After weathering failure, rejection and layoffs, ImmunoGen touts a new ‘breakthrough’ drug in its comeback plan – Endpoints News

While the comeback plan for its lead drug is still up in the air, ImmunoGen says it has a second shot at an antibody-drug conjugate breakthrough.

The FDA has granted breakthrough therapy designation to IMGN632, which targets CD123, in relapsed or refractory blastic plasmacytoid dendritic cell neoplasm. The aggressive cancer primarily affects the skin, bone marrow and lymph nodes.

Having presented initial data on the first-in-human study at ASH 2019, the biotech said it will report updates from the dose expansion cohort in December.

We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies, CEO Mark Enyedy said in a statement.

IMGN632 was one of three programs that Jazz Pharma paid $175 million in cash to collaborate on, in an R&D pact stretching out to 2024.

A longtime player in the ADC game, ImmunoGens tech platform had a significant role in developing Roches Kadcyla. But its had less luck with its own programs, getting slapped down by the FDA after the lead drug, mirvetuximab soravtansine, failed a Phase III study for ovarian cancer.

Having initially sought accelerated approval based on a secondary endpoint, the company is now counting on a new, single-arm trial to support the OK. The SORAYA study zeroes in on women with folate receptor alpha (FR)-high platinum-resistant ovarian cancer who have been previously treated with Avastin.

Amid the twists and turns Enyedy who slashed the headcount by a few months after he took the job in 2016 reached again for the axe to conserve cash. In addition to laying off 220 staffers, he also shelved IMGN779, the program for adults with relapsed/refractory CD33-positive AML, and subleased the extra empty space.

ImmunoGen reported $219.5 million in cash and cash equivalents as of June 30, 2020, compared with $176.2 million at the end of 2019.

The big idea around ADCs is that by attaching a cancer-killing toxin to a specific antibody, drugmakers can direct the payloads precisely to where they want them. While ImmunoGen boasts of expertise in all aspects targets, antibodies, payloads and linkers the key component of IMGN632 is the in-house novel indolino-benzodiazepine payloads, which they promise to be more potent than traditional chemotherapy to cancer cells but less toxic to normal marrow progenitors.

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After weathering failure, rejection and layoffs, ImmunoGen touts a new 'breakthrough' drug in its comeback plan - Endpoints News

Remember how urgent it was to support embryonic stem cell research? That was then; this is now – BioEdge

Remember how urgent it was to support embryonic stem cell research? That was then; this is now

The hot button bioethical issue of 2004 was embryonic stem cell research. Supporters spoke of life-saving cures and dismissed ethical misgivings. Surfing a wave of hope, Californian voters voted for a US$3 billion bond issue to establish the California Institute for Regenerative Medicine.

Sixteen years later, the CIRM has almost run out of money and its backers are rattling the tin in the hope that voters will approve a $5.5 billion bond issue to support its research.

Some of the states major newspapers have editorialised against it. With many of its critics, they contend that the CIRM has not delivered on its miracle cures, that its governance has been poor and that there was too much potential for conflict of interest.

The Los Angeles Times decried the earlier over-sell:

[The CIRM] hasnt yet yielded a significant financial return on investment for the state or the cures that were ballyhooed at the time. Though no one ever promised quick medical miracles, campaign ads strongly implied they were around the corner if only the funding came through. Proponents oversold the initiatives and voters cant be blamed if they view this new proposal with skepticism.

The San Francisco Chronicle, which exposed some of the CIRMs deficiencies in a 2018 expos, criticised the way its funds had been spent:

More than half the original funding went to buildings and other infrastructure, education and training, and the sort of basic research that, while scientifically valuable, is a long way from medical application. Theres nothing inherently wrong with that, but it is at odds with the vision of dramatic advancements put to voters."

