Big3Bio Spotlights Q&A with Ian Chan, CEO & Founder, Abpro

abpro logob3b

 

 

 

About Abpro
Abpro is an integrated life science company focused on industrial biochemistry. Through its DiversImmune™ platform, Abpro leverages synthetic biology and immunology to create novel biomolecules for use in research, diagnostics, animal health and therapeutics. Abpro’s platform has been validated by major pharmaceutical, biotechnology and academic labs around the world.

What was your inspiration for founding Abpro?

We wanted to save the time required to generate basic biomolecules, so that life science research can be accelerated so that treatments can be developed faster. We had been end-users of biomolecules before and many times you are just waiting around for several months for biomolecules before research can even be started.

diversimmune

Tell us about Abpro’s proprietary DiversImmune™ Platform.

Historically, generating biomolecules takes a very long time – from months to years. This is because it requires teams of highly skilled scientists working to find the exact conditions to generate each biomolecule one step at a time. The DiversImmune platform replaces the previously labor intensive steps with technology so that the entire process can be accelerated. Traditionally, antibodies can take up to twelve months to make, for example. With our platform, we have been able to reduce this to less than two months. We leverage massively parallel processes so that multiple steps can be run at the same time. We call this process industrial biochemistry because it replaces manual work with the latest technologies in immunology, next-generation sequencing and engineering.

Why do we hear “more shots on goal” with the Abpro platform?

Our platform allows scientists to design new products by allowing the rapid study of genes. Our Diversimmune platform allows the byproducts from the genes to be quickly created and studied so that new products can be created. Our platform creates “more shots on goal” since we are able to very rapidly create the test products that meet targeted endpoints.

What is synthetic biology, sounds like a contradiction in terms?

Synthetic biology is an application of engineering concepts on a broad scale to understand the complex world of biology in a more simple way. It allows biology to be used deliberately to create novel products.

What are the advantages of using Abpro antibodies?

In addition to more shots on goal, our platform creates biomolecules that are similar to the ones create in Nature. For example, in the case of antibodies, these generally have characteristics such as high binding, specificity and functionality. Our biomolecules, especially monoclonal antibodies, are engineered to be as close to the ones you would find in Nature as possible. These natural characteristics make them very appealing since they generally contain fewer side effects compared to artificially-made antibodies. Additionally, our platform is also much faster than competitive approaches.

Who are your current partners? Can you drop some names?

Some of our partners include Amgen, Genzyme, Merck, Pfizer and others. In addition, Abpro has collaborated with several academic research centers, including Harvard University, Massachusetts Institute of Technology and Stanford University and leading academic medical centers to include Massachusetts General Hospital and Brigham and Women’s Hospital.

What do you look for in your partners?

We generally look for partners that are at the forefront of research that have a track record of developing products that have the ability to improve living health, in the research, diagnostics and therapeutics industries. Our partners are global at this point and we are fortunate that they include some of the largest and most successful companies in the industry, such as top academic and research centers and Fortune 100 companies.

You’re often cited as a pioneer in industrial biochemistry. Would you please elaborate?

Industrial biochemistry is the application of synthetic biology and immunology to the life sciences industry so that novel products and treatments can be brought to patients faster. We focus the power of synthetic biology on the life sciences industry.

It sounds like your platform is giving Mother Nature an assist?abpro-ann-liu-l

Immuno-oncology is the fastest-growing category of mAb therapeutics entering clinical studies today and represent tremendous potential. These treatments stimulate Nature’s own immune system to fight cancer.

Immuno-oncology treatments have broad implications for treating disease:

  • We can create molecules that treat disease the way our natural immune system intended to, with better efficacy and lower side effects
  • New therapies can be created that were previously not available against diseases such as cancer

What are some of the goals you hope to achieve at Abpro? Your vision for the future?

Our vision is to be able to help usher in an era powered by biology with novel products that are developed faster and can benefit mankind. Biology is relevant in all aspects of society. By being able to understand biology faster, we can design new products and bring them to market in an accelerated manner. This includes treating disease, such as cancer, at a new level with cutting edge products.

Any final words?

We are excited about the current trends using antibodies to treat disease. There is real progress being made to help patients. We look forward to continuing to play a major role in the industry and helping our partners not only accelerate their research but to bring novel products that can improve living health to market.

 

Life Science Leader Features Stefan Weber, CEO of Newron Pharmaceuticals SpA, on Drug Company Discovery & Commercialization

newron-logo

lsl

Drug Company Discovery & Commercialization: An Election Year Analogy

stefanweberBy Stefan Weber, CEO and Executive Director, Newron Pharmaceuticals SpA

When smaller, boutique drug companies move from precommercial discovery to postcommercial marketing, they can experience a shock. Precommercial work is typically rigorous and controlled with trials conducted in sequential fashion and oversight done by recognized governing bodies. Of course there can be detours along the way, but generally speaking, the path itself is well-known. In contrast, postcommercial work expands the ecosystem and, therefore, brings with it an increasing number of participants, functions, relationships, and unknowns.

To continue reading this story, subscribe to Life Science Leader.

