A First Treatment for Hearing Loss, Tinnitus and Vertigo? Meet the CEO Behind

Thomas Meyer, CEO of Auris Medical, discusses how biotech can finally bring solutions to those who live with hearing loss, tinnitus and vertigo.

Thomas Meyer is at the forefront of a wave of drugs that could, for the first time, show efficacy in treating common hearing disorders. In 2003, he founded Auris Medical to address the lack of effective treatments for conditions such as hearing loss, tinnitus and vertigo.

The company is expecting imminent results from a Phase III trial that could lead to the approval for the first therapy for sudden deafness, the most frequent type of acute hearing loss – in Europe, it affects almost 5 out of 10,000 people.

Actually, when you look at ear disorders, they are even more frequent than eye disorders,” Meyer told me. “And still, they are a blind spot in medicine.” Curious to learn why it has been so challenging to treat hearing disorders in the past, and how biotech companies like Auris could finally put a stop to it, I asked Meyer about his journey, from creating a new technology from scratch to the brink of approval.

Thomas, how come there are no effective drugs available for hearing disorders? Is that why you decided to create Auris Medical?

Definitely. There are absolutely no FDA-approved drugs, and some older drugs licensed in a few European countries. There is relatively widespread off-label use of steroids, of vasodilators, but none has actually been tested rigorously for efficacy in inner ear disorders. Effectively, there are no specific inner ear therapeutics on the market.

I was really intrigued by the complete lack of treatment options for people with these problems. People around me suffered from tinnitus or hearing loss, but they never spoke about it. One acquaintance once told me that when he listened to certain keys on a piano, he heard zero sound. That was because his tinnitus was about at that frequency. I asked him why he hadn’t said that before and he told me: “Why should I talk about it? I have had this for 20 years now. The more I talk about it, the more I think about it, and the more I hear it. I just have to live with it.

Tinnitus manifests as hearing sound when there isn’t

I eventually figured out the reason why there were no drugs available was actually a classic situation: big pharma had been just too used to systemic delivery – pills, tablets, etc. If you try to treat inner ear disorders systemically, it’s impossible, in many cases, to get meaningful concentrations to the inner ear. You would need a very high dose, which can lead to side effects.

But a group at Inserm had done quite a lot of very good, exciting work in glutamate receptors in the inner ear. They had some good ideas, and they were eager to see them move into the clinic. So I decided to start my own business, and Auris Medical was born.

We focus on three acute inner ear conditions, which we estimate to have a worldwide market potential of $3Bn. The reason why we focus on acute hearing loss and acute tinnitus is because we understand the biology. Chronic conditions are a much bigger challenge, with a much bigger market potential, of course. But you’d better not start with the most challenging step.

Auris Medical is about to release Phase III data for a potential first treatment for acute hearing loss. How are you treating this condition?

Both acute hearing loss and tinnitus can be triggered by an injury to the inner ear. Think of firecracker accidents, of a sudden change in pressure when flying or diving – called a barotrauma –, an infection, or a disruption in the blood supply to your inner ear.

When that happens, some of the damaged cells die right away, and they will never recover. When you are born, you have the maximum number of sensory cells, called hair cells, and neurons. And from there, there’s only one way to go, which is down.

But within the first four weeks, some cells can still recover naturally – some birds can actually regrow these cells after four weeks, but not humans. We try to protect these cells from dying and allow them to recover using a peptide called D-JNKI-1, or brimapitide, which can enter the sensory cells using Tat, a peptide transporter derived from HIV research. Once inside, brimapitide blocks the JNK MAPK stress pathway that ultimately leads to apoptosis – programmed cell death – of the sensory cells.

hearing loss tinnitus vertigo

Now, this has to be given relatively early. We have been conducting our clinical trials within the first three days after acute hearing loss with this treatment, which we call AM-111. We expect results from the first of two Phase 3 studies with AM-111 very soon. We enrolled a total of 256 patients with sudden deafness, and measured hearing recovery from baseline to day 28. The goal is to show statistical significance in improving upon the natural recovery process, meaning an improvement of at least 10 decibels over placebo. Decibels are a logarithmic measure, so 10 decibels mean that you can hear sounds that are half as loud.

