Companies Archives - Page 42 of 59

Plexxikon’s Glaub: personalized medicine is ‘the wave of the future’

October 7, 2011

They came from all parts of North Carolina’s Research Triangle, and several of them from far beyond, to hear the story of how a small biotechnology company developed a breakthrough cancer treatment, blazed a path for future development of personalized medicine treatments and was purchased in a deal valued at $935 million — the biggest venture-backed acquisition this year.

The company is California biotech Plexxikon. And one of its investors was Durham, North Carolina-based Pappas Ventures, which saw a return greater than 10 times its original investment. Plexxikon President Kathy Glaub was the guest speaker at a packed house for Pappas Ventures’ annual life sciences symposium. Pappas was one of Plexxikon’s early investors, pumping money into the company shortly after its 2001 launch. Art Pappas, founder and managing partner of the firm, said the investment was as much in founder and CEO Peter Hirth as it was in the science. Pappas said he thought Hirth could do with Plexxikon what he had done with previous company Sugen, whose cancer drug Sutent is now a blockbuster drug for Pfizer (NYSE:PFE).

Plexxikon - 10/07/2011

Plexxikon’s Glaub: personalized medicine is ‘the wave of the future’

Plexxikon’s breakthrough melanoma drug Zelboraf received U.S. Food and Drug Administration approval in August. But buzz about the drug started building years before while the drug was still in clinical trials.

Zelboraf was discovered through Plexxikon’s proprietary drug-discovery platform that develops families of protein targets. The technology allows researchers to see the way a compound binds to a particular target. That information guides Plexxikon on where to go. Cancer was not Plexxikon’s overall goal. If you’re looking for cancer drugs, you’re not going to see the diabetes drug staring you in the face, Glaub said.

Diabetes was in fact Plexxikon’s first target. PLX204 showed promise as a diabetes treatment and in 2004 the company partnered with Wyeth to develop the compound. But emerging safety concerns around GlaxoSmithKline‘s (NYSE:GSK) diabetes drug Avandia made development of all diabetes drugs a riskier endeavor. Glaub said that while PLX204 showed safety and efficacy, the partnership was terminated because of economic risks.

PLX4032, the compound that would become Zelboraf, was next in the drug pipeline. Here the company sought to continue its strategy of “ongoing partnering.” In 2006, the company entered into what would be its first partnership with Roche (OTC:RHHBY). In clinical trials, results were dramatic with some patients even being able to return to work after just two weeks of treatment.

“You hear patients saying, ‘I can see the lesions melting before my eyes,’” Glaub said of patients in phase 1 studies.

PLX4032 works only for patients whose tumors express a particular gene mutation. Plexxikon also sought to develop a test to identify patients that would respond to the treatment. When the FDA approved Zelboraf in August, the agency also approved a Roche companion diagnostic for the drug.

Plexxikon raised just $67 million in venture funding, the last round coming in 2006 before the company’s first deal with Roche. Partnerships have yielded more money: $243 million to date. Ten years is a long time for venture capitalists to hold on to an investment and Glaub said that last year, as the company weighed financing options, it considered going public. The company also sought bids from pharma companies, an effort complicated by the fact that its lead melanoma drug candidate was already committed to Roche’s oncology unit Genentech in a co-promotion agreement.

Daiichi Sankyo‘s acquisition of Plexxikon was announced in February. The Japanese pharma paid Plexxikon shareholders $805 million up front with up to an additional $130 million to be paid upon achieving milestones. As for Zelboraf, Daiichi Sankyo gets Plexxikon’s rights to co-promote the drug with Genentech.

The deal also allows Plexxicon to continue as an independent operation for two years. Plexxikon’s pipeline has so far turned out eight new chemical entities, all of which Glaub says are blockbuster drug opportunities. Glaub said that Plexxikon believes the personalized medicine approach taken with Zelboraf can also be applied to its other compounds.

“We love personalizing medicine,” Glaub said. “We think this is the way to go for patients.”

Plexxikon - 10/07/2011

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 - 09/16/2011

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 - 09/16/2011

Syndax Pharmaceutical's Positive Phase 2 Data Supports Potential For Entinostat In Advanced Breast Cancer

WALTHAM, Mass., Sept. 6, 2011 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announced today that ENCORE 301, a randomized, placebo-controlled phase 2 study of exemestane with and without entinostat hit its primary endpoint of an improvement in progression-free survival (PFS). The study showed that patients who received entinostat, a novel, oral small molecule inhibitor of class I histone deacetylases, with the hormone therapy exemestane, lived longer without their disease getting worse than people who received exemestane alone. Safety and efficacy results from the trial will be presented in a poster and an oral presentation at the American Society of Clinical Oncology (ASCO) Breast Cancer Symposium 2011 in San Francisco, CA this week.

