Luke Timmerman put together his definitive list of biotech movers and shakers that you should follow on Twitter (or at least a group of interesting Tweeters who offer insight in their areas of expertise). Luke should know, so check this esteemed "A list" out.
See Xconomy.
Posted by Bruce Lehr Sep 24th 2012.
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From Luke Timmerman, a tale that the 9 biotech IPOs so far in 2012 are not only doing better than expected but are actually leading more prominent Tech company IPOs from this year. From his post this morning:
Regular readers of this column [Xconomy's BioBeat] know that I’ve long been skeptical about how much appetite investors have for biotech IPOs. But I did notice some “modest signs of life” in the IPO market a few months ago, and was curious to follow up and see what has happened. By my count, there have been nine biotech IPOs so far this year, compared with 12 in all of 2011. That still says to me there’s limited demand from investors for new drugs, devices, and diagnostics. But of those nine companies that made it through the IPO gauntlet, six are trading above their IPO price and none have crashed.
So all is not lost in the Land of the Biotech IPO.
Posted by Bruce Lehr Aug 13th 2012.
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ADC Bio received a new development grant from the Welsh government for its new antibody drug conjugate manufacturing technology that it hopes will make drug production cheaper. The new "lock and release" method will minimize production steps and cut costs.
ADC Bio wins development grant for new ADC production tech.
The new technology is performed on a solid support versus current methods done in solution at high dilution. Binding the antibody to a solid support prior to the conjugation step provides some of the following advantages according to ADC Bio:
ADC Bio expects to begin testing commercial scale production in the next year and a half. It plans to license the technology to CMOs and drug companies. The prospect of ADC's making a much bigger splash in cancer therapeutics over the next decade bodes well for demand for ADC manufacturing services and technologies.
Posted by Bruce Lehr Dec 13th 2011.
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iBio successfully expanded the use of its technology to biosimilar mAbs by producing rituximab in non-transgenic green plants, thereby expanding its use beyond production of viral antigens for vaccines.
"The production of functional rituximab in plants suggests that many if not all mAbs can be produced using the iBioLaunch system," says Terence Ryan, senior vice president.
iBio says that the rituximab produced in plants underwent a number of preclinical tests to evaluate efficacy. The plant-derived treatment showed similar target cell cytotoxicity and antigen recognition to rituximab produced in mammalian cells. No word if the products were compared under similar guidelines used by the EMEA to judge a biosimilar versus the approved reference product -- or not.
Rituximab success paves way for plant produced mAbs.
That's it. Run get your gardening gloves and shovel. Order some mulch and fertilizer. Cell culture is DEAD! Or perhaps word of its death is greatly exaggerated.
Posted by Bruce Lehr Oct 10th 2011.
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A Lilly spokesman said the company will invest multi-millions in its biotechnolgy programs in order to develop new multi-specific therapies for a variety of diseases. Multi-specific therapies use molecular biology techniques to combine more than one drug "mechanism of action" on a single drug molecule. This differs from combination therapies which involve more than one drug.
Lilly plans to hire more biochemists and biologists to support this research effort. Therapeutic areas to be pursued include diabetes, cancer, and autoimmune diseases where often one drug is not sufficient to effectively treat the disease. See Bloomberg.
Posted by Bruce Lehr July 5th 2011.
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A few weeks ago, Battelle Memorial Institute issued a report estimating the economic impact of mapping the human genome. The conclusion? The US Government earned a handsome return on its $3.8 billion investment between 1988 and 2010. See Patent Doc blog.
The major findings in the report were as follows:
In calculating these returns, the work of private entitities like Celera Genomics were included in the analysis by Battelle. The project has been called "one of the best uses of of taxpayer dollars the US government has ever made."
What do we do for an encore? More government support for R&D in the pharma and biotech industry - tax credits anyone -- to support more translation of the genome findings into therapies? Imagine that! a government investment in technolgy that paid off big.
Posted by Bruce Lehr May 24th 2011.
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Pfenex and MedImmune will partner up in a three year pact to use Pfenex Expression Technology to develop bioprocesses for MedImmune human therapeutic proteins and vaccines.
Pfenex expression technology to engineer production strains for MedImmune's proteins and vaccines.
Pfenex will engineer production strains, using its Pseudomonas fluorescens organism, broad tool box, and high throughput robotically enabled strain screening platform, to express MedImmune lead molecules. Pfenex claims that it routinely can go from DNA to an identified production strain within 8 weeks. MedImmune will carry forward preclinical and clinical development.
MedImmune senior vice president of biopharmaceutical development, Gail Wasserman said "Pfenex's scientific approach to strain development and protein expression is robust and aligned with the way we work at MedImmune."
