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<ul class="summary-list"><li><keyword id="10934079" type="UNKNOWN" weightage="60" keywordseo="rubius-therapeutics">Rubius Therapeutics</keyword> shares surged 84% during Monday's trading session. </li><li>The biotech firm outlined encouraging data from testing of RTX-240, a potential <keyword id="6355291" type="UNKNOWN" weightage="60" keywordseo="Cancer">cancer</keyword> treatment. </li><li>Rubius said data collected provide initial proof-of-concept of its red blood cells generation system Red Platform.  </li></ul><p><a href="https://markets.businessinsider.com/stocks/ruby-stock">Rubius Therapeutics </a>shares more than doubled during Monday's session after investors received the biotech firm's outline of results from early-stage tests of a potential cancer drug. </p><p>The company said data from an ongoing <keyword id="122283" type="PERSON" weightage="60" keywordseo="Clinical-trial">clinical trial</keyword> of patients with advanced solid tumors contributed to providing initial proof-of-concept for its platform to generate red blood cells.</p><p>Shares of Rubius jumped as much as 136% to $38.71 then trimmed closed the session up by 84%. Trading was heavy, with volume of nearly 38 million shares outrunning the average daily volume of about 1.5 million shares.</p><p>Among the data from an ongoing phase 1/2 trial of RTX-240, the company's cellular therapy product candidate, there was a 54% reduction in target lesions in a patient with metastatic anal cancer.</p><p>Rubius said the data collected "provide clinical validation" of its Red Platform red blood cells generation system, said Pablo Cagnoni, chief executive at Rubius, in a statement.</p><p>With "encouraging" initial safety and preliminary efficacy data for RTX-240, he said the company plans to initiate a phase 2 expansion cohort in the first quarter of 2022 and a new phase 1 arm of the RTX-240 trial to evaluate it in combination with another therapy during the second half of 2021.</p>

Rubius Therapeutics surges 84% on encouraging results from early-stage testing of cancer treatment

<p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>AP</span></p><p class="caption">A nurse reaches for blood samples taken from a patient receiving a kind of immunotherapy known as CAR-T cell therapy at the Fred Hutchinson Cancer Research Center in Seattle.</p></div><p></p></div></div></p><ul><li><strong>Celgene is acquiring Juno Therapeutics, a company developing personalized cancer treatments in a deal worth $9 billion. </strong></li><li><strong>It's the second deal in 2018 for the biotech giant, which has been under pressure from investors.</strong></li><li><strong><strong>The highly personalized treatments Juno makes, called CAR T-cell therapy, are at the beginning of what some are calling<span> </span></strong>"a big new field of medicine."</strong></li></ul><p> </p><p><a href="http://markets.businessinsider.com/stock/CELG-Quote">Celgene</a> is buying<a href="http://markets.businessinsider.com/stock/JUNO-Quote"> Juno Therapeutics.</a> </p><p><span>The biotech giant is acquiring the cancer drugmaker in a $9 billion deal, Celgene said on Monday. Celgene, which already owned 9.7% of Juno's shares, will pay $87 per share in cash. </span></p><p><span>Juno is known for its experimental, highly personalized cancer treatments called <a href="http://www.the-scientist.com/?articles.view/articleNo/42462/title/The-CAR-T-Cell-Race/">CAR T-cell therapy</a> (CAR is short for chimeric antigen receptor).<br /></span></p><p><span>"The acquisition of Juno builds on our shared vision to discover and develop transformative medicines for patients with incurable blood cancers," Celgene CEO Mark Alles said in a news release Monday. Celgene, which has been <a href="https://www.statnews.com/2018/01/08/celgene-acquisition-next-steps/">under pressure from investors</a> to make some changes <a href="https://www.statnews.com/2017/10/26/celgene-revenue-guidance-cut/">after a rocky 2017,</a> has now made two acquisitions this month, after picking up Impact Biosciences in a <a href="https://www.reuters.com/article/us-impact-biomedicines-m-a-celgene/celgene-to-buy-impact-biomedicines-for-up-to-7-billion-idUSKBN1EW0U9">$7 billion deal</a> on January 7. </span></p><p><span>2017 was a big year for these CAR-T treatments: the <a href="http://www.businessinsider.com/car-t-cell-therapy-approval-gilead-kite-2017-10">Food and Drug Administration