 

 

Oticon Showcases New Hearing Technology in Phoenix

Oticon NPR KJZZ

Audiology Innovators Showcase New Hearing Technology In Phoenix
(Click title to hear the Radio version of the story)

By Andrew Bernier
April 25, 2016

Oticon TryAt the Oticon exhibit, virtual reality simulates visual and audio sensory comparing a traditional hearing aid to their new hearing aid technology while sitting in the middle of a long, crowded dinner table. (Photo by Andrew Bernier – KJZZ)

When it comes to hearing, we usually don’t think about it until it starts going away. For those who are hard of hearing, new innovations in audiology recently exhibited in Phoenix offer new options for those often missing out on conversations.

New York Times

Hearing Aid Prices Under Pressure From Consumer Electronics

By Andrew Pollack
April 20, 2016

Oticon Hearing Aids

Oticon hearing aids displayed at the Audiology Now! convention in Phoenix last week.(Credit: David Jolkovski for The New York Times)

PHOENIX — At the Audiology Now! convention here last week, visitors stood next to blowing electric fans to experience how a new hearing aid could screen out wind noise. They donned goggles to attend a virtual reality dinner party to learn how new technology made it easier to hear conversations around them.

Cydan Development Announces Formation of Imara Inc.

CydanImara

 

Cydan announced the launch of Imara, Inc. Imara will develop IMR-687, a disease-modifying therapeutic selected specifically for the treatment of sickle cell disease and other hemoglobinopathies.

 

Cydan Development, Inc., an orphan drug accelerator dedicated to creating therapies that improves the lives of people living with rare genetic diseases, today announced the launch of Imara, Inc. This is the second orphan drug company launched by Cydan since 2015. Imara will develop IMR-687, a disease-modifying therapeutic selected specifically for the treatment of sickle cell disease and other hemoglobinopathies. IMR-687 was discovered by H. Lundbeck A/S.

 

Xconomy

Cydan, NEA’s Orphan Drug Accelerator, Targets Sickle Cell With Startup Imara

BBJ

Cydan Spins Out Second Rare Disease Biotech with $31M and a Pill for Sickle Cell

big3bio_boston1

Cydan Startup Imara to Target Sickle Cell Disease

dow-jones-venture-wire

Cydan Creation Imara Raises $31M for Sickle Cell Treatment

MedCityNewsMorning Read: American Well Deal Gives CVS MinuteClinic Customers Access to Cleveland Clinic Providers

Fierce Biotech

 Pfizer, NEA Help Supply Cydan’s Second Startup with a $31M Launch Round

SCRIP2

Pharma-Backed Incubator Cydan Launches Imara With $31.5m

The-Wall-Street-Journal-Logo-Font

The Daily Startup: GV Leads $40 Million Round for Quartet Health

 

Abpro Forms Alliance With Essex Bio

Abpro
dow-jones-venture-wire

 

Brian Gormley
April 06, 2016
(c) 2016 Dow Jones & Company, Inc.

Abpro Corp., a biotechnology company that has funded itself largely through collaborations, said it has formed a drug-development alliance with Essex Bio-Technology Ltd. and received $3.5 million in Series C equity from that company.

Affiliates of Essex Bio have also provided an undisclosed amount of funding to Abpro, which formed in 2007 and previously raised $2 million in seed financing from individuals, according to Chief Executive Ian Chan.

More on this story can be found here.

bbj

 

 

Woburn Biotech Will Use Funding from Chinese Firm for Hiring

Apr 6, 2016, 9:12am EDT

Don Seiffert
BioFlash Editor

A 9-year-old Woburn maker of proteins for research and diagnostic tests has gotten a $3.5 million equity investment from a Chinese biotech under a partnership to develop drugs for cancer and eye disease.

Abpro, which uses synthetic biology to speed up the manufacture of biomolecules for big pharma firms including Eli Lilly (NYSE: LLY) and SanofiGenzyme (NYSE: SNY), announced the partnership with Essex Bio this morning. The company said that in addition to the $3.5 million from Essex, it’s also getting an undisclosed amount from other companies under the agreement.

abpro-ann-liu-l-750xx2710-1524-0-236

Abpro plans to grow its headcount from 35 to 50 by the end of the year.

Abpro CEO Ian Chan said in an interview that the money will help fuel growth from around 35 employees today to 50 by the end of the year.

Chan said the partnership is aimed at developing a type of large-molecule drug called monoclonal antibodies in two areas: One would be to fight cancer using the immune system like recently-approved drugs like Keytruda and Opdivo, and the other is for ophthalmology.

“This partnership with Essex Bio adds further validation to our discovery platform and provides an opportunity to advance novel therapeutics with one of the largest ophthalmology companies in China, which is the second largest pharmaceutical market in the world,” said Chan in a statement. “This agreement results in a strong partnership with R&D efforts and significant capabilities both in the United States and China.”

Abpro was founded in 2007 in Kendall Square, and moved out to Woburn a couple years ago, according to Chan.

While the company has received past undisclosed equity investments, Chan said it generates revenue from the sale of biomolecules. It’s also increasingly developing drugs through partnerships, under which it typically does the early-stage discovery and pre-clinical work, then a partner takes over clinical development.