The Pfenex system utilizes defined development and production media that are free of animal proteins. The platform has been accepted by US and international regulatory agencies in multiple human clinical trials up to Phase III currently in progress.
Posted by Bruce Lehr May 12th 2011.
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Researchers at the University of California earlier this month formed the UC Berkeley Synthetic Biology Institute (SBI) to advance efforts to engineer cells and biological systems. Agilent Technologies is providing infrastructure, expertise, and funding for the new institute. The move signals growing research and commercial interest in the nascent field of synthetic biology.
PharmTech Talk » Synthetic Biology Takes Another Step Forward.
Synthetic biology came to the public ken last year when the J. Craig Venter Institute (JVCI), a genomic-research organization founded and headed by J. Craig Venter, announced the successful construction of the first self-replicating synthetic cell. This represented a significant step in the still-emerging field of synthetic biology. With that proof of principle, JVCI is working on creating an organism that contains the minimal genome required to sustain itself and its replication to be used as a platform for analyzing the function of every essential gene in a cell. The researchers envision eventual wider use of the technology in the development of a range of therapeutic products, such as pharmaceuticals and vaccines.
SBI is looking to take synthetic biology to the next level. SBI’s ultimate aim is to “create an industrial revolution in biological engineering,” said Matthew Tirrell, chair of Berkeley’s Department of Bioengineering and SBI’s founding director. “SBI seeks to bridge the gap between the small-scale, biological engineering of the present and industrial-level production by developing design tools and other infrastructure to produce synthetic biological systems reliably on a large scale.”
“Synthetic biology potentially can have as profound an impact in the 21st century as semiconductor technology had in the 20th,” said William P. Sullivan, Agilent’s CEO and president. “To get there, we need to engineer biological solutions that are scalable, reliable, and safe. This is precisely what the UC Berkeley Synthetic Biology Institute is addressing, and why Agilent is enthusiastic about providing infrastructure, expertise, and funding for this new institute.”
This is an interesting new approach to complement or compete with genetic engeering to produce production scale systems. It's clearly many years away and we'll have to see if it will be competitive to the current systems and their large head start in biotechnology.
Posted by Bruce Lehr April 30th 2011.
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i don't know why exactly -- but thought this was an interesting development. Probably as I have always been skeptical as to how quickly recombinant therapeutics in plants would take to make it to market -- i.e. be commercially and regulatorily viable. Even though, I've seen many projects at this pont that were technically possible.
Caliber opens world’s largest plant-based manufacturing facility.
The US-based vaccine specialist, Caliber Biotherapeutics, has opened the world’s largest modular pharmaceutical manufacturing facility utlizing plant technology at its headquarters in Bryan, Texas. The company claims the new facility is capable of producing 10-100 million low-cost vaccine doses per month, along with other protein therapeutics such as monoclonal antibodies.
“With plant-based systems we have an unprecedented level of flexibility and scalability,” said Barry Holtz, Caliber's CSO.
Biodefense expert and chief medical officer for Caliber, Brett Giroir, said the new facility provided the company with a flexible, scalable manufacturing capacity to meet changing demands in the global vaccines market.
In addition to the company’s new plant-based facility in Bryan, Caliber also announced its intention to develop a proprietary product pipeline for cancer and infectious diseases, which it claims will utilize cell and microbial-based production systems.
We shall see what impact this facility and technology actually has on the market. The low-cost production and flexibility being described above would seem suited to production of biosimilars and vaccines for developing areas in the world to name two target segments.
Posted by Bruce Lehr April 26th 2011.
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Xconomy - San Francisco gives an update on Jenerex's progress with its oncolytic virus technology targetting liver cancer. The company is seeing good results so far with its JX-594 vaccine directed to patients with hepatocellular carcinoma. So far the company has only been able to look at 26 patients and needs 4 more to complete this small trial.
Jennerex is trying to compare treatment with JX-594 to the current standard of care with Bayer/Onyx Pharmaceuticals Nexavar. They need more patients and need randomized survival data before any conclusions can be definitively drawn.
Based on the limited 26 patient sample, it appears the low dose course with JX-594 is comparable to Nexavar and the high-dose course is performing better using median survival time as a measure (not complete data set yet for statistical significance - watch out in oncology for this!).
Nevertheless, Jennerex's results appear to be positive enough for now to draw more investor interest, especially since Amgen recently acquired another oncolytic virus property in its deal with BioVex. Let's wait for Jennerex next round of larger trial data they hope to complete by the end of 2012.
Posted by Bruce Lehr Feb 19th 2011.