Michael Cook is editor of BioEdge

Originally posted here:
Remember how urgent it was to support embryonic stem cell research? That was then; this is now - BioEdge

Hematopoietic Stem Cell Transplantation (HSCT) Market to eyewitness massive growth by 2026 | Escape Therapeutics Inc., Cryo-Save AG, Regen Biopharma…

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North America(the United States, Canada, and Mexico) Europe(Germany, France, UK, Russia, and Italy) Asia-Pacific(China, Japan, Korea, India, and Southeast Asia) South America(Brazil, Argentina, Colombia, etc.) The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

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At last, the study gives out details about the major challenges that are going to impact market growth. They also report provides comprehensive details about the business opportunities to key stakeholders to grow their business and raise revenues in the precise verticals. The report will aid the companys existing or intend to join in this market to analyze the various aspects of this domain before investing or expanding their business in the Hematopoietic Stem Cell Transplantation (HSCT) markets.

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Hematopoietic Stem Cell Transplantation (HSCT) Market to eyewitness massive growth by 2026 | Escape Therapeutics Inc., Cryo-Save AG, Regen Biopharma...

Stem Cell Therapy Market to Show Incredible Growth by 2025 – The Daily Chronicle

The current report on Stem Cell Therapy Market covers a comprehensive analysis demonstrating actionable insights for clients. In addition, the report offers business insights that encourage them to take suitable decisions which are likely to leverage their business processes. Moreover, the report is a detailed study exhibiting current market trends with an overview of future market study.

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Some of the players in the Stem Cell Therapy market include:

Cytori Therapeutics Inc. (U.S.), Fibrocell Science (U.S.), Cellartis AB (Cellectis) (France), BioTime, Inc. (U.S.), GE Healthcare (U.S.), Thermo Fisher Scientific (U.S.), STEMCELL Technologies Inc. (Canada), Fujifilm Holdings Corporation (Japan), Vericel Corporation (Aastrom Bioscience) (U.S.), Brainstorm cell therapeutics (U.S.), and Osiris Therapeutics, Inc. (U.S.) to name a few.

PrecisionBusinessInsights has recently launched a latest report on Stem Cell Therapy Market for its clients. This report offers the clients with factual data validated by industry experts and business heads. The report highly involves chapter wise explanation for every aspect of the market wherein the drivers, trends, opportunities, leading and trending segments are discussed in detail with specific examples. Profiles of leading players are also discussed along with their business expansion strategies.

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Geographical markets are covered separately within the report that includes a competitive analysis on their market performance in the base year as well as predictions for the forecast year. Extensive primary research is conducted to carry out leading information in order to understand the market condition and competition within a specified geography. Comparison between two or multiple geographical markets is carried out effectively to know where to invest in.

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What is the Impact of Covid-19 Outbreak on the Stem Cell Therapy?

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Stem Cell Therapy Market to Show Incredible Growth by 2025 - The Daily Chronicle

Global Animal Stem Cell Therapy Market Professional Survey 2020 by Manufacturers, Regions, Types and Applications, Forecast to 2024 – The Daily…

In its newly published report, Global Marketers has provided unique insights about the Animal Stem Cell Therapy Market for the given period. One of the major objectives of this report is to categorize the various dynamics of the market and to offer the newest updates such as mergers and acquisitions, various technological developments, new entrants in the market, which make an impact on different segments of the Animal Stem Cell Therapy market. The report also takes into account the impact of the COVID-19 pandemic on the Animal Stem Cell Therapy market and offers a clear evaluation of the future market demand during the forecast period.

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The following manufacturers are covered:

Medivet Biologics LLC VETSTEM BIOPHARMA J-ARM U.S. Stem Cell, Inc VetCell Therapeutics Celavet Inc. Magellan Stem Cells Kintaro Cells Power Animal Stem Care Animal Cell Therapies Cell Therapy Sciences Animacel

This is likely to drive the Global Animal Stem Cell Therapy Market over the forecast period. This research report covers the market landscape and its advancement prediction in the near future. After studying key vendors, the report focuses on the new entrant contributing to the enlargement of the market. Most companies in the Global Animal Stem Cell Therapy Market have currently adopted new technological trends in the market.

Segmentation by Region Of Animal Stem Cell Therapy Are:

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Animal Stem Cell Therapy Market Segment by Type, covers:

Dogs Horses Others

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Veterinary Hospitals Research Organizations

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This Animal Stem Cell Therapy market breakdown also offers the scope of different segments and applications that can in fact impact the market in the future. Thorough information is based on current trends and significant milestones. The Animal Stem Cell Therapy market analysis mentions the volume of sales by region from 2020 to 2024. A thorough evaluation of the limitations included in the market analysis portrays the drivers and gives scope for strategic planning.