Pancreatic Cancer Vaccine Makes Progress in Two Late-Stage Trials

NewLink Logo 11.19.13
OncLive_Logo

 
 
 
Tony Berberabe
OncLive
March 10, 2016

The novel therapeutic vaccine algenpantucel-L, which is genetically engineered from human cell lines, is being evaluated in two phase III trials in patients with resected pancreatic cancer (IMPRESS) and borderline resectable or locally advanced unresectable pancreatic cancer (PILLAR). According to the manufacturer, NewLink Genetics, both trials have completed patient enrollment, and top-line results from IMPRESS will be available later this year.

In developing the immunotherapy agent, researchers are seeking to change the equation for patients with pancreatic cancer, where the current 5-year survival rate is a dismal 7.2%, according to the National Cancer Institute.

Thomas-George“Unfortunately, the vast majority of patients with pancreatic cancer, even those who are candidates for surgical resection, will relapse,” said Thomas J. George, Jr, MD, a principal investigator at one of the more than 70 US sites where the IMPRESS trial is being conducted.

The current standard of care for this patient population consists of surgery, followed by postoperative adjuvant chemotherapy and/or chemoradiation, said George, an associate professor and director of the Gastrointestinal Oncology Program, University of Florida Health Cancer Center. “Offering additional treatment after surgery, whether it is chemotherapy or chemoradiation, definitely benefits patients, more so than surgery alone,” he said.

Algenpantucel-L is an allogenic pancreatic cancer vaccine based on the concept of hyperacute rejection, a primary barrier to xenotransplantation. It is comprised of two human pancreatic ductal
adenocarcinoma cell lines (HAPa-1 and HAPa-2) that have been genetically engineered to express α(1,3)-galactosyl epitopes (αGal) by using retroviral transfer of the murine αGT gene. This manufacturing process is highly reproducible, making it suitable for use in a larger scale manufacturing platform for administration as a potential “off-the-shelf” vaccine. IMPRESS (NCT01072981) is a randomized, two-arm, open-label study that was launched in April 2010 and has accrued 722 participants. Patients who have undergone surgical resection are randomized to receive an adjuvant regimen of either algenpantucel-L (up to 18 immunizations of 300 million cells) plus gemcitabine (1000 mg/ m2/d, once a week for 3 weeks) with or without 5-fluorouracil (5-FU) (200-250 mg/m2/d over 5.5 weeks) with radiation or gemcitabine with or without 5-FU chemoradiation.

The primary endpoint is overall survival (OS). The secondary objective of the trial is to assess disease-free survival (DFS) and to conduct correlative scientific studies of subject samples to determine the mechanism of any observed antitumor effect. Data analysis is ongoing, said George, and “there have been several data monitoring assessments, with no signs of futility issues. This has been a well-tolerated intervention, with only injection site irritation reported.”

Algenpantucel-L Phase III Trials in Pancreatic Cancer

NewLink Trials

5-FU, 5-fluorouracil; CA 19-9, cancer antigen 19-9; FOLFIRINOX, oxaliplatin, ironotecan, leucovorin, and fluorouracil; RO, complete resection with grossly and microscopically negative margins of resection; R1, grossly negative but microscopically positive margins of resection.

Source: NewLink Genetics website. http://goo.gl/AibtcP. Accessed February 29, 2016.

The median age of patients is 65 years and 52% of patients are male, with 80% of tumors resected from the head of the pancreas. Nodal status (N+) is 70% and 55% of patients had tumor size ≥3.0 cm. NewLink Genetics reports that a second interim analysis demonstrated a median OS of 28.5 months from time of randomization for both cohorts blended together. The impetus for the IMPRESS trial was the positive outcomes reported from an earlier phase II trial, in which patients with completely resected pancreatic cancer received algenpantucel-L in addition to chemotherapy and chemoradiation in the adjuvant setting. In this study, 73 patients were enrolled, with 69 meeting the criteria.

After a median follow-up of 21 months, the 1-year DFS was 62%, and the 12-month OS was 86%. The median DFS was 14.1 months. There were 34 patients with a documented site of recurrence. The most common grade 1 and 2 adverse events (AEs) were induration, fatigue, and injection site reaction. Twelve percent of patients experienced grade 3 AEs and no grade 4 events; grade 3 events included fatigue, injection site reaction, pain, and lymphopenia. PILLAR (NCT01836432), launched in October 2012, is a two-arm, open label, randomized study that has accrued 280 patients. Patients with borderline resectable or locally advanced unresectable pancreatic cancer receive either a regimen of FOLFIRINOX or gemcitabine/nab-paclitaxel with or without algenpantucel-L.

The primary endpoint for PILLAR is OS and secondary endpoints include progression-free survival, safety (frequency and grade of adverse events) of administration of algenpantucel-L, and immune response to the immunotherapy agent. NewLink Genetics reports that enrollment was completed in December 2015. A vaccine like algenpantucel-L has a mechanism of action that is different from other immunotherapy agents such as the checkpoint inhibitors nivolumab and pembrolizumab, George explained.