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From Seeking Alpha, Seattle Genetics is increasing "in" and Immunogen increasingly "out" in ADC projects in Genentech. Genentech recently advanced 3 more antibody drug conjugate (ADC) programs to phase I using the SeaGen technology. This is in addition to another more advanced program for a CD22 ADC aimed at blood cancers. Genentech has not confirmed the identity of the three programs but it is speculated that CD97b (lymphoma) and TENB2 (prostate cancer) are among them.
Beyond that, Genentech still has TDM-1 based on Immunogen technology and it has shown remarkable activity and a surprisngly benign safety profile. All of the Genentech ADCs employ non-cleavable linkers and Genentech appears to prefer the SeaGen technology for that purpose. Genentech also seems to prefer targets where non-cleavable linkers can be used with success - which again points toward more Seattle Genetics projects if that trend continues.
Posted by Bruce Lehr Feb 16th 2011.
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Fierce Biotech reports on a New York Times feature article that recounts how Big Pharma is currently withdrawing from its previous activity with RNAi therapeutics. The story points out that Roche started the trend publicly last fall with its announced withdraw from the field. But other companies like Abbott, and Pfizer have similarly cut their investment (see here).
Merck-Sirna and Novartis-Alnylam deals have also failed to show much in terms of deliverables though Novartis continues to work targets uncovered in its Alnylam deal but decided not to extend it further. Now Big Pharma companies who were pioneers working with the RNAi innovators are focusing their efforts elsewhere looking for more immediate payoffs. In some cases, RNAi may no longer be the only or even best means to effect certain cellular pathways thus reducing the need to rely on this technology.
It may be many many years before any therapies utilizing RNAi hit the clinics -- and the pioneer RNAi companies may be the ones who will back that play.
Posted by Bruce Lehr Feb 8th 2011.
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Delbiopharm and Marina Biotech will partner on the development of treatments against bladder cancer using Marina's RNAi technology. Delbio will pay $25 M in R&D milestones and Marina will also receive royalties on sales of any therapeutic reaching commericialization.
In additon to bladder cancer, Marina's pipeline has therapies aimed at treating familial adenomatous polyposis and hepatocellular carcinoma. See Fierce Biotech.
Posted by Bruce Lehr Feb 5th 2011.
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Seeking Alpha wrote a piece today about Sangamo's zinc finger nuclease technology as perhaps providing the basis for the next platform technology to do targetted gene manipulation -- which could serve as the means to develop a plethora of new therapies.
Therapeutic areas cover a span from gene therapy and regenerative medicine to more conventional development of protein-based biotherapeutic drugs. Sangamo is in fact pursuing therapeutics to address diseases as disparate as diabetic neuropathy and a "functional cure" for AIDs.
SAFC has a licensing deal for the Sangamo technology to apply it to the development of cell lines - particularly CHO cell lines for the production of biotherapeutic drugs. The ability of ZFNs to knock out, knock in or modify very specific genes of interest is critcally important in this application. It allows SAFC to help pharma and biotech customers alter genes of interest to them to improve the performance of their biotherapeutic production cell lines (platform lines).
Thus cellular properties like enhanced growth, decreased cell death, enhanced proten production can all be altered and manipulated simultaneously with ZFNs. This can lead to the development of a "Super CHO" production cell line. Cell genes that can change glycosylation patterns or produced proteins can also be changed to confer greater clinical efficacy or reduced clearance of the final drug protein. Viral or cellular proteins that might co-purify with the desired protein drug can also be eliminated by use of ZFNs.
SAFC has recently introduced ZFNs to allow customers to alter the dhfr and GS selection marker in their system. ZFNs that affect and control glycosylation are coming this year as well as ZFNs for genes that affect culture productivity and growth. Platform cell lines with either the dhfr or GS knock out will be available and adapted to chemically-defined, animal component free media. These should be available about mid-year 2011.
The technology is very versatile and truly enabling in many new applications -- only a few of which are discussed here.
Posted by Bruce Lehr Feb 1st 2011.
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As covered in the Patent Doc blog, like PhRMA, BIO issued a statement whole-heartedly supporting the President following his State of the Union address calling for support of innovation in biotechnology. BIO emphasized that no American industry is in better position to be a World leader.
BIO called out several areas in which US biotechnology is poised and ready to support the President's agenda of building innovation with some help from Washington.
America is the World leader in biotech and will continue to be so with sustained investment -- and with support of the right goverment policies that encourage investment in biotech.
Posted by Bruce Lehr Jan 28th 2011.
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Nature Methods have picked Zinc Finger Nucleases (ZFNs) as the "Method of the Year" for cell engineering. These tools allow for fast and very selective modification of the genome by knocking out, knocking in or modifying specific genes in a wide varitey of organisms.
