpox).
On Monday, Chimerix presented data at the 24th International Congress of the Transplantation Society in Berlin concluding that CMX001 has potential to reduce end-organ damage associated with BKV in hematopoietic stem cell transplant recipients. Data came from a Phase II study that was the largest retrospective analysis of BKV-associated signs and symptoms collected in a randomized, placebo-controlled trial reported to date.
Chimerix has sat down with FDA officials for an end-of-Phase II meeting to discuss CMX001 against CMV infection in stem cell transplantation. “We are proceeding as rapidly as possible, aggressively, toward Phase III in hematopoietic stem cell transplant patients, starting with patient dosing in 2013,” Moch said.
In addition to these deals, Merck says it plans to advance into Phase IIb clinical trial an internally developed candidate, MK-1439, a next-generation non-nucleoside reverse transcriptase inhibitor. Merck is initiating a dose-ranging clinical trial to evaluate the safety and tolerability and efficacy of MK-1439 in HIV positive, treatment-naive patients compared to efavirenz, both in combination with Truvada. The trial is expected to commence in September.