“The checkpoint inhibitors affect one particular switch. Once that switch is flipped, immune activation can proceed normally,” he said. “Pancreatic cancer is so complex and this mode of immune stimulation [algenpantucel-L] is much more comprehensive.”

NewLink Genetics suggests its HyperLink Cellular Immunotherapies platform is able to take advantage of a hyperacute response by the immune system that is metabolically active and uses whole-cell immunotherapy with multiple antigens. The resulting immune response consists of activated antibodies, T cells, and eosinophils. With the emergence of checkpoint inhibitors, the question of optimal sequencing is also a concern. George believes that the sequence of treatment demonstrated in the phase III trial design is likely the best way—that is, giving the immunotherapy after surgery once the majority of the cancer has been removed. “It’s a numbers game in which there is less cancer for the immune system cells to have to find and attack,” he said. “In addition, the immune system is most potent when there’s the least amount of physical cancer present.”

Most impressive was how well the vaccine was tolerated when combined with standard care, said George. “It is promising that we don’t have to abandon our standard of care,” he concluded.

Five Things You Should Know About James McArthur

Boston GlobeCydan_new logo_full_RGB

 

Robert Weisman
February 19, 2016

James McArthurJames McArthur is founder and chief scientific officer at Cydan Development Inc., a three-year-old “accelerator” firm spawning companies that develop therapies for rare genetic diseases. Last year, Cydan launched its first company, Vtesse Inc., and it plans to start three more in 2016. McArthur, 53, spoke at Cydan’s office outside Kendall Square in Cambridge.

  1. McArthur, who has a British mother, a Canadian father, and an American wife, carries three passports. He was born in London, moved to Canada when he was 5, and went to high school in Connecticut when his father worked for the Canadian consulate in New York.

“I went to college at McGill [in Montreal], where my father, my grandfather, and my uncle had gone, and thought I would wind up staying in Canada,” he said. “But I was advised that it would be a good idea to come down to the US and go to MIT for a postdoc. Then I ended up going out to California and married an American and we had two daughters. So I figured, ‘I guess I’m staying in the US after all,’ and I became an American citizen.”

  1. His interest in science was sparked when he was about 10 years old and his parents returned from a tropical island vacation with a queen conch shell. McArthur was so intrigued by its shape and structure that he decided to cut through it with his father’s hack saw.

“I started collecting queen conch shells and thought it was just interesting that this overgrown slug could produce a shell that had the same sort of beauty and proportionality over and over. And that’s what got me into science. I was probably the only 12-year-old in Montreal who said he was going to go get a PhD.”

  1. Although he started his higher education determined to study oceanography, McArthur switched to biochemistry after he took a riveting course in molecular and cell biology and saw an ad in the McGill student newspaper that referenced the scarcity of jobs in marine biology.

“I still remember it well. It said, ‘George has a master’s degree in marine biology and a job driving a taxi cab. Can you give George a job?’ ”

  1. McArthur worked as a senior scientist at Somatix Therapy Corp., served as vice president of preclinical development at Phylogix Inc., and led drug development for Synovex Corp. before cofounding Cydan in 2013. Fighting rare diseases is a family occupation. McArthur’s wife, Cara Hesse, is associate director of global patient advocacy at Sanofi Genzyme, a leading rare disease drug maker. McArthur’s birthday falls on Feb. 28, which is typically Rare Disease Day (although the disease awareness day is scheduled for Feb. 29 this year because of leap year.)

“We never celebrate my birthday because we’re both busy that day.”

  1. When they do get time away from the office, McArthur and his wife, sometimes accompanied by their college-aged daughters, sail their boat, named “Hypothesis,” around the Boston Harbor Islands. McArthur will also sail alone to regain perspective in trying times.

“There have been times when I needed to just head out to the islands and just sail around for an afternoon. It just clears your head. That’s one of the things about Boston. I love sailing back through the Boston Harbor as the sun’s coming down and seeing the light off the buildings in Boston. That intimacy for me is one of the jewels about living here.”

 

A Divide-and-Conquer Approach to Rare Disease Drugs at Cydan

bbjCydan_new logo_full_RGB

 

Don Seiffert
February 19, 2016

Chris Adams

(Boston Business Journal) The idea for Cydan began a few years ago, when two biotech executives with a long history of developing drugs for rare diseases decided to try and find a faster, cheaper way to do it.

“Cydan actually began as an experiment. All of us had worked at small companies, mid-sized companies, ventures. And we wanted to find a more efficient way of identifying drugs we thought could really impact the health of patients with monogenic rare diseases outside of the oncology space,” said James McArthur, founder and chief scientific officer of the Kendall Square firm.

McArthur and Chris Adams, now CEO, founded Cydan three years ago as “an accelerator with a bank attached” — that is, with funding from a slate of biotech investors whom they could approach with new startup companies they formed around promising new drugs. The twist was, those drugs would only be for rare diseases caused by a single, known gene mutation, and the very early, preclinical work of validating the science and making sure there’s a market for them would have already been done by the team of experts at Cydan.

