WALTHAM, Mass., May 16, 2012 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., an oncology company moving into phase 3 having completed randomized, placebo controlled phase 2 studies, announced Luke Evnin, Ph.D. will join the board of directors replacing Steven St. Peter, M.D. 

"We are thankful to Steven for his commitment over the past few years and we are excited to have Luke join the board given his experience and track record of building cutting-edge biotechnology companies since 1990," said Dennis Podlesak, chairman of the Syndax board of directors.  "Syndax is well positioned to bring its lead product entinostat into phase 3 testing and to continue building out the company to support this growth phase."

Dr. Evnin has served as a managing director at MPM Capital since he co-founded MPM's asset management business in 1997.   Dr. Evnin focuses on global healthcare investing for MPM. Prior to joining MPM, Dr. Evnin was at Accel Partners for over seven years including four as a general partner. He was involved in biopharmaceutical, medical device and healthcare service companies for several of Accel's funds.  Dr. Evnin currently serves as a director of Enteromedics, Inc. (ETRM) and Pacira (PCRX),  publicly-traded companies, as well as private companies, NeuroTherapeutics Pharma, Inc. and Oxagen Limited.  Dr. Evnin earned his Ph.D. in the department of biochemistry at the University of California-San Francisco, and received his A.B. in molecular biology magna cum laude from Princeton University.

"With entinostat, a promising late-stage oncology product candidate, and a talented management team in place, our vision at MPM that we invested in several years ago is now being realized," said Dr. Evnin.  "If the randomized phase 2 data is confirmed in a phase 3 trial, entinostat, an oral HDAC, will be a new and compelling option to allow women to remain successfully treated with  hormone therapy, the standard of care for metastatic breast cancer.   Entinostat has shown in preclinical trials the ability to reverse or delay the emergence of epigentically driven resistance to targeted therapies in solid tumors.  I am looking forward to contributing to moving this promising oncology product candidate forward and building a company that can maximize its impact for patients."

About Syndax Syndax is a late-stage oncology company initiating pivotal programs in solid tumors based on employing epigenetic strategies to overcome the problem of resistance in oncology care. Syndax holds worldwide rights to entinostat, an oral, highly selective histone deacetylase (HDAC) inhibitor, which inhibits the cancer-relevant class 1 HDAC enzymes that contribute to epigenetic alterations driving cancer growth and drug tolerance. Entinostat's unique pharmacokinetic properties, convenient oral dosing and HDAC selectivity, maximize the opportunity to safely combine with and potentially extend the benefit of proven cancer therapies. Entinostat has been studied in more than 600 cancer patients with clinical activity in solid tumors and hematologic malignancies. Randomized, placebo-controlled phase 2 studies with entinostat have demonstrated promising results in combination with aromatase inhibitors in breast cancer (ENCORE 301) and with the EGFR-TKI erlotinib (ENCORE 401) in non-small cell lung cancer. Results from the ENCORE clinical program have provided the basis for moving entinostat into pivotal, phase 3 testing across a platform of solid tumor indications. NCI and Syndax are collaborating on the development of entinostat under a Cooperative Research and Development Agreement.

The company is supported by top venture capitalists and led by industry experts developing treatments for large markets including metastatic breast and lung cancer. Formed in 2005, Syndax's intellectual property is based on work from scientific founder Ronald Evans, Ph.D., recipient of the 2004 Albert Lasker Prize for Basic Medical Research, a Member of the National Academy of Sciences, a professor at the Salk Institute for Biological Studies and a Howard Hughes Medical Institute Investigator. For more information please visit www.syndax.com.

Scott will sit on a panel focusing on raising US venture capital at the BioFinance 2012 conference in Toronto on May 29-30, 2012

WALTHAM, Mass., April 18, 2012 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., an oncology company moving into phase 3 having completed randomized, placebo controlled phase 2 studies, announced the appointment of Arlene M. Morris as chief executive officer.  Joanna Horobin, MD will serve as president.

