Allele Biotechnology & Pharmaceuticals Forming Cell Banking Business for Personalized Medicine

Allele to Generate Human iPS Cells under Good Manufacturing Practice for Private Individuals for Potential Therapeutic Use and Future diagnostics; Cell Banking Scientific Advisory Board formed

October 06, 2015 11:25 AM Eastern Daylight Time
SAN DIEGO–(BUSINESS WIRE)–Allele Biotechnology & Pharmaceuticals, Inc. (“Allele”), a leader in the development of specialized cells for regenerative medicine and pharmaceutical drug discovery, today announced plans to form a commercial business for the banking of human induced pluripotent stem cells (iPSCs) by private individuals.

Allele is pleased to have Drs. Mahendra Rao and Joseph Paulauskis as the first members of its Scientific Advisory Board (SAB) for iPSC banking and cGMP production. Dr. Rao is a world-renowned scientist in the fields of stem cells and medicine, having served as the VP of Regenerative Medicine at Invitrogen, founding Director of the NIH Center for Regenerative Medicine, Chair of the Biological Response Modifiers Committee (BRMAC, now CTAGT) of the FDA, and he is currently Chief Strategy Officer at Q Therapeutics. Dr. Paulauskis is the Chief Operating Officer of Paradigm Dx as well as the Vice-President of Research and Biobanking for the International Genomics Consortium, and has previously held senior positions in pharmacogenomics at Pfizer. Allele plans to make additional appointments to the SAB as individuals with world-class experience and expertise are identified.

Human iPSCs are cells that can be grown to virtually infinite numbers and can become any cell in the human body, features which hold great promise for therapies that can alleviate or cure human disease. Allele’s business model recognizes that an individual can have their own cells ready for future therapeutic use via the generation and storage of iPSCs from that individual’s skin cells. While this is similar to what is done with newborn cord blood, iPSCs can be generated from humans of any age. The banking of human iPSCs for potential future therapeutic use is a relatively new industry with unprecedented potential, and Allele is benefitting from expert opinions internally and from current and future SAB members, ensuring a solid scientific and ethical foundation for this business.

In addition to serving its customers, Allele’s iPSC bank will be an unparalleled resource for biomedical research. Proper consent and privacy guardianship will allow thousands of iPSC lines with accompanying sequence database and health information to be made available from the bank to scientists and clinicians. Currently, iPSC banks are funded by government agencies at multi-million dollar costs per project; Allele’s model does not rely on tax dollars and provides potentially a larger bank of iPSCs of higher quality to aid research and treatment efforts. To this end, NIH Director Dr. Francis Collins recently announced the implementation of the Precision Medicine Initiative (PMI), the goal of which is for health care professionals to have the resources to take into account individual differences in genes, environments, and lifestyles that contribute to disease when providing treatments in the new era.

“We are happy to have the guidance from world leading experts in stem cells, biobanking, and cell therapy fields such as Drs. Rao and Paulauskis”, said Jiwu Wang Ph.D., President and CEO of Allele. “We believe that setting the bar high will be ultimately beneficial to future customers, fellow researchers, industry partners, and regulatory agencies alike. We are happy to see the recent release by the International Society for Stem Cell Research of a draft of ‘Guidelines for the Clinical Translation of Stem Cells’, whose principals we plan to follow closely. We also intend to obtain certification by the cord blood banking association AABB, if possible, and abide by other regulatory rules as they become public, such as the “Stem Cell Clinical Research Management (tentative)” by the Health Commission of China, if and when we move to operate under that jurisdiction”.

Towards the establishment of this business effort, Allele has recently purchased an 18,000 square-foot facility, located near its headquarters in San Diego, California. This new facility will be the center of cGMP-production of human iPSCs using Allele’s proprietary synthetic mRNA platform, a technology that generates cells with neither the random integration of foreign DNA nor the use of viruses or virus-based elements, drawbacks common to other technologies for making hiPSCs; thus, the “footprint-free” cells generated by Allele’s synthetic mRNA platform are optimally suited for therapeutic use, and Allele’s technology has been licensed for clinical trials by companies such as Ocata Therapeutics (formerly ACT). This effort received strong support from Yuan Capital and Yifang Ventures.