approved two</a> treatments, one to treat treat <a href="http://www.businessinsider.com/why-the-fda-approved-kymriah-a-car-t-cell-therapy-to-treat-cancer-2017-8">pediatric acute lymphoblastic leukemia</a> in people up to age 25 and another to treat <a href="http://www.businessinsider.com/how-many-patients-car-t-cell-therapy-can-treat-2017-10">aggressive B-cell non-Hodgkin lymphoma</a>. And in August, Gilead Sciences nabbed CAR-T drugmaker <a href="http://www.businessinsider.com/why-gilead-bought-kite-pharma-for-12-billion-2017-8">Kite Pharma in a $12 billion</a> deal. </span></p><h2><span>How CAR-T cell therapy works</span></h2><p>These treatments aren't your run-of-the-mill pill - or even a <a href="http://www.businessinsider.com/how-well-biosimilars-are-saving-money-2017-4">biologic drug</a>, like insulin - that can be mass produced. Since the therapy is made from a person's own immune system, the process can take about three weeks.</p><ul><li>To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient. In a healthy body, the immune system can recognize abnormal, cancerous cells, but for people with cancer, it doesn't recognize that the cells are spreading.</li><li>Then the cells are taken to a manufacturing facility at which point the cells are reengineered to recognize cancer cells and wipe them out.</li><li>Those reprogrammed cells are sent back and administered to the patient.</li></ul><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Ana Pelisson/Business Insider; Novartis</span></p></div><p></p></div></div></p><p>While the treatments don't work in all patients, it can have dramatic results in those who do respond. For example, <span>in a </span><a href="https://www.novartis.com/news/media-releases/novartis-pivotal-ctl019-6-month-follow-data-show-durable-remission-rates">trial of 63 patients</a><span> treated with Kymriah - <a href="http://www.businessinsider.com/why-the-fda-approved-kymriah-a-car-t-cell-therapy-to-treat-cancer-2017-8">the first cell therapy approved</a> - 83% were in remission after three months, and 64% were still in remission after a year.</span></p><h2>'A big new field of medicine'</h2><p>With two CAR-Ts already approved and more in the works over the next few years including Juno's, the field of cell therapies is starting to emerge.   </p><p>"We're at the very beginning of what's going to be a big new field of medicine," David Epstein, who helped license Kymriah from the University of Pennsylvania while at Novartis,<span> </span><a href="http://www.businessinsider.com/why-the-fda-approved-kymriah-a-car-t-cell-therapy-to-treat-cancer-2017-8">told Business Insider in August after Kymriah was approved</a>.</p><p>Epstein left Novartis in 2016 as CEO of its pharmaceuticals divisions. He's now the executive chairman of Rubius Therapeutics, a biotech firm that's also working with cell therapy to develop treatments like the CAR-Ts that don't have to be as personalized. The hope is that one day doctors will be able to prescribe a cell therapy and use it that same day instead of waiting weeks to get it back.</p><p>Epstein said he envisioned cell therapies having much shorter life cycles than traditional drugs. Instead of getting a better, updated therapy for a disease every decade or so, we might begin to see second-generation cell therapies in a few years.</p><p>One challenge these therapies still face is how toxic they can be. CAR-T's side effects can be deadly. In May 2017, Kite disclosed that<span> </span><a href="https://endpts.com/one-of-kites-car-t-patients-died-from-cerebral-edema-triggering-a-safety-alarm/">one person had died</a><span> </span>in a clinical trial for its late-stage CAR-T therapy from cerebral edema, a condition in which excessive fluid causes the brain to swell. Juno said five people in its<span> </span><a href="http://www.genengnews.com/gen-news-highlights/juno-halts-development-of-car-t-cell-cancer-immunotherapy-candidate-jcar015/81253961">clinical trials had died</a>, all from cerebral edema.</p><p>Eventually, cell therapies could go beyond blood cancers, and include solid tumors and maybe even autoimmune diseases like Type 1 diabetes, Epstein said.</p>    <div class="margin-top">        <h3>NOW WATCH: <a href="http://www.businessinsider.com/why-some-people-believe-the-world-is-flat-according-to-an-astronomer-2018-1">This is why some people believe the world is flat, according to an astronomer</a></h3>        <div>                    </div>    </div>