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Some Points from Table of Content

Global Animal Stem Cell Therapy Market Report 2020 by Key Players, Types, Applications, Countries, Market Size, Forecast to 2024

Chapter 1Report Overview

Chapter 2Global Market Growth Trends

Chapter 3Value Chain of Animal Stem Cell Therapy Market

Chapter 4Players Profiles

Chapter 5Global Animal Stem Cell Therapy Market Analysis by Regions

Chapter 6North America Animal Stem Cell Therapy Market Analysis by Countries

Chapter 7Europe Animal Stem Cell Therapy Market Analysis by Countries

Chapter 8Asia-Pacific Animal Stem Cell Therapy Market Analysis by Countries

Chapter 9Middle East and Africa Animal Stem Cell Therapy Market Analysis by Countries

Chapter 10South America Animal Stem Cell Therapy Market Analysis by Countries

Chapter 11Global Animal Stem Cell Therapy Market Segment by Types

Chapter 12Global Animal Stem Cell Therapy Market Segment by Applications

Chapter 13Animal Stem Cell Therapy Market Forecast by Regions (2020-2024)

Chapter 14Appendix

Access full Report Description, TOC, Table of Figure, Chart, etc.at:

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Global Animal Stem Cell Therapy Market Professional Survey 2020 by Manufacturers, Regions, Types and Applications, Forecast to 2024 - The Daily...

Coffee enemas and stem cell injections: The life of a biohacker – Wales Online

He has spent $15,000 having stem cells injected into his body and considers weekly coffee enemas the norm.

Sensory deprivation tanks, constant testing, and clothing designed to block electromagnetic fields are also routine for Welshman Kris Gethin a man who says he has a 'biological age' of 25 despite being 46 years old.

While it might not be common practice for many for the world-famous fitness guru these are just some of the many elements biohackers like him have to consider to understand and optimiae the body in a way that has never been done before.

Its a long way away from the boy who grew up in the Powys countryside of Llandrindod Wells.

Once considered a practice exclusively for the multimillionaires and big-thinkers of Silicon Valley, biohacking has made the headlines in recent years by individuals taking it to the extreme. Alongside talk of gene editing, terms such as transhumanists those who put implants such as chips into their body are banded about, including one man who now has a built-in compass in his chest which will vibrate every time he faces north.

But although it may sound like stuff of the future its a way of life that is gaining increasing momentum during a time where our health is more precious than ever before.

Put simply biohacking, otherwise known as health optimisation, can be described as those who use technology, drugs, and other substances to improve the quality of our body and mind. Also known as do it yourself biology, its a practice which is not limited to those working within the scientific field.

Every year a Health Optimisation Summit is held with last year's attracting 1,100 people from around the world eager to share their experiences and knowledge.

Kris own journey into the industry, however, came from just wanting to understand why he was feeling so under the weather and why there were no answers for it.

As personal trainer to the rich and famous, as well as a natural bodybuilder and someone with their own health club franchise and health nutrition supplement company, being unwell was simply not part of the plan.

Kris, who now lives in Idaho in the United States, said: I was living in India for a little while I was training Bollywood actors and I've got a gym franchise over there. And in the place that I stayed in there was obviously mould that you can't see and I got mould toxicity. I couldn't sleep I'd sleep on average about three hours a night and you can imagine what that does to you.

I wasn't the best person to be around and I expended all possibilities of what it could be. I tried all types of supplements and medication and everything and nothing helped until I was pointed in a direction of this doctor in Florida at his clinic.

Once I went there I had like 62 blood tests and brain scans. Every type of sample my body could produce was sampled and it was they who diagnosed me with mould toxicity.

That's when I realised, okay, I thought I was healthy but I was in fact not. I started quantifying everything like my blood sugar levels, my heart rate variability, my sleep, absolutely everything, and that's when I kind of started going down the rabbit hole of biohacking my health because nobody else could.

As someone who has grown up in a family of farmers, food in particular is a part of biohacking that Kris knows volumes about. On the subject of mould toxicity he explains mould levels are particularly high in coffee and that the US will tolerate levels of mould found in grains that the UK will not, all down to the vats in which they are stored.

