Merck snags Chimerix antiviral HIV program in $168.5M deal

Merck snags Chimerix antiviral HIV program in $168.5M deal

Research Triangle Park, NC-based Chimerix has inked its first big partnership, reaping a $17.5 million upfront payment and a promise of up to $151 million more from Merck ($MRK), which gains rights to a mid-stage antiviral–CMX157–which has prospects as a new addition to future HIV cocktails.

It’s a key deal for Chimerix, which has a platform for a lipid-antiviral conjugate technology that promises to rev up existing meds, turning them into chemical antiviral assault weapons that can trump anything that’s currently expected of them. In this case, CMX157 is a more potent version of Viread. 

“It’s a lipid technology that dramatically alters the ADME (absorption,distribution, metabolism, and excretion profile) of the drug, really intracellular drug delivery,” CEO Ken Moch tells FierceBiotech.

For Merck, the Chimerix pact is the most prominent move in a flurry of actions on the HIV front. While it was readying the news Merck–an active player in the HIV field–also signed a deal to develop Yamasa’s inhibitor EFdA, which has showed some potential against the HIV virus. And Merck is readying a mid-stage study of MK-1439 in treatment naive patients.   

Both of Chimerix’s programs are “orally delivered, absorbed through the gut, and remain intact in the blood stream,” says the CEO. “It’s only inside the cell membrane that the molecules are broken apart by the enzymes inside the cells, and converted into active, potent antivirals.” Merck’s main goal here is to be on the cutting edge of the next generation of antivirals. “We think this drug has the chance to be a much longer delivery cycle,” he adds, which can change the dosing parameters while maintaining a positive safety and efficacy profile.

The deal with Merck leaves Chimerix focused squarely on its lead program. Company officials have wrapped up their end of Phase II meeting with regulators and are preparing for Phase III. Under an ideal timeline, says the CEO, they can be on the market in 2016, with plans to retain U.S. marketing rights while partnering outside the states. 

Those partnering talks, he adds, are already well under way. And with a pharma giant like Merck signing up for a licensing deal, he says, the tech endorsement should improve the company’s prospects. Chimerix’s staff has swelled to about 50 and the company has raised $101 million in venture cash.

Merck snags Chimerix antiviral HIV program in $168.5M deal

 

July 24, 2012

Research Triangle Park, NC-based Chimerix has inked its first big partnership, reaping a $17.5 million upfront payment and a promise of up to $151 million more from Merck ($MRK), which gains rights to a mid-stage antiviral–CMX157–which has prospects as a new addition to future HIV cocktails.

It’s a key deal for Chimerix, which has a platform for a lipid-antiviral conjugate technology that promises to rev up existing meds, turning them into chemical antiviral assault weapons that can trump anything that’s currently expected of them. In this case, CMX157 is a more potent version of Viread.

“It’s a lipid technology that dramatically alters the ADME (absorption,distribution, metabolism, and excretion profile) of the drug, really intracellular drug delivery,” CEO Ken Moch tells FierceBiotech.

For Merck, the Chimerix pact is the most prominent move in a flurry of actions on the HIV front. While it was readying the news Merck–an active player in the HIV field–also signed a deal to develop Yamasa’s inhibitor EFdA, which has showed some potential against the HIV virus. And Merck is readying a mid-stage study of MK-1439 in treatment naive patients.

Transplant antiviral strong in phase 2; Chimerix plans phase 3 start this year

 
February 6, 2012

North Carolina biotechnology company Chimerix reported positive phase 2 results for a broad spectrum antiviral agent expected to have applications fighting infections faced by bone marrow transplant patients.

Chimerix now plans to start phase 3 clinical trials on CMX001 later this year. The company is studying the compound for the prevention of cytomegalovirus diseases, or CMV, in patients who have had hematopoietic stem cell transplants. Durham, North Carolina-based Chimerix said that compared to a placebo, CMX001 had a statistically significant benefit in preventing CMV from entering the bloodstream or from causing CMV disease 13 weeks after a transplant. The data were presented at a blood and marrow transplant conference in San Diego last Friday.

CMV is a member of the herpesvirus group of viruses; like other herpesviruses CMV has the ability to remain dormant in the body for long periods of time. The virus can lead to serious disease and even death in transplant recipients, cancer patients and others who have compromised immune systems.