In Phase 2, we showed a rapid recovery of hearing that was already significant after 3 days with a single dose of AM-111. If we can confirm what we saw there, we will start discussions with the EMA and the FDA next year. We’ve got orphan drug designation from both those agencies, so approval could happen as soon as 2019.

What could make this approach work where others don’t seem to have succeeded before?

We are using a local delivery approach where a physician injects the drug into the middle ear. This technique, called intratympanic injection, has been around for several decades. But in the past, it was always used with liquid solutions. 

And when the patient swallowed, they drained off through the Eustachian tube. We use a viscous gel formulation to ensure the drug stays in the right place and diffuses into the inner ear through the round window, a tiny membrane that communicates with the inner ear, just a few square millimeters in surface.

There are also fantastic, sophisticated hearing aids out there that keep getting better and better. But if you can preserve your natural hearing, that’s simply better. The truth is that hearing aids cannot know what sound you want to focus on and distinguish it from background noise.

You’re also treating tinnitus and vertigo – how?

In the case of tinnitus, the therapeutic time window is longer than for hearing loss – from about 3 months up to 6 months. Tinnitus is triggered by the glutamate receptors, or NMDA receptors, inside the inner ear. After an acute injury, they become hyperactive and generate a phantom sound inside your inner ear.

We block that NMDA receptor activity, in order to allow the auditory system to readjust and rebalance, using esketamine, a drug that is structurally very similar to the anesthetic ketamine. It’s a safe drug and we are using minimal concentrations thanks to local delivery.

We had, unfortunately, a setback with that program last year. We failed to show significant differences for the entire study population, though we saw efficacy in some sub-groups. This was due to trial design issues; when you measure tinnitus, unlike in a hearing test where you hear and react to tones, it’s much more subjective, relying on patient-reported accounts.

We’ve changed the protocol and the questionnaire, and we feel confident that we will have a very good chance of demonstrating the efficacy of Keyzilen, which also got fast-tracked by the FDA. We expect to have results from a Phase 3 trial in February.

Our third program, AM-125, which is in Phase I, is a little bit different. Here, we are talking about vertigo, a sensation of movement even when there is no movement. It’s also kind of phantom perception.


Vertigo is the feeling that the world around you is moving when it isn’t

There have been some older drugs around for quite some time – basically antihistamines that sedate the whole vestibular system. But they have one big disadvantage, which is that though they help you in the very short run, they delay the recovery of the sense of balance.

We use betahistine, a drug that has been around since the 1960s in oral form. But its oral bioavailability is very low, of about 1%. Nowadays, nobody would seek to develop a drug with such a low bioavailability, because it implies a lot of variability from patient to patient. But by delivering betahistine through the nose, we could give a very significant boost to its efficacy.

You’re not the only ones trying to treat ear disorders. Who are your competitors?

Back when we began in 2003, we were the first kid on the block, so to speak. But since then, a few other companies got started. There’s Otonomy in the US, which had a major setback quite recently – a Phase 3 in Ménière’s disease – whose symptoms include vertigo, tinnitus and hearing loss – of that showed zero difference between placebo and treatment. They do have one tinnitus program that completed Phase 1, so they are relatively early in the game here. There is a UK company called Autifony, a spinoff from GSK. They use systemic delivery and did a Phase 2 in tinnitus and another in hearing loss, which both failed.

Then, there is a French company called Sensorion, which has one drug for vertigo in Phase 2 and also works on systemic delivery. There is a private US company called Sound Pharmaceuticals, working more on the prevention of short-term hearing loss. And another company called Decibel Therapeutics, based in Boston, that is very early stage.

Novartis works with GenVec to regenerate hair cells in deaf cochlea, and there is a Phase 1 study going on. There is Roche, which has an early stage collaboration with a company at Stanford. There is one named Audion, in the Netherlands, that’s also relatively early stage. And another company in Basel, called Strekin, which is repurposing a diabetes drug.

However, there has been no drug approved yet. So, if AM-111 and AM-101 are successful, they clearly have the potential to become the first approved inner ear therapeutics.