More widely the nutrients we get from food are ever-changing, all down to the over-harvesting of our soil.

Kris said: With the vast majority of my clients even though they eat healthy, they will have a deficiency because the soil is very different to what it was 30 years ago with GMO, with glyphastate [herbicide], and Roundup. Then theres over-harvestation because of population increase we don't have the nutrients that we once did.

Our grandparents would eat an orange and they'd have six to seven times the amount of vitamin C than what we actually get from an orange from Aldi or something.

As well as help from supplements, tackling such deficiencies are exactly where biohacking really comes into play.

On top of the foundations of being hydrated and having the right levels of sunlight, nutrition, and movement, Kris describes it as the icing on the cake or the shiny bits that only make a difference if you have the basic principles right.

Even a quick conversation with Kris shows the seemingly endless list of hacks that can be adopted on a day-to-day scale.

First, for example, there are the infrared panels in Kris house to provide him with restorative red light. While the bulbs upstairs may make his house look like a brothel, he admits, red light therapy is known to repair tissue and wounds as well as give the cells energy.

Downstairs, however, its all about incandescent yellow bulbs able to block harmful blue light something Kris says can spike our cortisol hormone better known for creating our fight or flight reaction.

Next up are the measures taken to reduce the EMFs, or electromagnetic fields, caused by everything from satellites to wifi routers. Their presence around us in the world is something the World Health Organisation continues to explore after launching the The International EMF Project in 1996.

While the WHO has concluded that evidence does not confirm the existence of any health consequences from exposure to low-level electromagnetic fields it acknowledges that some individuals may be more sensitive to it than others causing headaches, nausea, anxiety, and depression.

To eliminate any potential risk Kris has everything from EMF-blocking clothing and underwear to a blanket designed for when he is flying as well as special metal stickers that will earth his shoes to the ground as soon as he lands if standing barefoot somewhere isnt an option. Being barefoot and the principle of grounding connecting with the electric connection and negatively-charged electrons in the earth is also a key principle of biohacking and credited by those who do it to reduce the level of our induced voltage.

For Kris such measures are particularly important given the effects he believes he experiences as a result of EMF.

He said: I went to a music festival [in Las Vegas] a couple of years ago and I felt terrible for days after. And this was in Vegas in a Speedway and nobody's phones would work there because there was so many people in the tight space.

And then when you finish up the festival you go to Vegas where theres a lot more EMF, lights, and electricity. And I didn't drink, I didn't do drugs or anything like that, but I felt terrible. And I thought, well, maybe it's something to do with that (the EMF). And I noticed when I'd stay in hotels I wouldn't sleep well, especially cities.

"I had Brian Hoyer in my house probably about four months ago and he's one of the world's leading building biologists. So he has thousands of dollars' worth of metres to tell you how high your EMF readings are in your house. He measured and our bedroom of all places had the highest level.

He put me in what's called a Faraday cage it was like a little tent on the mattress which blocked all the EMF. I slept in there and I wear an oura ring which tracks my REM, my deep sleep, and I had the best night's sleep ever.

If Faraday cages may sound extreme its nothing compared to the lengths that Kris has gone to in the past to repair his body from the wear and tear of being an athlete.

There is the sensory deprivation tank he uses regularly a facility where you float on 1200lb of magnesium salt in complete darkness and silence to reconnect and then theres no forgetting the coffee enema that happens every Monday morning.

Depending on your point of view, however, its the stem cell treatment Kris received in Colombia that probably raises the most eyebrows.

I'm 46 years old and, even though I have great internal age, I train hard. I train like a bodybuilder. I also do kettlebell work and I also do a lot of running.

I know that my body goes to wear and tear because of it and I don't want to be 80, 90, 100 years old and in a wheelchair or having to deal with hip replacements or anything like that. So I studied a lot on stem cells.

I've broken a lot of bones from motocross, from surfing, from snowboarding and I want to make sure that I'm able to still feel good as I get older. So I went and had stem cells basically the stem cells from an umbilical cord from a baby.

"I had them injected into my elbows, into my knees, into my shoulders. Ive had shoulder surgery, Ive had a lot of injuries. I also had IV stem cells as well and it was the best money I ever invested.