Celgene is buying cancer drugmaker Juno Therapeutics for $9 billion

<p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Courtesy Rubius</span></p><p class="caption">Rubius CEO Torben Straight Nissen</p></div><p></p></div></div></p><ul><li><strong>Rubius Therapeutics, a biotech developing red blood cell therapies, just raised $100 million.</strong></li><li><strong>This is the second time the startup has raised money in the past year. In June 2017, <a href="https://www.rubiustx.com/wp-content/uploads/2017/10/rubius_financing.pdf">Rubius raised $120 million</a> from investors including <a href="http://www.businessinsider.com/flagship-pioneering-hires-former-jpmorgan-executive-stephen-berenson-2017-6">Flagship Pioneering</a>.</strong></li><li><strong>The company is starting by developing enzyme replacement therapies for rare conditions in which the body doesn't make a particular enzyme, as well as cancer therapies that aim to re-engineer the body's immune system. </strong></li></ul><p><br />Rubius Therapeutics, a startup building red blood cells that have been reprogrammed to treat conditions like cancer, just raised $100 million.  </p><p>It's the second time the startup has raised money in the past year. In June 2017, <a href="https://www.rubiustx.com/wp-content/uploads/2017/10/rubius_financing.pdf">Rubius raised $120 million</a> from investors including <a href="http://www.businessinsider.com/flagship-pioneering-hires-former-jpmorgan-executive-stephen-berenson-2017-6">Flagship Pioneering</a>. Thursday's crossover funding round included investments from mutual funds and institutional investors that weren't immediately named. </p><p>Red blood cell therapies can be thought of like pretty much any other medication, with one distinction: It's made out of red blood cells, not chemicals or other <a href="http://www.businessinsider.com/category/biosimilars">biological materials</a>. </p><p>"<span>They're basically superblood," Rubius CEO Torben Straight Nissen said. The red blood cells, produced in tanks at Rubius's labs, are "armed" with a therapeutic protein. That superblood is then infused into the body - an amount less than 1% of the total blood in your body - where it can get to work treating a particular condition.</span></p><p>To start, Rubius is developing enzyme replacement therapies for rare conditions in which the body doesn't make a particular enzyme, as well as cancer therapies that aim to re-engineer the body's immune system. </p><p><span>This funding will ideally get Rubius into clinical trials for some of its programs, and possibly even into later-stage trials that the company could bring to the FDA.</span></p><h2>The potential for cell-based therapies</h2><p>In 2017, the Food and Drug Administration first approved two highly personalized cancer versions of cell therapy, known as<span> </span><a href="http://www.the-scientist.com/?articles.view/articleNo/42462/title/The-CAR-T-Cell-Race/">CAR T-cell therapy</a><span> </span>(CAR is short for chimeric antigen receptor). These treatments - approved for certain forms of blood cancer - aren't your run-of-the-mill pill that can be mass produced. Since the therapy is made from a person's own immune system, the process can take about three weeks.</p><p>To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient. In a healthy body, the immune system can recognize abnormal, cancerous cells, but for people with cancer, it doesn't recognize that the cells are spreading.</p><p>Then the cells are taken to a manufacturing facility at which point the cells are reengineered to recognize cancer cells and wipe them out. Those reprogrammed cells are sent back and administered to the patient.</p><p><span>Rubius, using red blood cells, wants to make treatments that don't have to be as personalized as these initial <a href="http://www.businessinsider.com/fda-approves-novartis-car-t-cancer-treatment-2017-8">cell therapies</a>. </span></p><p><span>"We think this is a great next generation cell therapy platform that has a lot of benefits over the CAR-Ts," Nissen said.</span></p><p><span>And to affect more people, the cell therapies would need to go beyond blood cancers. Right now, that's where most of the big successes have come from. But cell therapies could one day tackle solid tumors and maybe even the rare diseases Rubius is going after, along with autoimmune diseases like Type 1 diabetes.</span><span></span></p>    <div class="margin-top">        <h3>NOW WATCH: <a href="http://www.businessinsider.com/wharton-david-reibstein-trump-bad-for-america-brand-davos-2018-2">Forget 'Make America Great Again'  - Wharton professor says Trump has been terrible for America's brand</a></h3>        <div>                    </div>    </div>