About Allele Biotechnology & Pharmaceuticals, Inc.

Allele Biotechnology and Pharmaceuticals, Inc. is a private, San Diego-based company that explores the mechanisms of biological processes to develop technologies and products for biomedical researchers. Allele utilizes proprietary non-integrating cellular reprogramming methods to generate human and non-human primate iPS cells, GMP-grade human iPS cells and their derivatives, and differentiated cell types. With additional expertise in genome modification and cell-based sensors/reporters, Allele provides advanced cell-based assays for drug discovery. Allele also has developed a wide variety of reagents including superior fluorescent proteins and camelid antibodies. The company has also been a leader in the RNAi field with its patents in Pol III promoter-driven siRNA, shRNA, and miRNA.

Contacts
Allele Biotechnology & Pharmaceuticals, Inc.
Matthew A. Singer, Ph. D.
Director of Business Development and Strategic Alliances
+1 858-587-6645, ext. 1
mattsinger@allelebiotech.com
www.allelebiotech.com

Tags: Allele iPSC, cell bank, cGMP, CIRM, GMP, iPSC, Mahendra Rao, NIH, personalized medicine, precision medicine, SAB, stem cell therapy

The NIH is one step closer to be short of $260 million from its 2011 budget

The National Institutes of Health (NIH) 2011 budget will be cut by $260 million in the budget that the House has just passed based on the last minute pact reached last Friday to avoid federal government shut down.

The NIH’s 2011 budget will be $30.7 billion, down 0.8% from its 2010 budget of $30.9 billion, according to news releases that can be found from various sources. Previously, the President proposed a $32.1 billion budget for the NIH and the House of Representatives allocated $29.4 billion to the agency. President Obama asked for a $1 billion increase for the NIH in 2012, which will be in new debate to start immediately. Chances are the 2012 budget for the agency will be less than what the administration wanted.

Combined with “the cliff effect” from the ending of the stimulus money the NIH has epically managed since 2009 to fund extra research projects, the negative growth of the NIH budget could mean less academic positions and tighter lab budgets ahead. Cutting-edge technology and cost effectiveness will be the key for survival of the fittest in the biomedical research jungle.

Promotion of the week: Save 10% on any purchase of feeder cells. Email brianahasey@allelebiotech.com with offer code : FDST11

New Product of the week: Damage-free cloning kit for difficult cloning projects—get recombined plasmids or failed ligation? Your DNA is damaged by purification bugger and/or UV, ask us how to deal with it oligo@allelebiotech.com

Tags: 2011 budget, budget, congressional republicans, federal budget, NIH, President Obama, research budget

Introducing Baculo Virus Expression System (BVES) with a Strong IRES

Internal ribosome entry site (IRES) can be used to initiate translation of a second open reading frame (ORF) of an mRNA, providing the benefits of: 1) avoiding promoter competition in a dual promoter situation; 2) having controlled ratio of expression of two proteins; 3) placing a dominant selection pressure on the entire bicistronic mRNA and hence the maintenance of the transgene when a selection marker is placed as the second ORF.

IRES elements are located mainly in RNA viruses except certain mammalian and insect mRNA molecules. Only one DNA virus has so far been found to contain an IRES, the while spot syndrome virus (WSSV) of marine shrimp. This IRES, compared to a very few other choices known to function in insect cells such as the IRES from Rhopalosiphum padi virus (RhPV), has strong translation initiation activity (~98-99% in reference to cap-dependent initiation), insect cell specificity, and encompasses only 180 base pairs.