It takes about six months for it to fully kick in for its efficacy. But after that six months any inflammation that you had, any kind of sore joints that you don't really realise because you get used to it... I feel like a teenager again, I'm alleviated of these issues.

Kris' story of biohacking himself healthy isn't as unique as it may sound. Tim Gray is the founder of the Health Optimisation Summit and one of the UK's leading biohackers.

Describing his experience he said: "I ran digital marketing agencies beforehand and was always at 200 miles an hour running companies, and whatnot, and I got ill.

"The first thing was meditation. My mind was so busy, crazy busy, all the time and I think that in hindsight looking back it's because my body wasn't being used very much except to walk to the office but my brain was being used pretty much around the clock.

"My body became chronically ill because I didn't exercise it enough, that I didn't give it the right building blocks or have the right nutrition. And I was just too busy-minded so calming the mind was step one."

According to Tim shows like Netflix's Biohackers series are more likely to be picked up in the media due to their focus on extremes like gene editing and futurism.

For him, though, it's a combination of whatever works for his health and things that can be quantified and explained.

He said: "When I re-labelled biohacking to health optimisation about 18 months ago in the UK we tripled in size pretty much within 16 weeks.

"It makes it much more accessible to people like my mom or, you know, family members that want to optimise their health whereas no one really wants to get into biohacking except for people that are into future advancements and at the forefront of testing things on themselves."

As well as the equipment at hand there is also the host of biohacking assessments that are constantly at play. Every six months Kris will have blood tests taken as well as heavy metal tests, the results of which will improve once he is able to fly to Germany to have his metal fillings removed.

Of all his test results he is proudest of his GlycanAge test putting his biological age at 25.

He said: There are testing parameters you can utilise to see what your biological age is. I have just had my most recent GycanAge test, which shows that Im at 25 even though my age is 46.

With GlycanAge theyve tested thousands of people but they've never had somebody come back with such a young age from an athletic background.

Away from the high-end technology and endless measuring, Kris is quick to acknowledge the scepticism surrounding the still relatively new and unknown world of health optimisation. While it undoubtedly has improved his health in some ways he says he has biohacked his way out of asthma since moving to the States the bodybuilder also understands it is not something for everyone.

There are also the more accessible principles of biohacking which go back to simpler times such as meditation, cold showers, exercising in a group, and enjoying meals without the distraction of a smartphone things Kris believes can improve anyones life regardless of their means and what they believe.

Everybody's different and we have to treat people as such. Everybody has a different counter, a different personality. We talk to people differently.

Some people respond to yelling in a team environment, other people you're going to have to be a little bit more sympathetic with, and I think it's very similar. When it comes to biohacking as well there are going to be a lot of people that are suspicious of it, they're going to be critical of it. But you have to appreciate what we're all different. We can't be so bold and brash to say it does or doesn't work."

Just like his bodybuilding career from his life back in Wales Kris admits biohacking is also an obsession of his. But for those who might consider his constant measurements and assessments a step in the wrong direction when it comes to avoiding stress Kris also has an answer to that.

He said: This is an obsession for me as well. I absolutely love it.

People say you should live a little. But those are the people that just see me online. I go camping all the time, I go snowboarding, I go wakeboarding, I go on holiday. I get away on the weekends.

I dont check my phone for an hour when I wake up and I don't have it on for an hour before bed and I enjoy my life so everybody is going to have to take it as a pinch of salt.

And, look, if it becomes controlling where youre going Oh my God, I'm stressing I cant get to sleep because I'm trying to quantify it then yeah, back off, maybe put your tracking device away for a couple of weeks and get back to what's important. Like I said thats being present and enjoying life exactly as we have it right now because who knows what's going to happen tomorrow?

You can find out more about Kris, and his books and podcasts, here.

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Coffee enemas and stem cell injections: The life of a biohacker - Wales Online

EMA starts rapid review of Bluebird’s gene therapy for rare disease CALD – – pharmaphorum

Bluebird bio could be just a few months away from approval of its gene therapy for rare disease cerebral adrenoleukodystrophy (CALD) in the EU, after the EMA started an accelerated review.