How are you feeling being so close to the finish line?

Oh, well, it took a bit longer than I had initially assumed, but I think that’s classic. When we started, there were no best practices, no guidelines. We had to build it from scratch. Sometimes it was two steps ahead and one step back. Or even three steps backwards.

I compare it to long-distance running, which is one of the few hobbies I still have some time for. You know it’s going to take a long time, and you need stamina. There are times when your batteries are running low and you need another push. But, overall, it has been an extremely exciting time.

Images via Auris Medical; Krankheiten Portal; Medical Art Inc / Didesign021 / Darren Baker /Shutterstock

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Let’s Clean Up Our Oceans! New Technique Can Find Even the Tiniest Pieces of Plastic

Current research suggests that we only remove 1% of the plastic waste in our oceans. Thankfully, researchers in the UK have developed a technique to find the rest!

Researchers at the University of Warwick, UK, have developed a new and cheap method to find even the smallest bits of plastic that are floating around in oceans. The research published in Environmental Science & Technology outlines how the fluorescent dye specifically binds to plastic particles, making it possible to see them under a microscope and easily distinguishable from natural materials. The researchers found that tiny pieces of plastic are present at much higher levels than previously thought, which challenges current beliefs regarding the fate of plastic waste.

We produce almost 300 million tons of plastic each year, and more than 8 million tons of this is thought to end up in our oceans. Large pieces of plastic break down over time through weathering, producing tiny particles called ‘microplastics’. These microplastics often go undetected and can be very dangerous for the wildlife living there.

Seawater samples from Plymouth, on the South West coast of England, were taken and used to test the researchers’ dye. The plastic-binding dye could effectively quantify very small fragments of microplastics, less than 1mm, under a fluorescent microscope. The researchers found that these microplastics were present at higher levels than previously thought, as the new technique could detect significantly more than traditional methods.

Ocean microplastics of less than 1mm made visible with a fluorescent dye and microscopy.

They also discovered that the majority of microplastic was polypropylene, which is commonly used for food packaging. Carbios, a pioneer in the bioplasturgy field, is tackling this problem head-on by developing infinitely recyclable bioplastics. This overcomes issues with the current process of recycling plastic, which requires high temperatures and a lot of energy. In contrast, Carbios’ system uses enzymes to break down plastics into their original monomers, which can be re-used.

Carbios recently teamed up with cosmetics giant, L’Oréal, which has agreed to use the biotech’s technology for its new packaging. More and more firms are keen to make themselves ‘green’. Coca Cola and Danone are working with Dutch biotech Avantium to develop sustainable bottles and yoghurt pots, while Audi is collaborating with the French Global Bioenergies for the production of renewable gasoline. Even Lego is investigating the possibility of making its toy blocks out of bioplastics.

Big firms getting involved in renewable materials and energy sets a great example for smaller companies. With companies making an effort to reduce the amount of waste that ends up in our oceans – and throughout the rest of the environment – the challenge of finding a way to remove what’s already there remains within reach.

Our propensity to dump our waste in the sea could have a big impact on our lives, not just the wildlife living in our oceans. Image taken from the How Ocean Pollution Affects Humans infographic on www.plasticoceans.org.

Images – Lycia Walter / shutterstock.com; University of Warwick; Plastic Oceans

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The Future is (Syn)Bio: How and when do we get there?

Last week, Philip and I attended a meeting with some of the pioneers and leaders of the synthetic biology field. They believe biology will be everywhere in the future, but how do we get ready for it?

Digital technologies are now present in almost all aspects of our lives. It seems obvious today that companies need to go digital in order to survive, but just five years ago, it wasn’t. The same will happen soon with the rapidly growing field of synthetic biology, and companies need to start adapting now, as John Cumbers, founder of the synthetic biology hub Synbiobeta, writes in his book “What’s Your Bio Strategy?

Much like digitalization has reshaped all sorts of industries, with examples like Uber in the taxi industry or Instagram in the photography industry, biology is expected to overtake all sorts of fields. A lot of materials used in textiles, plastics or cosmetics are already manufactured, at least in part, using biological processes. Big names like Adidas have already jumped on the synbio train, partnering with the German company AMSilk to produce biodegradable silk sneakers using yeast.