SAFC is using ZFNs to modify CHO cells in particular to create platform cell lines that can be used in biopharmaceutical production. The platforms thus created can combine one or more gene modifications in a single platform line - for example a selective marker like GS and a gene controlling glycosylation like Neu-3 - matched to optimized chemically-defined (CD) media and feed sets for an off the shelf production solution. This would also include protocols, validation and application data showing the production of mAbs and non-mAb proteins.
In October 2010, SAFC introduced catalog ZFNs that can modify dhfr and GS in CHO. In early 2011, cell lines with these modifications matched to CD media and feeds will also be available in the catalog offering. We expect that these type of cell lines will be useful to biotechs, CMOs and biosimilar producers for biologic production.
Nature Method article - Download ZFN method of year
Posted by Bruce Lehr Jan 27th 2011.
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Supposedly big upfront money deals in biotech are dead. Somebody forgot to tell Amgen when they purchased BioVex and its OncoVex vaccine for $435 M upfront plus milestones that could run the total purchase price to $1 B. Why?
Xconomy today published an interview with Amgen's Roger Perlmutter, executive vice president of R&D, who is the staunch technical advocate behind the deal, and who explains why the deal was done.
Bottom line: Perlmutter believes the technology works and that it can be used to attack other tumors (cancers). The proof will come with the phase III trial results with both melanoma and head and neck cancer patients. Then it may be Amgen Rolling on the River.
Posted by Bruce Lehr Jan 26th 2011.
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Amgen announced it will acquire BioVex and its promising cancer vaccine for the upfront sum of $425 M plus milestones that could bring the total deal to $1 B. The therapy, OncoVex, is a dual-action, novel cancer vaccine consisting of an engineered virus that will attack and kill cancer cells plus evoke an immune response directed to the same cells.
Analysts noted the size of the upfront payment as being more unusual these days, and further stated that the deal may strongly signal Amgen's continuing intention to invest more in the anti-tumor treatments. "The virus should be generally applicable in tumor settings" said Roger Perlmutter, Amgen's executive vice president of R&D. Oncovax is now in phase III for metastatic melanoma as well as head and neck cancer.
If the trial is successful, it could be the basis to win FDA approval for the first oncolytic virus therapy. Other companies are working on oncolytic therapies - Genesys, Jennerex, Onyx Pharmaceuticals, and Oncolytics Biotech - but none have been approved as yet. Amgen's bet on BioVex may pay off big with a new anti-tumor therapy relatively soon or it may prove to be money washed away on the river. See Xconomy and Fierce Biotech. Posted by Bruce Lehr Jan 25th 2011.
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According to the Patent Doc blog, BIO commissioned a survey who's results [surprise, surprise] support its position on gene patents. The survey was conducted by Public Opinion Strategies of 400 "elite" voters - that is voters with a college degree, a household income of >$75,000 and "who closely follow such matters".
The Survey says:
So expect BIO to use the latter terms in its subsequent rounds of press releases.
Posted by Bruce Lehr Jan 13th 2011.
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Pandemics and drug resistant bacteria afford opportunities for improved treatments for infectious diseases - namely the development of new prophylactic and therapeutic vaccines.
Vaccine Innovations That Will Expedite Access for the Next Generation of Treatments.
For pandemic readiness, there is a need for more effective, shelf-stable and easy to administer (no needles) vaccines for rapid deployment - especially in the developing world. Affordability is also a key requirement. This opens the door for new technology and new methods to improve vaccine production and delivery.
The incorporation of nano-emulsion-based vaccine adjuvants is one possibility to address stability and shelof life issues. Adjuvants have been unchanged in vaccine manufacture for a long time and this is now a budding area where new aduvants ae now being researched and tested in newer vaccines coming to the market -- particularly with some of the cancer therapeutic vaccines in development. But there is not reason to not extend improved adjuvants to other areas of vaccine development. GSK's HPV vaccine recently incorporated the first new adjuvant on the US market in more than 30 years and there is no reason for this type of innovation to be limited.
Posted by Bruce Lehr Jan 5th 2011.
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An team from SAFC's Cell Sciences and Development department, led by Dr. Nan Lin, recently published a paper in Biotechnology Progress profiling microRNAs in parental CHO DG44 and CHO K1 cell lines as well as 4 recombinant DG-44 derived CHO lines producing a recombinant IgG.
MicroRNAs play an important role in global gene regulation and it has been theorized that miRNAs could be useful biomarkers and cell engineering targets for recombinant protein production. More work needs to be done with miRNAs in CHO cells though.