Today — just about a week before Rare Disease Day on Feb. 29 — Cydan itself is organized as a limited liability company with six employees, and isn’t designed to grow into a rare disease giant like Sanofi Genzyme (NYSE: SNY) or Shire Pharmaceuticals (Nasdaq: SHPG). Rather, it’s intended to be a clearinghouse to seek out and test potential new drugs that would otherwise have little chace of being developed, spinning out the most promising ones into startup companies.

In three years of operation, the Cydan team has looked at more than 300 assets culled from academic and government sources all over the globe. It’s brought 16 of them in-house to work on them, and that’s now resulted in one company already spun out and five more in the works. The rest of them have been determined to be too risky from a toxicology or business standpoint — usually within six months and for just a couple hundred thousand dollars.

“That’s time and money, essentially, that the investors don’t have to spend a multiple of to get to the same point,” said McArthur.

Cydan’s first spinout, called Vtesse, is in Phase 1 trials with a potential drug for Niemann-Pick Disease. While it’s based in Maryland, Adams says Cydan’s future spinouts will more likely be more local. This year, the company plans to launch a couple more biotechs, one within just the next few weeks which Adams says they acquired as “a bucket of small molecules with no data whatsoever.”

While Cydan acts in some ways like a venture capital firm — the management of the company will personally invest in the spinout companies alongside the five partner organizations — they say it isn’t just performing due diligence on the drugs it develops. Cydan actually advances those drugs toward clinical trials, and even if it opts not to spin it out into a company, it will often return it to the original owner or a disease foundation with clear instructions on what it would take to turn it into a viable drug.

“Even if the project itself fo that disease doesn’t move forward, we’ve made a difference to that foundation because we’ve educated them on, ‘Here’s what you need to look at’,” said Adams. “That’s part of the impact we hope to give back as Cydan.”

More focus needed on non-opioid treatments

bbjhydra

 

 

​More focus needed on non-opioid treatments

 

Russell Herndon

February 5, 2016

New England lawmakers and Massachusetts medical schools have joined the growing conversation on the opioid abuse epidemic. We commend public policy leaders who are passionate about driving this critical discussion toward a positive course. However, the public anecdotes on the scourge of addiction and all the societal ills that follow represent only half of this public health crisis. The other half of this conversation needs to focus on what is being done to develop better treatment options for the millions of patients who suffer from chronic pain.

Chronic pain is a serious problem in health care. The Institute of Medicine estimates that there are 100 million Americans suffering from chronic pain; and 10 million have pain that is so severe they are considered disabled. Seven million people have painful diabetic neuropathy, the most common form of neuropathic pain, and projections say the numbers will grow to 9 million patients with diabetic neuropathy within seven years.

We need to provide physicians with new, innovative medicines and to further invest in developing drugs for new pain targets and mechanisms, which is challenging when less than 2 percent of the NIH’s $30 billion annual budget goes to funding pain research.

Biotech and pharmaceutical companies, including two in Massachusetts, are making advances in developing new non-opioid, non-addictive pain treatment options for patients. Advances are being made in studies for nerve growth factor inhibitors, or NGFs, such as tropomyosin receptor kinase A (TrkA) and inhibitors of angiotensin II type 2 receptors (AT2).

Cambridge-based Hydra Biosciences is studying the ion channels that help us sense and respond to environmental changes. Ion channels are proteins in the cell membrane that allow tiny electrical signals to flow in and out of the cell. Hydra’s HX-100 is a molecule that blocks the activation of TRPA1, which this year will be studied in a phase 2 trial for the treatment of diabetic neuropathic pain.

In Burlington, Flexion Therapeutics is developing non-opioid treatment candidates for pain.

The company is leading a phase 3 trial for a sustained-release steroid for moderate to severe osteoarthritis pain and a phase 1 trial with a small molecule that targets the TrkA receptor for post-operative pain. Purdue Pharma in Stamford, Connecticut, also is developing a compound to target the TrkA receptor.

While this list is by no means exhaustive and does not include any early academic research, it provides some semblance of hope to the communities of patients suffering from chronic pain, but we still need, support and investment into research and development efforts focused on finding new solutions to the chronic pain epidemic.

Russell Herndon is CEO of Hydra Biosciences; Cheryl Bartlett is the former Massachusetts Department of Public Health Commissioner; and Cindy Steinberg is national director of policy and advocacy for the U.S. Pain Foundation and policy chair for the Massachusetts Pain Initiative.

NewLink Genetics Gains Coverage on its Zika Vaccine Research

The-Wall-Street-Journal-Logo-FontNewLink Logo 11.19.13

 

 

 

Drug Industry Starts Race to Develop Zika Vaccine

 

Noemie Bisserbe and Betsy McKay

February 2, 2016

Drug companies are beginning early-stage research to develop a new vaccine against the rapidly spreading Zika virus, joining the race to control an outbreak that the World Health Organization said constitutes a global public-health emergency.

PARIS—Drug companies are beginning early-stage research to develop a new vaccine against the rapidly spreading Zika virus, joining the race to control an outbreak that the World Health Organization said constitutes a global public-health emergency.

It might be years, however, before any vaccine reaches the market, meaning the new wave of research is unlikely to help curb the current outbreak. Though Zika generally makes people only mildly ill for a few days, it has been linked to a serious birth defect in which babies are born with undersized skulls and brains.