A startup that's making 'superblood' to treat conditions like cancer just raised $100 million to get its treatments through key trials

<p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Hollis Johnson/Business Insider</span></p></div><p></p></div></div></p><p>Hello, </p><p>It's been a long, exciting albeit tiring week for the healthcare team as we made our way around San Francisco's Union Square during the <a href="https://www.businessinsider.com/category/jpm19">J.P. Morgan Healthcare Conference</a>. <a href="https://twitter.com/lydiaramsey125/status/1083091659821244421">Hills were climbed</a>, <a href="https://twitter.com/erbrod/status/1083608285041778689">cricket tacos consumed</a>, and <a href="https://www.businessinsider.com/jpmorgan-healthcare-conference-buzz-2019-1">healthcare discussed</a> at length. </p><p>Many, many stories ahead from those conversations. But to start, here's what kept us busy when we weren't bustling from meeting to meeting. </p><p><strong>New to our weekly newsletter? You<span> </span><a href="http://newsletter.businessinsider.com/join/4np/health-insider&amp;hash=f4e91136c13f3c40c496d77bc7347502">can sign up here</a>.</strong></p><p>For starters, the week kicked off with Eli Lilly making an $8 billion bid for <a href="https://www.businessinsider.com/eli-lilly-to-buy-loxo-oncology-in-8-billion-cancer-drug-deal-2019-1">Loxo Oncology</a>. That has Wall Street increasingly optimistic that there's <a href="https://www.businessinsider.com/author/emma-court">more M&amp;A to come in healthcare</a>.</p><p>And <a href="https://www.businessinsider.com/author/emma-court">Emma Court</a> spoke to an investor who made $470 million on the deal. </p><h3><a href="https://www.businessinsider.com/aisling-capitals-steve-elms-on-loxo-oncology-and-other-biotechs-2019-1">A top investor who just made $470 million on buzzy biotech Loxo's $8 billion takeover told us where he might place his next bets</a></h3><ul><li>Eli Lilly &amp; Co.'s about $8 billion acquisition of biotech Loxo Oncology could mean a $470 million payday for venture-capital firm Aisling Capital.</li><li>Aisling Capital was a founding investor in Loxo and most recently held a 6.6% stake.</li><li>Aisling Capital managing partner Steve Elms told Business Insider about the other biotechs and scientific areas the firm is intrigued by.</li></ul><p>Emma also broke down what's going on with Bluebird Bio's plan to pay for one-time gene therapy treatments in the way you might pay for a washing machine - that is, in installments over 5 years. Bluebird laid out its plan at the conference on Tuesday. </p><h3><a href="https://www.businessinsider.com/biotech-bluebird-bio-suggests-installment-plan-for-gene-therapy-lentiglobin-2019-1">A biotech is proposing a plan to pay for its pricey rare-disease treatment the same way you'd buy a TV or dishwasher. Here's the inside story.</a></h3><ul><li>Biotech company Bluebird Bio proposed a five-year installment plan for its pricey gene therapy at a major healthcare conference on Tuesday.</li><li>The company hasn't put out a price tag for the experimental product, which hasn't yet been approved, but capped it at $2.1 million a treatment.</li><li>Bluebird CEO Nick Leschly told Business Insider the inside story of how the plan came about and what challenges it could face.</li></ul><p><a href="https://www.businessinsider.com/author/erin-brodwin">Erin Brodwin</a> covered one of the biggest stock movers of the conference, Sage Therapeutics, which revealed on Monday positive clinical trial results for its new depression drug. </p><h3><a href="https://www.businessinsider.com/sage-depression-drug-positive-results-2019-1">A drug that works differently from all existing depression drugs just got a big boost</a></h3><ul><li>On Monday, a new drug for depression got a big lift from positive clinical trial results. Stocks surged on the news.</li><li>The drug is made by Sage Therapeutics, a Cambridge-based pharmaceutical company that focuses on brain disorders.</li><li>Nearly all existing antidepressants, from Celexa to Zoloft, work on the brain's serotonin network. But the drugs fail for as many as 1 in 3 people and take 4-6 weeks to have an effect.</li><li>Sage's new drug targets a different brain system than these antidepressants. As a result, it appears to work faster and last longer.</li></ul><p><a href="https://www.businessinsider.com/author/zachary-tracer">Zach Tracer</a> and I were closely tracking CVS Health's presentation at the conference - its first since its deal with Aetna went through. Now with the insurance business in tow, CVS CEO Larry Merlo laid out how it's going to shake up how we access healthcare. </p><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Reuters</span></p><p class="caption">CVS Health President and CEO Larry J. Merlo</p></div><p></p></div></div></p><h3><a href="https://www.businessinsider.com/cvs-health-reveals-plans-for-health-hub-stores-2019-1">CVS Health just revealed a key piece of its plan to change how Americans get healthcare</a></h3><ul><li>CVS Health and Aetna have officially combined to create an entirely new kind of healthcare company.</li><li>In a presentation Tuesday at the J.P. Morgan Healthcare Conference in San Francisco, CVS CEO Larry Merlo laid out the first steps the combined company is taking to change healthcare.</li><li>CVS is opening a test store in Houston with more healthcare services, and also plans to test programs to treat chronic diseases and keep patients out of the hospital.</li></ul><p>Early in the week, Erin and I sat down with Verily chief medical officer Jessica Mega, who explained to us the common thread unifying all that the life sciences arm of Alphabet is working on. </p><h3><a href="https://www.businessinsider.com/verily-google-alphabet-ceo-shares-common-theme-behind-projects-2019-1">We talked to the top scientist at Alphabet's life-sciences company about the common thread uniting all its seemingly random health projects - and how she plans to spend $1 billion</a></h3><ul><li>Verily, the enigmatic life-sciences company formerly known as Google Life Sciences, recently raised $1 billion and appears to have its hands in a wide range of health initiatives.</li><li>The company is building advanced contact lenses; releasing hordes of bacteria-infected (and thus sterile) mosquitoes in Fresno, California; and building a watch that helps researchers gather data for clinical studies.</li><li>Verily's chief medical officer told Business Insider there's one thread that unites all of its projects: information.</li></ul><p>We covered a wide range of topics, so stay tuned for more from that interview as well. </p><p>And to end the week, Zach summed up<a href="https://www.businessinsider.com/biotech-stocks-tumbled-fell-jpmorgan-healthcare-conference-2019-1"> the biggest losers coming out of the conference.</a> Amid a mainly positive week, bad news brought down the stock price of a number of biotech companies, including Rubius Therapeutics and Sangamo Therapeutics. </p><p><strong>Looking to digest more of what went down this week at the conference? <a href="https://www.businessinsider.com/category/jpm19">You can find all our coverage from within and around the walls of the Westin St. Francis here.</a> </strong></p><p>With that, I'm going to go recover from the red-eye flight I somehow thought was a good idea. Please feel free to send recovery tips, conference observations, or reminders of what we might have missed while running up and down San Francisco to the team at healthcare@businessinsider.com. And as always, you can find me at lramsey@businessinsider.com.</p><p>- Lydia </p>    <div class="margin-top">        <h3>NOW WATCH: <a href="https://www.businessinsider.com/tried-22-day-revolution-beyonce-vegan-diet-weight-loss-2017-9">I went on Beyoncé's 22-day diet - and I lost 15 pounds</a></h3>        <div>                    </div>    </div>

