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Anesti A.-M.,BioVex Ltd | Coffin R.S.,Biovex Inc.
Expert Opinion on Biological Therapy | Year: 2010

Importance of the field: Pain is a hugely important area of research attracting considerable academic and commercial interest. However, the application of RNA interference (RNAi) to the study of nociceptive processes and the development of new analgesics has been limited by the specific challenges associated with the delivery of RNAi triggers to the cell bodies of sensory neurons in the dorsal root ganglia (DRG).Areas covered in this review: In the past five years, delivery of small-interfering RNA (siRNA) to the DRG and spinal cord has achieved effective and specific silencing of targeted genes in various animal models of pain. However, delivery of short-hairpin RNA (shRNA) or artificial microRNA (miRNA) to sensory neurons in vivo has not been feasible using most delivery systems currently available. What the reader will gain: Replication-defective vectors based on herpes simplex virus (HSV), which are particularly efficient at targeting DRG neurons, have been recently engineered to express shRNA and artificial miRNA. Whilst silencing induced by siRNA is transient and requires relatively high doses of silencing triggers, HSV-mediated expression of shRNA/miRNA in sensory neurons allows silencing of targeted genes for at least one week following a single injection.Take home message: The potential to use inducible or tissue-specific promoters and to simultaneously silence multiple gene targets, in addition to recent studies suggesting that artificial miRNAs may have improved safety profiles, hold clear advantages for the use of miRNA-based vectors for gene silencing in sensory neurons.


Coffin R.S.,Biovex Inc.
Current Opinion in Virology | Year: 2015

Viruses have been suggested to be useful as anti-cancer agents since the early 20th century, although following the advent of chemotherapy and radiotherapy work largely stopped until the 1990s when a number of groups began to explore the use of engineered viruses. This overview summarizes the development of the field from the 1990s to the present day, an era when oncolytic viruses have now demonstrated clear clinical benefit to patients. The hurdles and challenges which needed to be overcome are discussed, and in particular the importance of the immune component in achieving a therapeutic effect is highlighted. Today, oncolytic therapy is generally thought of as an immunotherapy, the term 'oncolytic immunotherapy' having been widely adopted. With the advent of immuno-oncology drugs based on immune checkpoint blockade, a clear rationale for synergy between the two approaches, and initial pre-clinical and clinical data suggesting this to be the case, it might be expected that oncolytic immunotherapy combined with checkpoint blockade will provide a cornerstone of future cancer treatment. © 2015 Published by Elsevier B.V.


News Article | September 9, 2010
Site: www.xconomy.com

Jennerex, Charging Ahead With Tumor-Killing Virus, Follows Biotech Road Less Traveled Sometimes the innovation community can be a tough insider’s club. If you’re a biotech startup, you’re only real when Merck/Pfizer/Novartis/Glaxo/Roche or some big VC like Kleiner Perkins bets cash that says you might be real. So sometimes a potentially groundbreaking idea has to find some other way to get critical support. That’s what San Francisco-based Jennerex is doing. This startup, founded in 2005, has raised $45 million from a group of wealthy individuals and struck three key partnerships with pharmaceutical companies that aren’t exactly household names in this country—South Korea-based Green Cross, China-based Lee’s Pharmaceuticals, and France-based Transgene. This cast of unusual suspects is setting out to do something that lots of scientists—including those at Emeryville, CA-based Onyx Pharmaceuticals and South San Francisco-based Cell Genesys—have failed to accomplish in the past. Jennerex, like those companies once did, is betting on the intriguing concept of oncolytic viruses. These are viruses that are genetically modified to replicate strictly inside tumors, killing tumor masses from the inside out, while also sparking the immune system to hunt down any residual cancer cells that have spread throughout the body. No one has yet secured an FDA approval for a cancer drug that works this way, despite lots of trying, so people have a right to be skeptical. But Jennerex has scored some new validation for a new variation on this theme, via a $116 million partnership announced this week with Transgene. That’s enabling Jennerex to lay the groundwork for the next serious step—the third of three stages of clinical trials needed to win FDA approval. If Jennerex’s team of 40 people have learned from the mistakes of the past, they could be sitting on a treatment that fights all sorts of solid tumors—starting with liver and colorectal cancer. And if that Phase III trial delivers proof that its treatment can extend lives, Jennerex will have done it without giving up massive ownership stakes and control to Big Pharma or VCs along the way. “Everybody acknowledges this has phenomenal potential,” says Jennerex CEO David Kirn. “Everybody is interested and wants to talk to us, but in terms of putting big money down, Big Pharma wants to see want randomized survival data with at least 80 to 100 patients. Once we have that, or have an FDA approval, it will break this field wide open.” “It’s really too novel for big companies to bite off just yet,” he adds. Kirn knows all the players quite well, having pursued this idea personally for a long time. He’s an oncologist, currently an adjunct professor for Oxford University, and a veteran from the early days of Onyx Pharmaceuticals. He pushed for the oncolytic virus approach there in the 1990s, just like he is pushing for it today at Jennerex. Of course, this isn’t just one committed guy at Jennerex up against a wall of resistance from Big Pharma. Woburn, MA-based BioVex raised $70 million in venture capital last year for its oncolytic virus treatment, which is currently being tested in the pivotal stage of clinical trials for patients with melanoma. Calgary, AB-based Oncolytics Biotech (NASDAQ: ONCY) is also in the hunt, as well as more than 100 academic groups around the world, Kirn says. BioVex and Jennerex appear to be the leaders in the field at the moment, he adds. So what’s new and different with this new crop of oncolytic viruses? Oncolytic viruses of the past tended to be safe and show some activity, but … Next Page »