Syndax - 09/06/2011

Tesaro - 2011 Fierce 15

The Scoop: There's a huge opportunity for life sciences entrepreneurs to hunt down potential gems among the many developmental cancer drugs available for licensing and sale. Big changes in Big Pharma R&D groups, for example, have led companies to shed some of their cancer assets. But the hard part is sorting the jewels from the junk. Enter Tesaro. With a proven team of cancer drug business vets led by CEO Lonnie Moulder, who helmed MGI Pharma through its $3.9 billion sale to Eisai in 2008, Tesaro has the expertise to dig into the piles of available assets in oncology and strike gold. And Moulder has raised an impressive $121 million from investors to fund the firm since its opening less than two years ago, providing means to license drugs for cancer patients and develop them for the market.

What Makes It Fierce: Tesaro turned heads with its $101 million Series B round revealed in June. The amount of the deal and the quality sources of capital--including firms such as lead investor Kleiner Perkins Caufield & Byers and founding backer New Enterprise Associates (NEA)--sent a clear signal that Tesaro is onto something big.

As venture folks often say, they like to invest in great entrepreneurs, which really means people who have the chops to succeed. Moulder and his co-founders--chief scientist Mary Lynne Hedley and financial chief Rick Rogers--already came away as winners as part of the team at MGI.

The trio later worked together at cancer drug firm Abraxis, but parted ways with that company--which was later acquired by Celgene ($CELG)--to set up shop on their own.

"We were at Abraxis, and it was obvious that the strategy was changing from what we set out to do," Moulder said. "So, we decided, 'why not start a biotech company from scratch with people that are like-minded with regard to vision, strategy and culture-building, and leverage our experience base and network in oncology.'"

And that's what they've done. Unlike biotech upstarts that sprout directly from lab discoveries, Tesaro has licensed drugs and quickly moved toward having a product on the market. NEA was the first venture firm to bet big on Tesaro's gambit, leading the firm's $20 million Series A round last year and underwriting an early expedition to find and license promising oncology drugs.

"We look at Tesaro as a company that unearths buried treasures, things that other companies wouldn't do, couldn't do," Hedley said, noting that the name of the company is based on the word ‘tesouro,' which is Galician for treasure. "We see the diamond in the rough."

What could become pharma treasure is Tesaro's lead candidate, rolapitant, which it's readying for a Phase III trial for reducing nausea experienced by cancer patients on certain chemotherapies. The company gained exclusive rights to the drug--a selective neurokinin-1 receptor antagonist--through a licensing deal late last year with OPKO Health. OPKO had picked up the drug in 2009 from Schering-Plough during the latter's merger with Merck ($MRK), which has the only existing neurokinin-1 blocker for chemo-induced nausea on the market, Emend.

If the late-stage studies confirm previous results from a randomized Phase II trial of rolapitant, it could potentially provide both dosing advantages and reduced risk of adverse drug interactions that could set it apart from the Merck drug, Hedley said. "Those could be significant benefits for patients," she added. "Just based on the convenience of single-day oral or IV dosing, and the lack of observed drug-to-drug interactions to date from a safety perspective, it could make this a much better choice for patients."

The company plans to conduct three Phase III trials of rolapitant, with the first trial slated to begin late this year, Moulder said.

Tesaro is also looking to gain rights to drugs at an earlier stage of development, and the firm has already in-licensed from Amgen ($AMGN) small-molecule inhibitors of anaplastic lymphoma kinase (ALK). It plans to push one of the molecules toward the clinic to combat ALK-positive non-small cell lung cancers. Think a next-generation version of Pfizer's ($PFE) crizotinib, but one with potential advantages over that drug.

While most biotech start-up chiefs are loath to predict IPO dates, Moulder isn't afraid to say that a public debut is part of the plan. He talked about doing an IPO in the second half of 2013, or sooner, depending on how the firm progresses.

That kind of winning attitude is very much in the spirit of Fierce 15.

Venture Backers: Kleiner Perkins Caufield & Byers, NEA, InterWest Partners, T. Rowe Price, Pappas Ventures, Oracle Partners, Deerfield Management, Leerink Swann and company management, which contributed $2 million to the Series A round.