This paper describes miRNAs that were found to be up- or down- regulated in IgG expressing CHO clones as compared to the parental, as well as differences in miRNA expression between the two parental CHO cell types. It is a first step toward potentially using miRNAs in cell engineering.
Posted by Bruce Lehr December 21st 2010.
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SAFC recently added two new CompoZrR Zinc Finger Nucleases (ZFN) as off-the-shelf catalog items to modify CHO cells for biopharmaceutical production. The two new ZFNs will knock out dhfr and GS genes - both of which are useful in selection of recombinant clones of interest. This catalog offer is in addition to services to create custom ZFN products for other genes of interest or custom cell engineering services (CCES) to create modified cell lines.
The offer is intended to enable biopharmaceutical customers to create robust, efficient cell lines, thus allowing them to focus their R&D efforts on developing new therapeutics. The ability to make targeted, heritable changes to genes has already lead to quicker development of knock-out cell lines for biopharm production.
This is an evolving offer at SAFC. The company plans to add new ZFNs targetted to different genes on a regular basis affecting properties like cell production, cell growth, culture longevity, recombinant protein quality (glycosylation), elimination of HCPs or viral elments, etc. Modified CHO K1 clones will also be offered as catalog items soon. The first cell lines will be biallelic knockouts of dhfr and GS with others soon to follow. It is SAFC's intention to offer a CHO cell line platform with optimized chemically-defined medium and feed sets, process instructions and complete validation and application package to support the production of therapeutics. We believe that this wil be interesting to biopharmaceutical, vaccine and biosimilar producers.
For more information on SAFC's ZFN offer visit. For more information on SAFC's Custom Cell Engineering Services (CCES) offer visit.
Posted by Bruce Lehr December 21st 2010.
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As part of the collaboration between SAFC and SartoriusStedim Biotech (SSB), the companies have worked to produce application guides showing rapid and scalable preparation of powdered media and buffers with single-use magnetic mixing systems and the LevMixerR technology.
For media, batch sizes ranged from 50 L to 1000 L and utilized SAFC's Ex-CellTM CHO Fusion and Ex-CellTM EBxR GRO-I formulations. For buffers, sodium citrate, PBS and Tris were used in tests in batch sizes from 50 L to 1000L at various transient concentrations of powders (16 g/L, 73 g/L, 224 g/L) before final dilution. The purpose of the study is to assess the performance of the FlexelR for Magnetic Mixer technology or the LevMixerR to dissolve the test powders.
In this study mixing time to achieve complete product dissolution was determined both by visual inspection and by conductivity measurements. In the case of the media, conductivity measures to determine when the product was completely dissolved is a novel application. Complete study details and results are contained in the reports below.
The study concluded that large volumes of media and buffer solutions were easy to prepare using the combination of SAFC product and the high efficiency mixing provided by the Flexel with Magnetic Mixer technology or LevMixer technology.
Download SAFC SSB Media prep with Magnetic Mixer
Download SAFC SSB buffer preparation single use magnetic mixer
Download SAFC SSB buffer preparation with LevMixer
Posted by Bruce Lehr December 19th 2010.
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Fierce Biotech updates the progress of late stage vaccines that if approved will begin addressing diseases with no current therapies. These vaccines if approved can help eliminate another cohort of diseases and may be blockbusters of the future. The list of vaccine-preventable diseases stands at 26, representing a major advancement in the quality of human health. Thus, one reason the Gates Foundation would like to extend this list.
There are many more vaccines in drugmakers' pipelines that are on course to eradicate some of today's most difficult-to-treat illnesses. In Kalorama Information's report on the future of emerging vaccines, the group estimates that by 2020, emerging vaccines could account for $24.7 billion in new sales up from about $16 B today.
See the emerging vaccines pipeline
Postede by Bruce Lehr November 18th 2010.
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As reported in Medical News Today, the Swedish Initiative - a collaboration between the Royal Institute of Technology in Stockholm and Uppsala University - is half way toward its goal of mapping all 20,000 human proteins. These proteins are being assembled in the Human Protein Atlas.
The Swedish Initiative To Map All Human Proteins Reaches Half-way Point.
The Human Protein Atlas project researchers in Sweden and Asia are able to map between eight and ten proteins each day, and 2,400 every year. The results are made available in a very detailed database which is hosted online for scientists from around the world to access free of charge here.
"Mapping the human proteins makes it possible to fully exploit the results from the human genome project. Together, mapping the human building-blocks at the genome and proteome level has the potential to transform modern medicine. Reaching this half way point is significant for the Human Protein Atlas project as it moves us a significantly large step closer to completion, which we anticipate to be in 2015."
Posted by Bruce Lehr November 16th 2010.
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