Allele Biotech, with its acquisition of Orbigen, is a major provider of BVES products and services with more than 10 years of experience. Allele’s featured New Products of the Week* this week are WSSV IRES containing baculovirus vectors, the sIRES (for Strong IRES from Shrimp virus) series plasmids. Currently one version is pOrb-MCS-sIRES-VSVG for pseudotyping baculoviruses (within the Emerald Baculovirus for Mammalian Expression series), with pOrb-mWasabi-sIRES-VSVG as a fluorescent protein control; the other is pOrb-MCS-sIRES-MCS for cloning a custom second cDNA. New versions in the future will include IRES driven mWasabi and other commonly used selection markers.

With a current research project for the National Cancer Institute (NCI) within the National Institutes of Health (NIH) involving development of modified BVES and mammalian protein expression and purification systems, Allele Biotech expects this product line to continue its expansion at a fast pace.

* Allele Biotech announces at least one new product every Wednesday through news release at AlleleNews or Allele Blog and social networks.

Tags: baculo, baculovirus, BVES, insect cells, IRES, NCI, NIH, Orbigen, ORF, protein expression, translation initiation

Stimulus money at work in labs now

Since signing into law in February, the American Recovery and Reinvestment Act of 2009’s ~10 billion dollar extra funding to the National Institutes of Health has resulted in funding 2,346 projects (or as supplements) so far. There have been several rounds of additional grant applications including the “Challenge” and the “Grant Opportunity” or GO grants, the funding of which will start in the fall. So, if you think you are seeing the leaves on the tree moving, maybe there is a breeze. Better proof for improvement, at least of the mood, of course would be the fact that your PI’s less stiff-looking face when you put in a request for purchasing reagents.

Buzz has it that right now is the hardest time for a postpoc to move on, even though it does not feel that great staying beyond a typical few years in the current lab either. Remember, job market recovery is a delayed action part of any economic recovery. So hold on tight and look ahead.

Companies in the research supply industry, large or small, are inevitably suffering along side with academic labs as well as the drug-aiming biotech industry and R&D centers of pharmaceuticals. Invitrogen (Life Technologies) let go of people in several rounds already. Specialty companies like Glen Research, leading supplier of oligo chemicals, are also shedding employees, it seems. Allele Biotech has not and is not planning to lay off team members, but we have not been able to replace people who recently left or support part-time employees’ level of work as we wanted to.

The ARRA stimulus money through NIH will be a main life line for many of us doing biomedical research in the next few months to a couple of years, depending on how Wall Street and the capital market shape up. The number of grants and total dollars will increase, however slowly it feels. No time to pop the cord yet but at least you can plan on doing that next experiment to get the paper published sooner rather than later, perhaps buying your genotyping kits and miniprep columns from us!

Don’t overlook the deep meaning of Independence Day. Enjoy the day and celebrate our freedom. Happy Independence Day.

Tags: bench work, biomedical job, budget, experiments, funding, graduate students, grants, independence day, July 4th, lower price, NIH, postdoc, researchers, SBIR, wet lab

NIH Challenge Grant, First Released Program Based on the Stimulus Fund

At least 200 million dollars will be channeled through a new, one off mechanism called the Challenge Grants that were designed as jumpstart funds for 2-year projects. The review process will be quicker than normal; the start date will be by the end of September 09. Among the topics are 15 areas designated as Specific Challenge Topics by the NIH, and high priority topics that individual institute such as the NCI added by their choices. For instance, the Clinical Proteomic Technologies for Cancer program, of which Allele is a participant through a cancer marker antibody development project, is running several proteomic related topics that the Challenge Grants will fund.

Many new areas such as iPS, cancer stem cells, and resource development for stem cells are among the selected topics. All domestic institutions, academic or for-profit, are encouraged to apply. This announcement came a couple of weeks after the passage of the stimulus bill, from the NIH that does not yet have a permanent director or a HHS boss, one has to commend it as efficient work with focus. We are expecting that more programs are to come every week here on out until it becomes clear how all ARRA (The American Recovery and Reinvestment Act of 2009 or the stimulus fund) will be spent in the biomedical research field.

Tags: 200 million, Allele, antibody selection, ARRA, Challenge Grants, iPS, NCI, NIH, stem cells, stimulus package