Dispensed: What we saw at JPMorgan's big healthcare investor conference

<p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Reuters</span></p><p class="caption">Cancer cells are seen on a large screen connected to a microscope at the CeBit computer fair in Hanover, Germany, March, 6, 2012.</p></div><p></p></div></div></p><ul><li><strong>The FDA just approved a cutting-edge therapy to treat more patients with certain forms of blood cancer.</strong></li><li><strong>It's the second approval for the drug, Kymriah, which is now approved to treat certain forms of leukemia and lymphoma.  </strong></li><li><strong>The therapy works by taking a person's own cells, reprogramming them, and inserting them back into the body to fight the cancer - in this case, certain forms of blood cancer.</strong></li></ul><p><span>The FDA just approved a cutting-edge cancer therapy to treat another form of blood cancer. </span></p><p><span>It's the second approval for Kymriah, also known as tisagenlecleucel, this time to treat patients with large B-cell lymphoma, and the first for adult patients. A</span><span>n </span><a href="http://www.businessinsider.com/why-the-fda-approved-kymriah-a-car-t-cell-therapy-to-treat-cancer-2017-8">August approval of Kymriah</a><span> approved the therapy to treat pediatric acute lymphoblastic leukemia in people up to age 25.</span></p><p><span>The highly personalized treatment is called <a href="http://www.the-scientist.com/?articles.view/articleNo/42462/title/The-CAR-T-Cell-Race/">CAR T-cell therapy</a> (CAR is short for chimeric antigen receptor). It's a type of cancer immunotherapy, which harnesses the body's immune system to take on cancer cells. It removes a person's cells, reengineers them, then puts them back in their body to attack cancer cells.</span></p><p>"I think this is the most exciting thing I've seen in my lifetime," said Dr. Tim Cripe, an oncologist who was part of the FDA advisory committee panel that voted in July to recommend the drug's initial approval.</p><p>The approval now puts Kymriah, made by Novartis, into direct competition with Yescarta, another CAR-T cell therapy that was <a href="http://www.businessinsider.com/car-t-cell-therapy-approval-gilead-kite-2017-10">approved in August</a> made by Kite Pharma, a company Gilead Sciences acquired in 2017. <span>There are more than 10,000 adults with large B-cell lymphoma who might benefit from these treatments, Dr. Fred Locke, an oncologist and researcher at Moffitt Cancer Institute in Tampa, Florida <a href="http://www.businessinsider.com/how-many-patients-car-t-cell-therapy-can-treat-2017-10">told Business Insider in October</a>. </span></p><p>Yescarta and Kymriah aren't your run-of-the-mill pill - or even a<span> </span><a href="http://www.businessinsider.com/how-well-biosimilars-are-saving-money-2017-4">biologic drug</a>, like insulin - that can be mass produced. Since the therapy is made from a person's own immune system, the process can take about three weeks.</p><ul><li>To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient. In a healthy body, the immune system can recognize abnormal, cancerous cells, but for people with cancer, it doesn't recognize that the cells are spreading.</li><li>Then the cells are taken to a manufacturing facility at which point the cells are reengineered to recognize cancer cells and wipe them out.</li><li>Those reprogrammed cells are sent back and administered to the patient.</li></ul><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Ana Pelisson/Business Insider; Novartis</span></p></div><p></p></div></div></p><p><span>The one-time treatments won't come cheap. Yescarta has a </span><a href="http://www.businesswire.com/news/home/20171018006639/en/Kite%E2%80%99s-Yescarta%E2%84%A2-Axicabtagene-Ciloleucel-CAR-Therapy-Approved">list price of $373,000</a><span>, which is lower than Kymriah's </span><a href="http://www.businessinsider.com/fda-approves-novartis-car-t-cancer-treatment-2017-8">$475,000 price tag</a><span>. </span></p><h2>'A big new field of medicine'</h2><p>Kymriah, and Yescarta are the first two CAR-T cell therapies to get approved, and several more are in the works.<span> </span><a href="http://markets.businessinsider.com/news/stocks/kite-pharma-juno-stock-price-surges-after-takeover-announcement-2017-8-1002288759">Juno Therapeutics, and Bluebird Bio</a><span> </span>are among a growing group of biotech companies working with CAR-T.</p><p>"We're at the very beginning of what's going to be a big new field of medicine," David Epstein, who helped license Kymriah from the University of Pennsylvania while at Novartis <a href="http://www.businessinsider.com/how-many-patients-car-t-cell-therapy-can-treat-2017-10">told Business Insider in August</a>.</p><p>Epstein left Novartis in 2016 as CEO of its pharmaceuticals divisions. He's now the executive chairman of <a href="http://www.businessinsider.com/rubius-therapeutics-red-blood-cell-therapy-raises-100-million-2018-2">Rubius Therapeutics</a>, a biotech firm that's also working with cell therapy to develop treatments like Kymriah that don't have to be as personalized. The hope is that one day doctors will be able to prescribe a cell therapy and use it that same day instead of waiting weeks to get it back, and possibly extend beyond the blood cancers treatments like Kymriah and Yescarta are able to treat.</p>    <div class="margin-top">        <h3>NOW WATCH: <a href="http://www.businessinsider.com/how-to-survive-avalanche-2018-4">Here is how to survive an avalanche</a></h3>        <div>                    </div>    </div>