TESARO - 09/06/2011

CoLucid Pharmaceuticals Raises $7.5 Million of Planned $9.5 Million

DURHAM, N.C., Aug. 30, 2011 /PRNewswire-iReach/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today that it has raised $7.5 million of a planned $9.5 million convertible note financing from its existing investors to support further late stage development of lasmiditan. Participating in the financing were Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures.

CoLucid Pharmaceuticals - 08/30/2011

CoLucid Pharmaceuticals Raises $7.5 Million of Planned $9.5 Million

DURHAM, N.C., Aug. 30, 2011 /PRNewswire-iReach/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today that it has raised $7.5 million of a planned $9.5 million convertible note financing from its existing investors to support further late stage development of lasmiditan. Participating in the financing were Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures.

"This financing provides important working capital for CoLucid to further advance lasmiditan into Phase 3 development," remarked Thomas P. Mathers, Chief Executive Officer of CoLucid. "We are embarking on additional clinical studies to further differentiate lasmiditan's safety profile from the triptan class of anti-migraine agents, as well as discussing with the FDA our final Phase 3 plans." said Mr. Mathers.

The Company is speaking with potential partners and is interacting with the FDA, and plans to advance lasmiditan into pivotal studies in 2012.

About Lasmiditan

Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. Lasmiditan is a member of a novel chemical class called "ditans" and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal pathway. Lasmiditan does not interact with vasoconstrictor 5-HT1B/1D receptors activated by triptans.

Five clinical studies have been successfully completed outside of the U.S., including a Phase 2b double blind placebo controlled oral dose ranging study treating a single migraine attack which was completed in 2010. In the Phase 2b study, lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing (p<0.0001) in 391 patients. Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing. Lasmiditan also achieved secondary endpoints, including relief of nausea, photophobia and phonophobia. Importantly, because there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous five clinical studies, CoLucid expects the pivotal Phase 3 studies to confirm that lasmiditan's side effect profile is highly differentiated from triptans and ergotamines.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company's investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company's pipeline includes lasmiditan, a novel treatment for migraine headache, COL-204 for wake promotion, and a conjugated stigmine platform that has generated a series of preclinical candidates for the chronic pain, Alzheimer's disease and psychiatric disorders. For more information, please visit CoLucid at www.colucid.com.

CoLucid Pharmaceuticals - 08/30/2011

CoLucid Pharmaceuticals Receives Clearance For Investigational New Drug (IND) Application For Lasmiditan For The Treatment Of Acute Migraine

August 20, 2011

CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced that it has received clearance to proceed with clinical studies of lasmiditan (formerly known as COL-144) under IND 103,420 from the Food and Drug Administration (FDA).

Lasmiditan is a first-in-class oral tablet formulation of a Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. Lasmiditan is a member of a novel chemical class called "ditans", and, unlike triptans, which target vasoconstrictor 5-HT1B receptors, lasmiditan penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.

CoLucid Pharmaceuticals - 08/20/2011

CoLucid Pharmaceuticals Receives Clearance For Investigational New Drug (IND) Application For Lasmiditan For The Treatment Of Acute Migraine

Five clinical studies have been successfully completed outside of the U.S., including a Phase 2b double blind placebo controlled dose ranging study treating a single migraine attack which was completed in 2010. In the Phase 2b study, lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing (p<0.0001) in 391 patients. Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing. Lasmiditan also achieved numerous secondary endpoints per other migraine symptoms such as nausea, photophobia and phonophobia. Importantly, lasmiditan's side effect profile is highly differentiated from triptans and ergotamines, and there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous five clinical studies.

"The migraine market, estimated at 30 million sufferers in the US, is an under-served market. No new class of therapies has been introduced for the treatment of acute migraine since the triptan class, which was first launched almost 20 years ago," remarked Thomas P. Mathers, Chief Executive Officer of CoLucid. "Patient and physician feedback note that only a portion of migraine patients are adequately controlled on triptans, and patients would welcome a new product that could offer a rapid speed of onset, superior pain relief and/or a lack of cardiovascular side effects as compared to currently available products. In addition, due to their vasoconstrictor activity, triptans are contraindicated in patients with cardiovascular disease. Many neurologists and primary care physicians feel uncomfortable prescribing triptans because of their potential cardiovascular side effects. Lasmiditan may address these unmet needs with its novel mechanism of action, and we look forward to the results of the Phase 3 trials to confirm its rapid speed of onset, superior pain relief and lack of cardiovascular side effects," said Mr. Mathers.

The Company is speaking with potential partners and is interacting with the FDA, and plans to advance lasmiditan into Phase 3 development.

CoLucid Pharmaceuticals - 08/20/2011