Transplant antiviral strong in phase 2; Chimerix plans phase 3 start this year

North Carolina biotechnology company Chimerix reported positive phase 2 results for a broad spectrum antiviral agent expected to have applications fighting infections faced by bone marrow transplant patients.

Chimerix now plans to start phase 3 clinical trials on CMX001 later this year. The company is studying the compound for the prevention of cytomegalovirus diseases, or CMV, in patients who have had hematopoietic stem cell transplants. Durham, North Carolina-based Chimerix said that compared to a placebo, CMX001 had a statistically significant benefit in preventing CMV from entering the bloodstream or from causing CMV disease 13 weeks after a transplant. The data were presented at a blood and marrow transplant conference in San Diego last Friday.

CMV is a member of the herpesvirus group of viruses; like other herpesviruses CMV has the ability to remain dormant in the body for long periods of time. The virus can lead to serious disease and even death in transplant recipients, cancer patients and others who have compromised immune systems.

Chimerix says that at least 65 percent of transplant recipients faced moderate to high risk of CMV from reactivated virus from donor or recipient tissue. The disease can lead to potentially life threatening conditions such as nephritis, pneumonitis or hepatitis. Complications are also possible leading to rejection of a transplanted organ. Currently available compounds to fight CMV carry significant toxicities.

Venture capital-backed Chimerix last year raised $45 million in a series F round of financing led by New Leaf Venture Partners. Other investors include Pappas Ventures, Morningside Group Canaan Partners, Sanderling Ventures, Alta Partners, Asset Management Company and Frazier Healthcare Ventures.

CMX001 is Chimerix’s lead drug candidate. The compound has also drawn interest from the federal government. Last year, the Biomedical Advanced Research and Development Authority, or BARDA, awarded Chimerix a contract valued at up to $81 million if the company develops CMX001 into an antiviral agent for small pox.

Chimerix Announces Presentation of Final Data from CMX001 Phase 2 Trial in Prophylaxis of Cytomegalovirus in Hematopoietic Stem Cell Transplant Recipients

Abstract Receives “BEST ABSTRACTS AWARD FOR CLINICAL RESEARCH” at 2012 BMT Tandem Meetings on February 3rd, 2012

RESEARCH TRIANGLE PARK, NC, January 25, 2012 – Chimerix, Inc., a biotechnology company developing novel antiviral therapeutics, today announced that final data from CMX001 Study 201, a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV), has been accepted for oral presentation at the BMT Tandem Meetings on February 1-5, 2012, in San Diego, California.  CMX001 is a broad spectrum, Lipid-Antiviral-Conjugate completing Phase 2 clinical development for the prevention of CMV in hematopoietic cell transplant (HCT) recipients.  In total, three abstracts related to CMX001 have been accepted for presentation at the 2012 BMT Tandem Meetings, the combined annual meetings of the Center for International Blood and Marrow Transplant Research (CIBMTR) and the American Society of Blood and Marrow Transplantation (ASBMT)….

Chimerix Announces Presentation of Final Data from CMX001 Phase 2 Trial in Prophylaxis of Cytomegalovirus in Hematopoietic Stem Cell Transplant Recipients

Abstract Receives “BEST ABSTRACTS AWARD FOR CLINICAL RESEARCH” at 2012 BMT Tandem Meetings on February 3rd, 2012

Chimerix, Inc., a biotechnology company developing novel antiviral therapeutics, today announced that final data from CMX001 Study 201, a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV), has been accepted for oral presentation at the BMT Tandem Meetings on February 1-5, 2012, in San Diego, California.  CMX001 is a broad spectrum, Lipid-Antiviral-Conjugate completing Phase 2 clinical development for the prevention of CMV in hematopoietic cell transplant (HCT) recipients.  In total, three abstracts related to CMX001 have been accepted for presentation at the 2012 BMT Tandem Meetings, the combined annual meetings of the Center for International Blood and Marrow Transplant Research (CIBMTR) and the American Society of Blood and Marrow Transplantation (ASBMT)….

Chimerix Announces Late-Breaker Presentation At 51st Interscience Conference On Antimicrobial Agents And Chemotherapy (ICAAC) Annual Meeting

DURHAM, N.C., Sept. 16, 2011 /PRNewswire/ — Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced today that investigators will present preliminary data for CMX001 in a late-breaker presentation at the 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, Chicago – September 17-20).

