Genetic Engineering & Biotechnology News

OCT1 2016

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.

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8 | OCTOBER 1, 2016 | GENengnews.com | Genetic Engineering & Biotechnology News See Biohybrid Solutions on page 10 Gail Dutton Biohybrid Solutions is pioneering a new ap- proach to bioconjugate production using polymer-based protein engineering. This in- novation allows more control, expands the available polymer library, and minimizes the issues inherent with attaching polyeth- ylene glycol (PEG) to proteins. Polymer- based protein engineering achieves the same outcomes as the more common molecular biology-dependent approach of classic pro- tein engineering. As Biohybrid Solutions co-founder and CEO Alan Russell, Ph.D., says, "Polymer- based protein engineering provides another option to scientists seeking to overcome the challenges of current PEGylation technology." PEGylation, which decorates the surface of protein with PEG, typically reduces a pro- tein's immunogenicity, extends a protein's time in the body, and can improve its solu- bility. PEGylation, however, is not an easily controlled reaction. "You essentially place PEG and proteins together and hope for the best," Dr. Russell explains. "There are few levers available to control and fine-tune the reaction." Although PEGylation is notori- ously difficult to commercialize, there are 10 FDA-approved protein-PEG conjugates currently marketed in the United States. When standard development methods are used, the functionality of PEGylated products also is limited. "It's very difficult to create a dense coating on the protein by reacting an existing polymer with the protein surface," notes Dr. Russell. "Each reaction slows the next reaction, so most PEGylated drugs on the market have few attached PEG chains." Immunogenicity also is becoming an issue. According to Dr. Russell, some peo- ple "are developing an immune response against PEG." To back this assertion, Dr. Russell cites studies that have detected anti-PEG anti- bodies in blood. In a 1984 study, anti-PEG antibodies were found in about 0.2% of people tested. In a 2015 study, they were found in approximately 25% of the 250 people tested. Discovering New Compounds for Drug Development Providing you with techniques and tools necessary to further innovations in early stage screening and drug discovery liebertpub.com/adt Sign Up for TOC Alerts Editor-in-Chief: Andrew D. Napper, PhD Polymer-Based Protein Engineering Outperforms PEGylation, Says Biohybrid Solutions Better Protein-Polymer Hybrids CORPORATE PROFILE > Allergan Buys RetroSense for $60M+ Allergan has acquired RetroSense Therapeutics for $60 million upfront- plus in a deal that adds RetroSense's Phase I/IIa gene therapy candidate for retinitis pigmentosa (RP) to the buyer's eye care pipeline. The gene therapy candidate, RST-001, takes an optogenetic approach to resolv- ing retinal degenerative conditions. It employs the channelrhodopsin-2 gene to create new photosensors in retinal ganglion cells. "The RST-001 program could be a real breakthrough across a host of retinal conditions," David Nicholson, Allergan's chief R&D; officer, said in a statement. > Sunovion to Acquire Cynapsus for $624M Sunovion Pharmaceuticals has agreed to acquire Cynapsus Therapeu- tics for about $624 million. The deal, which would expand Sunovion's central nervous system drug portfolio, includes Cynapsus' Phase III Parkinson's disease candidate APL-130277, a sublingual therapy designed to manage "off" epi- sodes associated with the disease. The deal came just two days after APL-130277 won the FDA's Fast Track Designation. At the time, Cynapsus said its Phase III clinical program was nearing completion, with the compa- ny planning to submit an NDA to the FDA in the first half of 2017. > Novartis Eliminates Cell and Gene Therapies Unit Novartis confirmed that it will elimi- nate its Cell & Gene Therapies Unit by in- tegrating its operations into the broader organization. The change will affect about 120 positions, most of which will be reassigned within the company. Novartis insists that the reorga- nization will not hinder its current gene therapy work, notably its global collaboration with the University of Pennsylvania to develop chimeric antigen receptor T (CAR-T) cells. "An isolated unit worked well under our prior Pharma Division structure," the company noted. "But with a new integrated development model, we can efficiently advance our work on CAR-T as part of our focus in immuno-oncology." n News Industry Watch This 3D structure for a chymotrypsin macro-initiator was derived from a 10 ns molecular dynamics simulation of the structure in water. The ball-and-stick figures depict how a lysine residue and the N-terminus were modified. The image was obtained by Sheiliza Carmali, Ph.D., who used the UCSF Chimera molecular graphics package.

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