News Article | January 26, 2011
Site: www.xconomy.com

Amgen’s R&D Chief, Roger Perlmutter, on Why BioVex’s Cancer-Fighting Virus Is Worth $1B Roger Perlmutter, the guy who runs R&D at the largest biotech company in the world, is an immunologist by training. So it shouldn’t be any surprise that he’s fascinated by recent advances in which scientists have shown they can harness the immune system to fight tumors. Now he’s acting on that emerging knowledge of cancer immunology in a big way, through Amgen’s potential $1 billion acquisition of Woburn, MA-based BioVex. Thousand Oaks, CA-based Amgen (NASDAQ: AMGN), which has significant R&D centers in South San Francisco, Seattle, and Cambridge, MA, made headlines yesterday with its big bet on a novel cancer treatment in development at BioVex. Perlmutter, the executive vice president of R&D at Amgen, has his fingerprints all over this deal, since he’s been working to transform Amgen into a more aggressive developer of anti-tumor drugs over the past decade. I’ve known Perlmutter for almost the entire time he’s been at Amgen, so I was eager to hear his thoughts the day after the big BioVex deal was struck. Scientists have been dreaming for decades about alternatives to traditional chemotherapy, radiation, or surgery—particularly those that can harness the body’s immune system to fight tumors as if they were a foreign invader like a virus. Most of these efforts went down in flames, until Seattle-based Dendreon (NASDAQ: DNDN) won FDA approval last year for the first treatment of this kind—which analysts say now has multi-billion dollar annual sales potential. One variation on this theme is through what BioVex and others have done, utilizing what are known as oncolytic viruses. These viruses are designed to specifically replicate inside tumors, causing them to burst, while also sending signals that alert the immune system to seek and destroy any residual cancer cells that might have been able to evade the virus. Neither BioVex, nor anybody else, has proven that it can fight tumors well enough to win FDA approval, but Amgen’s bet is that BioVex will validate the oncolytic virus approach much like Dendreon proved cancer immunotherapy a year ago. “I’ve looked at this field for a long time and found it to be rather discouraging,” Perlmutter said of oncolytic viruses. But over the last couple of years, after seeing what BioVex has done in clinical trials, Perlmutter says he was impressed by not just the company’s engineered virus, but the immune system effect it was able to trigger. “It seemed to me it was more and more likely they were seeing an effective immune response. It looked more and more promising.” BioVex has been pursuing this challenge for a long time, having been founded in 1999 by Robert Coffin, a virologist from University College London. A dozen years later, Amgen snapped it up as BioVex was pushing its lead program, OncoVex GM-CSF, through the third and final stage of clinical trials normally required for FDA approval. The company is enrolling patients with both melanoma, a deadly form of skin cancer, and head and neck cancer. The science is really interesting here, and Perlmutter was clearly happy to talk about what interested him (maybe he was bored with poring over spreadsheets on yesterday’s earnings call?). Here’s the basic idea. The BioVex team has … Next Page »