Chimerix Announces Late-Breaker Presentation At 51st Interscience Conference On Antimicrobial Agents And Chemotherapy (ICAAC) Annual Meeting

DURHAM, N.C., Sept. 16, 2011 /PRNewswire/ — Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced today that investigators will present preliminary data for CMX001 in a late-breaker presentation at the 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, Chicago – September 17-20).  

Genovefa Papanicolaou, M.D., Associate Member of Infectious Diseases Service at Memorial Sloan-Kettering Cancer Center and one of the lead investigators in Chimerix’s ongoing Phase 2 cytomegalovirus (CMV) study, will give a presentation entitled, “CMX001 is not nephrotoxic or myelosuppressive in 183 patients with life threatening dsDNA infections including refractory Cytomegalovirus, Adenovirus, and BK Virus,” on Sunday, September 18 at 8:30 am CDT.  Immediately following Dr. Papanicolaou’s presentation, Richard Whitley, M.D., Distinguished Professor at The University of Alabama at Birmingham, will present “New Antivirals for Herpes Viruses: What Can We Look Forward to and When?,” which highlights CMX001. Both presentations are part of the “Herpes and Other Viruses” slide session that begins at 8:30 am CDT.  In accordance with ICAAC embargo policy, these data remain under embargo until conclusion of the late-breaker session on Sunday, September 18 at 11:00 am CDT.  

Data from Dr. Papanicolaou’s presentation was generated as part of Chimerix’s expanded access program, through which Chimerix has dosed over 300 subjects with CMX001 since March 2009, including 183 subjects under investigator-held Emergency Investigational New Drug applications (EINDs) or foreign equivalents at over 80 medical centers in the United States, Canada, Europe, and Israel.  Through EINDs, CMX001 has been used for the treatment of a wide range of life-threatening infections caused by dsDNA viruses, including CMV, adenovirus (AdV), BK virus (BKV), Epstein Barr virus (EBV), herpes simplex virus (HSV), and JC virus (JCV), for which there are no FDA-approved treatments or where patients have failed available treatments. There is no evidence of otherwise unexplained nephrotoxicity or myelosuppression in these immunocompromised patients. These data support positive interim results seen in CMX001’s ongoing Phase 2 placebo-controlled clinical trial evaluating the safety, tolerability and ability of CMX001 to prevent or control CMV infection in R+ hematopoietic cell transplant (HCT) recipients.  

About CMX001

CMX001 is an oral Lipid-Antiviral-Conjugate (LAC) that delivers high intracellular levels of the active antiviral agent cidofovir-diphosphate.  Its broad spectrum activity against double-stranded DNA (dsDNA) viruses without the myelotoxicity and nephrotoxicity of current agents has the potential to improve outcomes for immunosuppressed patients.  In development for the treatment or prevention of life-threatening dsDNA viral diseases, more than 600 patients have been dosed with CMX001 in placebo-controlled clinical trials and open-label treatment protocols.  More than 300 of these individuals have received CMX001 under Emergency Investigational New Drug Applications (EINDs) or as part of the CMX001-350 Open-Label Study to help treat life-threatening dsDNA viral diseases for which there were no other therapeutic options.  CMX001 is also being developed as a biodefense countermeasure in the event of a smallpox release.  The growing body of evidence of CMX001’s antiviral activity against all five families of dsDNA viruses that cause disease in humans, including smallpox, has strengthened the compound’s potential as a dual-use product prescribed as a traditional pharmaceutical and stockpiled as a biodefense countermeasure.  

Chimerix Awarded BARDA Contract for Advanced Development of CMX001 as Medical Countermeasure Against Smallpox

Chimerix, Inc., a pharmaceutical company developing orally available antiviral therapeutics, today announced that it has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Chimerix’s broad spectrum antiviral drug candidate, CMX001, as a medical countermeasure in the event of a smallpox release.

Chimerix Completes $45 Million Financing to Fund Further Development of Novel Antiviral Therapeutics CMX001 and CMX157

 

Financing Reflects Significant Clinical Progress and Positive Data in Lead Programs

RESEARCH TRIANGLE PARK, NC, February 14, 2011 – Chimerix, Inc., a pharmaceutical company developing orally- available broad spectrum antiviral therapeutics, today announced the completion of a $45 million Series F financing. New Leaf Venture Partners led the round, with participation by new investors Pappas Ventures and Morningside Group, as well as existing investors Canaan Partners, Sanderling Ventures, Alta Partners, Asset Management Company and Frazier Healthcare Ventures.