"Syndax is leading the field of epigeneticsa novel way to control gene regulationto address unmet needs in cancer due to the problem of resistance," said Dennis Podlesak, chairman of the Syndax board of directors. "With the positive phase 2 randomized, placebo-controlled data and the addition of Arlene Morris to our impressive leadership team, Syndax is well positioned to successfully complete the final phase of clinical development to achieve our goal of providing a new treatment option for women with metastatic breast cancer."

During her eight years as president and CEO at Affymax, Ms. Morris led the company through the development of peginesatide (Omontys®), a strategic collaboration with Takeda and an Initial Public Offering. Prior to Affymax Ms. Morris was the president and CEO of Clearview Projects, an advisory firm which counseled biopharmaceutical and biotechnology companies on strategic transactions. Before that she was the senior vice president, business development at Coulter, a biotechnology company focused on immunotherapeutic approaches to cancer, autoimmune and infectious diseases, where she completed numerous transactions including a $1.0 billion merger between Corixa and Coulter. Ms. Morris began her career at Johnson & Johnson (J&J) as a sales representative rising to vice president of business development. Ms. Morris received her bachelor's degree in biology and chemistry from Carlow College. In addition to Syndax Ms. Morris serves on the board of directors of Neovacs and MediciNova.

"After working with Syndax as a director over the past nine months, I am excited to take a more active role now as we move entinostat forward and secure the financing and personnel required to take this exciting product candidate for breast cancer through the final phase of testing," said Ms. Morris.

About Syndax
Syndax is a late-stage oncology company supported by top venture capitalists and led by industry experts developing treatments for large markets including metastatic breast and lung cancer. The Company's platform is based on employing epigenetics to overcome the problem of resistance in oncology care. Syndax holds worldwide rights to entinostat, an oral, highly selective histone deacetylase (HDAC) inhibitor, which inhibits cancer-relevant HDAC enzymes which contribute to epigenetic alterations driving cancer growth and drug tolerance. Entinostat's unique pharmacokinetic properties, convenient oral dosing and HDAC selectivity, maximize the opportunity to safely combine with and potentially extend the benefit of proven cancer therapies. Entinostat has demonstrated promising activity in randomized, phase 2 clinical trials in combination with targeted therapies.   For more information please visit www.syndax.com.

WALTHAM, Mass., April 5, 2012 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announced Arthur M. Pappas will join the board of directors.

"We are delighted to have Art Pappas join the Syndax board given his rich background as a former senior level pharmaceutical executive and as a highly experienced life science venture capital investor," said Dennis Podlesak, chairman of the Syndax board of directors. "As Syndax advances into this exciting growth period and we build out the company to support the global phase 3 initiative, Art's leadership and extensive experience will be an invaluable asset."

"With the impressive overall survival results seen in the breast cancer population, entinostat represents a promising medicine for the Syndax team to lead its development," said Mr. Pappas. "This is an important time as the company prepares to move in to phase 3 clinical testing. As the phase 2 trials are confirmed, entinostat could be a promising new treatment option for women with ER positive metastatic breast cancer. I am pleased to be part of this effort."

Mr. Pappas is the founder and managing partner of Pappas Ventures, a Research Triangle Park, North Carolina-based venture capital firm that invests nationally in the life science industry. Mr. Pappas and his team of investment, biotechnology and medical experts manage over $350 million and oversee investments in more than 40 portfolio companies. Prior to founding Pappas Ventures in 1994, Mr. Pappas held senior level leadership positions at several multinational pharmaceutical companies. He was an executive member of the board of directors of Glaxo Holdings plc, for which he was the chief executive responsible for international operations including research, development and manufacturing. He previously was vice president of commercial operations for Abbott International Ltd., and he held various executive positions with Merrell Dow Pharmaceuticals and the Dow Chemical Company, in the United States and internationally. In addition to Syndax, Mr. Pappas is a director of Afferent Pharmaceuticals, Inc., CardioDx, Inc., CeNeRx, Inc., Chimerex, Inc., CoLucid, Inc., and TyRx, Inc. He was also involved in Plexxikon, Inc. which was sold to Daiichi Sankyo last year. Mr. Pappas received his BS degree in Biology from Ohio State University and his MBA in Finance from Xavier University.

