AlloCure (private) Raises $25 million in series B for Cell Therapy in Kideny Disease

Allocure Inc. (Burlington, Mass.) raised $25 million in a series B round. New investor Lundbeckfond Ventures joined existing investors SV Life Sciences and Novo A/S in the round. AlloCure plans to start Phase II testing this summer of AC607 to treat acute kidney injury.

AC607 is a novel biologic therapy under development for the treatment of AKI. AC607 also possesses potential applications in other grievous illnesses. AC607 comprises allogeneic bone marrow-derived mesenchymal stem cells that are harvested from healthy adult donors and then expanded via a mature and state-of-the art manufacturing process. AC607 homes to the site of injury where it mediates powerful anti-inflammatory and organ repair processes via the secretion of beneficial paracrine factors, without differentiation and repopulation of the injured kidney. Importantly, AC607 avoids recognition by the host's immune system, enabling administration in an "off the shelf" paradigm without the need for blood or tissue typing.

The capital just raised will be used to support the next step of clinical development: "Building on the encouraging AC607 Phase 1 results presented last fall at the American Society of Nephrology annual meeting, AlloCure is poised to conduct a multicenter, randomized, double-blind, placebo controlled trial of AC607 for the treatment of AKI beginning this Summer at a number of the leading academic institutions and hospitals in the United States.

Tengion ($TNGN) reports Q4 EPS ($0.26)

Tengion (NASDAQ: TNGN) Reports a Q$ loss of $0.26 with $15.6 mln in cash at year end, enough to fund through Sept. 2012.

Updates on two programs:

1. Neo-Urinary Conduit: Tengion enrolled a fourth patient in its ongoing initial clinical trial of its lead product candidate, the Neo-Urinary Conduit, which is being evaluated in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy).The company plans to discuss with the Data Safety Monitoring board a reduction in the timelines between future patient implants. If granted and assuming appropriate safety data, the company anticipates that it will complete implantation of up to 10 patients by the end of 2012.
2. Neo-Kidney Augment: The company submitted a pre-IND filing to the FDA for its lead preclinical program, the Neo-Kidney Augment, which is intended to prevent or delay the need for dialysis or kidney transplant in patients with advanced chronic kidney disease (CKD).

Following the submission, Tengion's board has authorized the company to aggressively pursue the development of its Neo-Kidney Augment program. Tengion has scheduled a meeting with the FDA to discuss the company's proposed GLP animal study program to support an IND filing.

The company expects to provide an update on its expectations for the clinical trial program in its Q1 2012 financial results announcement in May.

See the full press release: Tengion Reports Fourth Quarter and Full Year 2011 Financial Results

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Tengion (TNGN) : NeoUrinary Conduit

Tengion had a press release earlier today, announcing that they will have several presentations on the company's Neo-Urinary Conduit™ (NUC) and Neo-Kidney Augment™ (NKA) programs at the TERMIS North America Annual Conference now being held (December 11-14), in Houston, TX. Reading the press release tells us that the data set is building for both the NUC and NKA programs. We believe that the market size on the kidney program is off the charts, but acknowledge that the program is still pre-clinical so it’s not a driver for the stock yet.

What we find striking here is the fact that Tengion was a rising star. IPO'd by two of the best healthcare Wall Street firms and since that time, the stock has plunged, now trading at a little over a $10 million market cap with some trading liquidity. According to the September SEC filing, the Company had $9 mln in cash and $11 mln in short term investments versus $1.9 mln ST debt and $3.3 LT debt.

We have seen the NUC device and the technology is impressive. We see a company like Tengion, and fast followers in the space like Organovo as breakthrough technology plays. Perhaps we will see interest from Medical technology companies who are more familiar with the intense surgical procedures and specialized markets for devices that take interest in a product like NUC.

Our View: We would not give up on Tengion here.

See all TNGN articles @ Daily Dose Equities.

Neo-Urinary Conduit: Oral Presentation

• Genetic Stability of Autologous Human Smooth Muscle Cells (http://www.tengion.com/news/documents/Justewicz-SMC-Stability-Tengion-TERMIS-NA-Houston-14Dec11.pdf)
• Characterization of Chemotherapy and/or Radiation Treated Human Smooth Muscle Cells for Use in Regenerative Medicine (http://www.tengion.com/news/documents/Justewicz-Cancer-Secretome-Tengion-TERMIS-NA-13Dec11.pdf)

Neo-Kidney Augment : Oral Presentations

• Selected Regenerative Renal Cells combined with Bioresorbable Natural Biomaterials Catalyze in vivo Kidney Tissue Regeneration (http://www.tengion.com/news/documents/2011-Jain-TERMIS-NA-Presentation.pdf)

• Multivariate Analysis of Preclinical Data from the Tengion Neo-Kidney Augment (http://www.tengion.com/news/documents/Spencer-TERMIS-Presentation_121411_rev2.pdf)