Tengion

Last updated
Tengion, Inc.
Type Public
Expert Market :  TNGNQ
IndustryBiotechnology
Founded2003
Headquarters,
Key people
David I. Scheer
( Chairman )

John L. Miclot
( Chief Executive Officer, President, and Director )
A. Brian Davis
( Chief Financial Officer, Principal Accounting Officer)

Timothy A. Bertram

Contents

DVM, PhD ( Chief Scientific Officer ) (Dec 31, 2012)
Number of employees
25
Website www.tengion.com [ dead link ]

Tengion, Inc. is an American development-stage regenerative medicine company founded in 2003 with financing from J&J Development Corporation, HealthCap and Oak Investment Partners, which is headquartered in Winston-Salem, North Carolina. [1] Its goals are discovering, developing, manufacturing and commercializing a range of replacement organs and tissues, or neo-organs and neo-tissues, to address unmet medical needs in urologic, renal, gastrointestinal, and vascular diseases and disorders. The company creates these human neo-organs from a patient’s own cells or autologous cells, in conjunction with its Organ Regeneration Platform.

The company declared Chapter 7 bankruptcy in December 2014, and it, along with its assets and tissue engineering samples, have been bought back by its creditors and former executives as of March 2015. The purchase was expedited, so that time-sensitive research can continue. [2]

History

Founded in 2003 and formerly headquartered in East Norriton Township, Pennsylvania before moving to Winston-Salem, North Carolina in 2012, [3] Tengion went public in 2010, after its stock has been approved for listing on the NASDAQ, through a $26 million IPO to help advance its research and development activities. [4] Some of the groundbreaking regenerative medicine technologies of Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, were the core from where those research and development activities developed. [5] [6]

On September 4, 2012, Tengion received a notice from NASDAQ stating that the company had not regained compliance with NASDAQ Listing Rule 5550(b)(1) and that its common stock would cease trading on the NASDAQ Capital Market effective on September 6, 2012, and would begin trading on the OTCQB tier of the OTC Marketplace. [7] The company was bought by former executives and creditors after declaring bankruptcy in 2014.[ citation needed ]

Products

All current Tengion's regenerative medicine product candidates are investigational and will not be commercially available until the completion of clinical trials and the review and approval of associated marketing applications by the Food and Drug Administration.

Product candidates in clinical development

Its most advanced candidate is the Neo-Urinary Conduit. A Phase I clinical trial of the Tengion Neo-Urinary Conduit was completed in some health care institutions, in patients with bladder cancer who require a total cystectomy. The trial ended in December 2014, however information on the results has not yet been made publicly available. [8]

The company also develops the Neo-Bladder Augment, a Phase II clinical trial product for the treatment of neurogenic bladder resulting from spina bifida in pediatric patients, as well as neurogenic bladder resulting from spinal cord injury in adult patients; the Neo-Bladder Replacement to serve as a functioning bladder, eliminating the need for an ostomy bag, for patients who have their bladders removed due to cancer; and the Neo-Kidney Augment to prevent or delay dialysis by increasing renal function in patients with advanced chronic kidney disease.[ citation needed ]

Product candidates not in active development

In addition, it is involved in developing the Neo-GI Augment, a gastrointestinal development program; and Neo-Vessel Replacement, which targets various blood vessel applications consisting of vascular access grafts, arteriovenous, and shunts for patients with ESRD (end stage renal disease) undergoing hemodialysis treatment, as well as for vessel replacement for patients undergoing coronary or peripheral artery bypass procedures.[ citation needed ]

Related Research Articles

An artificial organ is a human made organ device or tissue that is implanted or integrated into a human — interfacing with living tissue — to replace a natural organ, to duplicate or augment a specific function or functions so the patient may return to a normal life as soon as possible. The replaced function does not have to be related to life support, but it often is. For example, replacement bones and joints, such as those found in hip replacements, could also be considered artificial organs.

Organ culture is the cultivation of either whole organs or parts of organs in vitro. It is a development from tissue culture methods of research, as the use of the actual in vitro organ itself allows for more accurate modelling of the functions of an organ in various states and conditions.