About Syndax
Syndax Pharmaceuticals, Inc. is a Waltham, MA-based, late-stage, oncology-focused pharmaceutical company. The company is building a portfolio of new oncology products to extend and improve the lives of patients by developing and commercializing novel cancer therapies in optimized, mechanistically driven combination regimens. Syndax has worldwide rights to develop and commercialize entinostat which has shown promise in randomized clinical trials in breast and lung cancers and in phase 2 clinical trials in Hodgkin's lymphoma. Syndax is backed by top-tier venture capital firms Domain Associates, MPM Capital, Avalon, Pappas and Forward Ventures. Formed in 2005, Syndax's intellectual property is based on work from scientific founder Ronald Evans, Ph.D., recipient of the 2004 Albert Lasker Prize for Basic Medical Research, a Member of the National Academy of Sciences, a professor at the Salk Institute for Biological Studies and a Howard Hughes Medical Institute Investigator. For more information please visit www.syndax.com.

Syndax Contact Information
E. Blair Schoeb
Phone: 908.277.0386
Email: bschoeb@syndax.com

Companies like Starbucks (NASDAQ:SBUX), Amazon.com (NASDAQ:AMZN) and Apple (NASDAQ:AAPL) aren’t healthcare companies, but one venture capitalist believes their example can guide personalized medicine.

Bob Kocher, a partner at venture capital firm Venrock, said that these consumer-focused companies have all taken steps toward personalizing their offerings. Personalization increases the value of those offerings and helps the companies make delivery of services and products more efficient.

“Because they can offer the right product, they can take away unnecessary costs,” Kocher said. “And in healthcare, that’s what we really need to do.”

Personalized medicine will help doctors determine what to treat, how to treat and how much to treat. That knowledge, Kocher said, will mean fewer medicines, not more. Evidence and data will guide treatment to the optimal level that strikes a balance between risks and outcomes.

Kocher spoke last week at a symposium held by Duke Medicine’s Center for Personalized Medicine in Durham, North Carolina. He and Turner Jenkins, an associate from Durham venture capital firm Pappas Ventures, were the only representatives from the venture capital community speaking at the event. From their perspective, here’s what VCs look for in personalized medicine investments:

Substantially saves money. Incremental ideas are not good enough, Kocher said. Investors are looking for ideas that substantially save money. If it substantially costs money and there’s little to no return on investment, the product won’t do well. And even the good ideas that are commercialized will take time to demonstrate just how much money they’ll save. Pappas is an investor in Palo Alto, California cardiovascular genomic diagnostics company CardioDx. Turner Jenkins, an associate at Durham venture capital firm Pappas Ventures, said that there is a gap between the launch of the product and its reimbursement by payers. Until payers start paying for the CardioDx’s genomics diagnostic, the company must subsidize its use.

Substantially changes outcomes. Investors want technologies that are substantially better than existing treatments or technologies. Plexxikon, a California biotechnology company that was acquired by Daiichi Sankyo last year for just shy of $1 billion, provides an example. The company’s melanoma treatment Zelboraf was developed to treat cancer that can’t be removed by surgery. Clinical trial results that showed some patients able to return to work after just two weeks of treatment had doctors clamoring for the drug even before it received U.S. Food and Drug Administration approval. But the drug works only in certain patients whose tumors express a particular gene mutation, which is identified by a companion diagnostic. Under priority review, FDA approval for Zelboraf and its companion diagnostic came last August, well ahead of the target dates for both products. If a personalized medicine technology doesn’t substantially save money or improve outcomes, its probably not a good idea, at least from an investment perspective, Kocher said. So what does Kocher mean by “subtantially?” Kocher said that it should be about 20 percent. “It has to be a large difference because once it gets scaled, you lose most of it,” he explained.

Must be a company. Investors are looking for companies to invest in, not just ideas. And even if your good idea has a company, there are a lot of other companies vying for VC dollars. Jenkins said Pappas Ventures receives 800 investment applications each year. Of that total, the firm invests in only one or two. “We see a lot of interesting science but say ‘no’ to a lot of companies,” Jenkins said. Pappas Ventures’ Plexxikon investment proved to be a successful one — the firm saw a return of about 10 times its original investment. But Jenkins said it remains to be seen whether these are the kinds of returns investors can expect from personalized medicine technologies. Molecular diagnostics company Genomic Health (NASDAQ:GHDX) has developed and commercialized diagnostic tests for cancer that help doctors make treatment decisions based on an individual patient’s cancer. The California company raised $60 million when it went public in 2005. But Jenkins said that in the years since, it’s still not clear if that success can be repeated, or if commercialized technologies will win reimbursement.

