Tengion

Tengion, Inc. was a U.S. development-stage regenerative-medicine company established in 2003 to create implantable replacement organs and tissues from a patient's own cells. Its work was organized around an Organ Regeneration Platform intended to produce what the company called neo-organs and neo-tissues. The platform focused on harvesting autologous cells, expanding or preparing them outside the body, and combining them with engineered structures or manufacturing processes designed to support the formation of functional tissue. The company's stated target areas included urologic, renal, gastrointestinal, and vascular diseases and disorders. Rather than operating as a conventional pharmaceutical company with a portfolio of approved medicines, Tengion pursued highly specialized tissue-engineering candidates that would require clinical validation and regulatory review before any commercial launch. Its most advanced disclosed candidate was the Neo-Urinary Conduit, an investigational construct intended for patients who required urinary diversion after removal of the bladder, including some patients with bladder cancer. A Phase I clinical trial was completed at participating health-care institutions, but publicly available information did not report the clinical results. Tengion's scientific program drew on regenerative-medicine work associated with the Wake Forest Institute for Regenerative Medicine and its director, Anthony Atala. The company was initially headquartered in East Norriton Township, Pennsylvania, and later relocated to Winston-Salem, North Carolina, in 2012. It obtained early financing from J&J Development Corporation, HealthCap, and Oak Investment Partners, and became a public company in 2010 through an initial public offering intended to fund research and development. Its common stock traded under the symbol TNGN. The public-company phase was short-lived. In September 2012, Tengion received a NASDAQ notice stating that it had not restored compliance with the exchange's minimum-stockholders'-equity or related continued-listing requirement under Listing Rule 5550(b)(1). Trading on the NASDAQ Capital Market was scheduled to end on September 6, 2012, after which the shares were to trade on the OTCQB tier of the OTC Marketplace. The move reduced the company's access to a major public exchange while it continued to seek resources for its development programs. Tengion ultimately ceased operating as an independent development company. It filed for Chapter 7 bankruptcy in December 2014 and liquidated its assets. In March 2015, creditors and former executives bought back the company's assets, including tissue-engineering samples, through an expedited transaction. Those purchasers subsequently formed RegenMedTX in Winston-Salem. Tengion therefore ended as a defunct regenerative-medicine brand, while some of its assets and technical work continued under a successor organization. No Tengion product received commercial approval according to the cited reference material.

Tengion was founded in 2003 as a development-stage regenerative-medicine company. Its founding financing included support from J&J Development Corporation, HealthCap, and Oak Investment Partners. The business was created around the idea that replacement organs and tissues could be manufactured from cells taken from the intended patient, reducing reliance on donor organs and potentially improving biological compatibility. The company referred to these prospective products as neo-organs and neo-tissues. Its technology program was based on an Organ Regeneration Platform using autologous cells. The intended process involved obtaining a patient's cells and using tissue-engineering methods to develop implantable structures for specific medical applications. Tengion identified urologic, renal, gastrointestinal, and vascular diseases as target areas. The company was not a commercial medical-device or pharmaceutical manufacturer: its candidates remained investigational and would have required successful clinical trials and approval of the relevant marketing applications by the U.S. Food and Drug Administration before they could be sold. The scientific basis for Tengion's work was associated with regenerative-medicine research at the Wake Forest Institute for Regenerative Medicine. Anthony Atala, the institute's director, was identified as a source of core technologies underlying the company's research and development activities. Tengion's initial headquarters were in East Norriton Township, Pennsylvania. In 2012, it moved to Winston-Salem, North Carolina, a location associated with the Wake Forest regenerative-medicine research community. Tengion became a public company in 2010. Its common stock was approved for listing on NASDAQ and the company raised approximately $26 million through its initial public offering. The proceeds were intended to advance research and development rather than support an established commercial product line. Its lead disclosed product candidate was the Neo-Urinary Conduit, an engineered urinary-diversion product intended for patients who required removal of the bladder, including patients with bladder cancer. A Phase I clinical trial was completed at some health-care institutions. The trial ended in December 2014, but the cited public account does not provide its results. The company's public-market position deteriorated during 2012. On September 4, NASDAQ notified Tengion that it had not regained compliance with Listing Rule 5550(b)(1). As a result, its common stock was scheduled to stop trading on the NASDAQ Capital Market on September 6 and to begin trading on the OTCQB tier of the OTC Marketplace. The exchange move occurred while Tengion was still attempting to develop and finance unapproved regenerative-medicine candidates. Tengion eventually became insolvent and discontinued its independent operations. In December 2014, it declared Chapter 7 bankruptcy and liquidated its assets. In March 2015, creditors and former executives bought back the remaining assets, including tissue-engineering samples, through an expedited purchase. The buyers then formed RegenMedTX in Winston-Salem. This transaction marked the end of Tengion as an operating corporate brand, although it provided a route for some assets and technical materials to continue under new ownership. The available reference material does not establish that Tengion obtained regulatory approval for, or commercially launched, any product.