A cancer treatment that one expert called the 'most exciting thing I've seen in my lifetime' just got approved to treat more patients

<p><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"><p class="source"><span><a href="http://commons.wikimedia.org/wiki/File:NHL_b-cell_meningiosis.jpg">Wikimedia Commons</a></span></p><p class="caption">CSF cytology of a diffuse large B-cell non hodgkin lymphoma.</p></div><p></p></div></div>The FDA just approved another revolutionary cancer treatment. </p><p>The treatment, called Yescarta, treats a type of blood cancer called aggressive B-cell non-Hodgkin lymphoma.</p><p>The <span>highly personalized cancer treatment called </span><a href="http://www.the-scientist.com/?articles.view/articleNo/42462/title/The-CAR-T-Cell-Race/">CAR T-cell therapy</a><span> (CAR is short for chimeric antigen receptor) is</span> made by Kite Pharma, a company that in August was acquired by <a href="http://www.businessinsider.com/why-gilead-bought-kite-pharma-for-12-billion-2017-8">biotech giant Gilead Sciences</a>. </p><p><span>It's a type of cancer immunotherapy, which harnesses the body's immune system to take on cancer cells. In this case, the therapy removes a person's cells, reengineers them, then puts them back in their body to attack cancer cells. </span></p><p><span>In August, the <a href="http://www.businessinsider.com/why-the-fda-approved-kymriah-a-car-t-cell-therapy-to-treat-cancer-2017-8">FDA approved another CAR-T therapy</a>, called Kymriah, to treat treat pediatric acute lymphoblastic leukemia in people up to age 25. The treatment was heralded as the first gene therapy, an area that's <a href="http://www.businessinsider.com/spark-therapeutics-hereditary-blindness-gene-therapy-advisory-committee-2017-10">gaining traction</a> as other treatments get closer to approval. <br /></span></p><p><span>"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer," FDA Commissioner Scott Gottlieb <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.htm">said in a news release</a>. </span></p><h2><span>How CAR-T therapies work</span></h2><p>Yescarta isn't your run-of-the-mill pill - or even a <a href="http://www.businessinsider.com/how-well-biosimilars-are-saving-money-2017-4">biologic drug</a>, like insulin - that can be mass produced. Since the therapy is made from a person's own immune system, the process can take about three weeks.</p><ul><li>To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient. In a healthy body, the immune system can recognize abnormal, cancerous cells, but for people with cancer, it doesn't recognize that the cells are spreading.</li><li>Then the cells are taken to a manufacturing facility at which point the cells are reengineered to recognize cancer cells and wipe them out.</li><li>Those reprogrammed cells are sent back and administered to the patient.</li></ul><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Ana Pelisson/Business Insider; Novartis</span></p></div><p></p></div></div></p><p><span>The one-time treatments won't come cheap. While Gilead might price the drug based on how well it works or opt for a refund if there hasn't been a response, <a href="http://www.businessinsider.com/fda-approves-novartis-car-t-cancer-treatment-2017-8">as is the case with Kymriah</a>, Yescarta's price tag </span><a href="https://www.bloomberg.com/news/articles/2017-06-08/novartis-gets-creative-in-pricing-next-generation-cancer-therapy">could still be $325,000</a><span>. Analysts expect the therapy to generate </span><a href="https://www.bizjournals.com/losangeles/news/2017/08/28/gilead-sciences-buys-kite-pharma.html">$1.7 billion in sales by 2022</a><span>. </span></p><h2>'A big new field of medicine'</h2><p>Kymriah, and Yescarta are the first two CAR-T cell therapies to get approved, and several more are in the works. <a href="http://markets.businessinsider.com/news/stocks/kite-pharma-juno-stock-price-surges-after-takeover-announcement-2017-8-1002288759">Juno Therapeutics, and Bluebird Bio</a><span> </span>are among a growing group of biotech companies working with CAR-T. </p><p>"We're at the very beginning of what's going to be a big new field of medicine," said David Epstein, who helped license Kymriah from the University of Pennsylvania while at Novartis.</p><p>Epstein left Novartis in 2016 as CEO of its pharmaceuticals divisions. He's now the executive chairman of Rubius Therapeutics, a biotech firm that's also working with cell therapy to develop treatments like Kymriah that don't have to be as personalized. The hope is that one day doctors will be able to prescribe a cell therapy and use it that same day instead of waiting weeks to get it back, and possibly extend beyond the blood cancers treatments like Kymriah and axi-cel are able to treat. </p>    <div class="margin-top">        <h3>NOW WATCH: <a href="http://www.businessinsider.com/parents-unsuccessful-kids-bad-habits-2017-10">Parents of unsuccessful kids could have these 6 things in common</a></h3>        <div>                    </div>    </div>