<span class="mw-page-title-main">Acute kidney injury</span> Medical condition

Acute kidney injury (AKI), previously called acute renal failure (ARF), is a sudden decrease in kidney function that develops within 7 days, as shown by an increase in serum creatinine or a decrease in urine output, or both.

<span class="mw-page-title-main">Transitional epithelium</span> A type of tissue

Transitional epithelium is a type of stratified epithelium. Transitional epithelium is a type of tissue that changes shape in response to stretching. The transitional epithelium usually appears cuboidal when relaxed and squamous when stretched. This tissue consists of multiple layers of epithelial cells which can contract and expand in order to adapt to the degree of distension needed. Transitional epithelium lines the organs of the urinary system and is known here as urothelium. The bladder, for example, has a need for great distension.

<span class="mw-page-title-main">Hydronephrosis</span> Medical condition

Hydronephrosis describes hydrostatic dilation of the renal pelvis and calyces as a result of obstruction to urine flow downstream. Alternatively, hydroureter describes the dilation of the ureter, and hydronephroureter describes the dilation of the entire upper urinary tract.

Autotransplantation is the transplantation of organs, tissues, or even particular proteins from one part of the body to another in the same person.

<span class="mw-page-title-main">Vesicoureteral reflux</span> Medical condition

Vesicoureteral reflux (VUR), also known as vesicoureteric reflux, is a condition in which urine flows retrograde, or backward, from the bladder into one or both ureters and then to the renal calyx or kidneys. Urine normally travels in one direction from the kidneys to the bladder via the ureters, with a one-way valve at the vesicoureteral (ureteral-bladder) junction preventing backflow. The valve is formed by oblique tunneling of the distal ureter through the wall of the bladder, creating a short length of ureter (1–2 cm) that can be compressed as the bladder fills. Reflux occurs if the ureter enters the bladder without sufficient tunneling, i.e., too "end-on".

The two main methods for replacing bladder function involve either redirecting urine flow or replacing the bladder in situ. Replacement can be done with an artificial urinary bladder, an artificial organ.

<span class="mw-page-title-main">Solifenacin</span> Chemical compound

Solifenacin, sold as the brand name Vesicare among others, is a medicine used to treat overactive bladder and neurogenic detrusor overactivity (NDO). It may help with incontinence, urinary frequency, and urinary urgency.

In biology, explant culture is a technique to organotypically culture cells from a piece or pieces of tissue or organ removed from a plant or animal. The term explant can be applied to samples obtained from any part of the organism. The extraction process is extensively sterilized, and the culture can be typically used for two to three weeks.

Neurogenic bladder dysfunction, or neurogenic bladder, refers to urinary bladder problems due to disease or injury of the central nervous system or peripheral nerves involved in the control of urination. There are multiple types of neurogenic bladder depending on the underlying cause and the symptoms. Symptoms include overactive bladder, urinary urgency, frequency, incontinence or difficulty passing urine. A range of diseases or conditions can cause neurogenic bladder including spinal cord injury, multiple sclerosis, stroke, brain injury, spina bifida, peripheral nerve damage, Parkinson's disease, or other neurodegenerative diseases. Neurogenic bladder can be diagnosed through a history and physical as well as imaging and more specialized testing. Treatment depends on underlying disease as well as symptoms and can be managed with behavioral changes, medications, surgeries, or other procedures. The symptoms of neurogenic bladder, especially incontinence, can have a significant impact on quality of life.

<span class="mw-page-title-main">Anthony Atala</span> American bioengineer and urologist

Anthony Atala is an American bioengineer, urologist, and pediatric surgeon. He is the W.H. Boyce professor of urology, the founding director of the Wake Forest Institute for Regenerative Medicine, and the chair of the Department of Urology at Wake Forest School of Medicine in North Carolina. His work focuses on the science of regenerative medicine: "a practice that aims to refurbish diseased or damaged tissue using the body's own healthy cells".