If approved, Lenti-D (elivaldogene autotemcel or eli-cel) could transform the prospects of people with CALD, the most severe form of the neurodegenerative disease ALD that usually emerges in boys during early childhood and causes physical and mental disabilities as well as behavioural problems.

Around 40% of patients develop the cerebral form of ALD, which in turn affects around one in 17,000 live births.

A few weeks ago, Bluebird reported new data from the phase 2/3 STARBEAM trial of Lenti-D which showed that 87% of CALD patients were still alive and free of major functional disabilities after at least two years follow-up.

The EU filing comes ahead of a filing for eli-cel in the US, which Bluebird says should take place sometime towards the middle of next year, having been delayed by the coronavirus pandemic.

If approved, eli-cel would provide a one-shot treatment for CALD, holding back the progressive breakdown in the protective myelin that sheathes neurons.

It would be the first alternative to a stem cell transplant to treat the disease, a therapy that can provide significant improvements and even halt progression in some patients if given early enough.

However it requires high-dose chemotherapy to destroy the bone marrow, and that poses significant risks to patients in its own right, and can also lead to graft-versus-host disease, a potentially life-threatening complication in which the bone marrow donors immune cells attack the recipients cells and tissues.

CALD is caused by mutations in the ABCD1 gene located on the X chromosome, which provides instructions for the production of the ALD protein.

ALD protein is needed to clear toxic molecules called very long-chain fatty acids (VLCFAs) in the brain, and if mutated causes the VLCFAs to accumulate and damage the myelin sheath.

Using eli-cel, the patients own stem cells are modified in the lab to produce a working version of the ABCD1 gene, producing functional ALD protein that can help to flush VLCFAs from the body.

CALD is a devastating disease, often marked by rapid neurodegeneration, the development of major functional disabilities, and eventual death, said Gary Fortin, head of severe genetic disease programmes at Bluebird.

If approved, eli-cel would represent the first therapy for CALD that uses a patients own haematopoietic stem cells, potentially mitigating the risk of life-threatening immune complications associated with transplant using cells from a donor, he added.

Aside from STARBEAM, which will follow treated patients for up to 15 years, Bluebird is also conducting the phase 3 ALD-104 trial of eli-cel in CALD, which is due to generate results in 2024.

The EU filing for eli-cel comes shortly after Bluebirds development partner received a 27 March 2021 FDA review date for anti-BCMA CAR-T cell therapy ide-cel, a potential therapy for multiple myeloma.

The biotech already has approval in Europe for Zynteglo, a gene therapy for haematological disease beta thalassaemia, and is due to file its related therapy LentiGlobin for sickle cell disease next year. The two therapies have been tipped to generate $1.5 billion-plus in peak sales by some analysts.

Continued here:
EMA starts rapid review of Bluebird's gene therapy for rare disease CALD - - pharmaphorum

‘Provocative results’ boost hopes of antibody treatment for COVID-19 – Science Magazine

Companies are developing COVID-19 treatments using monoclonal antibodies, Y-shaped immune proteins that target the pandemic coronavirus.

By Jon CohenSep. 30, 2020 , 5:15 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

A second company has now produced strong hints that monoclonal antibodies, synthetically produced versions of proteins made by the immune system, can work as treatments in people who are infected with the pandemic coronavirus but are not yet seriously ill.

The biotech Regeneron Pharmaceuticals has developed a cocktail of two monoclonal antibodies that attach to the surface protein of that coronavirus, SARS-CoV-2, and attempt to block it from infecting cells. Yesterday at an investor and mediawebcast, the firm revealed early results.

The company showed slides with detailed data from 275 infected people in a placebo-controlled trial that ultimately plans to enroll 2100 individuals who are asymptomatic or, at worst, moderately ill. The analysis divides patients into two groups: those who had detectable antibodies against SARS-CoV-2 at the trials start and those who did not, a so-called seronegative group. The monoclonal cocktail showed little effect on people who already had antibodies against the virus. But it appeared to help the seronegative patients, powerfully reducing the amount of virus found in nasopharyngeal swabs and alleviating symptoms more quickly. These are provocative results, says Myron Cohen of the University of North Carolina, Chapel Hill, who was not involved with the study but is helping Regeneron test its monoclonal cocktail as a preventive.