The food industry could also change dramatically, for example with the advent of animal-free meat and milk. Mars, the famous manufacturer of snickers bars, just launched a project to design and produce an enzyme to help neutralize food toxins, using synthetic biology. And talking about information itself, DNA has the potential to store massive amounts of data, and biocomputers could overtake silicon-based computational algorithms.

Virtually anything could soon be manufactured using biology. But before we get there, there’s a few challenges that the synthetic biology field needs to solve first.

Synbio meeting last week at BlueYard’s office in Berlin (you can spot me in the front row taking notes!)

Biology is complex

Though we know the possibilities biology offers are theoretically infinite, the hard truth is that there’s still a lot that we don’t understand about it. “We’re still taking single gene circuits and trying to understand them in detail,” says Thomas Meany, co-founder and CEO of Cell-Free Technology, a company making open source biological tools.

But making all the necessary experiments to understand the intricate complexity of biological systems can be an arduous task, and a huge bottleneck. “We need automation and faster analytics to run hundreds of experiments at the time,” says Tim Fell, CEO of Synthace, a company developing a framework to automate experimental procedures across different equipment and tasks.

Most synbio companies come from academia, where everything is done manually,” explains Ali Afshar, co-founder of HackScience. His startup is seeking automate cell culture, which Afshar points out as the process in which most of the budget of a biology lab goes. “That’s not where the value is in synbio.

Making sense of data

Collecting and analyzing data is a big drawback in the development of new bioprocesses. One of the main challenges to speed up the whole process is the lack of a single, common framework to store and access all the data available.

Companies like 23andMe and big pharma like AstraZeneca or Novartis are sequencing the DNA of millions of people and accumulating data. This data is precious, but having it stored in silos makes no sense, you cannot learn from it,” says Maria Chatzou, CEO of Lifebit. Her startup provides open-source programming framework to make genomic data analysis.

Chatzou co-founded the company after realizing during her PhD in genomic data analysis, that 80% of the time was spent on computational tasks rather than actual research. She believes that sharing data will be the key to democratize synthetic biology and make it accessible to organizations of all sizes.

The use of artificial intelligence (AI) is gaining enormous traction at the moment in multiple applications, including medicine, and could also be of big help for synthetic biology when interpreting large amounts of data or making predictions for the design of new gene circuits or organisms. However, Chatzou reminds us that the quality of data and the processing it requires before actually being able to use AI is still the main bottleneck.

Scale up, price down

While researchers and engineers struggle with data and automation, an area where synbio has improved extremely fast is the development of faster and cheaper technology and hardware. In particular, DNA sequencing has experienced a huge reduction in terms of price and time, and will keep going down thanks to the technology being developed by companies like Oxford Nanopore or DNA electronics. Writing DNA could soon follow thanks to Twist Bioscience and DNA Script.

It’s easier for companies to enter the field of synbio now that tech is more affordable,” says Ali Afshar. “Hardware costs massively going down are making it possible for us to innovate in this field. That’s what leading the next wave of products.

Scaling up processes that are currently mostly done at the lab scale is certainly a challenge, but it’s what will make synbio a viable business. AMSilk, the company making Adidas’ biodegradable sneakers, is a great example for many to come. “The first kilogram cost about a million to produce,” says CEO Jens Klein. “We now sell our [recombinant silk] product at the ton scale to the cosmetic industry.

Andreas Jurgeit, Investment Director of the Life Science team of Merck Ventures, is optimistic that the field will get there in time. “It took 40-50 years for the transistor to scale. It will take another 20-30 years for synthetic biology to do the same.” He remarks that the companies that will make it possible are being founded today, and that it’s absolutely the right time to invest in the field.

Images via Arkela /Shutterstock; BlueYard; Synbiobeta; Perception7 /Shutterstock

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Roche’s Potential Hemophilia Blockbuster and Lung Cancer Drug Succeed in the Clinic

Roche has enjoyed a dream start to the week with both its immuno-oncology candidate, Tecentriq, and its hemophilia A drug, Hemlibra, succeeding in the clinic.