Zika’s explosive spread could give pharmaceutical companies a new opportunity in an increasingly important category of drugs, but the impact of a vaccine would depend on the prevalence of the virus when it hit the market, and the ability and willingness of governments to launch massive vaccination campaigns.

To attack Zika, French drugmaker Sanofi SA said Tuesday it would take advantage of the research it did for its newly approved vaccine for dengue fever—the world’s first against the mosquito-borne illness. The Zika and dengue viruses are in the same family.

“Theoretically, there could be some cross immunity,” said Nicholas Jackson,global head of research at the company’s Sanofi Pasteur vaccines unit, who will be running the new project. “We will need to investigate this clinically.”

Michael Diamond, an infectious-disease specialist at Washington University in St. Louis, said Sanofi’s expertise on the dengue virus would likely give it a head start in developing a Zika vaccine. But he also cautioned that Zika’s similarity to dengue would add complexity to vaccine development. The two viruses’ close resemblance means researchers would need to establish whether a Zika vaccine would be as effective in people with existing dengue immunity, and also whether immunity to Zika could affect how people respond to the dengue virus. “That’s going to have to be studied,” he said.

U.S. biotech company NewLink Genetics Corp. said it too was working on developing treatment options for the disease.

NewLink’s infectious-disease team felt that searching for a Zika vaccine “was a project they could really sink their teeth into,” said Charles Link, the company’s chief executive.

NewLink hasn’t begun human testing of any potential Zika vaccine candidates. “This is going to take some time and effort,” said Dr. Link. “This is not going to be an overnight deal.”

Epidemic diseases generally draw little investment from pharmaceutical companies because demand for those products is sporadic and unpredictable.

The WHO, the U.S. government, the pharmaceutical industry and others are working on ways to improve research and development for epidemic diseases, in the wake of the Ebola crisis in West Africa and as new epidemics such as Zika emerge.

At least a dozen Ebola vaccine and drug candidates were under development when the virus began to spread in West Africa.

Even so, there is still no licensed treatment or vaccine. One vaccine candidate, developed by NewLink and licensed out to Merck & Co. proved effective in a clinical trial, and the company is gathering data to apply for licensure.
The WHO, the United Nations public-health agency, acting on the recommendations of an emergency committee, on Monday called for more surveillance, research and efforts to control the virus’s spread. Currently, there are no rapid and reliable diagnostic tests, drugs or vaccines for Zika.

Last month, GeneOne Life Science Inc., a South Korean biopharmaceutical company, said it had launched a joint research program with U.S. biotech firmInovio Pharmaceuticals to develop a DNA-based vaccine to prevent and treat the Zika virus infection. U.K. drugmaker GlaxoSmithKline also said last week that it was assessing its research platform for the potential to develop a Zika vaccine.

The U.S. National Institutes of Health also is accelerating research into rapid diagnostic tests, vaccines, and therapeutic drugs for Zika, said Anthony Fauci,director of the National Institute of Allergy and Infectious Diseases, an arm of the NIH.

The NIH has long conducted research into flaviviruses, the class of viruses to which Zika belongs, with about $97 million in funding in fiscal 2015. But none was going into Zika, Dr. Fauci said.
The institute is pursuing two different pathways to a Zika vaccine, and may get one into an early Phase I clinical trial this year, he said. But, he cautioned: “We will not have a widely available safe and effective Zika vaccine this year and probably not even in the next few years.”

The once-obscure virus has become a major global health concern over the past few months, mainly because of its possible links to microcephaly in babies and Guillain-Barré, a rare disorder in which the body’s immune system attacks nerve cells.

Health authorities in Brazil, where as many as 1.5 million people may be infected with the Zika virus, have confirmed 404 cases of microcephaly since October.

Brazil isn’t alone. Authorities now say they believe that some cases of microcephaly in babies in French Polynesia may be linked to an outbreak of Zika that occurred there in 2013 and 2014. Brazilian and international health authorities also say Zika may be linked to a rise in the number of cases of Guillain-Barré syndrome.
Dr. Fauci said Zika is “the latest of a series of mosquito-borne diseases that have expanded their reach in the past 20 years or so.” It follows dengue and chikungunya, he said.

“There will almost certainly be others,” he said. “We need vaccine platforms that can be quickly modified for protection against emerging new threats and we need broad spectrum antiviral drugs effective against whole classes of viruses.”
—Peter Loftus and Denise Roland contributed to this article.

SCRIP

 

 

NewLink Brings Flavivirus ‘Dream Team’ To Zika

Donna Young

February 3, 2016

NewLink Genetics Corp. is not just another company jumping on the bandwagon of the latest global health crisis – in this case, the Zika virus, a mosquito-borne illness rapidly spreading throughout Central and South America and certain US territories, with the first continental US transmission of the disease reported on Feb. 2, which apparently involved sexual contact.

Indeed, the Ames, Iowa-based biotech, which recently gained worldwide recognition for its experimental Ebola vaccine – which so far has shown to be the most effective among those that have been tested in the past year – comes to Zika with one of the most experienced and knowledgeable vaccine development teams working in flaviviruses.