Cohen notes that Regenerons data look similar to those in a press release from Eli Lilly 2 weeks ago about early results from a trial of its single monoclonal antibody against SARS-CoV-2. Both of these reports go in the same direction, Cohen says. But he cautions that neither has been published, both trials are ongoing, and more data are needed to understand howor whetherthese experimental medicines can best help patients. Lilly, oddly, did not see an impact at the highest dose of antibody tested, and Regeneron saw no difference between its low- and high-dose preparations used in the study.

James Crowe, a viroimmunologist at Vanderbilt University who is working with AstraZeneca to develop COVID-19 monoclonal antibodies, welcomed Regenerons detailed preliminary results. I applaud Regeneron for releasing so much information, Crowe says. Theyre contributing to public health by releasing this as soon as possible. But he notes even people who did well on the monoclonal cocktail still had low levels of virus detectable after their treatment, which in theory could cause problems. I was surprised that there was any virus at all given that these are such potent antibodies, he says, adding that the residual virusdetected in the swab tests may not be capable of copying itself.

The monoclonal antibodies from the two companies are clones of potent SARS-CoV-2 antibodies that can neutralize the virus in test tube studies. Researchers plucked the genes for these antibodies from humans who recovered from COVID-19 or from mice artificially infected with the virus. The companies then put the genes in Chinese hamster ovary cells to bulk manufacturethe antibodies, which were given to the COVID-19 patients as infusions.

At the webcast that announced Regenerons results, George Yancopoulos, president and co-founder of the company, emphasized how the target population for the monoclonal cocktail are SARS-CoV-2 infected people who have not yet mounted their own immune response and have exceedingly high levels of the virus. What we really want to do is turn them into patients who have already started to effectively fight the virus, Yancopoulos said.

In the Regeneron data, the most dramatic drops in SARS-CoV-2 were seen in seronegative patients who had the highest levels of virus at the trials start. In comparison with patients who received the placebo, the results were clearly statistically significant.

Daniel Skovronsky, Lillys chief scientific officer, says the Regeneron data are quite confirmatory of their own. I dont expect there to be large differences between good neutralizing antibodies, Skovronsky says. Antibodies will work best in people who cant clear the virus on their own. One key difference between the two studies, he says, is that Lilly enrolled fewer seronegative people and still found an impactalthough the company, in contrast to Regeneron, is withholding details until it publishes results. Lilly also stressed that people receiving its antibody were shown to have fewer hospitalizations or emergency room visits: five out of 302 (1.7%) treated patients versus nine out of 150 (6%) in the placebo group. Yes, these are small numbers by some measures, Skovronsky says, but by other measures, there are significant differences in hospitalization.

Regeneron hasnt yet accumulated enough data to show the same protection. Its trial had only 12 patients who had COVID-19related medically attended visits. Although there was a trend toward more of these in the placebo group than treatment arms, only one was hospitalized.

Regenerons data raise difficult questions about when to use its cocktail. People who test positive for SARS-CoV-2 arent routinely screened for antibodies to it or for levels of the virus. If the decision is going to be made to deploy such a therapeutic solution in the patients who might benefit the most and need it most, were going to have to solve the problem of using the right point-of-care diagnostic tools, either for serology or high viral load, Yancopoulos said, noting that their partnersincluding Rocheare developing these types of assays.

Skovronsky says Lilly has a simpler plan: Offer monoclonals to people who test positive for the virus if they are in high-risk groups for developing severe disease, which include the elderly and people with underlying diseases such as diabetes or who are overweight. Running extra tests before treating people, as Regeneron suggests, is just not going to meet the needs of the population, he says

Both Lilly and Regeneron say they are discussing their data with regulators to see whether their monoclonal antibodies might warrant moving to widespread use more quickly through mechanisms like the U.S. Food and Drug Administrations emergency use authorization process. Additional studies of their monoclonal treatments are underway in hospitalized COVID-19 patients and, separately, as preventives in uninfected people.