A cancer treatment that's part of 'a big new field of medicine' just got approved

<p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>AP</span></p><p class="caption">A nurse reaches for blood samples taken from a patient receiving a kind of immunotherapy known as CAR-T cell therapy at the Fred Hutchinson Cancer Research Center in Seattle. Immune therapy is the hottest trend in cancer care and its next frontier is creating "living drugs" that grow inside the body into an army that seeks and destroys tumors.</p></div><p></p></div></div></p><ul><li><strong>Biotech giant Celgene is in talks to acquire Juno Therapeutics, <a href="https://www.wsj.com/articles/celgene-in-talks-to-buy-juno-therapeutics-1516140153">The Wall Street Journal reported on Tuesday</a>.</strong></li><li><strong>If the deal goes through, it'd be the second deal in the past few months for companies working on treatments that use the body's immune cells to fight cancer, following Gilead's <a href="http://www.businessinsider.com/why-gilead-bought-kite-pharma-for-12-billion-2017-8">acquisition of Kite Pharma</a>. </strong></li><li><strong><strong>These highly personalized treatments, called CAR T-cell therapy, are at the beginning of what some are calling </strong>"a big new field of medicine."</strong></li></ul><p><br />A new form of cancer treatment that harnesses the body's immune cells to treat cancer is back in the headlines.</p><p>The <a href="https://www.wsj.com/articles/celgene-in-talks-to-buy-juno-therapeutics-1516140153">Wall Street Journal reports</a> that <a href="http://markets.businessinsider.com/stock/CELG-Quote">Celgene</a> is in talks to buy cancer drugmaker <a href="http://markets.businessinsider.com/stock/JUNO-Quote">Juno Therapeutics</a>. </p><p>Juno is developing a <span>highly personalized cancer treatment called </span><a href="http://www.the-scientist.com/?articles.view/articleNo/42462/title/The-CAR-T-Cell-Race/">CAR T-cell therapy</a><span> (CAR is short for chimeric antigen receptor). </span></p><p><span>2017 was a big year for these treatments: the <a href="http://www.businessinsider.com/car-t-cell-therapy-approval-gilead-kite-2017-10">Food and Drug Administration approved two</a> treatments, one to treat treat <a href="http://www.businessinsider.com/why-the-fda-approved-kymriah-a-car-t-cell-therapy-to-treat-cancer-2017-8">pediatric acute lymphoblastic leukemia</a> in people up to age 25 and another to treat <a href="http://www.businessinsider.com/how-many-patients-car-t-cell-therapy-can-treat-2017-10">aggressive B-cell non-Hodgkin lymphoma</a>. And in August, Gilead Sciences nabbed CAR-T drugmaker <a href="http://www.businessinsider.com/why-gilead-bought-kite-pharma-for-12-billion-2017-8">Kite Pharma in a $12 billion</a> deal. </span></p><p><span>The interest in Juno has drummed up excitement for a possible deal for Bluebird Bio, another company developing cell therapies that has <a href="http://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-announces-global-strategic-collaboration-celgene">partnerships with Celgene</a>. Bluebird was up as much as 7% on Tuesday evening following the Celgene-Juno report. </span></p><h2><span>How CAR-T cell therapy works</span></h2><p>These treatments aren't your run-of-the-mill pill - or even a <a href="http://www.businessinsider.com/how-well-biosimilars-are-saving-money-2017-4">biologic drug</a>, like insulin - that can be mass produced. Since the therapy is made from a person's own immune system, the process can take about three weeks.</p><ul><li>To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient. In a healthy body, the immune system can recognize abnormal, cancerous cells, but for people with cancer, it doesn't recognize that the cells are spreading.</li><li>Then the cells are taken to a manufacturing facility at which point the cells are reengineered to recognize cancer cells and wipe them out.</li><li>Those reprogrammed cells are sent back and administered to the patient.</li></ul><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Ana Pelisson/Business Insider; Novartis</span></p></div><p></p></div></div></p><p>While the treatments don't work in all patients, it can have dramatic results in those who do respond. For example, <span>in a </span><a href="https://www.novartis.com/news/media-releases/novartis-pivotal-ctl019-6-month-follow-data-show-durable-remission-rates">trial of 63 patients</a><span> treated with Kymriah - <a href="http://www.businessinsider.com/why-the-fda-approved-kymriah-a-car-t-cell-therapy-to-treat-cancer-2017-8">the first cell therapy approved</a> - 83% were in remission after three months, and 64% were still in remission after a year.</span></p><h2>'A big new field of medicine'</h2><p>With two CAR-Ts already approved and more in the works over the next few years, the field of cell therapies is starting to emerge.   </p><p>"We're at the very beginning of what's going to be a big new field of medicine," David Epstein, who helped license Kymriah from the University of Pennsylvania while at Novartis, <a href="http://www.businessinsider.com/why-the-fda-approved-kymriah-a-car-t-cell-therapy-to-treat-cancer-2017-8">told Business Insider in August after Kymriah was approved</a>.</p><p>Epstein left Novartis in 2016 as CEO of its pharmaceuticals divisions. He's now the executive chairman of Rubius Therapeutics, a biotech firm that's also working with cell therapy to develop treatments like the CAR-Ts that don't have to be as personalized. The hope is that one day doctors will be able to prescribe a cell therapy and use it that same day instead of waiting weeks to get it back.</p><p>Epstein said he envisioned cell therapies having much shorter life cycles than traditional drugs. Instead of getting a better, updated therapy for a disease every decade or so, we might begin to see second-generation cell therapies in a few years.</p><p>One challenge these therapies still face is how toxic they can be. CAR-T's side effects can be deadly. In May 2017, Kite disclosed that<span> </span><a href="https://endpts.com/one-of-kites-car-t-patients-died-from-cerebral-edema-triggering-a-safety-alarm/">one person had died</a><span> </span>in a clinical trial for its late-stage CAR-T therapy from cerebral edema, a condition in which excessive fluid causes the brain to swell. Juno said five people in its<span> </span><a href="http://www.genengnews.com/gen-news-highlights/juno-halts-development-of-car-t-cell-cancer-immunotherapy-candidate-jcar015/81253961">clinical trials had died</a>, all from cerebral edema.</p><p>Eventually, cell therapies could go beyond blood cancers, and include solid tumors and maybe even autoimmune diseases like Type 1 diabetes, Epstein said.</p>    <div class="margin-top">        <h3>NOW WATCH: <a href="http://www.businessinsider.com/uk-china-countries-drive-left-side-road-traffic-ancient-rome-sword-fight-2016-12">The surprising reason some countries drive on the left side of the road</a></h3>        <div>                    </div>    </div>

The hottest thing in cancer drug development is a takeover target again - here's what you need to know about it