Turner will provide his perspective on adopting personalized medicine and the potential ROI at the Duke Center for Personalized Medicine Symposium on March 29 in Durham, NC.

Art will provide featured remarks to the Harvard Business School on personalized medicine and venture capital on Thursday, March 29 in Boston, MA.

Art Pappas will participate on a panel to discuss exit strategies, the growing role of Pharma venture capital and alternative financing strategies at the 8th annual BioExec Institute Retreat on Friday, March 23 in Miami, Florida.

WASHINGTON Hundreds of thousands of people die each year from diseases for which there are no cures. But legislation being pushed by patient advocates and biotech firms could shave years off the federal drug approval process to get promising treatments to those who need them.

The TREAT Act, introduced by U.S. Sen. Kay Hagan, D-Greensboro, accelerates the review and approval process for medicines that treat an unmet medical need or significantly advance the standard of care for people suffering from deadly diseases. A similar expedited approval bill was introduced in the House last week.

Lisa Macdonald survived breast cancer, but still worries about her cancer coming back. Macdonald, executive director of the Carolina Breast Friends, a Charlotte support organization, met with a mother last week who learned she had cancer when she was breast feeding her second son. She has since been in chemotherapy for four years and is taking part in national clinical trials hoping for a cure.

“I’m looking at this young woman who has two small sons and that’s why the TREAT Act is really important,” MacDonald said. “For us, it’s all about providing hope. We haven’t won the war on cancer. Wasn’t it Richard Nixon who originally declared the war on cancer in the ’70s? It’s now the 21st century. A lot more breast cancer patients live and thrive like me. And there are still some who don’t.”

The bill could be a boon for the state’s smaller biotech firms that often struggle to bring drugs to market. But the legislation, which is now in committee, is expected to meet resistance from the Food and Drug Administration, those who worry that drug safety will be compromised and some large pharmaceutical companies who could potentially lose market share.

But Dr. Amy Abernethy, director of Duke’s Cancer Research Program, estimated that hundreds of thousands of people could benefit from a more up-to-date, accelerated approval process.

It takes 10 to 15 years and more than $1 billion on average to bring a drug to market. The National Organization for Rare Disorders reports that of 7,000 known rare diseases, fewer than 250 have FDA-approved therapies.

People die waiting for promising therapies, said John Vernon, an associate professor of health policy and management at UNC-Chapel Hill. A former senior economic policy advisor at the FDA, Vernon said the political consequences are much greater for the agency if a bad drug is approved and someone is hurt or dies.

“They’re pulled before Congress. They get a tongue lashing,” he said. “But nothing happens if they spend an extra two or three years studying a drug to make sure it’s perfectly safe. Think during those two or three years, how many patients die or don’t get access to treatments?”

Durham-based Chimerix is developing CMX001, a treatment for life-threatening viral infections for patients whose immune systems have been compromised by disease or drugs. President and CEO Kenneth Moch said Hagan’s bill could get CMX001 to patients faster.

“We’re a 50-person company. We obviously have limited resources,” Moch said. “This could provide additional flexibility and speed for approval. We have a drug we believe can be used for patients where there is no other available therapy.”

Pressure on FDA

Karen Riley, a spokeswoman for the FDA, would not comment on the proposed legislation but said the FDA has several existing programs for expediting the review of promising drugs. She said the agency is “happy to work with Congress to see if there are ways to better utilize our tools while retaining our high standards for safety and efficacy.”

The FDA is often under pressure from patient advocates and biopharmaceutical companies to loosen up safety requirements so more drugs can be brought to the market, said Erik Gordon, a business professor at the University of Michigan who specializes in the biomedical industry. But he said the FDA’s decisions must be based on science and not be swayed by emotion or political will.