Roche’s week started with a bang as two of its drug candidates achieved positive results in Phase III trials. Tecentriq and Hemlibra are being tested for the treatment of advanced lung cancer and hemophilia A, respectively.  The back-to-back successes gave Roche’s stock price a 6% boost, giving it a market cap of CHF 210B (€180B), with investors jumping on the chance to climb on board now that the company appears to be on a roll.

Tecentriq has been used in combination with Avastin, a monoclonal antibody that interferes with cancer growth and spread, and chemotherapy. Full results will be released next month, but the preliminary data suggest that the triple therapy significantly improved progression-free survival and risk of death as a first-line treatment in a group of lung cancer patients.

Hemlibra, a bispecific antibody that binds both factor IXa and factor X, two factors that are vital for natural coagulation, could be a blockbuster in the hemophilia field. On Friday, the candidate received accelerated approval from the FDA based on earlier clinical data, but it has now demonstrated superior prophylaxis in comparison with factor VIII, without the thrombotic events that had been problematic in previous studies.

Spirits will be high at Roche HQ, situated in Basel, Switzerland.

Roche’s news has not made such happy reading for its competitors. Shire recently received orphan drug designation for its hemophilia A gene therapy, but today saw its stock price fall by almost 4%. Roche has also succeeded where AstraZeneca failed, whose combination of combination of durvalumab and the CTLA 4 immunotherapy tremelimumab missed its progression-free survival target.

Roche will now hope to be in pole position to bring its highly performing candidates to the market, in the hemophilia and non-small cell lung cancer fields, which are thought to be worth $25B (€21B) by 2024 and $12B (€10B) by 2025, respectively.

Images – kongkanglp / shutterstock.com; Oliver Foerstner / shutterstock.com

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Bacterial Art Starts a Debate on Money and International Borders

We have been told over and over that bacteria are everywhere around us, especially on your smartphone screen. But most of us haven’t stopped to reflect on the fact — and consequences — of bacteria being all over our money.

A scientific study by the New York University called the Dirty Money Project revealed in 2014 the presence of 3,000 different types of bacteria living on 80 $1 banknotes circulating in New York. These bacteria came from human skin, mouths and genitalia, and, like money, they could be freely transported and exchanged across the world.

Artist Ken Rinaldo explores the many consequences of bacteria living on money in his project Borderless Bacteria; Colonialist Cash. Rinaldo cultured microbes on agar plates containing banknotes from currencies around the world that were collected at the international border at the Lisbon Airport. After letting them grow for two weeks, the pieces are exhibited to spark the debate on bacteria, money and borders.

Bacterial cultures, fungi, and viruses finding transport on monetary exchange systems do not respect or understand borders,” states Rinaldo. “There are no visas or passports for microbes that hitch rides from hands, noses, and genitalia.

The artist compares how bacteria use money as vectors to colonize new places to how Europeans colonized America, wiping 95% of native populations by bringing with them the germs that cause diseases like smallpox, measles or influenza. He calls microbes “the original colonizers,” since according to the evolutionary theory of Lynn Margulis, the eukaryotic cells that form our bodies evolved long ago from prokaryotes.

Jumping back to 2017, Rinaldo wonders how our economy and politics will influence the distribution of bacteria around the world. Do Chinese yuens and US dollars share the same bacteria given the extensive trade between both countries? Will bills from Palestine have less microbes because of the Israeli blockade? Do different microorganisms live on money from rich and poor countries? Could then microbes become a sign of wealth and status?

Given the fact that money could one day be a vector for the rapid distribution of dangerous microbes resistant to antimicrobials, the answer to these questions could actually help us understand and fight the spread of deadly diseases, especially as antibiotic resistance becomes an increasingly pressing issue.

Works from Borderless Bacteria; Colonialist Cash New Art Festival are currently on show at the in Lisbon until November 30th and will be at FACTT in Berlin from November 29th.