• 2015

  Assets transferred to new owners

  [1]Tengionen.wikipedia.org

  Creditors and former executives acquire Tengion assets and subsequently form RegenMedTX.

• 2014

  Chapter 7 bankruptcy

  [1]Tengionen.wikipedia.org

  Tengion files for Chapter 7 bankruptcy and liquidates its assets.

• 2012

  Headquarters move to Winston-Salem

  [1]Tengionen.wikipedia.org

  The company relocates from East Norriton Township, Pennsylvania, to Winston-Salem, North Carolina.

• 2012

  NASDAQ trading ends and OTCQB trading begins

  [1]Tengionen.wikipedia.org

  After failing to regain compliance with NASDAQ Listing Rule 5550(b)(1), Tengion's shares are scheduled to leave the NASDAQ Capital Market and trade on OTCQB.

• 2010

  Initial public offering

  [1]Tengionen.wikipedia.org

  Tengion becomes publicly traded on NASDAQ and raises approximately $26 million to advance research and development.

• 2003

  Tengion is founded

  [1]Tengionen.wikipedia.org

  Tengion is established as a development-stage regenerative-medicine company with financing from J&J Development Corporation, HealthCap, and Oak Investment Partners.

A development-stage regenerative-medicine company pursuing patient-specific replacement organs and tissues through autologous-cell engineering and its Organ Regeneration Platform.

• Regenerative medicine / urologic tissue engineering

  Neo-Urinary Conduit

  The Neo-Urinary Conduit was Tengion's most advanced disclosed product candidate. It was intended to provide an engineered urinary conduit for patients requiring urinary diversion after total cystectomy, including some patients with bladder cancer. The candidate was based on Tengion's autologous-cell and tissue-engineering approach. A Phase I clinical trial was completed at participating health-care institutions and ended in December 2014. It remained investigational; the cited reference does not report publicly available results or regulatory approval.

• Autologous tissue-engineering platform

  Organ Regeneration Platform

  Tengion's Organ Regeneration Platform was the underlying technology framework for creating patient-specific neo-organs and neo-tissues. It used cells obtained from the intended recipient and was presented as a way to develop replacement structures for urologic, renal, gastrointestinal, and vascular conditions. The platform supported research programs rather than a commercially available product portfolio.

• 2014

  Chapter 7 liquidationOther

  Background

  Tengion was unable to continue operating as an independent development-stage regenerative-medicine company.

  Action taken

  The company filed for Chapter 7 bankruptcy and liquidated its assets.

  Aftermath

  Creditors and former executives acquired the remaining assets in March 2015 and formed RegenMedTX.

  Source

• 2012

  Relocation of headquarters to Winston-SalemStrategy

  Background

  Tengion moved its headquarters from East Norriton Township, Pennsylvania, to Winston-Salem, North Carolina, while developing regenerative-medicine candidates connected to the Wake Forest research ecosystem.

  Action taken

  The company transferred its headquarters and operations to Winston-Salem.

  Aftermath

  The relocation did not prevent later financial distress, delisting from NASDAQ, or the company's Chapter 7 bankruptcy.

  Source

• 2012

  Transition from NASDAQ to OTCQBOther

  Background

  NASDAQ determined that Tengion had not regained compliance with Listing Rule 5550(b)(1).

  Action taken

  Trading on the NASDAQ Capital Market was scheduled to cease on September 6, 2012, with the shares moving to the OTCQB tier of the OTC Marketplace.

  Aftermath

  Tengion continued as a public company outside NASDAQ while pursuing its development programs, but ultimately entered bankruptcy in 2014.

  Source

1. 1Tengionen.wikipedia.org