“The first rule of medicine, the oldest rule of medicine, and probably the best rule of medicine is do no harm,” he said.

The TREAT Act would not alter existing FDA safety standards, but experts note that accelerated approval programs don’t always work in ways doctors and patients hope.

Under the current accelerated program, approval is granted on the condition that clinical trials continue after the drug’s release to verify its benefits. But Abernethy of Duke said keeping up with testing can be difficult and the industry needs to come up with better data collection methods.

She points out the case of Mylotarg, which was given early approval in 2000 to treat elderly patients with a form of leukemia. The drug had to be pulled in 2010 after ongoing clinical trials showed no improvement in clinical benefits. The FDA said more patients died receiving the drug than those receiving chemotherapy alone.

“It’s a double-edged sword,” Abernethy said. “With accelerated approval comes the expectation that we’re going to continue to investigate these drugs and follow them post-approval to understand do they really do their job and work.”

The hub of N.C. firms

The N.C. biotechnology industry employs about 36,000 people who work in pharmaceutical research, development and manufacturing. North Carolina ranks 14th among U.S. states in bioscience patents, according to the N.C. Biotechnology Center. More than 2,300 bioscience patents were granted to N.C. companies between 2004 and 2009.

According to the Biotechnology Industry Organization, a trade group for the industry, 61 percent of venture capitalists cite FDA regulatory challenges as having the highest impact on their investment decisions.

Supporters expect Hagan’s proposal would ease the challenges many small companies face trying to develop and bring new drugs to market.

“We all know that new drugs come from small biotech and not big biotech,” said Dr. John Powderly, an oncologist at Carolina BioOncology Institute. Powderly said smaller biotech firms “don’t get a second swing at the bat” if the FDA changes expectations during clinical trials.

Powderly’s Huntersville clinic is often the last place cancer patients go before entering hospice care. He’s seen about 4,000 patients since the clinic opened in 2005. It provides research drugs to patients with metastatic cancer, which has spread through their bodies. Most do not make it.

“If patients can get access to a new drug and they have the right target and the drugs hit the target, there are phenomenal results,” he said.

What Hagan’s bill is for

Hagan’s proposal is similar to another FDA fast-track program. Its goal is to get medication to patients earlier provided researchers can show scientific proof of a drug’s benefits and safety. However, the process was created through regulations, not law, and its application has been limited mainly to treatments for HIV and cancer.

The TREAT Act would allow researchers to use more types of scientific evidence that can be measured to prove safety and effectiveness of drugs being considered for early release.

Hagan said she decided the legislation was needed after hearing from parents seeking treatment for their children. She met with the parents of one child with Spinal Muscular Atrophy, a rare genetic cause of infant death, she said.

“With the small number of patients available for large clinical trials, rare diseases like SMA have a hard time clearing the FDA hurdles for approval, and you can imagine the frustration of this family, and so many others like them,” Hagan said.

The National Organization for Rare Disorders, The Friends of Cancer Research, Parkinson’s Action Network and the Biotechnology Industry Organization have pledged their support for the Hagan’s proposal.

But some larger pharmaceutical companies have yet to fully embrace Hagan’s bill

Gordon, the University of Michigan business professor, said the bill could make smaller companies less dependent on big pharma. Currently many small companies often team with their larger counterparts who have the experience and capital to run long FDA trials. In return, large pharma get a share of the profits.

The trade group, PhRMA, said it’s supportive of Hagan’s efforts, but has not taken an official position on the full bill.

Sarah Alspach , a spokeswoman for GlaxoSmithKline, one of the Triangle’s largest employers, said the company thinks the best way of getting medicines to patients faster is through modifications of the current accelerated approval process.

Eric Linsley offered his perspective on personalized medicine’s development during a symposium for PMC's recent report, The Case for Personalized Medicine. Linsley joined Jennie Hunter-Cevera, Ph.D., Executive Vice President, RTI International; Jonathan Roy, Senior Director and Head of Commercial Diagnostics for GlaxoSmithKline; Amy Abernethy, M.D., Director, Cancer Care Research Program at Duke University and David King, CEO of the Laboratory Corporation of America.

The Personalized Medicine Coalition latest newsletter summarizes these perspectives.