Borderless Bacteria; Colonialist Cash at BioArts Lab School for the Visual Arts, New York

Images via Ken Rinaldo’s website

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German Cancer Sensor Raises the Alarm and Puts the Fire Out

No need to call the fire brigade! The University of Dresden’s cancer sensor spots a mutation to p53, the most important cancer gene, and kills the cell.

Researchers at the University of Dresden, Germany, have developed a molecular sensor that detects a mutation in tumor protein p53 – implicated in 50% of cancers – and kills the cell. The research, published in Nature Communications, found that the sensor can detect mutations in p53 and kill the cell before it undergoes the cancer transformation process. Although the technology is at a very early stage, it could offer additional levels of protection against the development of cancer-causing mutations.

Cancer remains one of the biggest causes of mortality, with 8.8 million deaths recorded in 2015. Cancers evolve through natural selection, as mutations accumulate in oncogenes and tumor-suppressor genes over time.  Strikingly, British researchers have recently shown that it can take as few as 10 mutations to cause cancer. For this reason, having a system in place to spot potential damaging mutations and prevent their spread to daughter cells could be a great way to get ahead of cancer.

The molecular “smoke detector” monitors p53, making sure that the gene is functioning as it should – binding DNA to stimulate the expression of p21, which controls cell division. The group designed a genetic element that makes the cell reliant on normal p53 function, which, if interrupted, initiates cell death. The researchers believe that this should suppress tumor formation at a very early stage.

The responses to cellular stress used by p53 to prevent uncontrolled cell division and cancer.

With the technology firmly in the preclinical stages, a lot of work remains to be done. However, Frank Buchholz, Project Leader at University Hospital Carl Gustav Carus, is hopeful the technology could have a big impact: “The p53 sensor enables an active precocious intervention for the first time. Our results show that cells with p53 mutations can be selectively detected and eliminated at an early stage. Hence, the transformation process is prevented.

p53 has been known about for a while now, with researchers and biotechs around the world devising plans to bring it back under control. Aprea Therapeutics is developing a drug to restore normal p53 function, which is being tested in a Phase II trial, while Orca Therapeutics has developed p53-expressing oncolytic viruses that rapidly eradicate tumors. Elsewhere, AstraZeneca and the Babraham Institute have improved our understanding of another cancer-causing gene, PTEN, which is highly implicated in breast and prostate cancers.

Looking forward, it will be interesting to see how clinicians decide who receives the p53 sensor if it can be developed for the market and whether the technology can be adapted for other genes like PTEN.

Images – Kateryna Kon / shutterstock.com; Meletios Verras / shutterstock.com

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This British Biotech Could Treat T-Cell Lymphoma without Leaving the Body Unprotected

Autolus has revealed a new strategy to treat T-cell lymphoma without harming healthy, protective T cells. The therapy is expected to start human tests soon.

T-cell lymphoma is a form of cancer that affects the cells responsible for protecting our body against infections. Unlike it’s done with cancer types that affect other blood cells, it’s not possible to just wipe all T-cells, which would leave the patient at the mercy of viruses and bacteria.

Autolus, a young biotech spun from University College London (UCL), wants to end this situation with a therapy that selectively removes cancerous T-cells while leaving enough healthy T-cells required for protection. In a study published today in Nature, researchers from Autolus and UCL detail their strategy and prove it works in mice.

The basis of Autolus approach is based on two subtypes of receptors that T-cells naturally produce, called TRBC1 and TRBC2. While healthy T-cells randomly express one of either, those affected by lymphoma always express only one of either in each patient. In the study, the researchers created CAR-T cells engineered to recognize and kill T-cells expressing TRBC1 in mice, which killed tumoral cells while sparing the portion of healthy T cells that expressed TRBC2.

This strategy is the basis of AUTO4, a CAR-T cell therapy being developed by Autolus. The company, which recently closed a big €68M Series C fundraising to boost its technology, expects the treatment to enter a first clinical trial in humans in the coming months. AUTO4 will be the fourth cancer therapy from Autolus to enter the clinic, and the first for T-cell lymphoma.