<p><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"><p class="source"><span>AP/Elaine Thompson</span></p><p class="caption">In this photo taken March 29, 2017, Dr. David Maloney of the Fred Hutchinson Cancer Research Center is greeted by patient Ken Shefveland, whose lymphoma was successfully treated with CAR-T cell therapy.</p></div><p></p></div></div>The FDA approved the first-ever gene therapy in the US on Wednesday.</p><p>The drug, <a href="http://www.businessinsider.com/fda-approves-novartis-car-t-cancer-treatment-2017-8">called Kymriah</a>, is a <span>highly personalized cancer treatment called </span><a href="http://www.the-scientist.com/?articles.view/articleNo/42462/title/The-CAR-T-Cell-Race/">CAR T-cell therapy</a> (CAR is short for chimeric antigen receptor).</p><p>It's a type of cancer immunotherapy, which harnesses the body's immune system to take on cancer cells. In this case, the therapy removes a person's cells, reengineers them, then puts them back in their body to attack cancer cells.</p><p>The <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm">FDA approved</a> Kymriah to treat <span>pediatric acute lymphoblastic leukemia in people up to 25 years old. </span></p><p><span>The one-time treatment isn't cheap: <a href="http://markets.businessinsider.com/stock/NVS-Quote">Novartis</a> said on Wednesday that the price would be $475,000, which is actually <a href="https://www.statnews.com/2017/08/30/novartis-car-t-cancer-approved/">lower price than many expected</a>. Only about 600 people per year could possibly get this treatment based on Wednesday's approval. Even so, the approval has industry experts and cancer doctors excited. </span></p><p><span>"This approval will open the floodgates for these kinds of therapy to be used in many different leukemias, lymphomas, solid tumors, myelomas," Dr. Prakash Satwani, a pediatric hematologist-oncologist at Columbia University Medical Center, told Business Insider. "I think this is just the beginning of a new era of gene therapy."  </span></p><h2><span>How Kymriah works</span></h2><p>Kymriah, which is made by Novartis, isn't your run-of the-mill pill, or even a <a href="http://www.businessinsider.com/how-well-biosimilars-are-saving-money-2017-4">biologic drug</a>, like insulin, that can be mass-produced. Since the therapy is made from a person's own immune system, the process can take about three weeks. </p><ul><li><span>To start, a doctor removes some of a patient's white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances. In a healthy body, the immune system can recognize abnormal cancer cells, but for people with cancer, the immune system isn't recognizing that the cancer cells are spreading and taking over the body. </span></li><li><span>Then, the cells are taken to Novartis's manufacturing facility in New Jersey, at which point the cells are reengineered to recognize cancer cells and wipe them out.</span></li><li><span>Those reprogrammed cells are sent back to the patient and administered, at which point the new cells try to kill off the cancer cells. </span><span></span></li></ul><p><span>While that is the only time the treatment's given, it's not the end of the road. About half of the patients in the Kymriah study got cytokine release syndrome, a response to the reprogrammed cells running loose around the body. It can cause high fevers and flu-like symptoms, and can be a life-threatening complication. If that happens, patients need to be admitted into intensive care units, which can bring additional costs. The FDA on Wednesday expanded the approval of Actemra, a rheumatoid arthritis drug that can also treat cytokine release syndrome.</span></p><p><span>There are other severe side effects that can pop up as well that can require hospitalization. Satwani - who hasn't delivered the CAR-T therapy himself but is heading up the program at Columbia, one of the 32 sites that Novartis will use - said patients need to be closely monitored for a month or so, meaning they'll need to be less than a two hour drive away from their hospital. But while the treatment is complex, it offers huge rewards. </span></p><p><span>"We have to keep in mind that patients will get cured of leukemia," Satwani said. "It's a great accomplishment." </span></p><p><span>In a <a href="https://www.novartis.com/news/media-releases/novartis-pivotal-ctl019-6-month-follow-data-show-durable-remission-rates">trial of 63 patients</a> treated with Kymriah, 83% were in remission after three months, and 64% were still in remission after a year. </span></p><p><span>"Patients who get this therapy basically have no chance to survive," he said. "Obviously this will change the lives of many patients and their families and the field."</span></p><p><span><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Reuters</span></p><p class="caption">Cancer cells are seen on a large screen connected to a microscope at the CeBit computer fair in Hanover, Germany, March, 6, 2012.</p></div><p></p></div></div></span></p><h2><span>'A big new field of medicine'</span></h2><p><span>Kymriah is the first CAR-T cell therapy to get approved, and there are several more in the works. Kite Pharma, <a href="http://markets.businessinsider.com/news/stocks/kite-pharma-juno-stock-price-surges-after-takeover-announcement-2017-8-1002288759">Juno Therapeutics, and Bluebird Bio</a> are among a growing group of biotech companies working with CAR-T. Kite Pharma, which just got <a href="http://www.businessinsider.com/gilead-to-buy-kite-pharma-for-12-billion-a-cancer-immunotherapy-company-2017-8">acquired by Gilead Sciences</a>, is expected to hear back from the FDA on its treatment for aggressive B-cell non-Hodgkin lymphoma by November. </span></p><p>"We're at the very beginning of what's going to be a big new field of medicine," David Epstein, who helped license Kymriah in from the University of Pennsylvania while at Novartis.</p><p>Epstein, the former CEO of Novartis' pharmaceuticals division, left in 2016 and now serves as executive chairman at Rubius Therapeutics, a biotech that's also working with cell therapy to develop treatments like Kymriah that don't have to be as personalized. The hope is that one day doctors might be able to prescribe a cell therapy and use it that same day, instead of waiting weeks to get the therapy back. </p><p>Epstein said he envisions cell therapies having much shorter life cycles than traditional drugs. Instead of getting an updated therapy that works better on a disease every decade or so, we might begin to see second-generation cell therapies in just a few years. </p><p>Those updates could potentially expand the number of patients cell therapies are able to treat. For now, only about 600 people a year will be eligible for Kymriah. That could expand to tens of thousands of people, but it'll require some major changes, Epstein said. </p><p>For one, the treatments will have to treat more types of cancer than the one approved on Wednesday. They'll also have to be less toxic, so more people can consider it instead of only those who have very few other options. The side effects to CAR-T can be deadly. In May, Kite disclosed that<span> </span><a href="https://endpts.com/one-of-kites-car-t-patients-died-from-cerebral-edema-triggering-a-safety-alarm/">one person had died</a><span> </span>in a clinical trial for its late-stage CAR-T therapy from cerebral edema, a condition in which excessive fluid causes the brain to swell. And last year, another company, Juno Therapeutics, said five people in its<span> </span><a href="http://www.genengnews.com/gen-news-highlights/juno-halts-development-of-car-t-cell-cancer-immunotherapy-candidate-jcar015/81253961">clinical trials had died</a>, all from cerebral edema.</p><p>And then, to impact more people, the cell therapies will need to go beyond the blood cancers. Right now, that's where most of the big successes have come from, but one day that could expand out to solid tumors, and maybe even auto-immune diseases like type 1 diabetes, Epstein said.</p>    <div class="margin-top">        <h3>NOW WATCH: <a href="http://www.businessinsider.com/how-and-when-our-universe-will-end-2017-8">The terrifying way our universe will end - and when</a></h3>        <div>                    </div>    </div>

You Searched For "rubius therapeutics" and got 8 results

Rubius Therapeutics surges 84% on encouraging results from early-stage testing of cancer treatment

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A cancer treatment that one expert called the 'most exciting thing I've seen in my lifetime' just got approved to treat more patients

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A cancer treatment that's part of 'a big new field of medicine' just got approved

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