The Wake Forest Institute for Regenerative Medicine (WFIRM) is a research institute affiliated with Wake Forest School of Medicine and located in Winston-Salem, North Carolina, United States

Urologic diseases or conditions include urinary tract infections, kidney stones, bladder control problems, and prostate problems, among others. Some urologic conditions do not affect a person for that long and some are lifetime conditions. Kidney diseases are normally investigated and treated by nephrologists, while the specialty of urology deals with problems in the other organs. Gynecologists may deal with problems of incontinence in women.

Articular cartilage repair treatment involves the repair of the surface of the articular joint's hyaline cartilage, though these solutions do not perfectly restore the articular cartilage. These treatments have been shown to have positive results for patients who have articular cartilage damage. They can provide some measure of pain relief, while slowing down the accumulation of damage, or delaying the need for joint replacement surgery.

In tissue engineering, neo-organ is the final structure of a procedure based on transplantation consisting of endogenous stem/progenitor cells grown ex vivo within predesigned matrix scaffolds. Current organ donation faces the problems of patients waiting to match for an organ and the possible risk of the patient's body rejecting the organ. Neo-organs are being researched as a solution to those problems with organ donation. Suitable methods for creating neo-organs are still under development. One experimental method is using adult stem cells, which use the patients own stem cells for organ donation. Currently this method can be combined with decellularization, which uses a donor organ for structural support but removes the donors cells from the organ. Similarly, the concept of 3-D bioprinting organs has shown experimental success in printing bioink layers that mimic the layer of organ tissues. However, these bioinks do not provide structural support like a donor organ. Current methods of clinically successful neo-organs use a combination of decellularized donor organs, along with adult stem cells of the organ recipient to account for both the structural support of a donor organ and the personalization of the organ for each individual patient to reduce the chance of rejection.

Avita Medical is a clinical and commercial company developing and marketing a range of respiratory and regenerative products. The first regenerative medicine product brought to the market by Avita Medical was ReCell spray-on skin for the treatment of burns. The two latest products are ReNovaCell, for Aesthetics and Plastic applications including skin trauma, and ReGenerCell for the treatment of chronic wounds. The Avita Medical regenerative product range is currently marketed in Europe, the Middle East, Africa (EMEA) and Australia.

Genital regeneration encompasses various forms of treatment for genital anomalies. The goal of these treatments is to restore form and function to male and female genitalia by taking advantage of innate responses in the body. In order to do this, doctors have experimented with stem cells and extracellular matrix to provide a framework for regenerating missing structures. More research is needed to successfully move the science from laboratory trials to routine procedures.

Mirabegron, sold under the brand name Myrbetriq among others, is a medication used to treat overactive bladder. Its benefits are similar to antimuscarinic medication such as solifenacin or tolterodine. It is taken by mouth.

Regeneration in humans is the regrowth of lost tissues or organs in response to injury. This is in contrast to wound healing, or partial regeneration, which involves closing up the injury site with some gradation of scar tissue. Some tissues such as skin, the vas deferens, and large organs including the liver can regrow quite readily, while others have been thought to have little or no capacity for regeneration following an injury.

References

  1. Health Care Sector Wrap Archived 2012-08-18 at the Wayback Machine , FOX BUSINESS (August 14, 2012)
  2. Craver, R. (2015, March 6). Bankruptcy Court approves offer to buy Tengion. In Winston-Salem Journal. Retrieved August 9, 2015, from http://www.journalnow.com/business/business_news/local/bankruptcy-court-approves-offer-to-buy-tengion/article_748ff1c4-c431-11e4-8b4c-6f6f7a43c3ed.html
  3. Tengion completes move to Winston-Salem Archived 2012-01-20 at the Wayback Machine , Winston-Salem Journal (January 05, 2012)
  4. Tengion Inc., Hoover's
  5. Matt Evans, Tengion plans IPO around Atala’s groundbreaking work, The Business Journal (February 15, 2010)
  6. Anthony Atala: at the cutting edge of regenerative surgery, The Lancet (15 October 2011)
  7. Tengion Common Stock to Begin Trading on The OTCQB™ Tier of the OTC Marketplace on September 6, 2012 [ permanent dead link ], heraldonline.com (September 5, 2012)
  8. Tengion. Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2016 April 10th]. Available from: https://clinicaltrials.gov/ct2/show/NCT01087697 NLM Identifier: NCT01087697.