CAR-T cell therapies have been hailed as a “miracle cure” for cancer. However, the first ones, which were approved just this year, are directed at blood cancers affecting B-cells instead of T-cells. If successful, Autolus could bring the first effective therapy for T-cell lymphoma, for which current treatment options are not good enough. So much so that the US National Comprehensive Cancer Network (NCCN) recommends clinical trials as the preferred option after a first treatment for patients diagnosed with this form cancer.

Images via Christoph Burgstedt /Shutterstock; Autolus

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Update: French Red Blood Cell Biotech Aims Higher for $125M Nasdaq IPO

Update: Erytech has upgraded its projected IPO to $125M by offering more shares than originally planned.

Originally published 09/10/2017

Erytech has filed for an IPO on the Nasdaq Global Market and a private placement on Euronext Paris while preparing for its first product approval.  

Erytech, based in Lyon, is developing a unique technology based on encapsulating drugs in red blood cells. The company has now announced the launch of a global offering to raise funds through an initial public offering of up to $100M (€85M) on the Nasdaq Global Market under the ticker “ERYP” and a private placement of shares, of an undisclosed amount, on Euronext Paris.

Both offerings seem to be timed with upcoming meetings with the FDA and the EMA’s CHMP to discuss the design of a Phase III study for its lead candidate, eryaspase, in pancreatic cancer. In addition, Erytech is preparing to resubmit for the European approval of eryaspase to treat relapsed or refractory acute lymphoblastic leukemia (ALL) after the first was withdrawn when the EMA requested additional data.

Erytech’s GRASPA, the commercial name for eryaspase in Europe and Israel, consists of the enzyme L-asparaginase encapsulated within donor-derived red blood cells. The enzyme depletes the amino acid asparagine from the bloodstream to starve the tumor cells that, unlike healthy cells, cannot produce their own asparagine. The treatment is under development to treat ALL, pancreatic cancer, acute myeloid leukemia (AML) and solid tumors.

Image via zhaoliang70 /Shutterstock

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More News! Novartis is going for EMA Approval for CAR-T Therapy

Try as we might, we can’t cover all the biotech news out there! Here’s a roundup of news that didn’t make the cut this week.

  • Allergan has returned development rights to Heptares for its muscarinic M1 agonist designed to treat Lewy body-based dementia.
  • In a secret deal, Oxford BioDynamics has a new “major US pharma” partner.
  • French spinout Dynacure licensed a drug for centronuclear myopathy from Ionis.

  • Novartis is looking for EMA approval of Kymriah, its recently FDA-approved CAR-T therapy.
  • Nordic Nanovector amended its protocol to continue with its Phase II trial for its mAb Betalutin in the UK.
  • ReNeuron also received approval to move its retinal disease candidate forward into Phase II.
  • Adaptimmune reported early-stage positive results for its SPEAR T-Cell therapy.

Images from Marco Diaz Segura, FACTORYPIC, Tilo G



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Interviewing Europe’s Most Intense Investor about Trends in Biotech

I interviewed Kate Bingham of SV Health Investors about Alzheimer’s, checkpoint inhibitors, gender diversity and more at BIO Europe.

BIO Europe 2017 was off to a racing start on Monday morning when I chatted with Kate Bingham, Managing Partner of SV Health Investors, formerly SV Life Sciences. Since she joined the firm in 1991, she has become a household name in biotech and usually moderates the opening panel of the conference. Before the session, she was kind enough to make time for my questions.

We started with a general one on her biggest lessons so far, but she turned it around: “What are the things have we not put in place that have caused things to fail?” she countered. “If it’s not really disruptive science, if it’s a me-too drug, or if it’s not radically interesting to make a significant impact on patients, then partners will not be as interested.”

Since drugs to be combined with checkpoint inhibitors seem to be all the rage nowadays, I asked Bingham if such drugs would cut it for SV’s investment strategy. She didn’t rule it out, telling me that checkpoint inhibitors do need a boost to be most effective and describing a very broad space for improvement.

“If you think about why cancers don’t respond to therapy, one is that they’ve got a repressive tumor microenvironment — a checkpoint inhibitor is good to decloak it,” she said. “The second thing you need is some form of antigen that tells the immune system that [a cancer] is foreign and has to be removed, and then you need a third thing to really elicit a strong immune response.”