“I’ve got what I call a flavivirus dream team,” declared Thomas Monath, chief scientific officer and chief operating officer at NewLink’s infectious disease division.

In Monath’s past life, he was the chief science officer at Acambis Inc., a publicly traded company that was acquired in 2006 by Sanofi-Pasteur, the vaccines division of Paris-based Sanofi SA.
While at Acambis, Monath led the development of the ChimeriVax flavivirus platform on which Sanofi’s now-successful dengue vaccine, Dengvaxia, was based.

Dengvaxia is the only approved dengue vaccine in the world – winning regulatory nods this past December in Mexico, The Philippines and Brazil.

Monath said the ChimeriVax flavivirus platform – which he called “my baby” – also was used to make vaccines against Japanese encephalitis and West Nile, although the latter is only used in animals, with the world still waiting for a product for humans.

Sanofi itself on Feb. 2 announced it, too, was launching a Zika vaccine project based on its dengue platform – declaring that its “expertise and established R&D and industrial infrastructure” for Dengvaxia could be “rapidly leveraged to help understand the spread” of the Zika virus “and potentially speed identification of a vaccine candidate for further clinical development.”

Monath said he brought along a “number” of his Acambis/Sanofi teammates to work with him at NewLink. And he convinced other colleagues to join him from another of his former companies, Xcellerex Inc., where he led the development of a yellow fever vaccine.

“So we’ve got a lot of expertise and experience in making vaccines against viruses like Zika,” declared Monath, a world-renowned virologist and vaccinologist, who before joining industry spent 20 years with the US federal government at the Centers for Disease Control and Prevention and the US Army Medical Research Institute of Infectious Diseases.

Investors apparently have faith the company can do the job – driving shares of NewLink up 7.3% on Feb. 2, before closing at $25.70, a gain of $1.28, or 5.2%.

A Different Approach
Instead of pursuing a live-attenuated vaccine – the approach used for Dengvaxia and for one of the two Zika vaccine candidates the National Institute of Allergy and Infectious Diseases (NIAID) currently is working on – NewLink plans to develop a non-replicating whole virus particle product, Monath explained.

“At the end of the day, we want a vaccine that can be given to pregnant women,” he said, noting what the World Health Organization (WHO) has called a “strongly suspected” link between Zika in pregnant women in Latin America and microcephaly, a congenital condition in which babies are born with abnormally small head, which often is associated with incomplete brain development.

Because of the more than 4,000 cases of microcephaly and neurological complications in infants in Brazil and the “strong association” with Zika, the WHO on Feb. 1 declared a “public health emergency of international concern” – hoping that by doing so, governments, researchers and industry would make a coordinated global effort to quickly develop diagnostics, therapeutics and vaccines.

With no clear understanding of how the virus may be causing the microcephaly, Monath said it may be “very, very difficult” to ensure a live-attenuated Zika vaccine is safe for pregnant women and won’t cause damage to the fetus.
“Therefore, I would prefer to start from the technology that was not complicated by those safety questions,” he said. “I think that’s the surest way to get a vaccine out there that will work.”

Monath emphasized that he wasn’t saying a live-attenuated Zika vaccine couldn’t be developed.
“I think they can,” he said. But, Monath added, “it’s going to take a longer haul.”

A non-replicating Zika vaccine, he said, also may have a somewhat better storage and management advantage over a live-attenuated vaccine, which must be freeze-dried or frozen at a low temperature.

And, Monath said, a non-replicating Zika vaccine also may “get to the finish line the quickest.”

Partners And Incentives
Like NewLink did with its Ebola vaccine – a product it licensed from the Canadian government and later partnered with Merck & Co. in developing, with financial support from the US federal government – the biotech likely will seek collaborators for its Zika vaccine, Monath said.

NIAID chief Anthony Fauci last week told Scrip there’s been a ” considerable amount of interest” from industry in taking Zika vaccine candidates through advanced development.
GlaxoSmithKline PLC is one firm that’s expressed interest in possibly taking on the challenge of developing a Zika vaccine, although it’s unclear currently whether it would produce its own product or partner with the NIAID, like it did with Ebola.

NIAID, which last month issued a call for researchers and industry to pursue “vital areas” of Zika R&D, declaring it would provide grants for the work, currently is staying mum about what companies it’s been in discussions with over the past few weeks.

It’s unclear whether President Barack Obama will call for other Zika funding in his fiscal year 2017 budget proposal, due out next week.

But some lawmakers have proposed providing incentives to companies to entice them to develop a Zika vaccine, like an FDA priority review voucher (PRV).

Reps. GK Butterfield and Susan Brooks (R-IN) introduced a bill on Feb. 2 to add Zika to the list of diseases eligible for the tropical disease PRVs, the holders of which can use them on a subsequent application that otherwise would not have qualified for a priority review – shaving off as much as four months from the FDA’s examination process – or sell them to the highest bidder.

While NewLink is in the early R&D stages of its Zika vaccine, Monath insisted “We have the right people on board who have done this before, we’ve got the expertise and we’ve got the roadmap in place.”

So, he said, “that’s really going to facilitate the development program.”