News Article | January 24, 2011
Site: www.xconomy.com

Amgen to Acquire BioVex for Up To $1B, to Obtain Cancer-Killing Virus Therapy Amgen is sticking its scientific neck out, and potentially $1 billion of its cash, to buy a company in Woburn, MA that hopes to deliver the first FDA-approved virus engineered to specifically kill cancer cells. Thousand Oaks, CA-based Amgen (NASDAQ: AMGN) said today it has agreed to pay $425 million upfront, plus another $575 million in additional development and sales milestones, to obtain privately-held BioVex. Amgen, which has significant research and development operations in South San Francisco, Seattle, and Cambridge, MA, said it expects to close this deal before the end of March. BioVex, which we last wrote about in November 2009, raised $70 million in venture capital that year to carry out the final steps of development with its oncolytic virus therapy. BioVex is seeking to harness decades of science, in which researchers have sought to genetically modify viruses to replicate inside tumors, while sparing healthy tissue. Once inside, the treatment (OncoVex GM-CSF) is supposed to cause tumor cells to burst. But it doesn’t stop there—it is also designed to provoke the immune system to mount an attack in the cancerous growth itself, and hunt down any cancer cells that have spread throughout the body. BioVex, as I noted in these pages just over a year ago, has attracted interest from scientists and investors based largely on one study of 50 patients with forms of melanoma, a deadly skin cancer, that have spread through the body. That study found that 13 of the 50 patients (26 percent) had their tumors shrink after they got the BioVex treatment. Even more interesting, eight of the 13 initial responders had their tumors completely disappear, and their responses were long-lasting. Although patients who entered the trial had terminal diagnoses, usually giving them six to nine months to live, according to BioVex CEO Philip Astley-Sparke, more than half of the patients were alive after one year (58 percent) and two years (52 percent), according to data presented at the American Society of Clinical Oncology in June 2009. Side effects were mostly mild-to-moderate flu-like symptoms, researchers said. The company is now in the midst of gathering more proof from a Phase III clinical trial which, if successful, could be the basis for it to win FDA approval of the first such oncolytic virus therapy. BioVex is running a trial expected to enroll as many as 430 patients, according to a posting on clinicaltrials.gov. The goal will be to show the BioVex drug offers an advantage in tumor shrinkage … Next Page »


We saw news of regulatory approvals, acquisitions, financings, and an even a new venture group surrounding Boston’s life sciences firms this week. —A European Medicines Agency committee advised against approval of fampridine (Fampyra), Weston, MA-based Biogen Idec’s drug for improving multiple sclerosis patients’ ability to walk. Biogen (NASDAQ: BIIB says it will appeal the opinion. —Ryan took a look at Dossia, a Cambridge, MA-based non-profit consortium that launched in 2006 to provide employees of its member companies with personally controlled digital health records. The group also has a for-profit unit that is looking to raise funding from outside investors and Dossia members, says chief executive Michael Critelli. —Newton, MA-based Clinical Data saw a nice bump in its stock price alongside news that the FDA had approved its treatment for major depressive disorder, vilazodone. Shares were trading at $24.05 apiece on Monday morning, a 60 percent jump from Friday’s closing price. Ryan took a look at the part Clinical Data’s (NASDAQ: CLDA) chairman, Randal Kirk, played in getting the regulatory approval for the drug. —Sanofi-Aventis has given shareholders in Cambridge biotech Genzyme (NASDAQ: GENZ) some more time to consider its $69-per-share tender offer, which was set to expire last Friday. Now, Genzyme investors have until just before midnight on February 15 to decide if they want to turn their shares over to the French drug giant at that price. —Amgen (NASDAQ: AMGN) announced it was buying Woburn, MA-based BioVex in a deal that could be worth as much as $1 billion. Amgen vice president of R&D Roger Perlmutter is an immunologist by training, so the acquisition of BioVex, which is engineering viruses to kill cancer while sparing healthy tissues, makes sense for Thousand Oaks, CA-based Amgen, Luke wrote. —Cambridge-based Stromedix, a developer of treatments for a cause of organ failure known as fibrosis, has raised $2 million of a debt offering that could hit $15.5 million, an SEC filing showed. —Area philanthropist and real estate developer John Flatley has recently founded a venture firm focused exclusively on investing in life sciences companies working on treatments for cystic fibrosis. Flatley Venture Capital is out to invest between $200,000 and $2 million in companies pursuing these treatments, who may not be able to afford to develop technologies for the relatively small cystic fibrosis market.