Bingham has some doubts that personalized medicine will make up for the efficacy deficit in checkpoint inhibitor strategies. “If you have to develop drugs for individuals, that’s going to be a huge cost for health systems, and I don’t’ think it’s a broad durable system,” she remarked, but she clarified that “What I’m rejecting is that every person is going to have a personalized vaccine based on their tumor makeups. I know there’s plenty of evidence that people are doing that now, but I think in the long term, that’s nondurable.”

Speaking of sustainable economics, Bingham also shared her thoughts on the current pricing debate, describing the two extremes of the UK, where “only very exceptional drugs with very strong health economics arguments are reimbursed” and the US, “where there is much less pricing pressure.” Bingham sees the best position as between the two and that there is much more work to be done.

She also remarked that she would ask companies to consider how they would develop drugs that are financially accessible. “The onus is on us to start building some of that cost-benefit argument early into the trials we do so that we ultimately end up with pricing that is acceptable,” she said.

On the subject of money, Bingham was careful to note that when it comes to the challenge of finding the right people for a biotech company, “people” includes investors: “We can have some really fun and exciting science but if you don’t have good people to execute, that can be a real problem — and I would include investors in people.” 

At ON Helix, I heard about the rise of charity investors, so I seized the opportunity to ask about the concern that charities and VCs have misaligned interests. “I think [charity investment] is entirely consistent,” she responded. “They’re completely motivated to invest and make returns to be able to continue to invest, so I don’t think that’s a conflict at all.”

We then shifted gears to discuss the Dementia Discovery Fund that she launched in 2015. For a sense of why Bingham went for it, I asked her about her sense of the space, especially as one of the most commons forms is Alzheimer’s Disease. “My fundamental view on dementia is that unusually we’ve had an incredibly narrow-minded view of the disease,” she said. “If you look at the dollars that have been invested both in academia and pharmaceutical R&D, it has been largely focused around the amyloid-beta cascade.”

“There have been multiple failures for interventions at all parts of that cascade,” she continued. “It’s not that we reject that association between amyloid beta and Alzheimer’s, but we reject that this is the only biological hypothesis that people are using. In the dementia Discovery Fund that we’ve launched, we are explicitly looking for biological interventions outside amyloid beta.”

She remarked that the field could go the way of oncology: fifteen years ago, a tumor was classified according to the organ in which it occurs, but now we talk about drivers of the disease. “We’ve seen what oncology has done by unpicking the different biological mechanisms that drive the cancer with genetics tools that actually allow you to target cell types and tumor types. I think we’ve got exactly this opportunity in dementia.” 

For this reason, the Fund’s explicit goal is to “open up whole new areas of biology in ways that haven’t been looked at before,” and Bingham described her interests in microglial biology, mitochondrial dynamics, synaptic health and signaling, and DNA damage response. “It’s a wide-open space and really exciting,” she said.

Finally, I asked her about the state of gender affairs in biotech since she and another woman penned an infamous letter in response to the hiring of models at JP Morgan in 2016. Bingham is optimistic: “They certainly haven’t gotten worse; in fact, I think they’ve generally gotten better. Here in Europe, I think we’re generally better on gender balance than in the US.”

But there’s still more work to be done, and she doesn’t think quotas will help. “We’re in such a high-risk area that if I have to recruit someone for diversity rather than because they’re the best possible person, I won’t do that,” she told me. “But, should we enrich recruitment processes to make sure that we have the broadest range of candidates from which to choose? I think we should be doing that.”

Importantly, since the two companies were called out, “one of them, Life Science Advisors, has become a very serious advocate and are pioneers now in gender diversity,” said Bingham. The firm has created a nonprofit, for which Bingham is a board member, to help well-qualified senior women join the boards of companies; so far, they’ve completed twelve placements.

“I think that’s a very clever way of increasing diversity,” she commented. Bingham views board membership as a stepping stone to more experience that will hopefully see women to the position of CEO. “I’m really amazed by how much progress has been made and really pleased by the broad attention it has got from industry,” she concluded. 

Images from the author



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