BioWorld

 

Sanofi, Newlink and others join Zika vaccine brigade

Michael Fitzhugh

February 3, 2016

Rising concern over the spread of the Zika virus, crystallized by Monday’s World Health Organization (WHO) labeling of it as a public health emergency, has jumpstarted efforts at Sanofi SA, Glaxosmithklineplc, Newlink Genetics Corp., Mymetics Corp. and Valneva SE to develop new vaccines against the dengue-related virus as interest from multiple quarters, including Congress, grows.

The WHO had estimated that as many as 4 million people could be affected by the virus as it spreads in Latin America and the Caribbean to North America in the coming months. So far, there is no vaccine or specific treatment for Zika nor an approved test for detecting infections before they become acute, for now leaving vector control as one of the most important means of potentially controlling its spread.

Sanofi said its Lyon, France-based Sanofi Pasteur division, a top supplier of vaccines for viruses in the same family as Zika virus, would work on the project. The company plans to leverage established R&D and industrial infrastructure put into place for its newly licensed vaccine for dengue, Dengvaxia, to potentially speed identification of a vaccine candidate for further development against Zika. (See BioWorld Today, Dec. 11, 2015.)

Sanofi spokeswoman Marisol Peron told BioWorld Today the company’s preventive vaccine in research and development for Zika is just at the starting line. “Although the scientific and public health communities agree that there are too many unknowns about Zika right now to reliably judge the ability to research and develop an effective vaccine,” she said that Sanofi Pasteur’s extensive experience in developing vaccines for flaviviruses, such as dengue, could potentially accelerate vaccine development for Zika.

GSK, another of the world’s largest developers of vaccines, is also said to be evaluating whether its vaccine technology is suited to the Zika virus.

Newlink’s infectious disease division, based in Devens, Mass., is evaluating various approaches for preventing Zika infection, too. Newlink’s chief scientific officer and chief operating officer, Tom Monath, told BioWorld Today the company has “a flavivirus dream team,” assembled from scientists, including Monath, who developed vaccines for three different flaviviruses during their employ at Acambis Inc., which was later acquired by Sanofi.
Monath said his team believes a nonlive, nonreplicating vaccine will be the best approach, given that it could be used safely during pregnancy and that probably it will take a couple years before the first clinical trial. “Until such time as we in the scientific community understand why microcephaly results from Zika virus infection, it poses a number of safety questions for any new vaccine, especially live viral vaccines with Zika proteins in them,” he said.

The company, which in 2014 joined forces with Merck & Co. Inc. to develop VSV-EBOV for Ebola, gained what Newlink CEO Charles Link said was “considerable experience during the Ebola crisis collaborating with national and international partners in a rapidly evolving public health environment.” Whether or not Newlink would leverage its internal resources or seek to move a potential Zika vaccine ahead with a partner is unknown at this point. (See BioWorld Today, Nov. 25, 2014, and Aug. 3, 2015.)

Though not committing quite yet, Lyon, France-based Valneva SE also suggested it might join the search for a Zika vaccine on Tuesday, noting that Zika is related to the Japanese encephalitis virus, another arthropod-borne flavivirus transmitted through mosquito bites, against which it has already developed a vaccine marketed as Ixiaro and Jespect. Considering what it called “the alarming spread of the Zika virus and the immediate medical needs,” Valneva said it would evaluate the technical feasibility of developing a vaccine and delivering a lead candidate within two years.

Other companies announcing plans to either join the project or explore it on Tuesday included Mymetics Corp., which, following notice of a terminated respiratory syncytial virus vaccine program on Jan. 28, said it has started to investigate Zika, too.

The companies join ongoing work at Replikins Ltd. and a partnership between Inovio Pharmaceuticals Inc. and Geneone Life Science Inc., which a representative of Inovio told BioWorld Today is evaluating a vaccine candidate in animal testing with hopes of beginning a trial before the end of 2016. (See chart, below.)

Zika Chart

Alongside work to develop vaccines, diagnostics makers have also been busy. The first in vitro diagnostic tests began shipping last week to labs in Brazil and other regions where the mosquito-borne infection has become epidemic, while Genekam Biotechnology AG, Altona Diagnostics GmbH and Vela Diagnostics Pte. Ltd. all have PCR-based diagnostics in varying stages of development. Though good for detecting acute viral infections, such tests may face challenges in making a big impact because it is difficult to detect asymptomatic infections, something which could be common if a well-studied past outbreak is a guide. (See BioWorld Today, Feb. 2, 2016.)

Behind the scenes, public health experts such as Bruce Aylward, executive director ad interim of WHO’s Outbreaks and Health Emergencies Cluster, are working to coordinate the global research community, industry, public sector and others in much the same way as was done during the Ebola crisis to “really look at [whether there] is merit for an accelerated product development agenda around this,” he told reporters during a Feb. 1 press briefing.

Aylward said that vaccine development is known to be “a 12-month-plus” project. “The time frame for developing a new diagnostic, if it’s technically feasible to have a better antibody detection: Well,” he said, “that should be shorter than that but we really need right now to be working with the tools that we have and we certainly have the tools to understand and diagnose infection.”