Monoclonal antibodies are more difficult to make than many drugs and often are extremely expensive, which means that supply could outstrip demand and many countries might not be able to afford them. The U.S. governments Operation Warp Speed has invested $450 million in Regeneron to produce up to 300,000 doses of its cocktail by the end of the year, which would be distributed to Americans free of charge. A substantial fraction of those are already available, Yancopoulos saidalthough its not yet clear what constitutes a single dose of the companys cocktail. Nonetheless, Regeneron, which is partnering with Roche to increase production capability, says it hopes to ramp up to produce 250,000 doses per month.

Skovronsky says if the lowest dose Lilly is testing works, it could have up to 1 million doses by the end of the year. Lilly is partnering with Amgen to scale up production to several million doses next year. Were rooting for Regenerons success, just as Regeneron is rooting for Lillys success, he says. None of us can make enough antibodies to meet the need.

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'Provocative results' boost hopes of antibody treatment for COVID-19 - Science Magazine

Stem Cell Therapy Market Size, Regional Insights and Global Industry Dynamics By 2027 | By Top Leading Vendors NuVasive, Osiris Therapeutics, JCR…

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Timothy Ray Brown, First Patient to Be Cured of HIV, Dies of Leukemia – BioSpace

Timothy Ray Brown, dubbed the Berlin Patient, the first ever to be cured of HIV, died from cancer on September 29.

Brown was cured of HIV in 2007. He was diagnosed in 1995, and about a decade later was diagnosed with leukemia. A physician at the Free University of Berlin used a stem cell transplant from a donor with a rare genetic mutation that provided natural resistance to HIV in hopes of curing both diseases. It took two procedures but was successful, and in 2008 Brown was announced free of both HIV and leukemia.

Two years later he went public with the announcement.

I am living proof that there could be a cure for AIDS, he told Agence France-Presse (AFP) in 2012. Its very wonderful, being cured of HIV.

In 2019, a second HIV patient, Adam Castillejo, underwent a similar procedure. He was dubbed the London Patient. A UK resident diagnosed with HIV in 2003, Castillejo began antiretroviral therapy in 2012. He was later diagnosed with advanced Hodgkins lymphoma. He was treated with a stem cell transplant in 2016 after he received chemotherapy. He then continued to receive antiretroviral therapy for 16 months.

To evaluate whether the HIV-1 infection was actually in remission, he went off the usual antiretroviral therapy. After he had been in remission for 18 months, testing confirmed that his HIV viral load was undetectable.

The donors for both men carried a rare genetic mutation called CCR5-delta 32. This made these patients resistant to HIV. Castillejo is currently living HIV-free.

Brown, 54, was born in the U.S. He was diagnosed with HIV in 1995 while living in Berlin. He developed acute myeloid leukemia in 2007.

The leukemia that eventually led to his HIV cure returned this year, where it metastasized to his brain and spinal cord.

Browns partner, Tim Hoeffgen, posted on Facebook, It is with great sadness that I announce that Timothy passed away surrounded by myself and friends, after a five-month battle with leukemia. Tim committed his lifes work to telling his story about his HIV cure and became an ambassador of hope.

The procedure itself is not routinely used to treat HIV because it is both too risky and aggressive. It is primarily used to treat certain types of cancer. In the case of both Brown and Castillejo, it was the combination of HIV and resultant cancers that are effectively treated with stem cell transplants, that made it feasible. Nonetheless, it gave patients hope that there may someday be a cure.

We owe Timothy and his doctor, Gero Hutter, a great deal of gratitude for opening the door for scientists to explore the concept that a cure for HIV is possible, stated Adeeba Kamarulzaman, president of the International Aids Society (IAS).

Sharon Lewin, director of the Doherty Institute in Melbourne, Australia, noted, Although the cases of Timothy and Adam are not a viable large-scale strategy for a cure, they do represent a critical moment in the search for an HIV cure. Timothy was a champion and advocate for keeping an HIV cure on the political and scientific agenda. It is the hope of the scientific community that one day we can honor his legacy with a safe, cost-effective and widely accessible strategy to achieve HIV remission and cure using gene editing or techniques that boost immune control.

Although largely a treatable disease, HIV/AIDS affects about 37 million people globally, and about 1 million people die from HIV-related causes each year. Treatment typically involves a cocktail of antiretroviral therapy, which HIV patients take their entire lives.

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