News Article | November 26, 2014
Site: www.fiercebiotech.com

While investors have been pouring hundreds of millions of dollars into a virtual Manhattan Project on new immuno-oncology drugs, a startup that sprang out of a lab at New York University's Langone Medical Center has taken the first steps in what it sees as a unique follow-up to the first wave of therapies. The biotech is BeneVir Biopharm, based in Rockville, MD. According to an SEC filing from Monday, the biotech has raised the first $2 million of a planned $12 million Series A--lunch money in the IO world. And it's using its seed cash to work on oncolytic viruses similar to Amgen's ($AMGN) T-Vec that can kill cancer cells. But there's a twist. The treatments are also supposed to "remodel" the antigens on antigen-presenting cells so that the immune system can target and eliminate both immune-susceptible cells as well as immune-evading cells. That triple shot at cancer, the biotech explains in a recent release, is designed to achieve a durable response--the key goal for new drugs that designed to both knock back cancer and then hold it back, preventing a relapse. The bright idea behind the fledgling was provided by Ian Mohr, a researcher at NYU's Langone Medical Center. NYU outlicensed the technology to BeneVir, which is run by Matthew Mulvey, who earlier completed a stint as a project director in diagnostics R&D at the antibiotics company Sequella. Mohr is running the scientific advisory committee with an NYU colleague, Alan Frey. Mohr's already done some work in the field, according to the release. He "discovered and patented SUP1, an attenuated, replication competent Herpes Simplex Virus" that was licensed to BioVex when it was assembling its IP for T-Vec, which subsequently was bought out by Amgen and is now in front of the FDA with positive but mixed data. Their seed money came from a nontraditional source. They're funded by Pansend, a subsidiary of HC2 Holdings, which has taken a stake in a variety of things like steel fabrication. "BeneVir intends to rapidly advance its lead candidate to the clinic. We look forward to working closely with Dr. David Present and Cherine Eldumiati Plumaker of Pansend as we move our programs forward and address the unmet medical needs of patients living with difficult-to-treat cancers," said BeneVir CEO Matt Mulvey. Related Articles: VentiRx banks $50M as it ramps up immuno-oncology research efforts in Seattle AstraZeneca adds Advaxis to a growing roster of immuno-oncology partners Bristol-Myers inks a $650M deal to pair with Five Prime on immuno-oncology gold rush


News Article | February 12, 2015
Site: www.fiercebiotech.com

Amgen ($AMGN) has high hopes for its new cancer vaccine, barreling toward global approvals with positive data in melanoma. But a narrow miss on one key endpoint could present a major hurdle, and Amgen will soon get a chance to defend the treatment before a panel of FDA advisers. Two of the agency's independent expert committees are slated to review talimogene laherparepvec (nicknamed T-Vec) on April 29, voting whether to recommend the vaccine for full approval. The FDA isn't required to follow the opinions of its advisers, but it most commonly does. The agency has promised to hand down a final decision on Amgen's candidate by Oct. 27. Across its expansive Phase III program, T-Vec proved it could shrink tumors, keep them from regrowing and improve median survival. However, in late-stage results unveiled last year, the vaccine hit its primary endpoint of durable response in patients with metastatic melanoma but missed its second goal of boosting overall survival. But it was close, the company noted, pointing to a "trend" toward statistical significance with a p value of 0.051. That's sure to come up when the agency's Cellular, Tissue and Gene Therapies and the Oncologic Drugs advisory committees pore over T-Vec's data. And while the issue is unlikely to derail Amgen's ambitions--the FDA has a well-established penchant for approving cancer treatments with much less supporting data than T-Vec--it could have a trickle-down effect on the drug's eventual value if and when it hits the market. For its part, Amgen has stayed upbeat about the treatment's potential, standing by its results in monotherapy trials and heralding its promise as part of a cancer-killing cocktail. To that end, Amgen has launched a combo study pairing the virus with Bristol-Myers Squibb's ($BMY) top-selling melanoma treatment Yervoy, and the company has teamed up with Merck ($MRK) to study how well its drug can complement Keytruda, a PD-1 checkpoint inhibitor approved last year. "The incidence of melanoma has continued to rise in recent years, and even with recent additional options in treatment, there is an important unmet medical need," Amgen R&D chief Dr. Sean Harper said in a statement. "We look forward to discussing the efficacy and safety profile of talimogene laherparepvec with the advisory committees, and we are committed to working closely with the FDA during its review of the BLA." Amgen picked up T-Vec in its $1 billion deal for 2009 Fierce 15 honoree BioVex. The vaccine, a re-engineered herpes simplex virus, is designed to replicate itself within tumor cells until they burst, all the while stimulating an immune response against the cancer cells. Related Articles: Amgen faces a make-or-break 2015 with its late-stage pipeline Amgen tests T-Vec's combo potential in trial with Merck's Keytruda Amgen is gunning for approval of viral cancer vaccine, adds positive combo data


News Article | February 17, 2011
Site: www.xconomy.com

Viruses that are genetically engineered to fight tumors, without harming healthy cells, may sound like sci-fi. But San Francisco-based Jennerex Biotherapeutics has started gathering some intriguing—albeit quite preliminary—clinical trial evidence that suggests this approach may be helping liver cancer patients live longer, Xconomy has learned. Jennerex, which I first wrote about here in September, flies below the radar of most biotech pros, and has collected its $45 million in financing from sources few in biotech have heard of. And to be clear, the data on Jennerex’s oncolytic virus therapy, JX-594, is about as far from scientific peer-review as you can get. It’s based on a small number of patients—26 so far—with liver cancer. More patients still need to enroll, more follow-up time is required, and the findings haven’t yet been presented at a scientific meeting. But if the early trends described by Jennerex CEO David Kirn hold up over time, this could be shaping up as the kind of result that cancer researchers will buzz about for a long time. “This trial is what everybody has been waiting for,” says Kirn, an oncologist and former VP of clinical research at Onyx Pharmaceuticals (NASDAQ: ONXX). “Everybody knew oncolytic viruses had been shown to be safe, and they show some anti-tumor activity, although not to the degree we’re seeing it. Everybody is waiting for randomized survival data. Nobody has shown data like this before.” Before diving into the nitty gritty details, a little background is required. Jennerex is one of a handful of companies actively developing viruses that are genetically modified to replicate strictly inside tumors. These injectable viruses are designed to work their way into tumors, where they replicate very fast, causing the cancer cells to burst. The Jennerex treatment is also made to target the blood vessels that nourish the tumor, and send signals that alert the immune system to seek and destroy any residual cancer cells that might have been able to evade the virus. Many companies—Onyx Pharmaceuticals and Cell Genesys—have tried similar approaches and no one has yet won an FDA approval. But the field saw a renewed burst of interest last month when biotech giant Amgen (NASDAQ: AMGN) agreed to pay as much as $1 billion to acquire a new player in the field, Woburn, MA-based BioVex. Jennerex’s drug, JX-594, isn’t as far along in clinical trials as BioVex’s. The Jennerex treatment has gone through a series of initial clinical trials in a total of 96 patients to date, mostly to establish safety, and to study the way the virus works, Kirn says. But the really interesting stuff is emerging from a mid-stage study, which has enrolled 26 patients since early 2009, Kirn says. The study is designed to enroll patients with primary liver cancer, known as hepatocellular carcinoma. Patients in the U.S., who get one of the standard drugs, Bayer and Onyx’s sorafenib (Nexavar) are generally thought to have a median life expectancy of 10.5 months, while patients in Asia typically have a life expectancy of about five to six months, Kirn says. Patients in the study were randomly assigned to get either a high dose or a low dose of the Jennerex treatment. Those who enrolled got three doses over a one-month period, and then were followed up. The study began in early 2009, and still needs about four more patients to reach its full enrollment target of 30, Kirn says. The primary goal of the trial is to see how long the Jennerex drug can keep tumors from spreading. But one of the secondary goals looks at the key question in all cancer trials—how long are patients actually living? Early returns show that a handful of the original 26 are still alive after more than two years of follow-up, and “close to 10″ have made it past one year, Kirn says. Not enough of … Next Page »

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